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STATE OF WASHINGTON
Pharmacy Quality Assurance Commission

Olympia, Washington 98504
December 11, 2015
Regular Scheduled
Business Meeting Agenda- AMENDED
Time:
Location:
Contact:
9:00 a.m.
Highline Community College
Mt. Constance
2400 S. 240 St.
Des Moines, WA 98198
Doreen E. Beebe, Program Manager
Phone: (360) 236-4834
doreen.beebe@doh.wa.gov
In accordance with the Open Public Meetings Act, notices were mailed electronically to individuals who
requested notification of meetings of the Pharmacy Quality Assurance Commission.
Times and Order: The meeting will begin at 9:00 a.m. and will continue until all agenda items are
complete. This agenda is subject to change. Items might not be taken in order of the agenda. Please call
(360) 236-4834 before the meeting date to confirm the meeting agenda.
9:00 a.m.
Call to Order
1.1
1.2
1.3
9:10 a.m.
Approval of Business Meeting Agenda.

Approval of October 29, 2015 Regular Business Meeting Agenda
Approval of October 30, 2015 Special Meeting Minutes .
Action
Action
Action
Consent Agenda
Items listed under the consent agenda are considered routine commission
matters and will be approved by a single motion of the Commission without
separate discussion. If separate discussion is desired, that item will be
removed from the consent agenda and placed on the regular business agenda.
Action
2.1
NPLEx Monthly Report Acceptance
2.2
October 2015
Pharmacies and Other Firm Application Approval
2.3
2.4
Al Linggi, Chair
New and Closed Pharmaceutical Firms Report

Pharmacy Technician Training Program Approval no items
Pharmacy Technician Specialized Functions Approval
a. Seattle Childrens Hospital Tech check Tech
b. MultiCare Medical Center (Tacoma Ge neral) Tech check Tech
c. Providence Holy Family Medication Reconciliation
d. Providence Sacred Heart
i.
Tech check Tech
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2.5
ii.
Medication Reconciliation
Automated Drug Distribution Device Approval
2.6
2.7
2.8
2.9
St. John Medical Center St. John Medical Broadway

Dialysis
Electronic Prescription Transmission System Approval no items
Sample Drug Distribution Approval no items
Tamper Resistant Prescription Paper/Pads Approval no items
Follow-up Report on Routine Remote Medication Order Processing
9:25 a.m.
4.1
Forks Hospital
Legislation
Paula Meyer, Executive Director Nursing Care Quality Assurance
Commission Discuss Commission request legislation for 2016
Information/Action
regarding notification of changes in applicant or licensees criminal

history.
4.2
The Commission is asked to provide feedback on legislation

proposed by the East Asian Medicine Practitioner Association to
amend RCW 69.41.030 to grant authority to purchase, possess, and
administer sterile water, herbs, minerals, vitamins in liquid form, and
nutritional supplements.
10:20 a.m.
5.1
Requests/Proposals
The Commission will consider a proposal by Evergreen Health
Monroe Pharmacy to provide remote medication order processing
services for the detox unit at Evergreen Health Recovery Center, a
licensed health care entity in Monroe.
10:40 a.m.
Break
10:50 a.m.
7.1
Rulemaking, and Committee Reports

The Commission will consider a request for rulemaking by the King
County Citizens Against Fluoridation and Washington Ac tion for
Safe Water to amend WAC 246-883-020 to clarify the designation of
legend drugs.
7.2

County Citizens Against Fluoridation and Washington Action for
Safe Water to adopt a new rule to clarify that fluoridation chemical
additives and fluoridated drinking waters are drugs pursuant to RCW
18.64.011(12), 69.04.009, and 69.41.010(9) when the intended use is
to aid in the prevention, mitigation and/or pro phylactic treatment of
dental caries disease.
Information/Action
Action
Action
Action
11:45 a.m.
Open Forum Morning Session

The purpose of the open forum is to provide the public an opportunity to address the
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Commission on issues of significance to or affecting the practice of pharmacy and that are
not related to topics for which a hearing has or will be scheduled.
Ground Rules: Persons wishing to address the Commission must sign -up in advance.
Speakers will be called forward by the Commission Chair in the order on the sig n-in sheet.
If time permits, all persons signing up will be given an opportunity to speak. Each speaker
is allotted two minutes
12:00 p.m.
Executive Session/Lunch & Case Presentations Closed Session

This time may also be used by the Commission to me et in Executive Session to discuss
personnel issues and pending litigation.
1:00 p.m.
Legislation Contd
4.3
The Commission will be briefed on activities associated with Senate

Bill 5052 the Cannabis Patient Protection Act. The Comm ission is
asked to weigh in on options regarding recommendations to the
Governor and Legislature on the rescheduling or de-scheduling of
marijuana.
Information/Action
4.4
Chris Baumgartner, Program Director will provide an update on

Prescription Monitoring Program.
Information/Action
4.5
The Commission will designate a representative and alternate
Action
member to participate on the weekly Department of Health Meet

Me Call to discuss legislative bills with potential impact to multiple
programs/professions.
2:10 p.m.
Requests/Proposals contd
5.2
2:50 p.m.
The commission will consider the policies and procedures of the

King County Call2recycle Pharmaceutical Waste takeback program
for potential collection sites in pharmacies.
Action
Break
3:00 p.m.
6.1
6.2
New Business
Consent Agenda items placed on the regular business agenda.
Discussion related to correspondence received or distributed on
behalf of the commission.
3:30 p.m.
Action
Information/Action
Characteristics of Complaints - report by Dr. Hecox
Rulemaking, and Committee Reports contd

7.3
Committee Reports
a. Technology Rules Committee
i. Designation of new Committee Chair
b. Pharmacy Business Practice Rules Committee
c. Inspection Process Rules Committee
Information/Action
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d. Pharmacy Compounding Rules Committee
3:50 p.m.
Commission Members Open Discussion and Reports

8.1
8.2
8.3
8.4
4:45 p.m.
5:00 p.m.
The Commission will hold election for 2016 Commission leadership.

Commission Member Reports
Designate Member to represent the Commission on University of
Washingtons School of Pharmacy Curriculum Committee
Commissioners open discussion related to items or issues relevant
to commission business/pharmacy practice.
i. Pharmacy Action Plan
ii. Survey members for special meeting date before 2016 to
discuss priority recommendations for statutory updates.
Staff Reports
9.1
9.2
9.3
9.4
Information/Action
Information/Action
Program/Department
Assistant Attorney General
Pharmacist Consultants
Pharmacist Supervising Investigator
Open Forum Afternoon Session

Speakers will be called forward by the Commission Chair in the order on the sign -in sheet.
5:15 p.m.
Business Meeting Adjourned.

Mission Statement
The mission of the Pharmacy Quality Assurance Commission is to promote public health and safety by
establishing the highest standards in the practice of pharmacy and to advocate for patient safety through
effective communication with the public, profession, Department of Health, Governor, and the
Legislature.
Vision Statement
The Washington State Pharmacy Quality Assurance Commission leads in creating a climate for the
patient-focused practice of pharmacy as an integral part of an accessible, quality based health care
system.
As a result, the citizens of Washingt on State:
Are well informed about medications;

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Take responsibility for their health;

Utilize pharmacists and other health care providers appropriately; and
Experience the highest level of health and wellness.
Next scheduled business meeting:

Time:
Location:
January 21, 2016

9:00 a.m.
Red Lion Hotel - Seattle Airport
18220 International Blvd
Seattle, WA 98188
Accessibility: This meeting is accessible to persons with disabilities. Special aids and services can be
made available upon advance reque st. Requests must be made no later than ten (10) days prior to the
meeting. If you would like general information about this mee ting, please call (360) 236-4834. If you
need assistance with special services, you may leave a message with that request at 1 -800-525-0127 or if
calling outside Washington State call (360) 236-4052. TDD may be accessed by calling the TDD relay
service at 1-800-833-6388. If you need assistance due to a speech disability, Speech -to-Speech provides
human voices for people with difficulty being understood. The Washington State Speech to Speech toll
free access number is 1-877-833-6341. Smoking is prohibited at this meeting.
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State of Washington
Department of Health
Business Meeting Minutes

October 29, 2015
BlackRiver Training and Conference Center
Cedar/Duwamish Rooms
800 Oakesdale Ave. S.W.
Renton, WA 98057
CONVENE
Chair Al Linggi called the meeting to order at 9:03 a.m.
Commission Members:
Al Linggi, RPh, MBA
Dan Rubin MPP, Public Member, Vice Chair
Christopher Barry, RPh,
Guest / Presenters:
Billy Chow, RPh for Bartell Drugs
Amy Pashinski, RPh for Bartell Drugs
Call Center Manager
Steve Anderson, RPh
Keith Koscielski, RPh from Shopko
Sepi Soleimanpour, RPh, MBA-HA

Elizabeth Jensen, PharmD
Maureen Sparks, CPhT
Nancy Hecox, PharmD
Olgy Diaz, Public Member
Judy Guenther, Public Member
Cheryl Adams, PharmD
Gary Harris, RPh,
Pharmacy
Steve Wanaka, RPh Director of Pharmacy
for Seattle Childrens Hospital

Doug Beck, RPh from Schick Shadel Hospital
Absent Commission Member:

Tim Lynch, PharmD
Arun Sambataro, Public Member
Matthew Ronayne, RPh
Staff Members:
Joyce Roper, AAG
Christopher Humberson RPh, Executive Director
Greg Lang, Pharmacy Investigator
Lisa Roberts, RPh. Pharmacy Consultant
Cathy Williams, RPh, Pharmacist Consultant
Doreen Beebe, Program Manager
Siri Thompson, Rules Coordinator
Irina Tiginyanu, Pharmacy Technician Analyst
Leann George, Secretary Senior
Gordon MacDonald, RPh, Chief Investigator
Grace Cheung, Pharmacy Investigator
Doug Beck RPH, from Schick Shadel
CALL TO ORDER
1.1 Approval of Business Meeting Agenda.
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1.2 Approval of September 17, 2015 Meeting Minutes.

MOTION: Elizabeth Jensen moved that the commission approve 1.1. Gary Harris second. MOTION
CARRIED: 12-0.
MOTION: Judy Guenther moved that the commission approve 1.2 with amendments. Chris Barry
second. MOTION CARRIED: 12-0.
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be
approved by a single motion of the commission without separate discussion . If separate
discussion is desired, that item will be removed from the consent agenda and placed on the
regular business agenda.
2.1 NPLEx Monthly Report Acceptance
September 2015
2.2 Pharmacies and Other Firm Application Approval
2.3 Pharmacy Technician Training Program Approval
a. Community Health Care
2.4 Pharmacy Technician Specialized Functions Approval
a. Allenmore Hospital Tech check Tech
2.5 Automated Drug Distribution Device Approval
a. Confluence Acudose
b. Schick Shadel Hospital
c. Seattle Childrens South Clinic
The commission requested that Items 2.3, 2.4, 2.5 (a) be pulled from the Consent Agenda for
further discussion. Items 2.6, 2.7 2.8, & 2.9 were deleted from the consent agenda.
MOTION: Maureen Sparks moved that the commission approve items 2.1, 2.2, & 2.5 (b &
c) on the consent agenda. Dan Rubin second. MOTION CARRIED: 12-0.
Old Business
Bartell Drugs
Cathy Williams introduced Billy Chow and Amy Pashinski from Bartell Drugs. Amy led the
power point providing the required status report for their Call Center that was approved July
2014.
Goals
Targeted workflow balancing throughout our network of stores
Perform and support targeted clinical services
Maintain and/or improve specific store level metrics

Increased time for local staff to perform clinical services as we continue to diversify our clinical
service offerings
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Principal Functions
Transfers less than 10% of store transfers
Direct technician supervision and spot check
Screen replication of call center tech work terminal on display at the call center pharmacist terminal
Workflow Issues
Prior Authorizations
Drug not covered
Staffing at both call center and store level
New Prescription Data Entry less than 5% of store data entry

Q.A. Assessment
Random spot checks logged by call center pharmacist on 1 out of every 10 scripts
Every transferred in prescription will be verified by call center pharmacist before release to
requesting host store
Final verification always conducted by store pharmacist

Challenges
Notification of completed Rx Transfers

Manual notification by call center pharmacist to requesting host store
Store Level Adoption

Initial transition to new model of workflow was difficult for stores
Employment Survey Results
Technician Workflow Data- Entry Benefits

Dispensing - 80%
Paperwork 70%
Expired Medications 55%
Returns 55%
Pharmacist Workflow Activities
Counseling -83%
Immunization 60%
MTM 23%
Travel Consultations 23%
Future
More complex patient case management

rd
3 Party
Specialty Pharmacy
Patient compliance communications
Inception of provider status for pharmacists (2017)
Initial MTM workup, actual CMRs delivered or performed in store by store level
pharmacist
Training and on boarding new staff
98% support continuing the call center because of the value to the stores
Billy Chow said what he learned is he would spend more time in helping employees understand
they didnt need to focus on data entry. Getting them to shift their core focus (mindset) of data
entry, as trivial as it sounds it was significant and took a few months and will help for the future.
There was minimal discussion regarding promise time and having pre-verification turned off
didnt affect anything. Bartell Drugs runs patient surveys all the time.
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MOTION: Christopher Barry moved that the commission approve the report and allow the program to
continue and report back in one year. Sepi Soleimanpour second. Steve Anderson recused himself .
MOTION CARRIED: 11-0.
Review Commission Policy #36

Doreen Beebe led the discussion with the commission regarding the suggested changes to
Commission Policy #36 permitting intern registration for postgraduate participation in residency
or specialized internship programs. She explained the amendments that were made.
Commission and staff discussed some pieces of the language in the Policy that will need more
review and work. Staff will go back make some amendments after listening to the concerns from
the commission.
MOTION: Christopher Barry moved that staff will work with Joyce Roper and make revisions to Policy
#36 and bring back to the December business meeting for commission approval. Elizabeth Jensen second.
Extending 2016 Business Meeting

Chris Humberson led the discussion to confirm the commission is still interested. Also, to
discuss the logistics for extending the business meetings in 2016 to one and one half day with the
intent to dedicating Friday to rule development and other strategic planning. These Fridays are
promised to the ad judiciary courts office for hearings. Each commission member provided Mr.
Humberson their concerns, opinion and whether or not it would work for them.
MOTION: Dan Rubin moved that staff plan for additional meeting time on the Friday after the business
meetings preferably in the morning and preferably in the same location as the business meeting. Steve
Anderson second. MOTION CARRIED: 12-0.
New Business
Joyce Roper discussed the implementation of Engrossed Second Substitute Bill 5052 as it relates
to the Governors veto message directing the department/commission to review and prepare a
report on the rescheduling of marijuana. The Governor vetoed two sections in Second Substitute
Bill 5052, which proposed to remove medical marijuana from Schedule 1 in the states Uniform
Controlled Substances Act, chapter 69.50 RCW . The Department of Health has been instructed
by the Governor to prepare a report in consultation with stakeholders prior to the 2016 legislative
session. The Department has a number of responsibilities under E2SSB 5052 and has staff
working on those responsibilities. That group has offered to undertake the stakeholdering
responsibilities to prepare the requested report. Statutorily, PQAC has the authority to
reschedule controlled substances .
Joyce asked the commission what level of involvement they would like in this process. Nancy
Hecox volunteered to represent PQAC during the stakeholdering process, working with the DOH
staff implementing E2SSB 5052. Elizabeth Jensen, Gary Harris, and Steve Anderson said they
wanted to go on record opposing the rescheduling of marijuana until the federal controlled
substances act is changed. Tim Lynch, who was not present at the meeting but asked it to be
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shown that he also does not support reclassification.

MOTION: Maureen Sparks moved that Nancy Hecox represent and update the commission during the
implementation of this part of Engrossed E2SSB 5052. Judy Guenther second. MOTION CARRIED: 90.
DOH Network via Citrix

Taylor Linke, HSQA Business Practice & Productivity Manager presented information on Health
System Quality Assurance Divisions move to electronic information systems for Boards and
Commissions. We are moving to an electronic information system for all of your official board
business
Phased Implementation
1. Citrix Account Creation
July 2015 - December 2015
2. Business Meeting Materials
January 2016
3. Credentialing Materials
2016
2016
4. Enforcement Materials
Current System:
Email documents to personal or work computers. If these documents are named in a
public disclosure request, personal or work computer could be subject to legal
discovery.
Mail documents to home or office. There have been some cases of lost and mishandled
deliveries.
Print and mail meeting and hearings documents to all participants is costly.
New System:
We will keep the information and files needed to do department-related business
electronically and move them behind the departments firewalls.
We will provide an account (Citrix) to reach those files from home or work computer.
Your program manager, executive director, investigative staff members and legal staff
members will post documents you need to do your work to your personal folder on the
departments network. You will work on and save documents to your folder on the
departments network rather than to your personal or work computer.
You will be able to use any brand of computer, any operating system and any browser.
You will continue to be responsible for your own personal and/or work equipment.
Court Ruling: Declared that government officials have no reasonable expectation of privacy
when using private devices. Information stored on private devices and in private accounts is
subject to public disclosure. The agency desires to establish a method that maintains a record of
all communications with members.
Risk Mitigation: In an effort to mitigate the risks and concerns associated with the transference
of sensitive and sometimes confidential information, Health Systems Quality Assurance (HSQA)
is implementing a secure electronic process to provide a secure method to accomplish the critical
regulatory work statutorily outlined for health professional board, commission, and committees.
Process Improvements:
Reduced costs by eliminating the need to print and mail documentation to health
professional board, commission and committee members.
Established consistency for process and product across programs and regulatory
authorities.
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Process optimization and efficiency to increase capacity for ongoing regulatory work.
Alignment of activities in support of the agency mission.
Today
The commission received Welcome Packets
Demonstration
Ongoing
Citrix User Guide
HSQA Call Center
Recorded Webinar
Expectations
Today Mobile Computing Form
In 7 days Log-In
o Survey
In 30 days NO Personal Email
The commission members were given a chance to ask Taylor questions and discuss concerns.
Taylor encouraged the commission members to contact herself or Doreen Beebe with any
questions, suggestions of methods that would make things better for future and any other input.
New Business
Pharmacy Technician Specialized Functions and Ancillary Utilization Plans

Doreen Beebe led the discussion regarding the concerns brought forward at the September
business meeting on Pharmacy Technician Specialized Functions and Ancillary Utilization
Plans.
With many internal transitions and staff retiring some information during training may not have
been passed on clearly. We rely on what is written in rule. She provided the commission the laws
that apply to AUP and specialized functions. IV admixtures are specialized functions under the
law and should have been placed on the consent agenda for Commission approval.
Prior to the DOH re-org, approval letters were sent, but since the re-org, for some unknown
reason, this practice did not continue. Credentialing staff and PQAC staff agreed they should be
sending approval letters and will work together to reinstitute the process of sending letters of
approval.
Joyce reminded the Commission and staff that under the Yoshinaka and Seymour cases, if the
statute requires the Commission s approval, the Commission cannot delegate that decision to
staff. Staff can review and prepare for the final approval but the commission must be the
approving body.
Some of the issues discussed:
Why would Transcribing orders be in the template AUP
this doesnt happen much, if at all, anymore.
when
It was noted that the sample AUP was approved by
a past board and the current Commission could change the sample to update it to current
practices. There was discussion on how to handle the issue of past AUPs, particularly specialized
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functions, which did not come before the Commission for approval. It was agreed that some
form of communication should be sent out. In addition, the requirement for Commission
approval could delay the opening of new pharmacies if they have to wait for Commission
approval of their AUPs, since our meetings are 6 weeks apart. The question arose about being
able to use a panel of Commissioners to approve the AUPs . Gordon MacDonald asked the
commission and staff to provide written direction on how to handle these during inspections. The
investigators will be given written direction once the commission choses how to move forward.
MOTION: Cheryl Adams moved that Maureen Sparks, Chris Humberson, Irina Tiginyanu and
Doreen Beebe will look into the scope and size of the issue and bring back preliminary
recommendations on how to move forward at the December meeting. They will consult with
Joyce. Secondly, they will develop updated template/guidelines and provide inspectors an
updated guideline on how to handle AUPs while in the field. The commission will have a panel
to review and approve AUPs. Steve Anderson second, Dan Rubin abstained . MOTION
CARRIED: 11-0.
Implementation of Engrossed Substitute Senate Bill 5460

Engrossed Substitute Senate Bill 5460 Section 1
Doreen Beebe put the document up for the commission members to discuss and share their input
and led the discussion on the implementation of Bill 5460. The law adds a new section to chapter
70.41 RCW regarding hospital licensing and regulation. It allows a practitioner in a hospital to
prescribe and distribute a limited supply of pre-packaged emergency medication to patients
discharged from the emergency department (ED) when access to community or hospital
pharmacy services are not available within 15 miles by road or if consistent with hospital policy
the patient has no reasonable ability to access a community or outpatient pharmacy. In
collaboration with applicable hospital staff, the director of the hospital pharmacy must develop
policies and procedures to implement this practice .
The commission discussed and agreed with most of the document and asked for an amendment
first
paragraph in the document.
to add outpatient before hospital pharmacy in a sentence at the beginning of the
MOTION: Dan Rubin moved that the commission authorize staff to proceed with rule making
with the CR 101 process on rules to implement SB 5460, section 1. Nancy Hecox second.
Open Forum
Jeff Rochon WSPA
There was been talk about the need for an appeals process in the inspection process. WSPA
members would like a more formal process to defend inspection results.
Many members are inquiring about the Compounding rules status and what the next steps are.
The board adjourned for Executive Session and Case Presentations at 12:05 p. m.
The board reconvened from Executive Session and Case Presentations at 1:05 p.m.
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New Business Contd

Consent Agenda Items Pulled for Discussion
2.3 Pharmacy Tech Training Program Approval
a) Community Health Care
Chris Barry has a question whether assistants can Return to Stock and it is a specialized
function and asked for this to be clarified. Irina Tiginyanu explained that it means return to a
shelf in its existing bottle.
MOTION: Chris Barry moved to approve 2.3 (a). Maureen Sparks second. MOTION
CARRIED: 12-0.
2.4
Pharmacy Technician
Specialized Functions Approval
a) Allenmore Hospital Tech check Tech
Chris Barry asked about certified technicians arent all technicians supposed to be certified. Do
they have IV Add mixture as a specialized function? Maureen explained they do now.
MOTION: Cheryl Adams moved that the commission approve Allenmore Hospital specialized
function for Tech check Tech 2.4 (a). Elizabeth Jensen second. MOTION CARRIED: 12-0.
2.5

a) Confluence Acudose
Nancy Hecox had a concern that the ADDD override guidelines are 2 and half years old. Cathy
Williams shared that per her request for this information this was given to her. This is the current
policy there will be an update but there wont be any changes.

MOTION: Nancy Hecox moved that the commission approve 2.5 (a). Judy Guenther second.
Cheryl Adams recused herself. MOTION CARRIED: 11-0.
Review Guidelines for Implementing Emergency Substitute House Bill 1625

Chris Humberson shared the developed guidelines with the commission and asked if they had
any input and guidance from the commission. He gave a brief background and Medical Services
program for the implementation of Substitute House Bill 1625.
One suggestion from the commission was to amend the guidelines to say ,
A statement of
responsibility that should read Pharmacy designee shall ensure the pharmacy practices and
complies with all federal and state laws and regulations. Maybe to place this in the first
paragraph that states the purpose.
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MOTION: Chris Barry moved the commission move this document forward with suggested
amendment. Steve Anderson second. MOTION CARRIED: 12-0.
Correspondence:
Chris Humberson discussed a document sent out by Roadrunner Pharmacy it was a letter of
concern by a couple US representatives regarding compounding for pet use. FDA has come up
with guidelines that they should be held to US 797. No further discussion.
Requests
List and Label Request
Cambia Health Solutions asked the commission to recognize them as a professional association to receive
a list for commercial purposes to assist their credentialing department with updating data in their internal
system.
MOTION: Chris Barry moved that panel A deny the request from Cambia Health Solutions as a
professional association. This denial is because they are not a professional or educational
organization. Steve Anderson second. MOTION CARRIED: 4-0.
Shopko
Cathy Williams introduced Keith Koscielski, RPh from Shopko Pharmacy. The commission had
already viewed and reviewed the power point presentation provided to them in the meeting
materials. Keith Koscielski did brief the commission on some of his presentation. Than allowed
for the commission to make comments or ask questions regarding any concerns.
Shopkos Pharmacy Computerized Workflow system is called EPS Workflow. It has the
optional capability to balance and share work between Shopko pharmacies. This system has the
capability to control what tasks are being shared with a sister pharmacy and what tasks need to
be done at the home pharmacy. The goal of the system is to balance and share tasked between
Shopko Pharmacies. The sharing and balancing of task reduces pharmacist workload and
increases patient safety.
As a part of a workload balancing group, pharmacies are currently allowed to share between
them only the Data Entry and Data Verification steps in the process.
Shopko allows only pharmacies licensed within that same state to workload balance with one
another. Within the application Shopko has set up different publishing scopes and retrieval stores
that determine what stores share with what stores. Each state will have their own unique
publishing scope that directs the system to only share pharmacys tasks with other pharmacies
with that same publishing scope.
The concern from the commission was, whether or not the pharmacist that does the final
verification is able to view the hard copy prescription. Yes, this is put in the file via a
photographic image and the pharmacist that does the counseling has the ability to see the
hardcopy. How often does the original prescription show up for the verification process? There
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is an option within the system that can be turned on to allow the pharmacist doing the first
refill the hard copy will be displayed. Is there a setting that can display the prescription for every
refill? Keith wasnt sure but will look into it and turn it on.
MOTION: Elizabeth Jensen moved that the commission approve Shopko requests to implement
workload balancing in its Washington pharmacies, with the contingency that if the system allows
the prescription to be displayed for every refill that it be turned on, if the system only has the
ability to display the prescription on the first refill than that must be turned on immediately.
With a one year follow up. Nancy Hecox second. MOTION CARRIED: 12-0.
Schick Shadel Hospital

Lisa Roberts led the discussion by providing a brief back ground of Schick Shadel Hospital. Schick
Shadel Hospital is a sixty bed hospital that serves as an acute medical detox treatment facility. The
pharmacy is open daily from 0900 to 1730 and employs one full-time pharmacist and three per diem
pharmacists. Currently no pharmacy technicians are employed. The pharmacy would be utilizing their
remote medication order processing vendor during closed hours of pharmacy operations (approximately
16 hours/day). Lisa introduced Doug Beck RPH, from Schick Shadel Hospital.
Since the commission has already viewed the power point for his request to use of remote medication
order processing services Doug Beck offered to answer any questions. He was asked about the
average of orders done after hours. The average number of orders is two. The average range can be zero
to six orders after hours. However, there are times at 2 am intoxicated patients show up. There are about
20 medications on this list. The intent will be to pair that down with Medication Review being able to
evaluate the orders to prevent any dr ug interactions. The full list is in the ADDDs request that was
submitted in the Consent Agenda.
MOTION: Elizabeth Jensen moved that the commission approve Schick Shadel Hospitals
request to use of remote medication order processing services, this motion was amended with a
requirement to report back a written follow-up in one year to include: error reporting by type; specific
outcomes of the quality assurance program; number of any security breaches (if any); number of users in
the system; number of daily transactions including those currently reported; and, feedback from hospital,
medical and pharmacy staff. Nancy Hecox second. MOTION CARRIED: 12-0.
Seattle Childrens Hospital

Cathy Williams introduced Steve Wanaka, RPh, and Director of Pharmacy for Seattle Childrens Hospital
(SCH). Steve asked the commission to approve his requests to use remote medication order processing for
locations specified in its proposal . The current request is to expand this program to allow all SCH
pharmacists at all SCH pharmacy sites (Seattle main campus, Bellevue, and the Seattle Childrens South
Clinic) to perform remote medication order processing for hospital and clinic administered medications.
A question from the commission regarding Narcotics for Patient Specific in the SCH ADDD and how
is it decided when to put a narcotic into the ADDD. Steve shared that this will most likely not come up
but sometime there is a baby who is weening off a narcotic so the hospital will draw these for patient
specific. This is not something that happens in a clinical setting. Steve was asked to explain why 100%
of medications are on override list. It is a contingency that will enable the provider to still provide
Kingsbury0015
medication in a situation where communication between systems may have broken down. This is not to
be used routinely. A comment made from the commission that this is excellent .
MOTION: Chris Barry moved that the commission approve the request for SCH to expand the
use of remote medication order processing for locations specified in its proposal with a written follow up
one year to report back on: outcomes data from the quality assurance program looking at any changes in
error rates; allocation of workload to support clinical activities; and, assessment of staff. Steve Anderson
Committee Reports
Technology Committee
Al Linggi provided an update on the status of the Technology Committee. There have been three
meetings for about two hours each. We have received excellent input from the different market
places on how they currently use these devices and how they would like to use it. Theres been a
lot of work put in from the committee and especially Lisa Roberts. The committee plans to start
the putting this work out there for some stakeholders input. The work is not done but they are
moving forward.
Pharmacy Business Practices Committee
th
The Pharmacy Business Practices Committee met on October 6 to continue discussion concerning Draft
PIC and Shared Accountability Rules . The committee reviewed and engaged in open discussion with the
stakeholders regarding their comment/concerns.
No definitive action was taken by committee members at this meeting it was purely carried out as a way
to discuss the rule proposals and comments with stakeholders and among committee members. The
discussion was very productive and brought forth insights and new ideas into the difficult process of
composing these rules. I would like to thank all the stakeholders for their positive input and support as
well as the committee members who were all physically present at this meeting.
There is a meeting scheduled for October 30, 2015. Well continue open discussion and comment review,
with the focus being WAC 246-869-062 Responsibilities of the PIC. The goal is to wrap up our
preliminary review of the rules proposals and comments without coming to any conclusions as to what
the final draft will actually contain, and begin to transition into the next category of BP rules, Quality
Assurance. QA and inspection are both addressed in the Accountability rules being discussed, so it will
only be possible to compose a final draft when QA is completed by the BPC and the committee writing
the inspection rules nears completion of its work.
Inspection Process Rules Committee

Cheryl Adams updated the commission the status and any work that has been done by the
Inspection process rules committee. At the last PQAC Business meeting, the commission agreed
to combine the two work groups (inspection priorities/ inspection process rule writing). We have
requested and received the reports from the Investigations department. We are in the process of
scheduling our next inspection meeting. The two chairs feel like the committee is too big. There
was a small discussion on the committee size and who should be on this committee. Chris Barry
Kingsbury0016
made it clear he wants to continue to participate in the committee.
Pharmacy Compounding Rules Committee

Chris Humberson updated the commission on where the compounding work is. A second draft
was released by DOH before Brittany Mahung left for maternity leave. The comments are being
collated right now. However, in October USP released a draft revision which is a substantial
change. Chris reached out to the committee members asking them their input on the newly
released draft from USP and the next steps for them. The new draft certainly contains significant
changes but the concern is that it could be a year before the new draft is released by USP .

Sepi Soleimanpour reported:
She attended the technology committee meeting

Participated in a couple long term care meetings
Chery Adams reported:
She was able to participate in a hospital inspection with an inspector

Cheryl attended the tour provided by Laurie St. Ours at a long term care facility and pharmacy
She participated in the redraft of the LTC letter
Attended the WRAPP Training in Tumwater
Cheryl also attended a WSPA Health Systems leadership meeting and tried to update the laws and
rules at this meeting. Thanks to Jeff Rochon who helped her.
Judy Guenther reported:
She attended the long term care facility tour as well

Participated in the WRAPP training in Tumwater
Olgy Diaz reported:
She attended the long term care facility tour

Assisted Cheryl Adams in drafting the LTC letter
Maureen Sparks reported:
She sat in via conference call as a listener to the LTC meetings

Maureen attended an ASHP Pharmacy Technician Training Accreditation visit in Texas
Christopher Barry reported:
He participated in the LTC project
Dan Rubin reported:
He has been working hard and chairing the business practice meetings
He has also been participating in the LTC meetings
Dan attended the LTC facility tour in Yakima with other members
He and Al Linggi met with staff at DOH
Elizabeth Jensen reported:
Kingsbury0017
She took the long term care facility tour

She has attended via conference call the LTC meetings as a listener
Elizabeth has attended the business practice meeting
She will be absent at the December 11, 2015 business meeting she will be moving to a new
pharmacy.
Steve Anderson reported:
Steve attended the meeting of the Oklahoma Board of Pharmacy in Oklahoma City for my
interview with the board to complete my pharmacist license requirements for their state. Their
board members and executive director asked him to convey greetings to the commission and an
open invitation to tour their new building and attend one of their meetings if any of us are ever in
the vicinity. He set in on a significant portion of their meeting, including the open disciplinary
hearings they conduct as part of their agenda. They face exactly the same issues concerning
patient safety as we do.
He attended the business practice meeting in Shoreline and the one in Lynwood.
October 9 and 22
Steve was a panelist on the Pharmacy 500 Professional Identity Panel at the UW SOP for the
incoming class.
th
nd
he attended the webinars for the draft letter to the legislature concerning
LTCFs
rd
October 23 Mr. Anderson taught the Intro to Pharmacy Law class to the first year pharmacy
students at the UW SOP. In that lecture he emphasized notification requirements for interns, so
hopefully we will have at least one class that correctly reports change of address, practice site,
and any brushes with the law.
Gary Harris reported:
He attended the pharmacy business practices meetings
He serves on the UW Campaign as Co-Chair for the School of Pharmacy
Gary held a UW Pharmacy Alumni Association retreat planning session at his home a
nice potluck and social time.
Nancy Hecox reported:
She has participated in the technology committee, assisted with the LTC document, and
attended the pharmacy business practice meetings
Nancy did some research at DOH regarding inspections and complaints. She did put
together a document on her research and contains UDA information.
She did a presentation
on Drug Addiction Medicine for the federal courts here in the

state of Washington. Attendees were Federal Officers, Federal AGs, DOC, probation
officers, and drug court staff.
Al Linggi reported:
He facilitated three long term care meetings

Chaired one Technology committee
Staff Reports
Executive Director
Chris Humberson reported:
Kingsbury0018
He attended a Take Back Summit Day in Lynwood for the morning session . This was a
joint summit including the state as well as Snohomish and King County with many
different interested parties and stakeholders.
Chris also attended a Veterinary Association Meeting in Kent to discuss the FDA
Compounding Guidance for pharmacies for veterinary practice.
He attended most of the committee meetings either in person or on phone

He has also kept up with his monthly meetings with Jeff Rochon at WSPA
A couple meeting with Hospital Association
Participated on legislative work group on opioids in September
Mr. Humberson did a law CE for WSPA for Technician Day in Renton

Joyce Roper reported:
She has been busy with Medical Marijuana integration into the recreational marijuana market.
DOH staff has been conducting rules hearings and stakeholder meetings in three primary areas.
1) Developing a data base which will be voluntary for patients
2) There is going to be a new certification issued by DOH for Medical Marijuana
Consultants
3) Marijuana products safe handling requirements
Joyce and the AAGs for the Veterinary Board of Governors and the Department of Fish and
Wildlife are in consultation on the question of the authority for wildlife rehabilitators who work
in partnership with veterinarians and who are regulated by the Department of Fish and Wildlife to
possess, store and administer drugs for their work as wildlife rehabilitators.
Lisa Roberts reported:
She participated in the LTC conference calls

She attended the Drug Take back Summit in Lynwood for the entire day sponsored by
DEA and Governors Office. This was a very interesting meetings and great ideas.
Lisa has been working with the pharmacy Intern Kyle Wu, today is his last day
E-prescribing update SureScripts sent out a letter by the Monday after the business
meeting in Yakima. She has been working through dozens of programs around 50 of
them at this point.
Cathy Williams reported:
She thanked Lisa Roberts and Chris Humberson for all the support and work they have
done with the Intern Kyle Wu.
Kyle Wu reported:
He has worked on drafting policy brief on USP Compounding draft that came out and he
looked at USP 800.
He spent most of the time working under Chris, Lisa and Cathy to learn about what
pharmacists do.

Gordon MacDonald reported:
Kingsbury0019
Attended the WRAPP Orientation it was very well done. He came away with much
greater appreciation for the WRAPP program.
He gave a Law Presentation to a group of technicians and pharmacists in Spokane

Gordon either listened in or attended most of the committee meetings
Met with Jeff Rochon with Mr. Humberson on a monthly basis
Met with Cheryl Adams regarding the inspection process and some of the challenges the
inspectors are facing.
Grace Cheung reported:
She was assigned investigations only for the past year and half and is happy to be back in
the field.
The main challenge the inspectors face in the field continues to be the gap with unclear
rules or previous decisions that were made in the past compared to the present.
The inspectors really appreciate and need written clarification communication from the
commission so we can all be on the same page. This will allow for clarity for all from the
pharmacies, pharmacist and investigators.
Open Forum
The purpose of the open forum is to provide the public an opportunity to address the Commission on
issues of significance to or affecting the practice of pharmacy and that are not related to topics for which a
hearing has or will be scheduled.
Commissioners open discussion

This is an opportunity for the commission members to openly discuss related to items or issues relevant to
commission business/pharmacy practice.
Cheryl Adams commented about how she really liked the process of asking the stakeholders/public for
comment after each motion.
She asked ifthere is a way to shorten the process ofreviewing ADDDs? Als response is that the
technology committee is working these things out and there really are different uses of these systems.
Most of this is process and we just need to get down to good credible safe process that ensures patient
safety and redundancy when the system doesnt work.

Elizabeth Jensen was thinking that even if something is on the consent agenda she does feel an obligation
to look through all ofthem. The idea ofall the AUPs that will need to be reviewed causes her a feeling of
being overwhelmed.
Dan Rubin mentioned he would like to hear more from public when asked if there were any comments
from the stakeholders/public. He also mentioned a concern about electing new Chair and Vice-Chair and
felt it was a vague process. Chris Humberson and Christopher Barry both suggested that commission
members that are interested in being Chair or Vice-Chair submit their names by Thanksgiving. When the
December Commission Packet goes out the names will appear for the other commission members to
decide on how to vote.
Kingsbury0020
Christopher Barry wanted to discuss the budget the issue was there was no detail in the spread sheet
provided to them and there was a significant difference to the before and after total. Doreen Beebe
explained that the information provided to her is usually detailed. This time due to a system update this
wasnt provided or available. Ifshe is provided the proper report in the interim she would be happy to
share that with the commission. There will be a much more detailed report provided in December.
BUSINESS MEETING ADJOURNED

There being no further business, the board adjourned at 4:45 pm
Respectfully Submitted by:
Leann George, Program Support

Approved December 11, 2015
Al Linggi, Chair
Washington Pharmacy Quality Assurance
Commission
Kingsbury0021
State of Washington

October 29, 2015
Renton, WA 98057
CONVENE
Commission Members:
Al Linggi, RPh, MBA
Guest / Presenters:
Call Center Manager
Steve Anderson, RPh

Nancy Hecox, PharmD
Gary Harris, RPh,
Pharmacy


Tim Lynch, PharmD
Staff Members:
Joyce Roper, AAG
CALL TO ORDER
Kingsbury0022

CARRIED: 12-0.
CONSENT AGENDA
September 2015
Old Business
Bartell Drugs
2014.
Goals

service offerings
Kingsbury0023
Principal Functions
Workflow Issues
Drug not covered

Q.A. Assessment

Challenges



Dispensing - 80%
Paperwork 70%
Returns 55%
Counseling -83%
Immunization 60%
MTM 23%
Future

rd
3 Party
Specialty Pharmacy
pharmacist
Kingsbury0024

the commission.

New Business
Kingsbury0025


business
January 2016
2016
2016
Current System:
discovery.
deliveries.
New System:
authorities.
Kingsbury0026
Today
Demonstration
Ongoing
Citrix User Guide
HSQA Call Center
Recorded Webinar
Expectations
In 7 days Log-In
o Survey
New Business

Plans.
approval.
approving body.
when
Kingsbury0027
CARRIED: 11-0.

first
Open Forum
Jeff Rochon WSPA
Kingsbury0028
New Business Contd

CARRIED: 12-0.
2.4
Pharmacy Technician
2.5



A statement of
Kingsbury0029
Correspondence:
Requests
system.
Shopko
Kingsbury0030


Kingsbury0031
Committee Reports
moving forward.
th

Kingsbury0032





Olgy Diaz reported:


Dan Rubin reported:
Kingsbury0033

pharmacy.
October 9 and 22
incoming class.
th
nd
LTCFs
rd

Al Linggi reported:

Staff Reports
Executive Director
Kingsbury0034


Consultants

them at this point.
Kyle Wu reported:
looked at USP 800.
pharmacists do.

Kingsbury0035

the field.
Open Forum


being overwhelmed.
Kingsbury0036


Al Linggi, Chair
Commission
Kingsbury0037
STATE OF WASHINGTON
October 29- 30, 2015
nd
October 29, 2015
Time:
Location:
Contact:
Amended Regular Scheduled

Business Meeting Agenda
9:00 a.m.
Blackriver Training and Conference Center
Renton, WA 98057
Phone: (360) 236-4834
In accordance with the Open Public Meetings Act, notices were mailed electronically to individuals who requested
notification of meetings of the Pharmacy Quality Assurance Commission.
Times and Order: The meeting will begin at 9:00 a.m. and will continue until all agenda items are complete. This
agenda is subject to change. Items might not be taken in order of the agenda. Please call (360) 236-4947 before the
meeting date to confirm the meeting agenda .
9:00 a.m.
9:10 a.m.
Call to Order
Al Linggi, Chair

Action
Consent Agenda
Items listed under the consent agenda are considered
routine commission matters and will be approved by a
single motion of the Commission without separate
discussion. If separate discussion is desired, that item
will be removed from the consent agenda and placed on
the regular business agenda.
Action
Action
September 2015
Kingsbury0038
2.6
2.7
2.8
2.9
9:30 a.m.
10:00 a.m.

Follow-up Report on Routine Remote Medication Order
Processing -no items
Old Business
Review of items or issues relevant to past or ongoing commission
business.
3.1 Bartell Drugs - Call Center status report
3.2 Review suggested changes to Commission Policy #36 permitting
intern registration for postgraduate par ticipation in residency or
specialized internship programs. The proposed adds reporting
criteria into the policy.
3.3 Commission will discuss the logistics for extending the business
meetings in 2016 to one and one half day with the intent to
dedicating Friday to rule development and other strategic
planning.
New Business
4.0 Discuss the implementation of Engrossed Second Substitute Bill
5052 as it relates to the Governors veto message directing the
department/commission to review the rescheduling of marijuana.
4.1 DOH Network via Citrix - Information on Health System Quality
Information/action
Information/action
Information/action
Information/Action
Information/Action
Assurance Divisions move to electronic information systems for

Boards and Commissions.
10:59 a.m.
Break
11:10 a.m.
New Business Contd

4.2 Pharmacy Technician Specialized Functions and Ancillary
Utilization Plans.
4.3 Discuss the implementation of Engrossed Substitute Senate Bill
5460 Section 1- Emergency Medications Prescription and
Distribution
11:45 a.m.
Action
Action

The purpose of the open forum is to provide the public an opportunity
to address the Commission on issues of significance to or affecting th e
practice of pharmacy and that are not related to topics for which a
Ground Rules: Persons wishing to address the Commission must
sign-up in advance. Speakers will be called forward by the
Commission Chair in the order o n the sign-in sheet. If time permits, all
persons signing up will be given an opportunity to speak. Each
speaker is allotted two minutes
2
Kingsbury0039
12:00 p.m.

This time may also be used by the Commis sion to meet in Executive Session to discuss
1:00 p.m.
New Business
Contd
4.4 Discuss Consent Agenda items placed on the regular business

agenda.
4.5 Review guidelines developed by the Emergency Medical Services
4.6 Discuss any correspondence received or distributed on behalf of
the commission.
2:00 p.m.
Requests
5.1 List and Label Request Cambia Health Solutions is seeking
recognition as professional association to receive a list for
commercial purposes to assist their credentialing department with
updating data in their internal system.
5.2 Shopko requests approval to implement workload balancing in its
Washington pharmacies.
2:40 p.m.
Break
2:50 p.m.
Requests Contd
5.3 Schick Shadel Hospital requests approval for use of remote
medication order processing services.
5.4 Seattle Childrens Hospital Pharmacy requests to use remote
medication order processing for locations specified in its
proposal.
3:15 p.m.
3:40 p.m.
Action
Information/Action
Action
Action
Action
Action
Information/Action
Committee Reports
6.1
6.2
6.3
6.4
Action
Technology Rules Committee

Pharmacy Business Practice Rules Committee
Commission Members
Open Discussion and Reports
Information/Action
7.1 Commission Member Reports

7.2 Commissioners open discussion related to items or issues
relevant to commission business/pharmacy practice.
4:30 p.m.
Staff Reports
Information/Action
8.1 Executive Director

8.2 Assistant Attorney General
3
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8.3 Pharmacist Consultants

8.4 Pharmacist Supervising Investigator
4:45 p.m.

to address the Commission on issues of significance to or affecting the
Commission Chair in the order on the sign -in sheet. If time permits, all
5:00 p.m.

Mission Statement
The mission of the Pharmacy Quality Assurance Commission is to promote public health and safety by establishing
the highest standards in the practice of pharmacy and to advocate for patient safety through effective
communication with the public, profession, Department of Health, Governor, and the Legislature.
Vision Statement
The Washington State Pharmacy Quality Assurance Commission leads in creating a climate for the patient-focused
practice of pharmacy as an integral part of an accessible, quality based health care system.
As a result, the citizens of Washington State:

Special
October 30, 2015
12:00 p.m.
Time:
12:00 p.m.
Location:
Kent Commons
220 Fourth Avenue South Room: Crystal Mountain
Kent WA 98032
Contact:

Phone: (360) 236-4834
Call to Order
Communication Plan the Commission will discuss Communication
Plan for the Pharmacy Quality Assurance Commission prepared by
Al Linggi, Chair
Informaton/Action
Kingsbury0041
Marie Sullivan on behalf of the Health Systems Quality Assurance

Division of the Department of Health. Strategic Planning
December 11, 2015
Time:
9:00 a.m.
Location:

Mt. Constance
2400 S. 240 St.
Accessibility: This meeting is accessible to persons with disabilities. Special aids and services can be made
available upon advance request. Requests must be made no later than ten (10) days prior to the meeting. If you
would like general information about this meeting, please call (360) 236-4947. If you need assistance with special
services, you may leave a message with that request at 1-800-525-0127 or if calling outside Washington State call
(360) 236-4052. TDD may be accessed by calling the TDD relay service at 1-800-833-6388. If you need assistance
due to a speech disability, Speech -to-Speech provides human voices for people with difficulty being understood.
The Washington State Speech to Speech toll free access number is 1-877-833-6341. Smoking is prohibited at this
meeting.
Kingsbury0042
Marijuana Scheduling
In Response to the Governors Directive
Stakeholder Input Session:
November 20, 2015 - Tumwater
Kingsbury0043
Objectives for this Session

1. Provide information about the veto
section of SB 5052 and the Governors

instructions to the department.
2. Discuss three options for marijuana
scheduling in Washington State.

3. Collect stakeholder feedback before
presenting a report to Washington State

Pharmacy Quality Assurance Commission.
Kingsbury0044
Agenda
Handouts
Guidelines
History of Marijuana Laws

Governors Directive
Overview of Three Options

Stakeholder Input
Wrap Up, Next Steps
Kingsbury0045
Guidelines for Participants

This is a public meeting and everyone is
welcome.
Since this is a public meeting anything
shared has the potential to be part of

public record.
The intent is for everyone to be respectful
of all parties present.

Kingsbury0046
1970 - 2015
Kingsbury0047
Federal Law
Members of Congress initially categorized cannabis as
a Schedule I substance, the most restrictive
classification available, in 1970.
Under this categorization, the plant is defined as
possessing:
a high potential for abuse, have no currently accepted

medical use in treatment in the United States, and
there is a lack of accepted safety for use of the drug or
other substance under medical supervision.
Kingsbury0048
Washington Law: I-692

Granted an affirmative defense to criminal
prosecution to qualifying patients and their primary
caregivers.
The patient was required to have a recommendation
from a healthcare practitioner and could possess no
more than a sixty-day supply of marijuana.

The initiative, codified as chapter 69.51A RCW, was
amended many times over the years.
Kingsbury0049

Legalizes the purchase and possession of
small amounts of marijuana for all adults.

It also created a taxed and highly regulated
system for the production, processing and

retail sale of marijuana.
Kingsbury0050
Washington Law: SB 5052

Beginning July 1, 2016, SB 5052 the Cannabis Patient
Protection Act will further protect the medical use of

marijuana for patients and designated providers who are
entered into the patient authorization database.
Patients and designated providers who choose not to be
entered in the database will continue to have an affirmative

defense to criminal prosecution.
The medical use of marijuana remains illegal at the federal
level despite a certain level of tolerance conditioned upon

having appropriate regulations in place.
Kingsbury0051
SB 5052: Sections 42 & 43

Remove from Schedule I of our states Controlled
Substances Act any medical marijuana product that
identifies in rule as appropriate for sale to qualifying
patients and designated providers in a retail outlet
that holds a medical marijuana endorsement.
Kingsbury0052
Instructions to the
Thoroughly consider this idea in consultation
with medical professionals and stakeholders,
and bring an appropriate resolution to me and
the Legislature by next year.
Kingsbury0053
Kingsbury0054
Option 1: Do Nothing at this Time

Does not require any changes to WA state laws
or rules.
Keeps WA Controlled Substances Act (WCSA)
aligned with federal law.

Ensures healthcare practitioners controlled
substance prescriptive authority is not put at risk.

Until the laws are changed, marijuana is still federally
illegal despite any changes made to WA state law.

The WCSA conflicts with 69.51A RCW.
Kingsbury0055
Option 2: Reschedule Marijuana to II-V or Legend

Conflicts with I-502s recognition and legalization of
recreational use of marijuana.

Makes medical marijuana subject to all the requirements of
any other prescription drug.
If treated like other prescription drugs, growing for personal
use would not be allowed.
Creates a direct conflict with federal law and WAs law:
Healthcare practitioners couldnt prescribe it.
Prescribing of marijuana may place prescribers federal
Drug Enforcement Agency registration at risk.
Marijuana would have to be dispensed through a
pharmacy, which conflicts with WA law.
Kingsbury0056
Option 3: De-Schedule When Used Within

Parameters of I-502 and SB 5052
Requires extensive changes to Washington law.
Marijuana would be able to be purchased by adults in
much the same way as alcohol and tobacco.

New penalties would have to be created to address law
violations.
Marijuana could continue to be authorized by
healthcare practitioners without risk.
Though not in compliance with federal law, WA State
would still have a tightly regulated system that focuses
on enforcement priorities.
Kingsbury0057
Limited time for comments
Kingsbury0058
Methods of Collecting Input

1. Verbal comments limited time
2. Individually written comments via worksheets

3. Comments collected from webinar participants
4. Comments emailed to department
medicalmarijuana@doh.wa.gov
Kingsbury0059
Verbal Comments
Each individual will have the opportunity for
limited input on each option.

Input must stay on topic and be related to the
three options presented or a proposed option

for scheduling of marijuana.
A note-taker will be summarizing the themes of
what were hearing and share on the web site.
Kingsbury0060

or rules.



Kingsbury0061


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violations.
Kingsbury0063
Wrap Up, Next Steps

What happens next?
Where can we find a summary
of comments received?
Thank you
Kingsbury0064
Contact Information
Website
www.doh.wa.gov/MedicalMarijuana
Email
ListServ
MEDICALCANNABIS@LISTSERV.WA.GOV
Phone
360-236-4819
Kingsbury0065
Patient Safety Quarterly

February 201 6
Executive Editor, Trina
Castle
Managing Editor, Gordon
MacCracken
Table of Contents
Prescription pain reliever
deaths down, heroin deaths
up
Medical marijuana rules on
track for July 1
implementation
Programs help impaired
practitioners get back on
track
Carbon Monoxide Poisoning
Prevention
Prescription pain reliever deaths down,

heroin deaths up
Prescription pain reliever overdose deaths in
Washington continued to decline in 2014, but an
ongoing increase in heroin-caused deaths led to little
overall change in the states opioid-related death total.
Prescription drug overdoses killed 319 people in
Washington during 2014, Washington State
Department of Health figures indicate. Thats down

from 381 in 2013. Such deaths spiraled from 24 in
1995 to a peak of 512 in 2008 before beginning a
continuous year-to-year decline. The highest
prescription drug overdose death rate is in the 45- to
54-year-old age group.
Heroin deaths in Washington rose from 227 in 2013 to
293 in 201 4. Thats nearly double the 201 0 total of

150. The largest increase in heroin overdose deaths is
in the 15- to 34-year-old age group, which corresponds
with age group trends in overall heroin use. Heroin use
has increased as its availability has spread and
because its less expensive than prescription pain relievers.

Overall, opioid-related deaths in Washington rose slightly from 608 in 2013 to 612 in
2014. The top figure for such deaths was 658 in 2008.
Although some parts of the trend may be favorable, overdose deaths remain a problem
in Washington. By way of comparison, motor vehicle traffic deaths took 545 lives in
Washington during 2014, fewer than died as a result of overdoses.
Researchers see a link between heroin and misuse of prescription pain relievers, many
of which contain potentially addictive medications classified as opioids. Hydrocodone
and oxycodone fall into this category. Many heroin users misused opioids first,
research indicates, and many drug users take both heroin and opioids.
Kingsbury0066
The departments Prescription Monitoring Program allows practitioners to track their

patients controlled substances prescriptions, thus reducing the chances of patients
receiving multiple or inappropriate prescriptions. In addition, prescribers must follow
pain management rules designed to reduce the potential for dependence and abuse.
Prescribing guidelines (updated June 2015), education and Medicaid efforts are also
involved in battling a prescription drug abuse epidemic that dates back to pain
management changes in the 1990s.
Naloxone/Narcan, an overdose antidote, is available. Opioid users and their friends or
family members can get prescriptions. Its also available directly from pharmacies in
some parts of Washington.
Medical marijuana rules on track for July 1 implementation

With passage of the Cannabis Patient Protection Act in 2015 (2SSB 5052), the
Department of Health is working to adopt rules starting July 1, 2016, to ensure highquality, safe products are sold to patients. The department is focusing on rules for
three aspects of the law, which was codified into chapter 69.51A RCW. They are
product compliance standards, developing a medical marijuana authorization
database, and a certification program for the medical marijuana consultant.
The department is committed to working with key stakeholders in the community to
ensure that the rules meet their needs while keeping with the intent of the law. Our
web pages, ListServ, and customer service email and phone line have allowed the
public to stay on top of our activities. Recently, the department has completed the
following:
Product Compliance
The proposed medical marijuana product compliance rules were filed on February 17,
2016, with public hearings scheduled for March 22 in Spokane and March 25 in
Tumwater.
The official logo to be used by those producers and processors who follow the
departments product compliance rules have been developed. Instruction for use will be
accessible on the medical marijuana web pages.
Medical Marijuana Authorization Database

The proposed medical marijuana authorization database rules were filed on February
17, 2016, with public hearings scheduled for March 22 in Spokane and March 25 in
Tumwater.
The department has contracted with a database administrator, CloudPWR. We are
working closely to incorporate all requirements needed for authorization card
administration and system access to ensure the system is up and running by July 1,
2016.
Medical Marijuana Certified Consultant
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The department held the public hearing for the medical marijuana certified consultant
rules on January 26, 2016. The expected effective date of the rules is April 1, 2016. This
will allow two months for those wanting to apply to be a certified consultant to attend the
approved training and to send in an application.
The goal is to have the application packet for those educational entities who want to
offer the training program available in mid-March. This should allow the department time
to review and approve those programs that meet the requirements and to have training
options available in April.
Governor Requested Reports

In addition to the rules, the department has been working on two reports requested by
the Governor within 2SSB 5052:
Medical Marijuana Specialty Clinics
Section 41 of requires the Department of Health (department) to develop

recommendations on establishing medical marijuana specialty clinics that would allow
for the authorization and dispensing of marijuana to patients of health care
professionals who work on-site of the clinic and who are certified by the department in
the medical use of marijuana. The department does not support establishing medical
marijuana specialty clinics in Washington at this time for the following reasons:
Health care practitioners cannot legally prescribe or dispense schedule I controlled

substances and would potentially risk criminal prosecution, as well as civil and financial
liability.
Injured patients may be left without an adequate remedy if malpractice does occur.
Further research using accepted scientific protocols is needed.
Significant changes to existing licensing laws for commercial marijuana would be

needed. Without such changes, practitioners at specialty clinics would not be able to
access the marijuana they would later dispense to patients, which could present issues
with supply.
Instead, the department recommends that individual practitioners become, to the
extent possible given limited scientific research, educated and knowledgeable about
the risks and benefits of the medical use of marijuana so they can provide their
patients with accurate information and safe, competent care. This report is available on
the medical marijuana web page.
Scheduling of Marijuana
The Governor vetoed Sections 42 and 43, which would remove from schedule I of
Washington States Controlled Substances Act any medical marijuana product the
Department of Health (department) identifies in rule as appropriate for sale to

qualifying patients and designated providers in a retail outlet that holds a medical
marijuana endorsement.
In his veto message, the Governor noted that rescheduling just medical marijuana
may cause serious problems such as having the unintended effect of limiting the types
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of marijuana that are considered medicine. Therefore, he directed the department to

thoroughly consider this idea in consultation with medi cal professionals and
stakeholders, and bring an appropriate resolution to me and the Legislature by next
year.
The department held a stakeholder meeting, collected public comment and presented
implications of several options to the Pharmacy Quality Assurance Commission for
input. The report is being reviewed by the Governors office prior to its release to the
Legislature.
Recent legislation changes medical marijuana law; improves patient safety

From 1998 when the medical use of marijuana was first authorized by Washington
State voter Initiative 692 to today there have been multiple legislative changes.
Washington voters passed Initiative 502, in November of 2012, legalizing the purchase
and possession of small amounts of marijuana for all adults. It also created a taxed
and highly regulated system for the production, processing and retail sale of marijuana.
In 2015, the Legislature reconciled the medical and recreational markets with the
passage of 2SSB 5052 the Cannabis Patient Protection Act - and HB 2136.
Beginning July 1, 2016, the changes to chapter 69.51A RCW created by 2SSB 5052
will integrate the medical market with the regulated market put in place under I-502.
The primary goals of the Act are to clarify what is meant by the medical use of
marijuana, and to:
Bring medical marijuana products under the same regulations in place for recreational
use to ensure a safe, adequate and consistent supply, and thus better protect qualifying
patients.
Allow for tax breaks for medical marijuana patients who are entered into the
authorization database.
Provide protection from arrest and prosecution for patients who are entered into the
authorization database.
Under the act, the Department of Health is directed to adopt product compliance rules
regarding marijuana products sold to patients; create a medical marijuana
authorization database; and develop a certification program for the Medical Marijuana
Consultant that will be required in each licensed retail store when the law goes into
effect on July 1, 2016.
The primary goals of the Act are to clarify what is meant by the medical use of
marijuana, and to:
The Medical Marijuana website has been updated to provide key information and
continues to be the best place to get the latest on our progress in implementing the law.
A standard authorization form has been developed.
An online method has been implemented so practitioners who authorize more than 30
patients in a month can report that as required.
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Emergency product rules were filed on October 5, 2015.

Rulemaking stakeholder meetings have been held for the authorization database,
consultant certificate and product compliance.
The successful vendor for the authorization database has been chosen and contract
negotiations are complete.
Drafted two required reports. One relating to specialty clinics and the other to consider
the current scheduling of marijuana as a controlled substance.
We continue working on rulemaking activities, implementing the authorization
database and preparing licensing processes for the consultant certificate and the
consultant training programs.
Programs help impaired practitioners get back on track

Alternative-to-discipline programs sometimes called impaired practitioner programs
were developed in the early 1980s to address the issue of alcohol or other substance
use disorders among nurses, but soon expanded to include other healthcare
professions. These programs are designed to encourage health professionals to seek
help before their substance use results in patient harm or avoid disciplinary action and
potential loss of their credential.
These programs goal is to allow a return to practice under strict guidance and
supervision that ensures public safety and holds the healthcare professional
accountable. To date, 41 states, the District of Columbia, and the Virgin Islands have
such programs. Washington has four such programs available to virtually all
Department of Health-credentialed healthcare providers.
Washington Physicians Health Program (WPHP) provides services to physicians,
osteopaths, physician assistants, veterinarians, and dentists. Washington Recovery
Assistance Program for Pharmacy (WRAPP) serves all pharmacy professions. Nursing
professions are served by Washington Health Professional Services (WHPS).
Washington Recovery and Monitoring Program (WRAMP) provides service to all
credentialed healthcare professionals not covered by the other programs.
Prospective participants can enter such programs through voluntary self-referral, as an
alternative to credential discipline, or as part of a disciplinary process.
No matter what the profession or the reason for entering a program, all participants
first complete a thorough substance use evaluation from a licensed behavioral
healthcare facility. This evaluation becomes the basis for determining if a person is
appropriate for a monitoring agreement and, if so, the length and terms of participation.
No matter what the profession or the reason for entering a program, all participants
first complete a thorough substance use evaluation from a licensed behavioral
healthcare facility. This evaluation becomes the basis for determining if a person is
appropriate for a monitoring agreement and, if so, the length and terms of participation.
Typically, monitoring agreements consist of participation in substance use disorder
treatment (if recommended); random alcohol and drug screening; participation in
community-based recovery support meetings, such as Alcoholics Anonymous,
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Narcotics Anonymous, Celebrate Recovery, Smart Recovery, etc.; practice monitoring;

and participation in a professionally-facilitated peer support group. Depending upon the
profession, there may be practice restrictions, such as no access to controlled
substances for a period of time.
Once people begin monitoring, they are required to check in daily online or via phone
to determine if they are required to complete a drug test. Participants are randomly
tested between 12 and 24 times per year, and may incur additional tests for missed
check-ins or any time there is reasonable suspicion of unauthorized substance use.
Two episodes of unauthorized substance use will result in discharge from the program.
Along with recovery-oriented meetings in the community, professional peer support
groups provide an opportunity to meet with other participants in the program under the
guidance of a professional facilitator to discuss issues affecting their recovery.
Participants who are working under their healthcare credential need to have a worksite
monitor (usually their direct supervisor) who submits monthly reports on the persons
progress. If there is an episode of unauthorized substance use while working,
participants agree to cease healthcare practice immediately and not to return to work
until they have been re-evaluated.
In addition to monitoring participants, program staff members provide outreach to
healthcare providers, substance use treatment facilities, professional associations,
boards and commissions, schools, and any other group wanting education about
addressing substance use in the workplace.
If you would like more information about these programs, please contact them directly.
Washington Physicians Health Program206-583-0127
Washington Recovery Assistance Program for Pharmacy360-629-9719
Washington Health Professional Services360-236-2880 (Option 1)
Washington Recovery and Monitoring Program360-236-2880 (Option 2)
Carbon Monoxide Poisoning Prevention

When power outages occur after severe weather (such as high winds and flooding),
using alternative sources of power can cause carbon monoxide (CO) to build up in a
home, and poison the people and animals inside. If you dont have electricity:
Never use a charcoal or gas grill in an enclosed space, such as inside your home,
garage, or in a tent or camper.
Don't burn charcoal in your fireplace. A charcoal fire will not create a chimney draft
strong enough to push the carbon monoxide to the outside.
Never use a generator inside your home, garage, carport, basement, or near an outside
window, door, or vent. One gas-powered generator can produce 100 times more carbon
monoxide than a cars exhaust. Generators should be at least 20 feet away from
buildings. Even at 20 feet away, air flow patterns could still blow carbon monoxide into
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homes through attic vents, windows, or doors, so it's very important to have a working
carbon monoxide detector inside the home.
Never use a gas range or gas oven to heat your home.
Never sleep in a room while using an unvented gas or kerosene heater.
Every year, at least 430 people die in the U. S. from accidental CO poisoning.
Thousands of others are treated in emergency rooms.
Carbon monoxide, often referred to as the invisible killer, is an odorless, colorless
gas that can enter your home through a number of ways -- leaky chimneys, furnaces,
gas water heaters, wood stoves, gas stoves, fireplaces, ovens, clothes dryers, portable
generators, lanterns, grills, vehicles running in attached garages, and cigarette smoke
(first- or secondhand). CO poisoning symptoms include headaches, nausea,
confusion, memory loss, fainting, and chest pains. CO poisoning can lead to death in
both people and animals. People who are sleeping or who have been drinking alcohol
can die from CO poisoning without waking.
The most important thing you can do to prevent CO poisoning is to properly install and
maintain CO detectors in your home, particularly near bedrooms. Never use alternative
means, such as ovens, grills, gas- or propane-powered devices to heat inside your
home.
Other important carbon monoxide poisoning prevention tips:
Change the batteries in your CO detector according to the m anufacturers directions. If
you don't have a battery-powered CO detector, buy one soon. In Washington State they
are required by law in new homes, in homes being sold, and in apartment units.
Never leave the motor running in a vehicle parked in an enclosed or partially enclosed
space, such as a garage.
Never run a motor vehicle, generator, pressure washer, or any gasoline-powered
engine within 20 feet of an open window, door, or vent where exhaust can vent into an
enclosed area.
Never use a charcoal grill, hibachi, lantern, or portable camping stove inside a home,
tent, or camper.
If conditions are too hot or too cold, seek shelter with friends or at a community shelter.
If CO poisoning is suspected, leave the space immediately. Call 911, and contact your
gas company. Dont go back into the home until the problem has been resolved.
CO poisoning is entirely preventable. You can protect yourself and your family by
acting wisely in case of a power outage and learning the symptoms of CO poisoning.
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ASAM Medical Marijuana Task Force White Paper

Executive Summary
Research into the therapeutic potential of cannabis and cannabinoids has lagged behind
that of other modern medications. The recent discovery and elucidation of the endocannabinoid
receptor system, coupled with improvements in technology and new research tools, has facilitated
analytical, pharmacological, and other preclinical research. Clinical research is also increasing,
although only a small number of controlled studies meeting modern scientific standards have been
published.
All cannabis-based and cannabinoid products should be subjected to the rigorous scrutiny
of the FDA regulatory process. This process provides important protections for patients, making
products available only when they 1) are standardized by identity, purity, potency and quality, 2)
are accompanied by adequate directions for use in the approved medical indication, and 3) have
risk/benefit profiles that have been defined in well-controlled clinical trials. The FDA has set forth
the criteria that must be met if a botanically-based medication is to achieve marketing approval
through this process.
All major medical organizations support the FDA approval process. Both the AMA and the
ACP have rejected the use of state legislative enactments to determine whether a medication should
be made available to patients. The Institute of Medicine has also rejected this approach and has
called for further research into the development of nonsmoked, reliable delivery systems for
cannabis-derived and cannabinoid products. Federal law prohibits, and federal agencies do not
support, the distribution of cannabis by dispensaries.
Rigorous research is needed better to understand the significance of different cannabinoid
formulations and ratios, methods of administration, and dose-response relationships. Cannabis has
a range of effects, some of which may be disturbing to patients with serious medical conditions,
adversely impact their cognitive skills, or impair their lung function; such effects should be better
understood, particularly in the context of chronic medical use.
Medical marijuana, currently distributed pursuant to state legislation, does not accord
with critically important aspects of the modern scientific model. It lacks quality control and
standardization; can be contaminated with pesticides and microbes; and does not assure patients a
reliable and reproducible dose. Increased cannabis potency heightens the risk of adverse events,
especially among cannabis-nave patients, as well as the dangers of dependence and addiction.
There are no effective risk management measures to prevent diversion and abuse, especially by
adolescents.
Despite the paucity of rigorous scientific data, dispensaries are now distributing cannabis
and cannabis products to large numbers of individuals. Yet physicians, who are the gatekeepers of
this process under state law, have inadequate information on which to base their judgment if they
choose to discuss cannabis as a treatment option with their patients. The practice of medicine must
be evidence-based. Physicians should carefully consider their ethical and professional
responsibilities before issuing a cannabis recommendation to a patient. A physician should not
advise a patient to seek a treatment option about which the physician has inadequate information
regarding composition, dose, side effects, or appropriate therapeutic targets and patient
populations.
1
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Introduction
During the past forty years, popular interest in the therapeutic potential of cannabis
has significantly increased, fueled by widespread media attention. Because cannabinoid
research poses special challenges, data from such research have accumulated more slowly
and only recently have gained substantial attention within the scientific and medical
communities. The conundrum in many states is this, liberal cannabis distribution to
patients with various medical conditions; yet, little scientific evidence exists to guide this
process in a rational and ethical manner and to ensure patient health and safety. This
report will examine the circumstances that led to this unsettling situation and explore the
scientific issues involved in moving toward a resolution. It will also set out
recommendations to assist physicians in coping with these issues and propose policy
recommendations for consideration that are intended to reduce the potential for more
problems in the future.
Modern History of Cannabis in Medicine
In the early part of the 19th century, the European medical community became
aware of the therapeutic potential of cannabis-based medications. Dr. William
OShaughnessy, an Irish physician, conducted clinical and nonclinical work in India with
cannabis preparations and upon his return to England, the results of his studies became
widely known. Across Europe and North America interest increased in the therapeutic
potential of these materials. 1 Pharmacists and early pharmaceutical companies2 developed
oral cannabis extracts and tinctures 3 for various medical conditions. These cannabis
preparations were flawed, however, because unlike opiates, cannabinoids are lipid-, rather
than water-soluble, and sensitive to degradation by heat and light. 4 Because of these
characteristics, and the limited technology available at the time, the active ingredients in
cannabis preparations were unknown, the preparations lacked standardization, and
patient response was variable.5
O'Shaughnessy WB. On the preparation of the Indian hemp or gunjah (Cannabis indica): the effects on the
animal system in health and their utility in the treatment of tetanus and other convulsive diseases. Trans.
Med. Phys. Soc. Bengal 1838-1840; 8: 421-461, reprinted in Mikuriya TH (ed.) Marijuana Medical Papers 18391972 (1973).
2 Hamilton HC, Lescohier AW, & Perkins RA. The physiological activity of cannabis sativa. J. Amer. Pharm. Assn.
1913; II:311-323, reprinted in Mikuriya TW (ed.). Marijuana Medical Papers 1839-1972 (1973).
3 Historically, cannabis was used for therapeutic purposes primarily in the form of teas, extracts, tinctures
(grains of hemp/hashish resin dissolved in alcohol)not in smoked form. Only in rare cases, involving
respiratory conditions was cannabis inhaled. Russo EB, History of cannabis and its preparations in saga,
science, and sobriquet. Chem. & Biodiversity 2007; 4:1614-1648, pp.1620, 1628. In the 1800s, the
composition of this resin would have been about half THC and CBD (of its primary cannabinoids). See
discussion below.
4 Garrett ER, Hunt CA. Physicochemical properties, solubility, and protein binding of delta9-THC. J. Pharm. Sci.
1974; 63:1056-1064.
5 Walton RP. Marijuana: therapeutic application. Marijuana: Americas New Drug Problem (JB Lippincott,
1928) 151-157, reprinted in Mikuriya TW (ed.). Marijuana Medical Papers 1839-1972 (1973).
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Reports often blame the enactment of the federal Marihuana Tax Act of 1937, which
imposed administrative limitations on the prescription of cannabis preparations, 6 for the
contraction in the use of marijuana in medicine. The main reasons for this disappearance
were the variable potency of cannabis extracts, the erratic and unpredictable individual
responses, the introduction of synthetic and more stable pharmaceutical substitutes such
as aspirin, chloral hydrate and barbiturates, the recognition of important adverse effects
such as anxiety and cognitive impairment.7 Accordingly, cannabis preparations gradually
fell out of use by the medical profession. 8 As one prominent physician in 1938 noted9:
The therapeutic application of Cannabis is more a matter of history than of presentday practice. Synthetic analgesics and hypnotics have almost entirely displaced
these preparations from their original field of application. The newer synthetics are
more effective and reliable and, in addition, have been more intensively exploited by
commercial interestsThe drug has certain remarkable properties and if its
chemical structure were determined and synthetic variations developed, some
of these might prove to be particularly valuable, both as therapeutic agents and as
experimental tools. 10
Waltons predictions today remain both hopeful and elusive.
Because of the technological challenges involved in cannabinoid formulation and
research, it was not until 1964 that the primary psychoactive ingredient in cannabis, delta9-tetrahydrocannabinol (THC), was identified and synthesized. 11 Coincidentally popular
The AMA Committee on Legislative Activities expressed concern about the negative impact that the Act
would have on the availability of cannabis preparations but acknowledged that such preparations were little
used:
Cannabis at the present time is slightly used for medicinal purposes, but it would seem
worthwhile to maintain its status as a medicinal agent for such purposes as it now has. There is
a possibility that a re-study of the drug by modern means may show other advantages to
be derived from its medicinal use.
7 Fankhauser M (2002). History of cannabis in Western Medicine. In: Grotenhermen F & Russo E (Editors),
Cannabis and Cannabinoids.
The Haworth Integrative Healing Press, New York, 37-51.
8 A similar situation occurred in the treatment of cancer chemotherapy-induced nausea and vomiting. In the
1970s and 1980s, there was considerable interest in using smoked cannabis and oral THC for these
conditions, since existing treatments were inadequate for control of emesis. A number of state departments of
health conducted open label studies comparing smoked marijuana, oral THC, and existing antiemetics.
Following the development of more effective antiemetic agents such as the 5-HT receptor antagonists
interest in using oral THC and smoked cannabis to prevent acute vomiting waned. Council on Scientific
Affairs Report 6. Medical marijuana. American Medical Association, Annual Meeting, Chicago, Illinois; June
2001.
9 Walton RP. Marijuana: Therapeutic Application in Marijuana: Medical Papers 1839-1972 (Mikuriya T., ed.)
(emphasis added). At about that time, Dr. Walton was Professor and Head of the Department of
Pharmacology and Therapeutics, Medical College of South Carolina, Charleston, S.C., and wrote and published
on cannabis in 1938.
10 Ibid. (emphasis added).
11 Mechoulam R, Gaoni Y. A total synthesis of d, 1-delta-1-tetrahydrocannabinol, the active constituent in
hashish. J. Am. Chem. Soc. 1965; 87: 3273-3275.
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interest in smoked cannabis began to increase significantly; the intersection of these two
occurrences have linked contemporary use to medical applications of marijuana
A number of individuals reported that when smoking cannabis for recreational
purposes it seemed to alleviate some of their medical symptoms. Interest grew in finding
therapeutic uses for smoked cannabis. More advanced technology in the 1800s and early
1900s might have made a range of cannabinoid medicationssimilar to that of modern
opiatesavailable, and cannabis smoking might have been relegated to the realm of nondependent, non-medical use for pleasure.12 Thus, the lag in the technological capabilities
of modern science probably contributed to the controversy of medical marijuana. That
technology has now arrived, and the era of modern cannabinoid medication development is
well on its way.
The momentum for such cannabinoid medication development gained tremendous
force following the discovery of endocannabinoid receptors in the late 1980s and early
1990s. 13 14 CB1 receptors are widespread in the body, but most prominent effects are
manifest in the CNS. CB2 receptors are primarily located in the periphery and immune
tissues but may be expressed in the CNS in inflammatory states. 15 Research identified
endogenous ligands (endocannabinoids), which interact with these receptors.16 The
availability of synthetic antagonists and high-affinity agonists, as well as the development
of knockout mice, further facilitated the exploration of the endocannabinoid system. 17
These discoveries clarified the mechanism of action of cannabinoids of all types
endocannabinoids, phytocannabinoids (plant based), and synthetic cannabinoidsand
ignited a tidal wave of preclinical scientific research:
This evolution has followed the same principles as the evolution of drug
therapy in general. The direction has been away from crude substances of
variable composition, stability, and potency, toward the development of
12
Unlike cannabis, the medicinal and recreational forms of opium were clearly distinct. Had medical
technology been advanced enough at that time to allow cannabinoids to be identified, formulated, and
delivered, the medical marijuana movement would probably not have occurred. As with the opium poppy,
prescription cannabinoid medications and crude herbal cannabis would have been used in very different
venues. McCarberg, WH and Barkin RL, The Future of Cannabinoids as Analgesic Agents: A Pharmacologic,
Pharmacokinetic, and Pharmacodynamic Overview, (2007) American Journal ofTherapeutics 14(5); 475483,476 (emphasis added).
13 Howlett AC. Pharmacology of cannabinoid receptors. Annu. Rev. Pharmacol. Toxicol. 1995; 35: 607-634.
14 Munro S, Thomas KL, Abu-Shaar M. Molecular characterization of a peripheral receptor for cannabinoids.
Nature. 1993; 365: 61-5.
15 Council on Scientific Affairs Report 6. Medical marijuana. American Medical Association, Annual Meeting,
Chicago, Illinois; June 2001 (citing studies).
16 Devane WA, Hanus L, Breuer A, et al. Isolation and structure of a brain constituent that binds to the
cannabinoid receptor. Science 1992; 258: 1946-1949.
17 Rahn EJ, Hohmann AG. Cannabinoids as pharmacotherapies for neuropathic pain: from the bench to the
bedside. Amer. Soc. for Exper. Neur. 2009; 6:713-737.
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progressively more specific or selectively active pure compounds that permit

dosage that is more precise and reduced risk of unwanted side effects.18
After a delay of over a century, we are now on the cusp of a new era in which
many cannabinoid products could become part of the physicians armamentarium.
A number of cannabinoid products are already in development. Several are plantderived (Sativex, Cannador); others are synthetic analogues 19 20 or ligands at
the CB2 rather than the CB1 receptor21; still others involve new delivery systems for
THC 22 23; some modulate or otherwise affect the endocannabinoid receptor
system24 25. It will take time for this research to evolve into a range of prescription
medications. The duration and complexity of this development process is, however,
necessary to ensure that a products pharmacology and risk/benefit profile are
adequately understood and such preparations can meet FDA standards of
consistency, safety and efficacy before the product is distributed to patients.
Medical Marijuana in the United States
Fourteen states have currently enacted laws that decriminalize the use of cannabis
for medical use. Some of the laws have been passed by popular vote through the initiative
process; state legislative bodies have promulgated a few. The first of these laws passed in
1996; after having failed for several years to obtain a legislative enactment, cannabis
advocates took the issue to the people of California through the initiative process. 26 In
18
Kalant H. Smoked marijuana as medicine: not much future. Clin. Pharm. & Ther. 2008; 83(4):517-519.
Burstein SH. The therapeutic potential of ajulemic acid (CT3). In: Grotenhermen F, Russo E, eds. Cannabis
and Cannabinoids: Pharmacology, toxicology and therapeutic potential. Benghamton, NY: Haworth Press;
2001.
20 Karst M, Salim K, Burstein S, Conrad I, Hoy L, Schneider U. Analgesic effect of the synthetic cannabinoid CT3 on chronic neuropathic pain: a randomized controlled trial. JAMA 2003; 290(13): 1757-62.
21 Rahn EJ, Zvonok AM, Thakur GA, Khanolkar AD, Makriyannis A, Hohmann AG. Selective activation of
cannabinoid CB2 receptors suppresses neuropathic nociception induced by treatment with the
chemotherapeutic agent paclitaxel in rats. J. Pharmacol. Exp. Ther. 2008; 327(2):584-91. Indeed, entire
scientific conferences have recently been held on CB2 agonism. See, e.g., CB2 Cannabinoid Receptors: New
Vistas http://people.ucalgary.ca/~cb2/scientific.html (2007).
22 Challapalli PV, Stinchcomb AL. In vitro experiment optimization for measuring tetrahydrocannabinol skin
permeation. Int. J. Pharm. 2002; 241(2): 329-339.
23 Miller J, Meuwsen I, ZumBrunnen T, de Vries M. A phase I evaluation of pulmonary dronabinol
administered via a pressurized metered dose inhaler in healthy volunteers. Paper presented at: American
Academy of Neurology; April 14, 2005; Miami Beach, FL.
24 Rahn EJ, Hohmann AG, supra.
25 Pacher P, Batkai S, Kunos G. The endocannabinoid system as an emerging target of pharmacotherapy.
Pharmacol. Rev. 2006; 58(3): 389-462.
26 There were several medical marijuana bills introduced into the California legislature, beginning in 1994,
e.g., SB 1364, AB 2933, AB 1529, AB 2120, but they either did not pass or were vetoed by the Governor.
Coincidentally, these bills followed immediately on the heels of the final disposition of a petition filed by the
National Organization for the Reform of Marijuana Laws (NORML), which was filed in 1972 shortly after
Congress placed marijuana in Schedule I of the Controlled Substances Act in 1970. NORML initially sought to
remove marijuana entirely from the CSA or, alternatively, place marijuana in Schedule V, NORML v. Ingersoll,
497 F.2d 654 (D.C. Cir. 1974),but agreed that US treaty obligations did not permit that course of action for
cannabis and cannabis resin. NORML v. DEA, 559 F.2d 735 (D.C. Cir. 1977) fn. 43. Subsequently, NORML
19
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most of these states, individual patients and/or their designated caregivers may cultivate
cannabis for medical purposes. Some states place limits on the medical conditions that can
qualify for legal protection, (e.g., Washington, New Jersey, New Mexico). A few permit the
distribution of cannabis by certain types of dispensaries, (e.g., Rhode Island, New Jersey,
and New Mexico). Without exception, all of the state laws make physicians the
gatekeepers, that is, a patient cannot qualify to use cannabis for medical purposes unless
a physician has recommended the use of cannabis for that person. 27
As a general rule, these laws do not create new rights under state law; rather, they
allow patients (and designated caregivers) to raise his/her personal medical use/
cultivation as an affirmative defense if the individual is arrested and charged with violation
of certain state criminal laws pertaining to cannabis. 28
In the first few years following the enactment of the first medical marijuana laws,
individual patients and their designated caregivers primarily conducted cultivation.
Accordingly, the laws had limited application, and research might have been able to
provide important data before widespread use occurred. Now, however, the situation has
changed dramatically. Fueled by the perceived permissiveness of the Obama
administration, dispensaries have proliferated at a rapid rate. Many physicians have
opened practices based exclusively on issuing cannabis recommendations (see further
discussion below). As a result, thousands of persons, with diverse medical conditions
(and/or non-medical reasons), are using cannabis, despite the fact that research has not
kept (and cannot keep) pace with such rapidly expanding use for the myriad of conditions
marijuana is reported to treat.
Reports from Expert Bodies
The early initiatives garnered widespread media coverage, public interest, and
controversy. As a result, a number of expert bodies examined the data relating to the
therapeutic potential of cannabis and cannabinoids.
National Institutes of Health
In 1997, the National Institutes of Health (NIH) hosted a workshop at which medical
experts discussed the potential medical uses of smoked cannabis. This group reviewed the
literature and conducted hearings relating to the therapeutic uses of cannabis to treat
conditions including: analgesia, neurological and movement disorders, nausea and
sought to move marijuana to Schedule II. That petition was denied by DEA and, after 22 years of litigation, the
DEA denial was upheld by the federal courts. ACT v. DEA, 15 F. 3d 1131 (D.C. Cir. 1994).
27 Since 1) no marijuana-based product has been approved by the FDA, and 2) marijuana is a Schedule I
substance under federal law, a physician cannot prescribe, nor can a pharmacist dispense, such a product.
Instead, physicians may recommend the medical use of cannabis to a specific patient. In Michigan, for
example, a physician must certify that the patient is likely to receive medical benefit from the use of cannabis.
28 For example, the California Supreme Court has ruled that California's laws confer only a limited immunity
which operates by decriminalizing conduct that otherwise would be criminal. People v. Mower 28 Cal.4th
457, 472; 122 Cal.Rptr.2d 326 (2002).
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vomiting associated with cancer chemotherapy, glaucoma, and appetite

stimulation/cachexia.29 For a number of these conditions, the group concluded that there
would only be limited value in pursuing further research into smoked cannabis, because
effective treatments were already available. However, they did recommend new controlled
studies on smoked cannabis, since current research did not provide definitive answers on
its risk/benefit profile. The consensus was that in these research studies, smoked cannabis
must meet the same standards as other medications in terms of effectiveness and safety.
Given that dronabinol is marketed to treat nausea and vomiting associated with
chemotherapy and appetite stimulation in AIDS patients, the expert group suggested that
the effects of smoked cannabis on these conditions be evaluated and studied to draw
comparisons between smoked cannabis and synthetic THC.
Experts also specifically suggested that NIH use its resources to develop a smoke-free
inhaled delivery system for cannabis or THC to eliminate the negative health effects of smoking in
research trials.
Institute of Medicine Report

In 1997, the White House Office of National Drug Control Policy (ONDCP) requested that
the Institute of Medicine (IOM) conduct a review of the scientific evidence regarding the
potential health benefits and risks of cannabis and its component cannabinoids. In 1999,
the IOM issued the report Cannabis and Medicine: Assessing the Science Base that became
the foundation of study into medical marijuana. 30 IOM made a series of recommendations
pertaining to the use of cannabis in medical treatment that revolve around the need for
more research and evaluation.
It its report, IOM made the following recommendations: 31
Recommendation 1: Research should continue into the physiological effects of

synthetic and plant-derived cannabinoids and the natural function of cannabinoids
found in the body. Because different cannabinoids appear to have different effects,
cannabinoid research should include, but not be restricted to, effects attributable to
THC alone.
Recommendation 2: Clinical trials of cannabinoid drugs for symptom management
should be conducted with the goal of developing rapid-onset, reliable, and safe
delivery systems.
29
National Institutes of Health. (1997). Workshop on the Medical Utility of Marijuana. Retrieved December
29, 2009 from http://www.nih.gov/news/medmarijuana/MedicalMarijuana.htm
30 Joy, J.E., Watson, Jr., S.J., & Benson, J.A. (Eds). (1999). Marijuana and Medicine: Assessing the Science Base.
Division of Neuroscience and Behavioral Health. Institute of Medicine. Washington, DC: National Academy
Press.
31 Ibid.
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Recommendation 3: Psychological effects of cannabinoids such as anxiety reduction

and sedation, which can influence medical benefits, should be evaluated in clinical
trials.
Recommendation 4: Studies to define the individual health risks of smoking
marijuana should be conducted, particularly among populations in which cannabis
use is prevalent.
Recommendation 5: Clinical trials of marijuana use for medical purposes should be
conducted under the following limited circumstances: trials should involve only
short-term marijuana use (less than six months), should be conducted in patients
with conditions for which there is reasonable expectation of efficacy, should be
approved by institutional review boards, and should collect data about efficacy.
Recommendation 6: Short-term use of smoked marijuana (less than six months) for
patients with debilitating symptoms (such as intractable pain or vomiting) must
meet the following conditions:
o failure of all approved medications to provide relief has been documented,
o the symptoms can reasonably be expected to be relieved by rapid-onset
cannabinoid drugs,
o such treatment is administered under medical supervision in a manner that
allows for assessment of treatment effectiveness, and
o Involves an oversight strategy comparable to an institutional review board
process that could provide guidance within 24 hours of a submission by a
physician to provide marijuana to a patient for a specified use.
The IOM clearly stated that the purpose of short-term studies with smoked cannabis
would serve, at best, as preliminary support for the development of cannabis-based or
cannabinoid modern medications. The goal of clinical trials of smoked cannabis would
not be to develop cannabis as a licensed drug but rather to serve as a first step
toward the possible development of nonsmoked rapid-onset cannabinoid delivery
systems (emphasis added). 32 Specifically, IOM stressed that there is little future in
smoked marijuana.
The IOM acknowledged that, until a nonsmoked rapid-onset cannabinoid drug
delivery system became available, there was no clear alternative for people suffering
from chronic conditions that might be relieved by smoked cannabis. The IOM suggested
that one possible approach would be to treat patients as n-of-1 clinical trials, in which
patients are fully informed of their status as experimental subjects using a harmful drug
delivery system. It recommended that their condition is closely monitored and
documented under medical supervision, thereby increasing the knowledge base of the risks
and benefits of marijuana use under such conditions. Under the current system of
cannabis distribution by dispensaries, with limited oversight by physicians, these patient
protections and data-collection functions are wholly absent.
32
Joy, J.E., Watson, Jr., S.J., & Benson, J.A. (Eds). (1999). Marijuana and Medicine: Assessing the Science Base.
Press.
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Professional Organizations
American Medical Association
In both 1997 33 and 2001 34, the AMA issued reports on the scientific data relevant to
the medical utility of cannabis. In November 2009, the AMAs Council on Science and
Public Health (CSAPH) revised several of its policy statements on cannabis. The
organization retained its previous recommendations for 1) further adequate and wellcontrolled studies into cannabis and cannabinoids; 2) urging the NIH to facilitate grants
applications for, and the conduct, of such trials; and 3) permitting free and unfettered
exchange of information on treatment alternatives between physicians and patients, which
should not subject either party to criminal sanctions.
In the Executive Summary, CSAPH noted that short-term clinical trials suggest that
smoked cannabis has efficacy in certain medical conditions (a conclusion presumably
further analyzed in the body of the report, which has not yet been published). In its
Recommendation, AMA urged that cannabiss status as a schedule I drug be reviewed.
The purpose of such review would be to ascertain whether rescheduling could facilitate the
conduct of clinical research and the development of cannabinoid-based medicines and
alternate delivery methods. AMA emphasized that this recommendation should not be
viewed as an endorsement of state-based medical cannabis programs, legalization of
marijuana or that scientific evidence on the therapeutic use of cannabis meets the current
standard for a prescription drug product. 35 The report stressed the patchwork of statebased systems that have been established for medical marijuana is woefully inadequate in
establishing even rudimentary safeguards that normally would be applied to the
appropriate clinical use of psychoactive substances. The future of cannabinoid-based
medicine lies in the rapidly evolving field of botanical drug substance 36 development, as
well as the design of molecules that target various aspects of the endocannabinoid system.
American College of Physicians
In 2008, the American College of Physicians (ACP) Health and Public Policy Committee
(HPPC) composed a position paper on the medical uses of cannabis that followed the lead
set forth by IOM. Their positions include: 37
33
Council on Scientific Affairs Report 10. Medical marijuana. American Medical Association, Interim Meeting,
Dallas, Texas; December 1997.
Chicago, Illinois; June 2001.
35 Council on Science and Public Health Report 3, Use of cannabis for medicinal purposes. American Medical
Association, Interim Meeting, Houston, Texas; November 2009.
http://www.ama-assn.org/ama1/pub/upload/mm/38/i-09-csaph-reports.pdf
36 For the meaning of botanical drug substance, see discussion of the FDA Botanical Guidance, below.
37 American College of Physicians. Supporting Research into the Therapeutic Role of Marijuana. Philadelphia:
American College of Physicians; 2008: Position Paper. (Available from American College of Physicians, 190 N.
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Position 1: ACP supports programs and funding for rigorous scientific evaluation of
the potential therapeutic benefits of medical marijuana and the publication of such
findings.
o Position 1a: ACP supports increased research for conditions where the
efficacy of marijuana has been established to determine optimal dosage and
route of delivery.
o Position 1b: Medical marijuana research should not only focus on
determining drug efficacy and safety but also on determining efficacy in
comparison with other available treatments.
Position 2: ACP encourages the use of nonsmoked forms of THC that have proven
therapeutic value.
Position 3: ACP supports the current process for obtaining federal research-grade
cannabis.
Position 4 (as amended): 38 ACP urges an evidence-based review of marijuanas
status as a Schedule I controlled substance to determine whether it should be
reclassified to a different schedule. This review should consider the scientific
findings regarding marijuanas safety and efficacy in some clinical conditions as well
as evidence on the health risks associated with marijuana consumption, particularly
in its smoked form.
Position 5: ACP strongly supports exemption from federal criminal prosecution; civil
liability; or professional sanctioning, such as loss of licensure or credentialing, for
physicians who prescribe or dispense medical marijuana in accordance with state
law. Similarly, ACP strongly urges protection from criminal or civil penalties for
patients who use medical marijuana as permitted under state laws.
In an addendum to the position paper, ACP addressed concerns raised that it was
promoting smoked marijuana as medicine. In this response, ACP states that it has not
advocated for the long-term use of smoked marijuana; rather, the paper explicitly discusses
the harm associated with chronic use of smoked marijuana and stresses the need for
development of nonsmoked forms of cannabinoid delivery systems strictly for therapeutic
purposes supported by the evidence. 39 ACP also stressed that it shares the concerns
expressed by some about state ballot initiatives or legislation that can undermine the
federal regulatory structure for assessing the safety and efficacy of new drugs before such
drugs can be approved for therapeutic use.
Independence Mall West, Philadelphia, PA 19106.)
http://www.acponline.org/advocacy/where_we_stand/other_issues/medmarijuana.pdf
38 ACPs original recommendation seemed to suggest that it was calling for the reclassification of cannabis
into a more appropriate schedule. After receiving extensive commentary on this point, ACP clarified its
position to state that the evidence merits a review of cannabiss Schedule I classification, but any change to
that classification should occur only if the review established that the evidence was sufficient to justify the
change.
39 American College of Physicians. Supporting Research into the Therapeutic Role of Marijuana. Philadelphia:
American College of Physicians; 2008: Position Paper. (Available from American College of Physicians, 190 N.
Independence Mall West, Philadelphia, PA 19106.)
http://www.acponline.org/advocacy/where_we_stand/other_issues/medmarijuana.pdf
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American Nurses Association

In December 2008, the American Nurses Association (ANA) published the following
statement on marijuana:
The American Nurses Association supports: 40
The education of registered nurses and other healthcare practitioners regarding

appropriate evidence-based therapeutic use of marijuana including those nonsmoked forms of delta-9-tetrahydrocannabinol (THC) that have proven to be
therapeutically efficacious
Protection from criminal or civil penalties for patients using medical marijuana as
permitted under state laws
Exemption from criminal prosecution; civil liability; or professional sanctioning,
such as loss of licensure or credentialing, for healthcare practitioners who prescribe,
dispense or administer medical marijuana in accordance with state law
Reclassification of marijuanas status from a Schedule I controlled substance into a
less restrictive category.
Confirmation of the therapeutic efficacy of medical marijuana
The Federal Position

The Controlled Substances Act (CSA)
All controlled substances are assigned to one of five schedules under the Controlled
Substances Act (CSA), depending on their medical usefulness and their potential for
abuse. 41 Cannabis/marijuana, ibogaine, mescaline, and peyote are botanical hallucinogens
listed in Schedule I. Schedule I substances are those said to have:
A high potential for abuse;

No currently accepted medical use in treatment in the US42; and
40
American Nurses Association (2008, December 12). Ethics and human rights. Retrieved December 29, 2009
from http://www.nursingworld.org/EthicsHumanRights
41 The following factors, often referred to as the eight factor analysis, determine the schedule to which a
substance is assigned:
1. Its actual or relative potential for abuse
2. Scientific evidence of its pharmacological effects
3. The state of current scientific knowledge regarding the drug
4. Its history and current pattern of abuse
5. The scope, duration, and significance of abuse
6. What, if any, risk there is to public health
7. Its psychic or physiological dependence liability
8. Whether the substance is an immediate precursor of a substance already under control
21 U.S.C. sec. 811.
42 In a proceeding which seeks to move a drug from Schedule I to Schedule II, the DEA will examine the
following factors in determining whether the drug has a currently accepted medical use:
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A lack of accepted safety for use under medical supervision 43.
Substances in Schedule II have:
A high potential for abuse;

A currently accepted use in treatment in the US or a currently accepted medical use
with severe restrictions; and
Abuse of the substance may lead to severe psychological or physiological
dependence.44
Opium, poppy straw, concentrate of poppy straw, and coca leaves are botanical materials
listed in Schedule II. At the time the CSA was enacted in 1970, modern prescription
medications derived from these botanical starting materials had already been approved for
marketing by the FDA.
Substances in Schedule I may only be used in research studies by investigators who
1) have protocols that have been approved by the FDA and 2) have received research
registrations from the DEA. Therefore, all possession, cultivation, distribution, etc., of
cannabis, even if permitted under various state medical marijuana laws, continues to be
illegal under federal law. A physician, however, has a First Amendment right under the
federal Constitution to provide a patient with bona fide medical advice, which may include
recommending the use of cannabis for medical purposes, so long as the physician does
nothing affirmatively to aid or abet a patient in obtaining cannabis. 45
1. The drugs chemistry must be known and reproducible;

2. There must be adequate safety studies;
3. There must be adequate and well-controlled studies proving efficacy;
4. The drug must be accepted by qualified experts; and
5. The scientific evidence must be widely available.
See Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C.Cir. 1994). 42 See 57 F.R. 10499,10506.
According to the DEA, a failure to meet any of the factors precludes a drug from having a currently accepted
medical use. 57 Fed.Reg. at 10507. Only a product going through the FDA process could meet all these criteria.
43
21 USC sec. 812(c) (Schedule I (c)).

21 USC sec. 812(c) (Schedule II (a)). Substances in Schedules III-V have decreasing levels of abuse potential
and are subject to lesser degrees of control.
45 Conant v. Walters, 309 F.3d 629 (9 th Cir. 2002). For a more detailed description of this issue, see California
Medical Association, CMA ON CALL, document #1315, The Compassionate Use Act of 1996: The Medical
Marijuana Initiative (Jan. 2010)
http://www.cmanet.org/bookstore/freeoncall2.cfm/CMAOnCall1315.pdf?call_number=1315&CFID=745764
&CFTOKEN=27566287 (accessed Feb. 18, 2010).
44
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Federal Departments and Agencies

On a number of occasions since 1996, the Drug Enforcement Administration has
closed cannabis dispensaries. 46 Under the Obama Administration, however, Attorney
General Holder suggested that the DOJ might adjust its enforcement policies. In October
2009, the federal Department of Justice issued guidelines to prosecutors. 47 Despite the
publicity these guidelines received, they are actually quite narrow. At the outset, the
provisions stress that marijuana is a dangerous drug. They confirm the (already-existing)
policy that federal prosecution priorities should be focused on significant48 traffickers, not
small-scale individual users. Hence, US attorneys are advised not to prosecute patients
with cancer or other serious illnesses who are using cannabis as part of a recommended
treatment regimen consistent with state law or caregivers in clear and unambiguous
compliance with state law who provide cannabis to such patients. 49 Commercial
enterprises, however, and those entities whose nonprofit medical marijuana distribution
activities are merely a pretext for for-profit endeavors, are subject to prosecution. 50
Subsequent to the issuance of these DOJ guidelines, the DEA issued a statement:
These guidelines do not legalize marijuana. It is not the practice or policy of
DEA to target individuals with serious medical conditions who comply with
state laws authorizing the use of marijuana for medical purposes. Consistent
with the DOJ guidelines, we will continue to identify and investigate any
criminal organization or individual who unlawfully grows, markets, or
distributes marijuana or other dangerous drugs. 51
Similarly, the Director of ONDCP stressed:
The Department of Justice's guidelines strike a balance between efficient use
of limited law enforcement resources, and a tough stance against those
whose violations of state law jeopardize public health and safetyEnforcing
the law against those who unlawfully market and sell marijuana for profit
will continue to be an enforcement priority for the U.S. government.52
The Department of Transportation (DOT) also emphasized that the guidelines
would not impact the DOTs drug testing program: The Department of Transportations
46
US v. Oakland Cannabis Buyers Cooperative, 532 U.S. 483 (2001).

US Department of Justice, Memorandum for Selected United States Attorneys (October 19, 2009)
http://blogs.usdoj.gov/blog/archives/192
48 Note: this term is broader than major.
49 California Attorney General, Guidelines for the Security and Non-diversion of Marijuana Grown for Medical
Use. http://ag.ca.gov/cms_attachments/press/pdfs/n1601_medicalmarijuanaguidelines.pdf.
50 The guidelines also allow prosecution of those distribution activities that may be consistent with state law
(in case a state decides to pass very liberal legislation), if necessary to serve important federal interests.
51 Drug Enforcement Administration, www.justice.gov/dea/pubs/pressrel/pr102209.html.
52 Office of National Drug Control Policy,
www.whitehousedrugpolicy.gov/news/press09/marijuana_legalization.pdf
47
13
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Drug and Alcohol Testing Regulation 49 CFR Part 40, at 40.151(e) does not authorize
medical marijuana under a state law to be a valid medical explanation for a transportation
employees positive drug test result. 53
In light of these statements, the current position of the federal government is
uncertain. Nevertheless, largely because of exaggerated media reports, the Obama
administration is viewed as lenient toward medical marijuana. This has encouraged
further proliferation of dispensaries which results in virtually unrestricted distribution of
cannabis.
Modern Medications and the FDA Approval Process
In earlier days in Western medicine, herbs and other botanical products were
common treatment options and remain so in many developing countries. By the end of the
20th century, however, these botanical mixtures and preparations had been replaced by
modern medications which were characterized by standardized, purified products,
whose active ingredients (AIs) were often of synthetic origin.
Folk Remedies
Use plant products whose composition is
uncertain and unregulated
Treat poorly defined illnesses or symptom
with unknown basis (e.g. cough from TB,
influenza, or etc.)
Are based on little understanding of the
pathophysiology of the disorders being
treated
Are based on little understanding of the
role of medicine in the therapy
Are used in inconsistent and hard-toquantify amounts
Modern Medicines
Use highly purified or defined products,
often comprising synthetic chemicals
Treat specific illnesses
Elucidate the nature of the illnesses
Use medicines that have a recognized

effect on pathological processes; often
understand the mechanism of action
Are administered in controlled doses;
delivery system provides predictable dose
over defined period of time
Even those medications that once originated in botanical material, e.g., digitalis,
were ultimately comprised of synthetic AIs. Dosage forms and delivery systems were
carefully tested to deliver a discrete, reproducible dose. The ever-increasing sophistication
and rigor of the FDA approval process contributed to this trend.
That approval process has been developed over the past century to protect patient
safety and welfare. It promotes the quality, safety, and efficacy of medications, and is
supported by all major medical/health care organizations. Extensive preclinical and clinical
53
Medical Marijuana Guidelines Dont Impact DOT Drug Testing, Land Line (Oct. 22, 2009)
http://www.landlinemag.com/todays_news/Daily/2009/Oct09/101909/102209-06.htm
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testingthe results of which are published in peer-reviewed journals--provides a robust

body of risk-benefit and pharmacological data, on which physicians depend in order to
make informed prescribing decisions. The registration and inspection procedures ensure
that the manufacturing process is conducted in accordance with validated quality control
tools and measures. Manufacturers promotional activities are limited to those claims
supported by the products label. Products are prescribed and dispensed under the close
supervision of licensed health care providers, primarily physicians and pharmacists.
In addition, the FDA has recently indicated that products, both with and without
abuse potential,54 must develop special plans to identify, evaluate, and mitigate the
products risks. Such plans must include, where relevant, the risks of abuse and
diversion.55 56
By contrast, herbal products and other dietary supplements are subject to a far
lesser degree of supervision. Composition and quality are uncertain; clinical data on safety
and efficacy are limited; and physicians generally do not feel qualified to opine about
specific products risks and benefits for particular medical conditions. 57 Various scholars
have suggested that the FDA should more stringently regulate many dietary supplements. 58
Generally, dietary supplements are ingested orally and lack abuse potential.59
Despite the reduced level of regulatory scrutiny and quality assurance, public
interest in botanically derived treatments continues to rise. Acknowledging such interest,
and the fact that technology has improved significantly in recent decades, the FDA issued a
2004 guidance document that sets forth the principles to which pharmaceutical
manufacturers must adhere when developing prescription medications derived from
complex botanical material. 60 The Guidance permits some leniency in the biochemical
characterization of a prospective botanical agent the early stages of research; however, at
the point of advanced clinical research (Phase III), or New Drug Application (NDA), a
product must meet all standards for a new chemical entity (NCE).
54
DHHS, FDA, Draft Guidance for Industry on Assessment of Abuse Potential of Drugs. 75 Fed. Reg. 4400 (Jan.
27, 2010).
55 DHHS, Food and Drug Administration, Identification of Drug and Biological Products Deemed to have Risk
Evaluation and Mitigation Strategies for Purposes of the Food and Drug Administration Amendments Act of
2007. 73 Fed. Reg. 16313 (Mar. 27, 2008);
56 FDA, Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies
(REMS), REMS Assessments, and Proposed REMS Modifications.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM18412
8.pdf
57 Dietary Supplement Health and Education Act of 1994 (DSHEA), Pub. L. No. 103-417, 208 Stat. 4325
(codified as amended in scattered sections of 21 U.S.C. sec. 301-399) (2000).
58 Cohen PJ. The Dietary Supplement Health and Education Act: Regulation at a Crossroads, 31 Am. J. L. and
Med. 175 (2005).
59 On December 30, 2003, the FDA announced its intention to ban the marketing of ephedra. Leak JA. The
Dietary Supplement Scene: An Update, 68 Am. Socy ofAnesth. Newsletter 29 (2004).
60 FDA, Guidance for Industry: Botanical Drug Products, http://www.fda.gov/cder/guidance/index.htm (2004).
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The document identifies three stages of development for a botanically derived

medication: Botanical Raw Material (BRM), Botanical Drug Substance (BDS) and Botanical
Drug Product (BDP). BRM is fresh or processed (e.g., cleaned, frozen, dried, or sliced) part
of a single species of plant or a fresh or processed alga or macroscopic fungus. BDS is
prepared from botanical raw materials by one or more of the following processes:
pulverization, decoction, expression, aqueous extraction, ethanolic extraction, or other
similar process. It may be available in a variety of physical forms, such as powder, paste,
concentrated liquid, juice, gum, syrup, or oil. BDP is a botanical product that is intended
for use as a drug, i.e., a finished drug product that is prepared from a botanical drug
substance. Botanical drug products are available in a variety of dosage forms, such as
solutions (e.g., teas), powders, tablets, capsules, elixirs, and topicals.
In 2006, the FDA rejected the contention that smoked herbal cannabis is a safe and
effective medication. FDA stated that:
A past evaluation by several Department of Health and Human Services
(HHS) agencies, including the Food and Drug Administration (FDA),
Substance Abuse and Mental Health Services Administration (SAMHSA) and
National Institute for Drug Abuse (NIDA), concluded that no sound scientific
studies supported medical use of marijuana for treatment in the United
States, and no animal or human data supported the safety or efficacy of
marijuana for general medical use. If a drug product is to be marketed,
disciplined, systematic, scientifically conducted trials are the best means to
obtain data to ensure that drug is safe and effective when used as indicated.
Efforts that seek to bypass the FDA drug approval process would not serve
the interests of public health because they might expose patients to unsafe
and ineffective drug products. FDA has not approved smoked marijuana for
any condition or disease indication.61
This statement does not imply that FDA will reject all cannabis-based medications. Indeed,
one cannabis-derived product, Sativex, is entering into Phase III trials in accordance with
the Guidance. 62
Medical Marijuana and the Modern Medication Model
The status of medical marijuana contrasts sharply with the critically important
aspects of the modern medication model. First, crude herbal cannabis is not a
homogeneous material; the term medical marijuana therefore does not refer to a single,
consistent substance or entity. The composition of herbal material, including its THC
61
FDA, Inter-Agency Advisory Regarding Claims That Smoked Marijuana Is a Medicine,

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108643.htm (April 20,
2006)
62 GW Pharmaceuticals, FDA Accepts Investigations New Drug (IND) Application for Sativex.
http://www.gwpharm.com/fda-accepts-application.aspx (Jan. 4, 2006).
16
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content, varies widely depending on the strain, cultivation, storage, and harvesting
practices, etc. The opium poppy can similarly vary in composition. Opium can be rich in
morphine, thebaine, or oripavine. 63 The methods of herbal cannabis administration
smoked/vaporized, baked goods, teas, infused honeys, elixirs, candies, etc.also do not
ensure that a patient receives an identifiable, standardized, and hence reproducible, dose.
Patients therefore cannot be certain that they will experience the same degree of benefit or
extent of side effects from time to time. Patients, particularly those unfamiliar with
cannabis, may be unwittingly dosed excessively, and incur frightening or severely
unpleasant effects. For example, in a media report, one patient with advanced cancer
ingested 1/8 teaspoon of cannabis-infused honey that she had purchased at a dispensary:
After a few hours, she was hallucinating, too dizzy and confused to dress herself for a
doctor's appointment. Then came vomiting far worse than her stomach upset before she
took the drug. 64
Second, quality control mechanisms are generally absent. As a result, cannabis
products may be contaminated with microbes. 65 Certain pathogens, such as aflatoxins, are
not destroyed by heat (as in smoking or vaporizing) and increasingly being recognized as
an underestimated source of neurological toxicity or infections such as aspergillosis.
Individuals who are using anti-inflammatory steroids or have compromised immune
systems are especially vulnerable to such infections.66 Heavy metals and pesticides may
also be present. Cannabis samples recently tested from dispensaries in Los Angeles
contained pesticide levels 170 times that permitted for herbal products.67 68The
manufacturers of these products have essentially no accountability, and the FDA does not
inspect their manufacturing facilities. Patients injured by harmful products have no legal
recourse.
Third, distribution of cannabis products does not take place within the monitored
and regulated channels of supply for pharmaceuticals, but rather through dispensaries,
collectives, and cooperatives. These products are not labeled with content information,
63
DEA, Authorized Sources of Raw Materials, 73 Fed. Reg. 6843 (Feb. 6, 2008).
Mathews AW. Is Marijuana a Medicine? The Wall Street Journal (Jan. 18, 2010).
65 A number of bacteria that are pathogenic to humans have been found on cannabis, including: Salmonella
muenchen, Klebsiella pneumoniae, Euterobacter cloacae, E. agglomerans, Streptococcus (Group D),
Thermoactinomyces candidus, T. vulgaris, Micropolyspora faeni, Aspergillus fumigatus, A. niger, A. flavus, A.
tamarri, A. sulphureus, A. repens, Penicillium chrysogenum, P. italicum, Rhizopus stolonifer, Alternaria
alternata, Curvularia lunata, and Histoplasmus capsulatum. See generally, McPartland JM. Contaminants and
adulterants in herbal Cannabis, in Cannabis and CannabinoidsPharmacology, Toxicology and Therapeutic
Potential (Grotenhermen F & Russo E eds.) (Haworth Press New York) 2002.
66 Hazekamp A, An evaluation of the quality of medicinal grade cannabis in the Netherlands. Cannabinoids
2006; 1(1):1-9.
67 Mem. P&A in Support of Plaintiff's Application for Temporary Restraining Order, Order to Show Cause Re
Preliminary Injunction and Preliminary Injunction, People v. Hemp Factory V et al., No. BC 424881 (Cal. Sup.
Ct. Oct. 30, 2009); .
68 In 2005, a cannabis advocate died from a neurological condition believed to have resulted from handling
cannabis contaminated by pesticides, which was being distributed through cannabis dispensaries. Gardner F.
Jane Weirick: Death of an Organizer, CounterPunch (Oct. 2005)
http://www.counterpunch.org/gardner10292005.html
64
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or with warnings and instructions for proper use, despite the fact that this is a requirement
for all medical products under both state 69 and federal law. Unlicensed and untrained
dispensary personnel offer medical advice concerning the efficacy or appropriateness of
various products.
Finally, appropriate physician supervision is virtually unavailable. As indicated
above, all state medical marijuana laws place physicians in an untenable positionon the
one hand, being appointed the gatekeepers of a patients access to cannabis, on the other,
having no access to the information necessary to provide meaningful advice and
supervision. Reliable dataessential to a physicians ability to assess a treatment option-are not being generated by the existing system of distribution and use. There is no
mechanism for collecting data reflecting efficacy or adverse events; therefore, the medical
community is precluded from knowing whether specific medical conditions are being
improved, to what extent, and in which percentage or subgroup of patients, nor whether
there are contraindications, drug-drug interactions, etc.
It is not surprising that, at national medical conferences in sessions describing New
Therapeutic Developments, herbal cannabis is almost never mentioned, despite its
prominence in the media. Without a foundation of rigorous data, developed in clinical trials
of proper length and design, and published in peer-reviewed journals, no cannabis product
can ever gain entrance into the physicians armamentarium and thereby become available
to patients as a legitimate option among various treatment choices. Therefore, if it
continues in its present form, the current cannabis distribution system has the
unfortunate--even ironic--effect of preventing the vast majority of patients--who wish to
be able to obtain meaningful guidance, advice, and supervision from their treating
physicians--from obtaining access to cannabis-based medications.
Physicians should carefully consider their ethical and professional responsibilities
before issuing a cannabis recommendation to a patient. A physician should not advise a
patient to seek a treatment option about which the physician has inadequate information
regarding composition, dose, side effects, or appropriate therapeutic targets and patient
populations. State medical boards have indicated that physicians who discuss cannabis
with a patient must adhere to the relevant standard of care and follow the basic
professional tenets of good patient care: a physical examination, medical history, review of
past medical treatments, development of a treatment plan, follow up and continuing
oversight. 70Failure to do so may result in a finding of unprofessional conduct and
significant sanctions, including license suspension or revocation.71 A physicians
69California
Sherman Food, Drug, and Cosmetic Act, Health & Safety Code secs. 109875-111915.
Medical Board of California, Medical Marijuana. www.medbd.ca.gov/Medical_Marijuana.html
71 Medical Board of California, In the Matter of the Accusation and Petition to Revoke Probation Against: Hany
Assad, MD.
http://licenselookup.mbc.ca.gov/licenselookup/lookup.php?LicenseType=A&LicenseNumber=54309 (Oct.
2009).
70
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professional liability coverage may also not extend to harm resulting from a patients use of
cannabis upon the physicians recommendation.72
This lack of effective physician oversight poses one of the greatest dangers to
patients in the system by which cannabis is made available for ostensible medical use.
The impact of this absence of professional monitoring is exacerbated by the fact that the
potency of cannabis herbal material and cannabis products has risen significantly over the
last few decades. 73 Such increased potency may heighten the risk of addiction.74 This is
particularly problematic in light of the fact that, increasingly, adolescents are obtaining
cards which enable them to purchase and use cannabis with legal impunity. A number of
adolescent psychiatrists have expressed concern at the rapidly increasing number of young
patients who enter treatment for cannabis dependence but who have cards facilitating
their continued use.75 Furthermore, several studies have revealed that a very large
percentage of individuals have sought cannabis cards in order to treat anxiety or
depression, rather than nausea/vomiting from cancer chemotherapy, HIV, or pain and that
almost all of those applicants initiated cannabis or other substance use during
adolescence. 76 77 Such individuals require close physicians supervision to ensure that they
are not developing or maintaining cannabis dependence, rather than attempting to
alleviate a medical condition. Finally, individuals who smoke or vaporize high-potency
cannabis are likely to experience intoxication, since inhalation rapidly raises plasma and
brain levels of THC. 78 79 This may prevent both physicians and patients from identifying
disease progression and hinder patients from obtaining appropriate treatment.80
72
Educating Voices, The Potential Medical Liability for Physicians Recommending Marijuana as Medicine.
http://www.educatingvoices.org/EVI_WhitePaper1.pdf (July 2003).
73 The University of Mississippi has been analyzing the THC levels of seized cannabis for over 30 years. In that
period, those levels (for domestic cannabis seizures) have increased from an average of 1.7% to 13%. See
University of Mississippi Marijuana Potency Monitoring Project,
www.whitehousedrugpolicy.gov/publications/pdf/mpmp_report_104.pdf.
74 National Center on Addiction and Substance Abuse, Non-Medical Marijuana III: Rite ofPassage or Russian
Roulette? http://www.casacolumbia.org/templates/publications_reports.aspx?keywords=marijuana (June
2008)
75 Thurstone C. Smoke and mirrors: Colorado teenagers and marijuana. Denver Post (Feb. 10, 2010) ; CMPC
doc
76 OConnell TJ, Bou-Matar CB. Long term marijuana users seeking medical cannabis in California (20012007): demographics, social characteristics, patterns of cannabis and other drug use of 4117 applicants.
Harm Reduction Journal 2007;4:16.
77 Gardner F./, Counterpunch (Oct. 23, 2006) What have California Doctors Learned About Cannabis,
http://www.counterpunch.org/gardner10232006.html
78 Huestis MA, Henningfield JE, Cone EJ. Blood cannabinoids. 1. Absorption of THC and formation of 11-OHTHC and THCCOOH during and after smoking marijuana. J. Anal. Tox. 1992; 16.
79 Huestis MA. Human cannabinoid pharmacokinetics. Chem. & Bio. 2007;4:1770-1804.
80 Medical Board of California, Medical Marijuana. www.medbd.ca.gov/Medical_Marijuana.html (The
physician should determine that medical marijuana use is not masking an acute or treatable progressive
condition, or that such use will lead to a worsening of the patients condition.)
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What Has Been Tried in Other Countries?

Both Canada and the Netherlands have government-supervised programs for
distributing cannabis for medical use. In Canada, court rulings mandated that the
government establish a procedure through which patients could qualify to cultivate and
possess cannabis for medical purposes. Subsequently, the government was required itself
to establish a regulated source of supply. 81
Physicians voiced serious concerns about this system. The Canadian Medical
Association stated:
Physicians are not in a position to counsel patients regarding the use of
marijuana. Specifically, they are unable to provide thorough and necessary
information regarding such issues as proper dosage, marijuana's interaction
with other drugs or its impact on other pre-existing medical conditions
Lack of information on the indications, risks and benefits of medicinal
marijuana hinders [a physicians] ability to inform properly patients and has
the potential to threaten the patient-physician relationship. CMA does not
support physicians controlling access to substances for which routine
pre-market regulatory review of safety, purity and efficacy, as required
for current prescription drugs, has not occurred.
Physicians for a Smoke-Free Canada concurred:
First, since marijuana has not been thoroughly tested as a medicine, most
physicians are familiar neither with its potential benefits (if any), nor with
the dosage required to achieve those benefits. Second, when a patient is
requesting smoked marijuana, the risks associated with smoking, coupled
with the lack of clinical knowledge about specific benefits, make any
accurate approximation of the risk to benefit ratio of treatment
impossible. 82
The Canadian Medical Protective Association voiced the same objections:
Given the fact that many physicians would not have the necessary knowledge about
the effectiveness, risks or benefits of marijuana, we believe it is unreasonable to
make physicians [the] gatekeepers in this process.83
81
Health Canada, Marihuana Medical Access Regulations http://www.hc-sc.gc.ca/dhp-mps/marihuana/lawloi/acts-reg-loi-eng.php

82 Physicians for a Smoke-Free Canada, Health Canadas Policies on Marijuana Put Patients at Risk, (January
2002) 1226A Wellington Street, Ottawa, Ontario K1Y 3Ai http://www.smoke-free.ca/pdf_1/psc-position-onmarijuana.PDF
83
Wharry, S., CMPA warns doctors of risks associated with prescribing marijuana, CMAJ (2002 Jan. 8)
166(1): 83; CMPA, Medical marijuana: Update for physicians who complete a medical declaration under the
Marihuana Medical Access Regulations, (revised May 2008) https://www.cmpaacpm.ca/cmpapd04/docs/resource_files/infoletters/2005/com_il0540_2-e.cfm (accessed Feb. 22, 2010).
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Kingsbury0092
In 2005, the MMAR regulations were revised to remove the requirement that
physicians recommend a specific daily dose, form and route of administration. However,
physicians are still required to indicate, in their medical declaration, the daily amount,
form, and route of administration that the applicant intends to use. Although physicians no
longer must state that the benefits of cannabis outweigh the risks, applicants must still
declare that they have discussed the risks with the physician who signs the medical
declaration. CMPA notes that the amended Regulations represent an improvement, but
do not address all the CMAs and CMPAs previously expressed concerns.
Under the Health Canada program, cultivation is required to be conducted under
Good Manufacturing Practices. Furthermore, in order to ensure that the microbial content
remains at acceptable levels, the cannabis is irradiated before it is provided to patients.8485
The dried cannabis has a THC level of 12.5 2%. Health Canada provides information to
both physicians and to patients concerning the use of cannabis, including potential side
effects. 86 Nevertheless, the system is foundering. An estimated 400,000-1,000,000
Canadians use cannabis for self-identified medical purposes, but approximately 4029
persons have government authorizations to possess cannabis. Fewer than 20% of those
access cannabis from Health Canada. 87 Detractors of the program claim, among other
things, that the government authorization process is too lengthy and cumbersome;
relatively few physicians will sign the necessary form; and the quality of the cannabis is not
satisfactory (although it is on average 12% THC). They further claim that patients wish to
select different strains for various medical conditions; and dosing limits confine patients to
5 grams a day, unless a physician is willing to explain a patients need for a higher daily
intake. 88 89 As a result, patients obtain their cannabisand their information about the
medical uses of cannabis and cannabis products-- from different compassion clubs.
CMPA advises their members to obtain a release from liability from a patient for whom the physician has
approved the use of cannabis.
84 Health Canada, Product Information Sheet on Dried Marihuana (Cannabis), http://www.hc-sc.gc.ca/dhpmps/marihuana/supply-approvis/index-eng.php .
85 The Netherlands has a similar program. That cannabis, too, is irradiated to reduce microbial levels.
Hazekamp A, An evaluation of the quality of medicinal grade cannabis in the Netherlands. Cannabinoids 2006;
1(1):1-9.
86 Health Canada, Product information Sheet on Dried Marihuana, http://www.hc-sc.gc.ca/dhpmps/marihuana/supply-approvis/index-eng.php , Information for Health Care Professionals,
http://www.hc-sc.gc.ca/dhp-mps/marihuana/how-comment/medpract/infoprof/index-eng.php
87 As of June 2009, 4029 persons were authorized to possess cannabis, and 2841 persons were authorized to
cultivate cannabis for medical purposes (2360 of which hold a personal use production license; 481 hold a
designated-person production license). However, only 798 are currently obtaining cannabis from Health
Canada; 891 have obtained seeds for cultivation; and 188 persons have received both. http://www.hcsc.gc.ca/dhp-mps/marihuana/stat/_2009/june-juin-eng.php
88 New rules slap in the face: Medical marijuana advocates, The Gazette (Jan. 2010)
http://www.montrealgazette.com/health/watchdog+takes+Canada+medical+marijuana+program/2611923
/Laws+ineffective+curbing+cannabis+Experts/2485837/rules+slap+face+Medical+marijuana+advocates/16
32440/story.html .
89
Belle-Isle L, Hathaway A. Barriers to access to medical cannabis for Canadians living with HIV/AIDS. AIDS
Care 2007; 19(4):500-506.
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In addition to criticisms from health care providers and patients, Canada has also
incurred a reprimand from the International Narcotics Control Board, which believes that
Canada is operating outside of its obligations under international treaties. In the aftermath
of the INCBs statement, governmental authorities have undertaken to review the Canadian
program. 90
The situation in Canada demonstrates that even government-supervised cannabis
cultivation and distribution programs are not sufficient to enable cannabis to become a
legitimate medication that physicians are (or should be) comfortable prescribing. In order
for cannabis-based products to become broadly available to patients through their
treating physicians, those products must go through the conventional domestic
medication approval processes.
Existing Research: What Do We Know and What Do We Still Need to Determine?
Issues for Additional Research
Considerable analytical and preclinical research and clinical investigations have
been conducted with cannabinoid agonists, antagonists, and other compounds that affect
the cannabinoid receptor system. In examining such research, it is essential to avoid
drawing excessively broad conclusions about the benefits and risks of smoked cannabis in
humans from the results of published studies involving other preparations and other
research settings. 91 For example, preclinical research studying synthetic THC, in vitro or in
vivo, may offer intriguing possibilities for future clinical research, but it is certainly not
determinative of the benefit/adverse event profile of smoked cannabis (or THC) in humans.
Evidence that THC can inhibit malignant tumor growth in rodents does not mean, or even
suggest, that smoking cannabis can prevent or cure cancer.92 Such studies provide at best a
foundation for pursuing small pilot studies of a cannabinoid formulation in humans.93 The
effects of pure oral THC may differ significantly from that of smoked cannabis, because of
both the formulation and the very different mode of delivery. Even different non-smoked
cannabinoid formulations may exert notably disparate effects, depending on the
cannabinoid composition and the method of administration. Finally, the effects of cannabis
or cannabinoids in experimental pain models may not indicate how patients with chronic
pain conditions would respond: The respective mechanisms underlying the whole variety
of chronic pain syndromes may considerably differ from acute nociception. 94
90
Edwards S., UN watchdog takes aim at Canadas medical marijuana program, The Gazette (Feb. 25, 2010)
http://www.montrealgazette.com/health/watchdog+takes+Canada+medical+marijuana+program/2611923
/story.html.
91 Case studies, surveys, and non-controlled studies are beyond the scope of this report and will not be
examined.
92 Guzman M. Cannabinoids: potential anticancer agents. Nat. Rev. Cancer. 2003; 3: 745-755.
93 Guzman M. et al. A pilot clinical study of 9-tetrahydrocannabinol in patients with recurrent glioblastoma
multiforme. Br. J. Cancer. 2006; 95: 197-203.
94 Hazekamp A, Grotenhermen F. Review on clinical studies with cannabis and cannabinoids 2005-2009.
Cannabinoids. 2010; 5(special issue): 1-21.
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Current research reports and reviews rarely acknowledge that the composition and
cannabinoid profile of modern herbal cannabis may be very different from that which
existed centuries or even decades ago. Although discussions of cannabis commonly begin
with the claim that cannabis has been used therapeutically for hundreds, if not thousands,
of years, these research reports or reviews fail to point out that the cannabis plant has
been significantly modified over that period through breeding techniques and modern
cultivation practices. The widespread use of sinsemilla (the bud of the unfertilized female
plant), coupled with sophisticated indoor cultivation projects, have in many cases
increased THC levels considerably above those present in cannabis even 40 years ago.
In addition, selective breeding techniques have resulted in cannabis plants almost
totally devoid of CBD (cannabidiol), a non-psychoactive cannabinoid with important
therapeutic potential. In the past, a harvest of wild cannabis would have often been
composed of approximately half THC and half CBD (of its major cannabinoids). 95 CBD has
analgesic, anti-psychotic, anticonvulsant, neuroprotective properties. 96 97 98 There is also
evidence that CBD may mitigate some of the negative effects of THC, such as
psychoactivity. 99 100 Numerous reports have confirmed that CBD is almost entirely absent
from modern black market cannabis. 101 Because of these trends, modern herbal cannabis
available in dispensaries may have very different effects than those reported centuries or
even decades ago. The absence of CBD, coupled with higher levels of THC, may have
adverse effects on patients, particularly in chronic use.102 103 More research is needed to
elucidate the effects of different cannabinoid (especially THC: CBD) ratios.
Dose-response relationships also require further research. Cannabinoids are known
to exhibit biphasic effects, i.e., a lower dose may relieve a symptom but a higher dose may
exacerbate it.104 A clinical study of smoked cannabis in experimental pain illustrates this
well. 105 Furthermore, since patients vary widely in their response to cannabinoids,
95
Potter DJ, Clark P, Brown MB. Potency of9 -THC and other cannabinoids in cannabis in England in 2005:
Implications for psychoactivity and pharmacology. J. Forensic Sci. 2008; 53(1): 90-95.
96 Russo E, Guy GW. A tale of two cannabinoids: The therapeutic rationale for combining
tetrahydrocannabinol and cannabidiol. Med. Hypoth. 2006; 66: 234-246.
97 Mechoulam R., Maximillian P, Murillo-Rodriguez E, Hannus LO. CannabidiolRecent Advances. Chem. &
Biodiv. 2007; 4:1678-1692.
98 Pertwee RG. The Pharmacology and Therapeutic Potential of Cannabidiol.
99 Karniol IG, Shirakawa I, Kasinski N, Pfeferman A, Carlini EA. Cannabidiol interferes with the effects of9 tetrahydrocannabinol in man. Eur. J. Pharm. 1974; 28: 172-177.
100 Karniol IG, Carlini EA. Pharmacological interaction between cannabidiol and9 -tetrahydrocannabinol.
Psychopharm. 1973; 33: 53-70.
101 Potter DJ, Clark P, Brown MB. Potency of 9-THC and other cannabinoids in cannabis in England in 2005:
Implications for psychoactivity and pharmacology. J. Forensic Sci. 2008; 53(1): 90-95..
102 DiForti M, et al. High-potency cannabis and the risk of psychosis. Br. J. Psych. 2009; 195: 488-491.
103 Sterling E. Why good old fashioned Cannabis didnt cause psychosis. Sterling on Justice & Drugs (Jan. 22,
2010) http://justiceanddrugs.blogspot.com/2010/01/why-good-old-fashioned-cannabis-didnt.html
104 Health Canada. Information for Health Care Professionals. http://www.hc-sc.gc.ca/dhpmps/marihuana/how-comment/medpract/infoprof/index-eng.php .
105 Wallace M et al. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in
healthy volunteers. Anesth. 2007; 107: 785-796.
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Kingsbury0095
inadequate dosing or titration, e.g., the use of fixed doses may cause a clinical study to be
negative, even if the investigative agent might otherwise have been expected to have
therapeutic value. 106
The method of medication delivery may also markedly affect both the extent of
efficacy and range of side effects. The IOM has stated that oral dronabinol has low
bioavailability and a prolonged onset of action, making it extremely difficult for patients to
adjust their dose. 107 Psychoactivity, often in the form of dysphoria, is a problem and may
prevent a patient from consuming a dose large enough to have therapeutic effect. It has
been reported that some cannabis dispensaries prepare elixirs, honeys, baked goods, and
candies, but there are no reliable data to indicate whether these preparations are more
efficacious and/or better tolerated than oral dronabinol.
Different subgroups of patients may have different responses to cannabis and
cannabinoids. Patients with debilitating and/or chronic medical conditions, elderly
patients, and those who are cannabis-nave may be more sensitive to CNS and other side
effects. There is evidence of a gender difference in responsiveness to cannabinoids,
particularly with regard to analgesia. 108
Results of Controlled Clinical Trials
Cannabinoid researchboth preclinical and clinicalhas increased almost
exponentially in the past 20 years. A number of thorough reviews have been published
which describe these studies.109 110 111 112 113Unfortunately, most literature reviews
structure their analyses by the type of disease state, rather than the specific type of
cannabis or cannabinoid intervention that was used to study that disease state. For the
reasons stated above, this has the result of creating confusion and uncertainty, since
different cannabis- and cannabinoid-preparations (with different formulations and dosage
106
Strasser F et al. Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in

treating patients with cancer-related anorexia-cachexia syndrome: A multicenter, Phase III, randomized,
double-blind, placebo-controlled clinical trial from the Cannabis-In-Cachexia_Study_Group. J. Clin. Oncol.
2006; 24(21): 3394-3400.
Press..
Cannabinoids. 2010; 5(special issue): 1-21.
Press.
110Ben Amar M. Cannabinoids in medicine: A review of their therapeutic potential. J. Ethno-Pharmacol. 2006;
105: 1-25.
Cannabinoids 2010; 5(special issue): 1-21.
112 Russo EB. Cannabinoids in the management of difficult to treat pain. Ther. And Clin. Risk Manage. 2008;
4(1): 245-259.
113 Health Canada. Information for Health Care Professionals. http://www.hc-sc.gc.ca/dhpmps/marihuana/how-comment/medpract/infoprof/index-eng.php.
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forms) may have different effects. Therefore, the brief summary of recent studies described
below will focus on the type of cannabis or cannabinoid product. In a limited number of
some studies, two such products were compared against placebo. In such cases, the studies
are generally mentioned twice.
Oral Cannabinoid Preparations
Dronabinol
Dronabinol (synthetic) is the best-known oral cannabinoid preparation. 114 The FDA
approved it in 1985 for treatment of nausea and vomiting associated with cancer
chemotherapy in patients who had failed adequately to respond to existing antiemetic
treatments and in 1992 for anorexia associated with weight loss in patients with AIDS. It
showed efficacy in early studies by comparison to then-available anti-emetics.115 It has not,
however, been compared with more recent anti-emetic medications, which have much
better efficacy. One study has shown efficacy in delayed chemotherapy-induced nausea
and vomiting comparable to ondansetron, although the combination of dronabinol and
ondansetron did not provide benefit beyond that observed with either agent alone.116 It did
not show efficacy in a trial comparing an oral cannabis extract (Cannador), THC and
placebo on appetite and quality of life in patients with cancer-related anorexia-cachexia
syndrome 117 and was not more efficacious than megestrol acetate.118 For a study
investigating dronabinol and smoked cannabis on viral load and food intake in HIV positive
patients, see discussion below.
Studies of Marinol as an analgesic and/or antispasmodic have been mixed. Early
studies found it efficacious in reducing cancer pain at doses of 10, 15, and 20 mg. but side
effects were prominent.119 120 It has been found effective in central neuropathic pain in
multiple sclerosis, 121 but not in postoperative pain. 122 The Institute of Medicine has stated
114
The branded name is Marinol. In Schedule III of the CSA, the substance is defined as: dronabinol
(synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a US Food and Drug Administration
approved product. 21 CFR sec. 1308.13(g)(1). Generic versions of Marinol are now on the market.
Chicago, Illinois; June 2001 (citing studies).
116 Meiri E et al. Efficacy of dronabinol alone and in combination with ondansetron versus ondansetron alone
for delayed chemotherapy-induced nausea and vomiting. Curr. Med. Res. Opin. 2007; 23(3): 533-543.
117 Strasser F et al. Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in
2006; 24(21): 3394-3400.
118 Jatoi et al. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated
anorexia: a North central cancer treatment group study. J. of Clin. Onc. 2002; 20: 567-573.
119 Noyes Jr. R., Brunk SF, Avery DH, Canter A. The analgesic properties of delta-9-tetrahydrocannabinol and
codeine. Clin. Pharm. and Therap. 1975; 15: 139-143.
120 Noyes Jr. R, Brunk SF, Baram DA, Canter A. Analgesic effects of delta-9-tetrahydrocannabinol. J. ofClin.
Pharm. 1975; 18: 84-89.
121 Svendsen KB, Jensen TS, Bach FW. Does the cannabinoid dronabinol reduce central pain in multiple
sclerosis? Randomised double blind placebo controlled crossover trial. BMJ. 2004; 329: 253.
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that, "It is well recognized that Marinol's oral route of administration hampers its
effectiveness because of slow absorption and patients' desire for more control over
dosing." 123
In a large trial of patients with multiple sclerosis, dronabinol124 did not show
objective improvement in spasticity measured on the Ashworth scale, although there was
objective improvement in mobility and subjective improvements in spasticity, spasm, pain
and sleep quality. 125 In a one-year follow up, patients showed a small objective
improvement in spasticity, as well as highly significant subjective improvements in
spasticity, spasm, pain, tiredness and sleep.126
Cesamet
Cesamet (Nabilone) is a synthetic cannabinoid analogue that is believed to be
more potent than THC. It is approved for the treatment of nausea and vomiting associated
with cancer chemotherapy in patients who have failed adequately to respond to available
antiemetics. In one small study, it has been shown to reduce spasticity-related pain in
patients with upper motor neuron syndrome. 127 In a controlled study of patients
undergoing various surgical procedures, high dose Nabilone in the presence of morphine
PCA was associated with an increase in pain scores.128
Cannador
Cannador is an oral cannabis extract (encapsulated), with reportedly a 2:1 ratio of
THC to CBD. It is under investigation in Europe by the Institute for Clinical Research. In a
study comparing Cannador with dronabinol and placebo on appetite and quality of life in
patients with cancer-related anorexia-cachexia syndrome, no differences were found
between Cannador, THC or placebo. 129 In a large study of patients with multiple
sclerosis, it did not show objective improvement in spasticity measured on the Ashworth
scale, although there was subjective improvements in spasticity, spasm, pain and sleep
122
Buggy DJ, Toogood L, Maric S., Sharpe P. Lambert DG, Rowbotham DJ. Lack of analgesic efficacy of oral
delta-9-tetrahydrocannabinol in postoperative pain. Pain. 2003; 106: 169-172.
Press. Pages 205-06
124 This study compared dronabinol, Cannador and placebo.
125 Zajicek J, et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis
(CAMS study): multicenter randomised placebo-controlled trial. The Lancet. 2003; 362: 1517-1526.
126 Zajicek JP et al. Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 123 months
follow up. J. ofNeurol., Neurosurgery and Psych. 2005; 76: 1664-1669.
127 Wissel J et al. Low dose treatment with the synthetic cannabinoid Nabilone significantly reduces spasticityrelated pain. J. Neurol. 2006; 253(10):1337-1341.
128 Beaulieu P. Effects of nabilone, a synthetic cannabinoid, on postoperative pain. Can. J. Anesth. 2006; 53(8):
769-775.
129 Strasser F et al. Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in
2006; 24(21): 3394-3400.
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quality. 130 In a one-year follow up, patients showed a small objective improvement in
spasticity, as well as highly significant subjective improvements in spasticity, spasm, pain,
tiredness and sleep. 131
In analgesic studies, Cannador has shown a modest dose-dependent decrease in
rescue analgesia requirements in postoperative pain. 132
Smoked/vaporized Herbal Cannabis
In 2003, a controlled residential study found that both smoked cannabis and
dronabinol had beneficial effects on appetite and weight gain in HIV positive patients on
stable anti-retroviral therapy. In the course of the 21-day treatment period, there was no
adverse effect on viral load or the number of CD4+ and CD8+ lymphocytes, nor did the two
forms of cannabinoids interfere with the protease inhibitors taken by the patients. 133 A
subsequent study demonstrated that both smoked cannabis and dronabinol increased food
intake in experienced cannabis smokers, although this increase paralleled increased ratings
of intoxication.134
In 1999, the Center for Medicinal Cannabis Research (CMCR) was established
pursuant to legislation commissioning the University of California to establish a research
program to investigate the therapeutic potential of cannabis and cannabinoids. 135 Over the
course of the next 10 years, CMCR approved and funded fifteen clinical studies, including
seven controlled clinical trials, of which five have completed and two are ongoing.136 Five
clinical studies have been published in peer-reviewed journals. Three of these studies
involved neuropathic pain; a fourth involved experimental pain, and one involved a pilot
study for a cannabis delivery device. 137 138 139 140
130
Zajicek J, et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis
(CAMS study): multicenter randomised placebo-controlled trial. The Lancet. 2003; 362: 1517-1526.
131 Zajicek JP et al. Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 123 months
follow up. J. ofNeurol., Neurosurgery and Psych. 2005; 76: 1664-1669.
132 Holdcroft A, Maze M,. A multicenter dose-escalation study of the analgesic and adverse effects of an oral
cannabis extract (Cannador) for postoperative pain management. Anesth. 2006;104: 1040-6.
133 Abrams DI et al. Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized,
placebo-controlled clinical trial. Ann. Intern. Med. 2003; 139(4): 258-266.
134 Haney M, Rabkin J, Gunderson E, Foltin RW. Dronabinol and marijuana in HIV(+) marijuana smokers: acute
effects on caloric intake and mood. Psychopharm. (Berl). 2005; 181(1): 170-178.
135 SB 847, establishing the Medical Marijuana research Act of 1999.
136 Center for Medicinal Cannabis Research, Report to the Legislature and Governor of the State of California
presenting findings pursuant to SB 847 that created the CMCR and provided state funding.
http://www.cmcr.ucsd.edu/CMCR_REPORT_FEB17.pdf
137 Abrams DI et al. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled
trial. Neurology 2007; 68(7): 515-521.
138 Wilsey B et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic
pain. J. Pain 2008; 9(6): 506-521.
139 Ellis RJ et al. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical
trial. Neuropsychopharm. 2009; 34(3): 672-680.
140 Abrams DI et al. Vaporization as a smokeless cannabis delivery system: A pilot study. Clin. Pharmacol. Ther.
2007; 82(5): 572-578.
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These studies have provided very preliminary evidence that further trials of
cannabis-derived and cannabinoid medications in neuropathic pain of various origins
should be pursued to identify desirable cannabis-based or cannabinoid formulations and
modes of delivery. The results of these studies cannot, however, be said to prove that
smoked cannabis should be made available to patients with chronic pain conditions. Each
study was conducted in a small number of patients and was of very short duration. In
almost all cases, the patients were cannabis-experienced; indeed, in one study, the authors
noted that only cannabis experienced patients were entered into the study in order to
reduce the risk of adverse psychoactive effects in nave individuals.141 Therefore, the
risk/benefit profile in these patientsparticularly the incidence of adverse CNS events-cannot be generalized to cannabis-naive patients. In fact, in one study, an incident of acute
cannabis-induced psychosis occurred in a cannabis-nave patient, resulting in his
withdrawal from the study. 142
Even among cannabis-experienced patients, the level of adverse events was notable;
in one study, cognitive impairment was especially prominent.143 This could suggest that an
inhalation mode of delivery may not be optimal. Such rapid delivery of THC may not be
necessary in patients with chronic conditions, so long as the dosage form enables patients
to titrate their dosing level to individual benefit/tolerability over several days. The
cannabis available in these studies was a maximum of 8% THC; in one study, cannabis of
only 3.5% generated a significant CNS side effect profile.144 Such CNS side effects would no
doubt be even more prevalent if patients were to use higher-potency cannabis, such as that
available in dispensaries. Finally, the effectiveness of the blinding is subject to question,
since the patients were cannabis-experienced and could be expected to be able to
distinguish active from placebo. In the Ellis study, blinding was evaluated; 93% of those
patients assigned to receive cannabis accurately guessed that they were on active
medication, whereas the patients assigned to placebo generally did not guess correctly.145
The results of these studies, while quite interesting, constitute at most the early
stages of cannabinoid medication development. Neither the efficacy nor the adverse events
in these short-term acute studies can be extrapolated to chronic use. Alone, they could not
form the basis of FDA approval, nor of cannabis rescheduling.
141
Wilsey B et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic

pain. J. Pain 2008; 9(6): 506-521.
143 Wilsey B et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic
pain. J. Pain 2008; 9(6): 506-521.
144 Abrams DI et al. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled
trial. Neurology 2007; 68(7): 515-521.
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Oromucosal/sublingual Cannabis-derived Preparations

Sativex (nabiximols) is a botanically derived cannabis extract with a defined 1:1
ratio of THC to CBD and delivered as an oromucosal spray. 146 Sativex has shown positive
results as an adjunctive treatment in controlled studies involving patients (with previously
intractable symptoms who remained on all their existing medications) with brachial plexus
avulsion 147, central neuropathic pain in multiple sclerosis,148 spasticity in multiple
sclerosis, 149 rheumatoid arthritis,150 peripheral neuropathic pain, 151 and pain associated
with advanced cancer. 152 Interestingly, in the cancer pain study, nabiximols showed
statistically significant analgesic effect compared with placebo, whereas a THCpredominant extract did not. This may suggest that the THC: CBD formulation has a
different therapeutic impact compared to THC without CBD.
Symptom relief with nabiximols was maintained in long-term studies, without the
need for dose escalation. 153 Patients who abruptly withdrew from nabiximols did not
exhibit a cannabis withdrawal syndrome 154 or any withdrawal symptoms requiring
treatment. Intoxication scores remained low, even during dose titration.155 Sativex does
not induce psychopathology or impair cognition in cannabis-nave patients with multiple
sclerosis. 156
It is approved in Canada under the Notice of Compliance with Conditions (NOC/c) as
an adjunctive treatment for neuropathic pain in multiple sclerosis and for pain associated
146
Sativex is produced by GW Pharmaceuticals in the UK. Nabixomols is the US Adopted Name (USAN).
Berman JS, Symonds C, Birch R. Efficacy of two cannabis based medicinal extracts for relief of central
neuropathic pain from brachial plexus avulsion: results of a randomised controlled trial. Pain. 2004; 112:
299-306.
148 Rog DJ, Nurmikko T, Friede T, et al. Randomized controlled trial of cannabis based medicine in central
neuropathic pain due to multiple sclerosis. Neurology. 2005; 65: 812-19.
149 Collin C, Davies P, Mutiboko IK, Ratcliffe S. Randomized controlled trial of cannabis-based medicine in
spasticity caused by multiple sclerosis. Eur. J. Neur. 2007; 14: 290-296.
150 Blake DR et al. Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine
(Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology (Oxford). 2006; 45:50-2.
151 Nurmikko TJ, Serpell MG, Hoggart B., Toomey PJ, Morlion BJ, Haines D. Sativex successfully treats
neuropathic pain characterized by allodynia: A randomized, double-blind, placebo-controlled clinical trial.
Pain. 2007; 133(1): 210-20.
152 Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind,
randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD
extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. Feb
2010;39(2):167-179..
153 Wade DT, Makela PM, House H, Bateman C, Robson P. Long-term use of a cannabis-based medicine in the
treatment of spasticity and other symptoms in multiple sclerosis. Mult. Scler. 2006; 12: 639-645. e
154 Budney AJ, Hughes JR. The cannabis withdrawal syndrome. Curr. Opin. Psychiatry. 2006; 19: 233-238.
155 Wade DT, Makela PM, House H, Bateman C, Robson P. Long-term use of a cannabis-based medicine in the
treatment of spasticity and other symptoms in multiple sclerosis. Mult. Scler. 2006; 12: 639-645.
156 Aragona M et al. Psychopathological and cognitive effects of therapeutic cannabinoids in multiple
sclerosis: A double-blind, placebo controlled, crossover study. Clin. Neuropharm. 2009; 32(1): 41-47.
147
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with advanced cancer pain.157 In the United States, it is undergoing advanced clinical
studies in patients with advanced cancer whose pain has not been adequately relieved by
strong (Step III) opioids. Sativex is expected to be approved in the United Kingdom and
Spain for treatment of spasticity associated with multiple sclerosis in the Spring of 2010,
and may be available soon thereafter in other European Union countries under harmonized
recognition procedures.
Are There Principled Reasons for Exempting Cannabis from the Quality, Safety, and
Efficacy Requirements of the Modern Medication Model?
Is Cannabis Benign?--Risks and Side Effects
Cannabis is not a harmless herb. According to the IOM, it is a powerful drug with
a variety of effects. 158 To be sure, all medications have potential side effects, some of them
quite serious. During the course of controlled clinical trials (both pre- and post-marketing),
many of these side effects are identified, and a products benefit/risk profile can thereby be
assessed, by both regulatory authorities and the medical profession. Ongoing physician
supervision allows these risks to be managed, e.g., by dose adjustment, discontinuation of
treatment, or rotation to/augmentation by an alternate or additional medication. Product
labels and inserts apprise patients of probable side effects. For example, patients should be
warned of the risks of driving or operating heavy machinery while under the influence of
cannabinoids. 159 160 Cannabis products distributed by dispensaries lack this information.
A number of these side effects may be of particular concern when used in significant
amounts daily, over a long period, in smoked form, by patients with debilitating medical
conditions. The acute effects of pure THC and high-THC cannabis that are relevant to
medical use include intoxication (including dysphoria), anxiety (including panic attacks),
hallucinations and other psychotic-like symptoms, somnolence, confusion, psychomotor
impairment, cognitive impairment, dizziness, orthostatic hypotension, dry mouth161,
tachycardia. 162 In clinical trials of cannabinoid products, patients with pre-existing serious
mental disorders, significant hepatic or renal impairment, epilepsy, cardiac conditions, or
157
Health Canada, Qualifying NoticeSativex. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/noticesavis/conditions/sativex_qn_aa_091289-eng.php (pain in MS0; http://www.hc-sc.gc.ca/dhpmps/prodpharma/notices-avis/conditions/sativex_qn_aa_109461-eng.php (cancer pain)
Press .
159 U.S. National Highway Traffic Safety Administration. Drugs and Human Performance Fact Sheets:
Cannabis/Marijuana (9-Tetrahydrocannabinol, THC) 2004.
http://www.nhtsa.dot.gov/people/injury/research/job185drugs/cannabis.htm
160 Inhalation of cannabis produces deficits in tracking, reaction time, visual function, and divided attention.
Beirness DJ, Porath-Waller AM. Cannabis use and driving. Clearing the Smoke on Cannabis. Canadian Centre on
Substance Abuse (2009) www.ccsa.ca.
161 Dry mouth can cause gum disease, tooth decay, and mouth infections, such as thrush.
Press .
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prior substance abuse/dependence are typically excluded. Nevertheless, patients with

these conditions are routinely added to the "membership lists" of dispensaries.
The IOM recognized that these acute side effects are within the risks tolerated for
many medications.163 As noted above, however, the side effects of other medications have
been identified by means of extensive testing and examination in both
nonclinical/preclinical and Phase I-III clinical trials, including large double-blind, placebocontrolled studies. The acute side effects of smoked cannabis have not been fully elucidated
through such comprehensive testing. As a result of these potential side effects, which may
more severely impact the elderly or those with hepatic or immune impairment, it is
imperative that specific cannabis and cannabinoid medications are studied in particular
medical conditions and patient populations, and patients using such medications in clinical
practice should be properly supervised by their treating physicians. Under the current
system in the 14 states that have medical marijuana laws, none of this data collection and
physician supervision is taking place according to regulatory standards.
The chronic effects of inhaled cannabis are of special concern in the context of
medical use. These chronic effects can be placed into several categories: the effects of
chronic smoking and the effects of inhaled THC. Patients often use 1-5 grams a day of
cannabis; this represents 1-8 cannabis cigarettes. 164 The remaining patients in the federal
Compassionate Use Program are provided with 300 cannabis cigarettes per month. 165
Cannabis smoke contains many of the components of tobacco smoke. Smoking a
cannabis cigarette can deposit as much as four times the amount of tar in the lungs,
compared to smoking a tobacco cigarette. 166 This effect results from the fact that cannabis
cigarettes lack filters and cannabis smokers inhale more deeply and hold their breath
163
Joy, J.E., Watson, Jr., S.J., & Benson, J.A. (Eds). (1999). Marijuana and Medicine: Assessing the Science Base.
Press at p. 126.
164 Comeau P. New dosage limits for medical marijuana: But wheres the science? CMAJ. 2007; 177(6).
165The
National Institute on Drug Abuse ( NIDA) supplies cannabis to several patients under single patient socalled 'compassionate use' Investigational New Drug Applications (IND). In 1978, as part of a lawsuit
settlement by the Department of Health and Human Services, NIDA began supplying cannabis to patients
whose physicians applied for and received such an IND from the FDA. In 1992, the Secretary [of Health and
Human Services] terminated this practice, but decided that NIDA should continue to supply those patients
who
were
receiving
cannabis
at
the
time.
http://www.drugabuse.gov/about/organization/nacda/MarijuanaStatement.html.
166
Wu TC, Tashkin DP, Djahed B, Rose JE. Pulmonary hazards of smoking marijuana as compared with
tobacco. N. Eng. J. Med. 1988; 318: 347-351.
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longer than tobacco smokers hold theirs. 167 There is no doubt that chronic cannabis
smoking is harmful to the lungs. 168 169 170
The inhalation of cannabis also poses a risk of abuse and dependency. As the IOM
stated: Adolescents, particularly those with conduct disorders, and people with psychiatric
disorders, problems with substance abuse appear to be at great risk for marijuana
dependence than the general population. Heavy cannabis use in adolescence is associated
with a variety of neurocognitive deficits.171 The high-potency cannabis now distributed by
dispensaries could exacerbate these risks. The fact that adolescents have ready access to
cannabis cards, without meaningful physician supervision, is particularly problematic.
These concerns are not vitiated by vaporization, currently popular with cannabis
advocates. First, there are wide varieties of vaporizers available for purchase on the
internet and at cannabis dispensaries, although the FDA has approved none of them as a
medical device. They vary significantly in the extent to which they reduce toxic
combustion products. Even the most sophisticated vaporizer, the Volcano 172, has not
been demonstrated to eliminate all polyaromatic hydrocarbons, at least at higher
temperatures 173. Even at lower temperatures, ammonia, carbon monoxide and
acetaldehyde have also not been shown to be eliminated.174 175
Second, the products of vaporization are dependent on the quality and composition
of the underlying herbal material. If that material is highly standardized, the composition of
the vapor will be uncertain. If the herbal material is contaminated with pesticides or
microbes, it is possible that these contaminants will be incorporated into the vapor. Unless
the vaporizer device has a lockout mechanism, variability in intra- and inter-patient
167Joy,
J.E., Watson, Jr., S.J., & Benson, J.A. (Eds). (1999). Marijuana and Medicine: Assessing the Science Base.
Press
168 Tashkin DP. Smoked marijuana as a cause of lung injury. Monaldi Arch. Chest Dis. 2005; 63(2): 93-100.
169 Diplock J, Plecas D. Respiratory effects of cannabis smoking. Clearing the Smoke on Cannabis. Canadian
Centre on Substance Abuse (2009) www.ccsa.ca.
170 In 2009, Californias Office of Environmental Health Hazard Assessment added cannabis smoke to its
official list of known carcinogens. See, Tomar RS, Beaumont J, Hsieh JCY. Evidence on the Carcinogenicity of
Marijuana Smoke. http://www.oehha.ca.gov/prop65/public_meetings/pdf/cicslides060509.pdf
171 Schweinsburg AD, Brown SA, Tapert SF. The influence of marijuana use on neurocognitive functioning in
adolescents. Curr. Drug Abuse Rev. 2008; 1(1): 99-111.
172 The Volcano is produced by Storz & Bickel GmbH & Co. KG in Germany. http://www.storzbickel.com/vaporizer/storz-bickel-company-vaporizer-manufacturer.html.
173 Gieringer D, St. Laurent J, Goodrich S. Cannabis vaporizer combines efficient delivery of THC with effective
suppression of pyrolytic compounds. J. ofCannabis Ther. 2004; 4(1): 7-27.
174 Russo E. The Solution to the Medicinal Cannabis Problem. Ethical Issues in Chronic Pain Management
(Schatman ME and Gant BL eds.) (Taylor & Francis, Boca Raton, FL).
175 It is important that the FDA assess medical devices that deliver vaporization products to the lungs. The
FDA has recently warned consumers about the dangers of toxic and carcinogenic chemicals contained in
electronic cigarettes, touted as a smoke-free and less harmful alternative to smoking. FDA, FDA News Release,
FDA and Public Health Experts Warn About Electronic Cigarettes.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.htm
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inhalation patterns may make it unlikely that a known and reproducible dose will be
delivered.
Third, vaporization does not improve the side effect profile exhibited by smoked
cannabis, including its psychoactive effects. Like smoking, vaporization causes THC plasma
levels to rise abruptly. 176 Rapid delivery of THC to the plasma and brain in increases the
likelihood of intoxication and abuse liability, and may promote dependency. 177 Again, such
rapid delivery is probably not necessary for patients with chronic conditions, so long as the
dosage form enables such patients to titrate their dose adequately and predictably. 178 For
example, rapid onset opioid medications, such as buccal fentanyl, are prescribed for
patients with breakthrough pain, not with chronic persistent pain. In fact, patients with
such persistent pain are often placed on extended release opioid products once their
individual daily dose is established through short-term release products.
Finally, if cannabis joints or vaporizers are shared, dangerous pathogens can be
spread amongst seriously ill patients.179
Could a Cannabis Preparation Achieve FDA Approval?
As indicated above, the FDA has set forth the requirements for the development of a
botanically based prescription medication. Those agency recommendations require that
highly standardized cannabis herbal material (Botanical Raw Material) be developed into a
Botanical Drug Substance and ultimately into a Botanical Drug Product. Under the
Guidance document, it may be challenging for herbal materialeven if standardized--to be
approved, since the herbal material must also be incorporated into a defined and
reproducible dosage form. As the AMA report recognized, The future of cannabinoid-based
medicine lies in the rapidly evolving field of botanical drug substance development, as
well as the design of molecules that target various aspects of the endocannabinoid
system. 180 Smoked cannabisparticularly for chronic usewould no doubt pose risks
that would be unacceptable to the agency. Improvements in vaporization technology would
need to occur in order fully to eliminate all toxic combustion products and ensure a
standardized and predictable dose.
176
Miller J, Meuwsen I, ZumBrunnen T., de Vries M. A Phase I evaluation of pulmonary dronabinol

administered via a pressurized metered dose inhaler in healthy volunteers. Paper presented at : American
Academy of Neurology; April 14, 2005; Miami Beach, FL.
177 Samaha AN and Robinson TE. Why does the rapid delivery of drugs to the brain promote addiction? Trends
in Pharmacological Sciences. 2005; 26(2): 82-87.
178 Inhaled cannabis has a shorter duration of action that oral or other dosage forms. Russo E. The Solution to
the Medicinal Cannabis Problem. Ethical Issues in Chronic Pain Management (Schatman ME and Gant BL eds.)
(Taylor & Francis, Boca Raton, FL).
179 Zanocco V. Meningococcal cases linked by sharing joints. Vancouver, BC, Canada: Vancouver Coastal
Health; 2005. http://www.vch.ca/news/docs/2005_04_07_mening_joints.pdf.
180 Council on Science and Public Health Report 3, Use of cannabis for medicinal purposes. American Medical
Association, Interim Meeting , Houston, Texas; November 2009 (Executive Summary and Recommendations).
http://www.ama-assn.org/ama1/pub/upload/mm/38/i-09-csaph-reports.pdf
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None of this is impossible. Therefore, the obvious question arises: why, as a policy
matter, should herbal cannabis be exempted from the modern medication model? Many
new promising medications are under investigation, and suffering patients understandably
seek to obtain access to them as early as possible. The FDA has established fast-track
procedures 181 to facilitate this access, and compassionate access through Treatment INDs
is often available during late-stage product development.182 Both the FDA and the federal
courts, however, have concluded that seriously illeven terminally illpatients will not
benefit on balance from products that have not completed the vast majority of steps
leading to an approved medication. 183In short, the concept of medical necessity is not
sufficient to override the provisions of the Food, Drug and Cosmetic Act184 or the
Controlled Substances Act. 185
Allowing cannabis to circumvent the requirements of the FDA process sets a
dangerous precedent for the future. For example, herbal products called Spice, Skunk,
and Sence are currently becoming popular in the US and Europe. These products contain
herbal preparations that are enriched with synthetic cannabinoids, such as HU 210,
which is much more potent than THC.186 Like THC, HU 210 is controlled under Schedule I of
the CSA, although most of these other synthetic cannabinoids are not scheduled. Could
Spice advocates in the future contend that these products, too, should be made available
to patients and other consumers without being tested through the FDA process? This is,
indeed, a dangerously slippery slope.
The Significance of Scheduling
Both the AMA and ACP have recently questioned the status of cannabiss placement in
Schedule I of the Controlled Substances Act. 187 Schedule II substances are, for the most part,
subject to the same restrictions and requirements under the Controlled Substances Act,
including manufacturing and procurement quotas, security measures, recordkeeping,
import/export permits, etc. It may be useful, therefore, to examine what the rescheduling of
cannabis (presumably to Schedule II) would and would not achieve. Cannabis advocates
commonly urge that cannabis be rescheduled so that it can be made available to patients on
prescription. Rescheduling herbal cannabis alone would not, however, be sufficient to create
181
21 C.F.R. secs. 312.80, 312.10, 314.500.

FDA may approve use of an investigational drug by patients not part of the clinical trials for the
treatment of serious or immediately life-threatening disease[s] if there exists no comparable or
satisfactory alternative drug or other therapy, if the drug is under investigation in a controlled clinical trials,
and if the drugs sponsor is actively pursuing marketing approval of the investigational drug with due
diligence. 21 C.F.R. sec. 312.34.
183 Abigail Alliance for Better Access to Developmental Drugs and
Washington Legal Foundation v. von Eschenbach , 495 F.3d 695 (D.C. Cir. 2007) cert. den. 128 S. Ct. 1069
(2008).
184 Ibid.
185 United States v. Oakland Cannabis Buyers Cooperative, 532 U.S. 483 (2001).
186 DOJ, DEA, Intelligence Alert, Spice-- Plant Material(s) Laced with Synthetic Cannabinoids or Cannabinoid
Mimicking Compounds.
http://www.justice.gov/dea/programs/forensicsci/microgram/mg0309/mg0309.html
187 Note cannabis is assigned to Schedule I under most state controlled substances laws, including Californias.
182 The
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a medication that physicians could prescribe and pharmacists could dispense. In order to be
prescribable, any particular medication must have successfully completed the FDA approval
process. The FDA does not approve bulk substances, such as cannabis (or raw opium or coca
leaves), for marketing and direct prescription. Therefore, a specific cannabis-derived product
would have to be developed in accordance with FDA standards, which would require that it be
standardized, formulated, tested, and administered in an appropriate delivery system. In
order for a Schedule II substance to be made available by prescription, it must be contained in
one or more specific dosage forms, as is the case for opium. Each and every one of such dosage
forms must pass FDA muster. 188 189
FDA approval of a specific cannabis Botanical Drug Product would constitute currently
accepted medical use in the US, thereby allowing that product to be rescheduled into
Schedule II or below. 190 191 Such FDA approval, however, would not necessarily require the
rescheduling of bulk cannabis, despite the fact that opium and coca leaves are in Schedule II.
Although the Controlled Substances Act schedules apply to classes of substances, rather than
specific products, precedent has developed for split scheduling. For example, synthetic
dronabinol, in a specific FDA-approved formulation, is listed in Schedule III, while pure THC in
any other form remains in Schedule I. 192 Similarly, Xyrem, an approved treatment for
narcolepsy, is classified in Schedule III, while street versions of GHB remain in Schedule I. 193
Therefore, if such a specific cannabis product were approved by the FDA and rescheduled by
the DEA, bulk herbal cannabis could still remain in Schedule I.
Rescheduling of cannabis would also not allow pharmacists to compound cannabis
products for large numbers of patients. The FDA has issued numerous warning letters to
compounding pharmacists, emphasizing that:
The drugs that pharmacists compound are not FDA-approved and lack an
FDA finding of safety and efficacy, however, FDA has long recognized the
important public health function served by traditional pharmacy
compounding. FDA regards traditional compounding as the extemporaneous
combining, mixing, or altering of ingredients by a pharmacist in response to a
188
Russo E. The Solution to the Medicinal Cannabis Problem. Ethical Issues in Chronic Pain Management
(Schatman ME and Gant BL eds.) (Taylor & Francis, Boca Raton, FL).
189 Interestingly, one prominent cannabis advocate, who has filed cannabis rescheduling actions, does not
contend that rescheduling would make cannabis prescribable to patients. Gettman J. Frequently Asked
Questions about Medical Cannabis and Rescheduling. http://www.drugscience.org/lib/freq_qst.html .
190 Grinspoon v. DEA, (1st Cir. 1987) 828 F.2d 881,890, citing H.R. Rep. No. 534, 98 th Cong. 2d Sess. 4 (1984),
reprinted in 1984 U.S. Code Cong. & Admin. News 540,543.
191 As noted above, fn 42, delineating the criteria that must be met in order for a substance to have a
currently accepted medical use in the US. These criteria can only be satisfied by a robust body of scientific
data, not by the enactment of state laws that decriminalize the use of cannabis for medical purposes. US
Department of Justice, DEA, letter to Carl Olsen (Dec. 19, 2008) (denying a petition for rescheduling).
http://www.iowamedicalmarijuana.org/petitions/pdfs/dea_20081219.pdf
192 DOJ, DEA, Technical Amendment to Listing in Schedule III of Approved Drug Products Containing
Tetrahydrocannabinols; Withdrawal of Proposed Rule. 73 Fed. Reg. 56533 (Sept. 2008).
193 Neuman A. GHBs Path to Legitimacy: An Administrative and Legislative History of Xyrem. (LEDA Harvard
Law School)(April 2004) http://leda.law.harvard.edu/leda/data/629/Neuman.html .
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physician's prescription to create a medication tailored to the specialized

needs of an individual patient. See Thompson v. Western States Medical
Center, 535 U.S. 357, 360-61 (2002). Traditional compounding typically is
used to prepare medications that are not available commercially, such as
a drug for a patient who is allergic to an ingredient in a mass-produced
product or diluted dosages for children.
Through the exercise of enforcement discretion, FDA historically has not
taken enforcement actions against pharmacies engaged in traditional
pharmacy compounding. Rather, FDA has directed its enforcement resources
against establishments whose activities raise the kinds of concerns normally
associated with a drug manufacturer and whose compounding practices
result in significant violations of the new drug, adulteration, or misbranding
provisions of the FDCA. 194195
Rescheduling cannabis would not automatically reduce or otherwise affect
federal criminal penalties for possession or trafficking. These statutes provide
specific penalties for marijuana or for possessing a controlled substance without a
lawful prescription. 196 Such statutes would require separate amendment in order
for existing penalties to be modified, and this amendment process would involve
different policy factors and considerations.
Cannabis rescheduling would also not necessarily allow the establishment of
additional cannabis cultivation facilities to produce cannabis for research purposes. The
United States is a signatory to the Single Convention on Narcotic Drugs 1961. That treaty
requires that cannabis cultivated within the US borders must be delivered to a national
agency. In the US, the national agency is the National Institute on Drug Abuse (NIDA). NIDA
has the exclusive authority over importing, exporting, wholesale trading, and maintaining
stocks. 197 Only the University of Mississippi under contract with NIDA currently cultivates
cannabis for research purposes. 198 The mandates of the treaty are not affected by
cannabiss scheduling under US domestic law. 199
There is one respect, however, in which the rescheduling of cannabis could facilitate
research. If a physician-investigator possesses a registration (the CSA term for a license) to
194
FDA, Warning Letter: Hals Compounding Pharmacy, Inc. (04-Dec-06)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm076195.htm (emphasis added).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124736
.pdf .
195 FDA, Compliance Policy Guide, sec. 460.200 (Pharmacy Compounding), 67 Fed. Reg. 39, 409 (June 7,
2002),
196See, e.g., 21 U.S.C. secs. 841,844.
197 Single Convention on Narcotic Drugs 1961, art. 23, 28. 18 U.S.T. 1407. There is an exception for stocks held
by manufacturers of pharmaceutical preparations. Art. 23, para. 2(e).
198 NIDA. Provision of marijuana and other compounds for scientific researchRecommendations of the
National Institute on Drug Abuse National Advisory Council. (January 1997).
199 For fuller discussion of the requirements of the Single Convention, see Department of Justice, DEA, Lyle E.
Craker; Denial of Application, 74 Fed. Reg. 2101 (Jan. 14, 2009).
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dispense an FDA-approved Schedule II controlled substance, he or she may conduct

research on any Schedule II substance, as a coincident activity to his/her registration to
dispense, without the need to obtain a separate research registration from the DEA. (Of
course, any such research would still need to be approved by the FDA and an appropriate
institutional review board, as well as perhaps by a state regulatory body. 200) By contrast, a
separate registration is required for Schedule I research. 201 In addition, each registration is
protocol-specific. If a researcher wishes to conduct a different study on the same Schedule I
substance, he/she must obtain a separate registration. Furthermore, a Schedule II
practitioner registration must be renewed every three years; whereas a Schedule I
research registration must be renewed annually. Thus, any delays associated with
obtaining and renewing a Schedule I research registration could be obviated by the
rescheduling of cannabis to Schedule II. This situation, however, could also be resolved by a
more limited statutory and regulatory change that permitted practitioners with Schedule II
registrations to conduct Schedule I cannabis/cannabinoid research as a coincident activity
to their existing registrations.
Conclusions
Cognitive dissonance is a term that aptly describes the current approach to
medical marijuana. Scientists recognize the public health harms of tobacco smoking and
urge our young people to refrain from the practice, yet most cannabis consumers use
smoking as their preferred delivery mechanism. The practice of medicine is increasingly
evidence-based, yet some physicians are willing to consider recommending cannabis to
their patients, despite the fact that they lack even the most rudimentary information about
the material ( composition, quality, and dose, and no controlled studies provide
information on its benefit and safety of its use in chronic medical conditions).
Pharmaceutical companies are responsible for the harms caused by contaminated or
otherwise dangerous products and tobacco companies can be held accountable for harms
caused by cigarettes, yet, dispensaries distribute cannabis products about which very little
are known, including their source. Efforts are being made to stem the epidemic of
prescription drug abuse, including FDA-mandated risk management plans required for
prescription medications, yet cannabis distribution sites proliferate in many states,
virtually without regulation.
In order to think clearly about medical marijuana one must distinguish first
between 1) the therapeutic potentials of specific chemicals found in marijuana that are
delivered in controlled doses by nontoxic delivery systems, and 2) smoked marijuana.
Second, one must consider the drug approval process in the context of public health,
not just for medical marijuana but also for all medicines and especially for controlled
substances. Controlled substances are drugs that have recognized abuse potential.
Marijuana is high on that list because it is widely abused and a major cause of drug
dependence in the United States and around the world. When physicians recommend use
200
201
21 U.S.C. sec. 823(f); 21 C.F.R. secs.1301.13.

21 C.F.R. sec. 1301.18.
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of scheduled substances, they must exercise great care. The current pattern of medical
marijuana use in the United States is far from that standard.
If any components of marijuana are ever shown to be beneficial to treat any illness
then those components can and should be delivered by nontoxic routes of administration
in controlled doses just all other medicines are in the U.S.
In order for physicians to fulfill their professional obligations to patients, and in
order for patients to be offered the high standard of medical care that we have come to
expect in the United States, cannabis-based products must meet the same exacting
standards that we apply to other prescription medicines. Members of the American Society
of Addiction Medicine are physicians first and experts in addiction medicine with
knowledge specific to the risks associated with the use of substances with high abuse
potential. ASAM must stand strongly behind the standard that any clinical use of a
controlled substance must meet high standards to protect the patient and the public; the
approval of medical marijuana does not meet this standard.
Recommendations
ASAM asserts that cannabis, cannabis-based products, and cannabis delivery devices should be
subject to the same standards that are applicable to other prescription medications and medical
devices and that these products should not be distributed or otherwise provided to patients unless
and until such products or devices have received marketing approval from the Food and Drug
Administration.
ASAM rejects smoking as a means of drug delivery since it is not safe.
ASAM recognizes the supremacy of federal regulatory standards for drug approval and distribution.
ASAM recognizes that states can enact limitations that are more restrictive but rejects the concept
that states could enact more permissive regulatory standards. ASAM discourages state interference
in the federal medication approval process.
ASAM rejects a process whereby State and local ballot initiatives approve medicines because these
initiatives are being decided by individuals not qualified to make such decisions (based upon a
careful science-based review of safety and efficacy, standardization and formulation for dosing, or
provide a means for a regulated, closed system of distribution for marijuana which is a CNS drug
with abuse potential).
ASAM recommends its members and other physician organizations and their members reject
responsibility for providing access to cannabis and cannabis-based products until such time that
these materials receive marketing approval from the Food and Drug Administration.
ASAM asserts that physician organizations operating in states where physicians are placed in the
gate-keeping role have an obligation to help licensing authorities assure that physicians who
choose to discuss the medical use of cannabis and cannabis-based products with patients:
Adhere to the established professional tenets of proper patient care, including
38
Kingsbury0110
o History and good faith examination of the patient;

o Development of a treatment plan with objectives;
o Provision of informed consent, including discussion of side effects;
o Periodic review of the treatments efficacy;
o Consultation, as necessary; and
o Proper record keeping that supports the decision to recommend the use of cannabis
Have a bona fide physician-patient relationship with the patient, i.e., should have a preexisting and ongoing relationship with the patient as a treating physician;
Ensure that the issuance of recommendations is not a disproportionately large (or even
exclusive) aspect of their practice;
Not issue a recommendation unless the physician has adequate information regarding the
composition and dose of the cannabis product;
Have adequate training in identifying substance abuse and addiction202.
202
This is particularly germane to the ASAM which consists of physicians knowledgeable in drug abuse and
addiction and who advocate to ensure that all physicians have the knowledge to manage CNS medications
responsibly in the general patient population and can identify and treat or refer for treatment cases of abuse
and dependence to psychoactive substances.
39
Kingsbury0111
Regulatory Toxicology and Pharmacology 69 (201 4) 284288
Contents lists available at ScienceDirect
Regulatory Toxicology and Pharmacology

j o u rn a l h o m e p a g e : w w w . e l s e vi e r. c o m /l o c a t e /yrt p h
Commentary
Cannabis, pesticides and conicting laws: The dilemma for legalized

States and implications for public health
Dave Stone
Oregon State University, Department of Environmental and Molecular Toxicology, Corvallis, OR 97331 , United States
ar ti c le
i n f o
Article history:
Received 1 9 December 201 3
Available online 20 May 201 4
Keywords:
Cannabis
Marijuana
Pesticides
Public health
Regulation
Risk
ab s t r ac t
State laws on the legalization of medical and recreational cannabis are rapidly evolving. Similar to other
crops, cannabis is susceptible to multiple pests during cultivation. Growers have an economic incentive
to produce large yields and high quality plants, and may resort to pesticides to achieve these outcomes.
Currently, there are no pesticides registered for cannabis in the United States, given its illegal status by
the federal government. This discrepancy creates a regulatory vacuum and dilemma for States with legal
medical and recreational cannabis that seek to balance lawful compliance with pesticides and worker or
public health. Pesticide use presents occupational safety issues that can be mitigated through established
worker protection measures. The absence of approved products for cannabis may result in consumer
exposures to otherwise more hazardous pesticides or higher residue levels. While many legal and scientic hurdles exist to register conventional pesticides for use on cannabis, legalized States have explored
other opportunities to leverage the present regulatory infrastructure. Stakeholder engagement and outreach to the cannabis industry from credible sources could mitigate pesticide misuse and harm.
201 4 Elsevier Inc. All rights reserved.
1. Introduction
Cannabis (Cannabis sativa and Cannabis indica), commonly
referred to as marijuana, is an annual plant that grows in a variety
of indoor and outdoor environments. Cannabis is the most widely
consumed illicit substance in the United States (Cerda et al., 201 2),
primarily due to the effects of the psychoactive compound delta9-tetrahydrocannabinol (THC). Since 1 996, a growing number of
States have allowed individuals with certain medical conditions
to possess or grow limited amounts of cannabis. In 201 2, Colorado
and Washington State voted in favor of the legal possession and
consumption of recreational cannabis for adults. It is likely that
more states will expand the legalization of cannabis (Van Ours,
201 2), requiring them to address a host of issues for producing,
selling, taxing and possessing cannabis. An emerging concern
among legalized States is how to address pesticide use and misuse,
while complying with federal laws. Furthermore, the trend among
the public is for decriminalization of cannabis, highlighting the
importance of addressing pesticide use as rules are implemented
and a regulatory framework is devised.
In the U.S., a robust regulatory framework exists that permits
pesticide use on diverse crops and within a variety of settings
Fax: +1 541 737 1 079.
based on the assessment of risks and benets. Federal, state and

tribal agencies, industry and academia collaborate in the assessment, registration, enforcement, and applicator training of pesticides. The initial step required for introducing new pesticides
into the marketplace is registration or exemption from registration
by the U.S. Environmental Protection Agency (EPA). Currently,
there are no products that have been registered specically for
cannabis by EPA. This stems primarily from the federal governments scheduling of cannabis as an illegal substance equivalent
to heroin, cocaine and opium. Despite the lack of product registrations for cannabis, pesticide use has been veried through residue
monitoring, enforcement activities and legislative testimony. The
protability of cannabis and expectation to produce high quality
plants that are free of pest damage and presence are likely factors
that contribute to pesticide use during cultivation.
The discrepancy between some state laws and federal drug law
poses a dilemma in how these states can address pesticide use and
potentially, violations in pesticide law. This legal incongruity also
presents a potential public health risk to workers involved with
the production of cannabis, residential growers and consumers.
In this vacuum, advisory groups and state agencies have been
tasked with developing novel approaches that can balance safety
issues with legal compliance. This article examines the public
health issues involved with pesticide use in cannabis production
and consumption, summarizes evolving State efforts to address
E-mail address: Dave.Stone@oregonstate.edu

http://dx.doi.org/1 0.1 01 6/j.yrtph.201 4.05.01 5
0273-2300/ 201 4 Elsevier Inc. All rights reserved.
Kingsbury0112
D. Stone /Regulatory Toxicology and Pharmacology 69 (201 4) 284288
compliance and safety, and examines opportunities to address

potential risks through education and existing infrastructure.
2. Pesticide residue and pests
Certain strains of Aspergillus and Fusarium mold are capable of producing the toxins aatoxin and zearalenone, respectively. Aatoxin
has been shown to survive the combustion process during cannabis smoking (Llewellyn and ORear, 1 977).
2.1 . Residues
3. Cannabis laws
The question of which pesticide active ingredients are used on

cannabis is a growing concern for regulators and consumers. A signicant constraint to answer this question is the lack of systematic
monitoring programs for residues on cannabis or even surveys
among growers (McLaren et al., 2008). Much of the discussion
about pesticide use on cannabis is anecdotal, poorly referenced
and lacking in peer-review. Numerous examples of this chatter
can be found in on-line chat rooms, websites, and interviews that
suggest pesticides are widely used in the cannabis industry.
Examples from enforcement actions are available to highlight
pesticide misuse among grow operations. In 201 2, workers at
Maines largest medical cannabis dispensary informed the State
that pesticides were being applied in violation of state law
(Shepard, 201 3). In California, the Los Angeles Police Department
purchased cannabis products from a medical dispensary and
detected bifenthrin residue, a pyrethroid insecticide in 2009
(McLean, 201 0). The California Department of Food and Agriculture
banned the sale of some cannabis cultivation materials that
included the plant growth regulators daminozide (Alar) and paclobutrazol (California Department of Food, 201 1 ) in 201 1 . The
extent of this issue among medical dispensaries is difcult to
gauge. However, according to interviews with numerous dispensaries, illegal pesticide use is common (Lindsey, 201 2). The American
Herbal Pharmacopeia published a list of pesticides that are most
likely to be used on cannabis, highlighting eighteen different active
ingredients consisting of acaricides, insecticides, fungicides and
plant growth regulators (American Herbal Pharmacopeia, 201 3).
3.1 . Federal cannabis law
2.2. Pests of cannabis

The resin glands of maturing cannabis plants contain cannabinoids and terpenoids with some capacity to defend against insect
damage (Pate, 1 999). However, dozens of insect and mite species
have been associated with cannabis, particularly spider mites,
aphids and thrips (McPartland, 1 996). Infestation can occur on
stems, leaves and owers, placing pressure on growers to use pesticides at multiple stages during cultivation. Powdery mildew and
other fungal diseases are problematic, potentially leading to the
use of various fungicides. Greenhouses and lighting systems are
particularly inviting for certain pests, including those that are common to cannabis (McPartland, 2000). The type of pest will depend
on when, how and where the plants are grown and processed.
While arthropods and vertebrates can cause economic damage
to cannabis plants, microbes in cannabis products can pose health
risks to consumers, particularly from smoking. It has been recommended that consumed cannabis should be free of bacterial and
fungal contamination for medically fragile patients to the fullest
extent possible (Tashkin, 2002). Bacteria and fungi can infest cannabis during cultivation, processing and storage, particularly if
stored in humid, unventilated areas (McPartland, 2002). Several
bacterial contaminants of cannabis have been detected including
pathogenic strains of Enterobacter, Strepococcus, Klebsiella and
Salmonella (Ungerleider et al., 1 962; Taylor et al., 1 982). Some mold
spores are able to survive within the smoke emitted from cannabis
cigarettes (Kurup et al., 1 983). While infections are rare, case
reports exist of immunocompromised individuals who developed
pulmonary fungal infections following inhalation of contaminated
cannabis (Hamadeh et al., 1 988; Szyper-Kravitz et al., 2001 ).
285
Under the Controlled Substances Act (CSA), cannabis is considered to be a Schedule I drug. This designation implies that it has a
high potential for abuse, does not have any accepted medical use
and lacks accepted safety under medical supervision. As recently
as 201 1 , the Drug Enforcement Agency (DEA) reviewed the scheduling classication of cannabis and determined it continues to
meet Schedule I criteria. Thus, the federal government does not
recognize medical cannabis, nor does it recognize the legality of
state cannabis laws that allow for its sale, possession or use. The
DEAs position has direct implications on the role that other federal
agencies may have in addressing issues related to pesticide use on
cannabis. As an example, it is unlikely that the EPA will register a
pesticide specically for cannabis as long as it is designated a Schedule I drug.
3.2. State cannabis laws
Since 1 996, 20 States and the District of Columbia have passed
laws that allow for the use of cannabis to treat diverse medical
conditions, including fteen States that allow for home cultivation
of medical cannabis. Many states do not explicitly mention pesticides in their legislation on cannabis, requiring them to address
this issue through subsequent administrative rules or statues. This
may stem in part from uncertainty in the ability for States to
implement or enforce pesticide regulations for cannabis given their
inconsistency with federal laws. Recently, Californias Research
Bureau was asked by legislators to address gaps in state medical
cannabis legislation (Lindsey, 201 2). A major nding of the report
was that the State lacked clarity on whether cannabis was a legitimate agricultural crop. If cannabis were designated as an agricultural crop, the study indicated that the California Department of
Pesticide Regulation would have the clear authority to implement
numerous safety programs.
In 201 2, voters in Colorado and Washington State passed initiatives legalizing recreational cannabis for adults. Washington
passed Initiative 502, which allows possession of one ounce of
dried cannabis, one pound of pot-infused edibles and 72-oz of
pot-laced liquid (Reed, 201 1 ). Washingtons Initiative 502 mandates the establishment of lot numbers that would identify the
date of harvest and calls for uniform testing standards by accredited labs. Recently, the Washington State Department of Agriculture (WSDA) released a list of pesticide products approved for
use on cannabis (Washington State Department of Agriculture,
201 3). The list includes several pesticides that are exempt from tolerances (primarily biopesticides and pesticides used in organic
production) and several minimum risk pesticides (known as section 25b) that are exempt from federal registration and are labeled
for use on food crops. Tolerances are developed by the EPA and
represent the legal maximum amount of pesticide residue that
can be on a raw agricultural product and still be considered safe.
The approved products from WSDA have label instructions for
unspecied or broad use sites, such as bedding plants, which
are interpreted as less restrictive compared with label instructions
for specic uses, such as apples.
Colorados Amendment 64 allows for the possession of one
ounce of cannabis, or six plants, with no more than three mature
Kingsbury0113
286
and owering plants (Colorado Department of Revenue, 201 4).

Amendment 64 mandates a cannabis testing facility licensed to
analyze and certify the safety and potency of the nished product.
As part of a comprehensive report from a State taskforce,
recommendations were made to include warning labels to list all
non-organic pesticides used in the cultivation and processing of
cannabis sold by licensed retail establishments, as well as a list
of prohibited substances. Several states with legal medical cannabis have implemented testing requirements for pesticides, as well
as mold, bacteria and metals. Their efforts include approved lists of
compounds similar to WSDAs approach, comparisons of residues
found in cannabis with the most stringent acceptable standards
for that residue in any food item or adopting maximum residue
levels based on broad chemical classes, such as total organophosphates or pyrethroids.
4. Federal pesticide regulations
4.1 . Pesticide registration
Since 1 947, the Federal Insecticide Fungicide and Rodenticide
Act (FIFRA) has been the central law for registering pesticides for
specic uses and establishing labeling requirements (United
States Environmental Protection Agency, 2008). While FIFRA is a
federal law, state and tribal agencies have a signicant role in its
execution when not preempted by federal authority. FIFRA clearly
states that only the federal government has the authority to register an active ingredient within the United States through Section 3
of FIFRA. States may introduce more stringent requirements than
dictated by FIFRA, but may not be less stringent.
Before a pesticide can be registered on a food crop, it must rst
be granted a residue tolerance or receive an exemption from a tolerance. Tolerances are developed through the Food Drug and Cosmetic Act and are intended to protect the public from consuming
too much residue or from exposure to unapproved pesticides on
food. Some Section 3 active ingredients do not require a tolerance,
which make them less restrictive compared to products that are
labeled with tolerance requirements.
The allowed uses for a pesticide are specic to the crops and
sites listed on the label, which is supported by data, including
environmental fate, toxicological studies, residue chemistry and
several other endpoints. A risk assessment is conducted using a
variety of scenarios and exposure factors to determine how much,
where and under what circumstances a pesticide product can be
registered. Cannabis would likely have signicant data needs compared with other recognized crops, as it is smoked, ingested in a
variety of edible forms and applied directly to the skin in numerous
formulations.
An important component of FIFRA is the authorization of
accepted sites or crops on which the product can be applied.
According to EPAs Pesticide Product Information System, there
are over 24,000 different crops and sites listed for possible registration, ranging from highly specic to more broad uses. When a
pesticide is registered for a specic crop and use site, such as
greenhouse grown tomatoes, specic restrictions and safety
measures are outlined. It should be noted that FIFRA registration
for one crop does not confer tolerance to another crop. Once registered, the product label becomes the primary means to communicate the manner in which a pesticide can be applied.
4.2. Additional approval processes
Several factors could impede Section 3 registrations of conventional pesticides for cannabis, most notably the Schedule I classication of cannabis, coupled with large data needs to develop
tolerances and assess risk. Given these barriers, other mechanisms

have been explored by legalized States to approve products for
cannabis cultivation. These include the Section 25(b) or minimum
risk pesticides, as well as other active ingredients that are exempt
from tolerance requirements, such as several biopesticides. WSDA
has utilized these mechanisms to develop their list of approved
products, as described above.
Minimum risk pesticides are exempt from the registration
requirements mandated by FIFRA for conventional pesticides
(United States Environmental Protection Agency, 201 4a). They
are assumed to be demonstrably safe by their intended use. These
products are limited to a small set of naturally occurring active
ingredients found in the diet and can only contain inert ingredients
classied by EPA as Inert Ingredients of Minimal Concern. Some
of the minimum risk pesticides are exempted from residue tolerance requirements. A potential limitation is that these pesticides
may not offer the best efcacy to control the desired pest. Biopesticides are certain types of pesticides that are derived from natural
materials (United States Environmental Protection Agency, 201 4b).
They are considered to be less toxic compared to conventional
pesticides as a general rule. Biopesticides encompass microbial
agents that attack pests, biochemical agents of natural origin,
plant-incorporated protectants genetically engineered for pest
control and certain minerals.
4.3. Organic standards
Organic production may appear as an attractive option for
growers, given the positive perception this label conveys to consumers. The U.S. Department of Agriculture (USDA) administers
the National Organic Program (NOP) to provide guidance and standards for the production, certication and labeling of organic foods,
as dened by the Organic Foods Production Act of 1 990. While NOP
standards exclude synthetic fertilizers and genetic engineering,
many pesticides have been approved for use. As a general rule,
synthetic pesticides are not allowed in organic agriculture, while
natural substances are permitted. Some State administrative rules
for medical cannabis mandate that organic labeling be permitted
only if certication occurs through NOP standards. However, it is
unlikely a USDA-aligned accreditation agency would be allowed
to approve the organic certication of cannabis given its Schedule
I designation.
5. Public health issues
5.1 . Occupational exposure
An immense amount of resources and surveillance has been
conducted on worker safety issues and pesticides. Federal law, primarily through Worker Protection Standards (WPS), mandates specic measures intended to reduce risk in occupational settings.
WPS measures include restricted-entry intervals, use of personal
protective equipment, and postings that notify workers of applications and re-entry times. In addition, WPS outlines the emergency
and decontamination materials that should be included on-site, as
well as the training and certication required to handle pesticides.
State and tribal pesticide regulatory agencies are responsible for
the implementation of many of these issues. The exclusion of cannabis as an agricultural commodity could impede the ability to
leverage existing WPS measures at many levels, including application, harvesting and processing.
Dermal contact is often the main cause of occupational exposures to pesticides (Ross et al., 2000). Skin exposures occur through
spills, during mixing and loading, from misapplications and during
re-entry into treated areas. After a pesticide is applied to foliar
Kingsbury0114
surfaces, handling of plant material or entry into a treated area can

result in a high amount of contact with residue. Inhalation of pesticide vapors and aerosols can present risks to workers, particularly
in conned and unventilated spaces that typify many indoor growing operations. Hand-to-mouth transfer of residue is possible during harvesting and processing, highlighting the need for best
management practices and hygiene. WPS has many elements that
directly address these type of worker exposures, particularly
through training, personal protective equipment requirements,
access to labeling information, restricted entry intervals and access
to decontamination materials.
5.2. Non-occupational exposure
Several scenarios are relevant when considering the general
public and cannabis. For individuals that qualify for medical cannabis, pre-existing medical conditions may exist that make them
more susceptible to chemical exposures. Many of these individuals
are likely taking pharmaceuticals and very little information exists
on the interaction between pharmaceuticals and pesticides. In
addition to the medically fragile, non-occupational exposures to
pesticides applied to cannabis can occur during the consumption
of edible products or through smoking cannabis.
Recently, researchers have conducted studies using spiked samples of cannabis and detected residue in mainstream smoke
(Sullivan et al., 201 3). The researchers examined three insecticides,
bifenthrin, diazinon and permethrin, as well as paclobutrazol, a
plant growth regulator. The recovery of spiked residues ranged
from 60% to 70% in an unltered pipe. The degree of inhaling cannabis smoke differs widely among users and different types of paraphernalia. Experienced smokers will typically inhale larger
volumes of smoke with longer retention times compared with light
users (Tashkin et al., 1 987), leading to potentially higher residue
intake. Dermal exposures to residue may be possible as well
through topically applied cannabis products. To date, these products have been formulated as ointments, lotions, patches, sprays,
balms and salves.
The THC extracted from cannabis is infused and ingested in a
broad range of solid and liquid-based forms. Common extraction
methods for removing THC from cannabis include heat, vegetable
oil, alcohol and butter. It is unclear how the extraction process
would affect the degradation or bioavailability of pesticides used
during cultivation. However, it is likely that more lipophilic compounds would be present in oil-based products. In addition, harvest intervals have not been established that could limit residues
and potential exposures for both workers and consumers.
Several States permit the home cultivation of cannabis plants,
particularly for medical use. Without credible information, consumers and retail establishments that cater to the cannabis industry will
continue to rely on unsubstantiated information and recommendations. This includes the rising popularity of the do-it-yourself (DIY)
movement for pest control. Simple web searches reveal detailed
instructions of how to combine common chemicals or food ingredients to control a variety of pests infesting cannabis. Beyond questions of efcacy and legality, numerous public health issues are
evident with DIY pesticides including exposures during the preparation, application and disposal of homemade concoctions.
6. Lessons from tobacco?
Qualitatively, tobacco smoke is similar to cannabis smoke without the nicotine and cannabinoids, respectively. Dozens of pesticides are registered for use on tobacco in nurseries, greenhouses,
storage areas, elds and other sites. To limit exposure to pesticides
among tobacco smokers and workers involved with the production
287
of tobacco, a report by the U.S. General Accounting Ofce was

delivered in 2003 (Stephenson, 2003). The report outlined a tiered
health assessment conducted by EPA, with the assumption that
residues declined over time as the tobacco was stored, cured, manufactured and burned. To address some data gaps, EPA asked manufacturers to conduct pyrolysis studies for two pesticides. The
studies revealed that the compounds were found in combustion
smoke at amounts below levels of concern. Ultimately, EPA scientists concluded that residues in cigarette smoke were not present
at sufcient levels to present short-term health concerns for consumers. The GAO report recommended risk mitigation measures
such as determining which pesticides can be used on tobacco,
extending restricted entry intervals, and requiring additional personal protective equipment.
Several limitations exist in applying tobacco-based risk mitigation measures as a surrogate for cannabis. A primary drawback is
that residue tolerances are not required for tobacco, since it is considered a non-food crop. The amount of residue in tobacco smoke,
which was deemed insignicant in the GAO report, may be
substantially different compared to residue found in cannabis
smoke. In studies of tobacco stream smoke, 21 6% of residues were
recovered (Cai et al., 2002) compared to over 60% in unltered cannabis smoke (Sullivan et al., 201 3). Differences in exposure factors
may include the frequency of tobacco cigarette smoking versus
cannabis, the presence of lters on many tobacco cigarettes and
variances in how cannabis and tobacco are processed, consumed
and stored.
7. Stakeholder engagement
To date, engagement between cannabis growers and experts in
pesticide science and regulation has been limited. Safety and
compliance information for this sector is virtually absent. Several
institutions have programs in pesticide safety education, entomology, horticulture, toxicology and other disciplines that promote
best management and stewardship practices for agricultural
commodities. University-based Extension Services can develop
and disseminate educational materials and foster local relationships with growers and retail establishments. Many of these
research-intensive universities are leaders in integrated pest
management (IPM) approaches for pest control as well. IPM
recommendations on cultural practices or mechanical controls to
control common pests of cannabis, such as spider mites or powdery mildew, could prevent initial pest infestation and the need
to resort to pesticides in the rst place (Cranshaw, 201 1 ).
The cannabis industry has not been a required participant in the
training and certication required to license and track professional
applicators. These programs provide opportunities to interface
with specialists and pesticide regulatory authorities in a forum that
encourages information exchange and conveys important legal and
safety concepts. The educational needs of the cannabis industry,
from growers to retail stores visited by growers, are immense. They
include basic information on worker protection standards, label
comprehension and compliance, storage and disposal issues, IPM
techniques, and fundamental tenets of pesticide toxicology. In
addition, outreach and engagement with the general public
engaged in the home cultivation of cannabis within legalized
States is important to help prevent misuse or harm (Johnson and
Miller, 201 2).
8. Summary of the issue
To address public health and occupational safety concerns associated with pesticides and cannabis, legalized States are likely to
continue to explore various approaches that balance safety with
Kingsbury0115
288
legal compliance. Legalized States are adapting complementary

approaches that leverage the existing pesticide regulatory infrastructure. During this transitional period, engagement between
credible resources and stakeholders is critical. The vetted regulatory and academic framework that benets numerous agricultural
sectors can be readily extended to the cannabis community. As this
industry emerges from the shadows, the opportunities to protect
health and promote good stewardship practices should not be lost.
Conict of interest
The author declares no conicts of interest.
Acknowledgments
I would like to thank the professionals in academia and government that answered my questions and provided their input. I
would like to specically acknowledge Erik Johansen with the
Washington State Department of Agriculture.
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United States Environmental Protection Agency, 201 4b. Regulating biopesticides.
Ofce of Pesticide Programs, Washington, DC. <http://www.epa.gov/oppbppd1 /
biopesticides/> (accessed 21 .04.1 4).
Van Ours, J.C., 201 2. The long and winding road to cannabis legalization. Addiction
1 07, 872873.
Washington State Department of Agriculture, 201 3. Criteria for pesticides used for
the production of marijuana in Washington. Department of Agricultural AGR
PUB 701 -398 (N/1 2/1 3), Olympia, Washington.
Kingsbury0116
Cannabis and the Regulatory Void

Background Paper and
Recommendations
California Medical Association
2011
Summary
In 2010, the California Medical Association (CMA) House of Delegates ordered the
formation of a technical advisory committee to recommend policy on marijuana
[cannabis] 1 legalization and appropriate regulation and education. The CMA
Legalization and Taxation of Marijuana Technical Advisory Committee (TAC) found
that the public movement toward legalization of medical cannabis has inappropriately
placed physicians in the role of gatekeeper for public access to this botanical. Effective
regulation is possible only if cannabis is rescheduled at the federal level
Policy Recommendation includes:

Reschedule medical cannabis in order to encourage research lending to responsible
regulation.
Regulate recreational cannabis in a manner similar to alcohol and tobacco.
Tax cannabis
Facilitate dissemination of risks and benefits of cannabis use.
Refer for national action.
Note: Marijuana is a slang term for the dried leaves and flowers of the varieties of the cannabis plant
that are rich (1-20+%) delta-9-tetrahydrocannabinol, or THC - the primary psychoactive cannabinoid
found in the cannabis plant. Throughout this background paper, the scientific term cannabis will be
used, except where the term marijuana is contained in a direct quotation or referring to an official title.
Kingsbury0117

Prepared by the California Medical Association, Marijuana Technical Advisory Committee.
Introduction
Cannabis is a plant (botanical) known popularly as marijuana, which has medicinal
qualities and is also psychoactive. Federal law classifies cannabis as a Schedule I drug
meaning it has no accepted medical use and a high potential for abuse and therefore
cannot be prescribed by physician for any use outside of research settings. That is, it is
illegal to prescribe this botanical. The Schedule I classification has limited research
on the potential therapeutic usefulness or potential risks of cannabis and its various
chemical components (cannabinoids, terpenoids and falvonoids).2 The Schedule I
classification of cannabis has contributed to several public policy dilemmas.
The federal illegality of cannabis coupled with the decriminalization of cannabis in
California has inappropriately placed physicians in the role of gatekeeper. Those
wishing to gain access to cannabis to avoid criminal penalties currently look to
physicians for a recommendation of medicinal cannabis. Unfortunately, for California
physicians, the popular justification for decriminalization actions has been a declaration
of the medical efficacy of cannabis when, in reality, current data have shown that the
medical indications for cannabis are very limited. For the medical uses listed in
Proposition 215, other drugs with documented effectiveness are available and may be
more commonly used for treatment.
Despite extensive law enforcement and other prohibition-related efforts at the state and
federal levels, unregulated cannabis continues to be easily accessible, often at low cost.
For this and several other reasons further outlined in this white paper, the California
Medical Association (CMA) has recognized that the criminalization of cannabis is a
failed public health policy. Based on the growing momentum of medical cannabis
decriminalization nationally (16 states and the District of Columbia have decriminalized
medical cannabis), there may also be growing public support in several states for
decriminalization of the cultivation, transport and use of cannabis.
Recognizing the growing national conversation surrounding cannabis, the California
Medical Association (CMA) in 2010 adopted policy HOD 101a-10 stating:
That CMA recognizes there is a public movement toward legalization of
marijuana and that CMA convene a TAC to develop a comprehensive white
2
Kingsbury0118
paper recommending policy on marijuana legalization and appropriate

regulation and evaluation.
Thus, the Legalization and Taxation of Marijuana Technical Advisory Committee (TAC)
was formed to consider the issue of cannabis legalization, taxation, regulation, and
education from the standpoint of a physician. The conclusions of this report stem from
the physicians code of ethics which states, First, do no harm, placing patient safety
and public health as the central goals.
The TAC recognizes two intersecting issues in this policy review: the use of medical
cannabis and the use of recreational cannabis. CMAs most direct concern is medical
cannabis as it addresses the potential benefits and risks of this now largely unstudied
botanical and its chemical components. CMA is also concerned with a failed policy of
prohibition for recreational use which coincides with a crescendo of public repudiation
of that policy. Additionally, CMA is concerned with the current inappropriate
justification for decriminalization as it relates to its medical utility. While policy options
are not new (think about alcohol prohibition a century ago), we do need to reconsider
the risks and benefits of this policy itself for individual patients and for the population
as a whole.
Discussion
Literature Review
Research surrounding cannabis that meets modern scientific standards has remained
limited due to cannabiss status as a federally restricted Schedule I substance. Cannabis
should be subject to the scrutiny of the federal Food and Drug Administrations (FDA)
regulatory process in order to allow for further clinical research and to work toward
standardizing the substance so physicians are no longer required to serve as
gatekeepers of a substance that has not been subjected to the scientific process. 2 In 2001,
the American Medical Association (AMA) Council on Scientific Affairs advocated that
the National Institutes of Health (NIH) implement administrative procedures to
facilitate grant applications to conduct well-designed clinical research into the medical
utility of cannabis.3
Such research has recently increased, but not to a level that allows for the development
Andrea Barthwell, et al. The Role of the Physician in Medical Marijuana. American Society of
Addiction Medicine. September 2010.
3 Report 3 of the Council on Science and Public Health (I-09): Use of Cannabis for Medicinal Purposes.
American Medical Association, 2009. Last Accessed March 9, 2011: <http://www.amaassn.org/ama/no-index/about-ama/13625.shtml>.
2
Kingsbury0119
of an evidence-based regulatory scheme for cannabis. In the past ten years, there have
been approximately twelve U.S. clinical trials investigating the therapeutic properties of
inhaled cannabis and more than twenty clinical studies worldwide studying the use of
cannabis-derived medications in the treatment of various medical conditions.
Therefore, the future may provide a clearer distinction for cannabis-derived
medications.
However, even with regard to cannabis used recreationally, there is a need for oversight
and quality control, just as there is with alcohol, tobacco, and food products. Such
oversight and quality control, aimed at protecting personal and public health, can be
accomplished with legalization and regulation at both the federal and state levels. Thus
far, the criminalization of cannabis has proven to be a failed public health policy for
several reasons, including:
a) The diversion of limited economic resources to penal system costs and away
from other more socially desirable uses such as funding health care,
education, transportation, etc. 4;
b) The social destruction of family units when cannabis users are incarcerated,
rather than offered treatment and other social assistance;
c) The disparate impacts that drug law enforcement practices have on
communities of color5;
d) The continued demand for cannabis nationally, which supports violent drug
cartels from Mexico and other international sources6;
e) The failure to decrease national and international supplies of cannabis from
criminal and unregulated sources7;
f) The failure of the federal governments limited actions through the War on
Drugs in mitigating substance abuse and addiction. 8
Currently in California, the use of medicinal and recreational cannabis has been
decriminalized. In 1996, Californias Proposition 215 decriminalized the cultivation and
use of cannabis by seriously ill individuals upon a physicians recommendation and, in
2004, the Medical Marijuana Program Act enacted an identification card program to
4
Beau Kilmer, et al. Altered State? Assessing How Marijuana Legalization Could Influence Marijuana
Consumption and Public Budgets. RAND Drug Policy Research Center, 2010.
5
Drug courts are not the answer: Toward a health-centered approach to drug use. Drug Policy
Alliance, 2011.
6
Beau Kilmer, et al. Reducing Drug Trafficking Revenues and Violence in Mexico: Would Legalizing
Marijuana in California Help? RAND Drug Policy Research Center, 2010.

7
War on Drugs: Report of the Global Commission on Drug Policy. Global Commission on Drug
Policy, June 2011.
8
Ibid.
Kingsbury0120
achieve greater consistency in the application and enforcement of the original

initiative.9 Regarding the recreational use of cannabis in California, Health & Safety
Code 11357 was implemented on January 1, 2011, making possession of less than one
ounce of cannabis a civil infraction rather than a criminal misdemeanor as it had
previously been categorized.
In focusing on the medicinal use of cannabis, its decriminalization has gained
momentum throughout the nation. However, aside from these actions at the state level,
very little clinical research or regulation of cannabis exists due to its current federal
illegality.
Cannabis components may have some medicinal efficacy as well as a variety of health
risks. Cannabis may be effective for the treatment of pain, nausea, anorexia, and other
conditions, but the literature on this subject is inadequate, dosage is not well
standardized, and cannabis side effects may not be tolerated. 10 Cannabis use has also
been associated with several health risks including addiction, 11 memory loss and slower
reaction time,12 development of psychotic disorders,13 and reproductive risks. 14
Cannabis acquired in California today is unregulated. Both medical and recreational
cannabis have no mandatory labeling standards of concentration (one cannabis clinic
labels one lollipop as Three Doses) or purity (are there harmful pesticides or
herbicides present?)
Legalization vs. Decriminalization

The legalization of cannabis is a continuing source of debate at both the national and
state levels. Legalizing cannabis consists of allowing for the cultivation, sale, and use of
the substance. The Netherlands has maintained a drug policy that distinguishes
between hard and soft drugs cannabis, although technically illegal, is viewed as a
soft drug. There, soft drugs are those believed to be less addictive and to have fewer
dangers associated with their use. The Dutch government officially tolerates the
California Health & Safety Code 11362.5.
Medical Marijuana. The Medical Letter On Drugs and Therapeutics. January 25, 2010: 1330.
11 Marijuanas Addictive Potential (for healthcare professionals). California Society of Addiction
Medicine. Last Accessed June 21, 2011: < http://www.csam-asam.org/MJAddictionMD.vp.html>.
12 S. Welch and B. Martin. The pharmacology of marijuana. Principles of Addiction Medicine 3rd ed.
Chevy Chase, MD: American Society of Addiction Medicine; 2003: 249-270.
13 Cannon Arseneault, et al. Causal association between cannabis and psychosis: examination of the
evidence. British Journal of Psychiatry No. 184, 2004: 110 -117.
14 H. Schuel. Tuning the oviduct to the anandamide tone. The Journal of Clinical Investigation Vol. 116
No. 8, 2006: 2087-90.
9
10
Kingsbury0121
personal possession and use of cannabis and also licenses and regulates cannabis cafes,
arguing that regulation creates, at the consumer level, a separation for the market for
cannabis from the market for hard drugs.
Decriminalization of cannabis may consist of a range of activities such as reducing
penalties for cannabis-related offenses. Portugal became the first European country to
decriminalize personal possession of cannabis, cocaine, heroin, and methamphetamine
in 2001. Therapy is now offered in place of criminal penalties for drug possession. In
2006, five years after implementing decriminalization policies, Portugal reportedly had
a lifetime cannabis use in people over age fifteen of 10 percent the lowest in the
European Union.15
Federal Law
Congress made cannabis use illegal when it enacted the Controlled Substances Act in
1970 (21 U.S.C. 811). Under federal law, cannabis is currently classified in statute as a
Schedule I drug, along with drugs such as heroin, LSD and peyote. The Controlled
Substances Act holds that it is illegal for anyone to knowingly or intentionally possess a
Schedule I substance because substances classified under this schedule are deemed to
have high potential for abuse, no currently accepted medical use in treatment, and a
lack of accepted safety for use of the drug under medical supervision. Therefore, the
intended use of cannabis, whether medical or recreational, is irrelevant under the
Controlled Substances Act.
On June 6, 2005, the United States Supreme Court ruled that the federal Controlled
Substances Act is valid even as applied to intrastate, noncommercial cultivation,
possession and use of cannabis for personal medical use on the advice of a physician. 16
The Courts ruling maintains the existing federal prohibition against possession,
cultivation, and distribution of cannabis.
Federal law establishes a clear prohibition against knowingly or intentionally
distributing, dispensing, or possessing cannabis (21 U.S.C. 841-44). A person who aids
and abets another in violating federal law, 18 U.S.C. 2, or engages in a conspiracy to
purchase, cultivate, or possess cannabis, 21 U.S.C. 846, can be punished to the same
extent as the individual who actually commits the crime. The penalty for a first-time
violation of these provisions in the case of less than 50 kilograms of cannabis is
imprisonment for a term of up to five years, a fine of up to $250,000, or both. The
penalty for a violation committed after a prior drug conviction is imprisonment for a
term of up to ten years, a fine of $500,000, or both (21 U.S.C. 841(b)(1)(D)).
15
16
Szalavitz. Time. August 26, 2009.

Gonzalez v. Raich (2005) 525 U.S. 1, 162 L.Ed.2d 1, 125 S.Ct. 2195.
Kingsbury0122
Other federal sanctions are also possible. If a physician were to aid and abet or conspire
in a violation of federal law, the federal government might revoke the physicians Drug
Enforcement Agency (DEA) registration through an administrative procedure.
Physicians should also be aware that a felony conviction relating to the unlawful
manufacture, distribution, prescription, or dispensing of a controlled substance results
in mandatory exclusion from the Medicare and Medi-Cal programs (42 U.S.C. 1320a7(a)(4)).
Because cannabis remains an illegal substance at the federal level, it is currently
impossible to adequately evaluate or regulate the substance nationally. The charge of
this TAC was to consider whether appropriate regulation or taxation is technically
irrelevant absent the federal legalization of cannabis because, in order to consider
supporting a taxation or regulatory scheme, cannabis must first be legalized. Merely
decriminalizing cannabis on a state-by-state basis is not sufficient because illegal
substances would not be regulated at the federal level, which is where most of the
regulation of labeling, quality control, safety, etc. of, for example, alcohol and tobacco
takes place. Colorado is the first non-federal jurisdiction attempting to regulate
cannabis absent such federal action.
State Law17
At the state level, California has seen a handful of efforts moving toward
decriminalization of cannabis under certain circumstances. On November 5, 1996, the
people of California approved Proposition 215, which decriminalized the cultivation
and use of cannabis by seriously ill individuals upon obtaining a physicians
recommendation (Health & Safety Code 11362.5). Proposition 215 was enacted to
ensure that seriously ill Californians have the right to obtain and use marijuana for
medical purposes where that medical use is deemed appropriate and has been
recommended by a physician who has determined that the persons health would
benefit from the use of marijuana, and to ensure that patients and their primary
caregivers who obtain and use marijuana for medical purposes upon the
recommendation of a physician are not subject to criminal prosecution or sanction
(Health & Safety Code 11362.5(b)(1)(A)-(B)).
In order to further clarify Proposition 215, the Medical Marijuana Program Act (MMP)
was enacted on January 1, 2004 (Health & Safety Code 11362.7-11362.83). The MMP
enacted an identification card program to achieve greater consistency in the application
and enforcement of the original initiative. The MMP also clarified that a primary
caregiver may be paid a reasonable compensation for services provided to a qualified
CMA ON-CALL Document #1315. The Compassionate Use Act of 1996: The Medical Marijuana
Initiative.
17
Kingsbury0123
patient to enable that person to use marijuana and that patients and primary
caregivers may cooperatively and collectively cultivate. The MMP requires the
California Department of Public Health to maintain a program for the voluntary
registration of qualified medical cannabis patients and their primary caregivers through
a statewide identification card system. The voluntary registration program is
administered through a patients county of residence, where the eligible patient submits
an application and provides medical records containing written documentation by the
attending physician stating that the patient has been diagnosed with a qualifying
medical condition and that the physician recommends the use of cannabis for medical
purposes.
Further decriminalization was enacted on September 30, 2010 when Health & Safety
Code 11357 was signed into law. Effective January 1, 2011, this statute makes
possession of less than one ounce of cannabis a civil infraction rather than a criminal
misdemeanor as it had previously been categorized.
In November 2010, California Proposition 19, the Regulate, Control and Tax Cannabis
Act of 2010, attempted to decriminalize the recreational use of cannabis in California,
while this use would have remained illegal at the federal level. Proposition 19 would
have permitted adults 21 years and older to possess up to one ounce of cannabis for
private use and would have also allowed local governments to license and tax its sale.
Proposition 19 would also have maintained the current prohibitions for driving under
the influence of cannabis, allowed for employers to address workplace impairment (that
is, not to drug test their employees for cannabis use), and prohibited the use of cannabis
in the presence of minors. Proposition 19 failed with 53.5 percent of voters voting no
on the proposition and 46.5 percent of voters supporting the initiative.
Medicinal Efficacy
The CMA Council on Scientific and Clinical Affairs (CSA) has developed a set of
medical cannabis recommendation guidelines for physicians indicating the limited
conditions for which the medical use of cannabis may be effective.18 CSA has opined
that the literature on this subject is inadequate, cannabis dosage is not well
standardized, and cannabis side effects may not be tolerated. Dosage is not currently
well-standardized and limited medical benefits have been established with the available
research. Currently, California law only allows patients with a physician
recommendation for medical cannabis to cultivate or use the substance.
CSA has also concluded that components of medical cannabis may be effective for the
18
Physician Recommendation of Medical Cannabis. CMA Council on Scientific and Clinical Affairs,
2011.
Kingsbury0124
treatment of pain, nausea, anorexia, and other conditions.19 Cannabinoids are presently
thought to exhibit their greatest efficacy when implemented for the management of
neuropathic pain, which is a form of severe and often chronic pain resulting from nerve
injury, disease, or toxicity.20 The University of California Center for Medicinal
Cannabis Research (CMCR) recently reported to the California legislature upon the
results of a number of studies. Among these, four studies involved the treatment of
neuropathic pain and all four demonstrated a significant improvement in pain after
cannabis administration.21
Other possible clinical benefits of cannabis have been discussed in the literature,
prompting the call for scientific study. Several national organizations have taken policy
positions as a means of encouraging additional study of cannabis. Most notably, a
Consensus Conference sponsored by the National Institutes of Health (NIH) 22 and a
review panel convened by the Institute of Medicine23 advocated that controlled studies
be performed for analgesia, appetite stimulation and cachexia, and nausea and
vomiting following chemotherapy. In 2001, the American Medical Association (AMA)
Council on Scientific Affairs advocated that the NIH implement administrative
procedures to facilitate grant applications to conduct well-designed clinical research
into the medical utility of cannabis. 24 In 2008, the American College of Physicians
(ACP) also urged an evidence-based review of marijuanas [cannabis] status as a
Schedule I controlled substance to determine whether it should be reclassified to a
different schedule. 25 One year later (2009), the AMAs House of Delegates put forward
a clear-cut message that marijuanas [cannabis] Schedule I status was no longer
Medical Marijuana. The Medical Letter On Drugs and Therapeutics. No. 52, January 25, 2010: 1330.
E.J. Rahn and A.G. Hohmann. Cannabinoids as pharmacotherapies for neuropathic pain: from the
bench to the bedside. Neurotherapeutics. Vol. 6 No. 4, Oct 2009:713-737.
21 Igor Grant, et al. Report to the Legislature and Governor of the State of California presenting findings
19
20
pursuant to SB847 which created the CMCR and provided state funding. UC San Diego Center for
Medicinal Cannabis Research, February 10, 2010. Last Accessed March 9, 2011:
<http://www.cmcr.ucsd.edu/images/pdfs/CMCR_REPORT_FEB17.pdf>.
22 Workshop on the Medical Use of Marijuana. National Institutes of Health, Bethesda, MD, 1997.
23 Marijuana and Medicine: Assessing the Science Base, 1999. Last Accessed June 9, 2011:
<http://www.nap.edu/openbook.php?record_id=6376>.
24 Report 3 of the Council on Science and Public Health (I-09): Use of Cannabis for Medicinal Purposes.
American Medical Association, 2009. Last Accessed March 9, 2011: <http://www.amaassn.org/ama/no-index/about-ama/13625.shtml>.
25
T. Taylor. Supporting Research into the Therapeutic Role of Marijuana: A Position Paper. American
College of Physicians, 2008. Last Accessed March 9, 2011:
<http://www.acponline.org/advocacy/where_we_stand/other_issues/medmarijuana.pdf>.
Kingsbury0125
appropriate and interfered with legitimate medical research. 26 Most recently, the
California Medical Associations House of Delegates adopted policy urging that
marijuanas [cannabis] status as a federal DEA Schedule I controlled substance be
reviewed with the goal of facilitating research (HOD 102a-10).
Risks of Cannabis Use

The literature documents several personal health risks, both short and long-term,
associated with cannabis use. According to the National Institute on Drug Abuse
(NIDA), cannabis use can result in distorted perceptions, impaired coordination,
difficulty thinking and problem solving, and problems with learning and memory. 27
These effects can last for days or weeks and may result in long-term personal health
problems such as addiction, anxiety, depression, psychosis, respiratory problems, and
heart attack. Epidemiologic data from a national comorbidity study indicate that about
nine percent of adult cannabis users become addicted and that this risk is substantially
increased among individuals who begin using before age eighteen. 28 Further evidence
suggests that cannabis can adversely affect adolescents who initiate use early and
young adults who become regular users because adolescents and young adults have a
much greater vulnerability to the toxic effects of cannabis on the brain. 29 These
conditions also have second-hand effects by posing health risks to those members of the
public around the user.
Those who oppose the decriminalization and legalization of cannabis cite these and
other potential threats that the use of this substance poses to public health and safety.
Epidemiological studies have been inconclusive regarding whether cannabis use causes
an increased risk of motor vehicle accidents; in contrast, unanimity exists that alcohol
use increases crash risk. 30 In tests using driving simulation, neurocognitive impairment
varies in a dose-related fashion, and symptoms are more pronounced with highly
automatic driving functions than with more complex tasks that require conscious
control.31 Cannabis smokers tend to over-estimate their impairment and compensate
26
K. OReilly. Delegates Support Review of Marijuanas Schedule I Status. AmedNews.com,

November 23, 2009. Last Accessed March 9, 2011: < http://www.amaassn.org/amednews/2009/11/23/prse1123.htm >.
27 Marijuana. National Institute on Drug Abuse. June 2009.
28
JC Anthony, et al., Comparative epidemiology of dependence on tobacco, alcohol, controlled
substances and inhalants: basic findings from the national comorbidity study, Experimental & Clinical
Psychopharmacology, No. 2, 1994: 244-268.
29 W. Hall. The adverse health effects of cannabis use: what are they, and what are their implications for
policy? International Journal on Drug Policy. Vol. 20 No. 6, Nov 2009:458-466.
30 R.A. Sewell, et al. The effect of cannabis compared with alcohol on driving. American Journal of
Addiction Medicine. May-Jun 2009;18(3):185-193.
31 Ibid.
10
Kingsbury0126
effectively while driving by utilizing a variety of behavioral strategies. Public health

risks correlated with adolescent cannabis include poorer educational outcomes and
occupational attainment. Under the current prohibition of cannabis, public health is
also affected by increased rates of crime surrounding cannabis cultivation, sale and use.
The California Legislative Analysts Office estimates that the incarceration and parole
supervision of cannabis offenders costs the state tens of millions of dollars annually. 32
Policy Recommendations
Cannabis is currently not sufficiently regulated. In order to allow for a robust
regulatory scheme to be developed, cannabis must be moved out of its current Schedule
I status within the DEAs official schedule of substances. Rescheduling cannabis will
allow for further clinical research to determine the utility and risks of cannabis, which
will then shape the national regulatory structure for this substance.
CMA policy has acknowledged the criminalization of cannabis to be a failed public
health policy (HOD 704a-09) and has recognized a public movement toward the
legalization of cannabis (HOD 101a-10). Cannabis illegality has perpetuated the
effective prohibition of clinical research on the properties of cannabis and has prevented
the development of state and national standards governing the cultivation,
manufacture, and labeling of cannabis products, similar to those governing food,
tobacco and alcohol products, most of which are promulgated by federal agencies.
So what shifts in public policy could protect public health and benefit personal health?
In order to fully evaluate and regulate cannabis, it should be legalized and
decriminalized.
Solutions
Sustain physicians as gatekeepers until a proper gate is built: CMA believes that the
physician role as gatekeeper should be sustained, under Council on Scientific and
Clinical Affairs (CSA) guidelines, until such time as the legal and regulatory
environment has changed from one in which medicinal cannabis is decriminalized at
the state level but illegal at the federal level to a desired environment in which cannabis
use is legalized and regulated at both the state and federal levels.
Reschedule cannabis: The federal Controlled Substances Act classifies cannabis as a
Schedule I controlled substance, therefore preventing prescriptions from being written
for the substance and subjecting it to production quotas by the Drug Enforcement
Agency (DEA). These production quotas make it extremely difficult to acquire cannabis
for clinical research purposes, thus contributing to the lack of data currently available
32
Legislative Analysts Office Analysis. July 12, 2010.
11
Kingsbury0127
about cannabis. As of 2010, CMA supports the rescheduling of cannabis to facilitate

further clinical research (HOD 102a-10). This clinical research should be targeted at
determining the safety and efficacy of cannabis and its constituent active chemicals.
Three options exist for rescheduling cannabis and supporting further research:
1. Move cannabis to an appropriate scientific schedule within the current DEA
scheduling structure;
2. Place cannabis on its own schedule with parameters unique from other
enumerated schedules;
3. Support the development of local cannabis regulations as an interim
alternative pending federal action.
The route to challenging cannabiss status as a Schedule I controlled substance is by
filing a rule-making petition with the DEA Administrator. The Administrator has the
authority to reschedule substances by considering the scientific evidence of [the
substances] pharmacological effect, if known and the state of current scientific
knowledge regarding the [substance]. 33
Because the DEA has historically denied petitions to reschedule cannabis, CMA should
encourage the formation of a national coalition between state medical societies, medical
specialty societies, and other relevant groups for the purpose of building support for
cannabis rescheduling. The national movement whereby 16 states and the District of
Columbia have decriminalized the use of medical cannabis should serve as a model for
building this coalition. With strength in numbers and the power to place the necessary
political pressure on the DEA, this coalition should consider jointly petitioning the DEA
to reschedule cannabis.
Regulate medical cannabis: Rescheduling medical cannabis to allow for further clinical
research is the acceptable avenue for providing an opportunity to formulate a workable,
evidence-based federal and state regulatory structure that protects public health and
safety. By allowing adequate research to determine the utility, safety and efficacy of
cannabis as well as the necessary controls for the substances production, distribution,
taxation, etc., cannabis regulation is able to mirror that of other prescribed medications.
The appropriate regulatory bodies can use funds collected through a cannabis tax to
enforce violation of the implemented standards. The regulation of cannabis should
address several broad areas, including:
Research: As with any drug or pharmaceutical product, the properties of
cannabis should be thoroughly studied through clinical research to determine
utility, safety, and efficacy for potential medicinal uses. The outcome of this
33
21 U.S.C. 811(c)(2), (3), 1994.
12
Kingsbury0128
clinical research should be used to determine an appropriate regulatory

framework for cannabis control.
Production & Distribution: Production of cannabis should be held accountable
to quality control measures and standardization. All vendors should be licensed
and distribution of cannabis should include restrictions on purchase and use to
all minors. All cannabis supply should be subject to purity, concentration and
product labeling standards. Labeling standards should include warning labels,
similar to those on tobacco and alcohol products. Pending federal regulation of
cannabis, local regulatory structures should be implemented in order to control
the production and supply of cannabis.
Public Safety: Workplace safety should remain a priority, with the enactment of
prohibitions against workplace intoxication, similar to the treatment of alcohol
use. Also, regulations surrounding driving safety and zero-tolerance for school
possession should be implemented.
Advertising: Public advertisement of cannabis should be subject to time and
place provisions, similar to tobacco and alcohol, with sanctions including loss of
licensure for those entities that violate this provision.
Reporting: An outcomes reporting system is needed to track beneficial and
adverse effects of cannabis in real-time.
Regulate recreational cannabis: Consider permissive federal authority for states to
regulate this more widely used cannabis for purity (strength) and safety
(contaminations) with current, education and research on outcomes of such policy.
These actions would mirror alcohol and tobacco control. While an unlikely political act
nationally at this time, Colorado is already attempting this without federal authority.
Growing local discontent with federal non-actions coupled with increasing violence
among cannabis dealers (cartels) in Mexico could help leverage this action. CMA
should authorize responsible collaboration with groups which support such state level
action.
Tax cannabis: A tax should be levied on cannabis as a means of collecting funds
dedicated to regulation, enforcement and education.
Facilitate dissemination of the benefits and risks of cannabis use as determined by clinical
research: The outcomes of clinical cannabis research should be publicly shared so as to
educate the public.
Support educational efforts: Various educational campaigns targeting different
demographics are needed. These educational activities can be funded through an
earmarked portion of the cannabis tax. The goal of these educational campaigns should
be to reduce cannabis use among children, adolescents, and young adults. Separate
campaigns should be launched targeting the public, physicians, and medical students.
13
Kingsbury0129
Within the general public demographic, smaller targeted campaigns will educate
specific cohorts such as youth, adults, and law enforcement officials.
Refer for national action: National advocacy is essential to promoting the adoption of
consistent, effective regulations at the federal level. Without a national solution, a
patchwork of state-by-state decriminalization efforts will persist, thus exposing
physicians and members of the public to liability and federal criminal sanctions.
White paper dissemination: This white paper shall be distributed to interested CMA
members, component medical societies, specialty societies, and other interested
organizations.
14
Kingsbury0130
Pain Management
PersPective
For reprint orders, please contact: reprints@futuremedicine.com
Re-branding cannabis: the next

generation of chronic pain medicine?
Gregory T Carter*,1 ,2, Simone P Javaher3, Michael HV Nguyen2,
Sharon Garret4 & Beatriz H Carlini4
Practice Points
Cannabis has been used for thousands of years by humankind as a safe and useful
means of providing analgesia.
Much of what has led to todays views on medicinal cannabis has been based on
political and societal agendas rather than purely on the available science.
There already exists in the available literature a strong evidence base supporting the
use of cannabis to treat chronic pain, particularly neuropathic pain.
There is a need for further research, particularly in to other forms of pain, using
standardized cannabis preparations and protocols.
There is a need for more rationale governmental regulations regarding the

scheduling of cannabis and its availability for clinical trials.
Cannabis can be eectively used to treat chronic pain with appropriate patient
screening and physician oversight.
SUMMARY The eld of pain medicine is at a crossroads given the epidemic of addiction
and overdose deaths from prescription opioids. Cannabis and its active ingredients,
cannabinoids, are a much safer therapeutic option. Despite being slowed by legal restrictions
and stigma, research continues to show that when used appropriately, cannabis is safe and
eective for many forms of chronic pain and other conditions, and has no overdose levels.
Current literature indicates many chronic pain patients could be treated with cannabis
alone or with lower doses of opioids. To make progress, cannabis needs to be re-branded
as a legitimate medicine and rescheduled to a more pharmacologically justiable class
of compounds. This paper discusses the data supporting re-branding and rescheduling
of cannabis.
KeYwoRdS
cannabis medical
marijuana pain palliative
care re-branding
Background
Cannabis (marijuana) has been used by humankind for medicinal, religious, and recreational purposes for over 5000 years. Medicinal use has been noted in ancient Chinese texts written in 2800 BC,
where it was recommended for analgesia [14] . Eastern Indian documents in the Athera Veda, dating
to 2000 BC, also refer to the medicinal use of cannabis for pain relief[3,4] . Archeological evidence
has been found in Israel indicating that cannabis was used therapeutically during childbirth as an
1
St Lukes Rehabilitation Institute, Spokane, WA 99202, USA

University of Washington School of Medicine, Seattle, WA 98195, USA
3
Health Policy Clinical Manager, Washington State Labor & Industries, Olympia, WA 985044321 , USA
4
Alcohol & Drug Abuse Institute, University of Washington, Seattle, WA 981 05, USA
*Author for correspondence: Tel.: +1 509 473 691 0; Fax: +1 509 473 6978; carterg@st-lukes.org
2
1 0.2217/PMT.14.49 2015 Future Medicine Ltd
Pain Manag. (2015) 5(1), 1321
part of
ISSN 1758-1869
13
Kingsbury0131
PeRSPective Carter, Javaher, Nguyen, Garrett & Carlini

analgesic [4] . In ancient Greece and Rome, both
the Herbal of Dioscorides and the writings of
Galen refer to the use of medicinal cannabis [4] .
The medicinal use of cannabis arrived in the
West much later when US Cavalry Army physician William OShaughnessy introduced a
cannabis tincture used for analgesia and a wide
array ofailments following his observations while
travelling in India in the 1840s [3,4] . In that same
era, Queen Victoria used cannabis for relief of
dysmenorrhea [3,4] .
Against the advice of the American Medical
Society (now Association) and not on the basis
of any scientic reasoning, all use of cannabis
was criminalized in 1937 in the United States [3]
and in 1942 it was ofcially removed from the
US Pharmacopoeia. Due to fact that hemp, a
non-medicinal form of the cannabis plant, grows
so much faster and more efciently than cotton,
it was temporarily re-legalized and used productively in World War II to make rope and clothing.
The hemp industry still thrives today in countries
such as China and Hungary.
In 1972, the Nixon-appointed Shaffer
Commission actually recommended that cannabis
be re-legalized but this was ignored [5,6] .
Today, the cultivation, possession and distribution of cannabis are strictly controlled by
international narcotic regulations, though some
states and nations interpret these regulations differently. For example, the Netherlands, Uruguay,
and Portugal have completely decriminalized cannabis possession for any purpose. In the USA, at
the time of writing, 23 states and the District of
Columbia have passed voter initiatives and referenda to allow the medicinal use of cannabis. In
addition, Colorado and Washington States have
legalized cannabis for recreational purposes for
individuals 21 and over.
can cause legitimate concerns, but this is not a

new phenomenon. Many currently used medications have the potential for misuse, however this
does not diminish their effectiveness in treating
patients when used as prescribed by a medical
provider. Cocaine and morphine are addictive,
but are still used medicinally as an anesthetic or
to stop epistaxis, and in the management ofacute
pain respectively. It is important to distinguish the
difference in how medicinal cannabis and recreational marijuana have been cultivated over time
to meet specic needs. Recreational marijuana,
grown for its psychedelic properties, contains
-9-tetrahydrocannabinol (THC) at much higher
levels than is sought in medicinal cannabis, which
tends to be rich in the non-psychoactive cannabinoid CBD, with relatively lower concentrations
of THC.
The campaigns against cannabis started with
the prejudicial treatment of Mexican farmworkers and the politically motivated media messages
that sensationalized cannabis as causing psychosis,
promiscuity, stunting of growth and addiction.
This manufactured fear of Reefer Madness laid
the groundwork for polarized social, economic,
and geopolitical opinions, which have fomented
controversy and confusion in the minds of both
the lay public and the medical profession.
Hence, there remains much debate over what
role, ifany, cannabis should play in modern medicine, particularly in pain management. While
medical professionals may also have negative
perceptions about cannabis, more often they are
reluctant to consider cannabis as a viable treatment modality because of practical and safety
concerns. First there is the concern that the
Federal United States Drug Enforcement Agency
(DEA) has not rescheduled cannabis to recognize
its medicinal value, thereby making it illegal to
prescribe. Providers are concerned about their lack
Barriers to progress
of control over the product in terms of consistDespite its rich history of therapeutic value, can- ency of the ingredients and the possible inclusion
nabis continues to be a controversial topic with of unknown ingredients with unknown effects.
many real and perceived barriers that have cre- They are unsure about correct dosing, the interated a kind of cultural gridlock. This has limited actions of cannabis with other medications, and
progress in research, has resulted in confusing its effect on performance in the workplace. These
laws, and has caused even the most knowledge- concerns bolster the argument for rescheduling,
able pain management specialists to be wary of regulating, and manufacturing pharmaceutiusing it. These barriers to progress center on cal grades of cannabis. By eliminating barriers,
negative societal perceptions and specic medi- research could happen more rapidly generating a
cal concerns [1] . Societys perceptions are mired in better understanding of the plants components,
the near hysterical political and social campaigns and regulation would allow for testing and labeof the past that branded cannabis as a danger- ling of the product as is occurring in Colorado
ous recreational drug. Recreational use of a drug and Washington State under the new regulations
14
Pain Manag. (2015) 5(1)
future science group
Kingsbury0132
Cannabis for chronic pain

that went into effect this year legalizing the use
of recreational marijuana.
Lack of education and training is another barrier to progress. The medicinal use of cannabis
is a frequently requested topic in lectures and
seminars on pain management, yet paradoxically
remains almost non-existent within the formal
training of medical students, residents, fellows,
and clinical pharmacists. An interesting paradox
in the age of the internet and wide accessibility to
databases like the National Library of Medicine
(http://www.ncbi.nlm.nih.gov/pubmed/), is the
increasing likelihood that pain specialists may be
asked about potential or actual cannabis use for
pain by their patients. Further, the patient may
already have accessed and gained knowledge of
the existing scientic knowledge base regarding
cannabis. One of the authors (GTC) has, on a
number ofoccasions, had a patient bring in copies
of a published scientic paper in order to argue
their case as to why cannabis use would be appropriate for their pain condition. The pain specialist
who simply responds to a patient inquiring about
cannabis use for their condition by saying there
is not enough evidence is not practicing to the
level ofcurrent knowledge. By summarily refusing
to discuss or entertain the use of medicinal cannabis with a pain patient, the physician is undermining the doctor-patient relationship. This also
encourages the patient to seek other, perhaps less
qualied or legitimate, sources of authorization.
This may include the so-called doc in the box
pot clinics where the patient will likely receive a
less than robust clinical evaluation and not likely
establish a bona de on-going relationship with
the practitioner. In addition, patients may not
share information about their use of cannabis
with the provider who had dismissed the idea,
leaving providers with incomplete information
and limiting their ability to make well-informed
clinical judgments.
Ultimately true progress can only be made when
governments and the medical community allow
legitimate clinical testing ofcannabis for complete
evaluation of its properties and therapeutic uses,
including strains that are specically cultivated
for pain relief with minimal psychoactive effects.
re-branding cannabis as legitimate
medicine for the management of
chronic pain
There certainly already exists a massive interest
in cannabis use on behalf of the general public
and media, centered primarily on recreational
PeRSPective
use. The medical community, including specialists in pain medicine, still appears to be holding
onto a perception that cannabis may be effective
for pain control, but poses too many dangers
and risks. To break this juggernaut and allow
chronic pain sufferers access to high quality,
safely administered doses of medicinal cannabis,
it must be re-branded in the minds of the public,
health care regulators, and the medical community. This is not the re-branding of a product in
the commercial sense, but a re-branding in terms
ofchanging how we react to the thought ofusing
medicinal cannabis; it requires a shift in its cultural meaning. Brands, at their best, are, among
other things, bundles ofmeanings, some ofthem
robust, some of them delicate, all of them poised
to speak to one or more segments and to deliver
an understanding of not just what the product
does, but what it means its cultural meaning.
[7] . This means changing how we talk about it,
for example, using the term medicinal cannabis
for its therapeutic use versus marijuana for recreational use, and discarding disparaging terms
such as pot-heads.
There are many examples of how our cultural
thinking in the past is almost inconceivable to us
now. To paraphrase German philosopher Arthur
Schopenhauer, all truth passes through three
stages, rst being ridicule, followed by opposition, before ultimately becoming self-evident. It
wasnt that long ago that cigarette smoking was
allowed everywhere in public places, including
hospitals.
Cannabis has been around long enough for
most clinicians to have had at least some experience
with it either professionally, socially, personally, or
otherwise; so the rst step in re-branding cannabis
would be for clinicians to examine their personal
perspectives about its general and medicinal use,
and the ramications ofthose opinions [811] . This
worthwhile reective exercise may reveal previously unrecognized biases that have inuenced
their clinical judgment. Ultimately, treatment
decisions should be based on current scientic
evidence, clinical indications and need given the
known risks and benets, and in the context of a
proper clinical evaluation and consultation. This
presumably includes a full history with careful
screening for past or current substance abuse, and
following appropriate guidelines.
the opioid epidemic
There has been near epidemic increases in deaths
related to prescription opioids. [1225] . There
www.futuremedicine.com
15
Kingsbury0133

appear to be a a correlation between the risk of
opioid overdose and increasing prescribed dosages [2123] . Data from the Centers for Disease
Control and Prevention (CDC) indicates that
the number of opioid poisoning deaths in the
USA nearly doubled, from approximately 20,000
to 37,000 from 1999 through 2006 [24] .
This concerning scenario contrasts with
the fact that cannabis has no known lethal
dose [1,4,26] . If cannabis based medicines were
more widely used to treat pain, potentially thousands of deaths from opioid toxicity could have
been prevented. However, these problems with
the use of opioids in the management of chronic
pain may actually have served to increase physician sensitivity to issues of abuse, potential
diversion, long term safety, patient screening and
monitoring for functional outcomes, many of
which are equally applicable to concerns around
the medicinal use of cannabis.
exempting bona de patients from prosecution

for the possession of cannabis and authorizing
cannabis cultivation programs to provide access
to a quality controlled and standardized herbal
cannabis product. It is poignant to note that
patient led efforts have been at the core of cannabinoid drug development. Past and present
reports of the effects of cannabis on symptoms
of, pain and spasticity triggered the clinical
development and evaluation of cannabinoid
drugs [3137] . Pharmaceutical studies have, to a
limited extent, validated these original claims,
particularly for neuropathic pain [3854] .
the science behind tHc & other

cannabinoids
Israeli scientists Mechoulam and Gaoni identied THC as the primary psychoactive ingredient of cannabis in 1964 [55] . Originally THC
was felt to be the main active ingredient in cannabis. However in the following decades, other
the legal side of the equation
compounds unique to cannabis (cannabinoids)
In the past decade many states have re-legalized were isolated and characterized. Cannabis is
cannabis for medicinal purposes. This is likely now estimated to contain over 100 such comprimarily based on political pressures placed on pounds, some of which were further evaluated
state governments by patients and their advo- by pioneering scientists including E. A. Carlini,
cacy groups. Actual true acknowledgement of who elucidated the potential medicinal benthe growing scientic evidence base by govern- ets of cannabidiol (CBD) [5659] . Despite this
mental agencies has so far played a minor role. basic science progress, the 1960s and 70s saw
To date, laws still differ considerably from state a resurgence in recreational use of cannabis,
to state, and even among countries, with much with it becoming a major part of the counterambiguity regarding what constitutes acceptable culture movement during that time period. By
medical use and guidelines for such usage. [2730] the early 1970s the medicinal use of cannabis
In the USA, the DEA laws, as determined began to be re-investigated, starting with a series
by the Controlled Substances Act (CSA), still of case reports from Harvard psychiatrist Lester
classies cannabis as a Schedule I drug, the Grinspoon [60] .
most tightly restricted category, reserved for
drugs which have no currently accepted medi- Dronabinol (marinol) & nabilone (cesamet)
cal value and considered too dangerous for use In the early 1980s, the main focus of the phareven under medical supervision. Thus there maceutical industry was on the THC molecule,
is no uniform set of quality control standards primarily for the treatment of pain, loss of appein place to assure the quality, consistency, and tite, and intractable nausea. Dronabinol, more
availability of medicinal cannabis for patients commonly known as Marinol, was initially prowith chronic pain. This is undoubtedly a barrier duced as synthetic THC, became the primary
for health care professionals who may otherwise cannabinoid based prescription medicine, folbe willing to recommend cannabis use for their lowed later by nabilone (also a synthetic THC
patients with chronic pain. While the scientic analogue), commercialized as Cesamet. These
eld of enquiry was expanding in the 1990s, the drugs remain as schedule III drugs today, with
therapeutic potential for cannabis, coupled with generic forms available worldwide. However,
prohibition on possession, became a source of dronabinol is 100% THC and most patients nd
patient-led legal challenges in several countries. it too sedating at standard dosing, and associThis ultimately gave rise to compassionate access ated with too many psychoactive effects [61,62] .
programs in Holland, Canada and Israel using Dronabinol and Nabilone are not appropriate
a variety of regulatory mechanisms aimed at substitutes for natural cannabis.
16
Pain Manag. (2015) 5(1)
Kingsbury0134
PeRSPective
cannabis programs suggest that self-reported

pain conditions are responsible for up to 90%
of cannabis authorizations [82] . Although the
mechanisms by which cannabinoids treat pain,
including chronic pain, are complex and remain
to be fully elucidated, there is a growing evidence base to support its use in this setting [83] .
The modulation of CB2 receptors producing a
decrease in the liberation of pro-inammatory
mediators has led some to propose that certain
chronic pain conditions may represent abnormalities in the endocannabinoid system [84,85] .
The immunomodulatory and neuroinflammatory properties, which would contribute to
the antinociceptive properties of cannabinoids,
would lend some credence to that hypothesis.
Whether isolating agents that would selectively
target peripheral CB1 and CB2 receptors would
improve overall analgesia and improve quality
of life for chronic pain patients remains to be
Endocannbinoid system
studied. However bypassing the other, more
Perhaps the biggest breakthrough in under- subtle and complex analgesic properties that
standing the potential medicinal applications of are seen in the cornucopia of cannabinoids that
cannabinoids was the the discovery of the endo- occur in the natural plant may not improve
cannabinoid system in the early 1990s [6569] . analgesia or safety. Indeed, there are even nonThere are at least two distinct G-protein-coupled cannabinoid, terpenoid compounds that are
cannabinoid receptors type 1 and 2 (CB1 and purported to provide analgesia, which occur in
CB2) which are widely expressed in the body the natural plant.
[7075] . The endocannabinoid system (ECS)
plays a major physiologic role in maintaining conclusions & future perspective
homeostasis, as well as the modulating a num- There is an increasing evidence base supportber of functions in the central and peripheral ing the use of cannabis for chronic pain disnervous systems, the immune system, the gut, orders. Yet regulatory and funding limitations
the cardiovascular system, among other critical have led to trials that are generally small, and
physiological systems [7681] . This includes mod- of short duration, particularly when compared
ulating the degree and perception of pain. The with industry sponsored trials. Moreover, in the
ECS is arguably the most important newly dis- USA the only approved route of administration
covered physiological pain moderating systems is smoking a cannabis cigarette that has been
discovered in the past quarter century. The ECS grown by the U.S. government. Overall, the
forms the underlying physiological and phar- limitations for doing clinical trials with cannamacological mechanistic basis to delineate the bis are considerably more restrictive than those
therapeutic actions of cannabinoid medicines.
required in pharmaceutical industry trials. Yet
the safety prole ofcannabinoids remains a comApplications in the eld of pain
pelling force to move this area forward. Despite
management
some conicting and paradoxical reports, the
Studies already show that chronic pain is the overwhelming data, including large populationmost common reason for patients to report the based studies of recreational cannabis use, indimedicinal use of cannabis [33,36] . Within chronic cate that the toxicity of cannabis is extremely
pain clinics, estimates of the prevalence of use low and adverse drug reactions are rare. The
range from 1215%, with patients with bromy- argument for allowing further clinical trials to
algia, degenerative arthritis, spinal cord injury be done, in a less restrictive, regulated fashion,
and multiple sclerosis (MS) being among the would appear to be strong.
main population who report using cannabis use
Whether it is necessary to make all reafor the relief of pain [36] . Data from medicinal sonable efforts to try standard therapeutic
Other cannabinoids
The cannabis plant is remarkably complex,

with several subtypes of cannabis, each containing over 400 chemicals [6365] . Cannabinoids,
consisting of alkylresorcinol and monoterpene
groups, are unique secondary metabolites that
are found only in Cannabis. Cannabinoids
may be broadly classied as terpenes and are
biosynthesized predominantly via a deoxyxylulose phosphate pathway [66] . Other major cannabinoids include cannabidiol (CBD) and cannabinol (CBN), both of which may modify the
pharmacology of THC, in addition to producing unique effects on their own [63] . Many cannabinoids are not psychoactive and this includes
CBD, which has signicant anticonvulsant and
sedative properties and modulates the activity of
THC [56] . Pre-treating mice with CBD will lead
to threefold increases of brain THC levels [59] .
17
Kingsbury0135

(pharmacological and non-pharmacological)
approaches before cannabis is considered is often
more a matter of legal statute than clinical indication. In other words, many laws require that
all standard means of treating pain be tried and
failed before cannabis can be offered. Arguably,
any decision to offer medicinal cannabis as a
treatment option will depend on the severity of
the underlying pain condition and the extent
to which other approaches have been tried.
Simply relegating cannabis to a third or fourth
line agent for chronic pain does not reect the
body of evidence showing that it could be a rst
line therapy for a condition like central neuropathic pain due to multiple sclerosis. The argument that dosing for herbal cannabis is difcult
due to lack of standardized dose forms is easily
removed by applying the universal principle of
beginning therapy with low doses and gradually increasing the dose as tolerated to maximum
benet with minimum adverse events. The available data would indicate that most patients can
get a benecial analgesic effect by using average
daily doses ofunder 5 grams per day [1] . However
some patients may require a larger amount to
obtain relief. As noted previously, the safety prole of cannabis is quite good and there is no hard
evidence of signicant toxicity at higher doses.
For the most part the risk of developing tolerance to the therapeutic properties of cannabis
is minimal, particularly when compared with
drugs like opioids and benzodiazepines.
It should also be noted that cannabis, like
many therapeutic medicines, has the potential
for adverse effects. The literature contains many
reports showing purported associations between
recreational cannabis use and early onset psychosis, impairments in driving with potential
increase in risk of accident, myocardial infarction, stroke, and risk of chronic bronchitis in
those that smoke it [34,45,86] . There is also potential for abuse, cognitive impairment, and risk of
dependency in susceptible patients. Yet from a
harm reduction standpoint, these problems are
less serious and less common than the potential risks and co-morbidities associated with
opioid use. In a clinical setting, a patient using
medicinal cannabis would not be smoking cannabis and the amount used would be monitored,
as would the potential for any risk factor and
comorbidity. The patient would presumably also
be using a less psychoactive form of cannabis.
Of course, practitioners must carefully construct a treatment plan, as they would in any
18
Pain Manag. (2015) 5(1)
chronic pain management program, and diligently supervise the patients medical care. A
well-constructed treatment plan would include
clinical monitoring, follow up, and mutually
agreed upon treatment goals such as reduction
in other medications, realistic expectations,
functional outcomes and pain relief. These are
essential yard sticks to measure therapeutic progress, and failure to demonstrate positive outcomes in a reasonable timeframe should prompt
reconsideration and possible cessation oftherapy.
Cannabis dependency is possible and if a point
arrives when a given patients use of cannabis
does not meet therapeutic standards, evaluation for possible cannabis abuse disorder may
be needed, along with referral for treatment.
Using cannabis as a highly therapeutic analgesic treatment option does not mean that it is a
panacea. Any recommendation to use cannabis
as an analgesic agent should be based on clinical judgment and thorough knowledge of the
available literature. However, using medicinal
cannabis for pain expands the armamentarium
of tools used to treat pain. Moreover, as opioid
analgesic overdose mortality continues to rise in
the United States, there is an increasing need for
new and safer modalities to treat chronic pain. A
recent study indicates that states in the USA with
medical cannabis laws have signicantly lower
opioid overdose mortality rates [87] . Medicinal
use of cannabis holds too much potential to
be held back by laws that are not consistent or
reective of the science.
As our knowledge of the exogenous and
endogenous cannabinoid system continues to
grow, we better clarify the role and importance
of this system and its therapeutic potential in
chronic pain. It remains to be seen whether the
future will lead solely to puried analogues or
more highly rened extracts of natural cannabis.
Regardless, purication and renement do not
always mean a safer drug or improved efcacy.
There does remain a need for further clinical
studies of inhaled (vaporized) and ingested
forms of herbal cannabis. Ideally this would not
be limited by restriction of access to high grade
medicinal cannabis or concerns of intellectual
property.
Pain medicine specialists should examine
their attitudes and beliefs about cannabis to
check for any bias, inform themselves about
the most current literature and clinical guidelines, and embrace the scientic process, which
continues to document the therapeutic effects
Kingsbury0136

of cannabis. Practitioners must be willing to
advocate for chronic pain patients who want to
legitimately access a medicine that could potentially help them and safeguard them from the
harmful effects of other options such as opioids.
Using science and logic rather than societal and
political posturing, we can bring our antiquated
cultural conditioning about marijuana into the
21 st century and help create safe, rational, and
useful regulations for medicinal cannabis.
Papers of special note have been highlighted as:

of interest; of considerable interest
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The authors have no relevant afliations or nancial
involvement with any organization or entity with a nancial interest in or nancial conict with the subject matter
or materials discussed in the manuscript. This includes
employment, consultancies, honoraria, stock ownership or
options, expert testimony, grants or patents received or
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21
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21 2 / Point/Counterpoint
Marijuana Liberalization Policies: Why We Cant Learn Much from Policy Still
in Motion
Rosalie Liccardo Pacula and Eric L. Sevigny
INTRODUCTION
California legalized the use of marijuana for medicinal purposes nearly 17 years ago,
representing a major challenge to the federal governments scheduling of marijuana
as a Schedule I drug in the 1970 Controlled Substance Act. As many predicted, California was simply the first. As of May 2013, 19 states and the District of Columbia
now provide legal protection to patients, and in many cases caregivers, for possession and supply of marijuana for medicinal purposes. In November 2012, Colorado
and Washington went even further, legalizing the sale and possession of marijuana
for recreational purposes. Given the tremendous natural experiment that is taking
place, one might expect that much would already be known about the benefits and
harms of liberalizing marijuana policies. Unfortunately, however, the tremendous
uncertainty regarding what protections actually exist, and for whom, in addition
to the enormous heterogeneity in the medical marijuana laws (MMLs) that continue to change over time, has meant that we do not yet know as much as we
should.
The questions of whether marijuana is medicine and whether recreational marijuana use is harmless are necessarily intertwined in all of the debates over policy
reform, but these are not the focus of this discussion. There is legitimate evidence
that active cannabinoids available in the marijuana plant are useful in the treatment
ofsome medical conditions and symptoms (Institute ofMedicine, 1999; Leung, 2011;
Watson, Benson, & Joy, 2000) and have been for centuries (Eddy, 2010; Grinspoon,
2005). As such, it is not surprising that the American Medical Association (AMA)
adopted a resolution in 2009 urging the federal government to review the case for
rescheduling marijuana, noting that doing so would facilitate research and development of cannabinoid-based medicine and avoid the patchwork of inadequate state
laws that do not focus on establishing clinical guidelines or standards for medically prescribing marijuana (AMA, 2009). There is also evidence in the biomedical
and public health literatures of reasonable pathways through which marijuana can
harm health or affect health outcomes (see Hall & Degenhardt, 2009; Hall & Pacula,
2003; Room et al., 2010; or Caulkins et al., 2012 for extensive reviews). However,
the causal linkage between recreational marijuana use and many of these health
outcomes has yet to be fully established and continues to be a matter of scientific
inquiry due to imprecise information on amounts consumed or potency of the substance used. Nonetheless, state liberalization policies move forward, and scientists
are trying to use these natural experiments to assist in the identification of benefits
and harms from these policies.
THE EFFECTS OF MMLS: A SUMMARY OF, AND PERSPECTIVE ON, THE LITERATURE
Researchers have tried to make use of variation in other state marijuana policies,
including penalties, decriminalization, and depenalization, to tease out causal relationships regarding the effect of use on outcomes, but these approaches suffer
Journal ofPolicy Analysis and Management DOI: 10.1002/pam
Published on behalf of the Association for Public Policy Analysis and Management
Kingsbury0140
Point/Counterpoint / 21 3
from important limitations when examining U.S. data. First, in many decriminalized states, the criminal status of marijuana possession offenses remains in effect
(Pacula, Chriqui, & King, 2003; Pacula et al., 2005). Thus, states cannot be uniquely
identified as having lower penalties based on the adoption of decriminalization policies. Second, many marijuana possession penalties have not varied much over time,
making it difficult to separate true policy effects from unobserved state characteristics correlated with policy adoption (Farrelly et al., 2001; Pacula, Chriqui, & King,
2003). Finally, where policy changes have occurred, they are often so minor that
they are unknown to the affected population (MacCoun et al., 2009).
Unlike other marijuana policy changes, MMLs and the two recent legalization
policies have received considerable media attention at the local and national level,
in part because many occurred through voter referendum. Thus, MMLs would seem
to represent an ideal policy for considering potential causal relationships between
marijuana access, use, and harm. Whether the policies affect supply or demand is
less relevant than the fact that effects through either mechanism should increase
consumption. Thus, to the extent that these policies increase use directly, they will
provide a unique source of independent variation necessary for identifying causal
relationships between use and harms or benefits.
Although numerous studies have examined the association among these policies, marijuana use, and harms, relatively few have used methods that would allow
for causal inference. Among those that do, the vast majority of studies employ
difference-in-differences (DD) approaches. Importantly, even with similarly rigorous identification techniques, the results have varied tremendously, with some studies concluding that MMLs have no significant impact on marijuana use (Anderson,
Hanson, & Rees, 2013; Harper, Strumpf, & Kaufman, 2012; Lynne-Landsman, Livingston, & Wagenaar, 2013) and others finding a positive effect (Cerda et al., 2012;
Chu, 2012; Pacula et al., 2010).
To some extent differences in findings can be explained by legitimate differences in
the populations examined, as specific age groups and subgroups represent different
types of users or margins of use. For example, Harper, Strumpf, and Kaufman (2012)
examine data over the period 2003 to 2008 and consider the impact of MMLs on
adolescent self-reported marijuana use and perceived harmfulness using aggregated
National Survey on Drug Use and Health (NSDUH) state data. First replicating and
then improving upon an earlier descriptive study by Wall et al. (2011), Harper,
Strumpf, and Kaufman use a DD approach with year- and state-fixed effects to
control for time-stable unobserved heterogeneity at the state level. They find that
state MMLs have no statistically significant effect on use regardless of age group
examined (12- to 17-year olds; 18- to 25-year olds, and 26 and above). Anderson,
Hanson, and Rees (2013) and Lynne-Landsman, Livingston, and Wagenaar (2013)
make use of data from the Youth Risk Behavior Survey (YRBS) and come to the
same general conclusion. Chu (2012) and Pacula et al. (2010), however, make use
of data on arrestees, who are well-established as having greater involvement with
drugs (Makkai, Fitzgerald, & Doak, 2000; Taylor & Bennett 1999; Taylor et al., 2001).
Thus, the fact that these studies find a positive association while those examining
casual use among the youth or household populations find no effect might simply
reflect differential responses in different populations.
Heterogeneity in populations examined is not the only explanation for the differences across studies. Anderson, Hanson, and Rees (2012) and Pacula et al. (2013)
offer two more reasons. In their Institute for the Study of Labor (IZA) working paper,
Anderson, Hanson, and Rees (2012) are the first to make the point that differential
state representation in various data sets used to evaluate these policies may lead to
different outcomes, as the source of identification of policy effects is coming from
different states that could conceivably have different experiences. In DD models,
including state- and year-fixed effects and state-specific time trends and making use
Kingsbury0141
Table 1. Summary of state medical marijuana laws as of January 1, 2012.
State
Alaska
Arizona
California
Colorado
Delaware
District of Columbia
Hawaii
Maine
Maryland
Michigan
Montana
Nevada
New Jersey
New Mexico
Oregon
Rhode Island
Vermont
Washington
Year initial medical

marijuana law
(MML) passed
Year home
cultivation
allowed
Year
dispensaries
legally allowed
1998
1996
1996
2000
2011
1998
2000
1999
2003
2008
2004
2001
2009
2007
1998
2007
2004
1998
1998
2010
1996
2000
NA
NA
2000
1999
NA
2008
2004
2001
NA
2007
1998
2007
2004
2011
NA
2010
2003
2000
2011
2010
NA
2009
NA
NA*
NA as of 2011 ++
NA
2009
2007
NA*
2009
2011
NA*
Note: NA means that cultivation or dispensaries are not legally allowed per state law. In some states,
indicated with an asterisk (*) dispensaries can be found in certain cities or regions, but state law does
not legally protect them, so they operate at their own risk. In Montana, initial state law was ambiguous
as to the legal protection of cooperatives and dispensaries, but a subsequent law in 2011 made it clear
they were not legally protected.
of combined data from the state and national YRBS, they find no statistically significant effect of MMLs on 30-day marijuana prevalence or frequency of use among
youth. They replicate these null findings with similarly comprehensive state-level
data from the National Longitudinal Survey of Youth 1997 Cohort (NLSY97) and
1992 to 2009 Treatment Episode Data Set (TEDS) data.
In Pacula et al. (2013), we examine the same data sets as Anderson, Hanson,
and Rees, but we find that the use of a single dichotomous indicator to represent
MMLs obscures important differences in policies across states and these different
dimensions have unique impacts on recreational use. Moreover, we show that these
relevant dimensions change over time, and hence the policy is not static over time.
When we control for specific dimensions of the MML policies, we find that states
restricting broad access to medical marijuana by requiring annual registration of
patients have lower marijuana prevalence rates among youth and adult and lower
admissions to treatment than states without such requirements. However, states
allowing home cultivation and legal dispensaries are both positively associated with
recreational use and in particular, heavy use. This important heterogeneity in policies had been overlooked in previous studies, and could easily explain the inconsistency in findings across studies that relied on variation in particular state/years for
identification.
WHY THE TIMING AND EVOLUTION OF MMLS MATTERS: PRICES AND POTENCY
As shown in Table 1, and described in greater detail in Pacula et al. (2013), medical
marijuana policies continue to evolve in important ways after initial adoption. The
Kingsbury0142
issue of supply mechanism, in particular, has changed a lot even within states over
time as more information is gained in terms of court interpretation of the legitimacy
of these policies and the federal response to them.
Our research suggests that initial policies that are either silent regarding source
of supply (Arizona in 1996, Washington, DC, in 1998, and Washington state in 1999)
or only allow access through home cultivation generate a different policy response
than MML policies that allow dispensaries or cooperatives. Why? Part of the answer
lies in the differential effects on price.
To better understand this, one has to think about the mechanisms through which
MML policies could potentially influence use. Passage of a MML could influence
recreational use through one of at least four channels as follows: (1) changes in
perceived harms, perceived risks, or disapproval (Bachman, Johnston, & OMalley,
1998, 1981; Khatapoush & Hallfors, 2004); (2) changes in social norms (Jacobson, 2005); (3) changes in ability to access marijuana (Thurstone, Lieberman, &
Schmiege, 2011); and (4) changes in the organization of supply that alter costs or
methods of production for the black market and, hence, reduce price (Pacula et al.,
2010). Any of the first three mechanisms would lead to a shift in the demand for marijuana, but such a shift in demand would mean higher total consumption putting
upward pressure on marijuana prices in the market. Indeed, we found evidence of a
rise in the average self-reported price per gram of marijuana paid among arrestees
using quarterly drug transactions across 40 counties in nearly 30 states using the
2000 to 2003 Arrestee Drug Abuse Monitoring Program (ADAM; Pacula et al., 2010).
Although changing norms might incentivize a casual user to engage in marijuana
use, higher prices will deter them from doing so substantially. Thus, the rise in total
consumption predicted by theory is likely to be driven by the consumption behavior of existing regular users more than the entrance of new users in equilibrium.
Such a behavioral response could lead to null findings in studies only considering
prevalence rates.
Dispensaries, on the other hand, can actually influence the cost structure of
supplying marijuana by creating a legitimate need for growers to produce sizable
amounts. Caulkins (2010) and Kilmer et al. (2010) explain how economies of scale
even at the low end of the production scale generate lower unit costs and, hence,
lower prices. A shift in the supply curve, as well as the demand curve, could mean
lower prices in equilibrium.
There is indeed evidence from two studies that MMLs, and more specifically
legally protected dispensaries, have generated lower prices over time. Anderson,
Hansen, and Rees (2013) provide the most direct evidence, showing that states
adopting MMLs experienced statistically lower prices for high-potency marijuana
over the period 1990 to 2011. Importantly, their models show that the negative impact of the MML policy is greater four and five years postimplementation of the
law than in the immediate year, but they still show a generally negative and significant impact on prices within the first year of adoption. Sevigny, Pacula, and
Heaton (2013) examine the potency of marijuana seized through local, state, and
federal law enforcement activities over the same time period (1990 to 2010). They
decompose MMLs into specific dimensions in their DD models that include state
and year effects. Although the simple dichotomous indicator of any MML has no
statistically significant impact on reported potency within the state, they find that
states with legally protected dispensaries do experience statistically higher potency
over time than states that do not have MML laws or do not legally protect dispensaries. Interestingly, there is no statistically significant impact on potency of either
states tolerating unauthorized dispensaries (e.g., Washington state and Michigan) or
those that allow for home cultivation. The findings from this study when combined
with findings from Anderson, Hanson, and Rees (2013) suggest that dispensaries are
what drive potency-adjusted marijuana prices down, not the MML laws themselves.
Kingsbury0143
Figure 1. Trends in Median THC to CBD Ratios (Potency) of Marijuana Seized in

California and Marijuana-Involved Nonfatal Hospitalizations.
So, MMLs that only shift demand generate higher prices and may not lead to
greater use among new users, but MMLs that include dispensaries will also shift
supply and lead to declines in the price of marijuana as well, which will increase
use among new and established users (Pacula & Lundberg, in press). Analyses that
treat all MMLs the same or look for one-time effects of policy adoption are missing
important dynamics. The importance of policy dynamics can be seen in Figure 1,
where we show the trend in potency of marijuana (measured in terms of the ratio
of the main psychoactive ingredient tetrahydrocannabinol [THC] to the naturally
occurring and counter psychoactive compound cannabidiol [CBD]) in California
over time (Burgdorf, Kilmer, & Pacula, 2011). The simple adoption of the MML
does not have a sustained impact on the median THC to CBD ratio until after
dispensaries were legally protected (the regulation passed in October 2003, but did
not go into effect until January 2004). At that point, the median potency of marijuana
clearly climbed through 2007. Analogously, we see in Figure 1 that while there was a
small increase in the rate of nonfatal marijuana-involved hospital admissions prior
to 2004, the rate substantially increased as the median THC to CBD ratio rose. The
positive correlation between nonfatal hospital admissions involving marijuana and
median THC to CBD needs to be more carefully explored, but demonstrates the
point that there may be differential effects of MML policies when supply shifts as
well as demand because of changes in potency-adjusted price and different user
groups responsiveness to this.
UNEXPECTED OUTCOMES OF MARIJUANA LIBERALIZATION POLICIES: REDUCTION IN
HARMS FROM ALCOHOL?
In RANDs assessment of the impact of legalizing marijuana in California under
Proposition 19, Kilmer et al. (2010) acknowledge a key limitation in assessing the
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net impact to society is the uncertainty regarding the relationship between marijuana and alcohol consumption. Although there are small recognized health costs
associated with using marijuana and treating dependence, these costs are dwarfed
in comparison to the criminal justice savings associated with legalizing and regulating the substance. Even if consumption were assumed to rise by 100 percent,
the savings of liberalizing policies would dwarf the known health costs associated with using marijuana. However, all potential savings associated with marijuana legalization could be entirely erased, and tremendous losses incurred, if alcohol and marijuana turn out to be economic complements, particularly for young
adults.
Unfortunately, the evidence on this relationship remains mixed, particularly if
looking specifically at the behavior of Americans. Early studies that relied on variation in state beer taxes, marijuana decriminalization policies, or increases in the
minimum legal drinking age suggested that alcohol and marijuana are economic
substitutes (Chaloupka & Laixuthai, 1997; DiNardo & Lemieux, 2001; Saffer &
Chaloupka, 1999). Subsequent studies that incorporate measures of the monetary
price of marijuana and look at demand for both substances simultaneously suggest that the two goods are economic complements (Pacula, 1998; Williams et al.,
2004). Behavioral economic laboratory studies also generally find complementarity among people who use harder substances (e.g., Petry, 2001), but occasionally
one comes across a study showing evidence of substitutability (e.g., Kadden et al.,
2009). Recent attempts to tease out the relationship have taken advantage of improved identification strategies, relying on discontinuities in the cost of accessing
alcohol that exist when individuals turn 21 and can legally drink. Even these studies generate inconclusive results. Yor
uk and Yor
uk (2011, 2013) find evidence of
complementarity, while Crost and Guerrero (2012) and Crost and Rees (2013) find
evidence of substitutability. Perhaps some of the inconsistency can be explained by
differential responses among polydrug users versus single substance users at the age
discontinuity, but even if such an interpretation is true, it does not help us translate
these effects into knowledge about the market demand curve, which is what is most
relevant for policy purposes.
MMLs have also been used to examine this relationship (Anderson, Hansen, &
Rees, 2012, 2013; Pacula et al., 2013), but analyses making use of the simple dichotomous indicator suffer the same limitations as discussed previously. The laws
are neither homogenous, nor are they static, and hence interpretation of findings
over any given time period will not necessarily reflect a true overall treatment effect. In our analyses, we considered the differential impacts of particular policy
dimensions and again found important nuances (Pacula et al., 2013). Strict registration requirements were negatively associated with self-reported alcohol use
and alcohol-related traffic fatalities for both adults and youth, while dispensaries
were found to be positively associated with both. These results are consistent
with findings for marijuana, suggesting alcohol and marijuana may be complements. However, it is not clear to what extent these effects reflect the true equilibrium impact of the policy or each of these dimensions. Far more work paying
closer attention to differential mechanisms is needed before conclusions can be
drawn.
SO WHAT CAN WE EXPECT FROM MARIJUANA LEGALIZATION?

Despite the insufficient consideration of heterogeneity and changes in MML policies over time, we believe that a few salient insights can be gleaned from the
current scientific literature and weighed in ones consideration of the desirability of liberalization policies for marijuana. First, we conclude from the current
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literature that the rescheduling of marijuana and provision of it through typical
highly regulated medical channels would not lead to widespread increases in its
use or harms. Second, legalization would generate savings in terms of reduced
criminal justice costs and improve social welfare by eliminating criminal sanctions
for minor marijuana offenses (Gieringer, 2009; Kilmer et al., 2010). These savings
will far exceed the probable regulatory cost of implementing even a highly regulated marijuana market, although one should not expect all criminal justice costs to
disappear unless drugged driving laws and underage use offenses are not actively
enforced.
Third, marijuana use will rise under legalization in large part because legally
sanctioned production and competition will drive down prices. It is hard to know,
based on the current literature, the extent to which greater marijuana use will lead
to greater harms. It will likely depend on a number of factors, including who ends
up responding the most to price. If it is the casual adult user who enters the market
and consumes in relatively small amounts, then the expected harms are very small.
If it is new young users, more involved heavy users, or users of other substances,
then the harms could be greater. The literature examining differential elasticities
across the population of users is very thin for marijuana (Pacula & Lundberg, in
press).
There remains a very important open-ended question regarding whether reforming marijuana laws will lead to more or less use of alcohol and other intoxicating
substances. The uncertainty of the literature with respect to alcohol in particular
is surprising given the attention this question has received. Ultimately, the mixed
results may be a function of poor identification strategies or the result of differential relationships occurring in different populations of users. At this point, we do
not believe it is possible to clearly say definitively which it is. But alcohol is not
the only relevant substance to consider. Important questions exist surrounding the
possible substitution of marijuana for prescription or nonprescription opioids used
to manage chronic pain. Reports from patients suggest that medical marijuana has
indeed reduced their need and use of these substances (Nunberg et al., 2011), but
more careful research systematically testing this claim is needed.
It is important to bear in mind that policymakers can take steps to mitigate some
of the potential health harms of liberalization policies if public health advocates become engaged. Regulations could be shaped that set limits on the maximum potency
or THC to CBD that can be available in the market and requiring regular random
testing of samples from producers and growers to ensure compliance. Similarly,
rules regarding proper labeling or limited product forms might also be considered.
Rules can be put in place to limit opportunities to use marijuana and alcohol together and reduce the commercialization of marijuana. Such ideas that represent
attempts to mitigate legitimate public health concerns appear to be missing from
current state policy debates, but are desperately needed.
Thus, we believe much remains unanswered about the potential effects of marijuana liberalization policies because the most relevant questions have yet to be
fully considered and addressed. Existing policy experiments have not been used
to answer what we see as the most important questions, namely are public health
harms from marijuana use a function of the person consuming it (age, polysubstance
user, or other identifying factor)? Amount consumed? Activities engaged in while
under the influence? Method of consumption? Potency? Or duration of use? How
responsive is problematic use to changes in price? To answer these questions definitively, researchers need a bit more time and a lot better data.
ROSALIE LICCARDO PACULA is Senior Economist and co-Director, Drug Policy
Research Center, RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica,
CA 904072138.
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ERIC L. SEVIGNY is Assistant Professor, Department of Criminology and Criminal
Justice, University ofSouth Carolina, 1305 Greene Street, Columbia, SC 29208.
ACKNOWLEDGMENTS
This paper was written with research support from the National Institute on Drug Abuse
(R01 DA032693-01). Several of the opinions reflected in this paper were shaped by previous
work and discussions with numerous colleagues including Mireille Jacobson, Beau Kilmer,
Paul Heaton, David Powell, Priscillia Hunt, Clinton Saloga, Anne Boustead, James Anderson,
Jonathan Caulkins, Jamie Chriqui, and Frank Chaloupka. The opinions reflect only those of
the author and not those of NIDA or RAND.
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The Legalization of Recreational Marijuana: How Likely Is the Worst-Case Scenario?
D. Mark Anderson and Daniel I. Rees
INTRODUCTION
Last fall, voters in Colorado and Washington approved measures legalizing the
recreational use of marijuana. In the near future, residents of these states who are
21 years of age and older will be able to purchase marijuana at retail stores (Donlan,
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Copyright of Journal of Policy Analysis & Management is the property of John Wiley &
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MedicalCannabisPositionStatement
ApprovedMay2012
Whereas,pharmacistshavethetraining,knowledgeandresponsibilityunderRCW246-863-095
toensurepatientsreceivesafeandappropriatemedicationtherapy;and
Whereas,thevotersandlegislatureofWashingtonStaterecognizethemedicalevidencethat
somepatientsmaybenefitfromthemedicaluseofcannabisunderChapter69.51A;and
Whereas,substanceswithmedicalbenefitandapotentialforabusemaybescheduledfor
legenddruguseunderChapter69.50;and
Whereas,pharmaciesdispensecontrolledsubstancestopatientswithawrittenprescription
fromaprescriberunderChapter69.50;and
Whereas,cannabisisasubstancethatwhenusedformedicalpurposesmaycausesideeffects
anddruginteractions;and
Whereas,patientswillbenefitfromfurtherinformationaboutthemedicalbenefitsandside
effectsofcannabisandresearchisrestrictedbytheScheduleIstatusofcannabis;and
Whereas,patientsandhealthcareprovidersrequireastandardizedandhighqualitycannabis
producttoensuresafetyandefficacy;
Therefore,wetheWashingtonStatePharmacyAssociationsupportthereschedulingof
cannabistoreflectitsmedicalproperties,dispensingofcannabisbypharmacistsviatheexisting
pharmaceuticaldeliverysystem,anddevelopmentofcommercialproductionfacilitiesutilizing
goodmanufacturingpracticestoensurequalityandstandardizationoffinalproduct.
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Information Summary and Recommendations
Medical Marijuana Scheduling

Options
January 2016
Publication Number 663-060

For more information or additional
copies of this report contact:
Health Systems Quality Assurance

Office of the Assistant Secretary
P.O. Box 47850
Olympia, WA 98504-7850
360-236-4612
John Wiesman, DrPH, MPH
Secretary of Health
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Contents
Page
1
Executive Summary
Marijuana Scheduling Options
Recommendation
History and Background
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Executive Summary
During the 2015 legislative session, Second Substitute Senate Bill 5052 (2SSB 5052) was passed
by the legislature. It was signed by Governor Inslee on April 24, 2015. The Governor vetoed
Sections 42 and 43, which would remove from Schedule I of Washington States Controlled
Substances Act any medical marijuana product that the Department of Health (department)
identifies in rule as appropriate for sale to qualifying patients and designated providers in a
retail outlet that holds a medical marijuana endorsement.
In his veto message, the Governor noted that rescheduling just medical marijuana may cause
serious problems such as having the unintended effect of limiting the types of marijuana that are
considered medicine. Therefore, he directed the department to thoroughly consider this idea in
consultation with medical professionals and stakeholders, and bring an appropriate resolution to
me and the Legislature by next year.

The department developed three marijuana scheduling options to propose for stakeholder input .
On November 20, 2015, we held a public meeting to present and discuss the three options. We
used the departments medical marijuana web page and ListServ as primary means of
notification. We also used email to notify all marijuana producer, processor and retailer licensees
and applicants of the Washington State Liquor and Cannabis Board (LCB). Law enforcement
and healthcare practitioners and organizations were also invited to attend.
Nearly 50 people representing patients, growers, and dispensaries/retail stores attended the
public meeting. None of the in-person attendees identified themselves as healthcare practitioners
or members of law enforcement. Some healthcare practitioners and members of law enforcement
listened to the meeting using web conferencing. We did receive email feedback from a
pharmacist and from a prescriber who were not in favor of rescheduling. To date we have not
received any feedback from members of law enforcement.
During the public meeting, a fourth option regarding scheduling emerged. We then held a
discussion with the Pharmacy Quality Assurance Commission (commission) at its public
meeting on December 11, 2015. We believed this was appropriate due to the commissions role
in regulating drug distribution and delivery in Washington including under RCW 69.50.201,
which grants the commission authority to add substances to or to delete or reschedule substances
listed in Washington s Controlled Substances Act . The commission proposed a fifth option .
After thoroughly considering all five options, the department recommends making no changes at
this time for the following reasons:
Medical and recreational users currently have adequate access to marijuana despite its
designation as a Schedule I controlled substance.
Federal designation of marijuana as a Schedule I controlled substance complicates

implementation of any meaningful state change and renders many options merely
symbolic.
Re-scheduling or de-scheduling marijuana would require significant revisions to state

laws and rules; further complicate and confuse the currently evolving regulatory system;
and potentially cause the federal government to intervene.
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The department initially proposed the following three options for consideration and discussion:
1) Do nothing at this time.

Implications of this option:
Maintains the current situation.
Does not require any changes to Washington state laws or rules.
Keeps the Washington Controlled Substances Act aligned with federal law.
The use of marijuana for either medical or recreational reasons continues to be illegal
under federal law.
Marijuana can be authorized (but not prescribed, administered or dispensed) by

healthcare practitioners without putting their DEA registration at risk.
Marijuana is distributed by retail outlets regulated by the LCB. Pharmacies do not

jeopardize their DEA registration or banking options by dispensing marijuana.
Schedule I penalties apply to any use, possession, sales, and distribution of marijuana or
THC products outside the legal market established under I-502, SB 5052 and chapter
69.51A RCW.
The Washington Controlled Substances Act continues to list marijuana as a substance

that has no currently accepted medical use, which conflicts with chapter 69. 51A RCW.
Though not in
compliance with federal law, Washington States tightly regulated system

focuses on meeting the federal governments enforcement priorities.
2) Change marijuana to Schedule II - V or to a legend (prescription) drug.

Requires changes to existing Washington State laws and rules.
Conflicts with I-502s
Formally recognizes that marijuana has medicinal benefits.
Makes marijuana subject to all the same requirements of any other prescription drug.
recognition and legalization of recreational use of marijuana.
The requirements for prescribing, manufacturing, wholesaling, distributing, selling,

dispensing, and administration of prescription drugs would apply.
Treated like other prescription drugs, growing for personal medical use would not be
allowed.
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Conflicts with federal law, so h ealthcare practitioners
wouldnt be able to legally
prescribe, dispense or administer marijuana. If they did, they could face federal criminal
and administrative penalties and their DEA registration could be revoked.
Marijuana would have to be dispensed through a pharmacy, which conflicts with the
systems created under I-502, SB 5052 and chapter 69.51A RCW .
Dispensing marijuana may place a pharmacys DEA registration in jeopardy and may
result in loss of banking options.
Healthcare practitioners and facilities that prescribe or dispense marijuana could be

excluded from participating in Medicare/Medicaid .
3) Amend Washington States Controlled Substances Act to be consistent with I-502, SB

5052 and chapter 69.51A. All other use would still be illegal.
Marijuana would no longer be a Schedule I drug for people following all the rules for
growing, processing, selling, possession and use under I-502, SB 5052 and chapter
69.51A RCW.
Schedule I penalties would still apply to any use, possession, sales, and distribution of
marijuana outside the legal market established under I-502, SB 5052 and chapter 69.51A
RCW.
The use of marijuana for either medical or recreational reasons would continue to be
illegal under federal law.
Marijuana could continue to be authorized (but not prescribed, administered or

dispensed) by healthcare practitioners without putting their DEA registrations at risk.
The Washington Controlled Substances Act would align with I-502, SB 5052 and chapter
69.51A RCW.
Though not in compliance with federal law, Washington States tightly regulated system
Stakeholders Proposed Option

The majority of responses by stakeholders to the three options proposed by the department were
that none of those options are preferred. Overwhelmingly, the stakeholders who actively
participated in the discussion were in favor of the following:
4) Remove marijuana completely from the Washington Controlled Substances Act, make it
unregulated, and treat it like any other plant.
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Requires extensive changes to existing Washington State laws and rules.
Removing marijuana from Schedule I without maintaining the existing regulation would
allow any person to possess, use and grow any amount, and to distribute and sell any
amount at any time to anyone in the same manner as any other plant.
Eliminates the current regulated recreational market implemented under I-502 and
codified in the Controlled Substances Act. This includes eliminating quality assurance
standards, testing and labeling requirements, protections for minors, and taxation which
funds marijuana treatment and education.
Eliminates the need for specific regulation for medical marijuana under chapter 69.51A
RCW, including the quality assurance standards in SB 5052.
Is not compliant with federal law or the Cole memo. An unregulated system does not
meet the federal governments enforcement priorities, particularly preventing the

distribution of marijuana to minors.
Pharmacy Quality Assurance Commission Meeting

On December 11, 2015, the department presented the four options to the commission and also
shared a summary of the stakeholders comments from the November 20 meeting. The
commission deliberated on the original three options and without strong support for any of the
options presented, decided to develop their own option:
5) Maintain I-502 for recreational marijuana; work with stakeholders to restructure SB

5052 and chapter 69.51A RCW to put medical marijuana under the commissions
jurisdiction and treat it as a prescription drug.
Requires extensive changes to Washington State laws and rules.
Recreational users would still use the retail market established under I-502 but patients
would have their medical marijuana prescribed by healthcare practitioners and dispensed
by pharmacies.
The LCB would transition authority to regulate production, processing, lab testing and
sales of medical products to the commission.
The commission would assume responsibility for ensuring patients have access to safe,
quality medication.
There is no scientific basis for determining what marijuana is medical or recreational.

Identical products are used for both medical and recreational purposes.
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allowed.
Under federal law, the DEA could take action against practitioners who prescribe
marijuana and pharmacies that dispense marijuana .

Patients could face inadequate access if pharmacies chose to not stock marijuana due to
concerns over federal law.
Though not in compliance with federal law, a tightly regulated system would still focus
on meeting the federal governments enforcement priorities.

Recommendation
The department sincerely appreciates the collaborative and amicable efforts of everyone who
participated in discussions regarding this issue. Clearly, there is no easy answer. Every option
presents both positive and negative implications depending on individual perspective and
preference. Of paramount significance is marijuanas ongoing federal status as a Schedule I
controlled substance.
Options two and five both involve making medical marijuana a prescription drug. While this
comports well with chapter 69.51A RCW s acknowledgement of marijuana as having medical
value, it fails to take into account the many collateral impacts of such an act. Prescription drugs
must be prescribed or administered by a healthcare practitioner and dispensed either by the
prescriber or a pharmacy. Prescribing, administering and dispensing marijuana remain illegal
under federal law. Healthcare practitioners who chose to engage in these actions could be
criminally charged. They could also face administrative sanctions such as loss of their DEA
registration and exclusion as a Medicare/Medicaid provider. Healthcare facilities such as
pharmacies and hospitals that participated or allowed these actions could also face administrative
sanctions as well as potential loss of banking opportunities.
It is likely that most pharmacies and hospitals would decline to allow prescribing or dispensing
of marijuana by healthcare practitioners for these reasons. If so, patients could face significant
difficulties in accessing marijuana for medical use.
In the alternative, Washington could take a purely symbolic action similar to Oregon, i.e. move
marijuana to Schedule II but take no affirmative steps to treat it as such . This creates a legal
fiction which diminishes the authority of law, further confuses the issue of legalization, and fails
to actually address the underlying issues.
Option four removes all regulatory control of marijuana. Many stakeholders strongly believe
marijuana is simply a plant and should be treated no differently than other plants (tomato plants
are a common comparison). While it is true that marijuana is, in fact, a plant, this reasoning
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ignores marijuanas psychoactive effects. It also diminishes the argument that marijuana should
be acknowledged and treated as medicine.
Simply removing marijuana from Schedule I without creating an alternative regulatory structure
would mean any person could grow, purchase, use, sell or trade marijuana without limitation.
The existing recreational and medical markets, which are both based on some level of regulation,
would become obsolete. A patient would no longer need an authorization to buy or grow as
much marijuana as desired. Licensing for producers, processors, and retail stores would no
longer be necessary because there would be no penalty for growing or selling outside the
formerly regulated market. There would be no controls on product safety or restrictions on youth
access. Importantly, it is unlikely that the federal government would allow such a situation to
exist in light of the enforcement priorities listed in the Cole memo.
If change were truly required, option three would be the least disruptive choice. It would
maintain the existing medical and recreational markets. Marijuana would be removed from
Schedule I if used in compliance with I-502, SB 5052 and chapter 69.51A RCW. Schedule I
penalties would continue to apply to violations of the regulatory system. In the alternative, it
could be removed entirely from Schedule I and new penalties could be devised for violations. In
this way, marijuana would be treated similarly to alcohol and tobacco in that it would be legal
but subject to strict regulation, with penalties for people operating outside that regulation.
However, the end result would be remarkably similar to the current situation marijuana would
be legal for recreational or medical use within the regulated system and illegal outside the
regulated system. The only real change would be the symbolic act of removing marijuana from
the states Controlled Substances Act.
In the absence of a solution that would not result in jeopardy for healthcare practitioners and
pharmacies, create an entirely unregulated situation, or be a merely symbolic act, the department
recommends option one do nothing at this time.
The current situation is not perfect. Washington is experiencing a monumental shift in law and
policy as marijuana becomes normalized. Changes from the 2015 legislative session are still
being implemented. Many cities and counties who have enacted bans or moratoria prohibiting
recreational marijuana, medical marijuana or both are now reconsidering their positions .
Licensed producers, processors and retailers bear the burdens and reap the benefits of strict
regulation. Most of all, patients are wary of the evolving regulation of medical marijuana
because they will no longer be able to grow, buy, sell and trade marijuana in the nearly
unfettered way of the past.
Despite this, the vast majority of both recreational and medical users currently have adequate, if
not ideal, access to marijuana. Changing the status of marijuana as a controlled substance in
Washington will not result in a significant positive change. Eliminating all regulation is not
responsible legal or social policy. Rescheduling marijuana or making it a prescription drug
would grant marijuana recognition as a legitimate medicine but it would also require it to be
prescribed and dispensed within the traditional medical system. Rather than benefitting patients,
this would likely reduce access due to concern about federal penalties and impacts.
Rescheduling without transitioning marijuana into the traditional medical system would be
purely symbolic, as would be removing it from Schedule I but maintaining essentially the same
penalties for violations.
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Finally, all state action regarding legalization or decriminalization of marijuana is contrary to

federal law. The current administration has elected to tolerate these actions based on the
existence of, and compliance with, a strict state regulatory structure. It could just as easily
decide to withdraw that tolerance and engage in robust enforcement action. The primary reason
to change the status of marijuana is its designation in the Controlled Substances Act as having no
medical value even though other state laws recognize it as having medical value. However, this
is mostly a philosophical argument. In reality, patients do currently have adequate access to
marijuana for medical use, just as recreational users have adequate access to meet their needs.
For this reason, the department recommends maintaining the status quo rather than inviting
uncertain outcomes and risk.

The department considered the following when assessing potential implications of each option.
Federal Law, 1970

Although criminalization efforts began decades earlier, Congress first categorized marijuana as a
Schedule I controlled substance, the most restrictive classification available, in 1970. Under this
categorization, marijuana is considered to have a high potential for abuse, no currently accepted
medical use in treatment in the United States, and a lack of accepted safety for use of the drug or
1
other substance under medical supervision. Healthcare practitioners cannot legally prescribe or
dispense Schedule I controlled substances.
Washington Law, 1971
Following the federal governments lead, Washington State enacted its own Controlled
Substances Act in 1971. Marijuana was, and continues to be, listed as a Schedule I controlled
substance. In addition to the legislative authority to amend the act, the state Board of Pharmacy
(later renamed Pharmacy Quality Assurance Commission) was granted rulemaking authority to
add substances or delete or re-schedule controlled substances. Petitions to the commission to reschedule marijuana in rule have been unsuccessful .
Initiative 692, Medical Use of Marijuana in Washington State, 1998

The medical use of marijuana in Washington State was first authorized by voter Initiative 692 in
1998. It granted an affirmative defense to criminal prosecution to qualifying patients and their
2
primary caregivers. The patient was required to have a recommendation from a healthcare
practitioner and could possess no more than a 60-day supply of marijuana.
The initiative, codified as chapter 69.51A RCW, was amended many times over the years. For
example, the list of terminal or debilitating conditions has been expanded, as has the list of
healthcare practitioners who may recommend or authorize the medical use of marijuana.
Notably, a 2011 amendment allowed up to 10 qualifying patients and/or designated providers to
form a collective garden for the purposes of combining resources.
21 U.S.C. 812(b)(1).
Primary caregiver was changed to designated provider in ESSB 6032 (2007).
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Initiative 502, Legalized Purchase and Possession of Marijuana in Washington State, 2012
In November of 2012, Washington voters passed Initiative 502. I-502 legalized the purchase and
possession of small amounts of marijuana for all adults. It also created a taxed and highly
regulated system for the production, processing and retail sale of marijuana. This resulted in the
existence of two distinct markets the unregulated medical market and the regulated recreational
market.
2SSB 5052, Cannabis Patient Protection Act in Washington State, 2015
The legislature reconciled the two markets with the passage of Second Substitute Senate Bill
5052 and Second Engrossed Second Substitute House Bill 2136 earlier this year. It is important
3
to note, however, that the medical use of marijuana is not yet legal at either the state or federal
level. Beginning July 1, 2016, 2SSB 5052 will legalize the medical use of marijuana for patients
and designated providers who are entered into a patient authorization database. Patients and
designated providers who choose not to be entered in the database will continue to have an
affirmative defense to criminal prosecution. The medical use of marijuana remains illegal at the
federal level despite a certain level of tolerance conditioned upon full compliance with
4
applicable state laws.
Marijuana Remains Illegal under Federal Law
In 2011, former Governor Chris Gregoire, together with the governor of Rhode Island, petitioned
the Drug Enforcement Administration (DEA) to reclassify marijuana as a Schedule II controlled
substance. Such rescheduling would make marijuana a drug with accepted medical uses but
would also impose strict regulation due to a potential for addiction. Schedule II controlled
substances can only be prescribed and dispensed by healthcare practitioners authorized to do so
by law. This would seriously impact patients ability to grow their own marijuana. It would also
conflict with Washingtons existing regulatory system for both medical and recreational
marijuana.
The DEA has not acted on the petition to reschedule marijuana. Thus, it remains illegal under
5
federal law for healthcare practitioners to prescribe or dispense marijuana.
Following the passage in 2012 of initiatives in Washington and Colorado to legalize the
recreational use of marijuana, Deputy U.S. Attorney General James Cole provided a memo for
all U.S. attorneys entitled Guidance Regarding Marijuana Enforcement. This document
(known as the Cole memo) listed nine enforcement priorities of particular import to the federal
government. U.S. Attorneys were instructed to focus their enforcement resources and efforts on
persons or organizations whose conduct interferes with those priorities regardless of state law.
The guidance rests on the expectation that states and local governments that have enacted laws
State v. Reis, No. 90281-0 (Washington Supreme Court, May 7, 2015)
A 2015 federal spending bill contained the following language, None of the funds made available in this Act to the
Department of Justice may be used, with respect to the States of Alabama, Alaska, Arizona, Califor nia Washington, and
Wisconsin, to prevent such States from implementing their own State laws that authorize the use, distribution, possession, or
cultivation of medical marijuana.

5
The National Institute of Drug Abuse (NIDA) does contract with the University of Mississippi to grow marijuana
for use in approved research studies. It also provides marijuana to a very small number of patients under the
Compassionate Investigational New Drug Program which was established in the late 1970s and is currently closed to
new participants. Neither of these actions by NIDA alters the federally illegal status of marijuana.
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authorizing marijuana-related conduct will implement strong and effective regulatory and
enforcement systems both on paper and in practice. 6

Oregons Attempt to Reschedule Marijuana
In 2009, the Oregon legislature passed Senate Bill 728 which required the state Board of
7
Pharmacy to classify marijuana as a controlled substance in Schedule II, III, IV or V. On June
16, 2010, the board adopted permanent rules rescheduling marijuana from Schedule I to
Schedule II, the most restrictive option permitted under the bill. Thirteen days later, the board
issued a news release stating it complied with the bill to correct a technical conflict in the law
and in no way intended to infer or imply that [marijuana] is or should be available by
prescription. In fact, marijuana is not available by prescription marijuana or products
containing any amount of marijuana will not be available by prescription in Oregon unless
they have been approved by the [Food and Drug Administration]. The Board of Pharmacys
action to reschedule marijuana on the state list does not supersede federal law or create a direct
conflict with federal law. It simply does not address federal law. (emphasis original)
8
Conant v. Walters
California became the first state to recognize the medical use of marijuana with the passage of
Proposition 215 in 1996. Shortly thereafter, the federal government promulgated a policy
declaring a physicians action of recommending or prescribing a Schedule I controlled substance
would lead to revocation of the physicians DEA registration to prescribe controlled substances.
Two months later, the Department of Justice and Department of Health and Human Services sent
letters to national, state, and local practitioner associations outlining the policy and warning that
physicians who intentionally provide their patients with oral or written statements in order to
enable them to obtain controlled substances in violation of federal law risked revocation of their
DEA prescriptive authority.
Patients suffering from serious illnesses, physicians licensed in California, a patient organization,
and a physicians organization filed an action in 1997 to enjoin enforcement of the governments
policy insofar as it threatened to punish physicians for communicating with their patients about
the medical use of marijuana. The District Court granted a permanent injunction against the
9
government which was later upheld by the Ninth Circuit Court of Appeals. The United States
Supreme Court declined to hear the case. Thus, it remains binding case law to this day.
The Court in Conant held that physician speech, including speech about the potential benefits of
medical marijuana, is entitled to First Amendment protection because of the significance of the
doctor-patient relationship. The possibility that the physicians recommendation may lead to
federally illegal conduct by the patient, i.e. possession of marijuana, is not sufficient to overcome
the physicians First Amendment rights. However, the Court recognized the slippery slope
between orally recommending the medical use of marijuana and taking affirmative steps toward
facilitating a federal crime. The injunction specifically did not bar federal prosecution of a
Cole Memorandum, August 29, 2013, http://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf,

accessed December 28, 2015.
7
In Oregon, all controlled substances are classified in board rules, not statute.
8
th
Conant v. Walters, 309 F.3d 629, United States Court of Appeals, 9 Circuit, 2002
9
The Ninth Circuit includes California, Arizona, Nevada, Hawaii, Montana, Idaho, Alaska, Oregon and
Washington.
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physician when government officials in good faith believe they have probable cause to charge
under aiding and abetting or conspiracy charges.
While the Court held that merely recommending the medical use of marijuana does not rise to
the level of aiding and abetting or conspiracy, it stated:
A doctor would aid and abet by acting with the specific intent to provide a patient
with the means to acquire marijuana. Similarly, a conspiracy would require that a
doctor have knowledge that a patient intends to acquire marijuana, agree to help
10
the patient acquire marijuana, and intend to help the patient acquire marijuana.
Under this holding, healthcare practitioners who dispense marijuana to their patients would be at
11
significant risk of administrative action and criminal prosecution under federal law.
Liability Issues
Under current Washington law, healthcare practitioners do not prescribe or dispense marijuana.
Instead, they may authorize or recommend its medical use. This is consistent across the other 22
states and Washington D. C. that have some sort of medical marijuana laws, as well as the 17
12
states that currently allow high CBD/low THC products for medical use. Most often, the
patients themselves ask for the authorization. Once the authorization is provided, patients
typically obtain the marijuana from a third party or grow it themselves. The authorizing
practitioner may or may not discuss specific types of products available or routes of
administration.
To date, the department has not identified any medical malpractice cases relating to the medical
use of marijuana. This is not surprising given that patients typically expect to receive no more
than an authorization from the healthcare practitioner, and the practitioner does not dispense or
administer the marijuana. However, as the medical use of marijuana becomes more widely
accepted, it is likely that the expectations for practitioners will increase. Lawsuits alleging
improper authorization, inadequate examination, adverse drug interactions, or failure to warn of
risks such as driving under the influence, cognitive effects, or the potential for addiction are
likely. This risk would increase if the practitioner or a pharmacy also dispensed the marijuana.
For example, a practitioner could be held liable for providing marijuana containing mold,
prohibited pesticides, heavy metals or other contaminants.
In early October of 2015, a lawsuit was filed in Colorado by a pair of marijuana users, one of
them a medical patient suffering from a brain tumor. They sued a large state-licensed marijuana
grower for allegedly using a potentially dangerous pesticide on products later introduced into the
retail market. Had this marijuana been provided by a healthcare practitioner or pharmacy rather
than purchased at a retail store, the practitioner or pharmacy could also potentially be held liable
for distributing a tainted product.
10
Conant at 636.
A subsequent U.S. Supreme Court case held the U.S. Attorney General cannot, by interpretive rule, prohibit
pract itioners from prescribing Schedule II controlled substances in compliance with Oregons Death with Dignity
Act. Gonzales v. Oregon, 546 U.S. 243 (2006). However, that case involved prescribing and dispensing legal
Schedule II drugs for a purportedly improper reason (i.e. to hasten death) rather than prescribing and dispensing
marijuana, a Schedule I drug.
11
12
Cannabidiol (CBD) is a cannabinoid that does not result in a high whereas tetrahydrocannabinol (THC) is the
primary psychoactive component of marijuana.

10
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Most healthcare liability insurers do not have specific exclusions for practitioners who authorize
the medical use of marijuana, but many do have exclusions for any claim alleging a criminal
violation of a state or federal law or rule. In the case of a medical malpractice claim based on
authorizing or dispensing marijuana, coverage could be denied based on these exclusions until
such time as the federal law is amended to allow prescribing and dispensing marijuana. This
would leave the practitioner without liability insurance and vulnerable to significant financial
loss. It could also lead to an injured patient having limited ability to collect on a claim against an
insolvent practitioner.
Medicaid/Medicare Provider Eligibility

To provide services to Medicaid recipients in Washington, a healthcare practitioner must
provide all services according to federal and state laws and rules WAC 182 -502-0016(1)(b).
A practitioners status as a Medicaid provider may be terminated for failure to abide by this
requirement. WAC 182-502-0030(1)(ix). A practitioner who has been suspended or excluded
from Medicaid may also be excluded from participation as a Medicare provider. 42 U.S.C.
1320a-7(b)(5).
Healthcare practitioners in Washington who prescribed and dispensed marijuana in violation of
federal law could be excluded from participation in both Medicaid and Medicare. In addition,
they could be subject to financial penalties for services rendered to those patients.
Supply
Recreational marijuana is produced, processed and sold by persons or entities licensed by the
LCB. All products are tracked from seed to sale and are subject to quality assurance standards,
testing, and labeling.
Healthcare practitioners and pharmacies licensed in Washington do not dispense marijuana for
medical use due to its designation as a Schedule I controlled substance at both the state and
federal levels. Distributing a Schedule I drug could result in criminal charges as well as loss of
DEA registration, Medicaid/Medicare provider status, and banking privileges.
Currently, patients with a valid authorization for the medical use of marijuana have limited
options for accessing products. They have an affirmative defense to criminal prosecution for
growing up to 15 plants at any given time. They have the same affirmative defense if they
participate in a collective garden with up to nine other patients or designated providers.
Dispensaries, which are commonplace although not authorized by law, are an off-shoot of the
collective garden model and currently provide retail access to patients. Patients age 21 and older
can also purchase marijuana products from more than 200 stores licensed by the LCB.
On July 1, 2016, collective gardens will be abolished. Patients and designated providers entered
13
into the authorization database will be able to legally grow plants and participate in small,
noncommercial cooperative grows. All state-legal commercial marijuana, whether intended for
medical or recreational use, will be grown, processed, and sold through the LCBs licensed
system.
13
The presumptive plant count will be six. A healthcare practitioner may authorize up to 15.
11
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Lack of Scientific Evidence Regarding Efficacy and Standardized Dosing

Existing evidence does not prove that marijuana either is or is not beneficial for medical use.
Many people claim marijuana provides more relief than approved prescription drugs, but this is
still largely anecdotal. The level of health risks involved with the various routes of
administration is also unknown. There is a genuine difference of expert opinion on the subject,
with growing amounts of scientific and anecdotal evidence supporting both points of view.
In June of this year, the Journal of the American Medical Association (JAMA) printed a series of
14
articles related to the efficacy of medical marijuana.
One article found the use of medical
marijuana for chronic pain, neuropathic pain, and spasticity due to multiple sclerosis is
supported by high-quality evidence and suggested that marijuana may be efficacious for these
15
indications.
A second article found only low-quality evidence that marijuana was associated
with improvements in nausea and vomiting due to chemotherapy, weight gain in HIV infection,
sleep disorders, and Tourettes syndrome. It also found an increased risk of short-term adverse
16
events.
A third article detailed a study of dose and label accuracy in edible marijuana products. It
evaluated 75 products purchased at medical dispensaries in Seattle, San Francisco and Los
Angeles. Of the 75 products, 17 percent were accurately labeled, 23 percent were under-labeled,
and 60 percent were over-labeled with respect to THC content. Labeling of other cannabinoids
was similarly problematic. Because the products were intended for use by patients with serious
health conditions, these inaccuracies raise concerns about the quality and consistency of
17
marijuana used for medical purposes.
Finally, JAMA published an editorial pointing out that most of the conditions for which a patient
may be authorized for the medical use of marijuana are based on low-quality scientific
evidence, anecdotal reports, individual testimonials, legislative initiatives, and public opinion.
It further notes that unlike approved medications that have a relatively uniform composition,
marijuana products vary substantially which makes precise dosing difficult. Marijuana is a
complex organism with more than 400 compounds including more than 70 cannabinoids. Each
of these cannabinoids has individual, interactive, and entourage effects that are not yet fully
understood. Similarly, the interaction of marijuana with prescription drugs has not been
18
sufficiently tested.
These articles illustrate the compelling need for further research performed according to accepted
scientific protocols. In 2015, HB 2136 created a research license in order to allow clinical
investigations and research regarding the efficacy and safety of administering marijuana as part
of medical treatment.
14
15
16
17
18
http://jama.jamanetwork.com/Issue.aspx?journalid=67&issueID=934167&direction=P
http://jama.jamanetwork.com/article.aspx?articleid=2338266
12
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13
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STATE OF WASHINGTON
DEPARTMENT OF HEALTH
WASHINGTON STATE BOARD OF PHARMACY

Meeting Minutes
January 10, 2013
Point Plaza East Conference Room 152/153
310 Israel Rd SE
Tumwater WA 98501
CONVENE
Chair Christopher Barry called the meeting to order at 9:07 a.m., January 10, 2013
Board Members:
Christopher Barry, RPh, Chair
Emma Zavala-Suarez, Public Member
Gary Harris, RPh,
Donna Feild, RPh, MBA, Vice Chair
Dan Rubin, Public Member
Absent Board Members:
Guest / Presenters:
Tim McCrea, Pharmacy Manager for Safeway
Alyson Kohl, Suicide Education Study Project
Manager for Dept of Health
Jennifer Kreidler-Moss, PharmD, BCACP,
BCPP, AE-C
Candace Joy, Executive Vice President,
WA State Veterinary Medical Association
Ngoc-Diep Thi Pham, Pharmacist Intern
Staff Members:
Joyce Roper, AAG
Christopher Humberson, Executive Director
Grant Chester, Chief Investigator
Tina Lacey, Pharmacy Investigator
Tim Fuller, Pharmacist Consultant
Cathy Williams, Pharmacist Consultant
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Approval
Approval
Approval
Approval
1.1
1.2
1.3
1.4
of
of
of
of

Amended September 27, 2012 Business Meeting Minutes
the November 7, 2012 Business Meeting Minutes
Consent Agenda
MOTION: Donna Feild moves that the board approves 1.1, 1.2, and 1.3. Gary Harris second.
CONSENT AGENDA
Items listed under the consent agenda are considered routine agency matters and will be approved by a
single motion of the board without separate discussion. If separate discussion is desired, that item will
be removed from the consent agenda and placed on the regular business agenda.
1) NPLEx Monthly Report Acceptance
2) Pharmacies and Other Firm Application Approval
5) Pharmacy Technician Specialized Functions Approval
Wenatchee Valley Medical Tech ck Tech
8) Electronic Prescription Transmission System Approval
a. NewCrop LLC Renewal
b. PetNet Solutions - Renewal
c. DCS Pharmacy Inc WinPharm
d. DrFirst Inc Renewal
e. OCHIN-Epic
be removed from the consent agenda and placed on the regular business agenda. Items 3, 4, 6, 9, 10,
and 11 were deleted from the agenda. Item 7 was removed for discussion.
MOTION: Dan Rubin moved that the board approve items 1, 2, 5, and 8. Donna Feild second.
Gary Harris was presented a plaque for the 8 years he served on the board.
REPORTS
Board Member
Dan Rubin reported:
Mr. Rubin was able to participate on the first phone call regarding legislative issues.
Elizabeth has been participating on the rules project conference calls. She finds these phone
calls to be useful and informative.
2
Kingsbury0170
She also was able to listen to the webinar provided by the state about the use of marijuana by
health care professionals.
Donna Feild reported:
She attended ASHP and was able to recruit a good bunch of new residents.
Mr. Harris in March he will be presenting his annual lecture on Pharmacy Law and Ethics at
Washington State University.
Executive Director
Christopher Humberson reported:
nd
Kitty Slater, Rules Coordinator transferred to OII position starting Jan 2

process of hiring for the position.
and we are in
Began the Rules Workgroup process of conference calls to focus on topics of rule rewriting.
These were in five areas of pharmacy operations and will be reviewed in todays meeting in
more detail.
Attended Webinar on I-502, Marijuana use by health professionals.

o Bottom line is that it will be treated similar to alcohol in enforcement actions.
Impairment means just that. With respect to drug testing by employers, private
businesses may have their own rules on employees. Any business receiving federal
money must adhere to federal rules, which include use of a class 1 drug
substance
COMPOUNDING ISSUES:
1428 in state pharmacies licensed in Washington, approx. 80 that do significant compounding.
584 non-resident pharmacies currently licensed. Currently there is no provision for fining
companies that violate RCW or WAC. This would be a helpful enforcement tool where
suspending, revoking or denying a license may not be necessary.
th
Submitted reports to both houses of Congress on December 7 regarding our current

compounding laws, rules and inspection process of compounding pharmacies. Each
state was asked to submit answers to questions:
o 6 Questions from the U.S. House Committee
o 9 Questions from the U.S. Senate HELP Committee
What our rules currently say on compounding?
Do we use USP 797 as standard?
What actions we have taken thus far?
Define compounding in your state
What are operating budgets for BOP and inspections for last ten years and
what disciplinary actions you have taken and for what?
NECC Updates and Actions; January 2013

o NECC agreed to an order revoking their license on Nov 29 th, 2012 by the Board of
Pharmacy.
o No patients in Washington have yet been affected by any NECC products that were
sent into Washington State.
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o
o
o
Article in January newsletter regarding compounding rules in Washington State,

Web site, and Listserv with information on compounding rules updated in
December 2012.
Letter addressed to licensed non-hospital pharmacies on compounding practices
finalized and being sent this Jan 2013.
Inquiries from state congressional members and public continue to come in and are
answered in a timely fashion
Looking at options to enhance licensing information provided by all compounding
pharmacies.
th
State of Washington was represented by Steve Saxe on December 19 at an FDA meeting

on Compounding practices held in Washington DC . He was there representing the entire
Department of Health and State of Washington. This meeting included a general discussion
and breakout sessions to discuss any regional issues. Discussion points of this session were
that:
o Traditional compounding has its place, but large volume compounding/interstate
distribution has created new issues.
o Those companies engaged in high risk compounding across state lines should be
licensed as a drug manufacturers and regulated by the FDA with assistance from
State Boards of Pharmacy. Additional resources to train pharmacy board inspectors
in compounding inspection procedures would be welcome.
o 1992 FDA compounding guidelines were never fully supported or embraced. Then
added CFR 503(a) to the federal register. However, these do not allow for large
volume anticipatory compounding .
o
o
o
o
Possible considerations include three tiered approach. The three tiers include:
compounding, non-traditional compounding, manufacturing
Having a centralized database of information, perhaps co-ordinate with NABP
would provide needed pharmacy information and communication with all state
BOP.
Washington would support a specific mandated national standard to enforce in nontraditional compounding facilities and would contribute to collective enforcement of
these types of facilities.
It was clear that products NECC shipped to Washington State were not produced in
response to specific patient prescription orders, as in the law in Washington State.
Summary of Breakout sessions;
Comfortable with their own states. Unsure of other states.
Improved communication needed with State and Fed.
Large uncovered area is physician compounding
Definitions are critical (including a clear definition of what FDA approval
would mean )
How to do assays of compounded material?
When companies can advertise
Addressing the drug shortages that contributed to compounding issues?
th
Met with Oregon Executive Director Gary Schnabel on Dec 7 to meet members of Oregon
Pharmacy team and review areas where Washington and Oregon can work together on
4
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issues of concern to both states. Suggested at that meeting the Washington BOP might want
to consider a survey of Washington pharmacists on working conditions similar to Oregon
2011 survey and compile results. I reviewed with Gary their rules on pharmacy business
practices and their process for stakeholder work and rule development.
Met in December with University of Washington Pharmacy Law class for a lecture on rules
work students have done with Dr. Tom Hazlet and their input into the rules process as
future pharmacists.
PMP Program was included in Gov. Gregoires budget for next two years.
Presented department recognition to Doreen Beebe, Tim Fuller and Cathy Williams for
twenty five years of service with Department of Health, BOP and State of Washington.
Met with Board of Naturopathy in November and emphasized the need to address educating
professionals in Washington State on limitations of prescribing, which will be done by their
board

Since the last meeting a reply brief was submitted in Stormans case.
Joyce has been working with Chris Humberson regarding compounding issues.
Joyce introduced Debra Defreyn a new AAG
Consultant Pharmacists
Tim Fuller reported:
Visit and dialogue with UW Law Class of Dr. Tom Hazlet
Office of Superintendent of Public Instructions

update of the Bulletin Administration of Medications
growing number of issues and guides for schools
Local Health Jurisdiction-Pharmacy MOU Operational Plan Working Group

how do you invoke assistance; what kind of disasters; standardizing
Chief Investigator/Field Investigator

Grant Chester reported:
Grant introduced Brad Dykstra as the newest pharmacist investigator. Mr. Dykstra was a 2007
graduate of Washington State University and has a retail pharmacy background. He will
replace Jim Doll who retires on March 1, 2013. Mr. Dykstra will be the investigator for SW
Washington which includes Cowlitz, Clark, Lewis, Skamania, and Thurston counties.
We recently completed our 2012 Pharmacy Inspection Customer Satisfaction Survey which is
part of the information packet you have already received. I used extreme caution in
interpreting the data and believe the survey was very favorable. However, since there was less
than 40% participation (16.8%) the survey can only be considered representative of the
pharmacists who responded. It cannot be interpreted as representative of the larger pharmacist
population. In order to have a survey representative of the larger population there has to be a
70% or greater participation.
The 5 year trend in pharmacies receiving unsatisfactory or conditional inspections has
gradually increased from 2.7% to7%.
5
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This is primarily pharmacies failing to learn from the educational approach to correct
deficiencies from previous inspections. This results in additional points being taken off
on the following inspection and in some cases a conditional or unsatisfactory
examination.
There is no discernible pattern for types of pharmacies. 70% or greater participation.
Other than during an investigation, when pharmacist investigators discover that
pharmacy firms / persons are or may be in violation of a law or rule it is considered an
educational opportunity and technical assistance is provided and documented.
Consent Agenda Item 7

Donna Feild shared her concerns. Her concern was there anything on the review form that focused on
overrides. Tim Fuller explained this has just become a focus regarding the Automate Drug Dispensing
Devices. This is not on the review form. Mr. Fuller will update the review form to focus on the
override portion of the policy.
7) Automated Drug Dispensing Device Approval
a. SCCA at Evergreen Health, Kirkland
b. Hoagland Pharmacy - Whatcom Hospice House, Bellingham
c. Summit Pacific Medical Center, Elma
d. Peace Island Hospital at Friday Harbor
e. Northwest Hospital and Medical Center, Seattle
MOTION: Donna Feild moved that the board will approve Consent Agenda Item 7 now that it has
been agreed that the override portion of a policy will be added to the review form. Gary Harris
seconded. MOTION CARRIED: 6-0.
PRESENTATIONS
Safeway Call Center
Tim Fuller provided the board a brief background on the Safeway Call Center that was approved April
2012. Tim McCrea Safeway Pharmacy Manager presented the status report to the board.
Safeway Seattle Division Call Center Overview of responsibilities
1. Resource for Patient Information
Answer questions that may be posed by patients that cannot reach their pharmacy. *(minimal use)
2. Transfer and Process prescriptions to include Phone forwarding if needed .
For hard to staff pharmacies *(This service has helped many pharmacies manage workflow)
Bad weather
Sick Tech (Unable to physically staff)
Have calls forwarded to call center as needed *(Not yet implemented)
New prescriptions
Refills
Patient questions
Third party billing issues *(Very successful especially for immunizations)
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Process prescriptions in the refill queue and e-scripts for pharmacies as needed. *(This has been
very successful 19,905 refills & 8,186 e-scripts in 2012)
3. Outcomes/MTM *(Very successful 1,231 MTM in 2012)
Assist pharmacy with calling and scheduling interventions
Be a resource for pharmacists on MTM issues.
4. Immunizations
Assist in review of recommended immunizations *(successful)
Assist in review and processing of third party billing *(successful)
Assist in identification of potential patents *(13% success rate)
Assist in vaccine allocations
5. Rx transfers
Transfer prescriptions in/out: to other pharmacies to allows the pharmacy staff to concentrate
on their customers in the store. *(29,573 in 2012)
Policy and Procedure Call Center Pharmacists and Technicians doing MTM
Overview:
Outcomes is a MTM Service Company that utilizes community pharmacists as providers of

Medication Therapy Management (MTM) services of the following types:
Comprehensive Medication Reviews (CMR)
Physician Consultations
Patient Compliance Consultations
Patient Education & Monitoring (most common)
TIPs*
Simply put, pharmacists are able to bill for services they are currently uncompensated for, such
as calls placed to a prescriber for formulary reasons, unsafe doses or interactions, and even
counseling a patient on a new medication.
Examp le: Medication A is not covered by patients insurance formulary. Action: pharmacist
consults with physician and medication is changed to B. Pharmacist provides and educates
patient on medication B. Patient receives a follow-up call in 3 days to monitor satisfaction with
medication B.
Billable services: $20 for calling doctor and $10 for counseling and monitoring the patient.
Two different claim submissions for the same prescription!
Adjudication Edits in PDX will notify you of which patients are eligible for Outcomes
Services. This is not a universal program, it applies to a select group of individuals that are
identified through the messaging.
Summary
The Safeway Seattle Division Call Center has been very successful at improving pharmacy workflow
and overall job satisfaction for our Washington State pharmacy personnel which ultimately improves
patient satisfaction and welfare since our staff are able to spend more time with patients face to face in
our pharmacies.
Our Quality and Assurance has found some areas to improve including; increase call center hours,
increase staff training, increase staff to implement / increase approved services. We also learned from
the Q&A that our local number was better to distribute than our original 1 -855 RX TRANS due to
high customer cell phone use. Also, we would like to expand to support our pharmacies in Idaho and
Montana. We are also in the process of developing a web based transfer form to better communication
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between our pharmacies and the call center which will expedite the transfer process. We will continue
to monitor our Policy and Procedures along with our Quality Control to continue to improve our call
center.
I would like to thank the Board of Pharmacy, Investigators, Tim Fuller, Cathleen Williams and Doreen
Beebe for all their help in this process and allowing us to improve our pharmacy services to our
patients in new and innovative ways.
The board requested that Tim McCrea report back after one year for another update.
The Suicide, Assessment, Treatment and Management Act
The 2012 Legislature passed engrossed substitute house bill 2366, which requires certain health
professions to include as part of their continuing education training in suicide assessment, treatment,
and management. Alyson Kohl, Department of Health Suicide Study Program Manager discussed with
the board whether to recommend the inclusion of pharmacy professionals in those healthcare providers
best suited to influence suicidal ideation.
ESHB 2366 Suicide Assessment, Treatment and Management Act of 2012
Section 1 requires mental health professions to obtain CEUs on Suicide every 6 years.
Occupational Therapist representatives volunteered to be part of the bill thus O.T.s are also to
obtain these CEUs if they see clients
Section 2 requires a study of evidence based training programs
ESHB 2366 Section 3

Conduct a Study evaluating the effect of evidence-based suicide assessment, treatment and
management training on the ability of licensed healthcare professionals to identify, refer, treat
and manage patients with suicidal ideation.
According to the Law the Purpose of the Study is:
1) Conduct a literature review regarding the relationship between healthcare providers completion
of training and suicide rates
2) Assess which healthcare professionals are best suited to positively influence individuals with
suicidal ideation
3) Evaluate the impact of healthcare professional suicide training on veterans with suicidal
ideation
4) 4) Review curricula of healthcare professional training programs at state educational
institutions regarding suicide prevention
Nationwide & Statewide Focus
The US Surgeon General just released the 2012 National Strategy for Suicide Prevention
ESHB 2366 is an attempt in Washington to decrease suicides
The study will help the Washington Legislature determine future steps based on research.
What we will be doing during the study
Obtaining educational curricula and contacting schools to identify if suicide information is
being taught
Reviewing current continuing education programs
Researching what's being done nationally and globally
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Asking Washington healthcare professionals for information and feedback about education and
experience regarding potential clients with suicidal ideation via an online survey to members
of professional associations
Please encourage members to complete the survey
Survey link may be sent to fellow providers (who are not members of associations) as well .
Questions to be answered
Is expertise at identifying suicide risk considered a requirement for your profession?
Are members of your profession expected to be trained in the assessment of suicide risk or
suicide prevention?
Approximately how often do you think potentially suicidal clients are seen in your profession?
Peninsula Community Health Services Workload Balancing

Cathy Williams gave the board a brief overview of the proposal. She introduced Dr. Jennifer KreidlerMoss who presented a proposal for Peninsula Community Health Services to use the PDX system to
implement workload balancing.
Peninsula Community Health Services (PCHS)

4 Independent Retail Pharmacies
6th Street Bremerton
Port Orchard
Poulsbo
Wheaton Way - Bremerton
Mission is to provide access to low-cost medications and pharmacy services otherwise
unavailable to patients with financial barriers.
Workload Balancing
Distributing work across all sites which does not require actual patient or drug contact
Not counseling
Not filling (labeling and preparing the medication for dispensing)
Not drug verification (correct drug in the bottle, correct cap, correct quantity)
Software automatically prioritizes the entire patient group so every task is given the appropriate
time and attention (think todays work today regardless of site)
Easy, permanent communication within filling software all the way to check-out step with
ability to require input (no loose sticky notes to get lost)
Why add workload balancing

Customer Service
One group of patients to be serviced by all staff based on stated pick-up times (one large
queue of daily work to be accomplished)
We have patients that routinely see providers at multiple clinics and use more than one
of our pharmacies based on transportation issues (e.g. bus schedule, rides with Access
or Para Transit, other appointments for self, family, friends)
We see all patients at any clinic as one group to serve and try to staff accordingly
Efficiency
We do not cover the costs of the program based on retail sales
Our mission calls for access to all patients but load balancing will help justify staffing at
slower sites
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Allows a better distribution of pharmacist time so that time spent on patient care can be
increased (we will be able to increase appointment slots at all sites)
Patient Safety
Work is allocated based on real-time volume so staff at one site is not being
unnecessarily pressured while another site is slow and could help

Old Rx Filling PDX Legacy
Rx gets to technician
Technician places into colored basket based on planned pick-up day
Red = waiting
White = not waiting
Label prints and technician prepares Rx (pharmacist overrides DURs if present)
Pharmacist performs manual check for accuracy and initials bottle and hardcopy
Gaps in Old System
Label previously printed immediately upon order entry (if no DURs) prior to pharmacist
verification for accuracy
No automatic capture of counseling pharmacist identity
No automatic capture of the filling technician identity
All steps are recorded to the individual employee level
No more errant scribbles (or lack of scribbles) on hardcopies that are supposed to mean
something
Each step can be locked down more stringently by security role to the appropriate staff person
even within a licensure level (e. g. float RPhs)
PDX - Enterprise Pharmacy System
Additional document from PDX highlighting Central Fill and Remote Processing
Huge undertaking for our FQHC
Incredible cost compared to our old system
No quick return on investment
Committed to patient safety as an organization
Potential to improve safety (more robust, modern system)
Potential to improve efficiency (work spread across more available staff)
We honestly believe this will increase safety and service for our vulnerable patients.
Patient Safety with Load Balancing
One patient database
Allows crosschecks between sites our patients tend to travel between sites based on
provider openings
One prescription filling profile
Allows crosschecks between sites our patients tend to travel between sites based on
provider openings
One queue of pending work based on anticipated pick-up time
Scraps of paper can get lost/shredded/mis-filed
Manual prioritization of work which was previously largely based on technician
judgment unpopular baskets could keep getting moved to the bottom
Load Balancing Workflow
Functionality will only be enabled for process items which are largely clerical in nature and do
not require in-person interaction with the patient or drug
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PDX - Enterprise Pharmacy System

Order Entry Rxs to be filled (timing of pick up)
Data Entry Technician enters info into filling software
Data Verification Pharmacist verifies accuracy and completes DURs
Fill Label prints and technician prepares Rx
Call Holding queue of Rxs needing technician attention (refill too soon, prior authorizations,
needs refills)
Third Party - Holding queue of Rxs needing technician attention for insurance rejects
Product Verification Pharmacist physical verification of labeled product
MTM Pharmacist notification queue of pending MTM events
Will Call/Counseling Queue of where an Rx is in the workflow
Quality Markers
Robust Quality Department set up to handle medical accreditation (e. g. JCAHO, AAAHC)
Unusual Occurrences are tracked by type, confounding factors, and staff involvement
Referral process to Peer Review with Root Cause Analysis for sentinel events
In other words, the Pharmacy Program is held to a very high standard as has become expected
in the healthcare industry.
Set-Up for Success
Teamwork shared workload on the medical side already using collaborative drug therapy
agreements (CDTAs) Anticoagulation, Vaccines, ECP, Refill Authorization & Adjustment
Technology
Pharmacy has complete access to electronic medical record
Most documentation occurs in the medical record
Innovative Practice
Progressive
Highly motivated group
Patient Centered Medical Home - Pharmacists are an integral part of the team (clinical
visits and prescription dispensing)
MOTION: Donna Feild moved that the board approve the proposal by Peninsula Community Health
Services to use the PDX system to implement workload balancing with a 1 year follow up. Dan Rubin
DISCUSSION
Drug Repackaging/Reuse
Tina Lacey, Pharmacy Investigator led the discussion with the board . They revisited and discussed
public comments received regarding the guidelines detailing requirements for the return and
reprocessing of drug products in long term care pharmacies - includes community based care settings
(WAC 246-865-060 and WAC 246-869-130 return, repackaging, and reuse of drugs).
The pharmacist investigators are reporting growing concern with repackaged modified unit dose
(bubble pack) medications being returned and reused multiple times after being initially dispensed to
community long term care facilities. These facilities have grown in numbers throughout the state and
include assisted living facilities, boarding homes, residential treatment facilities and adult family
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homes, in addition to nursing homes. The facilities listed vary in staffing, oversight, security, control
and storage of medications.
The relevant rules WAC 246-865 and WAC 246-869 were developed and promulgated in 1991.
These rules apply to extended care facilities defined in rule as nursing homes. The rules are silent
relative to the community care facilities listed above in paragraph one.
After Tina Lacey went through proposed guidelines and there was some d iscussion with Joyce Ropers
input. The proposed guidelines are inconsistent with the current rules and would be a risk for the board
to make changes. This will need to go to rulemaking.
MOTION: Donna Feild moved that the board authorize that requirements for the return and
reprocessing of drug products in long term care pharmacies - includes community based care settings
be moved to rulemaking. Elizabeth Jensen second. MOTION CARRIED: 6-0.
DISCUSSION Contd
2013 Legislative Session
Meet Me calls began January 7, 2013. These are conference calls held every Tuesday
for 30
min. They designed to speak to specific legislation that Department of Health boards and
commissions are involved in. Several board and commission members along with staff
participate on these conference calls,calls; a summary review of each bill is done by staff with
some time for input from folks that participate on the call.
HB1003 Prohibits a person who applies or holds a license or temporary practice permit and has
a final finding issued by the Department of Social and Health Services of abuse or neglect of a
minor or abuse of anement neglect or financial exploitation of a vulnerable adult for practicing
in a health care position in the state until proceedings of the appropriate disciplinary or
authority have been completed.
Legislation starts Monday January 14, 2013 at 10:00 am.
There will be a bill regarding e prescribing that will be re introduced this year.
The board will be provided a weekly summary of bills that involve pharmacy. There will be an
update at board meetings as well.
Another bill is about providing public health facilities giving public health nurses the authority
to provide drugs or devices for purposes of communicable diseases or birth control and will be
very specific only for patients that frequent local health jurisdiction only
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Disposal of Controlled Substances

The board discussed the federal Dr ug Enforcement Administrations (DEA) proposed rulemaking to
implement the Secure and Responsible Disposal Act of 2010 for possible comment. Public comment
must be post marked on or before February 19, 2013.
Joyce Roper, AAG pointed out that the DEA did not recognize a common carrier that was registered.
The board recommended that board staff seek clarification on the registered transportation.
Dispensing Prescriptions Written for Animals

Candace Joy, Executive Vice President, Washington State Veterinary Medical Association requested
audience with the board to discuss a pharmacists role and responsibility for counseling and educating
clients while filling a veterinary prescription.
There is an alarming trend in recurring problems by pharmacists unfamiliar with veterinary
pharmacology and physiology. Survey respondents reported the following unauthorized changes to
veterinary prescriptions by retail and online pharmacists:
1) Pharmacists are switching drugs, altering dosages, and changing the quantities from what was
prescribed. These unauthorized changes are largely because of a lack of knowledge in
veterinary pharmacology and physiology and also because pharmacies are not keeping an
adequate supply of the appropriate veterinary drugs.
2)
Pharmacies are dispensing larger quantities than were prescribed as they work to provide a
cost savings to the pet owner and build customer loyalty.
3)
Pharmacists are counseling pet owners with incorrect information with regard to
administration.
4)
5)
6)
Pharmacists are unaware of adverse drug reactions in pets.

Pharmacists are telling the client that the veterinarian was wrong and should not have
prescribed the drug accordingly, undermining the veterinary-client-patient relationship and
casting doubt on the veterinarian s competency.
Written instructions are not being included on the medications and instead
use as
directed is printed on the label.

7)
Online pharmacies are also issuing prescriptions beyond the allotted time or without approval
of the prescribing veterinarian.
8)
Compounding pharmacies are not providing adequate quality control.
9)
Retail pharmacies are not charging the appropriate sales tax.
The board suggested that Candace put together some materials to educate pharmacist . The board would
like staff to prepare an article in the newsletter that can direct pharmacists where to get general
information regarding dispensing vet medications. Lisa Hodgson, Executive Director for Veterinarian
Board of Governors will work on the education portion of this issue. Christopher Humberson,
Executive Director for Board of Pharmacy will support focus on this matter and answer any questions
to the Veterinary Board of Governors via email.
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NABP Pharmacist Assessment for Remediation Evaluation

Christopher Humberson led the discussion with the board on the potential of utilizing the National
Association of Boards of Pharmacy computer-based assessment tool when imposing
conditions/sanctions in cases involving noncompliance with pharmacy practice standards.
The Pharmacist Assessment for Remediation Evaluation (PARE) is a multi -dimensional

assessment that the boards of pharmacy may use as an auxiliary tool when making decisions
regarding pharmacist practice deficiencies that are due to noncompliance with pharmacy
practice standards, laws or regulations, and result in compromises to patient safety.
The PARE is a computer-based assessment that consists of 210 multiple choice questions.
Examinees have a maximum of 4.5 hours to complete the exam. The questions will be drawn
from three content domains:
Medication Safety and the Practice of Pharmacy (Area 1 - 50% of questions)
Professional Ethics/Pharmacist Judgment (Area 2 - 25% of questions)
Clinical Pharmacy Practice (Area 3 - 25% of questions)
To pass the PARE, you must achieve an overall score of at least 80 as well as a minimum score
of 75 in each of the three content areas. In the case of a Fail, the score report will include the
overall score and performance in each of the three content areas.
The PARE is a Web-based examination administered via computer. The Board of Pharmacy
will decide whether to allow the examinee to use their own laptop for testing or supply a
laptop/desk-top.
After registration, NABP will email the registrant a PDF copy of the PARE Examinee
Handbook, which contains details about the processes and procedures on the test day as well as
the Authorization/Release and Confidentiality Agreement. Examinees may review the
agreement prior to testing and will be asked to agree to it electronically on the test day.
The PARE will be administered in a two -week testing window approximately four times per
calendar year. The next available testing windows will be:
February 11-22, 2013
June 3-14, 2013
September 16-27, 2013
December 2-13, 2013
The fee for the PARE is $250.
Request for Exception to 91 day Waiting Period

A board panel was asked to consider a request by a Pharmacist Intern to authorize NABP to waive the
91 day waiting p eriod following a no score report on the North American Pharmacist License Exam.
MOTION: Elizabeth Jensen moved that the board approve the request by Ngoc-Diep Thi Pham,
Pharmacist Intern to waive the 91 day waiting period following a no score report to take the North
American Pharmacist License Exam. Emma Zavala-Suarez second. MOTION CARRIED: 3-0.
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Rules Re-write Project for Pharmacy

Christopher Humberson led the discussion on the progress and recommendations for next steps offered
by workgroups established to further flesh out rule priorities for R2P2. The five topic areas identified
at the b oards strategic planning session formed the following workgroups.
1. Pharmacist/Pharmacy Interns: MOTION: Donna Feild moved to authorized staff to file a
CR101 to initiate rules to update and establish minimum core standards of practice for
pharmacists, opening all applicable WAC chapters. Dan Rubin second. MOTION CARRIED:
6-0.
2. Pharmacy Technology: MOTION: Donna Feild moved that the board develop a new chapter
on Pharmacy Technology. Elizabeth Jensen second. MOTION CARRIED: 6-0.
3. Pharmacy Ancillary Staff: The board and board staff agreed to go back and reconfigure what
direction to go with this rule workgroup.
4. Pharmacy Operations: MOTION: Elizabeth Jensen moved that the board prepare to file a
CR101 to add this to chapter 246.869. Dan Rubin second. MOTION CARRIED: 6-0.
5. Compounding: MOTION: Donna Feild moved that the board file the CR 101 for the
Compounding chapter. Dan Rubin second. MOTION CARRIED: 6-0.
Correspondence
The board discussed any correspondence received or distributed.
WAStateResponse.NECC .House
WAStateResponse.NECC .Senate
OPEN FORUM
There being no further business, the board adjourned at 4:15 p.m.
PRESENTATION OF AGREED ORDERS
CLOSED SESSION
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Next scheduled business meetings: February 21, 2013 9:00 a.m.

800 Oakesdale Ave SW
Renton WA 98057

Approved on February 21, 2013
Christopher Barry, Chair

Washington State Board of Pharmacy
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STATE OF WASHINGTON
MEETING MINUTES
January 21, 2010
Green River Community College
12401 SE 320th St
Lindbloom Student Center - 1st floor - Glacier Rm
Auburn WA 98092-3622
.
CONVENE
Chair Gary Harris called the meeting to order at 9:08 a.m., January 21, 2010.
Board Members present:
Gary Harris, RPh, Chair
Christopher Barry, RPh
Albert Linggi, RPh
Rebecca Hille, BA-Public Member
Vandana Slatter, PharmD
Rosemarie Duffy, RN, MA, MSN, Public Member, Vice-Chair
Board Member absent:
Dan Connolly, RPh
Staff Member present:
Joyce Roper, AAG
Susan Teil Boyer, Executive Director
Grace Cheung, Investigator
Guest / Presenters:
Jeff Rochon, Chief Executive Officer
of Washington State Pharmacy Association
Tina Tweedly, Pharm, Franciscan Health System
Shannon Fry, PharmD, Franciscan Health System
Tim Lynch, PharmD, MS,Franciscan Health System
Brian Robers, Pipeline Healthcare, CEO
Chris Ciolko, Rph, Pipeline Healthcare
Jason Furbush, University of Washington Extern
Patrick Gallagher, PharmD
Guest / Presenters continued:

Dr. Thomas Hazlet, University of Washington
UW PharmD Students
Julie Benefiel,
Matthew Berg
Kyle Fowler
Linda Lei,
Caitlin Kelley
Nathan Kenney
Demetri Kollias
Sara McElroy
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Tyler Mamiya
Lisa Rogers
April White
Amy Iverson
Jill Marquis
Elizabeth Parker
Johanna Thompson
Shawn Picco
Tracy Yep
Lori Greenwood
Zsolt Hepp
Ji Hyon Mun
Takashi Sakano
CONSENT AGENDA
1.2
Pharmacy & Other Firm Application Approval.

New Pharmaceutical Firms -11/02/09- 01/05/10
1.4
Closed Pharmaceutical Firms- 10/27/09-01/05/10

Pharmacy Tech Training Program Approval.
Sawyer College- San Jose, CA - Christie Owens Smith
Everest College- Los Angeles, CA- Deborah Grimes
Southern Careers Institute- Corpus Christi, TX- Jennifer Damron
Everest College- West Valley, Utah- Jennifer Phuong Nguyen
Bryman School of Arizona- Phoenix, AZ- Patrick Reehl
PIMA Medical Institute- Tucson, AZ- Raymond Gomez
Kenya Medical Training College- Kenya, Africa- Lawrence Kiunga

1.5 Automated Drug Dispensing Device Acceptance
St. Lukes Rehabilitation Institute Pharmacy

1.6
Board Minutes - Approval. (December 10, 2009)
Items listed under the consent agenda are considered to be routine agency matters and will be approved
by a single motion of the board without separate discussion. If separate discussion is desired, that item
will be removed from the consent agenda and placed on the regular business agenda. Items 1.1 and 1.3
have been deleted from the agenda. There were four programs pulled from item 1.4.
MOTION: Rebecca Hille moved that the board approve items 1.2, 1.4, 1.5 and 1.6. Al Linggi second.
REPORTS
Board Member
Al Linggi reported:
He will be getting monthly updates from American Society of Health-System Pharmacists
(ASHP). This update will be a condensed version of what ASHP receives from all the boards of
pharmacy that are representatives. Mr. Linggi will share these reports with the board.
He had a discussion with Dean Bailey, University of Washington School of Pharmacy. Mr.
Bailey agreed to work with the board on some of our goals. Dean Bailey has assigned Don
Downing, a UW faculty member to work with the board on the future of pharmacy.
He and Joyce Roper attended an Attorney Generals Prescription Drug Task Force meeting.
They participated in a discussion regarding Prescription Monitoring Program (PMP) funding.
Most organizations representing individual licensees are not willing to pay a $12.00 fee. The
enthusiasm was not very great. There was some discussion on getting funding from settlements
from Pharmaceutical Firms. The next meeting will be held in March.
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Discussion will soon begin to set trial dates to move forward with the Stormans case. The
board will be updated when this occurs.
Chief Investigator
Recently, there have been several inquiries as to what kind of services a pharmacy can provide
to non-nursing home long term care facilities. After researching the current rules, and with
some assistance, the following statement was developed:
Pharmacies providing pharmaceutical services to long term care facilities, such as
residential treatment facilities, boarding homes, and adult family homes not covered in the
Extended Care Facilities (nursing home) rule (WAC 246-865) must provide only patient
specific medications. A pharmacy may utilize an automated drug dispensing system
(PYXIS, OPUS, etc) in long term care facilities with staff credentialed to administer
medications. It is the pharmacys responsibility to obtain Board ofPharmacy approval

(WAC 246-872) for all automated drug dispensing systems and DEA approval
(21CFR1301.27) if controlled substances are involved.
The total number of pharmacy inspections for 2009 was 1,274.
Grant developed a metric for automated patient medication record systems.
December 1, 2009 Stan Jeppesen met with the Mercer Island Police Department.
December 2, 2009 Jim Doll spoke to the Clover Park Technician students about pharmacy law
in Tacoma, WA.
Executive Director
Susan Teil Boyer reported:
Susan acknowledged the excellent and extraordinary amount of work Doreen Beebe has put in
to Tamper Resistant Prescription Pads. The seal that the board had approved has been slightly
modified for practicality reasons. Susan handed out an example of the seal for the board to
review.
Since the current legislative session began, there has been a flurry of bills regarding pharmacy
issues. This is Susans first experience in writing a Bill Analysis and it has been an interesting
learning process. Bills that add any additional cost are being looked at very carefully.
HB2829 regarding the Prescription Monitoring Program (PMP) revisits support for the
program and allows the Secretary to approve a single statewide PMP funded by the private
sector. This would allow private entities to submit a proposal for privately funded PMP . This
requires prescribers to submit data to this private PMP . This will also require rules to be
adopted. It would not allow Department of Health and the Board of Pharmacy to access data,
which is a concern. Law enforcement would have to obtain a court order to gain access to the
data.
Work continues on the Veterinary Wholesaler Rule. Susan met with the State Veterinarian Dr.
Eldrige, his assistant and the chair of the Veterinary Board of Governors. The next step is to
recommend a rule change which would allow vet wholesalers to distribute directly to producers
of livestock.
Susan participates in a H1N1 Healthcare Workgroup. Approximately 2 million doses of the
vaccine have been distributed throughout the state. Pharmacies have played a very big part in
administering the vaccine.
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Cathy and Stan Jeppesen met with Tom Hazlet, University of Washington School of Pharmacy.
The meeting was to discuss 93 questions for the pharmacy law review classes.
Emergency Response to Swine Flu Pandemic via the Receiving, Storage, and Staging (RSS)
facility continued at a much slower pace. The focus has shifted to processing hundreds of emails that they received.
He has been working with Kris Reichl, policy analyst, to complete the CR103 for scheduling
carisoprodol (Soma ) to Schedule IV status, effective February 5, 2010.
Tim continues to meet with Customer Service about collaborative drug therapy agreements
(CDTA), development of CDTA reports, and a pharmacy extern rotation.
He has begun review and analysis of pre-filed legislative bills.
Tim met with the Pharmacy Director and pharmacy residents
at St. Josephs Medical Center in

Tacoma about pharmacy technicians preparing lists of patients medications.
Special Announcements:
Gary Harris shared that board member Rosemarie Duffy will be finishing her appointment with the
Board of Pharmacy. She will continue to serve on the board until a new member is appointed.
On behalf of the board, Gary stated the Department of Health and the people of Washington State
wanted to thank Rosemarie for her active participation and for serving as a Board of Pharmacy
member. Rosemarie was appointed by Governor Gregoire January 18, 2006. She served as Vice Chair
during 2009. The board wishes her well on her future endeavors. Gary presented Rosemarie a letter
and a plaque in recognition and appreciation for her dedicated service to the board.
PRESENTATIONS
Proposed Legislation
Jeff Rochon from the Washington State Pharmacy Association presented a white paper drafted for
st
proposed legislation to add pharmacy robbery to Washington Criminal Code Robbery 1 Degree
[RCW 9A.50.200(b)]. Washington State Pharmacy Association believes that increasing the penalty for
these crimes will play a role in decreasing pharmacy robberies. He asked the board to consider
supporting the white paper.
MOTION: Vandana Slatter moved that the board work through the Department of Health to craft a
letter to support the white paper drafted for proposed legislation to add pharmacy robbery to
st
Washington Criminal Code Robbery 1 Degree [RCW 9A.50.200(b)]. Rosemarie Duffy second.
Pharmacy Technicians Trained to Take Patient Medication List
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Tina Tweedly, PharmD, Franciscan Health System, presented a proposal to the board for consideration
to allow trained pharmacy technicians to interview patients to obtain a medication list .
Overview:
Medication Reconciliation Process Background and Overview
Joint Commission National Patient Safety Goal (NPSG) requirement.
NPSG 8: Completely and accurately reconcile medications .
At admission, obtain and document medication list .
Compare list to ordered medications.
Reconcile discrepancies.
Technician training program
Didactic Education (taught by a pharmacist) .
Process for obtaining medication lists .
Interview techniques.
Completion of competency exam.
Practical Education
Shadow pharmacist for minimum of 3 hours .
Training under supervision until deemed competent.
Immediate pharmacist feedback with each medication list review .
Meetings to review process and assure quality patient care .
Proposed Franciscan process
Patient enters hospital through emergency department .
Technician interviews patient and contacts retail pharmacy or medical providers as needed to
obtain medication list.
Physician reviews list and reconciles medications .
Quality Assurance
Assess pre- and postimplementation.
Medication reconciliation audit reports .
Time to medication reconciliation availability post-admission .
Satisfaction surveys.
MOTION: Chris Barry moved that the board approve the proposal by Franciscan Health System to
train and utilize pharmacy technicians to interview patients and collect medication history in the
Emergency Department. Franciscan Health System will report back to the board six-months after
implementation. Rebecca Hille second. MOTION CARRIED: 5-0.
Guideline for Pharmacy Technicians Trained to Take Medication List

This item was tabled until the next board meeting scheduled for March 11, 2010. The board will be
asked to review a draft guideline to establish standards for utilization of pharmacy technicians to
collect a patient medication list.
Telepharmacy
Tim Fuller gave the board background on Pipeline Healthcare then introduced the CEO, Brian Roberts
and VP Chris Ciolko. Mr. Roberts asked the board to consider a proposal by Pipeline Healthcare,
which is a multi-state organization, to provide telepharmacy services to Washington pharmacies.
Overview:
Background
They are based in Rosemont, IL with an Illinois Telepharmacy pharmacy license.
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Pipeline provides remote order review, clinical consultations, patient counseling, technical
assistance, data analysis, and reporting to support the efficient operation of its clients
pharmacies.
They partner with clients to put in place continuous quality improvement processes and
accountability for its services.
Pipeline provides a service extension of pharmacy operations with audio-visual links to the
patient or dispensing site.
Provides
Enhanced patient care and medication safety.
Real-time seamless extension of the clients pharmacy department.
Eliminates on-call.
24/7 access to drug information.
Increases pharmacy and nursing staff satisfaction and retention.
Increase patient/customer satisfaction and potential compliance.
Process
Remote pharmacist reviews and verifies medication orders/prescriptions on real-time basis .
Utilizes the clients pharmacy information system.

Seamless integration with the clients pharmacy:
Clients policies and procedure.
Clients workflow.
Clients web portal.
Secure and HIPPA compliant network.
Auditing and reporting capabilities via secure client portal.
The operational policies and procedures provide considerable information about administrative
responsibilities, personnel selection and evaluation, the Director of Pharmacy or Pharmacist in
Charges duties, pharmacist functions, confidentiality compliance, computer equipment,

electronic connections, and forms.
MOTION: Vandana Slatter moved that the board approve the proposal by Pipeline Healthcare to
provide telepharmacy services as defined by remote order entry. When Pipeline Healthcare has a client
(retail or hospital) they will work with a Board of Pharmacy Investigator and report back to the board 6
and 12 months post implementation. Rosemarie Duffy second. MOTION CARRIED. 5-0.
Guidelines for Telepharmacy Services
Tim Fuller presented the board with a draft guideline to establish standards for telepharmacy services
to include pharmacists working from home . After providing the board with some background, he led
the discussion and answered the boards questions.

MOTION: Rosemarie Duffy moved to use the outline with suggested additions from Al Linggi to
develop guidelines as an interim process to rule making . Rebecca Hille second. MOTION
CARRIED. 5-0.
Petition for Rulemaking
The board heard and considered a petition from Jason Furbush, University of Washington Extern.
Mr. Furbush has requested the board engage in rulemaking to develop a new rule to prohibit the
distribution and dispensing of drug samples except by vouchers made available by drug manufacturers
to authorized prescribers.
Jeff Rochon, Washington State Pharmacy Association, offered their services to help Mr. Furbush push
his request through a more effective channel for legislation.
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MOTION: Rosemarie Duffy moved to deny the petition for reasons that the board cannot change
statute by rule making. Rebecca Hille second. MOTION CARRIED. 5-0.
Disciplinary/Hearing Process
Karl Hoehn, Legal Unit Manager, DOH, and Marlee ONeill, Attorney Generals office, led a
discussion with the board on the hearing and disciplinary process from pre-hearing activities to the
issuance of a final order. They provided the board with answers to their questions regarding these
processes.
EXECUTIVE SESSION
The board adjourned for Executive Session at 12:20 p.m. to discuss implications and options resulting
from a recent Court of Appeals decision.
CASE PRESENTATION
DISCUSSION
2010 Legislation - Updates
Susan Boyer updated the board on the following 2010 legislation:
SB5798: Medical Marijuana This bill has died and the initiative is being filed.
SB6224: Uniform Controlled Substance Act this conforms the Uniform Controlled Substances Act to
existing state and federal law. HEA - Majority; 1st substitute bill be substituted, do pass . SB6224
passed to Rules Committee for second reading .
HB2454: Concerning ephedrine, pseudoephedr ine, and phenylpropranolamine This bill requires the
Board of Pharmacy to adopt rules to classify ephedrine, pseudoephedrine, and phenylpropranolamine
as legend drugs and schedule III controlled substances. This requires all shopkeepers who purchase
from a wholesaler and sell these items as OTCs to become a licensed pharmacy. A public hearing
was held January 14, 2010 in the House Committee on Health Care and Wellness. This has now been
made into a substitute bill, which would require electronic tracking of these drugs.
HB2391: Pain management Requires professions authorized to prescribe Schedule II controlled
substances to complete one pain management education program as part of the Continuing Education
requirement. This requires that the secretary develo p the criteria by rule by November 15, 2010 and
publish an annual listing of approved programs beginning January 1, 2011. This went to hearing
January 12, 2010. There are some concerns regarding this bill.
Gary Harris updated the board on the Tuesday Meet-Me-Calls. The first call was held on January 12,
2010 and most of the bills discussed during the call died in session. The second call was held on
January 19, 2010 And he had no comment on any particular bills brought forth during that call.
Joyce Roper shared with the board that the proposed bill to reorganize Medicaid out of DSHS has been
dropped.
Continuing Education Pharmacy Technicians
Patrick Gallaher, PharmD, presented a proposed bill to the board and asked for a formal letter of
support. Mr. Gallaghers bill is requesting that the board be authorized to establish continuing
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education requirements for pharmacy technicians. He stated his reason for the proposal is because he
values the input of pharmacy technicians and their experience and education. The bill will be in
hearing on January 26, 2010.
MOTION: Rebecca Hille moved that the board provide a formal letter of support to the bill that will
authorize the board to establish continuing education requirements for pharmacy technicians. This
letter must be provided before this bill goes to hearing Janaury 26, 2010. Al Linggi second. MOTION
CARRIED. 5-0.
Boards Strategic Plan

Susan Teil Boyer updated and reviewed the boards 2009 - 2011 initiatives, goals, and
strategies.
Goal #1
Adopt a process/tool to evaluate rules using criteria based priorities .
She set a meeting up with Steve Saxe and Kristi Weeks to understand how we can
speed up our rules process. The division goal is to achieve a rule in eighteen months.
Cathy Williams, Tim Fuller and Susan are working on restructuring their workload
to set aside time to work on their assigned rules.
We are looking at training some Call Center employees to be able to answer some of
the phone calls that come in regarding pharmacy issues.
Gary Harris and Vandana Slatter requested that an updated list of rules be in the
board book.
Goal #2
Safe drug delivery system.
Gary Harris, Chair, and Joyce Roper, AG, are participating on the Prescription Drug
Taskforce
Further define drug delivery to include remote order entry, telepharmacy, pharmacy
technician medication lists, and stickerless Rx.
Goal #3
Develop a proactive approach to defining and responding to the future of pharmacy.
Contact and reach out to schools of pharmacy and WSPA.
Review and resurrect previous proposals of Quality Improvement that have gone before the
board.
Susan asked the board for some feedback on how they would like to prioritize their efforts
to meet these goals.
Temporary Practice Permit

Doreen Beebe asked the board to consider initiating rules to amend WAC 246-863-035 to issue a
temporary practice permit to license transfer applicants who are waiting for fingerprint-based national
background checks to be completed.
MOTION: Rebecca Hille moved that the board move forward on expiditing the rule making process if
possible to amend WAC 246-863-035 to extend the Temporary Practice Permit to 90 days with
passage of the MPJE. Also, striking number four passing score on the multi-state jurisprudence
examination and to strike number 5 in its entirety. Vandana Slatter second. MOTION CARRIED. 50.
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Correspondence
The board discussed correspondence received/sent.
NABP State News Roundup
December 2009
December 2009
Support for Agency for Healthcare Research
ISMP Medication Safety Alert

Letter to Thomas Gallagher
and Quality grant.
Article re: Drug-import program: In like a lion, out like a lamb.

Response to Petition for Rulemaking to Amend WAC 246-873-090(1)
OPEN FORUM
Jeff Rochon from WSPA thanked the board for the work being done with regard to the Tamper
Resistant Prescription Pad work. He also assured the board that the WSPA is there if they need
anything regarding the legislative session.
PRESENTATIONS contd
University of Washington, School of Pharmacy
Pharmacy Students presented their pharmacy law projects to the board.
Guidelines for the Implementation of Telepharmacy in Washington State Rural Hospitals and
the Potential Impact on Patient Safety
Julie Benefiel, Matthew Berg, Kyle Fowler, Linda Lei,
Tyler Mamiya, Lisa Rogers, April White
Currently there are few telepharmacies operating in rural hospitals nationally, however this practice is
not yet widespread. The majority of states have not adopted regulations that define telepharmacy, nor
have they outlined practice protocols and the minimum accepted technologies to be used within a
telelpharmacy. The majority of sites that have implemented telepharmacies, including those in
Washington State, have done so under the auspices of being pilot projects
Clinical pharmacists in hospitals have been associated with improved patient safety and reduced
adverse drug events. The 2006 Institute of Medicine report sponsored by Centers for Medicare and
Medicaid Services states a greater use of information technologies in the prescribing and dispensing of
medications is an important step in reducing the number of medication errors. Due to a nationwide
shortage of pharmacists and difficulty recruiting pharmacists to rural areas, many rural hospitals cannot
staff an on-site pharmacy 24 hours per day, 7 days per week. This causes limited patient access to the
care and supervision of a pharmacist. In one study surveying 387 rural hospitals, over 27% of
respondents had 0.5 full time employees or less. Studies such as this show there is a great need for
pharmacists in rural areas. This need can potentially lead to a greater increase in medication errors and
thus greater adverse drug events. Telepharmacy is a potential solution .
Rescheduling Tramadol to Class IV

Amy Iverson, Caitlin Kelley, Nathan Kenney, Demetri Kollias,
Sara McElroy, Shawn Picco, Tracy Yep
The Washington State Board of Pharmacy (WSBOP) recently rescheduled the legend drug
carisoprodol (Soma) to Schedule IV status, as defined by the Controlled Substances Act (CSA). This
recent change has placed focus on examining other legend drugs that have abuse potential. Tramadol
has been mentioned as a likely candidate for rescheduling by WSBOP members, University of
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Washington School of Pharmacy faculty, community pharmacists, and pharmacy students. Analysis of
Tramadol's abuse potential is necessary and rescheduling is a reasonable subsequent step to decrease
abuse and increase patient safety.
Rescheduling Tramadol will help move us toward one of our goals as pharmacists by increasing
patient safety; more specifically, decreasing rates of addiction and abuse in patients. A reduction in the
people admitted annually to the hospital for accidental overdose by at least 5 0 percent over three years
would be ideal.
Removing Primatene Mist From Over the Counter Status

Lori Greenwood, Zsolt Hepp, Jill Marquis, Ji Hyon Mun, Elizabeth Parker,
Takashi Sakano, Johanna Thompson
Primatene Mist is the only over the counter inhaler for asthma available in the United States. It is an
epinephrine inhaler that is designed to treat mild asthma. It is less potent and shorter acting than
albuterol, the standard prescription asthma rescue inhaler. It is less effective than albuterol in treating
1
shortness of breath.
However, we dont think this product is terribly dangerous. We just think its not very effective. The
main danger it poses is that people use Primatene Mist instead of getting proper medical treatment and
better drugs to treat their asthma.

CLOSED SESSION
Case presentations
Disciplinary Hearing
Town Center Two, Room 145
111 Israel Rd SE
Tumwater, WA 98501
January 22, 2010 9:00 a.m.
_______________________________
Approved on March 11, 2010
_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON
PHARMACY QUALITY ASSURANCE COMMISSION

Regular Scheduled
January 23, 2014
Point Plaza East
Conference Room 152/153
310 Israel Rd SE
Tumwater, WA 98501
CONVENE
Chair Christopher Barry called the meeting to order January 23, 2014.
Commission Members:
Gary Harris, RPh,
Dan Rubin, MPP, Public Member
Steve Anderson, RPh
Nancy Hecox, PharmD
AL Linggi, RPh, MBA
Tim Lynch, PharmD
Maura Little, Public Member
Kristina Logsdon, Public Member
Elizabeth Jensen, PharmD, Vice-Chair
Absent Commission Members:
Emma Zavala-Suarez, J. D., Public Member
Guest / Presenters:
Ronald Friedman, Attorney for RMI
Christopher Kenney, Director and Treasurer
for RMI
Brian Beach, PharmD, Vice-President, Kelly-Ross
Long Term Care
Ron Jennings, RPh for Yakima Neighborhood Health
Services in Sunnyside
Dennis McAllister, RPh FASHP Senior Director,
Pharmacy Regulatory Affairs
Phil Wickizer, Senior Legal Counsel
Beata Przebinda, Regional VP for Comprehensive
Pharmacy Services
Inga Fricke, CAWA Director of Shelter and Rescue
Group Services
Staff Members:
Joyce Roper, AAG
Gordon MacDonald, Chief Investigator
Brad Dykstra, Pharmacy Investigator
Peggy Crain, Rules Coordinator
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1.3 Approval of December 5-6, 2013 Meeting Minutes .
CARRIED: 11-0.
MOTION: Steve Anderson moved that the commission approve 1.3 with suggested changes. Tim
Lynch second. MOTION CARRIED: 11-0.
CONSENT AGENDA
single motion of the Board without separate discussion. If separate discussion is desired, that item will
November and December 2013

NW Hospital and Med Center _ Revised
2.7 Electronic Prescription Transmission System Approval
a. Albertsons LLC_ARx
b. Cerner Power Orders
c. GEMMS One
d. gMed, Inc gGastro
e. Health Care Systems Inc HCS eMR/HCS eRx
f. Kroger Easyfill PRN
g. Integrate HER MDE3000
h. McKesson Condor Rx90
i. Netsmart Technologies
j. SRSsoft
Items listed under the consent agenda are considered routine agency matters and are approved by a
be removed from the consent agenda and placed on the regular business agenda. Items 2.3, 2.4, 2.6, 2.8
and 2.9 were deleted from the agenda.
MOTION: Dan Rubin moved that the Commission approve items 2.1, 2.2, 2.5, and 2.7. Tim Lynch
second. Elizabeth Jensen recused herself from 2.7(g), AL Linggi and Steve Anderson recused
themselves from 2.7 (h) Gary Harris recused himself from 2.7 (f). MOTION CARRIED: 11-0.
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REPORTS
Commission Members
Al Linggi reported:
He attended the University of Washington (UW) curricula committee. We are moving forward
on changing the curricula for students moving forward in the future.
Al emailed someone from the UW regarding synthetic drugs and is waiting for a response. He
will continue to reach out for help regarding redesigning our rules on synthetic drugs.
Pam Sanders came to our class and gave a presentation on laws, rules for pharmacy technicians.
She was great very entertaining and informative.
Tim Lynch reported:
He has been working with a committee to look at the medication reconciliation process to come
up with best practices for transitioning care between long term care and acute care. Some of this
will be presented at an upcoming safe table event in February.
Tim has been working with ASHP on the section advisory group for pharmacy business
management on presentations around transition care in pharmacy practice.
Elizabeth has had the opportunity to participate on the meet-me-calls . She feels this really
gives her more of an understanding of the legislation process and all that goes along with it.
Nancy was approached by some of the Fred Meyers clinical staff to help with Collaborative
Drug Therapy Agreements (CDTA).
Executive Director
Chris participated in a series of meeting involving the Interagency Unintentional Poisoning

Workgroup and worked to clarify charter of organization on this issue directly related to
medical and pharmacy practice.
An effort of the workgroup to develop a pharmacists counseling aid with respect to

opioid drugs and assessment of appropriate naloxone prescriptions when necessary was
put into place
He met with a small hospital in Elma Washington regarding HCE licenses and their relationship
to pharmacy. With hospitals purchasing medical clinics, there is some question as to the need
for HCE to apply to those owned and managed by the hospital entity. Chris helped to explain
the pharmacy commission jurisdiction with respect to the differences in hospital surveys and
pharmacy inspections and the necessity of sterile compounding standards regardless of
rural/urban setting, that all patients deserve consistent standards of pharmacy care.
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Attended NABP Law Enforcement and Legislation Committee meeting, where resolutions are
crafted into policy thru the model act revisions or establishment of task forces to help boards
and commissions in their regulation in the practice of pharmacy.
General items discussed and put forward to the Executive Committee were:
More consistency and uniformity in inspection forms that can be shared cross state
platforms for common understanding and usefulness and other strategies related to
consistent inspections and informational sharing among boards and commissions.
Issues related to the extent of PBM regulations within states and how NABP can assist
boards and commissions to move in this direction.
Based upon Resolution 109-2-13 passed in May 2013 in St .Louis, place language in the
model act to restrict the grey market purchases from pharmacies by other business
entities by more carefully defining the five percent rule in the Model Act.
Further define in the Model practice Act what medication synchronization means and
that this must be a patients directed activity, not pharmacist or business directed without
patient consent.
Update the model act to list specific language as to the frequency of appropriate
inspections of both resident and non-resident pharmacies, depending upon their business
model, ie sterile compounding more frequent than pharmacies not doing sterile
compounding.
To have NABP help in the efforts to eliminate labeling issues and reach a standardized
label format with all state boards and commissions.
Place in the Model Practice Act the contents of Resolution 109-7-13 related to
Performance Metrics and Quotas in the Practice of Pharmacy. Discussion related to

production metrics (rx per hour/guaranteed rx times/quotas on rx- immunizations) that
while some argued these were business practices,( argument by me that so was
compounding ) the majority agreed that production metrics were detrimental to patient
safety and should be stated as such in the Model Act for boards and commissions to refer
as they work to include these in their respective states . (FAA STORY HERE ON
WEATHER).

There have been 5 or 6 bills regarding regulating medical marijuana, primarily aimed at
reconciling the regulation under Initiative 502 (recreational marijuana) with the far less
regulated medical marijuana market. This reconciliation is considered necessary to comply with
the federal guidelines in the Department of Justice letter for the federal government to take a
hands-off approach to this states legalization of recreational marijuana.
Regarding the Stormans case, there has been some recent activity in the Ninth Circuit Court of
Appeals involving an appeal for which we are more or less on the sidelines being an observer.
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There was an appeal filed by Legal Voice (formerly Northwest Womens Law Center) on a
discovery dispute. Legal Voice was asked to produce documents in a discovery request and they
challenged the requirement to provide the documents and believed that under the federal
discovery rules required the Plaintiffs to pay them for the costs of producing those records. The
9
th
Circuit decided that Legal Voice should have been paid to provide these documents in
discovery to the Plaintiffs .
Tim attended meeting in Senator Mark Mullens Office about implementing the use of Epi-Pens
in schools. The focus was the administration by non-licensed workers . There was no money
attached to the legislation for training. Those present were ready to push ahead and the school
lawyer believed the schools can shoulder the liability.
He joined with the Nursing Consultant to conduct a hearing on standing orders. No legal
definition of standing orders exists. Standing orders appear to be used anywhere health care is
provided. Nursing expects to pursue an interpretive statement on standard ordering.
Hes been participating in pharmacy Commission CDTA Subcommittee meetings .
Provided a presentation 2014 New Laws-New Drugs in Seattle.

Tim contributed to Public Health Emergency Planning and Response .
Supervising Pharmacist Investigator/Field Investigator

Candidate interviews of the finalists for the Pharmacist Investigator Position in Region 4
(Eastern Washington) were held in Spokane in December. An offer was extended and
received from Cher Eleanor Carbett. Eleanor, as she prefers, began her training on January
16th and will be assuming her duties in the field shortly. Eleanor is a graduate of the
University Of New Mexico College Of Pharmacy where she earned her Doctor of Pharmacy
degree. During her studies Eleanor was also the recipient of the Pharmacy Summer Research
Fellowship, the UNM Health Sciences and Informatics Award of Excellence, the New
Mexico Pharmacists Association Scholarship and the Norman and Lila Levit
Radiopharmaceutical Science Memorial Scholarship. Candidate interviews of the finalists for
the Pharmacist Investigator Position in Region 4 (Eastern Washington) were held in Spokane
in December. Eleanor has experience working in community retail, compounding, nuclear and
long term care pharmacy settings. Her most recent position was at the Medicine Shoppe
Pharmacy in Deer Park, WA. She is licensed as a pharmacist in both Washington and Idaho.
The most common violations noted in Pharmacy License inspection reports (violation cited in at
least 139 inspections) are as follows:
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WAC 246-875-020 - Patient Medication Record Systems.
Main violations of this
chapter are incomplete patient allergy and chronic medical conditions. A secondary
violation includes complete lack of or inadequate performance of DUR .
847 violations. Occurred in 80.2% of all pharmacy inspections.

WAC 246-869-210 Prescription Labeling. Main violation of this
chapter is
improper or invalid expiration dates .

WAC 246-869-100 Prescription Record Requirements. Main violation includes
incomplete prescriber and/or patient information on the original prescription.
170 violations. Occurred in 16.1% of all pharmacy inspections

WAC 246-869-150 Physical Standards for Pharmacies Adequate Stock.
Main
violation includes expired merchandise (stock drugs) on shelf.

WAC 246-869-230 Child-resistant containers Main violation is
lack of proof
of authorization from patient to dispense medication in non-child resistant (ez open)

containers.
PRESENTATIONS
Remote Medical International (RMI)
Chris Humberson introduced Christopher Kenney, Director and Treasurer for RMI and Ronald
Freidman, Attorney for RMI. They are asking the commission to approve their request to export nonnarcotic controlled substance diazepam . Christopher Kenney provided the commission a brief power
point of what they do, who their customers are and the laws they are required to follow.
MOTION: Dan Rubin moved that the commission send a letter to RMI stating we dont have
jurisdiction. RMI can then forward the letter on to the Drug Enforcement Agency (DEA). Steve
Kelley Ross Pharmacy

Cathy Williams introduced Brian Beach, PharmD, Vice-President, Kelly-Ross Long Term Care. Brian
provided the commission a brief background of Kelly-Ross . Kelly-Ross is requesting the commissions
approval to operate a Central Fill Pharmacy based at Kelley-Ross Long Term Care Pharmacy to fill
multi-dose compliance packaging for other divisions of Kelley-Ross and Associates, Inc. (Kelley-Ross
at the Polyclinic, Union Center Pharmacy).
Overview:
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Kelley-Ross and Associates, Inc. consist of four distinct Washington State Licensed pharmacies:
Kelley-Ross Prescription Pharmacy, Kelley-Ross Pharmacy at the Polyclinic, Kelley-Ross Long
Term Care Pharmacy and Union Center Pharmacy. All of these pharmacies are securely connected
via a common Virtual Private Network environment allowing for secure storage and sharing of data
between physical locations.
Kelley-Ross Long Term Care Pharmacy is a closed-door pharmacy that utilizes various
technologies to create compliance-packaging options for patients in a variety of settings. These
technologies all employ systems that assist in reducing the potential for errors in the production
process. By utilizing the advantages of technology in this production, the end product for the
patient can be of higher quality and accuracy compared to a manual fill process.
Under the central fill pharmacy process, the prescriptions would be entered into the pharmacy operating
system of the primary store. All product selection, billing, and DUR verifications would be done at the
primary store by the appropriately licensed staff at that site. Upon notification of the patient and
verification of current medication regimen, the primary store would generate an electronic batch file
that would be transmitted for processing at Kelley- Ross LTC Pharmacy. Controlled substances would
be filled on site at the primary pharmacy and not transmitted to the central fill pharmacy.
Upon receipt of the batch file, Kelley-Ross LTC staff would prepare the batch and follow the standard
procedures for producing a finished compliance package. Two independent quality control checks are
in place at the central fill pharmacy. First, upon completion of filling, a pharmacy technician performs
standardized quality checks of the prescription packaging and labeling. Second, a pharmacist performs
the final central fill quality check ensuring that each of the medications listed on the label are in the
appropriate locations and quantities before it leaves the pharmacy. Labels will include the address of
the dispensing pharmacy along with all State and Federal labeling requirements.
All delivery services are performed by internal Kelley-Ross delivery staff. A delivery record is
generated that will include information of all patients, medications, and amounts contained in the
packages being processed at the central fill pharmacy. These receipts will be maintained in the primary
pharmacy for a period of 2 years after delivery. The medications are transported in temperature
controlled vehicles and packages to ensure compliance with current USP Guidelines for storage and
handling of medications. No medications will be kept in a delivery vehicle for longer than 4 hours
during transport between the central fill and primary pharmacies.
At the primary pharmacy, a pharmacist will complete the ultimate verification of the package to ensure
that all appropriate medications are included in the correct locations and quantities based on the
information within the primary pharmacys database. It will then be placed in the will call section of
the pharmacy along with any medications filled at the primary store.
When the patient arrives to pick up medications, all current processes for dispensing of medications are
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followed in regards to HIPAA compliance, counseling and acknowledgement of receipt of medications.
MOTION: Gary Harris moved that the commission approve Kelly-Rosss request to operate a Central
Fill Pharmacy based at Kelley-Ross Long Term Care Pharmacy to fill multi-dose compliance
packaging for other divisions of Kelley-Ross and Associates, Inc. (Kelley-Ross at the Polyclinic,
Union Center Pharmacy) and to report back in one year. Sepi Soleimanpour second. MOTION
CARRIED: 11-0.
Yakima Neighborhood Health

Ron Jennings, RPh responsible pharmacist for Yakima Neighborhood Health Pharmacy in Sunnyside is
requesting approval from the commission to provide central refill services to its Yakima pharmacy.
Introduction to the clinic:
Yakima Neighborhood Health Services (YNHS), a private not-for-profit health clinic, was
founded in 1975 to provide healthcare and education services to low-income and homeless
people. YNHS Pharmacy is a closed 340B pharmacy that provides services only to patient
seen by the clinic or referred out by clinic providers. (i.e. specialist)
Due to the recent acquisition of a grant to extend services in the Sunnyside area, the current
clinic has now expanded (also now in service) with a large portion of that building
allocated to an in-clinic pharmacy to serve the patients there. The pharmacy is still
awaiting the Grand-Opening
The Sunnyside Pharmacy (SSP) will act as a traditional pharmacy just as the Yakima
branch has for the last 9 years
In addition, due to the large allocation of space we are proposing to use it to relieve the
burden of the ever growing Pharmacy needs in Yakima.
Both locations will use the same shared pharmacy software (QS1) and electronic medical
record system (NextGen).
All patient pharmacy profiles are only accessible to pharmacy personnel from both sites.
How?
Treat refills from the Yakima site as transfers to Sunnyside to be processed .
Patient calls into YNHS retail pharmacy
E-Faxed from provider (refill request responses)

Walk-in: request dispensed in-house or recorded on refill log and
faxed to SSP
Call transferred to IVR line (patient can request fill at Yakima or SSP
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site)
No refills = med information tasked to provider in NextGen or sent

directly through QS1 (via Surescripts)
Prescription numbers for the two sites have different prefixes to indicate
which site they were filled, as well as the label that contains the address of the
filling site.
Delivery
Once prescriptions are filled and checked they will be transported by pharmacy staff back
to Yakima.
Rx(s) for each patient will be individually bagged with receipt stapled to
outside.
Auxiliary label of each Rx will be placed on delivery receipt log.

Pharmacy courier will verify refilled medication bag with those prescriptions
noted on delivery log using barcode technology ( Retrieve Rx) and have
pharmacist approve final list.
Medications place in tote and delivered to Yakima

Yakima technician will verify using bar-code technology) and sign all medication on
delivery log is accounted for:
Retrieve Rx system for pick up
Any discrepancies will be reported to the SSP and resolved prior to the
courier leaving the Yakima site.
Signed delivery log is faxed to SSP to compare with pharmacy End-OfDay reports by the pharmacist.
Why?
Increased demand for prescriptions in Yakima out growing current work space.
Decreased wait time for patients.
Improve safety and efficiency by balancing workload of our staff.
Free-up Yakima pharmacy staff to pursue/provide additional clinical services.
MOTION: Elizabeth Jensen moved that the commission approve the request to provide central refill
services to its Yakima pharmacy from the Yakima Neighborhood Health Pharmacy in Sunnyside as a
demonstration project. The commission provided Ron Jennings a list of specific areas they would like
the report to include at the July meeting: Areas of error analysis such as wrong fills or double billing,
analysis of volume, turn-around time, mislabeling, any problems the patients have, number of scripts
returned from Sunnyside back to Yakima, impact of error rate in Yakima and error rate in Sunnyside,
amend the P&P regarding the scanning image and document tracking of original prescription. Tyler
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Varnum is to also report back. Dan Rubin second. MOTION CARRIED: 11-0.
LEGISLATION AND RULE MAKING

Chris Humberson provided the commission an update on 2014 legislation, and commission rulemaking
activity (if applicable). The commission discussed the bills and where they are at in the House or the
Senate. Elizabeth Jensen also shared an update with the commission members she is participating in the
Meet-Me-Calls.
MOTION: Tim Lynch moved that the commission formerly send a letter to Senator Becker and
Representative Cody that the commission does not support HB 2326 & SB6091. Elizabeth Jensen
Peggy Crain updated the commission on the Compounding Rules . There have been internal meeting
and stakeholder meetings will be starting soon. At this point the draft needs more work.
PRESENTATIONS Contd
FairFax Hospital Everett and Kirkland
Tim Fuller introduced Beata Przebinda, Regional VP for Comprehensive Pharmacy Services. This item
was tabled at the December 2013 meeting the commission wanted the P & P to be amended to clarify
verbal orders. FairFax Hospital requested to use RxRemote Solutions to provide remote medication
order entry services.
Beata Przebinda briefly provided the commission an overview on the amended policy and procedures.
The commission had a few more questions regarding the updated P&P.
MOTION: Gary Harris moved that the commission accept FairFax Hospital proposal to use RxRemote
Solution to provide remote order medication services for their facility. The commission would like a
report back in one year. Nancy Hecox second. MOTION CARRIED: 11-0.
Express Scripts, Inc.
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Dennis McAllister is asking the commission to approve his requests of pharmacy license for Spokane
location dba Expres Scripts (ownership change). The pharmacy provides remote medication order
entry services and stocks no drugs on site.
Additional Background of Why We Are Before the Commission

As part of the Change of Ownership Application for the existing license and facility, an
inspection was requested in concert with the submission of the Change of Ownership
Application.
The Commission Compliance officer, Mr. Tyler Varnum, Pharm.D., visited our site on
December 11, 2013 to perform the onsite inspection and review our facilities, workplans,
and personnel.
We were able to provide Mr. Varnum with all requested materials both during and following
the inspection. From an inspection perspective no deficiencies were reported.
To complete the pending application, Mr. Varnum after consultation determined that we
should seek an appearance with the Board to have the application and his inspection
approved for issuance of the new license.
Specifically, to ask the Commission to approve use of the existing staff and workplans with
no changes to the new name and ownership.
Express Scripts Pharmacy, Inc. DBA Express Scripts History

The pharmacy opened in 1990 as a mail service pharmacy. It received mailed in
prescriptions, processed the prescriptions, and dispensed the final prescriptions at the same
facility.
In 1999 Medco opened a high tech robotic dispensing facility in Las Vegas, NV and manual
dispensing operations in Spokane were slowly phased out, and the facility began a more
concentrated focus on cognitive services (please note the higher number of RPhs employed
on slide 8) .
The WA BOP was consulted on any regulatory issues that would bear on the processing of
prescriptions via electronic means, and dispensing at another facility that was out of state.
At that time, we worked with then BOP staff to ensure that our systems and processes
provided adequate safeguards to ensure quality and safe outcomes for Washington patients.
The pharmacy has operated in this manner since 1999 until the present.
There have been 10 successful inspections since that time with no findings
There has been no discipline on the license since that time.
Express Scripts Pharmacy, Inc. DBA Express Scripts

Current Staffing
38 Technicians
139 Pharmacy Assistants
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51 Pharmacists
Assistants Utilization Plan (WAC 246-901-100)
Attached to this presentation (Business confidential, Commission eyes only)
Life of a Prescription
Attached to this presentation (Business confidential, Commission eyes only)
Average Prescription Activity
16,000 Rxs/day
1000 Patient calls/day
300 Prescriber calls/day
Existing and WA Approved Pharmacy Operations and Services Model for Express Scripts
Operates in 10 states using a shared services/ common database model. This model is
codified in Washington rules supporting the practice (WAC 246-869-090(4) & WAC 246875-040). All of our pharmacies are licensed as WA pharmacies or hold non-resident WA
pharmacy licenses that participate in our common database.
This model provides for unprecedented accuracy. ESI operates at Six Sigma or better
quality. (>99.996% accuracy)
This network filled nearly 170 million prescriptions in 2013.
Each prescription is viewed by at least 4 different individuals, providing for elimination of

individual errors due to a single person doing all of the processing and dispensing.
Processing and dispensing data is retained down to the individual keystroke. All
calls are recorded and archived. Compliance investigations can determine who
did what when, and where the activity occurred.
Express Scripts Objective
Express Scripts respectfully requests that the Washington Pharmacy Quality Assurance
Commission vote under WAC 246-869-030 to approve the Change of Ownership Application
and resident license for Express Scripts Pharmacy, Inc. DBA Express Scripts (formerly known
as, Medco Health Solutions of Spokane, Resident License # PHAR.CF.00003890)Please note
the following as you deliberate & vote:
Everything in the pharmacy is the same, only the name on the door has changed.
Washington patients will receive the same safe and quality services that have
been provided by this pharmacy and our network of pharmacies for the last 15
years.
We respectfully request that you approve our pending Change of Ownership Application for
this facility and license and also approve the existing (and formerly approved for Medco)
legacy central fill/processing and Ancillary Personnel Utilization Plan presented herein.
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MOTION: Al Linggi moved that the commission grant a conditional pharmacy license to the Liberty
Lake facility to expire on March 31, 2014. The commission requested that Express Scripts return to
th
present at the March 6 meeting on its use of pharmacy ancillary staff at the Liberty Lake pharmacy
operation. To include specific delineation of task assignments, and a method to identify those tasks that
are discretionary functions that fall within the scope of the license holder. Dan Rubin second. Elizabeth
Jensen abstained. MOTION CARRIED: 9-1.
Humane Society of the United States

Doreen Beebe led the presentation by providing some background information. Inga Fricke, CAWA
Director of Shelter and Rescue Group Services joined the meeting via telephone asking the commission
for approval of national euthanasia training program curriculum, and updated HSUS euthanasia
reference manual. The commission does not approve euthanasia training programs.
MOTION: Tim Lynch moved that the commission approve the HSUS euthanasia reference manual.
Nancy Hecox second. MOTION CARRIED: 11-0.
OTHER
A panel was chosen to hear the request from Walmart Stores Inc. to be recognized as an educational
organization, or professional association for the purpose to receive contact lists of credential holders.
MOTION: Al Lingii moved that the commission panel deny the application from Walmart Stores Inc.
to be recognized as an educational organization, or professional association to receive contact lists of
credential holders based upon the information that was presented. Nancy Hecox second. MOTION
CARRIED: 8-0.
Draft Pharmacy Quality Assurance Commission Bylaws

Christopher Humberson continued discussion and review of draft bylaws to provide a framework for
commission operations and management not covered in law or rule. Chris allowed the commission to
provide input during this discussion. He asked the commission members to send any more comments or
suggestions. He will put together a revised draft and send out by January 30, 2104 to the commission
members for further review.
Pharmacy Intern Registration

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Chris Humberson led the discussion on the qualifications for registration - enrollment as defined by the
commission. Commission continues to discuss when to allow an intern to register for their pharmacist
intern license. Keeping in mind the credentialing workload for DOH and the ability to safely allow the
registrant to hold that license and work in a pharmacy. After some discussion Chris Humberson will
meet with credentialing and ask if it is possible to have an effective date no sooner than the registrants
first day of school. He will update the commission in March.
Policy Review - Policy/Procedure #40 Qualification for Re-exam NAPLEX

Doreen Beebe asked the commission for proposed changes to the commissions policy to clarify that reexam internship hours are in addition to the hours required for licensure not in lieu of. The commission
made amendments to the language to the Policy/Procedure #40 Qualifications for Re-exam NAPLEX.
MOTION: Dan Rubin moved that the commission use the revised language for the Policy/Procedure
#40 Qualifications for Re-exam NAPLEX. Steve Anderson second. MOTION CARRIED: 11-0.
CriticalPoints Sterile Compounding Boot Camp

Gordon MacDonald asked the commission to extend funding for another investigator to attend
CriticalPoints Sterile Compounding Boot Camp Training program. This is training on current sterile
compounding best practices through presentation of theoretical and practical information.
MOTION: Gary Harris moved that the commission extend funding to allow another pharmacy
investigator to attend CriticalPoints Sterile Compounding Boot Camp. Sepi Soleimanpour second.
Correspondence
The board discussed correspondence received or distributed.
a. Wing Lim Chow, RPh., Director or Pharmacy Operations and Clinical Services,
Bartell Drugs re: WAC 246-863-100 Collaborative Drug Therapy Agreements .
MOTION: Tim Lynch moved that the commission form a subcommittee to evaluate options regarding
collaborative drug therapy agreement options. Sepi Soleimanpour second. MOTION CARRIED: 110.
The CDTA Subcommittee consists of selected commission members Dan Rubin, Tim Lynch, Nancy
Hecox, Elizabeth Jensen, and Sepi Soleimanpour. The staff that will be participating in the
subcommittee meetings will be Joyce Roper, Tim Fuller, Doreen Beebe, and Gordon MacDonald.
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Grant Chester re: Disclosure of Dashboard statistics on application and inspection processing times .
Christopher Humberson will discuss this with credentialing and how to track realistic numbers . If this is
not discussed in March he will discuss this in April.
b. FDA Federal and State Oversight of Compounded Drugs
c. Support Adding Tramadol to Prescription Monitoring Program
MOTION: Dan Rubin moved that the commission proceed with stakeholder process to add Tramadol
to the Prescription Monitoring Program . Nancy Hecox second. MOTION CARRIED: 11-0.
OPEN FORUM
Grant Chester shared his strong opinion again regarding his petition. The petition suggests that the
Pharmacy Quality Assurance Commission needs to disclose the timelines to the public regarding
processing times of applications and inspections.

BUSINESS MEETING ADJOURNED.


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STATE OF WASHINGTON

MEETING MINUTES
January 24, 2008
CenterPoint Corporate Park Corporate Center
20809 72nd Ave South (Conference Room)
Kent, Washington 98032
Board Office: (360) 236-4825
CONVENE
Chair Rebecca Hille called the meeting to order at 9:07 a.m. on January 24, 2008.
George Roe, RPh
Rosemarie Duffy, RN Public Member
Susan Teil-Boyer, RPh
Board Members absent:

Gary Harris, RPh, Vice-Chair
Dan Connolly, RPh
Staff Members present:

Guests/Presenters
Steven Saxe, Executive Director (Acting)
Linda Furkay, Patient Safety Adverse
Lisa Salmi, Executive Manager
Event Quality Specialist
Joyce Roper, AAG Advisor
Casey Lirot, UW Pharmacy Extern
Kristi Weeks, Staff Attorney
Robert Cordier, CEO Bates Pharmacy
Kevin Slivers, RPh Bates Pharmacy
Richard Morrison, Pharmacist Investigator
Louie Foster, DocuTrack - Product Mgr
Ken Culver, PharmD Crescent PharmD
UW PharmD Students:
Ellen Smith
Abby Frye
Brandon Chrisopulos
Ryan Bolonesi
Christine Brooks
Edward Osei
Jennifer Chow
Joey Chase
Charles Huckabay
Shannon Duke
Gina Park
Curt Geier
Leah Lopez
Michelle Gouker
Sean Akamine
Paul Choi
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Mission Statement
The mission of the Board of Pharmacy is to achieve the highest standards in the practice of pharmacy,
to promote public health and safety and effectively communicate with the Governor, Legislature, the
Department of Health, the public and profession.
Vision Statement
The Washington State Board of Pharmacy leads in creating a climate for the patient-focused practice
of pharmacy.
Pharmacists inform, educate, consult, manage drug therapy and provide products as an integral part of
an accessible, quality based health care system.
As an outcome, the citizens of Washington State:
Special Announcement:
Madame Chair Hille presented Susan Teil-Boyer with a plaque in recognition of her hard work and
active participation on the Washington Board of Pharmacy. The award honors her contributions and
dedication to the citizens of this state and the pharmacy profession through her devoted service as a
member board. March 23, 2000 through January 25, 2008.
CONSENT AGENDA
1.2
Pharmacist License Application Approval
1. Micah Rydman Nuclear Pharmacist
2. Michael Chee Nuclear Pharmacist
3. Mary Johnson Nuclear Pharmacist
1.2
Pharmacy & Other Firm Application Approval
New and Closed Pharmaceutical Firms 11/16/2007 12/31/2007
1.4
Pharmacy Tech Training Program Approval
1. Elsie Grant Apollo College in Albuquerque NM
2. Nigist Asfaw Century Community and Technical College in White Bear Lake, MI
3. Raheela Rasheed - University of Karachi in Pakistan
1.5
Collaborative Drug Therapy Agreement Acceptance
1. Becky Bauer Community Health Center Refills
2. Various Pharmacists Legacy Salmon Creek Hospital Renal Dosing
3. Various Pharmacists Reliant Rx of Washington Anticoagulation
4. Various Pharmacists Community Health Association of Spokane Anticoagulation
5. Dave Morio Fife Pharmacy & Gifts Emergency Maintenance Medications
1.6
Automated Drug Dispensing Device Acceptance
1. Kadlee Medical Center
2. North Star Lodge Pharmacy North Star Lodge Cancer Center
1.8
Board Minute Approval December 14, 2007
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by a single motion of the Board without separate discussion. Items 1.3, and 1.7 have been deleted
from the agenda. MOTION: George Roe moved that the Board approve items 1.1, 1.2, 1.4, 1.5, 1.6
and 1.8 from the consent agenda. Susan Teil-Boyer second. MOTION CARRIED. 4-0.
REPORTS
Executive Manager
Lisa Salmi reported:
Health System Quality Assurance Division restructure workgroups continue to meet
weekly. Grant Chester is a member of the Investigation and Inspection Workgroup. Ms.
Salmi participates on the Health Professions and Facilities Workgroup.
Gary Harris and staff responded to a request for comments from the Federal Drug
Administration regarding behind the counter class of drugs.
The 60th Legislative Session convened on January 14. The session is scheduled to end on
March 13.
Governor Gregoire announced she has included funding for the prescription-monitoring
program (PMP) in her budget proposal. We will also be applying for the Bureau of Justice
PMP Implementation Grant. The deadline for submission is February 14.
The new Integrated Licensing and Regulatory System (ILRS) is on schedule for
implementation on February 19.
Board Members
Susan Teil-Boyer reported:
The Joint Commission on Accreditation of Hospitals has changed its name to the Joint
Commission. The commission is emphasizing new national patient safety goals focusing
on high-risk drug categories, and how hospitals are minimizing risks to patients.
American Society of Health-System Pharmacist will be meeting June 8 11 in Seattle.
Chair Rebecca Hille reported:
Attending meet me calls reviewing proposed legislation that crosses multiple health
professions. Representatives from several professions participate on these weekly
conference calls.
Will meet with the Washington State University Dean of Pharmacy next week to discuss
board activities.
Attorney Generals office has filed a motion for a stay with the district court to stay the
preliminary injunction and proceedings in the Stormans case. The plaintiffs have filed a
motion to modify the preliminary injunction. The plaintiffs agree that the preliminary
injunction was written too broad and should apply only to the plaintiffs; and the
pharmacists named in the case. They also seek to include the pharmacists employers who
remain unnamed.
In the motion to modify, the plaintiffs also requests that the judge clarify that the injunction
is not limited to the anti-discrimination clauses in the pharmacist and pharmacies
responsibilities rules.
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We filed our opposition to the inclusion of unnamed plaintiffs and the motion to modify the
provision of the injunction to apply to all aspects of the rule. Modification of the provisions
of the injunction would be inappropriate since the case is on appeal.
Motions have been scheduled for argument on February 15 at 9a.m. in the Tacoma District
Court. Arguments will address the motion to stay and motion to modify preliminary
injunction.
Casey Lirot, University of Washington Pharmacy School Extern
Involved in emergency response program setting up cache of anti-viral drugs.
Assisted with the Nursing Care Quality Assurance Commission interview process to fill the
Nurse Practice Advisor position.
Chief Investigator
Investigator Tyler Varnum has completed the Department of Health basic investigator
course and will begin conducting investigations.
Grace Cheung, Kristi Weeks and Mr. Chester, with the assistance of Casey Lirot, finalizing
medication error sanction guideline for presentation to the board.
Cathy Williams is up-to-date on reviews and approvals of continuing education programs,
ancillary personnel utilization requests and renewal of technician training programs.
Tim Fuller is up-to-date on collaborative agreements and is working on electronic
prescription transfer applications.
Interviews are completed for both investigator vacancies. Employment offers have been
submitted to the Human Resources office for approval.
Investigations and inspection data for November and December 2007.
Program Manager
Doreen Beebe reported:
Pharmaceutical Services in Correctional Industries rule stakeholder meeting held on
January 15. First meeting looking at pharmaceutical practices in correction facilities
without pharmacies.
Conducting interviews on January 17 for clerical board support position.
Washington State Pharmacy Association meeting October 25 location has not been
determined Rod Shafer, CEO of the WSPA extended an invitation to the board to attend
the June Tri-State meeting in Coeur dAlene, Idaho.
Updated the board on the top four rule priorities:
o Pharmacy Technician National Standardized Exam Working on small business
economic impact statement (SBEIS). We will be evaluating board-approved
programs in areas of training and examinations to determine whether there are
deficiencies. And estimating costs associated with possible program revisions
needed to prepare pharmacy technician applicants to successfully complete a
national examination. Rosemarie Duffy volunteered as board sponsor. Plan to
schedule hearing this summer.
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o Tim Fuller provided updates:

Working on re-writing the SBEIS regarding draft rules on Extended Care
Facilities Controlled Substances.
Assessing whether we have adequate scientific data to determine if we have
enough information to support the rescheduling of SOMA. Tim Fuller
assigned as staff lead.
DISCUSSION
2008 Legislative Session Update.
Lisa Salmi updated the board on several bill proposed by the legislature.
HB 2583 Refilling Prescriptions in Emergencies requires health plans to waiver refill time limits
and authorizes payment to pharmacies for at least 30-day supply if certain conditions exist. Legislation
does not seem to cover controlled substances. Referred to committee.
HB 2659 Prescription Drug Marketing and Disclosure Act Pharmaceutical manufacturers must
report/disclose to the Board of Pharmacy information on each gift, fee, or payment made to recipients
in the state. The board will be required to report annually to the governor and legislature. This bill
requires rule making. Referred to committee. HB2659 similar bill.
HB 2664 Prescription Privacy & Integrity Act Prohibits the sale of prescriber identifiable
prescription data. Penalties may be assessed up to $50,000 for non-compliance. SB6241 bill requires
the Department of Health to establish an integrity program, which allows prescribers to give
permission allowing their information to be released/sold. DOH would update and make the list
available.
HB 2694 Prescription Drug Evidence-Based Education Act Requires the Health Care Authority in
consultation with others named in the bill to develop a prescription education program providing
information and education using evidence based materials.
SB 6189 Requires pharmacy owners to file an annual declaration of compliance stating the pharmacy
is complying with its duty to dispense lawfully prescribed drugs and meet the pharmaceutical need of
its patients. The bill requires pharmacies to facilitate delivery of the drug by filling or confirming
referral to another pharmacy. The Board of Pharmacy can grant exception based on the nature and
needs of the population served by the pharmacy. Rules regarding exceptions are required by January
2009.
SB 6361 Recognizes pharmacists and pharmacies right of conscience objection. Pharmacies must
provide written notice of services it provides. The Board of Pharmacy must establish a mechanism to
recognize the rights of pharmacies and pharmacists to exercise religious beliefs and to ensure patients
have timely access to services. Extends the right of conscience to a business.
SB 6519 Duty of Pharmacies to Facilitate the Delivery of Lawfully Prescribed Drugs/Devices
Pharmacies have a duty to facilitate delivery by dispensing, guarantee access by referring to a
pharmacy or medical provider that can dispense, return unfilled prescription if patient or caregiver
objects to the referral. Bill includes exceptions when a pharmacy may not be able to deliver drugs in a
timely manner.
HB 2691 Referral of patients by health care providers Prohibits health care providers from
referring patients to other providers, services of facilities in which the referring provider or an
immediate family member has a financial interest unless the interest is disclosed. The bill includes
exceptions. Violations are a misdemeanor and may be disciplined as unprofessional conduct.
HB 2721 Adopting model rules for public agencies under the public meetings act Requires the
attorney general to adopt rules.
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HB 3292 Recording executive sessions under the open public meetings act. To determine if
executive session is held appropriately.
HB 2883 Governor request legislation. Amends the Uniform Disciplinary Act. 1) changes the
process for denying applications; 2) creates a citation and fine for disclosure of documents in response
to investigative requests; 3) restores criminal justice agency status to the Department of Health staff to
access non-conviction data and allows national criminal background checks; 4) expands the list of
crimes to be reported to the department; 5) allows permanent revocation in certain cases. This bill is
tied to recommendations made in the performance audit of Health Professions Quality Assurance
Office.
HB 2907 Operating agreements between the secretary of health and health care licensing and
disciplinary boards. Modifies operating agreements. The bill also gives boards and commissions the
authority to select and hire its executive director. Allows boards and commissions to adopt
independent administrative procedural rules.
HB 2600 & 3064 Stewardship bill. Creates a producer managed and funded product stewardship
program to collect and dispose of unwanted residential drugs. Departments concerns relate to increase
workload with no funding.
SH 6360 Establishes a task force chaired with bi partisan leadership appointed by the governor. The
task force will address primary care physician recruitment and retention strategies.
Board was briefed on the impact of Initiative 690 on proposed legislation. I690 passed last year
requires all fee increases to be approved by the legislature. All bill proposals for fee increases require a
10-year study to estimate total costs. In the future fees will be adopted in law (RCW) not rule (WAC).
First legislative cut-off - February 8
Continuing Education Credits for Board Meeting Attendance.
From the 2007, planning session the board discussed an interest in adopting a new procedure for
approval of continuing education credits for board meeting attendance. The procedures were drafted in
consultation with board members Dan Connolly and George Roe.
The board acknowledges its confidence in providers approved by the American Council on
Pharmaceutical Education but at the same time recognizes the value of attendance and participation in
board meetings.
MOTION: Rosemarie Duffy moved that the board approve continuing education credits of 1.5 contact
hours (.15 CEUs) for half day and 3.0 contact hours (.3 CEUs) for a full-day board meeting
attendance and participation. A maximum of 3.0 contact hours (.3 CEUs) may be earned per renewal
period. Dr. Vandana Slatter second. MOTION CARRIED. 4-0.
The draft procedure will be amended as moved and an attendance log will be created and maintained
for four years. Notices of the new procedure will be posted to the web, April newsletter and distributed
via listserv.
Multi-state Pharmacy Jurisprudence Examination (MPJE) State-Specific Annual Review Meeting
Pharmacist Investigator Dick Morrison briefed the board on his participation in the MPJE program
review. Eight-two representatives attended the meeting from 40 member states. The review consists of
a reviewing questions content, appropriateness, compliance with federal laws, if products mentioned
were still available, punctuation, grammar, and the questions defensibility.
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Statistics
Reviewed 1,754 questions in the existing pool - 1,643 items are used in the pool to calculate
the candidates exam score.
Sixty-nine items make up the pretest and do not affect the candidates test score.
Fifty-two items were deleted seven may be reused if suggested changes are made.
Reviewed approximately 1,000 new questions and selected 179 for use in the Washington exam
question pool.
After the review was completed, the current pool consists of 1,881 questions.
National Association of Boards of Pharmacys 104th Annual Meeting
ACTION: Rosemarie Duffy moved that the board name Steven Saxe official voting delegate and
Rosemarie Duffy alternate for attendance at the NABP meeting on May 17 20, 2008. Susan TeilBoyer second. MOTION CARRIED. 4-0.
University of Utah School on Alcoholism and Other Drug Dependencies
Due to budgetary restraints, the board amends its earlier decision and selects only one board member
(Dan Connolly) and Pharmacist Investigator Tyler Varnum to attend the University of Utah School on
Alcoholism and Other Drug Dependencies in June 2008.
ACPE Evaluation of WSU Doctor of Pharmacy Program
MOTION: Rosemarie Duffy nominates George Roe to represent the Washington Board of Pharmacy
as observer during the Accreditation Council for Pharmacy Educations (ACPE) accreditation site visit
of the Washington State University School of Pharmacy. Susan Teil-Boyer second. MOTION
CARRIED. 4 0.
PRESENTATIONS
Washington Patient Safety Coalition.
Acting Executive Director Steven Saxe provide background on how many of the issues addressed in
the legislation passed in 2006 regarding patient safety and adverse events and incident reporting may
be applicable to the boards discussions around quality improvement programs. He then introduced
Linda Furkay, the Patient safety Adverse Event Quality Specialist. Dr. Furkay is a registered nurse by
profession and holds a PhD.
Dr. Furkay provided an overview of the legislation codified at RCW 70.56.
Adverse events are defined by the Nation Quality Forum. Washington law requires that acute
and psychiatric hospitals, childbirth centers, Department of Corrections medical facilities, and
beginning in 2009 ambulatory surgery centers, report adverse events and the subsequent root
cause analysis of that event to the Department of Health.
Quality Choir, formed in the summer of 2007 includes:
Agency for Health Research and Quality (AHRQ)
The Joint Commission
Centers for Medicaid and Medicare (CMS)
Institute for Healthcare Improvement
Leapfrog Group
National Quality Forum (NQF)
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Washington is one of 27 states with mandatory reporting. Reporting is voluntary in Oregon.

The law requires an independent entity to collect adverse event reports.
Implemented an 800 number for facilities to report events.
Quality Improvement activity Facilities are required to report and produce a root cause
analysis. Information used to provide consultation and site visit. Information is not shared with
the investigative team. Program will be part of the Community Health Services section.
2007 Serious Reportable Events majority of reports relate to pressure ulcers.
Reports from 46 of 93 hospitals.
Information non-disclosable not necessarily important to identify which facility had an error,
but what they did to ensure it doesnt happen again.
The Board adjourned at 11:50 a.m. and reconvened at 12:45 p.m.
PRESENTATIONS Contd
Remote Order Entry proposal by Capstone Health Group
Tim Fuller provided background on Capstone Health Group, Inc. and introduced Ken Culver, PharmD
to present its proposal to the board.
Capstone Health Group, Inc. doing business as Crescent PharmD is a licensed California pharmacy
requesting licensure in Washington. The pharmacy does not stock or dispense medications, but
provides real time remote services to acute care hospitals. Crescent PharmD provides various hours of
coverage to assist hospitals in managing medication practices when a pharmacist in not on site. The
remote services provides hospitals with trained clinical pharmacist to review medication orders and all
prescriptions for appropriateness before the medication is administered to the patient standards
established by the Joint Commission (Medication Management 4.10).
Highlights:
Hospital Point of Care System Electronic Medication Administration Records (e-MAR)
Security HIPPA compliant encrypted link; firewalls; password access; audit and tracking
mechanism.
Communication Medication orders are transmitted fax or digital imaging system by a hospital
nurse. Each hospital has a dedicated workstation, fax, and phone number.
Medication orders screened - drug interactions; allergies; compliance with hospital policies and
procedures.
Quality Assurance collect statistics remote order entry volumes; track medication errors,
interventions (avoidance of adverse drug event) and assess for system issues or individual
pharmacist issues; trend and track for regulatory compliance.
Continuous performance improvement
Medication reconciliation/verification
Pharmacy Information System acknowledges whether a patient is active or inactive (e.g.
discharged)
If approved Capstone Health Group, Inc. will obtain Washington licensure for non-resident pharmacies
and pharmacists providing services to Washington locations.
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ACTION: Susan Teil-Boyer asked staff to develop remote order entry guidelines specific to hospital
practices. The current board approved Remote Processing of Medication Orders Guidelines are written
specifically for retail practices.
MOTION: Susan Teil-Boyer moved that the board approve the proposal from Capstone Health Care,
dba Crescent PharmD, and require all pharmacists processing orders for hospitals in Washington State
are licensed in this state. MOTION CARRIED. 4-0.
DocuTrack Electronic Prescription System.
Bob Cordier of Bates Pharmacy presents a proposal to use DocuTrack, an electronic prescription
system used for recordkeeping, prescription file storage and communication with providers.
Product Manager, Louie Foster provided an overview of the DocuTrack system.
Highlights
Stores document image.
Interfaces with the pharmacy system.
Automatic caller identification on faxed documents reducing fax spoofing.
Standardize and track workflows.
Images can be enlarged to help reduce transcription errors.
Capable of linking documents to the DocuTrack image.
Ability to add notes and annotations to the document without altering the original image.
Notes/annotations added may not be removed once the document is saved in DocuTrack.
No documents can be deleted from the system once saved. Documents can be archived saving
all related attachments and notes/annotations. Document history and audit trail details who,
what, and when all actions were taken on the document.
Documents may be retrieved based on various criteria date, time, and any associated data via
DocuTrack or the pharmacy system.
MOTION: Rosemarie Duffy moved that the board approve the use of the DocuTrack system.
Electronic storage of prescriptions are approved if they are in compliance with patient medication
record systems and are readily retrievable by the board, or its agent for inspection. Dr. Vandana Slatter
second. MOTION CARRIED. 4-0.
NOTE: This does not authorized destruction of the hard copy of the prescription. Prescriptions
received in hard copy may be scanned and processed digitally, but the original document (hard copy)
must be retained for a minimum of two years pursuant to all federal and state laws and rules.
Pharmacies using DocuTrack must implement a safe method for storage and backup for electronic
information.
University of Washington Pharmacy Students Law Presentation.
Dr. Thomas Hazlet, Assistant Professor of Pharmacy at the University of Washington provided
introductions.
Students presented on the following pharmacy law related topics. The presentation included
summarizing existing laws; discussed basis for proposed changes; evaluated alternatives;
research/evidence gathered; stakeholder input; and the conclusions they developed from their study.
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1.
2.
3.
4.
Out-of-State Prescribing Authority for Physician Assistants and Nurse Practitioners

Notation of Purpose
Can We Fix Illegible Prescriptions?
Defining a Sixty-Day Supply for Medical Marijuana
The Board extended its appreciation to the students for presenting their law study projects.
OPEN FORUM
Madame Chair shared an email she received regarding concerns about a recent proposal to the board
requesting to increase the pharmacist to pharmacy technician ratio to 1:5. The author, K. Douglas
Crafton, was opposed to the proposal when the ratio included off-site pharmacists.
Business Meeting Adjourned
There being no further business, the Board adjourned at 4:00 p.m. The Board of Pharmacy will meet
again on March 5, 2008 for its planning session and March 6 for its regularly scheduled business
meeting in Tumwater, Washington.
CLOSED SESSION - Case Presentations.
_______________________________
_______________________________
Rebecca Hille, Chair
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WASHINGTON STATE DEPARTMENT OF HEALTH

BOARD OF PHARMACY
CenterPoint Corporate Park
Kent, Washington
CONVENE
Chair Asaad Awan convened the meeting at 11:24 a.m. on January 26, 2006. Board Members
present:
George Roe, RPh
Donna Dockter, RPh
Gary Harris, RPh
Sharron Sellers
Rebecca Hille, Vice-Chair
Joyce Roper, Assistant Attorney General
Steven Saxe, Executive Director
Tim Fuller, Pharmacy Consultant
Andy Mecca, Pharmacy Consultant
Grace Cheung, Chief Investigator
Stan Jeppesen, Pharmacist Investigator
CONSENT AGENDA
ACTION: George Roe moved to accept the following:
Pharmacist License Application Approval for:
Ken Martin Nuclear Pharmacist
Froilan Rivera Nuclear Pharmacist
Pharmacy and Other Firm Application Approval
Collaborative Drug Therapy Agreements Approval for:
Fred Meyer Pharmacy TB Testing
Jones Pharmacy Medical Lake Antiviral Therapy
Jones Pharmacy Pseudoephedrine Prescriptive Authority
Board Minutes December 14, 2005 MOTION CARRIED.
Pharmacy Technician Training Program Approval
Home Call Pharmaceutical Services, Lower Columbia College, Cascade View Pharmacy
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Donna Dockter questioned why the Board was being asked to approve an out-of-state pharmacy
technician program. Andy Mecca explained that the Home Call Technician Training Program in
Maryland was completed by an applicant applying for certification in Washington. Washington
rules requires a technician complete a board approved training program and stipulates that out of
state pharmacy technician applicants must meet the same requirements as a technician trained in
this state. This particular applicant has a PTCB certification but the Maryland Board does not
recognize the tech training program. The only way for him to be certified here was to get Board
approval of the training program which was found to be comparable to a Washington program .
The applicant must meet all WA certification requirements, which includes certification of
completion of 8 hours of Washington law training. ACTION: Susan Teil-Boyer moved to accept
the Technician Training Programs for Lower Columbia College, Cascade View Pharmacy. And,
to accept the technician training program Home Call Pharmaceutical Services with the provision
that this program is approved on a one time basis for a specific applicant. MOTION
CARRIED.
Note: Staff will marry the technician application with the training program .

Lake Chelan Community Hospital, Seattle-King County Jails
Lake Chelan Community Hospital does not have a full time pharmacy. The automated drug
dispensing devices at this location will be stocked by Sacred Heart Hospital Pharmacy. Donna
Dockter pointed out a discrepancy in the policy and procedures submitted by Lake Chelan. The
procedures stated under Authorized Personnel and Security/Override Authority allows the
pharmacy technician to refill a medication that required RX Check without having a
registered pharmacist check the medication. Tim Fuller clarified that the procedures in
Appendix B indicates that the restocking process is done via camera-on-wheels to observe the
technician restocking the unit . MOTION: Rebecca Hille moved to accept Seattle-King County
Jails automated dispensing device. And, moved to accept Lake Chelan Community Hospital
automated dispensing device with clarification on pharmacy technician supervision in restocking
medstations, and clarification regarding emergency room medstation drug access granted to
paramedics. MOTION CARRIED.
REPORTS
Executive Director
Steve Saxe reported on the following:
Welcome to the new Board Chair, Dr. Awan. A special thanks to George Roe for his
many years of service as our Board Chair and to Sharron Sellers for extending her
appointment for one more meeting.
Governor Gregoire has finalized the appointment of a new board member. Rosemarie
Duffy, the new public member will be joining us at the March meeting. She has a very
diverse background as a clinical nurse, health care administrator, educator, community
service and service in the Air Force. Ms. Duffy resides in Spokane.
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Health Professions Section Four
Administered the Veterinary Technician Exam to 57 applicants.

Judy Haenke, Program Manager participating on a legislatively mandated
committee looking at vision screening for school age children.
Staff attended training to look at performance appraisal process developing

competencies.
Attended with Doreen Beebe training on client services contract required training
for persons working with these types of contracts.
Joined Andy Mecca, Dr. Fassett, and Dr. Hazlet conducted a 4 hour session on new laws to
150 attendees.
Participated on a Web Cast with several representatives from the Department of Health and
the National Academy for State Health Care Policy. Subject targeted Facilities Services
Licensing in maximizing the use of state adverse data to improve patient safety. Washington
requires hospitals to report adverse events and how they are able to collect the data and
actions to improve quality.
Bremerton Naval Hospital spoke with Medical Services Corp of Administrators

Association regarding health care management, and ethics in healthcare
Legislative Session several staff have attended training sessions on bill analysis-reviewing
bills related to health professions or Department of Health. They will provide input on
specific bills, assisting the department to determine its position to support, oppose, or to be
neutral.
Meet Me Calls new process in place involving one member of health profession boards,
commissions and committees to provide feedback on bills that cross all professions. ViceChair Rebecca Hille is this boards participant.
Many HPQA work activity groups looking at issues such as disciplinary process,
credentialing, intake and assessments, complaints and how they are managed, and
sanctioning. Lisa Salmi is participating in a group looking at continuing education and expert
witnesses.
Working with the departments Human Resources Office to fill the support position,
reporting to Ms. Beebe, supporting the Board of Pharmacy and the Orthotics and Prosthetics
Advisory Committee.
Marla Randall new credentialing manager. Ms. Randall comes from the HPQA Public
Disclosure Records Center and has worked for the Medical Quality Assurance Commission
and Facilities Services Licensing Transient Accommodations Program.
Nomination of Board Investigator Jim Doll for the Lester Hosto/Inspector Distinguished
Service Award was sent to NABP.

Joyce Roper reported that she has begun reviewing the new FDA regulations on patient labels
and evaluating any implications to state statues or regulations. Part of the new FDA regulation
purport to preempt malpractice actions against manufacturers and healthcare providers, primarily
prescribers, for failing to warn if they relied on the insert .
Board Member
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Kingsbury0235
Rebecca Hille reported that The Spokesman Review had a good article on purchasing
pseudoephedrine products, questions and answers, written by a retail chain pharmacist.
Pharmacy Consultant
Andy Mecca shared that recently the most frequently asked question changed from
pseudoephendrine to the DEAs policy on multiple issuance of C2 prescriptions . This issue
made its debut last April.
Tim Fuller mentioned that the DEA plans on seeking additional authority regarding multiple C2
prescriptions.
Electronic stakeholder meeting is in process regarding long-term care controlled substance
disposal. Comments are being accepted until January 30, 2006.
th
Emergency Response the Strategic National Stockpile will conduct a full drill on February 15 .
Pharmacist Investigator Jim Doll and Mr. Fuller are attending meetings each week with Lead
Chiefs from the different areas.
National Standardized Technician Exams Stakeholder meetings scheduled for March in Kent
and one in April in Yakima.
Chief Investigator
Grace Cheung reported on the following:
Inspection Statistics
December
Inspections conducted during the month:

Inspections per field investigator:
Satisfaction with process (per survey):
36
4.5
100%
Investigation Statistics
December
Open investigations (on the last day of month):
81
Investigations closed with final disposition:
13
Average time (in days) to investigate all cases:

High priority investigations (on last day of month):
114.5
0
Meetings, training, and/or special assignments
Jan 18- 20, 2006 Dick Morrison and Grace Cheung participated in the National Boards of
Pharmacy Multi State Pharmacy Jurisprudence Examination State Specific Review.
Jan 5, 2006 Randy Flett provided training and technical assistance on new rules requiring
retailers to collect transaction information on EPP products at the Snohomish County Drug
Task Force Meeting.
Dec 20, 2005 Tim Fuller, Andy Mecca and Grace Cheung participated in a meeting with staff
members of the Office of Community and Rural Health and, via conference call, with
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representatives of free clinics around the state of Washington. The topic of discussion related
to dispensing of medication.
Dec 19, 2005 Dick Morrison participated in setting guidelines for admissions interviews and
other criteria that will be used to make admissions decisions for the pharmacy class at
University of Washington School of Pharmacy.
The investigator vacancy in Central Washington continues to pose challenges for the rest of
the investigators especially with the winter traveling conditions . In addition to their own
workload many investigators have been assigned Central Washington cases, practice reviews
and non-routine inspections (i.e. new, relocation and remodel inspections).
Jim Doll and Jim Lewis continue to participate in a work group that is reviewing Department
of Corrections handling of medications .
2006 Investigators Meeting dates are as follows:
March 1-2 George Roe (tentative)

June 7-8
September 6-7
December 6-7
PRESENTATION
Washington State Pharmacy Association Right to Refuse
William Fassett, representing the Washington State Pharmacy Association, provided a summary
of the work done last year by the WSPA ad hoc committee tasked with reviewing the
Associations position and providing recommendations on a pharmacists right to refuse to fill
prescriptions. Members of the Committee formed in July 2005 are CJ Kahler, Chair; Merrie Kay
Alzola; Marie Bach; Renee Cook; Bill Fassett; Teri Ferreira; Lee Funkhouser; Tim Lynch; Sue
Merk; Jim Ramseth; Rod Shafer; and Sepi Soleimanpour.
The Committee considered it important that the pharmacist communicate clearly with the patient
the nature and extent of his or her services so that the patient can establish a professional
relationship with a pharmacist who is best prepared to meet his or her needs. A patient and
pharmacist must enter into a professional relationship and patients should choose pharmacists
that meet their needs.
Committee concluded that pharmacist must have options in place to offer patients when the
pharmacist is unable to fill an otherwise lawful prescription, e.g., conscientious objections, out of
stock, not stocked or other reasons. The pharmacist must do more that just state, I cant help
you.
Some members of the committee did not want to require an individual pharmacist to initiate a
referral to another pharmacy on the basis that for some pharmacist the active referral in their
mind constitutes a moral connection to something that violates their moral commitment. The
committee did agree that the referral is an appropriate option to have.
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In the presentation, Mr. Fassett discussed actions for which the committee identified as
professionally unacceptable.
Refusing to identify another pharmacy when asked by the patient for a referral.
Refusing to transfer a prescription to another pharmacist .
Destruction of a valid prescription and/or refusal to return a valid prescription to the patient .
Violation of the patients privacy.
Inflicting on the patient an unsolicited lecture regarding the patients healthcare choices. (not
the same as counseling)
Failure to treat the patient with dignity, or otherwise demeaning the patient
The Committee concluded that the pharmacist must act in accordance with the demands of his or
her conscience, based upon an accurate understanding of the medical facts and circumstances,
and that the pharmacists decision must respect the autonomy of the patient, and not impede the
patients right to seek the service being requested.
The Ad Hoc Committee recommendations were adopted by the WSPAs Board of Directors.
These recommendations included recognizing and respecting the professional responsibility of a
pharmacist to provide pharmaceutical care for his/her patients and that a pharmacist must act in
accordance with his or her moral, ethical or religious principles. The WSPA supports the
establishment of individual systems that protect the patients ability to obtain legally prescribed
and therapeutically appropriate treatment; and the reasonable accommodation of a pharmacists
conscientious objection.
The Committees recommendations further identifies that a pharmacist has a serious
responsibility to always hold the autonomy, dignity, and confidentiality of his/her patients in the
highest regard; to appropriately communicate the availability or unavailability of pharmacy
services to his/her patients, and the prescribers in the community; to have options in place to
communicate to patients when the pharmacist is unable to fill prescription; to diligently develop
his/her conscience-guided response to selected pharmaceutical services; and to inform and reach
agreement with an employer and the pharmacys staff, as appropriate, concerning his/her
anticipated response to identified pharmaceutical care requests.
The Pharmacy Board members recognize that this is a very complex issue and not just about
reproductive rights. Some Board members expressed concern with a regulatory body requiring
all prescriptions be filled but felt it was appropriate to identify unprofessional conduct as placing
additional barriers before patients.
The Board expressed an interest in being able to take disciplinary action for actions the
committee found professionally unacceptable. Joyce Roper reminded the Board that its authority
to take disciplinary action would be more clear if the board adopted a rule finding the
professionally unacceptable actions to be unprofessional conduct or outside professional
standards of practice and the Board could then cite for failure to comply with a board rule
defining or establishing standards of patient care or professional conduct or practice [RCW
18.130.180(7)] rather than having to rely on RCW 18.130.180 (4), incompetence, negligence, or
malpractice which results in injury to a patient or creates an unreasonable risk that a patient may
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be harmed because then the state would have to prove harm or unreasonable risk of harm .
MOTION: Rebecca Hille moved that the Board begin the rule making process . MOTION
CARRIED.
Steve Saxe reminded the audience that the CR101 form initiated rule making notice to
interested parties and does not contain specific language for rule-making. Normal process can
take 12 months or more.
Nancy Sapiro, Northwest Womens Law Center and Kelly Reese of Planned Parenthood request
an opportunity to provide comment on this issue and the recommendations by WSPA at a future
meeting.
Seattle/King County Public Health Emergency Planning Pharmaceutical Distribution
Dean Webb, Chief of Pharmacy of Seattle/King Co
Emergency Planning briefly updated the board on Seattle-King Countys activities.
They have been directed by the CDC, in conjunction with the Department of Health to prepare
plans and build capabilities to respond to site specific release (involving less than 1,000
individuals) and community release (involving 10,000 to 100,000 individuals) of anthrax .
The plans have been developing for a number of years on how to provide antibiotic treatment to a
small or very large numbers of people in a very short time period. Less than 48 hours from the
time a decision is made that people need to be treated to the time that all treatment is completed.
Mr. Webb stated that they could not create a burden on the healthcare system by simply referring
people to the emergency room. It is Public Healths responsibility to protect the integrity of the
healthcare system and identify additional staff from the community needed to help manage this
type of operation; specifically pharmacists.
Models
1. Site specific mobilize staff including pharmacist, physicians, and independent practitioners
to dispense the medications . Medications would likely be stored locally and mobilized to the
facility where the dispensing is to occur at the time. Standardized educational matters will be
developed in advance, counseling at the site to educate patients about the disease as well as the
medication.
2. Communitywide Public health department prescribing the medications. All patients coming
in would be screened for contra indications by nurses. Drugs will be administered by nurses to
those with no contraindications; all others would be seen by a pharmacist, physician or other
health care practitioner for additional counseling and review. All medication will come from the
national strategic stockpile.
3. Pre-staging Providing first responders with access to medications at the beginning of an
event.
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Dr. Andy Stregachis, Regional 6 Coordinator indicated that the planning process is on going. It
includes: preparedness planning, building plans, training to plans, exercising plans and revisiting
plans and doing the whole cycle again.
Anthrax provide quality pharmacy care and save lives .
1. Mass dispensing clinic need to be established selected on a criteria familiar to the public,
access parking, major activity.
2. Fill out form, show form, pick up meds and exit. Points of Distribution Medication
Centers Pocket Guide (distributed to the Board).
a.
Record of what was dispensed- check in form as a profile and record of dispensing
(asked for board comment)
b. Group working on public information

c.
Staffing parallel effort with WSPA medical reserve corp established.
3. Storage Drug Cache how can this be done to meet legal requirements?
a.
Concerns about storage in non-licensed location
These models focus on anthrax and other agents that can be treated with doxycycline or
ciprofloxacin.
Concerns raised by the Board:
Storage in non-licensed locations,

What do community pharmacists tell the community?
How will out of date drugs be cycled out of storage caches?
Why are we creating a distribution system when we have one in place? (local pharmacies)
Susan Teil-Boyer asked that the Board to clarify the pharmacists authority in emergency
situations as to what a pharmacist can and cannot do. Joyce Roper mentioned that mirroring the
hospital emergency planning may be an option.
Tim Fuller shared that a survey is planned for distribution to all pharmacies is planned for
distribution within the next several weeks to assess the quantity of specific pharmaceuticals on
hand. Our sense is most pharmacies have gone to a just in time kind of inventory and there
may not be a lot out there. Joyce Roper cautioned that some of the information obtained will
likely be protected from disclosure under RCW 42.17.310 (1)(ww), so information can perhaps
be reported out in the aggregate but likely not by specific location.
Comments were provided by DOH staff Dave Owen, Strategic National Stockpile Coordinator;
and Valerie Munn, State Emergency Response Coordinator; and Seattle King County Public
Health staff Michael Loehr and Michelle Pennylegion.
GMAP Government Management, Accountability and Performance Report
Steve summarized the report presented to Governor Gregoire, on December 15, 2005, by the
Department of Health, which focused on the departments oversight and discipline of health care
professionals.
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10 Governor appointed boards which regulate 23 professions ( 2 professions are overseen

by licensing boards but the secretary has disciplinary authority)
4 Governor appointed commission which regulated 9 professions .

Secretary programs -23 professions. (advisory committees)
Over 300,000 health professionals are credentialed by HPQA -57 separate professions .
For the 03-05 biennium, the department received 14,000 complaints representing only 4.8% of
all the health care professionals credentialed by HPQA. 85% of HPQAs budget is spent on the
disciplinary process.
Licensure Growth Rate in the last 10 years
Pharmacies and other pharmaceutical firms showed a 13% decline.

Pharmacist 33% increase
Pharmacy Technicians 130% increase
Pharmacy Assistants registered - 194% increase
Steve summarized the process for complaints to final disposition.

1. Complaint redacted complaint presented to Board Panel (3 Member) close or
authorize investigation
2. If authorized moves to investigative unit - 8 Pharmacist Investigators, 1 Chief
Investigator (Investigators assisted other programs in the past with drug related/diversion
investigations.)
3. Investigation completed report assigned to Reviewing Board Member (RBM)
4. RBM presents to Panel of the Board - recommended actions include NOC, Stipulated
Informal Disposition STID or Statement of Charges.
5. To Assistant Attorney General Prosecutor for negotiation with respondent .
a.
Agreed Order brought to the board
b. Hearing before the Board. Decision rendered by the Board

2003- 2005 Biennium
14,027 complaints, 6888 closed before investigations, 6474 investigated, 4637 closed after
investigation and 1812 proceed to legal action. 458 Informal Disposition, 1354 Formal
Disposition, 689 settlements, 499 defaults, 166 decisions following hearing.
Steps to Improve Patient Safety
National Practitioner Databank Checks (included in 2006 supplemental budget)

Denial of Licensure
Sanctioning Guidelines
Sexual Misconduct Rules

Monitoring Compliance- Show Cause Hearing
Public Information Access - Credential Status
Increasing Public Member Representation
Secretary Selecky is scheduled to present status update to Governors Cabinet. Regular GMAP
updates are planned for future Board agendas.
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Costco Corporation Central Fill Pharmacy

For the Record George Roe disclosed that he retired from Costco 4 years ago and holds no
stock in the company.
Tim Fuller distributed copies of the Boards Central Fill Guidelines and provided background on
Costcos proposal for a central fill pharmacy. Costco has entered into an agreement with
McKesson in the operation of a central fill pharmacy. The program complies with the
requirements developed by the Board.
Craig Norman, Vice-President of Operations for Costco Pharmacy Division led the presentation.
Mr. Norman introduced his associates; Jon McArther, Director of Pharmacy Training leading
the system development and testing; Brian Moores, Regional Supervisor - in charge of the
facility operations; Chris Pierce, Director of Pharmacy Benefits Services; and, Randy Hyun,
representing McKesson (partner).
The central fill pharmacy will address growing volume by diverting some prescriptions through
the central fill facility with the intention not to reduce staffing but to free up the pharmacists
time to assist patients, increase productivity and service improvement . The central fill pharmacy
will primarily process refills and provide services to all Washington and Oregon Costco
pharmacies. Pharmacist at the facility are Costco pharmacists and will be licensed in both WA
and OR.
Mr. Norman provided a brief overview of the process: DUR will be done by the dispensing
pharmacy. The prescription is sent electronically to the central fill location to be filled and
returned the following day to the dispensing pharmacy. The central fill pharmacy will fill,
package and conduct NDC verification. The filling process is done primarily by pharmacy
technicians using a barcode matching process and verification by the pharmacist using first
databank image, label instructions, and digital image verification of prescription contents . Once
approved, the prescription is moved to the McKesson distribution center for distribution to the
dispensing pharmacies with the normal daily drug orders. The system is capable of processing
600 prescriptions per hour and 5000 scripts per shift.
The dispensing pharmacy will check-in the prescription matching the NDC#. If the NDC# does
not match an error has occurred or the prescription was already filled by the dispensing
pharmacy. The sign and brochure for posting in the dispensing pharmacy, which was included in
the policy and procedures, did not provide notice to patients of their option to decline the central
fill service. MOTION: Rebecca Hill moved to approve Costcos central fill plan with the
exception that they must clarify the language on the sign making patients aware that they may
decline the services. MOTION CARRIED.
DISCUSSION
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Update on Implementation of Methamphetamine Rules

Steve Saxe shared with the Board a letter received from Attorney General Rob McKenna
strongly supporting the implementation of the sales product log rules and noted that ID theft
concerns was addressed by removing the signature and address without compromising the
deterrent effect of the product log or lessening its value as an evidence gathering tool.
Mr. Saxe also shared that Chris Johnson, Policy Director, encourages the Board to continue to
evaluate the technical feasibility of implementing an electronic log utilizing the barcode feature
on the drivers license.
Steve attended a meeting with WA Association of Sheriffs and Police Chiefs where a device was
demonstrated that could read the barcode on the back of drivers licenses issued in any state - the
system is being piloted in a county in Kentucky. The information once scanned would go to a
central repository where the information could be screened with specific parameter to identify
frequent purchases. (Future Technology Agenda Item)
The rules adopted on December 14
th
were filed with the Code Reviser on December 22 with an
effective date of January 1, 2006. A letter was sent to all registered shopkeepers, itinerant
vendors and licensed pharmacies summarizing the rules and providing a sample log. This
information may also be viewed and printed from the Boards webpage.
The recently mailed Boards newsletter, which was printed prior to the Board reconsidering the
rules, does not have the amended language. A correction notice will be disseminated in the next
newsletter and other means as determined necessary.
Steve Saxe has contacted the Washington Association of Sheriffs and Police Chiefs, Washington
State Patrol and Washington Association of Police and Sheriffs making them aware that the
Board has delayed enforcement of the rules until February 1, 2006. At this time, Board
Pharmacist Investigators and Law Enforcement are visiting retail locations to provide education
and technical assistance.
Rebecca Hille discussed the bills presented to the Meet Me call group. These bills are not
included in the Governors budget.
HB2399 & SB6193 Requiring survey of health professionals statistics and demographics
age, gender, race, ethnicity
SB6194 - Requiring multicultural education for health care professionals to avoid barriers
gender appropriate and cultural healthcare. Requires all training schools to add multicultural
training to their curriculum .
HB 2431- Requiring Criminal Background checks cost of background checks added to
credential fees, criminal unprofessional conduct checks through the FBI.
The department shall adopt rules requiring review of national federal practitioner databank and
federal healthcare integrity and protection databank for each license holder. All license holders
are required to have a review conducted within 4 years of the implementation and every 4 years
thereafter. Licensee is exempt from review if after 3 consecutive reviews show no reports.
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HB1850 Retired volunteer medical workers For emergency events/management-concerns

regarding the effectiveness of retired health care workers that have not been in practice or
completed continuing education for a number of years .
Steve Saxe continued the discussion of legislative bills .
HB3171 - Formation of a commission on psychoactive pharmaceuticals report December 1,

2007 unsure of intent
HB2341- Optometry licensure amends current 5 tier licensure level to a single level. By 2011
licensed to prescribe oral medication- DOH support
SB6505 Drug paraphernalia focuses on criminal sanction for retail business sales/displays of
drug paraphernalia suggested to amend 3 current laws with similar language.
HB2292 Relating to improving health care increasing patient safety, reducing medical errors,
reforming medical malpractice insurance and resolving medical malpractice claims fairly. And
elicits changes to the Uniform Disciplinary Act example: mandatory revocation for three serious
act of unprofessional conduct within 10 years, consider prior findings/sanctions in imposing
sanctions against a licensee, no reinstatement from revocation, adds two public advocate
members to the Medical Quality Assurance Commission and establishes changes in standard of
proof. Requirement for hospitals to report adverse events. Also has the medical associations
proposed language requiring prescriptions to be hand printed, type written, or electronically
generated.
HP2473 - Protection of unfair prescription drug practices by pharmacy benefit managers allows
access to records and requires disclosure of conflict of interest by benefit managers. They must
disclose all financial terms and utilization information to ensure that saving through the
pharmacy benefit management process is passed though to the covered entities. Joyce Roper
clarified that the information may contain patient specific information therefore; it may remain
exempt from the Public Disclosure Act although the Department of Social and Health Services
and the Health Care Authority may be able to get some of these records
SJM8032 Plan B prescriptions Memorial addressed to President Bush, US Senate and House
of Representatives, and the Director of the FDA - suggesting that the FDA follow through with
its proposal to make Plan B prescriptions over-the-counter.
HJM4033& SJM8028 - Memorial addressed to President Bush, US Senate and House of
Representatives regarding Washington States right to set Medical Marijuana laws.
SB6591 Wholesale Distribution bill addresses the issue of counterfeit and adulterated drugs.
It provides additional definitions, facility standards, penalties, background checks, due diligence
and drug pedigree to the RCW. Copies of the bill and a letter from the Healthcare Distribution
Management Association (HDMA) were distributed to the Board.
Reuse of unused medication Steve Saxe, Rod Shaffer - WSPA, Andy Mecca and Siri Childs Medicaid met with the committee analyst on this proposal to discuss current regulations and
guidelines. May not proceed to a bill. There was an article in a national publication to all
legislators about programs for indigent populations that prompted interest in this issue.
Correspondence
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Steve Saxe discussed recent correspondence sent from the National Association of Boards of
Pharmacy.
NAPLEX passing scores NAPLEX passing rates have dropped from 2004s 97.38% to
92.36% in 2005. This may be a result of new standards establishing the lowest acceptable
level. Passing rates for all candidates testing in their 2
nd
trimester is 89%, slightly lower
than in 2004.
Model State Pharmacy Act Letter providing information on how to access the Model
State Pharmacy Act and Rules on the NABP website.
Activities at the 2005 Fall Educational Conference attended by Grace Cheung.
Official Board Delegate NABP

Official Board Delegate (voting member) to the NABP 2006 National Meeting. MOTION:
Rebecca Hille moved that Steve Saxe be named the official Board delegate with voting authority
and George Roe be named alternate delegate. MOTION CARRIED.
Rule Making
Wholesale Distributors Andy Mecca distributed charts illustrating wholesaler rules/legislative
actions taken in California, Indiana, Oklahoma and Nevada. He encouraged the Board to
consider the rule making process to strengthen our wholesale distributor regulations to protect the
public by ensuring the integrity of the drug supply. MOTION: Susan Teil-Boyer moved that a
CR101 be filed to initiate pharmaceutical wholesaler rule making. MOTION CARRIED.
Steve reminded the Board that legislation is still pending in this area.
Sexual Misconduct the Board of Pharmacy and all other health professional boards and
commissions are being asked by the Secretary of the Department of Health to consider initiating
rule making to adopt sexual misconduct rules. The work completed by several professions that
have adopted rules and the departments secretary professions that have begun rule making for
sexual misconduct may provide a model for our process. ACTION: Rebecca Hille moved that a
CR101 be filed to initiate the sexual misconduct rule making process. MOTION CARRIED.
Accreditation of Schools/Colleges of Pharmacy
The Board was asked to consider adopting the American Council on Pharmaceutical Education
(ACPE) 2006 accredited professional programs of colleges and schools of pharmacy as the
official list of approved pharmacy programs. ACTION: Rebecca Hille moved that the Board
adopt the ACPE accredited professional programs of colleges and schools of pharmacy as the
official list of approved pharmacy programs. MOTION CARRIED.
ACPE no longer recognizes accreditation for Canadian pharmacy schools since that are
baccalaureate programs. Foreign pharmacy graduates must take the Foreign Pharmacist Graduate
Equivalence Examination (FPGEE) which is offered at limited times throughout the year and at
select locations. Canadian graduates have been allowed to take NAPLEX and were exempt from
taking the FPGEE.
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Last year, the Board evaluated the 2004 Canadian graduates performance on the North American
Pharmacist Licensure Exam (NAPLEX) in comparison to the national and foreign average
scores. In 2005 these numbers were not available because NABP no longer differentiates
between foreign and Canadian graduates . The Board is asked to reaffirm the current policy
statement setting requirements for Canadian Pharmacy School graduates after January 1994 to
allow them to sit for the NAPLEX exam without obtaining a certificate from the FPGEE.
ACTION: Susan Teil-Boyer moved to affirm the current policy statement setting Intern
requirements for Canadian Pharmacy School graduates. MOTION CARRIES.
Navigating the Board of Pharmacy Web Page
Steve Saxe demonstrated navigation within the Washington State Board of Pharmacys webpage
and search capabilities of the Code Revisers site. The Chair Asaad Awan was concerned that
the website did not offer a user friendly means of searching the laws and rules. Staff is working
to providing more Q&A on the webpage.
Adjournment
There being no further business, the Board adjourned at 3: 40 p.m. They will meet again on
March 10, 2006 in Kent, Washington.
__________________________________________
_________________________________________
Dr. Asaad Awan, Chair
Board of Pharmacy
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STATE OF WASHINGTON
MEETING AGENDA
January 26, 2007
Department of Labor & Industries
Auditorium
7273 Linderson Way SW
Tumwater, WA 98501
Board Office: (360) 236-4825
CONVENE
Chair Asaad Awan convened the meeting at 9:16 a.m. on January 26, 2007.
Gary Harris, RPh
George Roe, RPh
Rosemarie Duffy, RN
Lisa Salmi, Acting Executive Director
Jim Lewis, Pharmacist Investigator
CONSENT AGENDA
1.1
1.2
Joseph Shultz Nuclear Pharmacist

1.4
New & Closed Pharmaceutical Firms

10/31/2006 thru 12/22/2006
Daniel Garcia
Everest Institute in San Antonio TX

Robin Crozier Trinity College in Fairfield CA
Ann Crisanto Centro Escolar University in Manila, Philippines
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Norman Beck San Joaquin Valley College in Bakersfield CA

1.5
Nancy Hecox
Sonia Allen
Dyspepsia Management
Anticoagulation
Therapy Management
Keith Fongemie Pseudo Products

Board Minute Approval December 14, 2006
1.8
Items 1.3 Pharmacy Technician Application Approval; 1.6 Automated Drug Dispensing Device
Acceptance; and 1.7 Sample Distribution Requests were deleted from the consent agenda.
MOTION: Susan Teil-Boyer moved that the Board approve 1.1, 1.2, 1.4, 1.5, and 1.8 of the consent
agenda. Rebecca Hille second. MOTION CARRIED 6-0.
REPORTS
December budget overview - the report did not include Attorney General Support expenses
accrued in the last few months due to work related to a disciplinary hearing scheduled for
February. Ms. Salmi acknowledged that the Board is considerably overspent in AG services.
The Board will receive additional allotment authority to cover these expenses. Under spent
in salaries due to vacancies: Executive Director, Board clerical support position, Central
Washington Investigator and part-time Precursor Investigator.
May explore funding for permanent over-hire for an additional investigator. ACTION: Ms.
Salmi will bring the proposal back to the Board at a future meeting.
The Board was authorized an increase in allotment authority to supplement the budget
increase requested by the Washington Recovery Assistance Program for Pharmacy
(WRAPP). An increase of approximately $40,000 over a period of four years.

Representatives of the WRAPP program expressed concerns that if program participants
are required to pay fees additional staff would be needed to manage/monitor fee
collection. In addition, WRAPP believed the added costs may pose a hardship for some
program participants.
NABP Annual Conference - currently the budget would support sending all members of the
Board to the May conference in Portland. The budget will need to be re-evaluated as we get
closer to May.
The Planning Session in February will provide an opportunity for the Board to develop
proposals and justification for additional allotment to fund special projects/interests for
consideration by the Department of Health in developing the 07-09 biennial budgets.
Auditors continuing to met with the disciplinary and credentialing staff. The auditors final
report will be submitted in July.
eLicensing, the new credentialing/disciplinary system implementation date is scheduled for

February 2008.
Staff working on workgroups for eLicensing, working with auditor, and preparing analysis on
the proposed rule for pharmacies/pharmacists responsibilities.
Jim Doll, Tim Fuller and Ms. Salmi participated in the strategic national stockpile tabletop
exercise involving reception, storage and staging facility. Full scale exercise planned for
October 2007 in Eastern Washington
Methamphetamine Workgroup met last week Donna Dockter will continue to represent the
Board. The Workgroup must report their findings and recommendations to the Legislature in
November 2007.
A request to increase the salary for the Executive Director position will be considered by the
Washington Management Services Committee in February.
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Board authorized a summary suspension of a pharmacist for diverting drugs from her place of
employment and providing those drugs to another person.
Ms. Salmi acknowledged Joyce Roper for her continued assistance.
Board Members
Rebecca Hille briefly discussed her participation in the Tuesday Meet Me conference calls held by
the Department of Health, Health Professions Quality Assurance office regarding legislation with
possible impact to multiple professions.
In Pierce County all the hospitals are getting together to discuss impending avian flu and the
coordination of staff, patient care and distribution of Tami flu.
Attended the American Society of Health-System Pharmacists (ASHP) mid-year clinical

meeting in early December. Ms. Teil-Boyer participated with representatives from several
state boards of pharmacy sharing issues and concerns. She was asked to provide an update
on Washingtons rule making activities regarding pharmacy technician certification
examination.

Washington Supreme Court issued a ruling, based on the U.S. Constitution, on the Ongom
case dealing with the burden of proof required for disciplinary cases. The court held that the
standard of proof for all licensed health care professionals shall be clear and convincing
evidence rather than a preponderance of the evidence. Clear and convincing evidence is a
highly probable standard as opposed to the more common civil case standard of
preponderance of the evidence, which is a more likely than not standard, but is lower than the
criminal standard of beyond a reasonable doubt. The office of the Attorney General will seek
a review by the U.S. Supreme Court on behalf of the Department of Health (Petition for Writ
of Certiorari).
Washington and Oklahoma are the only two states where there has been a ruling that the
United States constitution requires a higher burden of proof. There are other jurisdictions
where the higher burden of proof has been established by the legislature.
Pharmacist Consultant/Investigator
Andy Mecca reported:
th
January 12 Mr. Mecca met with Board Investigator Stan Jeppesen, and University of
Washington School of Pharmacy Professor Tom Hazlet to design the March review law
course offered to pharmacy students to prepare for the Multistate Pharmacy Jurisprudence
Examination (M PJE).
January 22 Mr. Mecca attended a meeting regarding the implementation of opioid

guidelines campaign. This group has begun talks on developing an educational pilot project
and is looking for physicians interested in participating .
Working on putting together a presentation on frequently asked questions for the Washington
th
State Pharmacy Association meeting on February 10 .
Mr. Mecca will conduct a review of proposals made in April and July of 2006 approving offsite pharmacy practices, which allowed Washington licensed pharmacists to work at their
home. The goal is to ensure that prior decisions are consistent with the Boards decision in
December. ACTION: Mr. Mecca will report back to the Board with recommendations after
reviewing the December request.
nd
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Chief Investigator
Updated the Board on the recruitment process for the Central Washington Investigator
position. One of the two applicants has withdrawn.
Andy Mecca gave a presentation to the Veterinary Board of Governors on appropriate

handling of medications.
Board Investigators Jim Doll and Dick Morrison provided technical assistance on the
appropriate handling of medications to the Skagit County Jail.
Ms. Cheung and Dick Morrison participated in the MPJE State Specific law questions
review. Forty-four states participated in the review this year. They reviewed over 1700
questions in the existing pool; deleted 46 out-dated or duplicated questions and approved 116
new questions out of a pool of 1100 resulting in a net gain of 70 questions.
Investigators Meeting: Asked Board members to check their calendars to identify who
might be available to attend. Dates as follows:
o March 8, Susan Teil-Boyer
o June 6 7
o September 12 13, George Roe
o December 5 -6
Program Manager
Ms. Beebe facilitated a workgroup tasked with developing strategies to avoid scheduling
conflicts for 2008 meeting/disciplinary calendars for Board and Commissions. Four of
the large Boards and Commissions are on 6-week meeting intervals with Thursdays
business meetings and Fridays disciplinary hearing. In 2007, the intervals have
consistently fallen on the same weeks resulting in scheduling difficulties for staff
attorneys, AAG advisors, prosecutors and health law judges.
PRESENTATION
PDX-Rx.com.
Chair Awan introduced Senior Vice-President Buck Stevens to present PDX-Rx.com proposal.
Mr. Stevens explained that PDX-Rx.com operates a Washington licensed pharmacy in Fort
Worth, Texas and is proposing to provide central fill pharmacy services to community
pharmacies in Washington State.
Highlights
Drug Utilization Review
originating pharmacy
Common database
Newest version of systems
imaging at both locations

Common prescription number originating pharmacy identified on label
Originating pharmacy retains prescription/refill, and conducts product verification
Originating pharmacy benefits:
o Retains ownership of original prescription/refill
o Ability to purchase medication by tablet
o Specialty pharmacy services
o An alternative for high cost/slow moving medications
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Medication Therapy Management
Concerns
Mailing prescriptions directly to the patient from the central-fill pharmacy is not permitted
where there is not a common ownership between the originating pharmacy and the centralfill pharmacy.
Patients must be informed of option not to utilize central fill services.
Final check pharmacist at the central-fill pharmacy must have the ability to view the
prescription.
Dispensing pharmacist is accountable for the dispensing the correct prescription to the
correct patient.
Representative stock requirements of Washington Administrative Code not fulfilled by

central-fill services.
MOTION: George Roe moves that the Board approve the PDX-Rx .com Central-fill proposal
upon receipt of written confirmation of contract compliance with the following conditions:
The Central Fill pharmacy is not permitted to mail prescriptions directly to the patient
must be sent directly to the originating pharmacy.
The contract must require that the originating pharmacy post signage informing patients
of their option not to participate in the central-fill process.
The dispensing and central fill pharmacies must share common electronic files or have
appropriate technology to allow secure access to sufficient information necessary or
required to dispense or process the prescription. It is expected that the central-fill final
check pharmacist have the ability to view an image of the prescription .
nd
Susan Teil-Boyer 2 . MOTION CARRIED. 6-0
The Board asks that staff (Andy Mecca) work with PDX-Rx.com to ensure that the conditions of
the approval is clearly communicated.
DISCUSSTION
2007 Legislative Updates
HB1100 Background Checks National electronic fingerprint checks, if deemed necessary.
HB1101 Amends Uniform Disciplinary Act Sanction Guidelines
HB1103 Amends Uniform Disciplinary Act Shifts authority to investigate/charge from the
Boards/Commissions to the Secretary of Health. MOTION: Susan Teil-Boyer
moved that the Board send a letter to the Secretary sharing the Boards concerns
regarding this bill and the potential impact to public health and safety. Rebecca Hille
second. MOTION CARRIED. 6 0.
HB1104 Amends Uniform Disciplinary Act Mandatory reporting; authorizes the revocation
of a health care provider's license for three separate courses of unprofessional conduct
over a ten-year period and restricts the type of cases that can be resolved by
Stipulation to Informal Disposition.
HB1300 - Department of Healths request legislation that amends the Uniformed Disciplinary
Act. The bill proposes to change to the process for denying applications, shifting the
burden of proof to the licensee rather than the department. This legislation would
allow the department to issue a notice of determination that an applicant could appeal;
allows for the permanent revocation of a license for egregious violations; and creates
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a citation and fine process to ensure documents are produced in response to an

investigative request.
HB1553 - Electronic Prescription Monitoring Program Requires the establishment of a realtime web-based monitoring program, requires dispensers to submit prescription
information electronically; requires the department to seek federal grants to cover
costs; and prohibits the department from collecting fees or taxing practitioners or
pharmacists to cover implementation or maintenance costs; provides a list of persons
who may access the information and allows us to share information with the
Department of Social and Health Services. Issues: funding, security and
implementation timeline.
HB1487 & HB1719 - Several bills increasing the penalties/provisions for pseudoephedrine.
st
SB5631 - Wholesale Distribution of Prescription Drugs 1 reading today program has not yet
analyzed this bill.
Planning Session
Lisa Salmi distributed the Boards two year goals and strategic action plan developed at the 20 04
planning session. The Board asks that the planning session include:
A review/evaluation of past goals and set goals for the next year.
Evaluation of rule making priorities.
Pharmacy Standards in Correctional Facilities

The practice of pharmacy in correctional facilities is unique. Staff recently reviewed the laws
and rules used to evaluate the standards of pharmacy services provided in correctional facilities.
They found that the Board does not have adequate standards in rule to evaluate pharmaceutical
services in correctional facilities. The Board was asked to prioritize the rule making process to
move this issue to the top of the rule making agenda.
MOTION: Susan Teil-Boyer stated that the Board acknowledges the importance of this issue
and moved that the Board authorized staff to begin stakeholder work to examine to the need to
develop rules regulating pharmacy standards in correctional facilities. Rebecca Hille second.
MOTION CARRIED. 6 0
The Use of Pharmacy Technicians to Collect Medication Histories
The Board was asked to provide direction to staff when answering recent inquires regarding the
scope of practice of a pharmacy technician in collecting medication histories from patients in an
emergency room setting.
Ms. Teil-Boyer provided additional background on this practice. Effective January 2006,
organizations accredited by the Joint Commission are required to implement medication
reconciliation processes as part of the National Patient Safety Goal. Upon entering the hospital
patients current medications are obtained and documented for review by the provider and can
also be reviewed by a pharmacist . Due to limited resources, some hospitals are using nurses, and
pharmacy technicians to collect medication histories.
Practice Settings:
Emergency Room - Discretionary task. Pharmacy Technicians are not permitted to take
medication history. Patient medication history is acted upon by a practitioner.
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Ambulatory & Outpatient Nondiscretionary task. Pharmacy Technicians may take

medication history from a patient, under the supervision of a pharmacist . Patient medication
history is not acted upon by a practitioner.
The Board affirms that collecting medication histories from patients in an emergency room
setting is outside a pharmacy technician s scope of practice.
Continuing Education Recognizing Accredited Certificate Programs

MOTION: Susan Teil-Boyer moved that the Board recognizing accredited certificate programs
such as Board Certified Pharmacotherapy Specialist (BCPS), Certified Diabetic Educator (CDE),
American College of Clinical Pharmacy (ACCP), Board Certified Psychiatric Pharmacist
(BCPP), American Society of Health System Pharmacists (ASHP), Board Certified Oncology
Pharmacist (BCOP), Certified Geriatric Pharmacist (CGP) and Pharmacist Self Assessment
Mechanism by the National Association of Boards of Pharmacy as acceptable continuing
education credit in the year they are earned. Rosemarie Duffy second. MOTION CARRIED. 6
0.
1.5 CEUs (15 hours) for accredited certificate programs and 0.9 CEUs (9 hours) for Pharmacist
Self Assessment Mechanism by NABP.
EXECUTIVE SESSION CLOSED SESSION

The Board adjourned for Executive Session at 12:00 p.m. to discuss personnel issues and
pending litigation.
The Board reconvened at 1:20 p.m.
DISCUSSION Contd
Pharmaceuticals from Households: A Return Mechanism
Board Investigator Stan Jeppesen updated the Board on the PH:ARM program and provided a
brief summary of the pilot for the audience. Mr. Jeppesen asked the Board to send a letter to the
Federal Drug Enforcement Agency (DEA) to request a waiver(s) or other mechanism so that the
program can be fully implemented by allowing the collection of controlled substances. A draft
was distributed for the Boards review.

Update
7 Group Health pilot sites

Collected 44 buckets (5 gallons each) of materials
Finalizing incineration process
pickup/delivery
MOTION: Susan Teil-Boyer moved that the Board issue a letter to the DEA stating its support
for the PH:ARM program and requesting the DEA to authorize the program to collect controlled
substances. George Roe second. MOTION CARRIED. 6 0.
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ACTION: Lisa Salmi will send the final draft of the letter to the Board for comments prior to
sending to the DEA. The letter will not be sent to the DEA until after the drugs that have been
collected are incinerated and staff have assessed the process.
PRESENTATIONS
Contd
Pharmacy Internship Requirements

Andy Mecca summarized the current pharmacy internship process and then introduced Dr. Tom
Hazlet to speak about some of the motivations for change. Dr. Hazlet reminded the Board that 3
student Fix the Law presentations in the past suggested changes to the internship process. In
addition, the American Council on Pharmaceutical Education (ACPE) has revised its
accreditation standards and guidelines for PharmD programs requiring experiential training
earlier on in the academic process. The University of Washington will be the first school in the
U.S. to be evaluated using the new standards.
Dr. Hazlet shared that the process of evaluating the new ACPE accreditation standards and
guidelines has presented an opportunity to review the current Preceptor/Internship processes.
Issues include: internship learning experience not well matched to the curriculum; inconsistent or
nonexistent training plans for the internship program; and preceptor/intern evaluations that dont
identify problems early on in the learning experience.
Suggestion: Of the 1500 internship hours required for licensure, 1200 of which is currently
earned as part of the curriculum, apply the remaining 300 hours to structured experiential
learning opportunities throughout the academic program.
Issues
1.
2.
3.
4.
5.
6.
7.
Develop model Intern utilization plans (stages)

Internship programs - referring mechanisms (already in place for clinical rotations)
Evaluations - timely progress reports (competencies)
Change/eliminate preceptor designation
Out-of-State Interns
ACPE does not permit academic credit and pay for the same activities.
Resources
Dr Hazlet acknowledged Andy Mecca, Bill Fassett, Annie Lam, Stan Webber, and Don Williams
for their participation.
The Board has determined that this is a worthwhile project and encourages staff participation.
University of Washington, School of Pharmacy.
nd
Dr. Tom Hazlet introduced the 2 year pharmacy students who presented to the Board pharmacy
law projects on Acetaminophen Overdose Leading to Hepatic Failure and suggested solutions.
Presenters: Nicholas Au, Thi Doan, Louisa Dubois, Christi Irons, Rebecca Kingsley, Laura Lutz,
Alexander McDonald, and Megan Melchiors.
OPEN FORUM.
No comments.
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PRESENTATION OF AGREED ORDER Orders presented to the Board for consideration.

CLOSED SESSION Case presentations.
There being no further business, the Board adjourned at 2:30 p.m. They will meet again on March 1,
2007 in Kent, Washington.

__________________________________________
_________________________________________
Board of Pharmacy
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STATE OF WASHINGTON

MEETING MINUTES
January 26, 2012
310 Israel Rd SE
Tumwater, WA 98501
CONVENE
Chair Al Linggi called the meeting to order at 9:04 a.m., January 26, 2012
Board Members:
Al Linggi, RPh, Chair
Gary Harris, RPh,
Christopher Barry, RPh, Vice Chair
Donna Feild, RPh, MBA
Guest / Presenters:
Billy Chow, RPh Bartells Drug
Thomas Gallagher, MD University of Washington
Roger Woolf, Pharm.D. Virginia Mason Medical Ctr
Caleb Banta-Green, PhD, MPH, MSW Alcohol and
Drug Abuse Institute, University of Washington
Dean Webb, RPh, MS Chief of Pharmacy, Public
Health-Seattle & King County
Phillip Coffin, MD, MIA Department of Medicine,
University of Washington
Staff Member:
Joyce Roper, AAG
Jim Doll, Pharmacy Investigator
Kitty Slater-Einert, Rules Coordinator
Greg Edmiston, University of Washington Intern
CONSENT AGENDA
1.1
Business Meeting Agenda Approval January 26, 2012
1.2
1.3
o Union Avenue Compounding Pharmacy
1.4
Automated Drug Dispensing Device Acceptance.
o Northwest Specialty Pharmacy
1.5
Sample Distribution Requests .
o Peninsula Community Health Services
1.6
Specialized Function Pharmacy Technicians Take Med Lists Approval.
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Board Minute Approval.

o December 15, 2011
1.7
Items listed under the consent agenda are considered routine agency matters and will be
approved by a single motion of the board without separate discussion. If separate discussion is
desired, that item will be removed from the consent agenda and placed on the regular business
agenda.
MOTION: Christopher Barry asked to remove Item 1.3 from the consent agenda for further
discussion.
MOTION: Christopher Barry moved that the board approve items 1. 1, 1.2, 1.4, 1.5, 1.6 and 1.7.
Donna Feild seconded. MOTION CARRIED: 6-0.
Item 1.3 MOTION: Christopher Barry moved that the board approve Union Avenue
Compounding Pharmacys utilization plan with suggested amendments. Donna Feild second.
REPORTS
Board Member
Elizabeth, Donna Field, Bill Kristin, and Grace Cheung are working on updating the
Investigator Inspection form.
She feels the Prescription Monitoring Program is very useful. She was having trouble
figuring out how to use it and said the help desk was such great help.
He spent 4 days testifying
for the Stormans case.
Mr. Harris wrote a letter of support for the current legislation for Cancer Drug
Repository.
He will be replacing Rebecca Hille on the Spokane Pharmacy Association Board.
Donna Field reported:
Working on the Investigator Inspection Form.

Al Linggi reported:
He was scheduled to testify at the Stormans case December 20, 2011 but did not receive
a call.
Al participated in a Legislative Meet Me Call January 10, 2012.
He testified on HB2512 in support of adding pharmacists to the Legend Drug Act on

January 23, 2012.
He took part on a disciplinary case conference call January 13, 2012.

On January 23 Mr. Linggi was supposed to meet with Steve Saxe to look at the
credentialing process but because of weather and the credentialing section moving this
will be rescheduled. He will provide an update after this meeting.
Executive Director
Susan Boyer reported:
Most of the month of January has been devoted to review and analysis of several drug
related legislative bills. Four bills have been introduced to allow return and reuse of
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medications. We met with Senator Keiser to review her two bills and have
recommended specific changes to tighten the requirements. I will discuss this topic on
the regular agenda later in the meeting today.
The access to medications trial began November 28 and continued through the week of
December 19. Board member, Gary Harris, pharmacist consultant, Tim Fuller, office
director Steve Saxe, and I testified at the trial. The closing arguments will be heard next
Wednesday with a decision to follow.
Marijuana lawsuit: Our AAG planned to file a motion to dismiss based upon lack of
standing and untimely filing. The plaintiff then filed his own motion to dismiss with
prejudice.
Staff met with Walgreens leadership December 16. The meeting was wide ranging. We
discussed the importance of patient counseling and the expectations of the board that the
point of sale systems not be a barrier to patient counseling.
Staff is working internally with DOH Emergency Preparedness staff to prepare for any
event where our staff will require treatment or prophylaxis to support distribution of
statewide emergency drug therapy.
We will be participating in an implementation advisory group put together by Labor and

Industries who recently promulgated the Hazardous Drugs Handling rules.
The U.S. Government Accountability Office (GAO) released a detailed report on the
abuse of prescription pain medications. The report notes that while efforts among federal
agencies have begun to coordinate educational efforts targeted at health care
providers, patients and the public, there remains a significant need to further pool
resources and share lessons learned, most notably among DEA, FDA, NIH, ONDCP and
SAMHSA. In addition, the 73-page report recommends that the Director of the Office of
National Drug Control Policy (ONDCP) establish outcome metrics and implement a plan
to evaluate proposed educational efforts and ensure that agencies share lessons learned
among similar efforts. .

Joyce spent a large part of December working on the Stormans case. The date for the
closing arguments has been rescheduled. The judge has not given a date he intends to
make a decision. Both parties sent in their proposed findings.
Mark Calkins, AAG handled the appeal on rescheduling marijuana . Mr. Worthington has
dismissed his case
On behalf of Attorney General Office, Joyce presented testimony on SB 6051, recycle

and reuse of prescription drugs.
Tim Fuller and Billy Chow from Bartell Drug provided the board some information regarding on
line Pet Pharmacy program.
Pet Pharmacy
Add a full-line veterinary program to community pharmacies.

Pharmacist and veterinarian on staff
Provides compounded medications
Founded in 1964
Value Proposition
Bring Cash Back to The Pharmacy
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Mitigate Barriers to Entry

Leverage Existing Customer Base
Integrate with existing products and processes (Sustainable)
Differentiate Marketplace Profile (sole provider in your area)
Comprehensive Pet Pharmacy Increase Customer Satisfaction and Enhance Customer
Experience
Full Inventory of Pet-Specific and Pet-Conversion Medications

Expert Compounding Laboratory
Fully Trained Pharmacists & Technicians in Pet Pharmacy
Full-Time Veterinarians
for Pharmacist (For Pet Owners Questions)
Proprietary Phoenix Vet RX Management Software
24/7 Customer Service Support for Pharmacists

Vet VIPPS
Center Pet knows how important quality products are to your pharmacy and your
customers. We have obtained NABPs highest veterinary pharmacy certification to

ensure:
All of our medications are being ordered directly from U.S. based pharmaceutical
companies (Merial, Bayer, etc.)
These companies are the same companies the vets order from
Customer brings in a veterinary Rx or the veterinarian calls prescription into pharmacy;

Rx is paid for at P.O.S.
Pharmacist decides if they can fill themselves (human conversion drug) or if they need to
send it to our central fill source.
Pharmacist sends fax cover letter and Rx to CPP.
Rx is drop shipped back to your pharmacy in 24-48 hours for customer pick up and
residual sales or home delivery.
Our technology and facilities are in compliance with Vet VIPPS standards
We comply with all NABP guidelines and procedures

How it works
CPP fills the Rx, labels it and inputs the Rx information into the Phoenix Vet Rx
Management System.
MOTION: Rebecca Hille moved that the board approve the proposal from Bartell Drugs online
Pet Pharmacy with the boards suggested amendments. Donna Feild seconded . MOTION
CARRIED: 6-0.
Tim attended a stakeholder meeting at Labor and Industries to discuss implementation of

ESSB 5594 which went into effect January 3, 2012. This law was put into effect to set
requirements to protect workers who handle chemotherapy and other hazardous drugs. It
requires that L&I adopt rules that are consistent with and do not exceed provisions in the
NIOSH 2000 Alert as updated in 2010. This document includes a list of hazardous
drugs. The pharmacists quickly pointed out that birth control pills, hormones, and
antidepressants do not require personal protective equipment and a special engineered
environment in the dispensing process. L&I realizes from previous input that
implementation will take some time. The adopted schedule states (1) a written hazardous
drugs control program must be completed and implemented by January 1, 2014, (2)
employee training must be implemented by July 1, 2014, and (3) installation of the
appropriate ventilated cabinets must be completed by January 1, 2015. The L&I staff
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understand there is more work to be done and are establishing an advisory committee to
provide recommendations for appropriate actions. A decision was made to not include
medical surveillance in the rule.
Cathy shared some information with the board regarding pain management rules.

In 2011, out of 350 complaints received, 183 investigations were opened which resulted
in pharmacists receiving 27 Notices of Correction and the following disciplinary actions.
In 2011 the Board of Pharmacy disciplined:

About one-fifth of 1% of pharmacists licensed by Washington State with 3
pharmacists either surrendering their licenses or having them revoked.
About one-tenth of 1% of pharmacy technicians licensed by Washington State with 7
technicians either surrendering their certificates or having them revoked.
About one-sixth of 1% of pharmacy assistants licensed by Washington State with 9
assistants either surrendering their registrations or having them revoked.
One wholesale firm was disciplined which resulted in the surrender of the license.
Washington has 9 MPJE Item Writing competencies that NABP considers under
represented. Even though it is difficult to develop questions our item writers will need to
focus on developing questions relating to these competencies. See attached sheet.
The Investigators recognize Rebecca Hille for her dedication to the people of Washington
as the longest serving Board of Pharmacy member . Rebecca is also recognized for her
participation in pharmacy related functions across the state, the advancement of
pharmacy practice, and her compassion for the public good.
Jim Doll reported:
Jim mentioned that the investigators are excited about the updated inspection process.
He asked the board how many pharmacy technicians in training can be part of the
pharmacy tech to pharmacist ratio.
PRESENTATIONS
Agency for Healthcare Research and Quality
The board heard a presentation by Thomas Gallagher, M.D. on a project to enhance the culture of health
care communication in order to improve patient safety and decrease medical malpractice liability.
Communication to Prevent and Respond to Medical Injuries:
Background
Medical injuries common

Poor team communication as cause of many injuries
Communication with patient often deficient in response to injuries
Disclosure often fails to meet patient expectations

Difficult for injured patients to receive fast, fair compensation
Presentation Goals
Present quick grant overview, progress to date, next steps
Communication training
Team communication training to prevent injuries

Disclosure/apology training
Disclosure and Resolution Process (DRP)
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To create a multi-stakeholder collaborative across Washington State to enhance

communication to prevent and respond to medical injuries.
To implement intensive communication training to prevent and respond to medical

injuries at 10 partner healthcare institutions.
To develop and evaluate a collaborative approach to adverse event analysis, disclosure,

and compensation between 5 of these 10 partner healthcare institutions and Physicians
Insurance.
To disseminate the communication training statewide via interactive e-learning modules

and assess its impact on patient safety and malpractice liability.
HealthPact Forum Goals
Create a platform for stakeholders across the spectrum of healthcare to share interests
around communication and transparency.
Provide a clearinghouse for best practices for communication and transparency in

healthcare.
Establish dialogue between the healthcare community and the general public with
emphasis on the integral role of patients in the healthcare team.
Pursue collaborative projects with HealthPact Forum participants to promote

communication and transparency within healthcare settings, institutions and professional
schools throughout Washington State.
The Problem
When unanticipated outcomes occur that involve multiple stakeholders (hospital,

providers, malpractice insurers):
Limited collaboration around event analysis, communication with the

patient/family, resolution
Role of system breakdowns underappreciated

Healthcare worker distress not addressed
Patient safety lessons learned not disseminated
Programs to promote disclosure and resolution at academic institutions showing

considerable promise
Disclosure and Resolution Process (DRP) Goals
Facilitate communication with patient/family about all outcomes of care, including

unanticipated outcomes
Support Just Cultures within healthcare

Attend to emotional needs to patients, families, providers
Promote collaboration around:
event analysis
communication with patients/families timely financial and non-financial
resolution
DRP Events
DRP study events: Unanticipated, adverse outcomes of care (from perspective of patient,
provider, or institution)
Many unanticipated outcomes are not caused by health care
Disease progression, unmet expectations
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Some unanticipated
outcomes may be adverse events (harm due to health care)
Some adverse events may be associated with care that was not reasonable
under the circumstances
Effective communication with patients important for all unanticipated outcomes
DRP Design Process
18 month process to date

TG/MM: 6 site visits to leading disclosure and offer programs across country
Initial draft developed by Claims and Compensation Core of study team
Mello, Gallagher, Olson, McCotter, Shepherd

Consultation with Rick Boothman, architect of Michigan DRP program
Feedback from potential participating sites
Draft 1-feedback from WSAJ

Draft 2-presented today for HealthPact Forum leadership group advice, counsel
Initial implementation planned 2/1/2012

Process will be refined over time
Key Principles
General
Providing safe, patient-centered care top priority

Open communication
Unanticipated outcomes are learning opportunities
DRP-specific
DRP is voluntary-anyone can withdraw at any time

DRP partners will collaborate in good faith
Attorney involvement is welcome
Event investigation is timely, comprehensive, allows for patient/family input.
Conclusions will be shared with patient/family
Offers of compensation/other resolutions will be well-reasoned, offered promptly

to patients/families, with adequate time for review
The DRP is not:
A rush to judgment
Telling the patient absolutely everything known about an adverse event
Paying patients when care was appropriate
CARE Process
Goal is to determine whether:
Care was reasonable under the circumstances

Immediate system improvements are necessary to avoid recurrences and support
patient safety
Other interventions or actions are warranted
Following CARE, partners meet to:
Review findings
Determine recommended joint approach to resolution
Determine content and process of subsequent disclosure to patient/family
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Identify possible system improvements to prevent recurrences and a strategy to

ensure implementation
Communicating with Patients and Families: Potential Resolutions
Appropriate apology
Information about actions to be taken, if any, to prevent recurrence of the event
Explanation that care was reasonable and notification of intent to defend any subsequent
claim
Supportive patient care and communication continues

If claim is pursued, partners collaborate on defense
Offer of compensation, which may include:
Waiving professional fees

Writing off co-pays
Paying out-of-pocket expenses related to the injury
Fully compensating economic losses
Providing compensation for pain, suffering, lost quality of life, or inconvenience
Washington State Hospital Pharmacy Performance Management Survey Results

Roger Woolf, recipient of the 2011 Washington State Health-System pharmacist of the year
award, presented results of a survey on Washington hospital pharmacy performance
management.
Objectives for this update
Summarize the findings of the Washington State practice assessment for hospital
pharmacy
Highlight the results & findings
Provide insight to Board of Pharmacy (BOP)

Make connections to national Pharmacy Practice Model Initiative (PPMI)
sponsored by ASHP
My views on practice evolution in this state

Next steps for Washington State Pharmacy Association (WSPA) and Health
System Academy
So what is the High Performance Pharmacy Assessment tool?
Interactive assessment tool (internet based)
McKesson is acknowledged for their considerable support of data aggregation and results
formatting.
Identifies the core best practices

Based on extensive literature review and guided by the Executive Alliance (national
group of pharmacy leaders dedicated to promoting the advancement of pharmacy
practice)
8 Dimensions of High Performance
Leadership
Medication preparation and delivery
Patient care services
Medication safety
Medication use policy
Financial performance
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Human resource management
36 assessments were used for analysis (32 complete)
Traditional pharmacy areas:

Dimension 2: Med preparation & delivery
Education
Demographics
Date range of assessments: June, 2008 June, 2011
Conclusion
STRENGTHS of Hospital Pharmacy Practice in Washington State:
Dimension 4: Medication Safety

Dimension 5: Medication Use Policy
Highly Implemented, High Impact Elements (% = Always practiced):

Advanced technician roles (88%)
Unit dose distribution system (91%)

Pharmacist role on patient care team (67%)
Active P&T Committee (77%)

WEAKNESSES:
Financial Performance holds lowest adjusted implementation score
Lowly Implemented, High Impact Elements (% = Never Practiced):

Residency training program (32%)
Dispensing incorporates machine readable bar coding (26%)
BCMA (26%)
Medication reconciliation (21%
Overall, respondents represent moderately high performance levels and appear to
be outperforming the national average. Opportunity areas include:
Patient Care Services
Patient Care Services & Education also have lower implementation and more room for
improvement
Use of Technology (such as BCMA & CPOE)

Indigent Care Medication Programs
Education Programs (such as Residency or Pharmacy Tech training)
Institute for Healthcare Improvement Lean Management

Roger Woolf, Administrative Director of Virginia Mason Medical Center, shared an overview of
the techniques and methodology of implementing lean processes to improve healthcare quality
and safety, while reducing waste.
Objectives
Provide the Board with a high level perspective on lean
Patient is always first
Highlight the key concepts

Provide a couple of examples
Encourage further learning
Health Care Challenges
Poor quality health care = 3% defect rate and costs the U.S. billions of dollars
Health care is unaffordable and unavailable to millions of people
Health care workers are negatively impacted by unreliable systems

Virginia Mason Production System (VMPS)
Values
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Focus on highest quality & safety
Watch the process
Engage all employees

Strive for highest satisfaction levels
Maintain a successful economic enterprise

Learning from Others
Timely access to what they needed when they needed it .
Used standard ways of doing things
no variation
They did not store or over process parts

Mistake proofing built into the process
The Methods & Tools that Transform Work

5S (Sort, simplify, standardize, sweep, self-discipline)
Value Stream Development
Cycle Time: The time required for one operator to complete one cycle of work (includes
wait within that cycle of work)
Standard Work
Flow
Mistake Proofing
RPIW (Rapid Process Improvement Workshop

VMPS - Teaching
Two of the elements of time are measured:
Lead Time: The entire time required to provide a service, from request to completion
1,200,000 doses/year
Is there an acceptable medication error rate?

1% error rate would allow 12,000 errors
0.5% error rate would allow 6,000 errors
0.1% error rate would all 1,200 errors
Let those who do the work improve the work

RPIW: A team of people who do the work, fully engaged in a rigorous and disciplined
five-day process, using the tools of VMPS to achieve immediate results in the elimination of
waste
Kaizen Event: A team of people who do the work, fully engaged in a rigorous and
disciplined two- day process, using the tools of VMPS to achieve immediate results in the
elimination of waste
Applying Lean Concepts
Lead Time
remove waste and waits

Walking distance put medication close to patient
JIT medication there when you need it
Visual Control signals operator
One Piece Flow reduce/eliminate batches
Set-up medications ready to use
Lean Concepts Applied: Mistake Proofing
Devices
automated dispensing devices

Inspection CPOE order sets, alerts and rules, bar code scanning
Standard Work design technology to drive a standard way to complete the
work
Visual Control
2010-11 KAIZEN ACTIVITY
Rapid Process Improvement Workshops
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Improving med room layout
Bar code medication supply
Medication preparation
Medication administration
Insulin administration
Bar code medication packaging
Bar code wrist band printing

Kaizen Events:
Crushed enteral medications
Reducing telephone interruptions
ED medication preparation
Standardized visual control @ automated dispensing cabinet
Reducing interruptions in patient room
Mistaking RN work @ automated dispensing cabinet
Electronic Prescription Storage System by Omnicare

Tim Fuller introduced Jerry Berndt, RPh. General Manager, Bridgeport Pharmacy. Jerry
presented a follow-up report on the use of the Omnicare electronic storage system for
prescriptions received through traditional facsimile transmissions. The original proposal was
approved November 2010.
Bridgeport Pharmacy believes the implementation of the electronic prescription storage
system in Omnicare Pharmacies has met the Board of Pharmacys requirements for secure,
accountable record storage and improved our work flows, which has increased focused time
on overall patient care.
They have found the benefits of the electronic storage are those expected in Omnicares request a
year ago. The accountability and ease of access are of particular importance. They clearly
recognize those prescriptions that must be printed, filed, and stored as hardcopy. There have
been over 67,000 prescriptions processed by the pharmacies.
DISCUSSION
Take Home Naloxone
Dr. Caleb Banta-Green, Dean Webb and Dr. Phillip Coffin all took part in a discussion on
Naloxone collaborative drug therapy agreements and other ways to promote overdose education
and take-home naloxone distribution to high risk populations .
Take-home naloxone to prevent opiate overdose deaths

Recent data findings summary
Rx-type opiate deaths decreased in 2009-10
Heroin deaths in King County remain low at 50 in 2010, compared to 144 in 1998
Signs of increase in 2011.
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Low purity heroin ( 2%) may be keeping heroin ODs low for now
Morphine, Oxycodone and Methadone prescribing have leveled off
Buprenorphine treatment/Rx increasing
Treatment data foreshadow a continuing cohort of young opioid dependent people at
substantial risk for OD and in need of treatment as they age
Naloxone
Public Health Seattle King County (PHSKC) Collaborative Drug Therapy Agreement
Overview
PHSKC planning to begin early in 2012
Recruitment via needle exchange
OD prevention and intervention training at Belltown PHSKC service office
Narcan prescribing and dispensing by PH pharmacist in Belltown building
CDTA PHSKC-BOP
Note that the PHSKC CDTA is likely more comprehensive than necessary in terms of trainingminimal elements likely to be:
Indication, Contra-indication, and Administration
PHSKC Naloxone Plan
1- Public Health Needle Exchange staff trained in overdose identification and naloxone
usage
2. Public Health Needle Exchange staff identify at risk clients
3. Clients who are interested receive training on use of naloxone
4. Trained clients receive certification indicating they were trained

5. Client presents certification of training form to pharmacist
6. Pharmacist, acting under the collaborative agreement, provides naloxone kit to clients.
Review materials if needed.
Implementation and evaluation of Massachusetts overdose education and naloxone

distribution program
MDPH Opioid Overdose Prevention Initiatives
Expand Screening, Brief Intervention Referral to Treatment
Community Health Centers and Emergency Departments
Post-Detox step down services
Buprenorphine: Expansion to community health centers
Enhance Prescription Drug Monitoring
Disseminate OD prevention/response educational materials
Train staff from criminal justice, addiction treatment and homeless services programs
Support Community Coalitions through MASSCALL2
Fund 15 communities to implement OD prevention strategies
Implement community-based Overdose Education and Naloxone Distribution (OEND)
Rationale for bystander overdose education and naloxone distribution
Most opioid users do not use alone
Known risk factors:
polydrug, abstinence, using alone, unknown source
Opportunity window:
opioid OD takes minutes to hours and is reversible with naloxone
Bystanders are trainable to recognize OD
Fear of public safety
Intranasal Naloxone and Prevention Educations Effect on Over Dose (OD) Study
Objective:
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Determine the impact of opioid overdose education with intranasal naloxone distribution
(OEND) programs on fatal and non-fatal opioid overdose rates in Massachusetts
Hypotheses:
Among MA communities with high burdens of opioid overdose, the implementation of
the OEND program is associated with
Decreased rates of fatal opioid overdose
Decreased rates of non-fatal opioid overdose
Analyses:
Poison regression to compare opioid-related overdose rates among cities and towns with
high vs. low implementation between 2002 and 2009
Natural interpretations as rate ratios (RRs) calculated by exponentiating the beta
Coefficients
Conclusions:
Fatal OD rates were lower in cities-towns:
Where OEND enrollment reached a density of 150 per 100k population
Where OEND user enrollment was high
Where there were high annual rates of reversals reported ED and hospital discharge rates
were higher in cities-towns:
Where OEND enrollment was greater than 100 per 100k population no increased rates
were seen when implementation defined by high user enrollment or high reversal rates
Limitations
True population at risk for overdose is not known
Adjusted for demographics, treatment, PMP, and year
Cause of death subject to misclassification
One medical examiner for all of MA
Non-fatal overdose measure >> Diagnostic codes are subject to misclassification
No reason bias should be in one direction
Overdoses may occur in clusters
Study conducted over wide area and several years
Measures of OEND implementation have not been validated
Implications
OEND programs should be part of public health efforts to reduce opioid overdose deaths
To impact overdose deaths, OEND programs should:
Train at least 150 people per 100k population
Target those who are likely to reverse overdose
As OEND enrollment increases, acute care utilization for opioid-related conditions
increase
Due to more community awareness, not more nonfatal overdose
The board agreed to write a formal letter of support. The board asked that staff work with WSPA
to write a newsletter article regarding the Nalaxone Collaborative Drug Therapy Agreements.
Susan Boyer led the discussion and update on the Legislative Session.
HB 1485 2011 bill Reintroduced Pharmacies permitted to fill prescriptions from out-of-state
ARNPs Amends 69.50.101 to allow pharmacies to fill prescriptions for controlled substances
written by out-of-state ARNPs.
HB 2142 Related to prescription monitoring program funding. If federal or private grants or
other funds are not sufficient the department of health may charge a fee ($15) for the operation
of the program
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HB 2228 Allowing for redistribution of medications under certain conditions. Bill allows any
practitioner or medical facility to donate prescription drugs and supplies to a pharmacy for
redistribution without compensation or the expectation of compensation to individuals who meet
the prioritization criteria. Medical facility" means a physician's office, hospital, health clinic,
nursing home, boarding home, or adult family home.
HB 2343 Electronic communication of prescription information for controlled substances.
Board and Agency request legislation. Allow prescribers to send prescriptions for controlled
substance by electronic transmission to a pharmacy. The bill amends chapter 69.50 RCW to
align with federal standards and allow electronically communicated prescriptions for controlled
substances.
HB 2495/ SB 6424 Prohibiting Pharmacists from Substituting Opioid Analgesic Drugs for an
Opioid Drug Incorporating Tamper Resistant Technology Without Obtaining Written Consent of
the Prescribing Physician.
MOTION: Donna Feild moved that the board write a letter of opposition to HB 2495/SB6424.
Elizabeth Jensen seconded . MOTION CARRIED: 6-0.
SSB 5969 Establishment of procedures for the professional licensing of military spouses after
relocation to Washington . Licensing authority is required to develop a method to authorize a
person who meets the criteria to perform service by issuing a temporary permit. Effective
March 14, 2012. Passed signed by Governor on December 20.
SB 6007 Placing certain synthetic cannabimimetics and certain substituted cathinones into
schedule I of the uniform controlled. With exception of chemical names, the bill mirrors the
boards rules adopted last year.

SB 6048 Permitting nursing homes to recycle unused prescription medicines.
SB 6049 Requiring the department of health to establish a cancer drug repository program. The
department of health establishes a cancer drug repository program for accepting donated cancer
drugs and dispensing these drugs to authorized WA residents. DOH to work with BOP in
adopting rules to establish eligibility criteria, standards and procedures for participating facilities
that accept, distribute or dispense donated cancer drugs. Department Of Health is to maintain
registry of participating facilities. The substitute bill adds a definition for donor, clarifies health
care facility removing laboratories and general language regarding places where healthcare
providers provide care to patients. Requires disclosure to patients that drug was donated, limits
acceptance and distribution/dispensing of donated drug to and by practitioners or pharmacies.
SB 6051 Concerning the donation and redistribution of unused prescription drugs. Donations of
unused prescription drugs to a health care facility or participating practitioner for redistribution
by the health care facility or participating practitioner are permitted. Before redistributing
donated prescription drugs, a health care facility or participating practitioner must examine the
donated prescription drug to determine that it has not been adulterated or misbranded and certify
that the drug has been stored in compliance with the products label. DOH will do rules. Health
care facility" means a hospital, clinic, nursing home, laboratory, office, or similar place where a
health care provider provides health care to patients. "Participating practitioner" means a
licensed health care practitioner who is authorized to prescribe drugs and who registers with the
department to participate in the collection of donated drugs, prescribed for use by established
patients of that health care practitioner and donated for the purpose of redistribution to
established patients of that health care practitioner .
SB 6280 Pharmacy Robberies makes robbery a first degree offense/ class A felony.
MOTION: Donna Feild moved that the board write a letter of support for SB6280. Elizabeth
Jensen seconded . MOTION CARRIED: 6-0.
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SSB 6197/ HB 2512 Including Pharmacists in Legend Drug Act. The bill corrects the statute that
identifies prescribers by adding pharmacists when authorized by the board. This is a technical
correction.
HB 2186 Concerning licensed midwives ability to work with registered nurses and licensed
practical nurses. A registered nurse may execute a medical regimen as prescribed by a licensed
midwife. A registered nurse or licensed practical may also administer medications, treatments,
tests, and inoculations, at the direction of a licensed midwife.
HB 2227 Medical assistants. New profession registration/certification. Bill is not consistent
with Sunrise Review done by DOH Bill allows MA to act under standing orders.
HB 2230 Requiring certain health agencies to use administrative law judges from the office of
administrative hearings. Moves the health law judges in the Adjudicative Clerks Office under the
Office of Administrative Hearings.
SB 6176/ HB 2490 Simplifying state and local tax and licensing systems. The bill amends
sections of the pharmacy practice act (Definitions and RCW 18.64.044 Shopkeeper registration)
to update references from master licensing to business licensing.
SB 6096/ HB 2303 Protection Against Unfair Prescription Drug Practices By Pharmacy Benefit
Managers. Establishes consumer protection from unfair prescription drug practice by pharmacy
benefit managers that contract with covered entities.
SB 6290/ HB 2524 Occupational licensing status for military spouses or registered domestic
partners during deployment or placement outside Washington. The bill requires that a license of
a spouse or registered domestic partner or s service member be place in inactive military status .
The license will be returned to active status for renewal within six months after the service
member is honorably discharged from service or sooner if requested.
HB 2130 Eliminating cost-based reimbursement for critical access hospitals.
HB 2220 Requiring certain health professionals to complete continuing education in suicide
assessment, treatment, and management.
HB 2261 Charitable donations of eye glasses and hearing instruments.
SB 6022 Changing the effective date of Initiative Measure No. 1163 concerning long-term care
related to requiring long-term care workers obtain criminal background checks and adequate
training.
SB 6054 Eliminating the certificate of need review for all health care facilities except hospitals.
SB 6227 Establish a Medicaid Fraud Hotline. Attorney General to establish a Medicaid hotline
for the public to report suspected Medicaid fraud. The hotline will be funded by the medical
quality assurance commission.
Correspondence
The board discussed correspondence received.
Hazardous Drugs Rule brief from WSHA

New chronic non cancer pain management rules memo
USPHS report calls for pharmacists to be recognized as providers
The board discussed a letter that was received . This letter is asking if an online pharmacy
that is VIPPS accredited have the ability to get licensed in Washington. After some
discussion the board decided to put this in the Rules parking Lot.
OPEN FORUM.
Jenny Arnold from WSPA shared that the addition of pharmacists to the Legend Drug Act
(18.41) was voted out of house and moved to the senate.
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Jim Doll Pharmacy Investigator shared that the PMP helped a pharmacist identify a woman from
a prescribers office and that she had picked up 50 prescriptions from 50 other pharmacy
locations. The DEA was contacted and she will be charged federally.
Presentation of Service Recognition

Al Linggi called Rebecca Hille to the front of the room to recognize Rebecca Hille and her time
served as a public board member. Rebecca served the longest of any previous board member.
Governor Gregoire appointed Rebecca in August of 2001 to complete an unexpired term of a
member who had resigned earlier in the year. Rebecca began her next official appointment
February 10, 2005. She was then reappointed February 19, 2008 and her appointment ends
February 2012. The board formally thanked Rebecca. She was also given a signed letter from
Governor Gregiore to Rebecca to thank her for her service. The board presented Rebecca a Rx
charm for her charm bracelet.
Prescription Monitoring Program Presentation
Update
Christopher Baumgartner, PMP Program Director gave the board another update on the
implementation of this program.
Newly Uploaded Claim Records 22,317
Begin Data Collection
Brand design - DONE
- 3,663 Provider Registrations Approved
Records Pending Standardized Address Update from Centrus 0

Records Waiting Name Matching Evaluation 0
Candidates for Clustering with Others Referencing the Same Physical Recipient 0
Standardized Claim Records Waiting for Stat Building 0
Standardized Claim Records that have Completed Stat Building 3,608,561
Total Claim Records 3,630,878 over 4 million as of today

Implementation Update
October 1, 2011
Begin Mandatory Reporting October 7, 2011
Begin DOH/PMP Staff/Licensing Board Access
October 26, 2011
Begin Oversight Agencies Access
November 15, 2011

Begin Pilot Data Requestor Access December 1, 2011
Begin Data Requestor Access January 4, 2012
Begin Law Enforcement/Prosecutorial Agencies Access
January 4, 2012
Begin Medical Examiners/Coroners Access
Operations, Maintenance, Enhancements

PMP Education Materials Timeline
February 1, 2012
ongoing
Dispenser Requirement Factsheet - DONE

Public factsheet - DONE
Provider factsheet
FAQs
DONE
DONE
Quick Tips - DONE

As of 1/13/2012
- 843 Pharmacists Registrations Approved
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CLOSED SESSION
January 27, 2012

S Nguyen - Pharmacy Assistant
Department of Health, Town Center 2 Room 145
111 Israel Road S.E.
Tumwater WA 98501
February 9-10, 2012
Veterinary Wholesale
Department of Health, Town Center 2 Room 145
111 Israel Road S.E.
Tumwater WA 98501
Pharmaceutical Wholesaler
Next scheduled business meetings: March 8, 2012

Mt. Constance Conference Room
th
2400 S. 240 St.
Des Moines WA 98198
_______________________________
_______________________________
Al Linggi, Chair
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STATE OF WASHINGTON
Regular Scheduled
MEETING MINUTES
PPE 152 & 153
Tumwater, WA 98501
CONVENE
Chair Al Linggi called the meeting to order January 29, 2015.
Commission Members:
Guest / Presenters:
Thomas Kloepping, RPh, D.Ph. from Grays Harbor
Community Hospital
Neal Matthews, Director of Pharmacy for Ocean
Beach of Hospital
Linda Kaino, Chief of Nursing Officer
Gary Harris, RPh,
Steve Anderson, RPh

Al Linggi, RPh, MBA
Tim Lynch, PharmD
Nancy Hecox, PharmD
Glen Adams, Pharmacy Director for Confluence

Rick Canning, Exec. VP for Confluence Outpatient Services
Richard Bennet, Sr. VP Quality for Confluence
Craig Peterson, Operations Manager
Carol Sue Jones, Legal Counsel for Confluence
Ray Bender, Product Manager for Centricity

Meredith Esonis, Sales Support Project Manager
Sepi Soleimanpour, RPh, MBA-MHA
For Centricity
Francis Toan, Program Manager for MedRx
Joshua Marker, Corporate Counsel
Cathy Null, RPh, Harborview Medical Center
Beverly Sheridan, RPh, Harborview Medical Center
Heidi Bragg, MBA, RPh, Director of Regulatory
Compliance for Cardinal Health
Michael Mone, JD; VP Associate General Counsel Cardinal Health
Ajay Sinha, RPh, Director of Pharmacy, Fairfax Behavioral Health
George Dimaris, RPh for Fairfax Behavioral Health
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Staff Members:
Joyce Roper, AAG
Christopher Humberson R.Ph, Executive Director
Tyler Varnum, Pharmacy Investigator
Julie Faun, Pharmacy Investigator
Lisa Roberts, R.Ph. Pharmacy Consultant
Cathy Williams R.Ph, Pharmacist Consultant
Absent Staff Members:
Gordon MacDonald R.Ph, Chief Investigator
CALL TO ORDER
1.2 Approval of December 11, 2014 Meeting Minutes.
MOTION: Dan Rubin moved that the commission approve 1.1. Chris Barry second. MOTION CARRIED: 9-0.
MOTION: Dan Rubin moved that the commission approve 1.2. Maureen Sparks second. MOTION CARRIED:
9-0.
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be approved by
a single motion of the commission without separate discussion. If separate discussion is desired, that item
will be removed from the consent agenda and placed on the regular business agenda.
December 2014
Ritzville Pharmacy
Western State Hospital Unit Dose Checking (tech check tech)

Okanogan Douglas District Hospital Pharmacy
Items 2.6, 2.7, and 2.8 were deleted from the consent agenda.
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MOTION: Elizabeth Jensen moved that the commission approve items 2.1, 2.2 & 2.3 and pull items 2.4 & 2.5
were pulled for from the consent agenda for further discussion Gary Harris second. MOTION CARRIED: 90.
REPORTS
Commission Members
Chris has an engagement to speak to a class at the Washington State University on the topic of the
Washington State Pharmacy Quality Assurance Commission in February. Mr. Barry asked Eleanor Carbett,
Pharmacy Investigator to participate with him.
January 5 & 6 she flew to Dallas, Texas for ASHP accreditation survey of a pharmacy technician program.
Maureen felt she learned a lot and it was very interesting.
February 7 Maureen will be participating in Pharmacy Technician day with WSPA at Clover Park
Technical College that allows technicians CE.
Mr. Harris met with the University of Washington (UW) Pharmacy Alumni Association.
He has been selected to be a member of UW strategic planning advisory committee.
He participated in the webinar/video conference for the Business Practice Meeting on January 6.
Mr. Anderson took and passed the MPJE Tennessee, Arizona and Virginia.
Elizabeth sat in on the webinar/video conference for the Business Practice Meeting on January 6.
Tim Lynch reported:
Tim is part of a workgroup working with the Nursing Commission regarding student nurses having access
to ADDDs this will be ongoing.
Attended ASHP mid-year meeting participated in discussion from commission members that are health
system pharmacists. The discussion was about pertinent issues impacting hospital and health system
pharmacy.
He participated in the webinar/video conference for the Business Practice Meeting on January 6 as a public
member.
She is prepping for attending sterile boot camp in March with Julie Faun and Brad Dykstra. Been online
taking 40-50 online monograph classes you must pass before arriving in Denver.
Monday she and Tyler Varnum visited the 3 Confluence sites.
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Dan Rubin reported:
A lot of work on business practice committee.

Late December Dan was asked to represent the commission on the legislative meet me calls.
Al Linggi reported:
Continue to work on Technology task force. CR101 and CR102 asking stakeholders to assist in looking at
different technical aspect associated with pharmacy. A few people have volunteered.
Al attended the ASHP mid-year meeting.

He also sat in on the webinar/video conference for the Business Practice Meeting on January 6.
Executive Director
Participated in meeting of Business practice Committee
Attended a NABP Compounding Workshop to help develop a uniform inspection format for
interstate use.
Chaired meeting of Unintentional Poisoning Workgroup for DOH on opioid overdoses
Presented talk to Veterinary Association on Pharmacy Issues and met with WSU Veterinary
Faculty.
Spoke at Pharmacy Student Day at Legislature

Met with WSHA representatives in Seattle to discuss common issues of concern

She prepared two memos for PQAC, which, at this point, attorney client memos. The memos have
been distributed to the commission members and address two topics: an overview of the authority
to regulate firms, at the request of Dan Rubin to potentially be used for the business practices
committee and a memo regarding Confluences request for approval. There will be further
discussion when these topics come up in the agenda.
She has been working for months now with Surescripts regarding electronic prescribing. The gentleman
she has been working with will be flying in for a meeting February 2 with Lisa, Al and Chris Humberson to
discuss the issues.

During the month of November, Pharmacist Investigators devoted 735 hours to inspections, 263 hours to
investigations and 104 hours providing technical assistance/education . Investigations were completed on
24 cases with 119 cases open.
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During the month of December, Pharmacist Investigators devoted 837 hours on inspections, 378 hours on
investigations and 94 hours providing technical assistance/education . Investigations were completed on 18
cases with 126 cases open.
Following is an updated Pharmacy License by Type report for January 2015. The report reflects an increase
in 36 out of state firms gaining licensure and 14 in state firms gaining licensure over the December Report.
Of special note, there are a total of 2101 in state firms and 1916 out of state firms licensed by the
commission. In state firms are closely regulated and monitored by the commission while out of state firms
are not subject to the same level of commission oversight.
During 2014 the pharmacist investigator team conducted 591 pharmacy inspections. Eighty-three of these
inspections (14%) were follow up re-inspections which were conducted due to Conditional (80-89 points)
and/or Unsatisfactory (79 points or less) scores earned on routine inspections of pharmacies (WAC 246869-190 (4)(5)).
RULEMAKING AND POLICY DEVELOPMENT/DISCUSSION

2015 Legislative Session Update
Several bills related to Pharmacy have been introduced:
HB 1369 on student volunteers
HB 1625 on providing drugs to ambulances
HB 1671 on Opioid overdose medications
SB5268 on eye drop refills
SB 5291 on epi pen uses in facilities
SB 5441 on patient medication coordination
SB 5460 on prepackaged ER medication
SB 5549 on Pharmacy assistants fee
Compounding rules update:
Chris Humberson updated the commission members on the compounding rule. There was an extension
put on the comment deadline which is now February 15, 2014. The draft has been out since October 1,
2014. The path going forward is once comments are in they will be sorted by topic, than evaluated by the
Compounding Committee . The crosswalk is completed and will be sent out the beginning of February.
The committee will be working on stake holder suggestions and prepare a second draft for first part of
May to go back out for more comments.
Technology Committee Update

Al Linggi provided the commission an update. The CR101 has been submitted. There has been
reasonable amount of work. The committee has looked at some states that have contemporary rules . They
reached out to stakeholders asking for them to step up from industry and community practice with respect
to the use of technology and they have received excellent responses and many offers to help support the
committee. They will be working towards stakeholder meeting. There is a lot of work to be done and Al
encourages stake holders to participate as much as possible.
5
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Pharmacy Business Practice Committee Update

Dan Rubin provided the commission members update.
The Committee met three times since the Commissions December 11, 2014 business meeting: immediately after
the December 11 meeting; on January 6, 2015; and on January 15, 2015.
A major part of all these meetings was devoted to presentation and discussion of preliminary results from the 2014
Pharmacy Survey. On December 11 the committee heard a preliminary report on responses to the open comments
field of the survey (Question 23), which was released on December 8 and is available on the Rules in Progress
section of the PQAC website.
Some public comments at the meeting noted that payment pressure is enormous throughout the health care
industry; that some negative comments might result from poor fit between individual staff and their specific job
duties; and requested the committee to be evidence-based and focus on patient safety. There were suggestions on
further analysis (by respondent profession, role, site, etc.) and some beginning discussion of quality improvement
approaches in use.
The January 6 committee meeting focused on presentation and discussion of the structured questions in the survey.
The January 6 meeting also included brief presentation and committee discussion of a high level Road Map
showing stages in the committees work.
Discussion of both structured and comment questions from the survey continued at the January 15 meeting,
which incorporated five sites. On January 15 the committee formalized moving forward to additional "stages" (on
the Road Map) in three areas:
Workload, pacing, interruptions, and staffing (the highest priority);
The part of problem definition that focuses on demonstrated impact on patients/public (distinct from the
experiences, perceptions and fears of staff);
Common understanding of our current legal environment in these topical areas (statute and rules); and
Prescription transfers (a more focused topic, possibly simpler); and
QI practices.
Specifically the work now proceeds to:
Preliminary review of remedies and standards used in various settings/jurisdictions, as a first step in
scanning for possible actions.
Efforts to accommodate multiple sites through technology continue to pose challenges. The committee is inclined
to build on in-person meeting opportunities the days of Commission Business meetings; focus multi-site
teleconferences on discussion (without attempting to also manage complex visual presentations); and use Webinar
methods for other meetings that do involve visual presentations.
PUBLIC RULES HEARING

Rules Hearing
The purpose of the proposed changes to chapter 246-870 WAC and WAC 246-887-020,-030 is to
implement Substitute Senate Bill 5416 to redefine electronic communication of prescription information;
revise prescription dispensing requirements for Schedule II through V controlled substances; and to
rename the Board of Pharmacy to the Pharmacy Quality Assurance Commission. The proposed rule was
filed with the Code Revisers office on November 26, 2014. The notice was published in the Washington
State Registry as WSR# 14-24-076.
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Peggy Crain summarized the proposed rule and explained the amendments. Peggy followed her
presentation by answering questions from the commission.
The Chair opened the hearing to public testimony. After the commission heard and responded to the few
comments, Peggy shared the four written comments she received for discussion with the commission. A
copy of the summary of the testimony/comments and commissions response will be sent out on Listserv
and mailed to individuals upon request.
Joyce Roper had already responded via memo to two of the comments Peggy received regarding
Schedule V prescriptions. Peggy Crain requested to have this memo added to the rule file.
MOTION: Elizabeth Jensen moved to waive the attorney client privilege specific to the memo from
Joyce Roper sent to Chris Humberson October 7, 2014. Dan Rubin second. MOTION CARRIED: 9-0.
A copy of the summary will be put into the rules file and sent to those who signed up for comment, those
attending this hearing and those who request a copy.
The hearing was concluded at 10:48 am.
MOTION: Chris Barry moved to adopt the proposed language as written for WAC 246-887-020 Uniform
Controlled Substances Act. Gary Harris second. MOTION CARRIED: 9-0.
MOTION: Steve Anderson moved to repeal WAC 246-887-030 Dispensing Schedule V Controlled
Substances. Elizabeth Jensen second. MOTION CARRIED: 9-0.
MOTION: Nancy Hecox moved to adopt the proposed language as written for Chapter 246-870 WAC
Electronic Transmission of Prescription Information, including the floor amendment to 246-870-060 to make
it clear that only non-controlled legend drugs may be transmitted electronically by a prescriber using a
computer system and received by a pharmacy via fax machine. Steve Anderson second. Motion rescinded.
MOTION: Dan Rubin moved to table the proposed language as written for Chapter 246-870 WAC
Electronic Transmission of Prescription Information, including the floor amendment to 246-870-060 to make
it clear that only non-controlled legend drugs may be transmitted electronically by a prescriber using a
computer system and received by a pharmacy via fax machine for 30 days . Nancy Hecox second. MOTION
CARRIED: 9-0.
Peggy will prepare a summary paper, along with amended language and submit to the listserv for 30 days
another hearing held on proposed language at the next meeting. Commission is looking for some clear
definitions.
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CONSENT AGENDA
Okanogan Douglas District Hospital Pharmacy
The commission asked Lisa Roberts about some clarification regarding possible double dispensing and how long a
fired employee will lose privileges for use of ADDD. After minimal discussion Lisa Roberts was able to answer the
concerns of the commission.
MOTION: Tim Lynch moved to approve Consent Agenda Item 2.5 Okanogan Douglas District Hospital Pharmacy
ADDD. Elizabeth Jensen second. MOTION CARRIED: 9-0.
Western State Hospital Unit Dose Checking (tech check tech)
Commission members wanted to have confirmation from Cathy Williams whether the policy and procedure were in
the documents sent by Western State Hospital. Cathy Williams confirmed that along with all other documents were
received. There were some other missing documents so this agenda item will be postponed until March 12, 2014.
Exception Application Criteria Matrix

Al Linggi and Kyle Karinen, DOH Attorney led the discussion asking the commission to consider
adopting a process for delegation of authority and criteria to approve or deny applicants based on
standards identified in the policy.
This was brought to the commission at the last meeting and Kyle was asked to make some revisions
regarding all the concerns and to make this pharmacy specific. There was some further discussion about
the amended matrix. This is just a guideline to assist in making consistent decisions regarding discipline .
Every situation is still looked upon as a case by case basis.
MOTION: Dan Rubin moved that the commission adopt the Exception Application Criteria Matrix and after six
months of use bring this back for a follow up discussion. Tim Lynch second. MOTION CARRIED: 9-0.

Dan Rubin led the discussion asking the chosen panel to recognize Health Market Science, Inc. as
an educational organization.
MOTION: Nancy Hecox moved to deny the request from Health Market Science, Inc . to be
recognized as an educational organization. Gary Harris second. MOTION CARRIED: 5-0.
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Remote Pharmacy Services:

Al Linggi led the discussion asking Commissioner Nancy Hecox and Inspector Tyler Varnum to provide
their findings after their visit to both Omak and Moses Lake sites. Then the commission was asked to
discuss recommendations by the taskforce regarding Central Washington Hospital/Confluence Health
pilot project to provide remote supervision of pharmacy technician preparing sterile parenteral products
for patients at satellite infusions center. Julie Faun, Pharmacy Investigator was also asked to provide
feedback and answer questions about her findings.
On January 26, 2015 Commission Member Nancy Hecox and investigator Tyler Varnum performed a site
visit at three Confluence Health oncology related infusion locations, Moses Lake, Omak and the parent
facility at Wenatchee Valley Hospital. The Moses Lake revisit revealed some positive changes had been
made since the previous observations in November of 2014. Namely, the ISO 5 area of the hood had
been cleared, the room was less cluttered and all cardboard boxes had been removed. Coats and flowers
were gone. However food and drink were still present. It was commented that after the initial November
2014 visit these and other changes had been made. Mrs. Hecox observed the technician in the preparation
of three compounds while Investigator Varnum interviewed Pharmacists Glenn Adams and Craig
Pedersen. Hecox found that some elements of the compounding facility did not meet USP 797.
CONCLUSIONS:
1. Considering that USP 797 was published in 2004, the Moses Lake pilot project has been in
existence since late 2012 and current state law has required USP compliance since May of 2013,
the facility is still in the process of meeting the minimum standards of USP 797.
2. The compounding sites are currently unlicensed with elements of pharmacy practice being
conducted.
3. Federal and State regulations may pose an issue when narcotics are stored in ADDDs with no
DEA licensure for the facility.
4. There are questions and concerns about the room cleanliness, security, and air flow where the ISO
boxes are placed to meet minimum USP797 standards .
5. There are questions about BUD dating meeting USP 797 standards .
6. Current pharmacists do appear to be well trained and credentialed.
7. Licensure of each site as a pharmacy would enable Confluence Health to get a pharmacy DEA
license for the narcotic over site, and would normally place a pharmacist at each site.
8. Aside from providing immediate and in-person supervision of technicians, on-site pharmacists
could, through CDTAs, provide bowel, skin, pain, refill and chronic medication prescription
authorizations along with MTM, DUR and valuable on site drug information duties .
9. On site pharmacists could also provide remote order verification (reverse-check orders) back to
the hospital, giving the pharmacist a full time function.
MOTION: Chris Barry moved that the commission waive the attorney client privilege to
release the memo written by Joyce Roper on January 28, 2015 responding to the
Confluences request for approval. Steve Anderson second. Elizabeth Jensen, and Maureen
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Sparks abstained. MOTION CARRIED: 7-0. (Motion corrected per request at the
March 12, 2015 meeting)
MOTION: Gary Harris moved that the Pharmacy Investigator inspect Confluence, Omak
and Moses Lake Clinics at a mutual agreed time. The investigator will provide detailed
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issues found for Confluence to resolve by April 30 , 2015. Confluence will be given three
months to meet current Washington State standards of USP797 and legal requirements of
pharmacy practice. Dan Rubin second. MOTION CARRIED: 9-0.
This continues to be a hot topic with two plus hours of detailed discussion. If you would
like more details, staff can provide further information.
Attorney Client Privilege

MOTION: Dan Rubin moved that the commission waive the attorney client privilege to
release the memo written by Joyce Roper on January 26, 2015 regarding Regulatory
Authorities of Licensed Business Entities. Elizabeth Jensen second. MOTION CARRIED:
9-0.
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National Association of Boards of Pharmacys 111 Annual Meeting

Doreen Beebe led the discussion asking the commission to identify attendee(s) and name a voting
delegate.
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MOTION: Christopher Barry moved that Dan Rubin attend the NABP 111 Annual
Meeting as the voting delegate and Chris Humberson attend as the alternate Elizabeth
Jensen second. MOTION CARRIED: 9-0.
Correspondence
The Commission may discuss any correspondence received or distributed.
a. Kelley Ross Central Fill Proposal Follow-up
b. King Countys Secure Medicine Return Regulations Update
c. Letter re: WSPQAC article on Changes Permitted with Hydrocodone/APAP
Prescriptions
d. Washington State University, College of Pharmacy re: Preceptors
PRESENTATIONS
Grays Harbor Community Hospital East
Lisa Roberts introduced Thomas Kloepping, RPh, and D.Ph. from Grays Harbor Community Hospital
East. He shared a brief presentation to the commission asking them to approve his proposal to receive
remote medication order processing from their West Campus Pharmacy.
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Grays Harbor Community Hospital East Campus is located in Aberdeen, Washington. The facility includes
a twenty-six bed Chemical Dependency Unit (NOT a Residential Treatment Facility), Wound Care
Outpatient, and a seven bed Special Procedure Center.
There is a licensed pharmacy at the East Campus Facility with limited pharmacy hours of Monday,
Wednesday, and Friday from 8:00am to 10:00am.
Medication orders from the East Campus facility are primarily generated from the Chemical Dependency
Unit. The East Campus pharmacy is requesting approval to receive Remote Medication Order Processing
from their commonly owned, West Campus Pharmacy when East Campus Pharmacy is closed.
Grays Harbor Community Hospital West Campus is a licensed 96-bed public hospital located in Aberdeen,
Washington. The West Campus Pharmacy is not open 24 hrs. /day, but would be able to provide Remote
Medication Order Processing services during hours of operation: 6:00 am to 11:30 pm weekdays and
6:00am to 9:30pm weekends and holidays.
West Campus would not be performing 24/7 Remote Medication Order Processing services to East
Campus as they are closed at night for 6.5 to 8.5 hours depending upon the day of the week.
There is an on-call pharmacist available after-hours for questions or to come in to mix IV products, but he
does not have the capability to verify orders during this time.
The pharmacy director has stated administration would like him to stretch his staffing to cover the
pharmacy 24 hours/day without any additional staffing.
The pharmacy director reports he is trying to come up with a scheduling plan to accomplish this. This
pharmacy had multiple points deducted during inspection for not providing 24/7 pharmacy services.
Grays Harbor Community Hospital West Campus Pharmacy is also requesting approval to provide
remote medication order processing to their East Campus facility.
MOTION: Christopher Barry moved the commission approve Grays Harbor Community Hospital Easts proposal
to receive remote medication order processing from their West Campus Pharmacy. He must provide the
commission and staff with a copy of the Q&A to identify breaches and a copy of the policy and procedures that
identifies what the course of action would be should this happen and report back in one year. Tim Lynch second.

MOTION: Elizabeth Jensen moved that the commission approve Grays Harbor Community Hospital West
Campus Pharmacy request to provide remote medication order processing to their East Campus facility with a
report back in one year. Steve Anderson second. MOTION CARRIED: 9-0.
Ocean Beach Hospital

Lisa Roberts provided the commission some background on this proposal. Neal Matthews, Director of
Pharmacy introduced his panel Linda Kaino, Chief Nursing Officer . Ocean Beach Hospital asked the
commission to approve his request to utilize Medications Reviews remote medication order processing.
Overview
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Critical Access Hospital

Located in Ilwaco, WA
15-bed Medical Unit, Emergency, Surgical and Outpatient Services
Trauma Level 4
Pharmacy Managed by one full time pharmacist
Uses Pyxis Automated Drug Distribution Device for medication distribution control
Remote Order Entry
For the last year OBH has entered most all of the orders via CPOE and the RPh verifies.
Provides 24-hour pharmacy services in accordance with WAC 246-873-050 including:
* Order entry
* DUR checks
* Drug information
* Dosage calculation
Procedure Overview
Order is entered into CPOE and scanned into EMR.
Pharmacist verifies order
Remote order entry pharmacist receives order and checks order against patient profile for accuracy
completeness and contraindications
Nurse can then access medication from the Pyxis Medstation for administration
Advantages (safety)
Every order is reviewed by a pharmacist for accuracy, allergies, interactions, etc prior to administration by
nursing staff
Orders are verified promptly, 24/7
Nursing staff has immediate access to a pharmacist via phone 24/7 365 days a year
Remote Access Security
Accessed via private VPN tunnel
SHA1 AES 256 Bit Encryption
Access to system granted to Medication Review by OBH IT department per hospital policy and procedure
Remote Order Entry Wrap-up
Valuable service to small rural hospitals
Increases medication safety
Ensures 24 hour pharmacy coverage
Increases quality of patient care
MOTION: Elizabeth Jensen moved that the commission approve the proposal from Ocean Beach Hospital to
utilize Medications Reviews remote medication order processing with a report back in one year. The
commission would like to see a quarterly report and how much this is used along with some customer service
feedback. Dan Rubin second. MOTION CARRIED: 9-0.
GE Healthcare Centricity
Pharmacy Consultant Lisa Roberts, PharmD. provided the Commission with some background regarding GE
Healthcare. Lisa introduced Ray Bender, RPh and Product Manager, along with Meredith Esonis, Sales Support
Project Manager from GE Healthcare. They were seeking approval for two electronic prescription transmission
systems:
a. Centricity Practice Solutions (CPS): An Electronic Medical Record (EMR) that uses a SQL Server
database typically used by smaller practices.
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b. Centricity Electronic Medical Record (EMR): An Electronic Medical Record using an Oracle
database generally used by larger practices. The Oracle database typically requires a dedicated
administration person, and it performs better when there are large numbers of concurrent users.
These two systems are nearly identical with only minor differences in how the applications interact with the
different databases. These systems are currently not permitted to transmit controlled substance prescriptions.
The three areas of concern for these systems were as follows:
1. These systems permit a Prescriber Agent to prescribe if the prescriber allows this regardless that this is not
permitted in WA State under WAC 246-870-020. Since the clients set the privileges for their own employees, the
Prescriber Agent is a viable feature that the clients could enable if they wanted to. GE Healthcare stated they
cannot disable this feature as their system is used in other states that do utilize Prescriber Agents.
2. These systems support an electronic faxing feature which could send the prescription to the pharmacy without
a manual, wet signature. GE Healthcare states this feature cannot be disabled as their system is used in other states
that do permit utilizing electronic faxing with no manual signatures.
3. There is no dedicated route field in the XML data field. WAC 246-870-030 (2) (5) requires a route on an
electronic prescription.
The discussion was whether electronic prescription transmission systems should be permitted in WA State when
they have features not lawful in this state. There was considerable discussion with Commission Members
regarding security, prescriber delegates, and features in these systems not permitted in this state. GE Healthcare is
currently working with Surescripts to incorporate a route field. GE Healthcare stated they placed a statement in
their WA State Policies and Procedures to inform all clients not to enable these features in question.
MOTION: Tim Lynch moved that the commission approve Centricitys request for two electronic prescription
transmission systems as stated with the understanding that the technology committee will be reviewing
requirements related to electronic transmission and should requirements or standards change Centricity is required
to meet those new requirements. Christopher Barry second. Gary Harris opposed. MOTION CARRIED: 8-1.
Practice Fusion
Pharmacy Consultant Lisa Roberts provided the commission a brief background of Practice Fusions
proposal. Francis Toan, Program Manager, and Joshua Marker, Corporate Counsel, for Practice Fusion
were requesting approval for their electronic prescription transmission system, Practice Fusion.
This system offers a free, on-line, cloud based electronic prescribing system to physicians . This system
was disabled by Surescripts in December 2014 after they discovered Practice Fusion was conducting
business in Washington State without first obtaining the required Washington State Pharmacy
Commission approval . The commission staff subsequently worked with the company to expedite their
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request for consideration at the January 29 commission meeting.
Commission Members had significant concerns and engaged in lengthy discussion regarding access and
security of their platform, issues related to provider patient marketing practices that may not include
affirmative patient notification, and no dedicated route field as required in current regulation.
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MOTION: Gary Harris moved that the commission deny this request for Practice Fusions electronic
prescription transmission system on the basis of prescribing security concerns, marketing concerns, and
lack of route. Steve Anderson second. MOTION CARRIED: 8-0. Tim Lynch was excused prior to the
vote. Practice Fusion was invited to work with staff to remedy concerns and return for reconsideration.
Harborview Medical Center

Cathy Williams led this discussion and introduced Beverly Sheridan from Harborview Medical Center
who requested approval for centralized prescription processing by its outpatient/retail pharmacies with
centralized prescription filling at the Pat Steel Pharmacy.
Central Fill Requirements
HMC central fill policy and procedure submitted for approval
Patient medication records required by WAC 246-875-020 are maintained in the shared electronic system
accessible and auditable at all licensed locations
All retail pharmacies at Harborview are licensed in Washington state, are under common ownership, and
share electronic files used to process prescriptions
Controlled substances are not included in this Central Fill Application, which is limited to small subset of
patient prescriptions packaged in strip-packs
HMC Fastpak Program Overview
Harborview Medical Center Ambulatory Pharmacy Services 2000 prescriptions filled per day in 6 licensed
retail pharmacies
Some patient populations have challenges maintaining compliance with complicated medication regimens
o125 patients are currently included in FastPak program
Patients are screened/identified as candidates for FastPak by their primary care provider and/or clinical
pharmacist
Clinical pharmacist provides education on the FastPak program to the patient. This includes notification to
the patient that a different pharmacy will be filling their FastPak medications. This education is
documented in the electronic health record.
Patients pick up FastPak prescriptions from their regular HMC pharmacy (note: not all medications are
included in FastPak)
Eligibility criteria for patients
Patient has two or more prescriptions for chronic medications that are dosed three or more times per day
Patient has no social support to help with compliance (i.e. no family or caregiver, homeless)
Stable drug regimen

Patient engaged and attempting to be compliant, but may be confused about dosing or schedule (i.e.
cognitive issues, elderly)
Patient must be seen in a Harborview Clinic which has a dedicated clinical pharmacist for education,
monitoring and follow-up
Central Fill Pharmacy Responsibilities
FastPak/central fill prescriptions are processed in Pharmacys Cerner Etreby computer system
After order entry and verification by a pharmacist, prescriptions are flagged in Etreby as FastPak
Flagged FastPak medications are compiled for filling by the AutoMed packaging machine
Designated pharmacy technicians are responsible for maintenance of the Automed packaging machine
Completed FastPak strip-packs are checked for accuracy by a pharmacist
FastPak pharmacy technicians prepare delivery receipts, which are sent with the FastPak prescriptions to
the dispensing pharmacy
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FastPak pharmacy technicians ensure receipt of signed delivery paperwork from dispensing pharmacy and
filing in the central fill pharmacy
Dispensing Pharmacy Responsibilities
Pharmacy personnel sign delivery log from central pharmacy

Signed delivery log is faxed back to the central fill pharmacy, and original copy filed in dispensing
pharmacy
Pharmacists counsel and dispense FastPak to patient

HMC Fastpak Quality Assurance
Central fill pharmacist reviews profiles for all FastPak patients every 28 days. If patient is not complaint
with FastPak pick-up, the central fill pharmacist communicates this information to the patients primary
care provider or clinical pharmacist for further follow-up
Clinical pharmacists routinely monitor and manage FastPak patients. If a patient is not compliant, their
clinical status is not improving, or they have new social support, they may be taken off FastPak. The
clinical pharmacist notifies the central fill pharmacy when patients are to be removed from FastPak
Program
If a Fastpak patient is admitted to the hospital, the central fill Fastpak team is notified by an automated
email alert. (FastPak patients are flagged in the Cerner system by central fill pharmacy staff). The central
fill pharmacist places a hold on FastPak, and ensures updated orders are received prior to resuming FastPak
fills after discharge
FastPak pharmacy technicians are responsible for routine maintenance of the packaging machine using
recommendations from AmerisourceBergen
Medication errors or near misses involving FastPaks are reported via an online tool - Patient Safety Net (a
University Health System Consortium application.) Harborviews medication safety pharmacist and area
managers review and respond to all PSN reports. If system changes are implemented, changes are
evaluated at an appropriate interval to ensure desired outcomes
MOTION: Christopher Barry moved that the commission approve the proposal from Harborview Medical
Center for centralized prescription processing by its outpatient/retail pharmacies with centralized
prescription filling at the Pat Steel Pharmacy. They are asked to report to Cathy Williams who will
provide a specific list that the commission would like to see in their report back. Steve Anderson second .
STATUS
Cardinal Health
Cathy Williams gave the commission background on Cardinal Healths Remote Order Entry Services to
Whidbey Island Hospital that was approved in July 2013. Cathy read a letter that was written by Director
of Pharmacy from Whidbey Island Hospital he wasnt able to attend. The letter was responding to the
outcomes of approved services . Heidi Bragg, Director of Regulatory Compliance and Michael Mone, VP
Associate General Counsel handed out a copy of a Consultation Category Report to the commission
members. They provided a brief statistical update to the commission on their remote order entry services
to Whidbey Island Hospital. There were a few questions from the commission.
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FairFax Hospital Everett/Kirkland

Cathy Williams introduced A. J. Sinah and George Dimaris from Fairfax Behavioral Health. They
updated the commission on the use of their approved Remote Order Entry Services from Rx Remote
Solutions since they were given approval.
Remote Pharmacy Data 2014
Kirkland Site: Mar - Dec 2014
Total Orders: 9,361

Ave. Orders per Day: 25.65
Total Interventions: 119
Average Turnaround Times: 2.00 minutes
Average Processing Time: 1.99 minutes

Everett Site: Sept - Dec 2014
Total Orders: 397
Review of Daily Client Communication reports
Monthly phone meeting with RX Remote Director to discuss operational issues
Continue remote services with RX Remote Solutions, per original commission approval in January, 2014.
Ave. Orders per Day: 1.09

Total Interventions: 6
Average Turnaround Times: 0.95 minutes
Average Processing Times: 0.91 minutes

Remote Pharmacy Quality Review
Daily review of new admit profiles
Monthly review of intervention reports
Monthly Summary Data of Activity reported to P&T Committee and Med Exec Committee
Other issues encountered by Rx Remote (e.g. nursing issues)

Remote Pharmacy Solution Ongoing Improvements
Formulary Updates
Policy and Procedure Updates
Rx Remote site specific education

Remote Pharmacy Future Plans
Approval for expansion of services to new and future Fairfax BH Sites (including Monroe, WA Summer
2015)
OPEN FORUM
Jeff Rochon from WSPA shared that he personally cant wait until the technology rules are complete so
we have more time on other topics.
Legislation that the WSPA is running and their intent: Patient Medication Coordination, very clearly
removing the barriers for patients by pro rating their copays. Pharmacy Benefit Management that was
passed last year hasnt been forced or really adopted in any way shape or form by the payers they are
suggesting the wording says they dont need to implement just update some things, WSPA is working to
fix this. The other bill is regarding medical services provided by pharmacists WSPA and others are
working diligently on the loopholes that exclude pharmacists from contracting for medical services and
the concern is that pharmacists that are not getting compensated for their work.
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Ian Corbridge from the Washington State Hospital Association thanked Christopher Humberson and Lisa
Hodgson for their input on ways HB1402/SB5460 can be strengthened. HCE licensing issues there are
still a lot of outstanding questions and issues. WISHA requested back in October that commission provide
a formal written position on the HCE licensing issue to date it hasnt been seen. The request is that the
commission put a stay on the enforcement until there is clarity. He asked that the commission put a 2
week extension on the ability to comment on the compounding rules after the crosswalk is sent out.
Lis Houchen from NACDS asked the commission changes that occurred with the licensing of Canadian
Applicants. It used to be a real streamlined process that took about 3 months. The concern is that the
process is taking much longer and they are being asked to take the FPJE. When did this change occur,
how was it changed and why? Doreen Beebe shared that the board had a policy that allowed them to
come in like U.S. graduates. A few years ago they withdrew that policy. They are now recognized as
foreign graduates.
Paul Leyva from Roadrunner Pharmacy wanted to support the veterinary community and the needs
they have for quality compounding medication on which their patients depend on, particularly in the
face of allocation shortages, backorder and discontinued medications and the growing need for
customized solutions for companion pets. Often time's regulators are not fully aware of the fundamental
differences of how a veterinary practice operates when compared to a human practice. Veterinarians are
expected by you and me to treat our pets on the spot for emergency care. He just wanted to remind the board
that veterinarians do practice differently and continue to clarify the need for vets offices to use compounding
and the ability to dispense small amounts.
Billy Chow from Bartell Drugs had a few concerns he wanted to get the commission guidance on. Bartell
Drugs has been contemplating a single click container for closures so all prescriptions will be dispensed
as a child safety closure. The intent is to do away with collecting signatures for a non-child resistant
closure. The commission will work with Bartell Drugs to make sure they are compliant.
Bartell Drugs has adopted a wireless a thermometer does Bartell Drugs need to dispose the manual
thermometer? Chris Humberson will discuss this with Tyler Varnum and Gordon MacDonald to clarify
this.

There being no further business, the board adjourned at 6:45 pm.
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Approved March 12, 2015
Al Linggi, Chair
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STATE OF WASHINGTON
MEETING MINUTES
February 3 - 4, 2011
12401 SE 320th St
CONVENE
Vice-Chair Christopher Barry called the meeting to order at 9:02 a.m., February 3, 2011
Gary Harris, RPh,
Dan Connolly, RPh
Kim Ekker, Public Member
Guest / Presenters:
Chris Baumgartner, Prescription Monitoring Program Director
Jeff Corsentino, Pharmacy Operations Manager
St. Joseph Hospital

Joyce Roper, AAG
Dick Morrison, Pharmacy Investigator
UW PharmD Students
Andrew Heinz
Melody Maa
Andy Briggs
Eddy Ho
Bridget Baumgardner
Thu Le
Doris Nguyen
Tuvy Pham
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CONSENT AGENDA
1.1
New Pharmaceutical Firms - December 1, 2010-January 20, 2011
1.2
Closed Pharmaceutical Firms December 1, 2010-January 21, 2011

Pharmacy Tech Training Programs
1.3
Charter College
CHS Pharmacy
YVMH _ Waters Edge Pain Relief Institute
1.6
YVMH_ Cornerstone Medical Clinic

Board Minute Approval. (December 16, 2010)
will be removed from the consent agenda and placed on the regular business agenda. Item 1.5 was
deleted from the agenda.
MOTION: Dan Connolly moved that the board approve items 1. 1, 1.2, 1.3 and 1.6. Vandana Slatter
REPORTS
Board Member
Dan Connolly reported:
He has been active in recruiting people to testify for a great number of legislative bills. There
are a lot of important issues in Olympia this year and he strongly urged others to get out and
support these important bills.
He was interviewed by Ken Schram on live radio regarding the access to medication rule.
Gary was in Olympia to testify on the crimes against pharmacy bill.
Executive Director
Susan Teil Boyer report:
Legislature convened January 10, 2011 and several bills were introduced. Major bills include
the Synthetic Cannabinoids, Medical Marijuana Dispensaries, Medicine Take Back, CE for
Pharmacy Technicians, Crimes against pharmacies, Regulating the handling of hazardous
drugs, out of state ARNPs prescribing CS.
Statewide Electronic Tracking of Methamphetamine Precursor Products Legislation:
The board staff has drafted new language to balance privacy and law enforcement concerns for
the revised CR 102 to be reviewed by the board today.
Chris Baumgartner is the new director of the Prescription Monitoring Program and has begun
the rulemaking process. Chris will be presenting to the board this afternoon and hopes to have
the Prescription Monitoring Program up and running this October.
The HHS Assistant Secretary of Health Dr. Howard Koh and his Region X colleagues
organized a public health summit to review and share lessons learned from the past two years
of influenza prevention. Susan presented a review of the growing pharmacists public health
role in providing influenza vaccine to the public in Washington State, including a review of
collaborative drug therapy agreements and the boards process. More people are vaccinated by
pharmacists than any other professional in Washington.
Susan and Tim met with a state representative regarding her interest in cutting Medicaid drug
costs by recycling unused medication to Medicaid patients.
Kingsbury0292
A letter was sent out via the Board of Pharmacy and RTF List serves to clarify guidance from
the DEA and Board of Pharmacy regarding controlled substance use in an RTF, this was an
update to the May 2010 letter concerning controlled substances.
Board Planning Retreat will be August 11, 2011.
Board and Commission Associations Meeting December 17. Meeting with associations to
discuss budget, licensing and discipline processes.
After the board decided to end the rulemaking on Access to Medications, the plaintiffs in the
Stormans case contacted Joyce and they met with the judge to re-activate the case and set a
new trial date. The date set for a 10 day trial will be November 28, 2011.
In December, Joyce attended an FDA/CDC Conference regarding emergency preparedness.
Legal counsel working on emergency preparedness for the states and territories were invited.
The FDA is interested in developing better processes so they can better assist states and
emergency responders during a major public health event.
Tim reviewed the states information about recycling of unused medications for indigent patients for
a legislator. He was unable to find any evidence to show the goals of the recycling were
accomplished.
He drafted a letter to PSC Environmental, LLC concerning the state licensing requirements
developed with input from the Department of Health legal department, the department of health
pharmacist investigator service, the Seattle field division Drug Enforcement Administration, and
the board of pharmacy consultants and staff. PSC is a reverse distributor that plans to operate
transportation terminals that distribute, package, prepare, and pick up the waste pharmaceuticals
from the customers site. The regulatory agencies determined the transportation terminals need to
become a licensed wholesaler to have medications at their locations.
On January 25-26, 2011 Tim participated in Operation Tree Frog at the Public Health Emergency
Response Warehouse (RSS). The new site was much smaller and they received 120 cases of
antibiotic. While there were space and flow of goods challenges, the volunteer force took them in
stride. He was the Quality Assurance Lead and Jim Doll was his alternate.
Tim determined methods to re-label medications for the Public Health and Emergency Response
program. CDC and the FDA utilized both extended expiration dates and emergency use
authorization which require changes in medication labeling. He also attended handheld computer
training for the Reception, Storage, and Staging (RSS) operation.
Mr. Fuller and Susan Boyer joined the Nursing QA Commission and Medical QA Commission to
begin the examination of nurse, RN and LPN, renewal of prescriptions. Nursing and Pharmacy
consultants regularly receive calls questioning the renewal of prescriptions.

In December Cathy attended the Washington State P&T Committee meeting.
Cathy met with Tom Hazlet, law professor at the UW School of Pharmacy in January to select
and prepare answers to questions for the Washington State Pharmacist Associations (WSPA)
New Drugs New Laws seminar held January 23, 2011.
She also attended the seminar on January 23, 2011 held by
seminar.
WSPAs New Drugs New Laws
Chief Investigator
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The Customer Satisfaction Survey Process is being continued because it helps investigators
notice trends early on. The belief is that item 2, the service or information was clear and
understandable is rated low because of the complexity of state and federal pharmacy regulation.
And that item 4 The staff was well informed; violations cited were appropriate was rated low
due to the fact that no one wants to believe what they have been doing is incorrect.
Announced or Unannounced Inspections have changed several times during the time Grant has
been associated with the board. In 2002 or 2003 the legislature created a law (RCW 70.41.120)
that required general hospital inspections be conducted with a prior notice of inspection. In
2009 the legislature changed the law and required that hospital inspections be unannounced.
Currently the Board of Pharmacy investigators perform unannounced inspections with an
inspection philosophy that includes technical assistance and education.
USP seeks comments on new standards for prescription labels which would go into effect some
time in 2012.
RECOGNIZE BOARD MEMBERS
The board recognized Dan Connolly and Vandana Slatter for serving their terms on the board.
Dan Connolly shared his retail and community perspective with the board during his term. Vandana
Slatter provided the board with a broad outlook and had great questions to issues brought before the
board. Both members will be greatly missed and are wished well with their future endeavors.
DISCUSSION
Implementation of Engrossed Second Substitute House Bill 2961 Additional Stakeholder Meeting
The board discussed follow-up comments regarding data access provided in approved rule language to
implement statewide electronic sales tracking system for methamphetamine precursors and will decide
whether to hold another stakeholder meeting.
Joyce Roper provided some background to the board. Joyce Roper and staff answered any questions
the board had regarding changed rule language.
MOTION: Vandana Slatter moved that the board move to reconsider data access language to the
CR102 rule in support of HB 2961 . Dan Connolly second. MOTION CARRIED: 4-0.
Stakeholder Meeting Implementation of E2SHB 2961

The board heard a few more comments from stakeholders . They were asked to decide whether to
modify the approved language or keep the recently updated draft for the rule . Doreen Beebe went
through the draft language with the board.
MOTION: Vandana Slatter moved to accept language as drafted on the screen for 0 246 889 110.
Gary Harris second. MOTION CARRIED: 4-0.
Failing the North American Pharmacist Licensure Examination (NAPLEX)

The board was asked to discuss strategies to develop a procedure to guide pharmacist applicants that
must seek authorization for re-exam . Doreen Beebe provided the board with a summary of what other
states have in place for applicants seeking authorization for re-exam.
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MOTION: Gary Harris moved that the after the third failure the applicant must complete 750 intern
hours and wait 1 year before re-exam or complete an ACPE accredited PharmD Program. Vandana
Slatter second. MOTION CARRIED: 4-0.
2011 NABP/AACP Annual District Meeting

The board heard an update from Susan Boyer and Leann George on plans for the upcoming District 6,
7, 8 meeting scheduled for October 4 -6, 2011 at the Edgewater Hotel, Seattle.
Rule Making Petition Requiring Identification
The board considered a petition from Michael Schiesser, MD, pain specialist . He is petitioning the
board to require valid identification when picking up a controlled substance prescription (WAC 246887) in order to address prescription drug abuse. Susan Boyer provided the board with some
background on this petition.
MOTION: Dan Connolly moved that the board accept the petition requiring identification when
dispensing controlled substance prescriptions. The petition will move forward for approval of
exemption from the rules moratorium . Vandana Slatter second. MOTION CARRIED: 4-0.
EXECUTIVE SESSION
The board adjourned for Executive Session at 12:30 p.m.

CASE PRESENTATIONS
DISCUSSION
contd
2011 Legislation
SB5101
Updates
Regulating synthetic cannabinoids into Schedule I
five substances mirroring
the boards emergency rule.

HB1285
SB5073/HB1100
SB5598/HB1550
HB1353
HB1417
SSB5307
HB1507
SB5390/HB1370
SB5229
Regulating synthetic cannabinoids into Schedule I adds eleven substances.

Medical use of cannabis Establishes licensure by the department of
agriculture for producers and proce ssors; the department of health license
dispensaries.
Regulating the sale of cannabis legalizing cannabis under the liquor control
board.
Continuing education for pharmacy technicians.
Evaluate military training and experience toward qualification for pharmacy
technician certification.
(substitute bill) Military training and experience satisfies training and
experience requirements for pharmacy technician certification unless the board
determines it is not substantially equivalent to the state standards.
Crimes against pharmacies Adds the robbery and burglary of a pharmacy to
the Washington criminal code.
Authorize WA pharmacies to dispense controlled substance Rx written by
ARNPS from other states.
Creates an exemption from preferred drug substitution for atypical
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HB1397
SB5234/HB1370
HB1496
HB1493
SB5594
SB5454/HB1304
antipsychotic drugs
Requiring the state Medicaid agency to establish a competitive bid process for
generic drug manufacturers.
Statewide program: collect/transport/dispose unwanted meds Establishes a
medication return association licensed by the board of pharmacy.
Disposal plan for residential sharps waste required of pharmaceutical
manufacturers that sell or distribute drugs into the state intended to be self injected at home.
Transparency in the health professions disciplinary process.
Handling of hazardous drugs - Department of Labor and Industries in
consultation with the department of health will establish standards for the
handling of hazardous drugs.
Administration of drugs by health care assistants (HCA) Narrows to two
categories of HCA previously certified to give injections.
Rules Update
The board discussed the proposed rulemaking workload.
Access to Medications Board moves to cease rule making Withdraw CR101 - Pending Agency
Approval.
Correctional Pharmacies CR101 need to conduct additional stakeholder work.
Update Animal Control Agency and Humane Society Rules (petition) CR101 approved language
pending CR102 filing.
Synthetic Marijuana Board authorized rule/emergency filing -CR103 E Emergency Rules filed
1/7/2011; CR101 pending. Gary Harris is appointed as Board Champion for this rule.
WDFW update approved controlled substances listed for chemical capture CR103 pending approval.
Delegation of authority to initiate investigations Repeal CR105 pending
Electronic tracking of pseudoephedrine, ephedrine, phenylpropanolamine Discussion and
stakeholder meeting today February 3, 2011 the approved language will move forward.
Hospital rules Tim Fuller is drafting an exemption request.
Intern Rules- Cathy Williams should be filing an exemption request.
WRAPP Advisory Board (petition) This rule needs an exemption request. Gary Harris is board
champion on this and has offered to help board staff prepare an exemption request.
Correspondence
The board discussed correspondence received and sent.
Charleston Baptist Church
InfuSource -License Exemption Granted
Internet Drug Outlets_ Not Recommended
ISMP/MSA January 13, 2011
ISMP/MSA January 27, 2011
ISMP/MSA December 16, 2010
NABP e-News December 2010
NABP e-News Jan 2011
NABP Internet Drug Outlet Report_ January 2011
PRESENTATIONS
Bellingham St. Joseph Hospital Update
Jeff Corsentino, Pharmacy Operations Manager for St. Joseph Hospital presented a follow-up on its
process to utilize on-call pharmacists entering medication orders from home.
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Two month study outcome:

Errors from home after 30 hour study there were no incidents.
Errors in hospital after 30 hour study there were 21 incidents.
Great program providing staffing flexibility.
Night time pharmacist can receive help in a pinch.
It has been great to have the ability to just call an at home pharmacist to cover during meetings
at the hospital.
Pharmacists at home are happy and grateful for this new program.
Pharmacy to technician ratio is good.
Error rates are great.
No turnover with at home pharmacists.
A total of 3 pharmacists are working from home.
Hospital is continuing to monitor errors.
Will be happy to provide another report in 6 months .
Prescription Monitoring Program
The board was given an update on the implementation of the Prescription Monitoring Program (PMP).
Chris Baumgartner provided the board information and updates on the PMP program since it has
received funding in 2010 to restart the program.
Background:
Legislation was passed in 2007
DOH obtained funding in July 2008 for start-up and first year operation from the legislature
DOH suspended the program due to budget constraints in December 2008
Federal funding was obtained in October 2010 to restart the implementation
DOH plans to release a RFP to find an Application Service Provider for data collection and
reporting
Department of Health Goals:
To give prescribers an added tool in patient care
To allow prescribers and dispensers to have more information at their disposal for making
decisions
To get those who are addicted into proper treatment
To help stop prescription overdoses
To educate the population on the dangers of misusing prescription drugs
To make sure that those who do need scheduled prescription drugs receive them
To curb the illicit use of prescription drugs
Adding Drugs to the Program:
RCW 70.225
Schedules II, III, IV, and V controlled substances and any additional drugs identified by the
board of pharmacy as demonstrating a potential for abuse
Rules will determine how this is done
Rule schedule:
Two Rule Web Conferences
1/21 & 1/27
DOH Review
Goal: February to April 2011
Public Hearing
Goal: Late May 2011
Rule Publication
Goal: July 2011
Proposed Implementation Timeline:
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Release an RFP in March 2011

Select a vendor by the end of April 2011
Begin customization of vendor system for WA Requirements in June 2011
Start data collection from dispensers in October 2011
Data requests begin January 201

Expiration date proposal for ADD/ADHD CII prescriptions

Troy Daniel, Kathy Glem, Andrew Heinz, Jessica Ritchie, Reilly Thomas,
Sophia Vuong, Michelle Wong
RCW 69.50.308(d) does not set an expiration limit for CII drugs. This can cause confusion for patients
because there is an expiration date for CIII-IV prescriptions.
By changing the law, we would hope to see less forgery, better patient care. We would also like to see
closer surveillance of patients and hopefully better patient awareness and parental supervision. We
believe our alternative would reduce confusion and abuse and increase patient compliance and
understanding of the medication.
Mandatory Notation of Purpose on Electronic Prescriptions

Bridget Baumgardner, Melody Maa, Thu Le, Andy Briggs, Doris Nguyen,
Eddy Ho, Tuvy Pham
Institute of Medicine study found that as many as 98,000 Americans were killed by medical errors in
hospitals each year. Medication errors result in about 7,000 deaths each year. Dispensing error rates
ranged from 0% to 13% in a 50 community pharmacy study. Overall dispensing error rate was 1.7%.
We would like to propose a mandatory notation of purpose field on electronic prescription
transmission systems . We feel this will reduce medication errors that lead to high healthcare costs and
adverse events.
OPEN FORUM
Gary Harris had a trophy that an old friend of his gave him. He decided he wanted to start passing this
trophy within the board members, staff and investigators. He chose to start the Pass the Traveling
Trophy to Doreen Beebe. He wanted to acknowledge all her hard work and her dedication to the
Board of Pharmacy. She may hold on to this trophy for as long as she wants and then pass it on to
whoever she wants to within the Board of Pharmacy.
Susan Teil Boyer stated the Washington State Pharmacy Association (WSPA) was formed in 1890 and
the Board of Pharmacy was formed in 1891. The WSPA worked to help get the board up and running.
Jeff Rochon (WSPA) thanked Gary Harris and the board for sending Gary Harris to testify on the bill
regarding crimes against pharmacies.
CLOSED SESSION
Case presentations
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Disciplinary Hearings___________________
WA State Criminal Justice Training Commission
19010 First Ave So Rm C-101
Burien, WA 98148
_____ February 4, 2011_9:30 a. m.
_______________________________
Approved on April 7, 2011
_____
___________
Al Linggi, Chair
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STATE OF WASHINGTON
MEETING MINUTES
February 21, 2013

Renton WA 98057
CONVENE
Chair Christopher Barry called the meeting to order at 9:03 a.m., February 21, 2013
Board Members:
Gary Harris, RPh,
Donna Feild, RPh, MBA, Vice Chai
Staff Members:
Joyce Roper, AAG
Guest / Presenters:
Jerry Berndt, RPh Bridgeport Pharmacy
Services and Omnicare Company
Randy McGladrie, Customer Facing
Technology Omnicare, Inc.
Glenn Adams, PharmD Director
Pharmacy for Confluence Health
Jennifer Tryon, PharmD Asst Director of
Pharmacy for Peachealth SW Med Ctr
Doug Beck, Pharmacy Director for Schick
Shadel
Jeannie Jenkins, Clinical Manager for Sarvey
Wildlife Care Center
Jeff Scott, Asst Operation Manager for Kroger
Central Fill
Jeff Welter, General Manager for Kroger/Fred
Meyer
Gerald Steel
Absent Staff Member:

Cathy Williams
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Approval of Business Meeting Agenda

Approval of January 10, 2013 Business Meeting Minutes
Approval of Consent Agenda
1.1
1.2
1.3
MOTION: Donna Feild moves that the board approves 1.1, 1.2, and 1.3. Gary Harris second.
CONSENT AGENDA
single motion of the board without separate discussion. If separate discussion is desired, that item will be
1)
2)

January 2013 Administration and Transaction Reports
3)
4)
5)
6)
7)
New and Closed Pharmaceutical Firms January 4 thru February 11, 2013
Ancillary Utilization Plan Approval
Continuing Education Program Approval
Automated Drug Dispensing Device Approval
8)
9)
10)
11)
NW Hospital and Medical Center

Electronic Prescription Transmission System Approval
Sample Drug Distribution Approval
Household Pharmaceutical Waste Take Back Program Approval
Tamper Resistant Prescription Paper/Pads Approval
Items listed under the consent agenda are considered routine agency matters and will be approved by a single
motion of the board without separate discussion. If separate discussion is desired, that item will be removed
from the consent agenda and placed on the regular business agenda. Items 3, 4, 5, 6, 8, 9, 10, and 11 were
deleted from the agenda.
MOTION: Elizabeth Jensen moved that the board approve items 1, 2, and 7. Gary Harris second.
REPORTS
Board Member
Dan Rubin reported:
He has been participating weekly legislative discussion calls.
Gary has been part of the panel interviewing for a new board member. He believes several of the prospects
seem as if they will make great future board members.
She attended a meeting that Janet Wright from the CDC presented. This was about the value of education
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to prevent high blood pressure, stroke and heart attacks.
She also attended the HIV National Strategy day.
Donna has also been on the interview panel for a new board member.
She has been busy interviewing for the residency program at the hospital.
Chris Barry reported:
Mr. Barry works half of his time in an IV room in a hospital. He visited the River Point Pharmacy in
Spokane which is a compounding pharmacy. He did not do this as a board member but as a pharmacist
looking at a compounding pharmacy that hospital occasionally uses. He also visited a Home Infusion
Company.
Executive Director
Chris Humberson acknowledged Doreen Beebe for all her hard work during the legislative session!
Rules Coordinator job position has been posted. Hope to have this position filled by April 1, 2013.
Interviews for a new board member have been completed packets have been submitted through DOH to
the Governors office.
There was an article put in the newsletter regarding compounding practices. Letters were mailed out to all
resident and non-resident pharmacies
We have been increasing contact with other boards and commissions.
He will be getting together with the Medical and Dental Commission on topics related to pharmacy.
Chris will attend the Naturopathy meeting February 22, 2013 and attending Veterinarian Board of
Governors meeting March 4, 2013.
Attended Health Care Committee chaired by Representative Cody on HB 1800 on compounding.
Tim Fuller and Cathy Williams and Chris attended and presented to the WSPA Law Review on February
10, 2013. This was very well attended.

Joyce has been included in an AGO internal workgroup focusing on Initiative 502, because she is the
attorney for the Board of Pharmacy and has worked on medical marijuana issues. The AGO has put
together an Initiative 502 workgroup for the various assistant attorneys general whose clients have some
role in implementing the initiative 502 recreational marijuana law to better assure consistent approaches in
addressing this new law. The Governor and Attorney General have met with U.S. Attorney General Eric
Holder and we are awaiting guidance from the United States Department of Justice about what they intend
to do with respect to these new laws in Washington and Colorado. Governor Inslee and Attorney General
Ferguson told Eric Holder that they are moving forward to fully implement the initiative as directed by
Washingtons voters.
Tim introduced University of Washington Extern Svetlana Nozdrina and Washington State University
Extern Robin Seagrove.
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Pharmacist investigator Jim Doll retires at the end of this month after 21+ years of service to the Board of
Pharmacy and Department of Health.
We are in the process of modernizing the pharmacy
February 7, 2013 he gave Pharmacy Tips for Consumers at the Department of Health in Tumwater.
investigators computer equipment.
February 7, 2013 Grant presented a Law Presentation at SW Pharmacy Association in Vancouver,

Washington.
Julie Faun reported:
They are finding that there are pharmacists who are responsible pharmacists at multiple locations. This is a
challenge because there really is not accountable.
Also continue to find pharmacists are overworked and wish the board would set guidelines for the amount
of prescriptions a pharmacist can fill.
The incentives that are offered for transferring prescriptions are causing problems with pharmacies
because they are ending up with incomplete files .
PRESENTATIONS
OmniviewDR
Tim Fuller introduced Jerry Berndt, General Manager for Bridgeport Pharmacy Services an Omnicare Company.
Jerry is asking for the boards approval to use OmniviewDR the Certified Electronic Prescription System which
has met the Drug Enforcement Agencys (DEA) standards. After some background and overview Randy
McGladrie was introduced by Jerry. Randy provided a demonstration on how the system works.
Overview:
OmniviewDr is the first electronic prescription transmission system in Washington State to meet the DEA
requirements for transmission of controlled substances. In addition it meets the requirements for both
prescribers sending electronic controlled substance prescriptions and pharmacies receiving them. The
Board needs to determine how the EPCS systems will be recognized in Washington State.
In Washington State electronic prescriptions for Schedule II controlled substances are not authorized in
law or rule. Schedule III and IV electronic prescriptions for controlled substances are.
There are many details to be satisfied to achieve compliance and use EPCS transmission systems. The
DEA is concerned about security and processing integrity to maintain a closed system for controlled
substances. The DEA Interim Final Rule for EPCS requires that the software for the prescriber and for the
pharmacy must be independently certified as compliant with EPCS as stated in 21CFR1311.
Potentially each prescriber and each pharmacy in the state would like to send and receive EPCS. The
pharmacy could receive a controlled substance prescription prior to arrival of the patient and prescriber
could see that the prescription arrived at the pharmacy. The software should make it easier to determine if
the prescription is for a legitimate medical purpose. Pharmacies and prescribers who do not have a DEAcertified software system will likely be upset. The decision could have a workload impact on the Board of
Pharmacy.
Board Concerns that were discussed:
Can the devices be shared or delegated? No, sharing devices is not allowed.
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Does this system prevent someone who has limited prescribing authority from prescribing medication
they are not authorized to prescribe? This was discussed and part of the motion some changes will be
made.
Does the system flag clinical errors, or any other type of alerts? The system does not flag all situations it is
the pharmacists responsibility.
MOTION: Elizabeth Jensen moved that the board approve the use of OmniviewDR with the following conditions.
This is specifically a closed system for use only in skilled nursing environments. The board does not imply that it
would approve a technically similar syste m for an open environment. The system is
approved at this point only
for Schedules 3-5. The board will reconsider this restriction if the Legislature enacts changes in law permitting eprescribing for Schedule 2, and assuming an appropriate request by Omnicare. The text telling prescribers what
classes of drugs they can e-prescribe will be changed to add the caveat that prescribing also is limited by specific
providers legal scope including any disciplinary conditions that may pertain. An addition also will be made to the
softwares reference library linking to the boards prescriber authoritys document. Training for prescribers will
include a caution to verify the prescribers audit profile frequently. A report is due to the board in one year
addressing the boards desire for further improvements to increase specificity of prescribing rights by provider
legal type, and other improvements. Donna Feild second. MOTION CARRIED: 7-0.
Sterile compounding
Tim Fuller introduced Glenn Adams, PharmD Admin Director of Pharmacy for Confluence Health. Glenn Adams
led the presentation to the board asking for them to consider the proposal from Confluence Health Systems (a new
healthcare organization). Confluence Health Systems is seeking approval for non-chemo sterile compounding be
performed by the non-chemo experts and distributed to affiliated hospitals/clinics and Chemo sterile
compounding be performed by the Chemo experts and distributed to affiliated hospital/clinics.
Overview:
Hospitals currently are aligning under a health-system management in response to the Affordable Care
Act. Pharmacy departments within these systems of care have sought efficiencies with these healthsystems. For example, they have changed from preparing sterile products pursuant to a prescription from a
provider at the pharmacys facility to using one pharmacy site to prepare sterile products for hospitals,
facilities, and home care programs.
Confluence Health is a new affiliated business in North Central Washington. Confluence Health operated
the following hospitals. Wenatchee Valley Hospital and Central Washington Hospital and associated
clinics for both.
The patients of Confluence Health will be receiving sterile products from hospital pharmacies that
specialize in either non-chemotherapy sterile products or in chemotherapy sterile products. This is
expected to provide increased quality of the products and care, particularly at clinic sites that do not
currently receive sterile products from the pharmacies .
The licensing of the hospital (compounding) pharmacies under the umbrella of Confluence Health allows
these pharmacies to continue to be licensed as hospital pharmacies.
The centralized system of parenteral product preparation and delivery should provide Confluence Health
with some additional efficiencies.
The standardization of the sterile product services will support the reduced expiration dating program
being developed by Confluence pharmacies.

Expected Outcome:
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Goal: To improve patient safety

Sterile Compounding Compliance: Confluence Health pharmacy is attempting to limit/eliminate our need
to outsource sterile compounding of medications. Instead of utilizing extended dating guidelines, we want
to produce medications in small batches, more frequently, with shorter expiration dates. Ultimately, our
goal is to utilize robot technology for sterile compounding procedures .
Workload Distribution: Confluence Health pharmacy would like to utilize our current equipment, space,
and staff at each facility to evenly distribute workload across the system.
Product Line Experts: Irrelevant of patient location, the pharmacy experts in specific areas of pharmacy
(i.e oncology) would perform the sterile compounding needs for the health system.
The board discussed and asked questions to clearly explore areas of risk as applied to clinic setting and therefore
there is no presumption that this would apply to other situations for central compounding for transport to clinical
settings and to non hospital settings.
Donna Feild moved that the board allow Confluence Health Systems non-chemo sterile
compounding be performed by the no-chemo experts and distributed to affiliated hospitals/clinics and Chemo
sterile compounding is performed by the chemo experts and distributed to affiliated hospital/clinics. Gary Harris
MOTION:
Pharmacy Services from Remote Locations.

The board was asked to re-consider a proposal by PeaceHealth Southwest Medical Center (PHSW), heard at the
November meeting, to allow staff pharmacists to provide limited patient care services from remote locations. The
board requested PHSW return with written policies and procedures to address issues such as competencies, opt-out
process, site inspection, dedicated workspace/time, security, etc.
Overview:
Why Remote Medication Order Processing?
In many instances when there is a situation which results in increased medication orders, it is impossible to
train new staff quickly and there is often a reduced number of pharmacy staff.
Due to the complexity of pharmacy care and lean staffing guidelines it allows the pharmacy to free up onsite staff with specialty knowledge to help co-workers (ex: NICU, Oncology) and better serve the patient.
Medication-Use Management and Safety
Policies and procedures reflect the special efforts required in the coordination of quality-assurance,
quality-improvement, and patient safety practices between the hospital and the remote site which include
safety, quality, and risk management. The remote pharmacist needs the ability to:
Review of the Patients Profile
Clarify Medication Orders

Participate in Quality-Assurance and Medication Error Reporting Systems
Handoff Communications.
Access Drug Information Resources
Access other related Hospital Policy and Procedures
Training and Orientation
Each volunteer will be trained to ensure competency with:
Technical Standards and Specifications
Confidentiality, Privacy, and Security.
Regulatory Considerations
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Communication and Problem Resolution

Inspection of Remote Sites
Implementation Requirements
Early and frequent communication
24/7 technical support
Education of other hospital staff
Flexibility to adjust to workload demands after the go-livedate

Report back to the Board of Pharmacy a year after implementation.
MOTION: Gary Harris moved that the board approve the proposal by PeaceHealth Southwest Medical Center
(PHSW), heard at the November meeting, to allow staff pharmacists to provide limited patient care services from
remote locations. Elizabeth Jensen second. Donna Feild recused herself. MOTION CARRIED: 6-0.
Automated Drug Distributions Device
Tim Fuller introduced Doug Beck, Pharmacy Director for Schick Shadel. The board was asked to
consider approval of the policies and procedures for the use of ADDDs by Schick Shadel Hospital.
Due to some pharmacy issues, it was determined in the spring of 2012 that Schick Shadel needed to reapply for
approval to use automated medication storage devices (Pyxis and MedStation). Doug provided the board a list of
override medications. He clarified that Schick Shadel Pharmacy did not employ a pharmacy technician.
The board discussed concerns regarding criteria used to override medications and who was authorized to do
overrides. A common concern in all ADDD proposals is who restocks these devices . Doug was able to provide the
board with answers and give any other explanations needed for the board. Doug was able to prove that the benefits
out ways the risk.
MOTION: Donna Feild moved that the board approve the policies and procedures for the use of ADDD s by
Schick Shadel hospital written. Dan Rubin second. MOTION CARRIED: 7-0.
P RESENTATIONS Contd
NAPLEX Study Plan
A board panel was asked to consider a request by Pharmacy intern Desiree Heslop for authorization to re-take the
North American Pharmacist License Examination. The intern will presented a study plan for consideration by a
panel of the board.
MOTION: Dan Rubin moved that the panel reject the study plan as submitted. Desiree was asked to work with the
Pharmacist Consultants and Chris Humberson for assistance in preparing a study plan to resubmit for consideration
from the panel. Elizabeth Jensen second. MOTION CARRIED: 3-0.
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Euthanasia Training Program

Doreen Beebe introduced Jeannie Jenkins, Clinic Manager for the Sarvey Wildlife Care Center. Jeannie asked
the board to consider a request from Sarvey Wildlife Care Center for approval of its euthanasia training program.
Training will consist of two parts:
A lecture will be taught by a licensed veterinarian or a person who has completed an approved training
program taught by a licensed veterinarian and a practicum using animal carcasses and live animals, if
available, taught by the same. This course will be at least four hours in length.
There will be a written exam directly following the course that will require a passing score of at least 75%.
The practical training will include step by step explanations and all participants will complete each step
until proficient before going onto another step or species.
Various dangerous and unusual circumstances concerning handling wildlife will be discussed along with
the proper safety precautions.
The final portion will be a demonstration of the correct method of logging controlled substances as per the
amended WACs 246-889.
The HSUS Euthanasia Training manual by R.H Rhodes, DVM, Compassionate Wildlife Euthanasia by
Lesanna Lahner, DVM, MPH, and Sarveys Amended WACs Protocol, Sarveys Record Keeping for
Controlled Substances February 2013 , Sarveys Procedures for Euthanasia , and Sarveys Dosing and
Administration will be the bases for the training.
The board asked questions regarding storage, accountability and keeping track of drugs being used.
MOTION: Elizabeth Jensen moved that the board approve the euthanasia training program from Sarvey Wildlife
Care Center with the amended sentence, Sarvey Wildlife Care Center will issue certificates of completion and
maintain a list of participants for at least two years. Donna Feild second. MOTION CARRIED: 7-0.
Central Fill Pharmacy Proposal

Chris Humberson introduced Jeff Welter from Kroger Fred Meyer who asked the board to consider a proposal by
Kroger/Fred Meyer for approval of centralized prescription processing and filling.
Workflow:
Users at the local pharmacy perform the following regular workflow steps:
Reception (or Rx Intake)
o
Data Entry
o
Release to Patient
o
Users at the Central Fill facility perform the following regular workflow steps for eligible Rxs:
o
o
o
o
o
DUR ( if any) (can also be performed by a store user)

Adjudication Exception handling (can also be per formed by a store user)
Pre-Verification (for new Rxs) (can also be performed by a store user)
Product Dispensing
Verification
Furthermore, for Central Fill processing some additional tasks are added to the workflow:
Local pharmacy options added for central fill processing:
o
Pull Back optional step to pull Rx back from Central Fill at any time
Check In filled Rxs from Central Fill added into local system when received
Central Fill tasks added for Central Fill processing:
o
Decline Back Central Fill can return Rx to local store for them to fill (dont
have drug, etc)
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Restock
Rxs returned to Central Fill are returned to stock (patient didnt pick
up, etc)
Check Out
for delivery
after Rx filling is complete, it is checked out & placed in store tote
Central Fill Prescription Eligibility:
The delivery time is equal to or greater than the Next Available CF Delivery Time
A promise time check is performed at two points during workflow. A Central Fill
o
eligibility check is done immediately after the Reception step to determine if CF can meet the
promise time. If a Central Fill facility cannot meet the time, then the prescription is not a Central
Fill candidate. Once it is identified that Central Fill can meet the promise time, the prescription
can proceed to the next workflow step.
After Pre-Verification of a new prescription and a DUR of refills, a second eligibility
o
check is performed to insure that the system can still meet the promise time, since time has elapsed
between the eligibility check and Pre-Verification. If CF can still meet the promise time, the
prescription is sent to Central Fill. Otherwise, it is moved to the dispensing queue in the local
store.
Central Fill stocks around 2800 drug items if the Rx is for a drug
Central Fill eligible and will be filled at the local store.
they dont stock, it is not
SIG: The SIG must be less than or equal to 144 characters.

o
Central Fill labeling does not have extended SIG functionality
Other factors that make Rxs NON-Central Fill candidates:
Controlled Substances: Central Fill does not stock any controlled substances.
Compound Prescriptions: compounds are NOT filled at Central Fill.
The system has the capability to prevent a patients prescriptions from being filled at Central Fill, if
the patient so desires.
Partial Fills: Partial and Completion fills are not allowed to go to Central Fill.
High Priority Fills: High priority fills are not allowed to go to Central Fill.
Bag Return and Return to Stocks:

Bag return
Empty Central Fill clear plastic bags should be returned DAILY
Return To Stocks
A store may return a prescription filled by Central Fill no later than 21 days from the dispense date
o
If the user attempts to return an item to Central Fill after 21 days from dispense date, the
system blocks the activity and prompts the user to place the item in local inventory instead.
If a store user cancels a fill that has been checked in from Central Fill but not been released to the
patient, the System alerts the user that the Rx was processed by Central Fill. The system presents the
following options:
o
Add Product to Your Inventory Black out patient name and mark bottle RTS before
shelving
Your BOH is automatically adjusted by EPRN
o
Return Product to Central Fill keep the Rx as-is seal in tote for return
If the Store user opts to return the prescription to Central Fill, the system routes the fill to Central
Fills Restock queue.
An itemized credit memo will be sent at the beginning of each week detailing the previous weeks
returns to Cen tral Fill with Rx #s and dollar amounts.
9
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Board Concerns that were discussed:
All pharmacists that will be filling must be licensed in Washington State .

Who will be held responsible/accountable if there is an error? Grant Chester spoke regarding this concern
stating that during an investigation once it is discovered where the error happened that pharmacist will be
held responsible.
MOTION: Donna Feild moved that the board approve Kroger Central Fill as submitted with the understanding
that they must meet all laws of Washington State and all pharmacists must be licensed in Washington State. Dan
Rubin second. Gary Harris recused himself. MOTION CARRIED: 6-0.
DISCUSSION
Rule Making Petition
Chris Humberson introduced Gerald Steel who is asked the board to consider a petition on behalf of the
Washington Action for Safe Water for rulemaking to amend WAC 246-883-020 Identification of legend drugs
for purposes of chapter 69.41 RCW, and WAC 246-879-010(9) to identify fluoride as a legend drugs.
Mr. Steel went through several chapters of the WAC explaining his recommended amendments. After the
board heard all of his suggested amendments, several Board members and the Boards AAG, Joyce Roper,
asked questions and engaged in a dialogue with Mr . Steel. Ms. Roper explained the Washington Supreme
Court decisions in the Parkland Light & Water and City of Port Angeles cases. Based on the Washington
Supreme Court decisions in those cases, in which the Supreme Court said the decision to fluoridate drinking
water is vested in the water districts, under chapter 57.08 RCW, and the State Board of Health and DOHs
Drinking Water Program, under RCW 43.20.050, the Board of Pharmacy discussed whether it had jurisdiction
on the question of fluoridation of water and decided that this was not within the jurisdiction of the Board of
Pharmacy.
MOTION: Dan Rubin moved that the board deny the petition with the understanding that the Board of Pharmacy
does not have jurisdiction over this issue. Gary Harris second. MOTION CARRIED: 7-0.

Dan Rubin presented a bill update from the calls he participated in.
HB: 1859 amends existing law adding provisions to evaluating the training experience of individual applying for
licenses including pharmacy assistants not pharmacist and pharmacy technicians.
SB: 5629 fines against hospitals for excessive boarding of patients in emergency department would go to support
the PMP.
HB: 1448 recognizes telemedicine as a reimbursable service by which an individual receives medical services
from a health care provider without face to face contact with the provider .
HB: 1565 a bill on funding PMP from Medicaid fraud penalty account . This has moved out of the policy
committee into the rules committee and is moving forward.
HB: 1596 authorizing Washington Pharmacies fill prescriptions written by Physician Assistants.
HB: 1518 this is the next step in the pilot to evaluate the effect of granting the commission additional authority
over budget development, spending and staffing.
SB: 5265 provides patients a meaningful estimate of fees and charges related to a specific service, visit or stay.
SB: 5148 was the original version of the medication distribution bill.
HB: 1003 applies to individuals applying for a license or temporary practice permit or holds either and has a final
Kingsbury0309
finding issued by the Department of Social and Health Services of abuse or neglect of a minor or abuse,
abandonment, neglect or financial exploitation of a vulnerable adult is prohibited from practicing in a health care
profession in this state until proceedings of the appropriate disciplining authority have been completed.
Chris Humberson presented updates to these bills
HB: 1609: Reformatting pharmacy board into Pharmacy Commission and increasing membership to 15 from 7.
This bill would increase the size of the pharmacy board from 7 members to 15 members, doubling the pharmacist
membership to 10, the public member ship to 4 and adding 1 pharmacy technician. It would rename the board of
pharmacy, Pharmacy Quality Assurance Commission. WSPA sponsored

HB: 1565 PMP Funding. This bill discusses funding sources for PMP program.
HB: 1596 Authorizes pharmacists to fill prescriptions from P.A.s in other states.
Interestingly, this is only for controlled substances, not legend drug.
HB: 1381 Transfers from DOH to office of administrative hearing, health care judges.
HB: 1155 Electronic communication of controlled substance prescription information, provisions.
This bill standardizes the electronic communication of controlled substance prescriptions with current federal laws.
HB: 1163 regarding administrative procedures that promote accountability, transparency, and economic relief.
This bill would place a moratorium on rule making for three years
HB: 1182 Prescription drugs, legend drug act, include pharmacists when authorized by board of pharmacy. This
bill lists pharmacists as providers when operating under a collaborative drug therapy agreement. This is mainly for
insurance billing purposes.
HB: 1084 Bill is concerning the medical use of Cannabis. Bill that provides clarity on medical use of cannabis as
opposed to the recreational use approved by initiative on November 2012s election.

HB: 1195 Bill is concerning nursing staffing practice at hospitals. Just of note, this bill speaks to workloads for
hospital based nurses. Similar issues facing pharmacist, but pharmacists were not listed on this billjust an FYI.
SB: 5469 Biosimilar Products. This bill allows for pharmacists to substitute biosimilar products on prescriptions.
SB: 5459 90 day supply limits on prescriptions . This tweaks the laws on prescriptions written for 30 day supply
with 90 day refills authorized by providers, except for controlled medications.
SB 5148 Prescription drugs and supplies donated authorizing to uninsured persons. This bill would allow
pharmacies to take back for reuse for patients that meet an income level, in date medications in sealed packages .
Similar programs in Iowa, Virginia.
SB 5149 Robbery of a pharmacy .This bill would enhance the penalties for pharmacy robbery.
HB: 1637 is a medication management bill, if a patient is on 5 or more drugs, they need counseling session for
reconciliation if there is any drug interaction or issues with their medications.
HB: 1800 only applies to compounding eye drops. If this goes through it will begin immediately and Board of
Pharmacy will need to begin rulemaking.
Background:
In response to the New England Compounding Center (NECC) tragedy, the board distributed notices to all nonhospital pharmacies (resident and non-resident locations) to emphasize the current compounding rules in Chapter
248-878 WAC. Following the mailing we have received several calls asking if pharmacies can compound for
physicians offices that are non-patient specific. We have said that all compounded medications must be based
Bulk or mass compound is manufacturing and requires a

manufacturers license with additional oversight by the federal Food and Drug Administration.
upon an individual prescription for a specific patient.
The discussion on the interpretation of the rules continued with input from the audience as well as additional
Kingsbury0310
guidance from the boards legal advisor Joyce Roper.
In conclusion, a notice will be sent out on behalf of the
board providing clarification to WAC 246-878-020(4) which does allow a pharmacy to provide compounded
products for office use to a practitioner for administration to a patient without a prescription.
2013- 2014 Board Travel Plans

MOTION: Donna Feild moved that the board vote that board member Elizabeth Jensen and Executive Director
th
Chris Humberson represent the board and are delegated to vote on behalf of this board at the NABP 109 Annual
Meeting May 18-21, 2013 in St. Louis, MO. Dan Rubin second. MOTION CARRIED: 6-0.
Planning Session and Rules Re-write Update

Chris Humberson updated the board regarding the rules re-write.
We are hoping to have a new rules coordinator by April 1, 2013.

There are no other updates for now because the Legislative session has been heavy.
Correspondence
Counseling Question
Hasche-Kluender MD
ISMP Alert- Glacial Acetic Acid
Office Use list
PhRMA Statement Disposal of Unused Meds
WSPA BOP Letter Office Use
OPEN FORUM

CLOSED SESSION
Next scheduled business meetings:
April 11, 2013 9:00 a.m.

PPE Room 152/153
310 Israel Rd SE
Tumwater WA 98501
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Kingsbury0312
PUBLIC HEALTH
WORKING FOR A SAFER AND
WASHINGTON
ALWAYS
HEALTHIER
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WASHINGTON STATE DEPARTMENT OF HEALTH

BOARD OF PHARMACY
Point Plaza East
Olympia, Washington
CONVENE
Chair George Roe convened the meeting at 9:00 a.m. on February 23, 2005. Board Members
present:
Asaad Awan, RPh, Vice Chair
Donna Dockter, RPh
Rebecca Hille
Leon Alzola, RPh
Sharron Sellers
Lisa Salmi, Deputy Director
Georgia Sage, Administrative Assistant
Richard Morrison, Chief Investigator
Jim Doll, Investigator
Patrick Hanley, Staff Attorney
CONSENT AGENDA
ACTION: Rebecca Hille moved to accept the following:
Pharmacy and Other Firm Application Approval
Pharmacy Technician Application Approval for:
Alice S. Sanchez
Pharmacy Tech Training Program Approval for:
Medicine Shoppe, Centralia
Valley View Clinical Pharmacists, Monroe
MOTION CARRIED.
Collaborative Drug Therapy Agreement Approval
ACTION: After receiving clarification on the prescriber signature for Target #1883, Donna
Dockter moved to accept the Agreements for the following:
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February 23, 2005

Kingsbury0314
Bartell #21, Altitude Sickness, Anti-malarial Prophylaxis, Epi-Pen, Motion Sickness and
Travelers Diarrhea
Bartell #58, Altitude Sickness, Anti-malarial Prophylaxis, Epi-Pen, Motion Sickness and
Travelers Diarrhea
Target Pharmacy #1883, Influenza treatment and Prophylaxis
Mt. Carmel Hospital Pharmacy
Mr. Fuller informed the Board that the corrections to their policy & procedures were to have been
submitted before the meeting. However, they were not received in a timely manner. ACTION:
Donna Dockter moved to deny the application for Mt. Carmel Hospital Pharmacy until the
requested items were received. MOTION CARRIED.
Swedish Medical Center, Issaquah
ACTION: Susan Teil-Boyer moved to accept the revised policy and procedures for Swedish
Medical Center, Issaquah. MOTION CARRIED.
Board Minutes
ACTION: After receiving clarification on Review of Rule Activity in the January minutes,
Donna Dockter moved to accept the minutes as submitted. MOTION CARRIED
REPORTS
Executive Director Steven Saxe reported on the following:
Attended Senate Health and Long Term Care, House Healthcare and Senate Judiciary
committee meetings on importation and methemphetamine precursor rules to answer
questions as needed.
Participated with the Meth Coalition Group on phone calls related to methemphetamine
precursor bills. The coalition includes law enforcement, retail pharmacy and other
entities.
Working with legislators and the Veterinary Association on legislation dealing with the
training required to become a Veterinary Technician.
The Optometry profession is proposing legislation to standardize their four tiered
licensing into one. There is also legislation regarding fairness to consumers with contact
lenses. This would allow the consumer to take any contact lens prescription to a
dispenser of their choice.
The letter regarding requesting a grant for the household medication waste was sent.
Continue to work on the restructuring of Section 4. There will be a credentialing
function, a case management section, program support function. The section will still
maintain the pharmacy investigators and pharmacy consultants.
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February 23, 2005

Kingsbury0315
Along with the Executive Director from Section 5, leading a group to review the intake
and assessment of complaints.
Working with staff on the electronic rule process.
Received several telephone calls from the media concerning the methemphetamine issue.
Also receive media calls when the most recent disciplinary information is released.
Work with the prescription-monitoring project continues. Don Williams is working part
time as the program manager. Mr. Williams recently visited Idaho, who has a program in
place. The information he received will be incorporated into the feasibility study.
Presentations to stakeholders continue. A six-month report to the Department of Justice
on the activities was recently submitted.
Participated with Bill Fassett of WSU and the Tom Hazlet of the UW on new drugs and
new law course. Also shared with participants the five goals set by the Board at their last
planning session.
Mary Selecky was recently reappointed by Governor Gregoire as Secretary of Health.
Board Member Reports
Susan Teil-Boyer reported that the Joint Commission on Accreditation of Health Care
Organizations will be visiting Good Samaritan on March 21. Their focus has changed over the
years and is currently on medication safety and how to protect the patients and public in terms of
medication safety and medication systems in facilities.
George Roe attended the Northwest Medication Safety Council and was appointed as a member.
Top Food Pharmacies will participate in the quality improvement project which will look at
errors, how they are made and what can be done to correct them.
Pharmacy Consultants
Tim Fuller discussed the following:
He noted that the Northwest Medication Safety Council will be collecting and reviewing
the error information that is not subject to disclosure.
The homeland security issue continues to move forward. The state will start various
exercises in April/May.
A stakeholders meeting was held regarding controlled substance returns from long term
care facilities. Good feedback was received to move to a permanent rule from the
emergency rule and should be ready to file soon.
Andy Mecca reported that:
He continues to answer pharmacist questions and is continuing to compile and edit a list
of Most Frequently Asked Questions.
In the process of scheduling stakeholder meetings for documentation of patient
counseling.
Along with Investigator Jim Doll, talked to UW pharmacy students about the complaint
process.
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February 23, 2005

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Chief Investigator
Dick Morrison reported on:
The next investigators meeting will be held in Tumwater on March 2, 2005. Board
member Susan Teil Boyer will attend.
From January 21 st through the 23rd, he reviewed for approval the pool of law
questions used in the Washington MPJE in Scottsdale, AZ. Representatives from 42
states and the District of Columbia were present.
Admission interviews for the University of Washington, School of Pharmacy are
underway. As a member of the admissions committee has had the opportunity to
participate in two sessions thus far. The candidates have been outstanding.
Assignments in territory #1 continue to be handled by Joe Honda, Kelly McLean, and
Mr. Morrison. He plans to make the transition into the territory within the coming two
months. He continues to work closely with Steve and Lisa in the recruitment of a new
Chief Investigator
PRESENTATIONS
Albertsons Corporation
Chris Dimos Vice President of Pharmacy Services, presented information to the Board and
requested approval for their use of Sure Script Electronic Prescription Transfer Program. Ms.
Teil-Boyer asked if the system was able to record the purpose of the prescription, patient
allergies, etc. Mr. Dimos indicated there was a notes field that would allow the prescriber to put
such information in. ACTION: Asaad Awan moved to approve the Electronic Prescription
Transfer Program. MOTION CARRIED.
Executive Session
The Board met in closed session to discuss legal procedures for the Board meeting
PRESENTATIONS CONT.
Steve Arndt, Medical Director of Valley Medical Center, Steve Berndt and John Swenson of
McKesson were present to provide information to the Board on their Electronic Prescription
Transfer Program. ACTION: Leon Alzola moved to accept the McKesson Electronic
Prescription Transfer Program for use at Valley Medical Center. MOTION CARRIED.
Automated Drug Dispensing Devices
Kirks Pharmacy
Rick Graham of Kirks Pharmacy requested approval to use the Pyxis medication system for the
Center for Acute Psychiatric Services in Olympia, Washington. ACTION: Susan Teil-Boyer
moved to approval the proposal from Mr. Graham and Kirks Pharmacy. MOTION CARRIED
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February 23, 2005

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Sacred Heart Medical Center, St. Joseph Care Center.

Larry Bettesworth petitioned the Board to reconsider their decision to deny the telepharmacy
proposal for St. Joseph Care Center. Tim Fuller distributed a handout that focused on the patient
order process. WSPA Executive Director, Rod Shafer also provided comments as to why the
system should be approved by the Board. The Board questioned AAG Advisor Joyce Roper
about the Boards authority to allow others than those licensed by the Board to input information
into the pharmacy system. Ms. Roper indicated that the rule addresses in the absence of a
pharmacist, only registered nurses, designated by the hospital and responsible pharmacist, can
obtain emergency drugs from the pharmacy. It does not give the Board authority in any other
area of another professional licensee. ACTION: Asaad Awan moved that the previous decision
of the Board stand for the Sacred Heart Medical Center proposal. MOTION CARRIED.
DISCUSSION
Washington Recovery Assistance Program for Pharmacy (WRAPP) Proposal
Miki Kedzierski, WRAPP Chair, Doug Beeman, WRAPP Advisory Board Member and Ruth
Kershbaum, WRAPP Program Manager were present to discuss their request for renewal of the
current contract until June 30, 2007. No increase in the current budget of $123,000 is being
requested. ACTION: Leon Alzola moved to accept the budget proposal submitted by the
WRAPP Committee. MOTION CARRIED. The Department of Healths contract office will
negotiate the actual contract.
Ms. Kedzierski updated the Board on the current transition taking place in WRAPP. Ms.
Kedzierski has submitted her letter of resignation as WRAPP Advisory Board Chair and
requested the Board approve the draft Statement of Work, which will enable them to move
forward to recruit new board members. ACTION: Susan Teil-Boyer moved to accept the
Statement of Work submitted by WRAPP. MOTION CARRIED.
American Council on Pharmaceutical Education (ACPE) Accreditation of Pharmacy Programs.
The Board reviewed the ACPE Accredited Professional Programs of Colleges and Schools of
Pharmacy as the official listing of approved pharmacy programs. ACTION: Donna Dockter
moved to accept the 2005 ACPE list of approved professional pharmacy programs. MOTION
CARRIED.
Canadian Pharmacist Graduate Board Policy Statement.
At the January board meeting, the Board discussed the recent announcement by ACPE to no
longer recognize accreditation decisions for Canadian pharmacy schools by the Canadian Council
for Accreditation of Pharmacy Programs (CCAPP). The Board also reviewed Board Policy
Statement #30, which permits Canadian pharmacists (who graduated after 1994) to take the
NAPLEX examination without obtaining a certificate from the Foreign Pharmacist Graduate
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February 23, 2005

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Examination Committee. ACTION: Sharron Sellers moved to continue to recognize Canadian

graduates as eligible to sit for the NAPLEX exam with the condition that proposed changes to the
policy statement be incorporated. MOTION CARRIED
DISCIPLINE
Staff Attorney Kristi Weeks presented Stipulated Findings of Fact, Conclusions of Law and
Agreed Order for Albert LeGault, RPh. The Board expressed concerns that no specific
suspension time was ordered for the seriousness of the violation. They also had concerns about
the time frame mentioned for the supervisor/responsible manager to notify the Board of their
employment. How could staff be certain Mr. LeGault was not working by himself in one of the
pharmacies he owned? They also questioned if Mason County would notify staff of any noncompliance with drug court and the time frame in which they would do so. ACTION: Rebecca
Hille moved to accept the Stipulated Findings of Fact, Conclusions of Law and Agreed Order for
Albert LeGault, RPh. No second to the motion, therefore it died.
The following Stipulated Findings of Fact, Conclusions of Law and Agreed Order were accepted:
William Wallace, RPh
Robert Blaine, RPh
Matthew Broxton, Applicant
Roshan Siddiqui, RPh
M. Randall Strait, RPh
Xiang Jing, Applicant
Stacie Aumiller, RPh
Todd Long, PhT
The following Stipulated Findings of Fact, Conclusions of Law and Final Order on Defaults were
accepted:
Michelle Franklin-Williams, PhA
Susan Reaser, PhT
DISCUSSION CONT.
Stillaquamish Tribal Clinic Telepharmacy Proposal.
This agenda item will be postponed to a future date as the required information was not
submitted.
Health Professions Fee Adjustment Rule Making.
A number of programs in Health Professions Quality Assurance Division have a surplus of
revenue in excess of the amount necessary to pay for administering the program. The
Department is pursuing rule making in all professions to amend fee rules. This would allow the
Department to adjust renewal fees for the duration of one renewal cycle. The program should
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February 23, 2005

Kingsbury0319
only retain a reserve of approximately 20%. The Board of Pharmacy is included in this fee
reduction. It is anticipated that the Board will have a surplus of 2.4 million at the end of this
biennium. ACTION: Susan Teil-Boyer moved to direct Mr. Saxe to discuss with the Secretary
the options for using fee dollars to provide financial assistance to WRAPP clients for treatment
and monitoring and to fund the development of a consumer education program. MOTION
CARRIED.
Homeland Security Initiatives.
Dave Owens, Department of Health coordinator for the Strategic National Stockpile was present
to update the Board on the Departments involvement with various initiatives, particularly in
delivery of medications. The Strategic National Stockpile started with 8 Push Packages, there
are now 12. Originally there were 100 containers, now there are 130, which is 50 tons of medical
supplies in each push package. There is the capability in each package to prophylaxis 300,000
people for 10 days. The vendors manage the inventories, which in turned are owned by the CDC
National Stockpile Program.
A new program (HRQA) is being instituted which would require 75% of the hospitals to create
readily available pharmaceutical caches to prophylaxis their personnel, patients & emergency
responders for 3 days prior to the push packages arriving.
Because of intelligence gathering in Afghanistan, it was learned that Al Quaida now has the
capability of weponizing Anthrax. This has led to additional money being provided by the
Federal Government to states to ensure cities are able to prophylaxis their population within 48
hours through the Cities Readiness Initiative. They are looking at various avenues to deliver the
medications in a timely manner.
Reimportation of Drugs.
The Board reviewed a proposed letter to Governor Gregoire offering the Boards assistance in
identifying options to address the high cost of and access to medications. ACTION: Leon
Alzola moved to have George Roe sign the letter to Governor Gregoire and send. MOTION
CARRIED
Rite Aid Corporation.
The Board considered a request from the Rite Aid Corporation for an exemption of the sale
limitations of Ephedrine/Pseudoephedrine/ Phenylpropanolamine products located in RCW
18.64.046(4). ACTION: Leon Alzola moved to grant Rite Aid an exemption from
pseudoephedrine reporting requirements as outlined in their information. MOTION CARRIED.
Drug Enforcement Administration (DEA) Pain Policy.
The Board reviewed a proposed letter to the DEA expressing concern with the DEA policy
statement that prohibits practitioners from writing multiple prescriptions on one day with
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February 23, 2005

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instructions to the pharmacist that the prescriptions not be filled until a certain date. ACTION:
Leon Alzola moved to send the proposed letter to the Drug Enforcement Administration.
MOTION CARRIED.
Proposed Legislation Review.
Steve Saxe reviewed the following proposed legislation with the Board:
HB 1018,
HB 1017,
SB 5123, HB 1316,
SB 5470,
HB 1194,
2SHB 168,
SB 6020,
SB 5846, HB 1889
SB 5149,
HB 1780,
HB 1884,
HB 1546,
HB 1479,
SHB 1137,
Precursors
Precursors
Precursors
Drug Reimportation (requested by Governor Gregoire)
Reimportation of Drugs
Reimportation of Prescription Drugs
Importation of Prescription Drugs
Unused Prescription Drugs in Long Term Care Facilities
Prescription Drug Marketing Disclosure of Gifts and Gratuities
Legible Prescriptions
Disallowing High Tech Excise Tax Exemption
Naturopathic Physicians
ARNP Prescribing
Physical Therapy
PRESENTATIONS CONT.
University of Washington Associate Professor Tom Hazlett introduced students from the
pharmacy law program that presented three projects they completed last semester. The programs
were:
Clarifying the Role of the Pharmacist in Offering Patient Counseling.
Proposed Limitations to Verbal Prescription Orders
Required Pharmacist CPR Certification
There being no further business, the Board adjourned at 4:15 p.m. They will meet again on April
6, 7, 2005 in Wenatchee, Washington.
Respectfully submitted,
Georgia A. Sage
Administrative Assistant
APPROVAL
____________________
Board Chair
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February 23, 2005

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February 23, 2005

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STATE OF WASHINGTON

MEETING AGENDA
March 1, 2007
nd
CenterPoint Corporate Park 2 Floor Room 1
nd
20435 72 Avenue
Kent WA 98032
CONVENE
Chair Rebecca Hille convened the meeting at 9:08 a.m. on March 1, 2007.
Gary Harris, RPh Vice Chair
George Roe, RPh
Rosemarie Duffy, RN
Joseph Honda, Pharmacist Investigator
Staff Member Absent:
CONSENT AGENDA
1.2
o New & Closed Pharmaceutical Firms 12/22/2006 thru 02/11/2007
1.4
o Diane Goncalves NW College in West Covina CA
o Svetlana Chuvashove The Perm State Pharmaceutical Academy in Perm, Russia
o Olga Perminova The Perm State Pharmaceutical Academy in Perm, Russia
1.5
o Auburn Community Health Centers of King Co Various Pharmacists
o Tom Roe & Various Pharmacists Warfarin Dosing
o Tom Roe & Various Pharmacists - Vancomycin
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Tom Roe & Various Pharmacists Antimetic Dosing

Tom Roe & Various Pharmacists Tapering Opioids for Pediatric Patients
Tom Roe & Various Pharmacists Pain Management
Board Minute Approval January 26, 2007
o
o
o
1.8
Items 1.1 Pharmacist License Application; 1.3 Pharmacy Technician Application Approval; 1.6
Automated Drug Dispensing Device Acceptance; and 1.7 Sample Distribution Requests were deleted
from the consent agenda. MOTION: George Roe moved that the Board approve 1.2, 1.4, 1.5, and
1.8 of the consent agenda. Susan Teil-Boyer second. MOTION CARRIED 6-0.
REPORTS
Acting Executive Director
February 6, 7, and 8 the Board held a hearing to consider Statement of

Charges with a notice of Intent to Deny the application of BioMed Inc. The
Board members participating on the panel included Asaad Awan, Rebecca
Hille, George Roe, Gary Harris and Protem members Don Williams and Leon
Alzola.
Performance Auditors continue to meet with credentialing and investigative

staff. The auditors are expected to complete interviews at the end of March.
The final report is due to the legislature in July.
Staff continuing to be participating in focus groups with the new licensing

program eLicense. Doreen Beebe and Janelle Teachman were selected to
attend intensive training the third week in March. They will then become the
primary trainers on the system for Section Four.
Grace Cheung, Judy Haenke (Program Manager for Veterinary and Vision
Programs) and Lisa Salmi are involved in the Health Systems Quality
Assurance (HSQA) organizational review workgroups looking at different
functional areas. Staff is involved with three of the five workgroups Inspection & Compliance, Customer Service, Health Professions and
Facilities, Legal Services and Community Health Services.
Proposed rules regarding Pharmacies and Pharmacists Responsibilities filed

with the Code Revisers office on February 20th. Rules hearing is scheduled
for March 29 and 30 in Renton.
th
February 28 was the first legislative cut-off. March 14 is the last day to
consider bills in the house of origin.
Methamphetamine Workgroup will meet on March 21 . The Workgroup is

scheduled to present its findings to the Legislature in November 2007. Current
legislation may potentially change the scope of this workgroup.
Upcoming meetings: HPQA Annual Leadership Conference May 14 in

Seattle, HPQA Annual Board/Commission and Committee Conference September 27 28 in Renton and Annual Citizens Advocacy Center
October 31 November 2 in Seattle (targeted for public members). The
Department of Health is discussing plans to hold an Open House for key
legislative leadership in the Fall of 2007 to showcase different activities of the
department.
Tim Fuller and Lisa Salmi participated in opening session of the Pharmacists
th
Day in the Legislature on February 16 . Speakers included: Senator Parlette
and Mary Selecky.
st
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Board Member Reports:

Dan Connolly, newest member of the Board, appointed by the Governor on February 16,
2007, has worked as a pharmacist for 40 years in a variety of practice settings - independent
community pharmacy, King County Hospital, Pay & Save Pharmacy and Bartell Drugs the last
20 years. Mr. Connolly will be attending t he Governors Gubernatorial New Member
th
Orientation on March 5 .
Gary Harris spoke briefly about his task to encourage pharmacists to sign-up for the
Boards electronic newsletter. The electronic list will also provide a mechanism to disseminate
information to pharmacists more effectively. http://listser.wa.gov/archives/wsbopnewsletter.html
Rebecca Hille, Madame Chair, announced that Vandana Slatter is unable to attend the
University of Utah School of Alcoholism and Drug Dependencies June 24 29, 2007. Therefore,
Gary Harris and Board Investigator Kelly McLean will attend.
Rebecca Hille and Tim Fuller reiterated
the Boards 2007 2009 Goals
Complete Rule Process for the Top Five Rule Priorities

1. Correctional Facilities
2. Pharmacy Technician National Standardized Examination
3. Extended Care Facilities Destruction of Controlled Substances
4. Soma CSA
5. Update Wholesalers Rules
Increase Communication & Awareness to the Profession and Public

1. Acknowledge Boards Accomplishments
2. Communicate Boards Mission & Vision
3. Frequently Asked Questions
4. For Public Safety Retaining Pharmacist Investigators
Establish Continuing Education Credit for Attending Board Meetings

Communicate Information via Email to Washington Pharmacists
Consultant/Investigator Pharmacists
Tim Fuller reported
Osteopathic Physician Assistants - proposed changes to ability to prescribe

controlled substances. Currently Osteopathic PA s are permitted to prescribe
Schedules III V. The proposed rule will allow those practitioners that pass a
National certification examination within the next year to prescribe Schedule II
V. Those that do not take or pass the examination will continue to have
prescriptive authority for Schedule III V. Note: Mr. Fuller will research whether
the department will issue an alternative designator that would identify those with
increased authority.
Attended University of Washington Annual Visiting Committee Day (member of
School of
Pharmacy Dean, was nationally recognized as Dean of the Year.
Deans Visiting Committee for the School of Pharmacy). Sid Nelson,
Attended Washington State Pharmacy Associations New Laws New Drugs

Annual presentation.
Attended WSPA Mid-year Conference and presented to the pharmacy technician

roundtable speaking about the national certification examination and other rules
involving technicians.
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Provided a presentation on Frequently Asked Questions at the WSPA Mid-year

Conference.
Attended the Washington State Patient Safety Coalition planning session on

February 16. Discussions focused on medication reconciliation and implementing
a program to get patients to carry cards identifying current medication regiments
and how pharmacists or providers may play a role.
Stan Jeppesen and Andy Mecca will be participating with the University of
Washington for the annual Multistate Jurisprudence Examination review.
Chief Investigator
Grace Cheung
distributed copies of the Chief Investigators report which highlighted

Board Investigators activities for January and February Inspection and investigation
statistics, educational projects, PH:ARM project, and the UW School of Pharmacy
Admissions Committee.
Investigators Meeting
March 8 - Susan Teil-Boyer
June 6/7 -Vandana Slatter Tentative
September 12/13 - George Roe
December 5/6 - unassigned
Program Manager
Rosemarie is schedule to attend the Governors Gubernatorial New Member
Orientation on March 5, 2007 and Vandana Slatter will be attending in September.
PRESENTATIONS
Providence Centralia Proposal to Utilize Remote Order Processing. The Board considered a
proposal from Providence Centralia to utilize Providence Everett Medical Center for after hours
remote order processing. The proposal meets the Boards guidelines for remote order processing.
Note: Provide copy of protocol to area investigator.
Pharmacist Manager Linda Higginson indicated that the volume of medication order is
approximately 20 per night. Ms. Higginson stipulated that remote order processing is provided
by Providence Everett Medical Center seven day a week from 12:00 a.m. until 6:00 a.m.
ACTION: Susan Teil-Boyer moved that the Board approve the proposal by Providence
Centralia to use remote order processing with its sister facility Providence Everett Medical
Center. Rosemarie Duffy second. MOTION CARRIED. 6 0.
ExcelleRx, Inc. requests for the Use of Automated Drug Distribution Device is postponed until a
future meeting. This agenda item was tabled at the October meeting to allow representatives
from ExcelleRx, Inc. to provide additional information.
Frequently Asked Questions Presentation. Andy Mecca presentation highlighted questions
frequently asked by callers contacting the Board office regarding a variety of issues. Staff and
callers are often challenged when the answers are not a simple yes or no and must rely on the
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pharmacist s professional judgment. Mr. Mecca explained that p harmacies share the Boards
mission to promote and protect public health and safety. The process of dispensing prescriptions,
similar to the disciplinary process, is individual and is ultimately designed to protect patient
health.
Mr. Mecca reviewed frequently asked questions relating to:
Prescriptive authority ARNPs, Optometrists, Naturopathic Physicians, Dentists,

Out-of-State and Canadian Practitioners
DEA Numbers
HPQA Practitioner Look-up Verification
Prescriptions from U.S. Territories
Practitioners prescribing for oneself and family
Scope of Practice
Off Label Use
Controlled Substance Inventory
Prescription Records
Prescription Information, Labels, and Expiration Dates
Office Use Prescriptions
Electronic Prescriptions
References
on-line or hardcopy
Pharmacist Responsible Manager Responsibilities

Faxing, Changing, and Emergency Fills of Controlled Substances
Suboxone, Methadone
The goal for pharmacists is to take care of the patient and use good judgment. Mr. Mecca
strongly encourages the documentation of your decisions as deemed necessary.
Telepharmacy proposal from Community Health Clinics of King County (CHCKC)
Tim Fuller provided background on a new community health services in King County. Due to
transportation challenges CHCKC is proposing to use telepharmacy services to meet the needs of
its patients.
Mr. Fuller summarized for the new Board members the history of Board approved telepharmacy
models, beginning with Community Health Association of Spokane (CHAS).
David Rose, Pharmacy Services Manager for Kent Community Health Services briefed the
Board on the proposed remote dispensing process and explained the pharmacists oversight. The
program uses automated drug distribution devices. No service is provided from the remote site in
times of power outages; patients are directed to the main pharmacy or other alternatives.
Main/supervising pharmacy located in Kent
Dispensing label will only print if the barcode indicates the medication is correct
Seven clinics through King County with two contract pharmacies to fill 30 medications
on behalf of the clinics
Initial target
Pre-filled medication will be labeled with barcode, drug name, strength, lot number,
expiration date and number of doses
Once medication is verified by pharmacist the patient is counseled by pharmacist via the
webcam
35 to 40 new prescriptions per day no refills
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Refills are process by the main pharmacy for pick-up or delivery to the clinic or by mail
to the patient
Provide access to patients
Formulary list updated monthly
CHCKC offers medications for free or sliding scale for indigent, working poor or
underinsured patients
Note: Susan Teil-Boyer asked that the Board conduct a site visit the next time the Board meets
in Kent to observe the process.
ACTION: Susan Teil-Boyer moved that the Board approve the SeaTac telepharmacy proposal
by CHCKC. Rosemarie Duffy second. Dan Connolly recused himself from the vote. MOTION
CARRIED. Susan Teil-Boyer, Rosemarie Duffy, Vandana Slatter and Gary Harris voted in
favor and George Roe opposed. Vote 4 1.
Accreditation of Schools/Colleges of Pharmacy .
ACTION: George Roe moved that the Board approve the accreditation of Colleges and Schools
of Pharmacy of Colleges and Schools of Pharmacy adopted through the American Council on
Pharmaceutical Education (ACPE) as the official list of accredited professional pharmacy
programs. Vandana Slatter second. MOTION CARRIED. 6 0.
Election of Officers. Roberts Rules of Order directs the Vice-Chair, Rebecca Hille, to assume
the role of Chair and a nomination for Vice-Chair was accepted. ACTION: George Roe
nominates Gary Harris as Vice-Chair. Rosemarie Duffy second. Mr. Harris accepted the
appointment. MOTION CARRIED. Unanimous vote in favor.
Official Delegate to the 2007 National Association of Boards of Pharmacy Annual Meeting.
ACTION: Susan Teil-Boyer moved that the Board name the Chair the official voting delegate
and the Vice-Chair the alternate to attend the NABP Annual Meeting. Rosemarie second.
MOTION CARRIED. 6 0.
EXECUTIVE SESSION
The Board adjourned at 12:00 p.m . for the Executive Session to discuss personnel issues and
pending litigation.
The Board reconvened at 1:00 p.m. for presentation of Agreed Orders.
DISCUSSION
2007 Legislation Update
Lisa Salmi updated the Board on 2007 legislation, but cautioned that there may have been
changes since the report was prepared.
2SHB1103 shift authority to the Secretary of Health to initial mandatory investigation when
there is a pattern of conduct. Boards and Commission should provide consultation and assistance
as requested by the Secretary when reviewing complaints. It also requires the Secretary to ensure
that Board and Commissions are actively involved in an investigation if the allegation involves
standard of practice or needs clinical expertise. (Includes portions of other legislation HB1101-
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sanction guidelines, HB1100 background checks and HB1104

gynecological exams.)
requires a chaperon during
Requires boards and commissions to develop continuing competency programs.
Permits members of boards and commission to communicate directly with members of

the Legislature regarding board and commission work, even if their position contradicts
Requires boards and commissions to submit a report as an adjunct to the annual report
generated by the Secretary.
the departments official position.
Allows the Secretary to spend unappropriated funds in the health professions account to
meet unanticipated costs when revenue exceeds more than 15% of departments six year
projection.
Modifies the process to be used for the development of sanction guidelines and allows the
Secretary to adopt permanent rules (change from original bill).
Gives the department authority to require fingerprint check-national electronic fingerprint

check when state background check is inadequate, for example applicants from another
state may have criminal background in jurisdictions other than Washington.
Authorizes the issuance of a temporary license for those with clear Washington State
background check pending national fingerprint check.
Requires the department to adopt rules requiring license holders to report any criminal
convictions with 14 days after conviction.
ACTION: Rosemarie Duffy moved that the Board develop a resolution address to the Secretary
of Health expressing the Boards opposition to the shift of authority to the Secretary in initiating
mandatory investigations when there is a pattern of conduct. It is not in the best interest of public
health and safety. It dilutes the Boards authority and actions will not be taking in a timely
manner. The Board has professional staff and the expertise to provide consistency and the Board
has historically acted on 30% of our complaints. Susan Teil-Boyer second. MOTION
CARRIED. 6 0.
SHB1553 Prescription Monitoring Program real-time web-based interactive monitoring
program to monitor the prescribing and dispensing of Schedule II through V controlled
substances. Required department seek federal grants to cover costs to operate the system and
prohibits the department from using license fees or taxes specifically designated for the program.
(Concept supported by Washington State Pharmacy Association)
SHB1797 Requires the Methamphetamine Work Group examine the feasibility of electronic
reporting of sales of ephedrine, pseudoephedrine and phenolpropanolamine.
SB5631 Distribution of Drugs transfers the authority for licensing and inspections of drug
wholesalers to the Department of Licensing. Adds definitions that refer to the drug distribution
chain for prescription drug and requires the tracking of drugs from the manufacturer to the
pharmacy (pedigree). The bill requires wholesalers to submit a security bond of $100,000.
Required the Board of Pharmacy to determine and target the implementation date for an
electronic pedigree. (This bill may be dead)
SB1519 Disclosure of Gifts by Pharmaceutical Manufacturers - Requires the Board of
Pharmacy to post disclosure reports on the internet and report to the legislature and Governor.
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HB2123 Exchange of antiepileptic drugs by pharmacies Prohibits a pharmacist from

interchanging antiepileptic drugs for a formulation of an antiepileptic drug brand name or
generic for the treatment of seizers without prior consent.
SSB5509 Modifies the Uniform Disciplinary Act (UDA) on how complaints are handled and
requires complaints to be in writing and signed by the complainant. Non-traditional treatment
alone is not unprofessional conduct so long as there is no injury and unreasonable risk of harm to
the patient. The bill adds definition for false, fraudulent or misleading advertising.
SHB1300 UDA Changes Department request legislation. Changes the process for denying
applications and allows permanent revocation for egregious violations. Create a citation and fine
process to ensure documents are produced in response to requests for investigative purposes.
HB1667 Health Professions Licensing Fees amend 43.72.050 establishes a three tier
credentialing fee structure for health profession regulated by the department. $125 licensed
professionals, $50 certified professionals, and $30 registered professionals.
SB5420 Public Access to Information Requires every public agency to post its minutes, rules
or resolutions within 15 business days. The bill requires posting the minutes prior to the Boards
approval but we would ensure that the minutes are clearly designated as drafts.
Pharmacy Assistants Registration Grace Cheung advised the Board that it can no longer allow
pharmacy assistants to work in pharmacies pending application to the state for registration. We
have no statutory authority to permit this practice. Initially, the 90 day grace period was granted
to allow applicants to complete AIDS training. AIDS training is now more readily available.
The department has a responsibility to conduct background checks on all applicants.
We will be providing technical assistance to pharmacies on this change by way of technical
assistance during inspections, newsletter article and other means of getting the word out.
The Uniform Disciplinary Act permits temporary licensure for individuals licensed in another
state that has licensing standards substantially equivalent to Washington (RCW 18.130.075).
Review Past Board Decisions regarding the practice of pharmacy by off-site pharmacists. Andy
Mecca explained that this information is a follow-up his report given in January asking to review
past Board decisions in regard to off-site pharmacy practices.
September 2003 Telepharmacy proposal allowed pharmacist to review orders from a

home workstation. Approved by the Board.
June 2006 Pharmacist to perform order entry, drug utilization review and other
functions from home. Approved by the Board.
July 2006 Proposal to allow pharmacists to provide drug utilization review. In this
proposal the pharmacy was located out of state. The Board approved the protocol
stipulating that the pharmacist must work for a pharmacy licensed in Washington, but did
not required the out-of-state pharmacist to be licensed in Washington.
December 2006 Proposal for Central fill - remote review of prescriptions . Approved by
Board- requiring the drug review take place within a licensed pharmacy not at home.
Staff Recommendations:
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Permit WA licensed pharmacies to practice pharmacy at an alternative work sites

(telecommute).
Out-of-State off-site practice is allowed when both the pharmacy and pharmacist
manager is licensed in Washington. The Responsible manager is accountable for the
development and implementation of necessary policies and procedures regarding
professional conduct and patient privacy in offsite pharmacy practices.
Questions for Consideration:
What is different about the December proposal?
How will the Board discipline an out-of-state pharmacist if not associated with a WA
licensed pharmacist?
Complaint/discipline/investigation coordinated through another jurisdiction?
Non-resident mail-order pharmacies shipping into Washington are required to be licensed

in this state. What about out-of-state pharmacist that does not engage in mailing
prescriptions but practice pharmacy interacting with residents of Washington? The
Board authorized this activity, in the past, so long as the pharmacy was licensed in
Washington.
Should the Wal-Mart proposal from December 2006 be brought back to the Board?
Doug Beeman, Group Health Cooperative, offered that the practices of pharmacy is changing to
include situations where pharmacists working independently or by contract to provide
medication management services for patients. Theses pharmacists are not associated directly
with a pharmacy.
Dan Connolly two different types of telepharmacy with different standards - 1) drug utilization
review only; and 2) dispensing.
ACTION: Susan Teil-Boyer moved that staff update the guidelines for telepharmacy/remote
order processing for review and considerations. Vandana Slatter second. MOTION CARRIED.
6 0.
Presentation of Agreed Orders
again on April 12 13 in Tumwater, Washington.

__________________________________________
_________________________________________
Board of Pharmacy
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STATE OF WASHINGTON

Regular Scheduled
March 6, 2014
Mt. Constance
2400 South St.
CONVENE
Chair Christopher Barry called the meeting to order March 6, 2014.
Commission Members:
Gary Harris, RPh,
Dan Rubin MPP, Public Member
Steve Anderson, RPh
Nancy Hecox, PharmD
AL Linggi, RPh, MBA
Tim Lynch, PharmD

Guest / Presenters:
David Armstrong, Director of Pharmacy
for Fresenius Medical Care Rx
Anita Treis, Director of Pharmacy
at Providence St. Mary
Linda Higgins, Director of Pharmacy
at Centralia Providence
Karen Bright, Director of Pharmacy
at Olympic Pharmacy
Dennis McAllister, RPh FASHP Senior Director,
Pharmacy Regulatory Affairs
Phil Wickizer, Senior Legal Counsel
Angelique Williams, Pharm D, Director of Pharmacy
at Forks Community Hospital
Charmaine Sanders, RPh
Gholam Shirali, PharmD
Cliff Richards, Director of Pharmacy at Othello
Hospital
Dr . Thomas Gallagher, MD

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UW PharmD Students
Christine Lee, Rory Cavaille, Michelle Choi, Hannah DeMeritt, Mayumi Robbins, Harry Lee
Alta Bergquist, Joe Clifton, David Lee, Tiffany Siu, Charlene Tauser, Jennifer Wilson
Linda Blak, Jordan Han, Lauren Price, Kris Sumida, Megan YoshimotoJames Lin, Paul Ma, Nina
Sharma, Kyle Sullivan, Sonny Tran, Danielle Deardorff, Donald Backus, Susan Diep, Ismael Simekha,
Si Bui, Jordan Dieckmann, Jessica Trahey, Ingrid Lee, Race Ragsdale, Amy Munekiyo, Genasee Aman,
Trang Tran,David Yiu, Jason Lin, Ming Chan, Shirley Quach
Staff Members:
Joyce Roper, AAG

1.2 Approval of January 23, 2014 Meeting Minutes.
MOTION: Elizabeth Jensen moved that the commission approve 1.1. Sepi Soleimanpour second.
MOTION: Dan Rubin moved that the commission approve 1.2 with suggested changes . Nancy Hecox
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be approved
by a single motion of the commission without separate discussion. If separate discussion is desired, that
item will be removed from the consent agenda and placed on the regular business agenda.
January and February 2014

a. Providence Sacred Heart Medical Center
b. River Village Pharmacy
a. Allscripts XML
b. Kaiser Permanente NW
c. Quest Diagnostics/MedPlus/Care360 EHR
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be removed from the consent agenda and placed on the regular business agenda. Items 2.3, 2.4, 2.5, 2.8
MOTION: Dan Rubin requested to remove 2.6 (a) from the consent agenda for further discussion.
Dan Rubin moved that the commission approve items 2.1, 2.2, 2.6 (b), and 2.7. Gary Harris second.
REPORTS
Commission Members
Tim Lynch reported:
He participated on an advisory group for ASHP on pharmacy business management.

Tim presented at a recent safe table event for Washington State Hospital Association on
readmission.
I have been working as subcommittee chair for leading the discussion around Collaborative
Drug Therapy Agreements (CDTA).
Dan Rubin reported:
He is also participating on the subcommittee group for CDTAs .
She is participating on the subcommittee group for CDTAs .
She is participating on the subcommittee group for CDTAs .
She is also on the subcommittee group for CDTAs .

Nancy took and passed the 30 hour CPE Critical Point for the Sterile Compounding.
Al Linggi reported:
He attended the Confirmation Hearing in Olympia, WA.

Attend the UW School of Pharmacy Curricula Committee
He took the opportunity to investigate the feasibility to change the rule to include the pharmacor
base rather than identify the specific molecule. Al reached out and identified the perfect person
who could possibly chair to push this thing through. He is a toxicologist and is very passionate
about dealing with substance abuse and public safety. He is hoping to have more to report back
at the next meeting.
In January beginning of February Al volunteered for a medical mission in Honduras.
Executive Director
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He presented with Tim Fuller at pharmacy association New Rules and Laws lecture on March
nd
at U. Washington.
Had site visit with Mr. MacDonald and Tina Lacey to Skagit Hospital to assist with their issues
related to discharge prescriptions and emergency room dispensing.

Chris attended several bill hearings related to pharmacy related legislation to provide
information or answer questions .

Testified for DOH and PQAC on the Dextro bill on Feb 25
th
He is serving on an internal DOH workgroup within DOH regarding an alternative disciplinary

process across all professions under very specific situations .
Chris is leading the UPWG on opioid poisonings and as part of that workgroup will be
establishing resources for pharmacists to use when counseling patients on these medications.
Continuing internal work on the Sterile Compounding rules project.

There was no request for reconsideration or appeal filed in the Fluoride case, so it is now
resolved.
Recently, the FDA issued a new guidance/ decision on emergency contraceptive plan B and its
generics. All of the Plan B products and its generics will be available over the counter with the
label stating it is for use for persons 15 years of age and older. However, there will also be no
ID requirement. Once this guidance is implemented by the manufacturers and sellers of this
product, the product will no longer be subject to the Pharmacies Responsibilities Rule, because
that rule does not address over the counter drugs available without restriction. With respect to
the Stormans lawsuit, Plaintiffs added the drug ella to their complaint and ella continues to be
available only with a prescription.

Since mid-January Pharmacist Investigators Tina Lacey, Greg Lang, Tyler Varnum and I have
participated in weekly meetings with commission staff surrounding the drafting of sterile
compounding rules. Participating in these working sessions has resulted in approximately160
combined hours out of the field resulting in an estimated 20 fewer inspections completed
during that time period.
Tramadol Overprescribing: I have had an increasing number of phone calls from pharmacists
concerned about the overprescribing of tramadol both in terms of excessive quantities
(greater than 240 tablets per month) and duration of therapy. In addition I have received
reports from pharmacists of virtual medical offices prescribing and supplying tramadol
over the internet to Washington residents.
The commission may want to consider either one of these alternatives, either classifying
tramadol as a Scheduled drug or requesting DOH add tramadol to the PMP as a drug of
concern to assist the commission in tracking and quantifying the impact of tramadol
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prescribing and usage patterns in the state.
Emergency Outpatient Medications: Investigators are discovering during normal routine

inspections that rural hospitals are dispensing through their emergency departments full
courses of therapy, mainly antibiotics, as well as dispensing of, typically, 72 hour supplies of
controlled substances up to and including oxycodone/APAP . Prescriptions or orders are then
sent back to the pharmacy for order processing after medication has been dispensed to the
patient. Typically there is no pharmacist review of allergies, chronic medical conditions,
DUR or other professional responsibilities required in WAC 246-863-095 are performed by
pharmacists prior to dispensing of these medications by the hospital (non-pharmacist) staff.
The commission may consider opening rulemaking regarding WAC 246-873-060, Emergency
outpatient medications, to change or further clarify the rules for emergency outpatient
dispensing.
Health Care Entity Licensure: Discussion of Health Care Entity licensure typically comes up
during routine pharmacy inspections when Investigators review pharmacy records,
specifically drug invoice and transfer records. It has been found during inspections that
pharmacies are supplying clinics and other settings otherwise not licensed by the state with
both legend and controlled drugs. During a recent routine inspection hospital pharmacy
staff supplied a list of 26 different clinics the hospital pharmacy was sending drugs to. None
of these clinics appeared to have the licensure needed to possess drugs as common stock
to be shared by providers working in the clinic.
Clinics and other facilities that receive these drugs typically view them as shared drug stock
which any employee prescriber may draw from in treating their patients. Drugs typically
are either ordered under the license of one of the clinic prescribers or are transferred to
the facility from the hospital pharmacy as an intercompany transfer.
The Investigators request guidance from the commission regarding possession of common
drug stock in otherwise unlicensed facilities and the applicability of the HCE license in
those situations.
PRESENTATIONS
Fresenius Medical Care Rx (FMCRx)
Cathy Williams led the presentation by Fresenius Medical Care Rx (FMCRx), a Washington licensed
non-resident pharmacy presented a business model where FMCRx will coordinate central fill services
with two other non-resident pharmacies. David Armstrong, Director of Pharmacy joined the meeting
via telephone because of bad weather. He was able to provide answers to the commissions questions.
The commission felt they needed some more information regarding their entire process.
Fresenius Medical Care Rx (FMCRx)
FMCRx is a mail-order pharmacy based in Franklin, TN that provides prescription services for
dialysis patients only
FMCRx is owned by Fresenius Medical Care North America (FMCNA), a major provider of
kidney dialysis services and renal care products
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FMCRx works together with Fresenius dialysis
clinics to provide coordinated care to dialysis
patients
FMCRxs Dispensing Arrangement
FMCRx has entered into a dispensing agreement with two non- resident central fill mail order
pharmacy partners, DaVita and WellDyne
FMCRx has contacted the Washington State Board of Pharmacy for guidance as to whether its
central fill regulations apply to the FMCRx dispensing model
MOTION: Sepi Soleimanpour moved that the commission defer this presentation until the next
meeting FMCRx will need to provide a clear definition of their entire process . Steve Anderson second.
Providence Centralia Hospital Report Back

This was a two part presentation led by Cathy Williams first was a report back on remote medication
order processing services approved in April 2013 between Providence Centralia Hospital and Olympic
Memorial Hospital. Karen Bright and Linda Higgins updated the commission with a power point and
then answered any questions from the commission.
Overview
Service started 5/18/2013
Providence Centralia Hospital (PCH) to Provide Remote Order Processing Service to Olympic
Memorial hospital between the hours of 2330 and 0600.
Period of 1 year with automatic renewal, may terminated by either party without cause with 60
days notice.
Seamless order verification through common EPIC platform.

PCH pharmacists will provide consultations per OMH
On site orient to Olympic Memorial Hospital on site prior to implementation of service.
Analysis of Data
UNUSUAL OCCURRENCE REPORTING
No reported events
EPIC REPORTS
Order Verification (data reviewed June through December)
Totals between 700 to 1000 orders monthly

Average of 32 orders / hours served
Order varied from 1 to 100/ hours served
NURSING SURVEY / EPIC CLINICAL DOCUMENTATION
Services Provided
Medication Administration Record Correction

Medication Administration Questions
Order Entry Assistance
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Order Clarification
Drug Information Questions
Reduction in medications removed from ADMs without a pharmacist review- overall 76%
reduction
Opportunities for Improvement
Vancomycin dose Standardized to meet ready to use product

Clarification point of contacts for PCH Pharmacist
Product standardization and familiarization
Providence Centralia Hospital Remote Services

Cathy Williams introduced Anita Treis Director of Pharmacy for St. Mary Providence who joined the
meeting via telephone. Linda Higgins at Providence Centralia Hospital requested approval of policies
and procedures for remote medication order processing services to Providence St. Mary Medical Center
in Walla Walla.
Providence Saint Mary Medical Center (SMMC)
Rural not for profit Catholic Hospital

Licensed 142 bed; Average Census: 40
Walla Walla, Washington
Pharmacy Hours 0530-2200 M-F;
0800-2000 weekends and holidays
March 2014 EPIC - EHR
PCH PSMMC Relationship
Both are licensed Providence Facilities
PCH to provide Remote Medication Order Processing to PSMMC during hours PSMMC
Share the same Mission and Core Values

PSMMC will implement the standard Providence EPIC EHR platform March 8, 2014
PCH will provide staff to support PSMMC EPIC go live

Contract Agreement Summary
pharmacy is closed
Agreement renewed annually, may terminate by either party without cause 60 days notice
Common EPIC build will provide seamless order verification process
PCH available for phone consultation to PSMMC staff for clinical questions
PCH to provide Go live support, PSMMC to provide orientation for PCH staff
Policy and Procedure Overview

Computerized Physician Order Entry
PSMMC staff clarify unclear orders

PCH pharmacists to be trained on PSMMC Policies and Procedures
PSMMC formulary, IV concentrations standardized with PCH to reduce variation
PCH Pharmacist
Verify Orders
Perform Drug Regimen reviews Manages Alerts
Interprets clinical data
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Performs Therapeutic Interventions

Provides drug information
PSMMC On-Call Pharmacist available for urgent on site referrals
Drug unavailable outside of normal channels
Drug storage drug requiring special mixing procedures
Unique clinical situations
Procedures related to another service line
PSMMC Designated Nurse Supervisor
Coordinate and direct medication access
Access to automated dispensing cabinets and after-hours cabinet
Coordinate communication with PCH pharmacist
Coordinate communication with PSMMC on-call pharmacist
Automated Dispensing Cabinets
Profiled in most areas
Override list approved by PSMMC medical, nursing and pharmacy staff
Overrides available only in urgent/emergent situations where delay may cause patient harm
Quality Assurance
Conducted routinely by PSMMC and PCH management

Adverse Drug Events reported & investigated by PSMMC Director and reported to PCH
Director
Compliance with Policies and Procedures by PSMMC Director
Monthly parameters monitored to include, variances in timeliness of order and any
variations outside of policy (UOR)
Volumes and timeliness of order verification
Availability of PCH Pharmacists for routine clinical questions
Performance feedback from PSMMC staff
Daily retrospective review by PSMMC of all medications removed on override or from the
night cabinet.
MOTION: Tim Lynch moved that the commission approve Providence Centralia Hospital policies and
procedures for remote medication order processing services to Providence St. Mary Medical Center in
Walla Walla with a report back in one year include a review of the night cabinet. Gary Harris second.
Christopher Barry recused himself. MOTION CARRIED: 9-0.
Express Scripts, Inc.

Chris Humberson briefly recapped the results of the last meeting and introduced Phil Wickizer from
Express Scripsts. Express Scripts requested approval of pharmacy license for Spokane location dba
Express Scripts (ownership change). The pharmacy provides remote medication order entry services
and stocks no drugs on site. This proposal is being revisited from January regarding ancillary
utilization.
Phil passed out packets that provided an updated Ancillary Utilization Plan (AUP). He went through
some of the laws that were relevant to the AUP. Scott Johnson went through an example e-prescribing
prescription step by step with the commission so they could get a full understanding of what Pharmacist
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Technicians and Pharmacy Assistants do. They then allowed further discussion on the concerns the
commission had in January.
MOTION: Tim Lynch moved that the commission approve Express Scripts proposal as a
demonstration project for Express Scripts, Inc. only and request that they report back in nine months to
provide quality data related to assistants and technicians used under these specialized functions with
special attention given to prescriptions received by means other than electronic transmission. Steve
MOTION: Dan Rubin moved that the commission approve to remove the conditional license and make
it a full license. Sepi Soleimanpour second. MOTION CARRIED: 10-0.
Forks Community Hospital Remote Medication Entry

Tim Fuller introduced Angelique Williams, Pharm D, Director of Pharmacy at Forks Community
Hospital requests the commission approval of its policies and procedures for the use of Medication
Review remote medication order entry services .
Overview:
Est. 1952
Clallam County Hospital District #1

Critical Access Hospital staff 12 beds
Hours: 0630-1500 M-F
1 Pharmacist, 2 Technicians
Olympic Medical Center, Port Angeles is 60 miles away
Grays Harbor Hospital, Aberdeen 110 miles away
Pre- 2009:
Handwritten pharmacy patient profiles

Handwritten nursing MARs
Patient med-room drawers + Hillbilly Pyxis (2001)
Current:
2009 Omnicell Automated Dispensing
Cabinets Acute profiled, ER, OR

1998 Meditech Magic
All orders entered electronically 3/2013

Telepharmacy: Medication Review 3/2013
eMAR 6/2013
CPOE 2/2014
BMV 2/2014
Telepharmacy:
2012 ROP
Medication Review, Spokane WA
Pipeline
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Envision
Remote Order Entry 24/7/365
Dose recommendations, Allergy/Interaction alert, MD
order clarification, RN
communication
Electronic Technician Supervision 80 hrs/yr

Sick, On vacation
Average # Rxs per month 900, 30/day
Average time to enter orders: 12 min, 7 min STAT
Quality Control/Performance Improvement:
FCH tracking order entry errors and good catches

Med Review internal error tracking
Information directly to providers to decrease deficient and ambiguous orders
Team approach to issues as they arise
Med Review Washington licensed pharmacists
On-Site training, visits
Value and Safety:
Budget restrictions in combination with low patient volumes

Timely response to changing needs
24/7 drug information support for providers & nursing staff
Extra process step catches more errors before they reach the patient
VPN link with Meditech, only specific users entered by Hospital IT staff have access
Perseverance of Rural Healthcare:
Gives opportunity to provide quality care despite
Restricted cost structure

Limited access to on-site providers
Increase patient safety and satisfaction
MOTION: Tim Lynch moved that the commission approve the amended motion to approve the remote
order entry process as proposed for 6 months Demonstration Project with provision that immediate
supervision by video camera is in place when pharmacist is not physically on site and development of
policy which states what activities a technician will perform when pharmacist is not physically present.
Nurses will double check cabinet stocked by technician when pharmacist is not on site and in the
absence of barcode verification for stocking medication. Report back on aggregate data - error
reporting . Nancy Hecox second. MOTION CARRIED: 10-0.
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CONSENT AGENDA
(a)Providence Sacred Heart Medical Center
The commission members had some questions regarding this consent agenda. Sean Dobbins, RPh was
asked to join the meeting via telephone to answer questions for the commission members.
MOTION: Dan Rubin moved that the commission approve the extension of the technician specialized
functions to include loading the ADDD . Maureen Sparks second. Christopher Barry recused himself.
PRESENTATIONS
Study Plan
A panel was chosen to hear the study plan from Charmaine Sanders, Rph. Charmaine Sanders is
requesting authorization to re-take the Multistate Pharmacy Jurisprudence Examination.
MOTION: Sepi Soleimanpour moved that the panel approve Charmaine Sanders request to re-exam.
She must wait the required wait-time as set forth by NABP. Steve Anderson second. MOTION
CARRIED: 10-0.
Waive Required Intern Hours

A panel was chosen to hear the request from Gholam Shirali, a Foreign Pharmacist Graduate he asked
the commission to consider waiving a portion of the required intern hours to qualify for licensure.
MOTION: Al Linggi moved that the panel accept Gholam Shiralis request to reduce intern hours to
750 once these hours are successfully completed he will be authorized to sit for the NAPLEX. Tim
Othello Hospital Remote Medication Entry

Tim Fuller introduced Cliff Richards, Director of Pharmacy at Othello Hospital. He requested approval
from the commission of its policies and procedures for the use of Medication Reviews remote
medication order entry services.
Policy:
All medication orders for Othello Community Hospital will be reviewed and verified by a
Washington licensed pharmacist prior to dispensing and administration 24 hours/day 7
days/week. To comply with the WAC codes covering medication order processing, it will be
necessary to contract with a Washington State Board of Pharmacy licensed remote order
processing company. Medication order processing will not include medication dispensing
from the processing company.
Procedure:
Othello Community Hospital is a licensed 25 bed critical access hospital. The hospital has a
pharmacist employed for limited coverage. The hospital will then provide continuous
pharmacy services for the patients during the absence of the on-site pharmacist. Hours of on-
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site pharmacist coverage hours vary, therefore, the remote medication order entry services are
contracted for 24 hours/day, 7 days/week.
In order to provide continuous pharmacy services, it is required that Othello Community

Hospital contract with a Washington licensed approved remote order processing company. This
was last accomplished by an oral presentation by Medication Review in July, 2011 to the
administration of Othello Comm1mity Hospital at which time a yearly reviewed contract was
signed.
The remote order entry company must have Washington state licensed pharmacists and be in
compliance will all state and federal laws and regulations. Any remote order entry processing
company will be approved by the Washington State Board ofPhan11acy prior to Othello
Community Hospital contracting with them.
All remote order entry pharmacists will be trained by the remote order processing company in
Othello Community Hospital policies and procedures related to medication orders. Also
inclusive will be formulary substitutions, administration times and formulary compliance.
Othello Community Hospital will also provide information including IV concentrations and any
dosing agreements need for order processing.
Any remote order processing company contracted by Othello Community will be

responsible for their staff:
receiving, interrupting, clarifying and processing of electronic remote orders

intem1pting clinical information
data verification and medication order information into a computer system
providing needed clinical information to medical/nursing staff
performing regime review
Any remote medication order processing company contracting with Othello Community
Hospital must share common files and have compatible technology to allow secure access to the
hospital's information system (in this case Meditech). Othello Community Hospital utilizes
computer physician order entry (CPOE).
Othello Community Hospital will be responsible for maintaining records for all order transactions
into their information system, including the order transactions from a remote order processing
company. Both the hospital's system well as the remote order
Processing company's system will have the ability to audit activities of the remote order entry
process by the pham1acists whom are processing orders.
The remote order processing company will provide Othello Community Hospital with a policy
and procedure manual related to the pharmacy companies operations. This will include:
the responsibilities of each pharmacy to one another

a list of the name, address, telephone numbers and all license/registrations involved
for remote order processing
protecting confidentiality/integrity of patient information (HIPPA)

compliance with all state/federal laws
Maintenance of all records for identifying all individuals associated
with the remote
order processing system.
The
remote order processing company will have a quality improvement program in place. This
program will evaluate and provide information to Othello Community Hospital. The
information will be gathered and presented routinely and will include but not be limited to;
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adverse drug event tracking

Appropriate medication orders for patients c.
resolving identified medication problems d.
medication order processing times
total medication orders processed

Error rates and resolutions feedback to Othello medical staff/nurses g.
clinical interventions and outcomes
annual policy and procedure manual review and documentation of such

any other information the remote processing company feels is appropriate to present for
quality improvement
MOTION: Gary Harris moved that the commission approve Othello Hospital's policies and procedures
for the use of Medication Reviews remote medication order entry services . Nancy Hecox second.
MOTION: Tim Lynch moved that the commission rescind the motion made to approve Othello
Hospital policies and procedures for the use of Medication Reviews remote medication order entry
services. Nancy Hecox second. MOTION CARRIED: 10-0.
MOTION: Tim Lynch moved that the commission approve the remote order entry process as proposed
for 6 months Demonstration Project with provision that immediate supervision by video camera is in
place when pharmacist is not physically on site and development of policy which states what activities
a technician will perform when pharmacist is not physically present. Nurses will double check cabinet
stocked by technician when pharmacist is not on site and in the absence of barcode verification for
stocking medication. Report back on aggregate data - error reporting . Nancy Hecox second.
University of Washington Pharmacy Students Law Presentation

Dr. Thomas Hazlet, University of Washington Pharmacy Students introduced the PharmD students .
Each group of student presented their pharmacy law projects to the board on these topics.
Reclassification of Tramadol
Christine Lee, Rory Cavaille, Michelle Choi, Hannah DeMeritt, Mayumi Robbins, Harry Lee
Petition to Eliminate Prescription Transfer Coupon/Rebate
Alta Bergquist, Joe Clifton, David Lee, Tiffany Siu, Charlene Tauser, Jennifer Wilson
The commission postponed discussion and vote on this petition until April 17, 2014.
Prescription Monitoring Program and Medicare Access

Linda Blake Jordan han, Lauren Price, Kris Sumida, Megan Yoshimoto
USP <797> A Practical Approach for Implementation
James Lin, Paul Ma, Nina Sharma, Kyle Sullivan, Sonny Tran
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Change the Law

Danielle Deardorff, Donald Backus, Susan Diep, Ismael Simekha, Si Bui, Jordan Dieckmann, Jessica
Trahey, Ingrid Lee, Race Ragsdale, Amy Munekiyo, Genasee Aman, Trang Tran
Expanding Access to Naloxone
David Yiu, Jason Lin, Ming Chan, Shirley Quach
Legislation update
The commission was provided a list of bills that are being watched throughout the legislative session.
Christopher Humberson gave a very brief update on what bills are still alive
Consideration for rulemaking WAC 246-873-060 Emergency Outpatient Medications

Christopher Humberson led this discussion asking the commission to authorize emergency rule making
for WAC 246-873-060 Emergency Outpatient Medications. He shared particular concerns of the rule
that really need to be updated.
MOTION: Elizabeth Jensen moved that the commission and staff craft emergency rules to address
emergent need for outpatient medication WAC 246-873-060 and special meeting to approve emergency
rule languet and to later file CR101 for permanent rules. AL Linggi second. MOTION CARRIED:
10-0.
OTHER
Health Care Entity Credential Overview
Pharmacy Investigator Grace Cheung led this discussion asking the commission for clear direction in
addressing this practice.
The alleged improper distribution of drugs by a pharmacy came to the forefront as a result of a
controlled substance loss; subsequently, we confirmed that it was common practice for various
pharmacies to distribute stock medications to various facilities improperly.
In 2009, the commission instructed investigators to continue to help licensees move towards
compliance.
While some organizations have complied many licensees disagree and believe that there
is no compliance issue with distributing drugs from a pharmacy e.g. a hospital pharmacy
distributing to off-site unlicensed clinics owned by the same organization.
There are limited options within our current rules leaving the Health Care Entity license as a
method for licensees to comply.
There is no argument that many of these facilities have a need for stock drugs to meet patient needs.
The question is how this can be accomplished legally. The key issue is that every site must have a
license that gives it authority to possess drugs and the need for oversight to ensure safe usage those
drugs.
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After some discussion Joyce Roper suggested that staff including investigators hold a staff meeting
regarding this subject. This meeting should be to list specific problems and suggestions of ways to
address this. This can be presented to the commission.
2014 Travel/Conference and Training
National Association of Boards of Pharmacy Annual Meeting
MOTION: Al Linggi moved that the commission select Chris Humberson as the voting delegate to
th
represent PQAC and Steve Anderson to also attend NABP 110 Annual Meeting. Tim Lynch second.

Utah School on Alcoholism and Other Drug Dependencies
MOTION: Maureen Sparks moved that the commission select Elizabeth Jensen to attend the Utah
School on Alcoholism and Other Drug Dependencies. AL Linggi second. MOTION CARRIED: 9-0.
CDTA Subcommittee
Tim Lynch the chair of the CDTA subcommittee updated the commission on its progress. Tim Lynch
handed out a copy of the notes taken during the stakeholder meetings . There has been some stakeholder
meetings held via teleconference. There has been quite a bit of input from the stakeholders as well as
the subcommittee. The next will be some face to face stakeholder meetings .
Correspondence
There was no correspondence.
PRESENTATIONS
Communication and Resolution Program (CRP)
Chris Humberson introduced Dr. Thomas Gallagher (MD). Dr. Gallagher presented an update in July
2013 on the CRP project. He is returning to partner with the commission to ensure the pharmacy
perspective is included in the design of the certification process currently underway.
The CRP is designed to reduce medical errors by shifting the practice of medicine and pharmacy
towards Just Culture. Pharmacists, Pharmacy Technicians, and Pharmacy Assistants are key
members of health care teams. The commission is invited to help motivate licensees to report medical
errors promptly to their facilities for root cause analysis and remediation.
Project Overview
Created HealthPact Forum

Ongoing engagement with trial attorneys, regulators among other stakeholders
Interprofessional communication training

Team Communication Training
Disclosure and Apology Coach Training
Created and piloting the Communication and Resolution Program (CRP)
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What is the CRP?
Be candid and transparent about unanticipated care outcomes

Much broader than just error
Conduct a rapid investigation, offer a full explanation, and apologize as appropriate

Where appropriate, provide for the familys financial needs without requiring recourse to
litigation
Build systematic patient safety analysis and improvement into risk management
How have CRPs worked elsewhere?
University of Michigan (Early settlement model)

Since implementing disclosure-with-offer program
Claims half as likely, lawsuits 1/3 as likely
Time to resolution cut nearly in half
Reduced liability costs
University of Illinois at Chicago (Seven Pillars)
Increase in patient safety event reporting from 1,500 to 7,500 per
year
50% reduction in new claims
Median time to resolution now 12 months compared with 55
months before program
Who is currently participating in the CRP in WA state?
Physicians Insurance A Mutual Company

Providence Sacred Heart Medical Center and Childrens Hospital
Providence Regional Medical Center, Everett
Providence St. Mary Medical Center
The Everett Clinic
The PolyClinic
The Vancouver Clinic
Swedish
CRP Certification Goals
Promote learning through early adverse event reporting by providers to their

institution/insurer, comprehensive event analysis, and implementation of prevention plans
Enhance patient-centered accountability

Stakeholders Involved in CRP Certification Design, Operation
MQAC
Institutions participating in CRP
Physicians Insurance
WSMA, WSHA, FHQC, HealthPact Leadership Group (includes patient advocates,
attorneys)
Key Next Steps

Addressing issues related to information sharing/protection
Exploring potential collaboration with other regulators
Preparing for pilot testing
Finalizing metrics
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OPEN FORUM


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STATE OF WASHINGTON

MEETING MINUTES
March 8, 2012
Mt. Constance (Building 8)
2400 S. 240th Street
CONVENE
Vice Chair Christopher Barry called the meeting to order at 9:03 a.m., March 8, 2012
Board Members:
Gary Harris, RPh,
Guest /Presenters:
Doug Pratt, Pharmacy, Director for PharMerica
Carey Sobel, Pharmacy Consultant for PharMerica

Tanis Rhines, Operations Manager for Adventist

Health
Lateef Olaniyan, RPh; PharmD, Southgate
Sepi Soleimanpour, RPh

Pharmacy
Kristina Nelson, Pharmacy Intern for Swedish
Medical Center
Staff Member:
Joyce Roper, AAG
Scott Christopher, Lead Pharmacist for Swedish

Medical Center
Mahalakshmi Hariharan, Pharmacist Intern

William Kristin, Pharmacy Investigator
New Board Members Background
Dan Rubin: Dan has had a career in health and social services policy and community
development. For the past ten years he has worked at CHOICE Regional Health Network, a
non-profit com m unity health collaborative serving a prim arily rural area of southwest
Washington. Prior to coming to CHOICE, Dan held a variety of policy development positions
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in the Washington State Department of Health from its form ation in 1989 to 2001, mostly in
the Office o f th e Secretary; and from 1976 to 1989 he was in the Department of Social and
Health Services including service from 1987-89 as Executive Director of the former State
Health Coordinating Council. Dan notes his life experiences with elderly, mentally ill,
disabled and term inally ill family members as a source of insight about consumers' needs.
His formal education includes a Masters degree in public policy from the University of
California, Berkeley and additional graduate work in public health and health policy at the
University of Michigan, Ann Arbor. At this point in his career he is working half time and
wants to make a personal contribution to safe, effective and efficient pharmacy services,
which he considers one of the crucibles of excellent health care.
Sepi Soleimanpour: Sepi earned her pharmacy degree from Ohio State University in 1994.
She earned her MBA in Health Care Adm inistration at University of Colorado in 2008. Sepi
has also been involved with training pharmacy students, pharmacy technicians at various
colleges and universities since 1998. Sepi is the com m unity Leader at Walgreens. Her current
role is to mentor, coach, manage pharmacy and store operation in Issaquah, Renton and
Kitsap Peninsula. She is a Clinical Assistant Professor at University of Washington and works
closely with other pharmacy schools outside Washington area. Sepi has been strongly
involved in com m unity &local business relation, pharmacy associations and public health to
prom ote health and wellness in the area.
Emma Zavala-Suarez: Emma is a 2006 graduate of the University of Washington, School of
Law. She was an instructor at Yunnan University in Kunming, Yunnan, People's Republic of
China. Emma earned her BA in Latin American studies with distinction from Whitman
College. As an undergraduate student, she interned for the America Reads Literacy Program
working with bilingual elementary school children in Walla Walla, WA. She spent every
summer working for the Migrant Summer School Program in Lyn den, WA. In law school,
Emma co- chaired the National Latina a Law Student Association Conference. Since joining
the Washington bar, she continues to be active in advocacy work on behalf of migrant farm
workers and the Latino commu nity. Emma recently left her position as a corporate associate
for Steel Rives, LLP, which is a Seattle based law firm to pursue a career in public health.
CONSENT AGENDA
1.1
Business Meeting Agenda Approval March 8, 2012
1.2
1.4
o Whidbey General ADDD
1.7
o January 26, 2012
agenda. Items 1.3, 1.5, 1.6 were deleted from the agenda.
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MOTION: Gary Harris moved that the board approve items 1.1, 1.2, 1.4 and 1.7. Elizabeth
Jensen seconded. MOTION CARRIED: 7-0.
REPORTS
Board Member
February 15, 2012 she went to Olympia for the Senate confirmation. Elizabeth found that to
be a very interesting process.
Elizabeth along with Donna Feild, and Pharmacy Investigators Grace Cheung and Bill
Kristin are working on updating the Pharmacy Inspection process.
She has also been working on putting together her discussion for counseling pharmacy
patients that will be addressed later in this meeting.

Mr. Harris went to the Washington State University and gave lecture on Pharmacy Law and
Ethics.
She was in Olympia for the Senate Confirmation February 15, 2012.
He is replacing Rebecca Hille as the board liaison with the Spokane Pharmacy Association.
Donna is also working on updating the Inspection Process.

Executive Director
Legislative Session Bills: Two bills directly affecting pharmacy practice have died
this session. One is the board and DOH sponsored legislation to allow electronic
prescribing of Controlled Substances. This bill became an amendment attached to
the bill placing pharmacists as practitioners in the Legend Drug Act. The second bill
is drug return and reuse bill, allowing voluntary return of pre-packaged drugs. Other
bills related to pharmacy will be discussed later on the agenda.
The out of state ARNP prescribing bill (controlled substances) passed.

Stormans' Trial: The access to medications trial began November 28 and continued
through the week of December 19. The judged ruled on February 22. We will discuss
next steps at the executive session today.
Board of Pharmacy members confirmed by Senate: Two new board members,

Donna Feild and Elizabeth Jensen testified before the Senate Health Care
Committee, February 15 and were voted out of committee for confirmation by the
Senate.
On March 1, 2012 the Drug Enforcement Administration. (DEA) issued a proposed

regulation placing Five Synthetic Cannabinoids pursuant to the Controlled Substances
Act (CSA). Regulation will extend the previous temporary scheduling that expired on
February 29, 2012. These substances will now be in Schedule I until August 29, 2012,
or until the proposed regulations become effective.
Online Renewals Project- Pharmacy Technicians: The purpose of the Online Renewal
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Project is to implement twenty-four (24) hour online access, seven days per week, to
submit license applications, renewals, and payments for healthcare providers.
Delivering online services directly to credential holders and new applicants should
reduce processing times.
Online Pharmacy Safety Act introduced in U.S. House this week, Rep. Bill Cassidy,
M.D. (R-LA-6) and Rep. Mike Ross (D-AR-4) introduced the bipartisan Online
Pharmacy Safety Act (H.R. 4095). The bill seek s to protect patients from illegal and
unsafe online pharmacies by updating federal law to clearly define what constitutes a
"legitimate online pharmacy" as well as a "valid prescription." The legislation also
requires the FDA to establish a consumer-friendly registry of legitimate online
pharmacy websites. A Senate companion bill (S. 2002) was introduced in December
2011.
Director of Health Professions and Facilities

Steven Saxe reported:
Mr. Saxe thanked Al Linggi and Rebecca Hille for their time and service on the Board of
Pharmacy. He thanked Susan Teil Boyer for her work as Executive Director for the Board
of Pharmacy.
He asked that 2 board members take part in the Executive Director recruitment.

The board will discuss options and next steps in the Stormans case in the Executive
Session scheduled during lunch today.
The plaintiffs are expected to file their motion for attorney fees and costs, which will
likely be for a large amount.
Tim attended the day long Health Pact meeting this was a unique attempt to connect
health care providers and improve the delivery of care.
Tim shared that developing partnerships between PHEPR (Public Health Emergency
Response) and Group Health and Cardinal and Safeway. These businesses have
packaging and distribution systems that could enhance the response to disasters.

In the past we have been instructed by the DEA that when a practitioner writes a
prescription for specific individual and then instructs that individual to bring the
prescription to the office where the prescriber administers part or all of the
prescription, it is not considered a valid prescription. The prescriber was required to
order controlled substances used in the office using a 222 or invoice which would
comply with 21 C.F.R.1305.13(c) and 1304.22.
The DEA furnished a copy of2IUSC802 (10) (15) & (27) which appears to preclude
the practitioner from ordering a controlled substance compounded product by either
invoice or prescription. The pharmacy can only compound for the ultimate user (a
4
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definition which excludes other practitioners.) pursuant to a valid prescription. Since

most practitioners (other than pharmacists, no longer compound) it now appears that a
pharmacy may no longer compound a controlled substance product for a prescriber
without first obtaining manufacturer's license.
Susan Boyer received word from the DEA and notified me 02/28/12 that prescribers
can now write prescriptions to patients for administration in their office.
The DEA has taken the position that our emergency refill rule (WAC 246-869100(2)(f) does not apply to controlled substances and instructed the DM of a major
pharmacy chain that his DEA registrations are at risk if the chain does not train the
pharmacists that our emergency refill rules do not include controlled substances.
The DEA has also taken the position that pharmacies cannot take refill requests for
controlled medications when requested by the pharmacy. They mandate a new
prescription must be written or generated every time. The pharmacy could still take
a verbal order over the phone but the refill request faxes which are then signed off
by the doctor are no valid.
Grant Chester introduced Don Painter who is the supervisor in Office of Investigations
and Inspections.
Bill Kristin reported:
The pharmacy investigators believe patient counseling should be done with every
prescription and use it as a tool for patient safety and to help prevent dispensing errors.
Investigators are finding that pharmacist out in the field are looking to decrease hours that
pharmacist and technicians work. These long hours bring concerns to the investigators
regarding errors made in dispensing medications.
PRESENTATIONS
Electronic Prescription Transmission System
By board request, PharMerica was asked to present for board approval its policies and
procedures for the use of EZ MAR, an electronic prescription transmission system. After
providing a short background Tim Fuller introduced Doug Pratt, Pharmacist Director of
PharMerica and Carey Sobel, Consultant Pharmacist for PharMerica.
EZMAR Overview:
- Order Entry
-Concise order entry screen
-Required Vitals
-Electronic Signature
-Orders Pending Approval
-easy Scheduler for non-daily administrations
-Medication Administration Module
-Color coded medication types
-PRN Documentation
- One click re order process
- Seven day history of documented vitals
Summary of Module Benefits:
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Order Approval Module:
Physician order entry can now be done by a data entry clerk, allowing
professional staff to spend more time with residents.
Orders are easily tracked, approved and sent to the pharmacy.

Electronic Signature Module:
Time savings away from tedious paperwork
Notes between Nurses and Physicians easily added and tracked.
Improved documentation
Reduction in omitted order or resident notes, greater visibility into how residents
are reacting to medications and treatments.
Improved productivity and access
Physicians and nurses can review resident Physician Order Sheets from multiple places, allowing
more time to be spent caring for residents when in the facility.
MOTION: Elizabeth Jensen moved that the board approve PharMericas policies and
procedures for the EZMAR electronic prescription transmission system as presented. Donna
Feild seconded. Gary Harris opposed. MOTION CARRIED: 6-1.
Remote Order Entry Proposal

The board was asked to consider a request from Adventist Health, a Washington licensed nonresident pharmacy, to provide remote order entry services for Walla Walla General Hospital
using TelepharmacyWest. Tanis Rhines presented an overview to the board using a power point.
Who is TelepharmacyWest
Adventist Health TelepharmacyWest (AHTW) is a non-profit department of Adventist

Health (Roseville, California). Our business unit was created to provide remote order
entry and review of medication orders for both our owned hospitals as well as for smaller,
non-Adventist hospitals. AHTW does not dispense medication to the patients we serve.
AHTW provides our services out of our office based at Glendale Adventist Medical
Center in Glendale, California.
Operations began in September 2010.

Staffing Model
Two teams of full time 10 hour shifts with 7-on/7-off scheduling.
PIC is scheduled 5 days a week overseeing both teams.
Multiple per diem 8 hour shifts.

Minimum two days per week.
Vacation/sick time coverage.
Contractual Relationships
TelepharmacyWest services are provided as described in our Ancillary Provider Services

Agreement which outlines the services provided by AHTW and the responsibilities of
both AHTW and our Client facilities.
Note: Walla Walla General Hospital and AHTW are part of the same corporation.
Orders can be received by two different methods:
For Clients that have Computerized Physician Order Entry (CPOE), AHTW works
directly in the client information system. For these orders, the AHTW staff review the
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information input by the physician and verify the appropriateness of the order placed by
the physician.
For Clients that do not have CPOE, AHTW utilizes OmniLinkRx , the secured order
management system by Omnicell, Inc, to communicate electronic copies of handwritten
orders to our office. The pharmacist reviews those orders and then transcribes them into
the Client information system via secure, direct access.
Remote Medication Order Processing
AHTW performs medication review and entry as stated in Addendums A and B of the
Ancillary Service Providers Agreement and in our policy on Host/Client Responsibilities.
Processing includes:
Reviewing the order for
Appropriateness
Completeness
Conformance to facility policies

Interpreting and clarifying orders
Data entry and transferring order information
Drug regimen review
Interpreting clinical data
Performing therapeutic interventions
Providing drug information
Each order received/reviewed will be screened for the following:

Appropriate dose, route, duration, frequency, and indication (e.g. PRN orders) as
per the Client facilitys policies on medication review.
Presence of unapproved abbreviations or incomplete or unsafe orders.
Identified medication/food allergies or sensitivities.
Drug: drug interactions with existing medications.
Duplication of therapy as related to current profiled medications or conflicting
medications (medication reconciliation).
Therapeutic appropriateness as related to patient diagnosis and co-morbidities
(e.g. renal function).
Other parameters as described in the Client facilitys P&P.
Orders will be screened to conform to the Client facilitys medication stop order policy.
Orders that are incomplete, contain unapproved abbreviations or are considered

inappropriate with respect to dose, route, indication, etc. by the processing pharmacist
will not be entered until clarified by the Client facility.
Client facility nursing staff is responsible for the initial contact with the ordering
physician. AHTW pharmacy staff is available to discuss the issue with the
ordering physician as is necessary.
Unresolved questions regarding orders received will be communicated to the
client facility for their follow-up during the morning handoff report.
AHTW will not accept or process the following order types. Orders for these
medications will be referred back to the facility to contact the pharmacist on call or will
be passed on to the Client facility with the morning handoff report:
TPN
Chemotherapy
Fentanyl patches
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Intervention Documentation
Interventions are performed and tracked via the intervention management system
Quantifi by PharmacyOneSource.
Intervention reports are submitted to all Client hospitals on a monthly basis.

Training
Preparation for servicing a Client facility:
On site visit.
Completion of a Client Hospital Assessment Form that includes (but is not limited to) the
following information:
Unapproved abbreviations
Standard medication administration times
Stop order policy
Automatic substitution policy
Formulary compliance policy
Training on the use of the Client facility PIS/EMR

The information obtained from the on site visit and Client Hospital Assessment Form is used to
create a training program for the AHTW pharmacy staff. This includes:
Creation of a Quick Reference Guide specific to the order entry and medication
management requirements of the Client facility.
A copy of the Hospital Assessment Form is also available for staff review.
Training on the facility specific requirements for review and entry of medication orders
into the Clients PIS.
The training of the AHTW pharmacy staff is recorded in the AHTW Training Log.
Secure Access
Secure access to the Client facilitys pharmacy information system will be established for
nonAdventist Health facilities.
In the case of Walla Walla General Hospital, AHTW has direct access, via our
corporation intranet, into their Cerner information system.
Record Maintenance
For orders communicated by fax or electronic order communication, AHTW maintains
records of all orders entered into the OmniLinkRx system for a minimum of six (6)
years as stated in our Ancillary Service Providers Agreement.
For Client facilities with CPOE, the original order information will be contained within
the Client facilitys PIS.
Auditing Capability
AHTW provides order entry/review directly into the Client facilitys PIS. The Client pharmacy
will have the full audit capabilities of all activities performed by the AHTW pharmacy staff.
MOTION: Gary Harris moved that the board approve Adventist Health, a Washington licensed
non-resident pharmacy, to provide remote order entry services for Walla Walla General Hospital.
Elizabeth Jensen seconded. MOTION CARRIED: 7-0.
Telepharmacy Proposal
Lateef Olaniyan, RPh; PharmD gave the board a one-year status report on telepharmacy services
provided by Southgate Pharmacy to Mattawa Community Medical Clinic.
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Southgate Telepharmacy Activities

Started in January 2011 with functioning remote dispensing equipment and a fax
machine.
All prescriptions, pts info sheets, & insurance info faxed from remote site to central
location for processing
Prescription transcription took place in central location
Medication released at Mattawa, checked by RPh via Sight speed
Waiting time for Rx was about 45 to 60 minutes
In March of 2011, Enterprise Rx software installed in Mattawa. Tech input pts info &
insurance info into the computer & still faxed the hard copy to central pharmacy for
verification.
Waiting time for Rx reduced to 25 minutes
Currently, Mattawa has a scanner. No need to fax hard copy since actual Rx copy is
available on the screen for RPh to see.
Current waiting time is between 5 to 10 minutes
Prescription/Dispensing Errors in 2011
A total of 5 incidents were reported in 2011.
None of the reported incidents affected any patient
No patient received any wrong medication in 2011
Economic Impact on the Clinic & Community
SG Rx participated in Mattawa Health Fair; donated glucometers
MHS students: Walk for Diabetes; raised $835.00
Money used to pay for newly diagnosed DM patients medications
City residents survey: Rx services in top 5 of needs
23 Mattawa Clinic jobs saved due to telepharmacy
Telepharmacy serves outside community members
25% increase in clinic visits due to telepharmacy
Currently, between 20-38 pts seen daily at the clinic
Controlled Medications
Controlled medications were neither stocked nor dispensed through the telepharmacy
system in Mattawa during this period, as stipulated in the Southgate Pharmacy
Dispensing System Policy and Procedures. Southgate Pharmacy has no intention of
dispensing any controlled substances via its telepharmacy system in Mattawa.
Conclusion
Southgate Pharmacy and Mattawa Community Clinic thanked the Washington State
Board of Pharmacy for allowing us to contribute to Improved Quality of Lives (QOL) of
the people of Mattawa through this telepharmacy program.
Pharmaceutical Take-back Program

The board was asked to consider a proposal by Swedish Medical Center to implement a
pharmaceutical take-back program using the TAKEWAY drug disposal system. Kristina
Nelson, Swedish Medical Center Pharmacy Intern and Lead Pharmacist Scott Christopher
provided an overview of their policy and procedure for the TAKEWAY drug disposal system.
Take Away Drug Disposal Service

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In support of the community effort to decrease the number of accidental ingestions,

Swedish Medical Center would like to institute the following program at all Retail
Pharmacy locations.
Retail Pharmacy Services- Take Away Drug Disposal Service Policy
All retail staff (pharmacists and technicians) will receive training on the Take-Away
Drug Disposal Service annually to include the policies and procedures of the vendor
(Sharps), internal pharmacy policies and procedures, and a review of any State or Federal
statues or regulations. Documentation of the training will be recorded in the employees
file
The Pharmacy Ambulatory Manager is the primary resource person for questions or
problems.
Take Away Sharps Containers will be stored completely within the interior of each retail
pharmacy when in use, and prior to shipping to the vendor for destruction, to prevent
patient access and potential diversion.
If at any time a sealed container is entered without approval by a Pharmacy Manager by

pharmacy personnel, a Swedish employee and/or a member of the community, the Board
of Pharmacy and local law enforcement will be contacted to report the incident.
Reporting to the Board of Pharmacy must occur within 72 hours of the time of the
incident or from the time the entry was discovered.
Should the Pharmacy Manager need to enter the secure system, it should be witnessed by
the patient or another pharmacy staff member.
At no time should any pharmacy personnel or other Swedish employee or patient try to
access the Take Away Container.
The program utilization, function, and Policy and Procedure will be reviewed annually.
Retail Pharmacy Services- Take Away Drug Disposal Service Procedure
This program is open to any person in the community who desires to dispose of
household unwanted medications. This excludes any businesses (physicians clinics,
dental clinics, etc) in the community which desire to dispose of business waste.
Patients who present to the retail pharmacy stating they wish to dispose of unused,
unwanted medications must be helped by a Pharmacist.
Only non-controlled substance, non-sharps medications will be accepted for disposal as

per DEA regulations.
This program is open to any person in the community who desires to dispose of
household unwanted medications. This excludes any businesses (physicians clinics,
dental clinics, etc) in the community which desire to dispose of business waste.
Patients who present to the retail pharmacy stating they wish to dispose of unused,
unwanted medications must be helped by a Pharmacist.
Only non-controlled substance, non-sharps medications will be accepted for disposal as

per DEA regulations.
Acceptable formulations for disposal include pills, capsule, liquids, ointments, inhalants,
etc.
Any liquids to be deposited must first be wrapped in paper towel or other absorbent
material and contained within a plastic zipped bag (Ziploc).
All approved medications should then immediately be deposited, in their original

containers, into the Take Away Environmental Return System container. Placement of
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medications into the container will be witnessed by the Pharmacist depositing the
medication and the patient who wished to dispose of the medication.
Acceptable formulations for disposal include pills, capsule, liquids, ointments, inhalants,
etc.
Any liquids to be deposited must first be wrapped in paper towel or other absorbent
material and contained within a plastic zipped bag (Ziploc).
All approved medications should then immediately be deposited, in their original
containers, into the Take Away Environmental Return System container. Placement of
medications into the container will be witnessed by the Pharmacist depositing the
medication and the patient who wished to dispose of the medication.
When the secure container is full per manufacturers guidelines it will then be sealed by a
pharmacist or other appropriate pharmacy staff per the manufacturers guidelines. Sealing
of the container should be done within 30 minutes once the container has been deemed
full.
Sealed full containers will be sent to Take Away Environmental Return System per
guidelines for shipping return through USPS. Until the time of removal from the premises
by USPS the container will remain sealed and in pharmacy possession within the retail
pharmacy.
Containers sent to Take Away Environment Return System will be followed via provided
tracking number and certification of documentation will be provided. Destruction of the
container is accomplished by Sharps and is witnessed by law enforcement personnel.
MOTION: Elizabeth Jensen moved that the board approve Swedish Medical Center to
implement a pharmaceutical take-back program using the TAKEWAY drug disposal system.
MOTION: Dan Rubin moved that the board delegate the review of take-back programs to board
staff and then placed in the CONSENT AGENDA for board approval. Elizabeth Jensen second.
DISCUSSION
Workload Balancing and a Pharmacists Accountability
Cathy Williams led the discussion of accountability for the accuracy of a prescription when the
process for filling a prescription is broken down into separate steps performed by multiple
pharmacists.
Background:
Historically the board has held that the pharmacist who performs the final check on a
completed prescription bears ultimate responsibility for all aspects of that prescription,
including counseling. With the advent of fully integrated pharmacy software systems the
ability to configure workflows into specific queues and delineated staff functions has
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emerged. Pharmacists can log into and out of a specific queue and multiple pharmacists
can be working in different queues during the processing of a single prescription. And
pharmacists are expected to participate from remote locations based on greater workflow
at any given time at another pharmacy. This type of processing is called work load or
load balancing.
At the March 2010 meeting Bartell Drugs was approved for a 2-store trial of the work
load balancing component of their recently purchased Enterprise Rx system with a 6month follow up before allowing expansion to all Washington pharmacy sites.
During the December 16, 2011 follow up Bartell Drugs raised the issue of pharmacist
accountability and asked the board to consider changing how pharmacist accountability is
determined.
MOTION: Gary Harris moved that the board consider each case individually based on the
investigation and circumstances of the case. Donna Feild seconded. Emma Zavala-Suarez
opposed. MOTION CARRIED: 6-1.
NAPLEX Study Plan

Christopher Barry chose a panel for this request Gary Harris, Elizabeth Jensen and Donna Field.
Pharmacist Intern Mahalakshmi Hariharan presented a study plan to the panel of the board. She
requested authorization to re-take the North American Pharmacist License Examination and
Multistate Pharmacy Jurisprudence Exam.
MOTION: Gary Harris moved that the board authorize Mahalakshmi Hariharan to re-take the
North American Pharmacist License Examination and Multistate Pharmacy Jurisprudence Exam
after completing 750 intern hours and after August 2012. Elizabeth Jensen seconded. MOTION
CARRIED: 3-0.
DISCUSSION Contd
HB 1486: 2011 bill Reintroduced Pharmacies permitted to fill prescriptions from out-of-state
ARNPs Amends 69.50.101 to allow pharmacies to fill prescriptions for controlled substances
written by out-of-state ARNPs. Passed the Legislature
HB 2142: Related to prescription monitoring program funding. If federal or private grants or
other funds are not sufficient the department of health may charge a fee ($15) for the operation
of the program. Dead
ESHB 2228: Allowing for redistribution of medications under certain conditions. Bill allows any
practitioner or medical facility to donate prescription drugs and supplies to a pharmacy for
redistribution without compensation or the expectation of compensation to individuals who meet
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the prioritization criteria. Medical facility" means a physician's office, hospital, health clinic,
nursing home, boarding home, or adult family home. Dead
HB 2343: Electronic communication of prescription information for controlled substances.

Agency request legislation. Allow prescribers to send prescriptions for controlled substance by
electronic transmission to a pharmacy. The bill amends chapter 69.50 RCW to align with
federal standards and allow electronically communicated prescriptions for controlled
substances. Dead
HB 2495: Prohibiting Pharmacists from Substituting Opioid Analgesic Drugs for an Opioid
Drug Incorporating Tamper Resistant Technology Without Obtaining Written Consent of the
Prescribing Physician. Dead
SB 6424
SSB 5969: Establishment of procedures for the professional licensing of military spouses after
relocation to Washington. Licensing authority is required to develop a method to authorize a
March 14, 2012.Passed signed by Governor on December 20
SB 6007: Placing certain synthetic cannabimimetics and certain substituted cathinones into
schedule I of the uniform controlled. With exception of chemical names, the bill mirrors the
boards rules adopted last year. Dead
SB 6048: Permitting nursing homes to recycle unused prescription medicines. Dead
SB 6049: Requiring the department of health to establish a cancer drug repository program. The
department of health establishes a cancer drug repository program for accepting donated cancer
drugs and dispensing these drugs to authorized WA residents. DOH to work with BOP in
adopting rules to establish eligibility criteria, standards and procedures for participating
facilities that accept, distribute or dispense donated cancer drugs. DOH to maintain registry of
participating facilities. The substitute bill adds a definition for donor, clarifies health care
facility removing laboratories and general language regarding places where healthcare providers
provide care to patients. Requires disclosure to patients that drug was donated, limits acceptance
and distribution/dispensing of donated drug to and by practitioners or pharmacies. Dead
SB 6051: Concerning the donation and redistribution of unused prescription drugs. Donations of
unused prescription drugs to a health care facility or participating practitioner for redistribution
by the health care facility or participating practitioner are permitted. Before redistributing
donated prescription drugs, a health care facility or participating practitioner must examine the
donated prescription drug to determine that it has not been adulterated or misbranded and
certify that the drug has been stored in compliance with the products label. DOH will do rules.
Health care facility" means a hospital, clinic, nursing home, laboratory, office, or similar place
where a health care provider provides health care to patients. "Participating practitioner"
means a licensed health care practitioner who is authorized to prescribe drugs and who registers
with the department to participate in the collection of donated drugs, prescribed for use by
established patients of that health care practitioner and donated for the purpose of redistribution
to established patients of that health care practitioner. Dead
ESSB 6280: Pharmacy Robberies makes robbery a first degree offense/ class A felony. Dead
SSB 6197 HB 2512: Including Pharmacists in Legend Drug Act. The bill corrects the statute
that identifies prescribers by adding pharmacists when authorized by the board. This is a
technical correction. Dead
EHB 2186: Concerning licensed midwives ability to work with registered nurses and licensed
practical nurses. A registered nurse may execute a medical regimen as prescribed by a licensed
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midwife. A registered nurse or licensed practical may also administer medications, treatments,
tests, and inoculations, at the direction of a licensed midwife. Passed Legislature
HB 2227: Medical assistants. New profession registration/certification. Bill is not consistent

with Sunrise Review done by DOH Bill allows MA to act under standing orders. Dead
HB 2230: Requiring certain health agencies to use administrative law judges from the office of
administrative hearings. This moves the health law judges in the Adjudicative Clerks Office
under the Office of Administrative Hearings. Dead
SB 6176 HB 2490: Simplifying state and local tax and licensing systems. The bill amends
sections of the pharmacy practice act (Definitions and RCW 18.64.044 Shopkeeper registration)
to update references from master licensing to business licensing. Dead
SB 6096 HB 2303: Protection Against Unfair Prescription Drug Practices By Pharmacy Benefit
Managers. This establishes consumer protection from unfair prescription drug practice by
pharmacy benefit managers that contract with covered entities. Dead
SB 6290 HB 2524: Occupational licensing status for military spouses or registered domestic
partners during deployment or placement outside WA. - The bill requires that a license of a
spouse or registered domestic partner or s service member be place in inactive military status.
The license will be returned to active status for renewal within six months after the service
member is honorably discharged from service or sooner if requested. 6290 Passed Legislature,
2524 Dead
SHB 2261: Charitable donations of eye glasses and hearing instruments. Passed Senate with
amendment must go back to House for concurrence. Passed Senate with amendment must go
back to House for concurrence.
SB 6022: Changing the effective date of Initiative Measure No. 1163 concerning long-term care
related to requiring long-term care workers obtain criminal background checks and adequate
training. Dead
SB 6054: Eliminating the certificate of need review for all health care facilities except hospitals.
Dead
ESSB 6227: Establish a Medicaid Fraud Hotline. Attorney General & Office of the Insurance
Commissioner to establish a Medicaid hotline for the public to report suspected Medicaid fraud.
The Office of the Insurance Commissioner must fund the hotline. Dead
2012 Travel Priorities/Assignments

The board discussed board travel priorities for 2012 and naming the voting delegate to the 108 th
Annual National Boards of Pharmacy Meeting. After brief discussion this item was tabled until later
in the meeting.
Affirmation of the American Council on Pharmacy Education Accreditation

The board was asked to consider reaffirming its recognition of an accredited school or college or
pharmacy as institutions that meet the minimum standards for accreditation by ACPE.
MOTION: Gary Harris moved to recognize the accredited schools or colleges of pharmacy as
institutions that meet the minimum standards for accreditation by ACPE. Elizabeth Jensen
second MOTION CARRIED: 7-0.
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Performance Measures
Susan Teil Boyer led the discussion with the board reviewing the pharmacy programs
performance in relation to established parameters or targets on discipline cases, credentialing and
nd
other key functions for the 2 quarter of fiscal year 2012. Steve Saxe and Susan Teil Boyer
asked to have someone represent the board and participate in a work group for Lean
Management project starting with credentialing. Donna Feild volunteered to represent the
board.
Patient Counseling
Elizabeth Jensen led the discussion to revisit the interpretation of what constitutes a new
prescription. She shared with the rest of the board her personal concerns regarding this rule.
Susan Teil Boyer pointed out that this is a rule and not a law. There was no action taken on this
item after further discussion.
WAC 246-869-220 reads:

The purpose of this counseling requirement is to educate the public in the use of drugs and
devices dispensed upon a prescription.
1. The pharmacist shall directly counsel the patient or patient's agent on the use of drugs or
devices.
2. For prescriptions delivered outside of the pharmacy, the pharmacist shall offer in writing,
to provide direct counseling and information about the drug, including information on how to
contact the pharmacist.
3. For each patient, the pharmacist shall determine the amount of counseling that is
reasonable and necessary under the circumstance to promote safe and effective administration of
the medication and to facilitate an appropriate therapeutic outcome for that patient from the
prescription.
4. This rule applies to all prescriptions except where a medication is to be administered by a
licensed health professional authorized to administer medications.
Inspection Process Project

Bill Kristin shared the updated Pharmacy Investigation Form with the board from the Project
Team Grace Cheung, Elizabeth Jensen and Donna Feild who are conducting the review/update of
the pharmacy inspection process.
MOTION: Donna Feild moved to have the inspectors do a pilot using the new form and the old
form during pharmacy inspections and ensure that these are helpful and logical changes.
Elizabeth Jensen second MOTION CARRIED: 7-0.
Technicians to Pharmacist Ratio
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Cathy Williams led the discussion on how many technicians in training should be included in the
3:1 technician to pharmacist ratio. Cathy provided the board some brief background on this issue.
After public and board discussion this matter was tabled and the ratio stays the same.
Update on Rules in Progress and the Rules Scan/Re-write Project
Susan Teil Boyer, Doreen Beebe and Kitty Slater updated the board on proposed rulemaking
workload and rules scan project.
Doreen Beebe asked the board to participate in providing an acronym for the Rules Re-write
Project.
Correctional Pharmacies - The latest draft language has been sent to Department of Corrections,
King County Public Health and is posted on the list serv. Next step after public comment is
updating current draft language to reflect comments. This should happen in late March, early
April. A Board champion is needed for this rule.
Update Animal Control Agency and Humane Society Rules (petition) - Rules Hearing
Scheduled for June 7, 2012. Pending CR102 filing.
Continuing Education for Pharmacy Technician-Rules Hearing Scheduled for June 7, 2012.
Rule Scan/Analysis- Board authorized to reviewing existing rules to determine what new
rulemaking activities may need to take place and then determining a timeline for such activities,
recognizing that a rules moratorium is currently in place until the end of 2012.
Presentation of Service Recognition

Christopher Barry called Al Linggi to recognize him for his time served on the Board of
Pharmacy.
Governor Gregoire appointed Mr. Linggi February 2008 which ended February 2012. Al was
also given a signed letter from Governor Gregiore thanking him for his service.
Correspondence
Rep Hunt Administrative Law Judges

Opioid Analgesic Drugs
NABP Internet Drug Outlet Report Jan2012
Robberies-Pharma
Seattle Update Brief January 2012
Election of Officers
The board was asked to consider re-affirmation of policy #4 and elect officers for 2012.
MOTION: Donna Feild nominated Christopher Barry as Chair and Christopher Barry
nominated Donna Feild as Vice-Chair. Elizabeth Jensen second. MOTION CARRIED: 7-0.
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Disciplinary Process Overview/Review

Jack Bucknell from Office of Legal Services provided the board a brief presentation on the
complaint/disciplinary process. This was to provide new board members a quick overview of this
process from beginning to end.
OPEN FORUM
Al Linggi commented that Washington State Board of Pharmacy needs to continue to be involved
with National Association of Boards Pharmacy.
Julie Akers, Washington State Pharmacy Associations (WSPA) shared WSPAs position on
patient counseling. She had just received an email from a member that was on the workgroup
regarding patient counseling in the 90s. The email stated that this was left squishy on purpose to
allow a pharmacist use professional judgment on counseling so there could be more time focused
on New Prescriptions.
Sepi Soleimanpour and Elizabeth Jensen were chosen to take part interviewing potential
applicants for Board of Pharmacy Executive Director.
th
Christopher Barry was decided to be the voting delegate to attend the 108 Annual National
Association Boards of Pharmacy Meeting. If he is unable to attend Donna Feild was chosen to be
the voting delegate.

CLOSED SESSION
Next scheduled business meetings: April 19, 2012
Mt. Constance Conference Room
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2400 S. 240 St.
Des Moines WA 98198
_______________________________
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MEETING AGENDA
March 10, 2006
CenterPoint Corporate Park
nd
Creekside Bldg #3 2 Floor
nd
20435 72 Ave
Kent, WA 98032
253- 395-6719
CONVENE
Chair Asaad Awan convened the meeting at 9:12 a.m. on March 10, 2006. Board Members
present:
George Roe, RPh
Donna Dockter, RPh
Gary Harris, RPh
Rosemarie Duffy, RN
Absent Member:
Lisa Salmi, Deputy Executive Director
March 10, 2006
Open Meeting
Welcome to New Board Member

The meeting began with the introduction of Rosemarie Duffy. Ms . Duffy was appointed by
Governor Gregoire on January 30, 2006 to serve a four year term as a public member of the
Board of Pharmacy. She has been a resident in Washington State for approximately 12 years and
is a nurse by profession. In her introduction she quoted Marian Wright Edelman summing up
her motivation for serving her community. Service is the rent we pay for being.
Pharmacy Intern Study Plan
Andy Mecca provided the regulatory basis for this request coming before the Board. Elise Ng, a
pharmacist intern, has been unsuccessful in passing the NAPLEX. Ms. Ng is requesting that the
Board approve her study plan and authorize her to re-take the exam. MOTION: George Roe
moved that the Board accept the Pharmacy Intern study plan and approve Elise Ng to re-take the
NAPLEX exam. MOTION CARRIED.
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CONSENT AGENDA
1.1
1.2
1.6
1.8

Thu N. Vu Application for Nuclear Pharmacist
Anthony Parks Application for Nuclear Pharmacist
Closed & New Pharmaceutical Firms 12/23/2005- 2/13/2006
Bridgeport Pharmacy Services
Sunnyside Community Hospital
Yakima Valley Memorial Hospital
Board Minute Approval
January 26, 2006 meeting minutes
Items 1.3 Pharmacy Technician Application Approval; 1.4- Pharmacy Technician Training
Program Approval; 1.5- Collaborative Drug Therapy Agreement Acceptance; and 1.7- Sample
Distribution Requests were deleted from the consent agenda. MOTION: George Roe moved to
accept 1.1, 1.2, 1.6 and 1.8 of the consent agenda items. MOTION CARRIED.
REPORTS
Judy Haenke, Program Manager and the Optometry Board is putting on a
seminar next weekend with 650 participants registered for continuing
education credits. The event will be held at the University of Washington.
She has also been involved in the Dispensing Optician exam (given twice a
year) and the North American Veterinarian licensing exam.
Personnel Issues
Section Four has hired a temporary staff person to assist with the credentialing
process during the absence of one permanent staff member. The temporary
position begins this week for 3 months.
The Veterinary Board is down two veterinarians and one public member.
Interested parties may visit the Governors web page for application
information.
The secretarys Orthotics and Prosthetics Advisory Committee also has two
vacancies.
Working with bill analysis for the Legislative Session ended 3/9.
Doreen Beebe, Program Manager to the Board of Pharmacy and the Orthotics
and Prosthetics Advisory Committee is interviewing to fill a support position.
Steve Saxe has participated on the interview panel with other Department of
Health staff to fill the Medical Directors position with the Washington
Physicians Health Program (WPHP). Dr. Lynn Hankes, who has held the
position for a number of years, plans to retire. Dr. Mick Oreskevich has been
selected to fill the position. Section Four works with 3 different impaired
practitioner programs: Washington Recovery Assistance for Pharmacy
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Program (WRAPP), Optometry Washington Health Professional Services and

WHPS.
The department is working on a strategic plan to develop one single complaint
process that will address complaints that encompass several programs. The
plan is looking to develop common business practices, enhance data
management, and looking at better technologies. DOH has signed a contract
for a new licensing system that will support credentialing, complaints,
inspection process, etc. The system will assist us in improving workforce
diversity, competency and satisfaction. The strategic plan has been finalized
and work will begin looking at organizational functions and structure. Each
section within Health Systems Quality Assurance Division has identified the
time it devotes to credentialing, complaints, compliance, inspections and
board support to determine if there are opportunities to improve the
functionality of the division. The Board will be updated as the process moves
forward.
BOARD MEMBERS
st
George Roe attended the March 1 Investigators quarterly meeting. Mr. Roe highlighted
concerns expressed at the meeting regarding the need to find business license holders
accountable for system related complaints. Actions against licensed personnel are often not
enough to solving system issues. In some cases operating procedures and conditions which are
controlled by employers may be contributing factors to dispensing errors and are controlled by
employers. Mr. Roe stated that this is something that the Board should address.
ASSISTANT ATTONEY GENERAL
Joyce Roper will be working with Steven Saxe to review the recently enacted Patriot Act, which
contains language addressing methamphetamine precursors. They will be comparing the federal
regulations to Washingtons laws to identify where there may be differences.
CONSULTANT PHARMACIST
Tim Fuller provided an update on the Automated Devices Rules. The hearing is tentatively
st
scheduled for June 1 . Mr. Fuller participated in an emergency response drill of the departments
reception, storage and supply facility. This facility will receive drugs from the strategic national
stockpile. Mr. Fuller along with Investigator Jim Doll and Deputy Director Lisa Salmi will
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participate in the statewide exercise planned for April 5 . The full scale exercise will include
filling and sending order to various sites.
Andy Mecca updated the Board on the collaborative work being done by the Department of
Health, Labor and Industries, Department of Corrections and other agencies in establishing
opiate dosing guidelines. Meetings are progressing. Final guideline will be reported to the
Board.
Patient counseling sign and letter explaining voluntary compliance has been posted to the
Boards website and an article has been submitted for the April newsletter, which will be mailed
to all pharmacists.
CHIEF INVESTIATOR
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Jan 31, 2006, Randy Flett provided an overview of precursor laws and rules to members
of King County Sheriff, various legislature staff, city, county, state, and federal personnel
from various agencies affected by methamphetamine.
Dick Morrison, as a member of the University of Washington, School of Pharmacy
Admissions Committee, has been involved in interviewing applicants to the University of
Washington, School of Pharmacy.
Stan Jeppesen and Andy Mecca are participating in a law review class designed for
individuals who are studying for the MPJE. These classes are held on two Saturdays in
March at the University of Washington.
March 1-2, 2006 Investigators Meeting. Board member George Roe attended on March
st
1 and had a chance to meet the entire Section 4 staff at our all staff meeting. We had a
full agenda of current issues and updates on procedures relating to case management.
The investigator vacancy in Central Washington continues to pose challenges for the rest
of the investigators. In addition to their own workload many investigators have been
assigned Central Washington cases, practice reviews and non-routine inspections (i.e.
new, relocation and remodel inspections).
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Donna Dockter tentatively accepted the invitation to attend the June 7 Investigators
meeting.
PRESENTATIONS
Cerner Corporation
Dr. Steve Ward presented Cerner Corporations EasyScript (Sending System) and PharmNet
(Pharmacy Receiving System) for Board approval.
EasyScript solution does not currently support NCPDP script standards it does not send
prescriptions out electronically but directly to the pharmacy fax machine. In the future,
should the system transmit prescriptions other than via fax, Cerner will request an
amended approval from the Board.
MOTION: George Roe moved to approve the electronic prescription transmission and receiving
systems by Cerner Corp with the stipulation that it documents chronic conditions and remove the
brackets on the refillprescription MOTION CARRIED.
PDX Inc.
Ben Loy, Senior Vice-President of PDX Inc. presented their eRx Network (Gateway System)
and Pharmacy PDX Retail Pharmacy Management System (Pharmacy Receiving System) to the
Board for approval. MOTION: George Roe moved to approve the electronic prescription
transmission and gateway systems by PDX Inc. once the system shows Dispense as Written
and the physicians DEA # on screen. MOTION CARRIED.
LSS Data Systems
Ken Carlson, CEO and Chief Technology Office of LSS Data System presented their electronic
prescription transmission system (Sending) to the Board for approval. MOTION: George Roe
moved to accept LSS Data Systems. MOTION CARRIED.
DISCUSSION
Update 2006 Legislative Session
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Steve Saxe recognized Rebecca Hille for her participation in the Monday meet me calls, which
provided the department an opportunity to receive input from representative of all Boards,
Commissions, and Advisory Committees on 2006 multi-profession bills .
Mr. Saxe provided a summary of legislative bills of interest to the Board and Section Four.
HB2292 Healthcare Liability Reform Patient safety malpractice bill legible prescription
clause, which requires prescriptions to be hand printed, type written or electronically generated
Signed by Governor. Effective 90 days after end of session.
ESB6194 Multicultural Education for Healthcare Professionals - Requires multicultural
education to be incorporated in the curriculum of the professional educational programs within
the state. The Department of Health will be charged with developing ongoing cultural diversity
education. This bill also looks into disparity in access to healthcare for different cultural groups.
This bill passed and is waiting to be signed by the Governor.
SHB2974 Health Professions Discipline Mandatory reporting of findings of unprofessional
conduct. A section of this bill provides that the disciplinary history is given to the boards as it
looks at authorizing investigations . This legislation emphasizes public safety. The Washington
State Patrol will report any violations that they may be aware of to any disciplinary boards .
There are concerns that this bill did not address property crimes, which is an issue when dealing
with vulnerable adults . Also related to this bill is a decision package for funding to do national
databank checks for all applicants. In addition, a provision of this bill authorizes a summary
suspension of the license status in Washington pending retribution for actions taken by another
state. This bill passed and is waiting to be signed by the Governor.
HB1850 Retire Volunteer Medical Workers License creates a retired volunteer medical license
up to 10 years out of practice. The Department of Health is charged with establishing
continuing competency requirements . This license is for working in emergency situations . The
bill also addresses liability issues for the retired worker. This bill passed and is waiting to be
signed by the Governor.
SB6193 Surveys of Health Professions Work Force Supply and Demographics . This bill passed.
Optometry Licensing eliminating tiered licenses for all Optometrist by 2011. All optometrist
must get have completed the training and licensure to prescribe oral drugs and epinephrine. This
bill requires rule making. New applicants in 2007 must meet new credentialing level. This bill
passed.
SB6591 Expanding provisions relating to wholesale distribution of dangerous drugs . This bill
did not pass. A significant amount of work and meetings went into this bill. There were issues
around pedigree and concerns raised regarding penalties. Look for this bill to return in 2007.
HB332 Controlled Substances Prescription Monitoring Program. Representative Hinkle dropped
this bill shortly before the session ended. The Board will be providing comments to prepare for
next session. The department had a grant last year and did significant stakeholder work and
wrote draft rule language.
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Health Systems Quality Assurance division reviewed 134 bills . The office of Health Professions
Quality Assurance was lead on 98 and assigned as support on 36 bills.
Engrossed Substitute House Bill 2266

The law which was passed in 2005, effective January 1, 2006, requires the Board of Pharmacy to
form a task force or work group to assess the effectiveness of methamphetamine precursor retail
logs. The group will evaluate:
Whether the log or other means of recording the transactions is an effective law
enforcement tool?
What information is needed to make logs or other means of recording a transaction useful
as a deterrent to criminal activity?
What is the most effective and lease intrusive method of obtaining, recording, and storing
the log or other electronic data?
How long the information should be maintained?

How can the information be most effectively transmitted to law enforcement and the
Board of Pharmacy?
The members of the Task force include representation from the Washington State Association of
Sheriffs and Police Chiefs, Washington State Patrol, Washington Association of Prosecuting
Attorneys, Attorney Generals Office, two representatives from the retail industry and a Board of
Pharmacy member. A letter will be going out soon to invite retail folks to come to the table to
select 2 representatives. We also need to identify a representative from the Board. It is
anticipated that the task force will meet for 8 half-day meetings.
MOTION: Rebecca Hille moved to appoint Donna Dockter with her valuable retail background
to the Meth Task Force as a representative of the Board. MOTION CARRIED.
University of Utah School on Alcoholism and other Drug Dependencies
Due to schedule conflicts Rosemarie Duffy and Gary Harris are unable to attend. MOTION:
Rebecca Hille moved Board staff appoint two appropriate staff members to attend the Utah
training. MOTION CARRIED.
Northwest Womens Law Center & Planned Parenthood
Steven Saxe reminded the Board that representatives from Northwest Womens Law Center and
Planned Parenthood requested in January to present to the Board their views following the
Washington State Pharmacy Associations presentation on a Pharmacists Conscience Clause.
Mr. Saxe went on to say that this is just one step in the rules process. The rule making process
initiated by the Board in January will consist of stakeholder meetings held in various locations
throughout the state and are scheduled to begin this spring. The Board will then determine
whether rules are needed. If rules are necessary, draft language will be written and additional
public comment received. This is a very open process.
Washington has been a leader first in the country where pharmacists with a collaborative
agreement can prescribe and dispense emergency contraception. Washington has the longest
running pharmacist emergency contraception training program. Training is available for
pharmacist through the American Pharmacy Association and the Washington Pharmacy
Association (WSPA) and included as part of the curriculum for pharmacy students.
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Steven Saxe reiterated that the Board staff advises pharmacists to be proactive by working with
their employers and colleagues to ensure patients receive timely and convenient patient care.
The following is a summary of the presentation made to the Board by Nancy Sapiro, representing
the NW Womens Law Center; Roberta Riley and Amy Luftig representing Planned Parenthood
Presentation.
The presenters provided a brief overview of the legal landscape in Washington and why they feel
that pharmacist have a greater responsibility to their patients under Washington law than the
position reported in the WSPAs position presented at the January meeting. Ms. Sapiro stated
that while they think that WSPAs proposal is viable in some respects they feel it is an
inadequate response to the issue of pharmacists refusals in this state.
They acknowledged that the vast majority of pharmacists in this state take their ethical and legal
responsibility very seriously and that they are committed to protect the patients safety and
timely access to needed medications. They went on to say, pharmacists in this state are refusing
to fill prescriptions and particularly refusing to fill prescriptions for birth control. In so doing
they are creating a significant new threat to womens reproductive healthcare. The impact of
these refusals is not simply minor inconveniences they pose significant barriers to necessary
health care for women. These negative impacts are greatest for those with limited access to
alternative pharmacies.
Reasons to fill legally prescribed medications:
Professional standards of conduct
National Pharmacist Codes of Ethics - requires pharmacist to avoid actions that
compromise the dedication to the best interest of their patients.
Washington laws
o Duty to fill pharmacy practice
o RCW 9.02.100 Reproductive Privacy Act - that an individual had a fundamental
right to choose birth control and that the state can not discriminate in a way that
inhibits an individuals ability to exercise that right.
o 1978 US Supreme Court noted that laws can not interfere with religious
belief/opinions, the constitution protects these individual beliefs; however, laws
may regulate our actions.
Reasons not to fill legally prescribed medications:
Professional judgment
o Forgery
o Contraindications
Amy Luftig highlighted trends in the nations and gave four examples from Washington State of
pharmacist refusing to fill prescriptions for antibiotics, syringes, prenatal vitamins and ECP
citing religious or implying other biases. Ms. Luftig stated that these examples pose a direct
health risk to the client and are not limited to emergency contraception.
National Trends
Other states and pharmacy boards summarily reject pharmacists right to refuse in favor
of patient protection
Wyoming and Nevada Boards of Pharmacy adopted a proposal that pharmacists can
refuse only on the basis of unlawful prescription or contraindications .
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North Carolina Board released a policy stating it is unacceptable for pharmacist to

impose their moral or ethical beliefs on their patients the serve.
Governor Jim Doyle of Wisconsin stated regarding a similar bill proposal - it is hard
enough for many people to get the healthcare they need.
They acknowledged that the WSPAs position paper recognizes the foremost responsibility of a
pharmacist is to provide pharmaceutical care to their patients. They strongly disagreed that in
those instances when a pharmacists personal beliefs conflicts with their professional
responsibilities the pharmacists has the right to refuse to fill. A referral is not a minor
inconvenience for many women who live in towns with only one pharmacy or have to go to
another town or across town. This is especially compelling when you think of emergency
contraception where the efficacy of the drug is decreasing.
Ms. Sapiro, Ms Luftig and Ms. Riley urged the Board to follow their colleagues in other states
and reach the same conclusion. They asked the Board to move forward with a policy that will
protect the health of all Washington residents to ensure that no one is denied safe and legal
prescriptions in this state because of an individuals personal beliefs. Without imposing an undo
burden on the employer, the employer should attempt to accommodate the employee. Pharmacies
can accommodation the religious refusal of pharmacist while protecting a patients rights if and
only if the patients care is not disrupted or delayed in anyway.
Comments from the Audience
There were approximately eighty persons in attendance. Twenty-one individuals provided their
input on the issue and their perspective of the presentation by the NW Womens Law Center and
Planned Parenthood. Eighteen supported a conscientious clause, three opposed. Speakers
included representation from healthcare practitioners, lawyers, political affiliations, pro-choice
activist groups, religious affiliations, pharmacy students and concerned citizens.
The Board acknowledges the passion of each speaker and appreciates the opportunity to consider
their input. The following is a summary of the comments addressed to the Board regarding a
pharmacists right to exercise their conscience.
RCW 48.43.065(2) - no individual healthcare provider may be required to participate in a

specific service if they object for reasons of conscience or religion.
RCW 9.02.100 - Reproductive Privacy Act
There are over 7000 pharmacist licensed in Washington no access problem.
Abortifacient verses emergency contraception ( prevents implantation verse prevents
ovulation)
To be required to refer a patient elsewhere would not honor the pharmacists conscience,
but rather a partner in the process.
Planned Parenthood has a financial interest in Plan B.
The Hippocratic Oath states above all do no harm.
According to the NotToLate webpage there are 515 providers of emergency
contraception in Washington, of which 87 providers are in the 509 area code.
Employers provide reasonable accommodations to allow a pharmacists to exercise
conscientious objection.
Washington State law provides for womens rights to reproductive choices
Even if I choose not to fill, I recognize that the prescriptions belong to the patient.
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st
The 1 Amendment of the Bill of Rights states in part Congress shall make no law
respecting an establishment of religion, or prohibiting the free exercise thereof
The name emergency contraception is a misnomer. There is no emergency. The drug is
effective if taken within 120 hours after unprotected intercourse.
Recognition of the civil rights of pharmacist does not infringe on the rights of patients.
There is no crisis of availability or access. Emergency contraception is available through
mail-order, internet, Planned Parenthood Health Center.
Other professionals such as physicians, lawyers, nurses, etc. have the right not to
participate in the termination of a pregnancy. RCW 9.02.150
Checks and balances are a good thing when it comes to critical matters of life and death.
State law defines that pregnancy begins with the implantation of the fertilized ovum on
the uterine wall.
Exercising ones conscience in not unrestricted.
What about drugs prescribed for assisted suicide?
Draft Response to Interested Parties

The letter drafted to respond to the number of letters regarding a pharmacists right to exercise
conscientious objection was distributed to the Board. Steven Saxe asked the Board for its input.
MOTION: Rebecca Hille moved to removed emergency contraception from paragraph 2 and
remove paragraph 3 entirely. MOTION CARRIED.
MOTION: George Roe moved that item 4.4 GMAP Presentation, 4.5 Operating Agreement, 4.8
Notice of Correction & Stipulations to Informal Disposition, and 4.9 Future Board Agenda be
postponed until a future meeting. MOTION CARRIES.
Adjournment
There being no further business, the Board adjourned at 4:00 p.m. They will meet again on April
20-21, 2006 in Yakima, Washington.

__________________________________________
Approved on June1, 2006
_________________________________________
Board of Pharmacy
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STATE OF WASHINGTON
MEETING MINUTES
March 11, 2010
Department of Health Kent Offices
Marketing Center Creekside Three
at CenterPoint
20435 72nd Ave S, Suite 200 Conference Room 1
CONVENE
Chair Gary Harris called the meeting to order at 9:03 a.m., March 11, 2010.
Albert Linggi, RPh, Vice Chair
Dan Connolly, RPh
Joyce Roper, AAG
Greg Lang, Investigator
Guest / Presenters:
Paula Meyer, Executive Director
of Nursing Commission
Chuck Cumiskey, Practice Advisor
for Nursing Commission
Kitty Slater, Compliance Officer for
the Board of Pharmacy
Michaelene (Micki) Kedzierski, RPh, CDP
William Rhodes, MSW, CDP, MHP
WRAPP Monitoring Program Manager
Leon Alzola, Chair of WRAPP
Michael Marr, BS pharm, Pharm.D
Dianna Gatto, Good Samaritan Hospital
Jeff Stimson, Good Samaritan Hospital
Mindy Collins, Local Source Control Specialist
City of Bellingham, Public Works Dept
Denise Jason, Compliance Officer for Genoa
HealthCare
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CONSENT AGENDA
1.1
1.3

1.5
Columbia Basin Hospital

Board Minute Approval. (January 21, 2009)
Items listed under the consent agenda are considered to be routine agency matters and will be
agenda. Items 1.2 and 1.4 have been deleted from the agenda.
MOTION: Dan Connolly moved that the board approve items 1. 1, 1.3 and 1.5. Rebecca Hille
REPORTS
Board Member
Chris Barry reported:
February 25, 2010 Christopher Barry was confirmed at the Senate Health and Wellness
Committee. He was asked a number of questions and did a great job representing the
board.
Mr. Harris was reconfirmed on February 25, 2010 but did not attend.
He has been on 2 more meet me calls. There were several weeks that the meet me calls
were cancelled because there were not any new bills.
Gary wrote emails to two representatives and the state senator regarding a couple of bills.
Al Linggi reported:
He was in contact with American Society of Health System Pharmacist (ASHP). Mr.
Linggi shared information with Susan Teil Boyer regarding the government affairs
committee and how government affairs nationally and state wide coordinate with Boards
of Pharmacy. He hopes the board will be updated monthly.
Al volunteered to serve on a mission to Honduras. There were 3 Pharmacists, 9
physicians, 2 dentists and 22 nurses. They created a formulary of about 90 drugs. These
drugs were labeled, with expiration dates, in Spanish. The volunteer health care givers
saw about 2,300 patients and filled about 9,000 prescriptions. This was his second
experience and it continues to be a meaningful experience.
University of Washington has a practice board and they will be having a meeting May 27,
2010. There are about twenty members from all practice settings. Al suggested that Susan
Teil Boyer attend this meeting.
Executive Director
The Tamper Resistant webpage was posted the week of February 22, 2010, a press
release to the media was also distributed, a newsletter article went to Washington State
Pharmacist Association (WSPA) and Washington State Medical Association (WSMA)
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and Tips for Tamper Resistant Prescription Pad has been posted to the professional
listserv s for prescribers. Subsequent to the press release, the Everett Herald, Seattle
Times, News Tribune and other news papers picked up the story. Donn Moyer and Susan
Teil Boyer were interviewed for radio stories on this topic.
Chris Barry and Gary Harris were confirmed by the Senate Health and Wellness
Committee February 25. Chris Barry answered questions regarding pharmacy issues and
well represented the board.
Legislative bills affecting pharmacy and health care.
o Uniform Controlled Substances Act
Incorporates carisoprodol as schedule IV
This bill aligns and conforms the state CSA to the Federal CSA
o Electronic tracking of pseudoephedrine, ephedrine, phenylpropanolamine
This bill creates a public/private contract to provide software to all
pharmacies and shopkeepers who sell these products. The bill requires
rulemaking and implementation of the program statewide
o Out of state ARNP prescribers
Pharmacists will be able to accept legend drug prescriptions written from
out of state
o Pain Management Education for prescribers
Education will be developed for prescribers and we will want to
have a pharmacist on the workgroup.
Susan also presented a law update with Grant Chester at the annual law seminar held at
University of Washington School of Pharmacy January 24, 2010.
On January 30, she presented a board of pharmacy update to the WSPA board. This was a
constructive and productive discussion.
Hospital Pharmacy Rule first stakeholder meeting with Hospital Pharmacy Director
group (WSPA) set for April 30, 2010, Valley Medical Center.
Jim Doll, Jim Lewis, Susan Teil Boyer reviewed and edited the Jail Medication Model
Policy and returned the document to Washington Association of Sheriff and Police Chiefs
(WASPC).
On February 12, 2010 new dates were set for trial and all other events that occur before
trial regarding the Stormans case. The Stormans plaintiffs acknowledged that there is no
need for more discovery. Dates were set to file Summary Judgment motions. A
Summary Judgment motion is a request to the judge to resolve the case without trial,
because there are only legal issues, no factual issues in the case. . If the case does not get
resolved on Summary Judgment then the trial will begin July 28, 2010.
February 4, 2010 Cathy attended the final meeting of the Agency Medical Directors
Group (AMDG) Opioid Guidelines Workgroup which is updating the guidelines for
publication in June.
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Cathy Williams, Stan Jeppesen and Tom Hazlet assembled review questions to help in
preparation for the Multistate Pharmacy Jurisprudence Examination, some easy, some
hard. PHARM 544 Survey of Pharmacy Laws met Saturday, February 27 & Saturday
March 6, 2010 .
On February 5, 2010 carisoprodol became a Schedule IV control substance in
Washington State. A detailed communication plan was implemented and there have been
surprisingly few questions.
Tim participated in Pharmacy Legislative Day along with Mary Selecky, Karen Jensen
and Steve Saxe.
On February 8, 2010 Washington State University Extern Will Quinby began a 6 week
rotation with the board. Wills father is a pharmacist in Aberdeen and he wants to have
his own pharmacy in the future. At this time Will has spent time in the field with four of
the board investigators and is working on projects for both Mr. Fuller and Grant Chester.
He prepared the CR101 and Cover Memo for the Hospital (Health-System) rule revision.
The National Association of Boards of Pharmacy Model Act and recent state hospital
pharmacy rules are being used in the revision process. Expect to have the first
stakeholder meeting in April .
Chief Investigator
Grant compiled a list of the pharmacy robberies in Washington State during 2009. His list
is 1 different (87) from the official DEA list (86).
January 24, 2010 Grant and Susan Teil Boyer presented at the New Drug Laws and Care
Management Seminar held at the University of Washington, School of Pharmacy.
February 5, 2010 Jim Doll held a presentation at Pacific Lutheran University on the
subject of Safely and Legally Prescribing Controlled Substances.
February 27, 2010 Stan Jeppesen and Cathy Williams presented at the University of
Washington Pharmacy Law Class.
Program Manager
She has been working hard on Tamper Resistant Prescription Pads approval process.
There are forty-six approved vendors, twenty-one pending applications. She commented
that 100% of the applications require follow-ups.
DISCUSSION
WRAPP
Micki Kedzierski, William Rhodes and Stan Jeppesen shared some background information on
the Washington Recovery Assistance Program for Pharmacy (WRAPP). They are asking the
board to discuss the Washington Recovery Assistance Program for Pharmacy guidelines on
reporting non-compliance.
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The WRAPP Guidance document will assist WRAPP and the Board of Pharmacy with guidance
and insight when processing individuals and their cases under the Impaired Pharmacist
Rehabilitation Rule or WAC 246-867. It also addresses the important reporting of alcohol use
and the below threshold incidents. The reporting of these below threshold incidents takes time
and resources from the Board of Pharmacy. The goal of WRAPP is to clarify and reduce the
reporting of the below threshold incidents.
Leon Alzola, Chair of WRAPP ended this discussion with a summary. He asked that the board
notify WRAPP when a pharmacist is board ordered to the program. Discipline appropriately
when the board is notified of non-compliance. Consider allowing credit to time spent in the
program before ordered into the program. Arrange for orientation and training on the program
between WRAPP and the board.
MOTION: Dan Connolly moved that the board implement the recommended guidelines on
reporting non-compliance from Washington Recovery Assistance Program for Pharmacy.
Rebecca Hille second. MOTION CARRIED: 5-0.
Al Linggi asked that board staff and WRAPP work together on developing an algorithm for the
board to be more consistent with the actions taken on non-compliance.
Request for Boards Opinion

The Spokane County Jail asked the Nursing Commission and the Pharmacy Board for a formal
opinion on the practice of allowing nurses to authenticate inmates own medications brought into
the Spokane County Jail by family or friends. Paula Meyer, Executive Director of the Nursing
Commission attended the board meeting to hear the discussion and to take the issue to the
Nursing Commission March 12, 2010.
During this discussion the board agreed that this would not be a safe practice nor in the best
interest of the patient/inmate. The Board of Pharmacy does not have authority over jails or
nursing practice. The board will respond with the Nursing Commission to this particular letter on
whether this should be allowed. The board may also provide opinions with some options.
MOTION: Dan Connolly recommended that the Spokane County Jail contract with a pharmacist
consultant for identifying drugs and for other medication policy review. Vandana Slater second.
Christopher Barry offered a friendly amendment that we disallow the practice. After further
discussion this motion was restated.
RESTATED MOTION: Christoph er Barry moved that the practice of authenticating inmates
own medications brought into the Spokane County Jail by family or friends as defined in the
letter is not acceptable. The board recommends that Spokane County Jail contract with a
pharmacist consultant to develop a policy and procedure to ensure patient safety and prevent
diversion. Al Linggi second. MOTION CARRIED: 5-0.
2010 Legislative Updates
SHB 2443 Uniform Controlled Substances Act (CSA).
Incorporates carisoprodol as schedule IV.

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This bill aligns the state CSA to the Federal CSA.
HB 2961 Electronic tracking of pseudoephedrine, ephedrine,

phenylpropanolamine
rulemaking and implementation of the program statewide.
SB 6627 Out of state ARNP prescribers
Pharmacist will be able to accept prescriptions written from out of state

and bordering Canadian provinces for legend drugs.
ESHB 2876 Pain Management Education for prescribers
Education will be developed for prescribers and we will want to have a
pharmacist on the workgroup.

Sample Drug Guidelines
Cathy Williams led the discussion to the board asking them to consider a final version of the
Sample Drug Dispensing Guidelines. Cathy incorporated the feedback from the board given
during the December 10, 2009 meeting.
MOTION: Christopher Barry moved that the board approve the amended Sample Drug
Dispensing Guidelines. Rebecca Hille second. Dan Connolly opposed. MOTION CARRIED:
4-0.
Stickerless Prescription Files
Grant Chester provided a matrix of information the board requested for their consideration to
initiate rules to allow Washington pharmacies to utilize an electronic process for recording and
maintenance of prescription data as required under WAC 246-869-100. This applies to legend
non-controlled substance drugs only.
MOTION: Dan Connolly moved that the board approve the recommendation as presented and
proceed with rulemaking in WAC 246-869-100. MOTION CARRIED: 5-0.
PRESENTATIONS
Pharmacy Technicians Trained to Take Patient Medication List
Michael Marr presented a proposal to the board for Providence St. Peter Hospital. He asked the
board to consider allowing trained pharmacy technicians to interview patients to obtain a
medication list.
Overview:
Medication reconciliation process
At entry, obtain and document medication list .
Complete and accurate list will improve safety.
List will be obtained at point of entry to hospital .
List should be obtained by persons familiar with:
Drug names, strengths, dosage forms and directions for use.
Pharmacist
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Pharmacy technicians
Pharmacist Technicians are effective
Several institutions in the area utilize technicians for medication reconciliation .
Familiarity with medications.
Work under direct supervision of pharmacist .
Cost effective.
Educating Pharmacist Technicians to obtain medication lists
Pharmacist taught education session.
Process to obtain list.
Interview techniques.
Completion of training with competency exam.
Pharmacist/Pharmacist Technician shadowing.
Training with supervision until deemed competent.
Minimum shadowing for three hours.
Workflow
Patient enters hospital through emergency department.
Pharmacy technician obtains medication list through patient interview.
Pharmacist reviews medication list for accuracy and completeness.
Pharmacist approves it by signing off.
Physician reviews list and reconciles medication.
Summary
Patient safety is the primary goal.
Medication list must be complete and accurate in order to be successful.
Trained pharmacy technicians are able to obtain accurate medication lists .
Pharmacist oversight and review will be conducted for each medication list.
MOTION: Vandana Slater moved that the board approve Providence St. Peter Hospitals
request to allow trained pharmacy technicians to interview patients to obtain a medication list .
Providence St. Peter Hospital is to report back to the board in 1 year and work with Tim Fuller
on developing policy and procedures. Rebecca Hille second. MOTION CARRIED: 5-0.
Good Samaritan Hospital Update
Dianna Gatto and Jeffery Stimson from Good Samaritan Hospital presented a follow-up on its
process implemented for using specially trained pharmacy technicians to obtain medication lists
for emergency department and hospitalized patients.
Follow up on process for technicians obtaining medication lists:

Where/when list is obtained
Emergency Department
Lists obtained 7 am to 2 am seven days per week.
ED pharmacist verifies each list.
Direct admissions
Pharmacists request technicians obtain lists on direct admits .
Technicians go to floor, obtain list, verify with decentralized pharmacist .
Number of technicians and lists obtained
Eight specially trained technicians participate in process .
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Med lists per month: average 466*.

Med lists per day: average 15.5*.
Time to obtain: average 17 min per list.
Feedback, pharmacist, physician
Pharmacists agree this saves time on unknown medications .
Nurses appreciate this help, saves time and the patient does not have to be asked
more than once.
Physicians love this.
Lessons learned
Obtaining accurate lists
Discrepancies between Rx bottle and patient.
Patient and mental health.
Documentation
Computer issues, Word document files .
Documentation of number obtained per day.
Other
Storage of home medications.
Conclusion
At Good Samaritan, trained pharmacy technicians are obtaining complete and accurate
medication lists with pharmacist oversight and review.
Our medication reconciliation process is successful with the addition of specially trained
technicians.
Guideline for Pharmacy Technicians Trained to Take Medication List
Tim Fuller presented a draft guideline to establish standards for utilization of pharmacy
technicians to collect a patient medication list to the board for their review. He answered
questions from the board. Tim asked for feedback from the board regarding this guideline draft.
After some discussion Mr. Fuller was asked to put some added focus on the Quality Assurance
piece of this draft. Christopher Barry recommended that Mr. Fuller send hospitals that are using
pharmacy technicians to obtain medication list, the draft guidelines for their review and ask for
feedback.
Bellingham Pharmaceutical Waste Program Proposal
Stan Jeppesen asked the board to consider a proposal by Bellingham Waste Water Program for
collection of pharmaceutical waste.
City of Bellingham Protocol Background:

The Bellingham protocol follows the protocols approved by the board for the
PH:ARM pilot where waste drugs are collected in a secure container system.
Prescreening of material to be collected has been shown to prevent the collection of
prohibited material, to include controlled substances. The Bellingham program will
continue to prescreen all material
City of Bellingham Protocol Attributes:
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All collection sites will be located at Bellingham licensed retail community

pharmacies. Five (5) sites are initially proposed for initial implementation. Five (5)
additional pharmacies are anticipated for the future.
The program will utilize two person witnessed access and transfer of all material.
Pharmacy staff is not allowed to physically handle the collected material. Pharmacy
staff will visually inspect all material prior to consumer deposit and reject any
material not allowed under the protocol.
Controlled substances are not allowed for collection.
Consumers will deposit their own material after material inspection by pharmacy
staff.
All collected material will be tracked from the collection site to ultimate destruction.
Ultimate destruction will be via a licensed Reverse Distributor.
Security of all collected material will be maintained at licensed facilities.
The secure collection containers are manufactured by dVault for the purpose of
collecting waste pharmaceuticals with dual key access, of the type previously
approved by the board and utilized in previous collection programs.
The protocol requires internal assessment to identify operating compliance with the
protocol.
Full unrestricted inspection is allowed by the Washington State Board of Pharmacy
and law enforcement.
The City of Bellingham, Public Works Department, is willing to provide the board with an
operational program update, at a time of the b oards request.
MOTION: Christopher Barry moved that the board approve the request from Bellingham Waste
Water Program for collection of pharmaceutical waste for a three year period. This allows the
five initial pharmacies and up to five additional sights. The Board of Pharmacy Executive
Director and board staff can make minor modifications as required. Vandana Slater second.
EXECUTIVE SESSION
CASE PRESENTATION
PRESENTATIONS contd
Telepharmacy
Tim Fuller introduced Wade Shutz who presented the proposal to the board for Bartell Drugs to
provide remote order entry services to other Bartell Drugs Pharmacies operating EnterpriseRx.
Implementation of Enterprise Rx software has created a central database with VPN
connection between stores and a common method of filling prescriptions.
The goal is to create a more flexible workflow and a work environment more amendable
to direct patient care.
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A log of user actions, for both Store A and Store B, and a step-by-step record of all
dispensing are maintained by the software for system and personal quality
determinations.
Workflow
The patient presents the prescription to Store A. Store A scans the prescription
and a digital image is sent to Store B.
Store B may perform data entry, interpretation, clarification, adjudication and
drug utilization for Store A.
Store A performs physical preparation and dispensing, final pharmacist
verification and ensures all data entry steps were done correctly.
MOTION: Christopher Barry moved that the board approve the request from Bartell Drugs to
provide remote order entry services between the two Bartell Drugs Pharmacies mentioned in the
presentation operating EnterpriseRx. They must report back to the board in six months. Rebecca
Hille second. Dan Connolly recused himself. MOTION CARRIED: 4-0.
Use of Emergency Dose Kits
Grant Chester provided the board some background and introduced Denise Jason who presented
the proposal by Genoa to provide E-Kits to residential treatment facilities and emergency
treatment facilities.
1.
2.
3.
4.
5.
Steps:
Verify Residential Treatment Facilities (RTF) license is in accordance with Department
of f Health (DOH).
o Secure the license is current w/no restrictions regarding medication
administration.
Verify RTF has a dedicated Director or Prescriber licensed to handle E-kit items.
o Secure the Director/Prescriber has a current license and Drug Enforcement
Agency (DEA) allowing them to be in possession of E-kit items/stock
Review location for storage of E-kit items
o Verify storage of E-kit items/stock is in accordance with the restrictions as set by
the Board of Pharmacy (BOP) for the storing of medications.
Security & Storage of medications
Inventory logging system
Destruction of expired/unused medications
Submit a limited/restricted formulary to the BOP approval
o Items to be limited to emergent needs
o Medication therapy to be restricted to therapy no longer than 7 days.
o PRN items to be dispensed in quantities of #15 or smaller
o Controlled items to be overseen directly by licensed/employed RTF
Director/Prescriber
Pharmacy to conduct an onsite biannual inspection/audit of RTF.
o Pharmacy to report any discrepancies to the Board of pharmacy as well as DOH.
Genoa is looking to allow continuity of care for those clients restricted into RTF either
voluntarily or involuntarily for treatment evaluation/modification. Genoa will work directly with
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each licensed RTF assuring that all regulating statues are adhered, reporting all discrepancies to
the BOP and DOH as required . We understand that we are working in unchartered waters with
the operation of E-kits in the RTF setting, but Genoa is unique in its business model, we are not
the typical corner pharmacy, we deal directly with the neediest of patients. Often these patients
only other alternative for treatment is our State Hospital where the cost of care is extreme and the
client s ability to work back into the community is limited.
Recommendations by the board of alternate acceptable methods:
1. Use a 24 hour retail or long term care pharmacy.
2. Use a 24 hour hospital pharmacy.
3. Use an automated drug dispensing system controlled by the pharmacy.
4. Use on-call staff to fill prescriptions after hours
MOTION: Christopher Barry moved that the board deny the request for Genoa to provide EKits to residential treatment facilities and emergency treatment facilities, and that Genoa should
explore other options. The proposal is in conflict with pharmacy rule. Dan Connolly second.
DISCUSSION contd
Animal/Veterinary Drug Wholesalers
Susan Teil Boyer led the discussion with the board revisiting the issue of animal drug
wholesalers delivering legend drugs to the end-user and to consider initiating rulemaking.
Pharmacist investigators have identified that veterinary drug wholesalers are filling
prescriptions for local veterinarian s and dispensing the drugs directly to the consumer.
The Board of Pharmacy and veterinary staff met with the chair, pharmacy board, the state
veterinarian, state assistant veterinarian and chair, veterinary board to discuss the best approach
to resolving this issue. The recommendation is to propose a rule change that allows an exemption
for the veterinary wholesaler to sell authorized veterinary medication products directly to the
livestock farmer pursuant to the veterinarians order.
MOTION: Dan Connolly moved that the board initiate rulemaking to allow an exemption for
the veterinary wholesaler to sell authorized veterinary medication products directly to the
livestock farmer pursuant to the veterinarians order or prescription. Vandana Slater second.
Doreen Beebe led the discussion asking the board to consider amending the proposal for rules to
expand the temporary practice permit to 180 days .
January 2010 a proposal was brought to the board to do rulemaking to expand the temporary
practice permit to 90 days. This expansion would accommodate the background checks and
fingerprints which are taking a long time. The board approved the 90 days . It was later
discovered that 90 days is not adequate time for fingerprints. Doreen discussed what other
programs are doing regarding this issue.
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MOTION: Rebecca Hille moved that the board amend the draft rule language to WAC 246-863035 to extend the duration of the temporary practice permit to 180 days. Al Linggi second.
Rules Update
Doreen Beebe and Susan Teil Boyer updated the board on the rulemaking workload.
Doreen went through the rules worksheet with the board and answered questions from the board.
There were no updates from the board staff on their rules.
Letter to Governor Red Jacket Correspondence WF#981729 regarding Cymbalta
Michael Nelson, a member of the public, had an opportunity to express his concerns regarding
Cymbalta. The board discussed concerns expressed in his letter to the Governor. Mr. Nelson
shared his experience with this drug and the adverse side effects. He would like to see this drug
discontinued.
The Board of Pharmacy does not have the authority to ban a drug that has been approved by the
Federal Drug Administration (FDA). The board referred Michael Nelson to the Med Watch
Program to fill out a report
Correspondence
The board discussed correspondence, articles and other written materials with significance to or
affecting the practice of pharmacy.
ISMP Medication Safety Alert January 2010
NABP State News Roundup January 2010
The Quarterly WRAPP-Up w/Letter from FirstLab.
Article: Drug disposal is a good plan.
Article: Putting docs in Duane Reade pays off
Article: SureScripts Going Against the Tide
Letter re: HB 2888
Letter re: SB 6498
Letter re: HB 2961
OPEN FORUM
There were no discussions in the Open Forum.
EXECUTIVE SESSION
Board met in Executive Session to consult with legal counsel matters relating to enforcement
actions.
CLOSED SESSION
Case presentations
Disciplinary Hearing _--- Cancelled __
______
March 12, 2010_9:00 a.m.
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_______________________________
_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON

MEETING MINUTES
March 12, 2015
Constance Room
2400 South 240 St.
CONVENE
Chair Al Linggi called the meeting to order March 12, 2015.
Commission Members:
Al Linggi, RPh, MBA
Gary Harris, RPh,
Steve Anderson, RPh
Guest / Presenters:
Ronald Friedman, Attorney for Practice Fusion
Joshua Maker, Legal Counsel for Practice Fusion
Richard Lumus, Practice Fusion
Jay Ross, Practice Fusion
Michael Li, PharmD, MHA CHI Franciscan Health
System
Tim Lynch, PharmD
Beata Przebinda, RPh for FairFax Behavioral

George Dimaris, RPh for FairFax Behavioral

Nancy Hecox, PharmD

Don DeChenne, RPh from Newport Hospital & Health

Services
Marcy Bryant for Providence Centralia Hospital
Anita Treis for Providence St. Mary Medical Center

Dr. Thomas Hazlet, University of Washington School of Pharmacy
UW Pharm.D Students
Christopher Andrews, Lianne Fijalka, Thao Nguyen, Amanda Popek, and Heather Tilley
Sandy C, David C, Lyna F, Bing H, Ben O, Kaley T
Staff Members:
Joyce Roper, AAG
Cathy Williams, R.Ph, Pharmacist Consultant
Gordon MacDonald, R.Ph, Chief Investigator
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CALL TO ORDER
1.2 Approval of January 29, 2015, Meeting Minutes.
MOTION: Dan Rubin moved that the commission approve 1.1. Chris Barry second. MOTION CARRIED: 9-0.
MOTION: Dan Rubin moved that the commission approve 1.2 with suggested amendment. Gary Harris second.
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be approved by a single
motion of the Commission without separate discussion. If separate discussion is desired, that item will be removed
from the consent agenda and placed on the regular business agenda.
February 2015
2.4
Hoagland Pharmacy
Chinook Pharmacy
Western State Hospital

a. Lourdes Medical Center
b. Lourdes Counseling Center
2.8 Tamper Resistant Prescription Paper/Pads Approval
Northern Documents
MOTION: Elizabeth Jensen moved that the commission pull items 2.4 & 2.8 for further discussion. Dan
Rubin second. MOTION CARRIED: 9-0.
MOTION: Dan Rubin moved that the commission approve items 2.1, 2.2, 2.3 & 2.5 on the consent agenda.
Chris Barry second. MOTION CARRIED: 9-0.
REPORTS
Commission Members
Nancy went to the WAMI Residents Retreat and did a 90 min presentation on addiction medicine with
professionals.
He attended two meetings for the University of Washington Strategic Planning Committee for the School
of Pharmacy.
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Steve attended the State Senate Pharmacy Commission Confirmation Hearing.

He participated in a couple of Business Practice Committee meetings.
He took the Alabama MPJE and passed. Steve is licensed in 13 states.
Tim Lynch reported:
Mr. Lynch attended a CE on Biosimilars

He participated in two meetings with the nursing workgroup regarding nursing students and access to
ADDDs.
Tim attended the ASHP section advisory group on business practice management.
He also attended the State Senate Pharmacy Commission Confirmation Hearing.
He attended a Committee meeting sponsored by DOH regarding the use of M.A.s to retrieve/dispense
medications.
He attended the Senate Pharmacy Commission Confirmation Hearing as well.

He spent time with sterile compounding group at DOH to revise the document based upon initial feedback
of comments.
Met with staff at DOH and talked about the pharmacy inspection process and possible changes.
She also participated in the business practice committee meetings.

Elizabeth attended the Committee meeting sponsored by DOH regarding the use of MAs to
retrieve/dispense medications.
Mr. Harris attended the WSPA CE, Cathy Williams was a presenter.
He attended a University of Washington Alumni Association scholarship dinner.
He also attended the business practice committee meetings.
Along with Steve he attended two meetings for the University of Washington Strategic Planning
Committee for the School of Pharmacy.
Dan Rubin reported:
He attended and will provide a report of the business practice committee meetings.
He along with the others attended the Senate Pharmacy Commission Confirmation Hearing.
Al Linggi reported:
Al attended University of Washington practice and policy board meeting for the School of Pharmacy.
Mr. Linggi attended the Senate Pharmacy Commission Confirmation Hearing with his colleagues.
He attended a sterile compounding steering committee.
He also attended a meeting with the Chief Investigator and other staff to discuss the concerns of the current
inspection process.
Mr. Linggi participated in the two nursing-pharmacy workgroup meetings via telephone regarding nursing
students having access to ADDDs.
She attended the Senate Pharmacy Commission Confirmation Hearing.

Sepi participated in the two nursing/pharmacy workshops via teleconference.
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Executive Director
Chris Participated in the University of Washington curriculum advisory meetings with Steve and Gary.
He attended the business practice meetings with the committee.
He met with Chris Barry and Al Linggi for an overview on compounding rules from former rules
coordinator Peggy Crain.
Mr. Humberson met with MR Barry and Linggi with IIO/DOH leadership regarding the current inspection
process.
He attended the Senate Pharmacy Confirmation Conformation Hearing with the commission members.
In between all of that, Chris attended Naturopathic Board meeting.
Chris participated in the use of MA to access medication task force meetings.
He participated on the interview panel for a new policy analyst for office of assistant secretary.
Mr. Humberson spoke at the Washington State University Student Legislative day.

She presented at the business practice committee meeting about the ability and extent of being able to
discipline firms.
Joyce and the AAG who advises the M.A. program attended the meeting regarding MAs dispensing
medications and talked about the current laws and potentially what changes may need to be made to
accommodate that process.
February 2 she and Al Linggi met with a representative from Surescripts to discuss further efforts to assist
PQAC in regulating electronic prescribing.
Lisa met with one of two companies that have submitted their proposal to King County for drug take back
program. King County has 60 days to accept or decline the proposal they have not heard from them yet.
She presented at the WSPA seminar.

Cathy is on the nursing tasking force regarding nursing students accessing ADDDs.

Julie Faun and Brad Dykstra will be attending the Compounding Boot Camp in Colorado.
Gordon provided the commission some statistics on about the inspections done in 2014. Only ten
inspected firms were subject to discipline for double failure in 2014 from over 500 inspections .He pulled
up a hospital inspection and had Tina Lacey and Greg Lang go through the inspection sheet and provide
the commission the process of how they deal with deficiencies and the re inspection process.
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CONSENT AGENDA
2.4
Western State Hospital
Elizabeth Jensen was unable to locate the specific specialized functions in the documents. Cathy Williams
explained that the information was in the overall body of the documents provided by Western State Hospital.
MOTION: Elizabeth Jensen moved to approve Consent Agenda Item 2.4 Western State Hospital Pharmacy
Technician Specialized Function. Sepi Soleimanpour second. MOTION CARRIED: 9-0.
2.8
Northern Documents
The concern was the different set ups the commission would like to have them to lock out the other formats when
using the paper in our state. A lot of these companies are out of state.
MOTION: Elizabeth Jensen moved to approve Consent Agenda Item 2.8 Northern Documents Tamper Resistant
Prescription Paper/Pad. Steve Anderson second. MOTION CARRIED: 9-0.
OLD BUSINESS:
Confluence Remote Pharmacy Services
Joyce shared that at the last meeting the legal advice memo was shared with Confluences and their legal counsel.
She spoke again with their legal counsel and was told Confluence will be operating under the hospital pharmacy
license. There is a new bill that would have all hospital based owned clinics operate under hospital pharmacy
license which has not passed at this time. However, under our current law the pharmacy license is a license of
location so it cant be based on the hospital license which is a different address. Joyce stated it is up to the
commission how they want to proceed with Confluences request. At this point there is no firm agreed language in
this bill and there is no companion bill in the house either. There has been a mock inspection and the report has
been delivered to Confluence. Staff will work with Confluence to help them meet the deadline given to them from
the January meeting. At this point the commission has decided to continue with their decision made at the January
29th , 2015 meeting.
Januarys MOTION: Gary Harris moved that the Pharmacy Investigator inspect Confluence,
Omak and Moses Lake Clinics at a mutual agreed time. The investigator will provide detailed issues
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found for Confluence to resolve by April 30 , 2015. Confluence will be given three months to meet
current Washington State standards of USP797 and legal requirements of pharmacy practice. Dan
Rubin second. MOTION CARRIED: 9-0.
RULES, LEGISLATION and POLICIES

Update 2015 Legislation
SB5549 Pharmacy assistant fee is currently still in senate dont anticipate it will come out this year.
Researcher fee is still ongoing: no update at this time.
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Pharmacy disciplinary bill to have fining authority may be brought back in 2016. This may pertain to other
models other than just pharmacy.
HB1339 Scope of practice bill in the Senate. This is regarding Physical Therapist feel they are allowed to
do dry needling and it is not under their scope of practice. FYI Any changes in the scope of practice is not
the prevue of the commission or the board, it is the prevue of the legislature.
Biologicals bill is out of senate and in the house. This may end up being adopted.
Health care services by pharmacists bill out of senate into the house.
HB1671 Opioid overdose medications this allows first responders to have naloxone on hand out of house
into senate.
Pharmacy benefit manager regulations bill is out of house into the senate.
SB5268 on eye drop refills which gives pharmacist the ability to give an early refill.
Al Linggi provided and update. There was information sent out via listserv. There was a request for input from
stakeholders. There have been about 12 volunteer stakeholders to assist us with this process. The committee has
looked at rules and regulations from 7 different states that practice contemporary rules. This is a slow moving
process because of all that is going on.

On February 10 discussed Joyce Ropers January 26 memo on Regulatory Authority for Licensed Business
Entities. The Committee also reviewed the formal questions that had been posed to the Department of Labor and
Industries on issues related to hours, lunch breaks and rest breaks, in preparation for a meeting with an LNI
representative. Steve Anderson offered to take the lead in reviewing other states laws in areas under consideration
by the committee.
On February 27, there was confirmation of existing legal authority for the Commission to proceed to enforcement
if a licensed pharmacy related business shares responsibility for violation (violated or permitted any employee to
violate of a pharmacy law). Modification of rules may not be necessary. Some discussion beyond the January 26
memo focused on oversight of non-resident pharmacies. There might be a role for rule-making in this area.
David Johnson, Wage and Hour Technical Specialist from the Department of Labor and Industries, met with the
committee to respond to questions posed on meal and rest breaks. Requirements for meal and rest periods are
established under authority of the state Industrial Welfare Act. It appears that state laws about meal and rest breaks
does not apply to most pharmacists due to the exemption of professionals established in rule in 1976 .It would
take a change in LNI rules to alter this professional exemption. The situation for pharmacy technicians and
assistants is different as by and large, they would not be exempted from meal and rest break requirements.
Pharmacy Compounding Rules

Al Linggi provided an update. There were a number of comments received regarding the draft of the compounding
rule. It was excellent input. The committee went back to the draft after the crosswalk and took comments from the
stakeholders and eliminated considerable amount of language that was put in the draft regarding USP800 as well as
a bunch of other language because the crosswalk didnt make it clear as to where it came from. Committee met two
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weeks ago, Irina Tiginyanu will take over until someone is hired to replace Peggy Crain. The Pharmacy
Association indicated in a letter that they were going to have a consultant embrace the subject. The committee is
hoping to have a second working draft out by first part of June.
Nursing/Pharmacy Joint Taskforce

Al Linggi led the update to the commission. Cathy Williams did a survey of different states and Tim Lynch did a
survey of available literature regarding the use of student nurses in regards to the ADDDs. Some overlapping
results with the research that the nursing commission did other than the basic safety. There really is a lack of
recommendations on this topic. The goal is to move forward on this and look at current legislation. Our current
WACs say that only licensed nurses are able to do this. Recommendations for a change hasnt been made at this
point.
Paula Meyer, ED for NQAC shared that they had identified a conflict in their statute. Their statute states that
students need to be able to perform all duties as if they were registered / licensed within their scope of practice.
Students need to have and be fully familiar with the access to the ADDDs. The conflict is the access of ADDDs
both the nursing statute and the pharmacy statute states that you must be licensed to have access to ADDDs. This
is why the task force was formed.
Mindy Shaffer RN: Our AAG and I went and looked at our statute it was made in 1949 very old. We have always
practiced as nurses. There is a lot of work to do before July and I feel we will come up with really great
recommendations and guidelines for this process.
Lauren Klein,UW Medical Center: believe it is an integral part of the educational experience for preparation for
pre licensure students in the process related to clinical reasoning and safe medication practice. The unintended
consequences of a nursing student to not have access of ADDs will affect us in preparation to transition them into
a license practitioner. We feel this is essential to their training.
Kris Hanshaw: Specificity of the rule regarding the ADDD. When there isnt an automated system that provides
additional safeguard there are no laws that prevents the students from using these system but the automated systems
that do provide safeguard they are not allowed to get access to these systems.
Dr. Maggie Baker with CNEWS testified about the concern of the pharmacy rules that prevent nursing students
getting access to ADDDs. Nursing student competence use in this system is critical to developing competency in
safe medication administration. The pharmacy rules that prohibit students from accessing ADDDs does not allow
accredited schools of nursing to teach to national standards and be compliant with accreditation requirements. This
doesnt allow us to prepare students who are ready for safe practice and for success in their new employment
setting post-graduation. The members of CNEW respectfully urge you to resolve this issue.
Kathryn Ogden, is thankful that you are looking at this conflict between statute and law. We feel this puts us at a
bit of a risk. For healthcare we are seeing a gap between seeing student being ready to practice as registered nurses
when they graduate. We feel that if students are not allowed to participate in the full aspect of medication
administration that this gap will widen. Thank you for addressing this issue.
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Review of Past Commission Policies and Procedures

Doreen Beebe was asked to make revisions to the Commissions policies and procedure in December 2014.
MOTION: Dan Rubin moved to approve the revision in Policy #24 Criteria for Random Biological Testing. Chris
Barry second. MOTION CARRIED: 9-0.
MOTION: Dan Rubin moved to adopt the new Policy #45 Verification of Internship Hours, which combines 3
policies. Chris Barry second. MOTION CARRIED: 9-0.
MOTION: Dan Rubin moved to approve the revision in Policy #35 Continuing Education Credit for Attending
Commission Meetings. Elizabeth Jensen second. MOTION CARRIED: 9-0.
DISCUSSION
Practice Fusion
Practice Fusion is an electronic prescription transmission sending system re-requesting approval in Washington
State. They appeared before the Pharmacy Commission at the January 29, 2015 meeting and were denied approval.
They are re-appearing at the March 12, 2015 meeting.
Practice Fusions legal counsel, Josh Marker, and program manager for software development, Francis Toan,
appeared before the Pharmacy Commission at the January 29, 2015, Business Meeting. The Pharmacy Commission
unanimously voted to deny approval of Practice Fusions electronic prescription sending system. The denial was
based upon Pharmacy Commissions concerns regarding security, published patient marketing practices, and a
deficiency in regard to route. Lack of security required per WAC 246-870-060 subsection 3(b)(c)(d) was
specifically noted at the Pharmacy Commission meeting. Concerns regarding patient marketing practices were
identified within Practice Fusions Healthcare Provider User Manual. WAC 246-870-030 lists components required
(such as route) to be included in the electronic transmission of prescription information. Required components
should be in readable standard based fields for interoperable computer to computer electronic data to be exchanged.
There was some discussion regarding the concerns the commission had from the presentation of their device in
January. The team from Practice Fusion explained and answered the questions while walking through some of their
processes with the commission.
MOTION: Dan Rubin moved to approve Practice Fusions electronic prescription transmission sending system
with the conditions that Practice Fusion must:
1. Modify their Provider agreement for use with WA providers modified to:
a.
Require prior affirmative consent from the provider for each content area where patient
authorization for release of personally identifiable health information (PIHI) will be requested on
behalf the provider;
b.
Notify patients that the request for authorization comes from a third party acting on behalf of the
provider
2.
Notify the Commission prior to any attempt to seek patient authorization to receive marketing information.
3.
Practice Fusion report back in one year on:

a.
The nature and extend of provider or patient complaints related to privacy breach or unwanted
b.
How have addressed credentialing the full range of providers with prescriptive authority in WA
marketing.
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including pharmacists utilizing CDTAs.

Steve Anderson second. Gary Harris, Elizabeth Jensen and Nancy Hecox opposed. MOTION CARRIED: 6-3.
DISCUSSION Contd
MPJE Study Plan
Doreen Beebe led the discussion to the panel who was asked to approve and authorize Mahalakshmi Hariharans
request to retake the MPJE after failing the exam. The panel was able to review her study plan she submitted.
MOTION: Tim Lynch moved to approve and authorize Mahalakshmi Hariharans study plan and request to retake
the MPJE after failing the exam. Sepi Soleimanpour second . MOTION CARRIED: 4-0.
Inspection Process
Al Linggi led the discussion and shared there has been a lot of calls regarding the current inspection process. Al
asked to sit with some of the staff to talk about why the inspection process is different, if it is, or is the enforcement
different. Currently the inspection process is based on points. 90 plus is an A, 80-89 is a conditional and 79 and
lower is unsatisfactory grade. Staff talked about what the some of the alternatives are and does the commission
have the authority to redo how inspections are being performed. We are working to assign a task force to look at
alternative and to discuss whether or not there will be changes. Few other states are using a point grade system.
Gordon MacDonald chief investigator shared that he and his team would like to see changes in the current
inspection process. The team is completely open to changes make the process better for the pharmacy and the ease
of these pharmacies being compliant. The current process seems cumbersome and makes it tough for the
investigators to provide pharmacies assistance to be compliant. The biggest concern is to put investigators in a
situation where maybe their decisions would be subjective. The idea of providing a statement of deficiency
followed by a plan of action to fix the deficiencies and a time line to get the deficiencies fixed is one everyone
seemed to believe will be a great change in the inspection process.
Recommendation would be by next month get input from stakeholder than have commission stop and think about
whats on their plate currently and whether or not this is a high enough priority. If commission feels this is a
priority then set up a quick time frame, gather a task force 2/3 stake holder 1/3 commission with outside advisory
from investigators. Within a 60 day period of time, have recommendation to be looked at.
PRESENTATIONS
Franciscan Health Systems Centralized Order Processing for Infusion Clinics
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Michael Li, PharmD, MHA, from CHI Franciscan Health System asked the commission to approve their proposal
for St Anthony Hospital (SAH), St Clare Hospital (SCH), St Francis Hospital (SFH), and St Joseph
Medical Center (SJMC) to utilize centralized oncology remote order entry based at SJMC.
Background
SAH, SCH, and SFH pharmacists are currently responsible for managing multiple clinical
areas throughout the day
Pharmacists have responsibility for inpatient units in addition to concurrently
managing outpatient oncology
Goal for our outpatient infusion areas is to provide safe, high-quality medications to patients
on time
Assessment
Needs observation and analysis conducted in 4/2014
Workflow and staffing model is not conducive to providing uninterrupted time
to review and process chemotherapy orders
Variations in how each site approached clinical oncology issues and handled
the timing and distribution of chemotherapy and supportive medications
Standardization would allow for consistent high-quality care utilizing best practices
Recommendation
Implement a centralized pharmacy oncology service for outpatient oncology infusion at
SAH, SCH, SFH, and SJMC
Staffed by a oncology pharmacist
This will dedicate a specialized resource for this service line and
Minimize risk of medication errors
Provide an expert to the clinics
Increase efficiencies through standardized workflows
Processed includes:
Dosing medications per protocol
Writing for supportive medications per protocol
Order review and verification in EMR
Appropriateness, unapproved abbreviations, identified allergies/sensitivities, drug-drug
interactions, duplicate therapy
Contacting providers for clarifications
Communicating with clinic providers
Working with RNs about patients ability to receive medications
Responding to clinical questions
Patient education
Coordinating medication needs between the clinic and inpatient pharmacy
Training includes:
Orientation to infusion clinics and pharmacies at each site
Review of CHI-Franciscan Policy and Procedure
CHI-Franciscan pharmacy services share a common policy and procedure set
Review of CHI-Franciscan pharmacy clinical modules and passing score on accompanying exam
Site specific pharmacy responsibilities:
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Maintain medication inventory

Admixture of chemotherapy and supportive medications
Final check of end medication products prior to delivery
Work with clinics surrounding delivery of medications to the infusion suite
Communicate distribution issues with central oncology pharmacists
Quality Assurance:
Monthly random audits conducting by the oncology pharmacy specialist
For each pharmacist, all orders from one day each month will be evaluated for accuracy,
safety, compliance with policy and procedure, and documentation
Pharmacists who do not meet expectations will meet with the oncology pharmacy specialist to
discuss improvement strategies and may meet with the PIC for potential disciplinary action
Audit results will be tracked and reported to the PIC on a quarterly basis
MOTION: Christopher Barry moved to approve as presented the proposal for St Anthony Hospital (SAH), St
Clare Hospital (SCH), St Francis Hospital (SFH), and St Joseph Medical Center (SJMC) to utilize
centralized oncology remote order entry based at SJMC . Elizabeth Jensen second. Tim Lynch recused himself.
Remote Order Processing

Cathy Williams briefed the commission on the Fairfax Hospitals proposal to expand services to new site, Valley
Hospital in Monroe. She introduced Beata Przebinda and George Dimaris from Fairfax Behavioral to present their
proposal.
Fairfax Hospital
157 licensed beds.

We offer
Inpatient Hospitalization
On 10/22/13, Fairfax Hospital received a Certificate of Need to operate a 30 bed acute psychiatric
hospital.
Fairfax Behavioral Health Everett (Fairfax Everett) will be located on the 7 floor in the South
Building at the Pacific Campus of Providence Regional Medical Center.
Partial Hospitalization
Treatment for co-occurring Disorders and Medical Detoxification.

Expansion to Everett
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Fairfax will be leasing 21,000 square feet for the unit.

The Pharmacy
Clean, secure, separate room.

Medications will be stored on shelves; controlled substances will be locked in a separate, locked
cabinet.
The pharmacy will contain a sink, a work space, an area to prepare medications, a refrigerator, and
climate controls.
Day to Day Operations
Fairfax Hospitals Medication Management Policies and Procedures will serve as the template for
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operations at Fairfax Everett Pharmacy.
A Pharmacist in Charge will work 4-5 hours a day Monday through Friday and will report to the
Director of Pharmacy.
Pharmacy staff members at Fairfax Hospital will be cross trained to work at both facilities.
Profile Driven Pyxis ADDDs (2) will be located in the medication room.
See Medication Management P&Ps for further information.
Fairfax Everett Pharmacy will utilize the same formulary as Fairfax Hospital, Kirkland.
AmerisourceBergen (ABC) will supply medications Monday through Friday.
A pharmacist will be present to accept all deliveries from ABC.
Control substances movement will be tracked and documented.
Medication orders sent up to 5pm, will be processed by the Fairfax Pharmacy, Kirkland location.
After hour medication orders will be processed by Remote Order Entry (Pending BOP approval.)
Pyxis ADDDs
These ADDDs will interface with the pharmacy patient profiles.
The pharmacist will be responsible for filling the ADDDs daily as required and for maintaining
them.
MOTION: Dan Rubin moved that the commission approve the existing Fairfax protocols to be expanded
to the Monroe site. Nancy Hecox second. MOTION CARRIED: 9-0.

Reverse Distributor Definition Problems:
Christopher Andrews, Lianne Fijalka, Thao Nguyen, Amanda Popek, and Heather Tilley
The problem is accumulation of medications in household medicine cabinets which causes Public health
and safety concern. Also causes pollution, abuse, misuse, diversion, and accidental ingestion.
A solution would be:
Proposed definition for Reverse Distributor

Reverse distributor licensing and regulation
Reverse distributor role in statewide drug take-back program
Financial benefits to pharmacies and patients

Societal and environmental benefits
More stakeholder input needed before future legislation
Naloxone Expanded Access

Sandy C, David C, Lyna F, Bing H, Ben O, Kaley T
The problem is nationwide injuries and deaths related to opioid overdose have steadily increased over the
past two decades.
Current law: RCW 69.50.315 - Medical Assistance --- Drug-related overdose --Naloxone --- Prosecution for possession
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(1)(b) A person acting in good faith
may receive a naloxone prescription, possess naloxone, and
administer naloxone to an individual suffering from an apparent opiate-related overdose .
Proposed law: RCW 69.50.315 - Medical Assistance --- Drug-related overdose --- Naloxone --Prosecution for possession
(1)(b) A person acting in good faith
may receive a naloxone prescription, PURCHASE AND possess
naloxone, and administer naloxone to an individual suffering from an apparent opiate-related overdose .
(b-1) Pharmacists must ensure education of the person to whom the drug is furnished, including but not
limited to opioid overdose prevention, recognition, administration of naloxone, possible side effects, and
the need to seek medical attention for the patient. (b-2) Prior to performing a procedure authorized under
this section, a pharmacist shall complete a training program on the use of opioid antagonists that consists
of at least one hour of approved continuing
education on the use of naloxone. (b-3) The person to whom the drug is furnished cannot refuse the
required consultation stated in b-1
Status Report
Cathy Williams provided some background to the proposal that was approved in March 2014 for Providence
Centralia Hospital to provide remote order processing services to St. Mary Medical Center. Cathy introduced
Marcy Bryant for Providence Centralia Hospital and Anita Treis for Providence St. Mary Medical Center who
provided a presentation to the commission with information the commission requested for their report back.
Report Back:
Providence Centralia Hospital
Rural not for profit Catholic health care

128 bed
Pharmacy Hours: 24/7/365
Epic- Electronic health record (EHR)
Rural not for profit Catholic Hospital

142 bed
Pharmacy Hours: 0530-2200 M-F, 0800-2000 weekends and holidays
Epic (HER) since march 2014
Relationship
Both are licensed Providence Facilities

PSMMC implemented the standard Providence EPIC HER March 214
PCH provided on-site staff support during PSMM EPIC go live, allowing on-site orientation to PSMMC
prior to implantation of services
Overview
Shared electronic health record allows seamless order verification and ensures secures access
Verbal hand-off between PCH and PSMMC pharmacists at each exchange
PCH pharmacists available by phone and pager to provide consultations to PSMMC staff or clinical
questions
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PSMMC Designate Burse Supervisor on-site

PSMMC On-Call pharmacists available for urgent on site needs
Epic Reports
Volume of RMOP
Average of 1903 orders monthly
Average of 7.4 orders / hours served
Timeliness of response
Turn-around time for PCH order verification
Average 14.48 minutes
Median: 9 minutes
Compliance with PSMMC Policies & Procedures
Annual education regarding protection of confidentiality and integrity of patient information required
Common therapeutic interchange list reduces variation
PSMMC medication policies, guidelines and dosing protocols available electronically at PCH
Feedback provided to PCH pharmacist when variances occur

Newport Hospital
Newport Hospital & Health Services
22 Bed Critical Access Hospital

14 of our beds are available for Transitional Care (Swing Beds)
One surgeon on site full time
Contracted specialists available several times per month e.g. ENT, Nephrology, Podiatry,
Orthopedics, Cardiology, Cancer Care, etc.
Outpatient Services:
Physical Therapy
Lab
Radiology
Mobile MRI
Service Area:
Pend Oreille River Valley including Southern Half of Pend Oreille County and West Bonner County including Priest Lake
and Priest River, Idaho areas
Telepharmacy History
2008: SHMC and Larry Bettesworth

2009: Envision Telepharmacy
2013-Present: Cardinal Telepharmacy Services

Patient Safety Systems in Place
Telepharmacy - Pharmacy order entry
ADDD = Pyxis - Live Jan.12,2015
(Profile Mode in Acute Care & Emergency
Department, Non-profile Mode in OB, OR, and Recovery)
Meditech E-Mar
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Meditech Bedside Medication Verification

Meditech - Computerized Physician Order Entry in the Emergency Department
One pharmacist on site approximately 15 hours per week (5 days/week) and as needed on
weekends. If census is high or problems arise, the pharmacist is available for additional
hours.
Pharmacy Technician training program in development to assist the pharmacist
Telepharmacy Services
Provide remote order entry 24/7.
Answer clinical questions of nursing staff and provide dosing calculations prn. Accessible
via phone or FAX.
Statistics
Telepharmacy reviews 100% of practitioners written medication orders .
In 2014 we processed a total of: 119,515 medication orders for the year.
Remote Order Entry Procedure and Safety Measures
All medication orders in acute care are handwritten by the provider, entered into Meditech,
and then double checked for accuracy.
The Meditech order is then scanned along with a copy of the original practitioners written
order to remote pharmacist with specified priority (STAT, Priority, or Normal).
Remote pharmacist verifies orders into patients Meditech profile or advises staff of any
problems or changes that need to be made (before verifying patient medications).
Meditech links medication to PYXIS patient profile and medication then becomes available
from patients PYXIS profile.
Medication is administered utilizing bedside medication verification (BMV) .
This step also charts the administration on
E-Mar (for conformation and billing).
Advantages & Patient Safety
Orders are entered promptly, 24/7.
Every order is reviewed by two professionals before transmitted to remote pharmacy.
Every order is reviewed by a pharmacist for accuracy, allergies, interactions, etc. prior to
administration by nursing staff (only verified orders can be given to patients).
Reduces Pyxis Override removals to only STAT or emergent situations (QI monitoring in
place).
Nursing staff has immediate access to a pharmacist via phone and FAX.
Medication orders and delivery maintained through Meditech and PYXIS files.
PYXIS files monitored by pharmacist for accuracy.

NHHS requirements for vendor
Acquire and maintain all appropriate Washington State licenses and approval for Pharmacy
and all employees
Ensure that all pharmacists providing remote order entry have been trained on NHHS
policies and procedures regarding medication order processing
MOTION: Elizabeth Jensen moved the commission approve the request from Newport Community
Hospitals Medication Order Processing services for 24/7 services with the conditions:
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1. That if a nurse is performing order entry from a prescribers written order, the pharmacy
processing this order must receive the original order or a copy of the original order for accurate
verification.
2. Only one designated registered nurse per shift may access the pharmacy for emergency only
purposes only during the absence of a pharmacist.
3. Until such a time the NHHS employs a WA state licensed pharmacy technician, the pharmacist
must be solely responsible for all loading/stocking, refilling, outdating and general maintenance of
the ADDD. A nurse is not permitted to load or stock and ADDD.
The commission recommended that NHHS to stop the pursuit of a pharmacy technician training program
because of concerns regarding the possibility of a registered nurse having dual licensure as a pharmacy
technician. NHHS must report back in one year with specific data requested by the commission. Steve
Anderson second. Nancy Hecox and Sepi Soleimanpour opposed. MOTION CARRIED: 7-2.

The commission felt they had enough information to approve all four proposals from Our Lady of Lourdes.
a. Lourdes Medical Center Pharmacy requests to receive remote processing of medication orders
from an outside vendor.
MOTION: Elizabeth Jensen moved that the commission Lourdes Medical Center Pharmacy requests to receive
remote processing of medication orders from an outside vendor . This approval comes with a requirement to
report back in one year, with specific data requested from the commission. Dan Rubin second. MOTION
CARRIED: 9-0.
b.
Lourdes Medical Center Pharmacy requests to provide remote processing of medication orders to a
commonly owned pharmacy.
MOTION: Elizabeth Jensen moved that the Lourdes Medical Center Pharmacy requests to provide remote
processing of medication orders to a commonly owned pharmacy. This approval comes with a requirement to
report back in one year, with specific data requested from the commission. Dan Rubin second. MOTION
CARRIED: 9-0.
c.
Lourdes Medical Counseling Center Pharmacy requests to receive remote processing of medication
orders from a commonly owned pharmacy.
MOTION: Elizabeth Jensen moved that the Lourdes Medical Counseling Center Pharmacy requests to receive
remote processing of medication orders from a commonly owned pharmacy. This approval comes with a
requirement to report back in one year, with specific data requested from the commission. Dan Rubin
d.
Lourdes Medical Counseling Center Pharmacy requests to receive remote processing of medication
orders from an outside vendor.
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MOTION: Elizabeth Jensen moved that the Lourdes Medical Counseling Center Pharmacy requests to receive
remote processing of medication orders from an outside vendor. This approval comes with a requirement to
report back in one year, with specific data requested from the commission. Dan Rubin second.
PRESENTATIONS Contd
Erika Brown, Jennifer Herbrand and Crissa Hanson from the Department of Health Customer Services
Credentialing Unit Presentation provided a presentation to the commission to share data on how long the
processing of credentials takes. This was a question answer opportunity for the commission and any concerns they
may have regarding licensure. They asked them to just provide specific licenses on their next update.
OPEN FORUM
Jeff Rochon, with WSPA we are happy to hear you will be looking into the inspection process. Legislative report
we are focused on our two main SB 5557 bill passed through the Senate unanimous, this is going to change
pharmacy practice as you know it. This will make insurance carriers recognize the services pharmacists provide in
the same manner they recognize nurse practitioners, PAs and others. Bill 5857 has been an all-out brawl. The
opposition really doesnt want this to happen it passed through the senate unanimous as well, regardless of what
has happened to try to stop this bill.
Julie Akers, WSU of College Pharmacy, her concerns had to do with intern license issues. Another significant
issue is CDTAs and getting the Yellow Fever Stamps. Some sites have had struggles with that because they are
waiting for some proof before they can apply for the Yellow Fever Stamp.
Sandra Locklear, thank you for your time today, and in Dec. 2013, when we shared the story of our son's
traumatic journey and death in WA's broken mental health system. We want to thank the PQAC very
much for supporting our family, and for your work around banning artificial cannabinoids.
Since then, we've met with Congressman McDermott's office, Representative Cody and Senator Nelson to
share our story, and we're analyzing Milo's systemic records and entering meetings to look at next steps.
Re: King County District Mental Health Court, currently there are no standardized protocols
among Probation Officers regarding the sharing of information with clients .
Re: regional hospital psychiatric, currently there are no mandates for the presence of Suboxone
certified doctors, so Suboxone is not dispensed. Therefore, co-occurring disorder patients with a
legal Suboxone prescription from a private provider, have it ripped away while in a state of
decompensation, and are discharged in a medically vulnerable state .
Re: Pioneer Housing, at-risk Mental Health and Drug Court clients are being warehoused in this
for-profit corporate arm of Pioneer Human Services, with no state oversight. This housing model
sadly passes for "safe and sober housing" in Seattle and is not reflected in Milo's records. We're
still waiting on the video surveillance tape which will show if and when any mandated room
checks occurred.
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Re: THS and SMH clinics' poor transition of care, we have all the records and are currently
analyzing their notes against the truth of my experience as our son's medical advocate. As of
today, I'm shocked and feel angry to finally learn about naloxone, and am stating for the record
that THS, SMH, Harborview, NAVOS, nor Fairfax informed or educated us about naloxone. It is
devastating to realize that our son might still be alive today.
Re: Snohomish County Jail, we've learned that there is no governing oversight body regulating
Jail Medical personnel is hired directly out of the Sheriff's Dept. instead of Public Health, like in
King Co.
Re: the King Co.'s Behavioral Health Dept., which administers RSN federal and state funding, the
staff is graciously assisting our family in a process of discovery.
We were glad to hear about the two bills currently up, and would very much appreciate an update on
the specifics of each bill: where they're at and what they mean for us. Christopher Humberson was
designated to provide Sandra Locklear with an update on the two specific bills she inquired about.
Post Meeting Update from Sandra Locklear: After this meeting Sandra Locklear contacted MH Court
herself and requested the General Administrative Orders. MH Court sent that document to me. What a
gut punch. We learned that indeed, guidelines do exist for the reporting obligations of the PO to both the
client and court. They just werent followed. While we were right in thinking that practices are
discretionary, we were wrong to assume that guidelines did not exist.

There being no further business, the board adjourned at 5:25 pm.

Approved April 30, 2015
Al Linggi, Chair
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STATE OF WASHINGTON
MEETING MINUTES
April 7, 2011
Washington State Department of Health
Point Plaza East
310 Israel Rd SE
Tumwater WA 98501
CONVENE
Chair Al Linggi called the meeting to order at 9:05 a.m., April 7, 2011
Elizabeth Jensen, RPh
Gary Harris, RPh,
Dan Connolly, RPh
Guest / Presenters:
Dr. Robin Corelli
Dean Webb, Pharmacy Director
of Public Health Seattle King County
Kristy Weeks, Director of Legal Services and HSQA
Legislative Liaison

Joyce Roper, AAG
Melissa Burke-Cain, AAG
CONSENT AGENDA
1.1
New Pharmaceutical Firms - January 21 - March 17
1.3
Closed Pharmaceutical Firms January 22 - March 16, 2011

MultiCare Regional Cancer Ctr - Puyallup
Skagit Valley Hospital Pharmacy
1.5
Swedish Pharmacies - ADDD

Pharmacy Technicians Take Medication List
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Providence Scared Heart Med Center - Holy Family Hospital
1.6
Yakima Valley Memorial Hospital - Techs Taking Med Lists.pdf

Board Minute Approval. (February 3, 2011)
will be removed from the consent agenda and placed on the regular business agenda. Item 1.2 and 1.4
were deleted from the agenda.
MOTION: Gary Harris moved that the board approve items 1. 1, 1.2, 1.3 and 1.6. Dan Connolly
REPORTS
Board Member
March 4, 2011 Gary, Al Linggi and Chris Barry met with Susan Teil Boyer and Steve Saxe to
discuss the Operating Agreement.
Mr. Harris gave a lecture to the Washington State University PharmD students on pharmacist
ethics and the disciplinary process.
Al Linggi reported:
Mr. Linggi was also part of the Operating Agreement discussion. He found it to be very
informative.
He attended the University of Washington practice advisory board.
Executive Director
Legislative Session 2011: Several bills continue to be alive in the legislature, see agenda item
4.1. Major bills include the Medical Marijuana Dispensaries, CE for Pharmacy Technicians,
Crimes against pharmacies, Regulating the handling of hazardous drugs, out of state ARNPs
prescribing CS, expanding the number of licensed Ambulatory Surgery Centers. The Drug
Take Back bill died in committee.
Welcome to our new board members Elizabeth Jensen and Donna Feild and Kitty Slater-Einert,
new board staff member.
On Line Renewals for Pharmacy Technicians in progress. Pharmacy Techs were selected as
one of four professional licenses to be moved into an on line renewal process as a proof of
concept pilot with ILRS.
o The Memorandum of Understanding is being negotiated with the board/DOH and
NADDI (national assn drug diversion investigators) and CHPA (consumer health
products assn).
Assisting with Potassium Iodide message to public and to pharmacists: The board and the
department have received multiple contacts regarding KI availability and appropriate messages.
These synthetic amphetamine and cocaine like substances have been of growing
concern the past several weeks. We will be taking this item up today.
Bath Salts:
Prescription Monitoring Program: Chris Baumgartner has provided us an update in writing and
is finalizing the CR 102 rule language. NABP reached out to us regarding their PMP
Interconnect project.
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DEA Drug Take Back Day is set for Saturday April 30.
Fee increases: Fee increases are being reviewed and considered for the pharmacy profession.
Final budget review and rulemaking to set the fees will begin this summer and fee increases
will go into effect October 2011. We will discuss this further in the Planning Session agenda
item.
Member of ASHPs Fellows Recognition Committee, we met by phone and will be

recommending over 30 candidates as Fellows of ASHP.
Board and Commission Leader meeting planned for June 14 from 1p to 4p.
and Chief Pharmacy Officer
for National Audit was reviewed. Cathy is updating the list of approved pharmacy technician
training programs and ILRS to include detailed data about tech training programs approved for
licensed pharmacies or that are academic programs that we do not license.
The DEAs letter dated Nov 1, 2010 to Rena Bielinski, PharmD,
Doreen sent out a reminder letter to previously approved tech training programs that are set to
expire on 6/1/11. As a result, there is an influx of programs to approve and send updated
information to.
She drafted information on the DEAs 2nd national drug take back day for t he agencys Sentinel
publication and the NABP newsletter.
Cathy discussed the FDAs Drug Safety Communication for Acetaminophen Products at the
4/7 board meeting.
The American Pharmacists Association held their Annual Meeting &Exposition at the Seattle
Convention Center and downtown hotels on March 25-March 28, 2011. He was fortunate to attend
and enjoyed the wide spectrum of pharmacy issues and products on display. His strategy was to
attend presentations that impact my practice as a pharmacist consultant.
On Friday he heard a rousing look ahead pharmacy talk from Rear Admiral Scott Gilbertson,
pharmacy chief for the U.S. Public Health Service. There were many former and current USPHS
officers in the audience. He then attended a 340B Drug Pricing Program session that described the
incredible growth of the program boosted by health reform Legislation. It was apparent how
pharmacists in several areas of the federal government came together to make the program work
with one pharmacist in the Office of Pharmacy Affairs.
Mr. Fuller went to the House of Delegates for the first hour to check in with the Washington State
delegation. He read some proposed policies: require influenza vaccination for all pharmacy
personnel, pursue a change in the Social Security Act to allow pharmacists to be recognized and
paid as providers of patient care services, urge the marijuanas status be changed from federal
Schedule I to Schedule II by the DEA and the FDA facilitate clinical research and alternate dosage
forms. His last presentation on Friday was The role of the community pharmacist in caring for
patients with cancer receiving oral oncologic medications. With the advent of oral rather than
intravenous oncology medications, pharmacists frequentl y find themselves without the patients
medical information and yet they are expected to dispense expensive medications with serious side
effects. He has received calls about this problem from Olympic Peninsula pharmacists trying to
care for patients of the downtown Seattle Medical Centers. A role was described that community
pharmacists can take to assist patients in getting the most benefit from their outpatient cancer
therapy.
On Saturday morning Tim attended a presentation that identified the patient-centered medical home
as a major health reform strategy to improve health and reduce health care costs. Pharmacists have
a unique opportunity to contribute, but need a model to emulate. The federally qualified community
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health centers have used the patient-centered for years and could be a useful practice model. Tim
had a chance to review some of the scores of posters. Many were done very well and were from
new schools of pharmacy. After that the Exhibits opened. He was impressed with a needleless
injection device and a small robot arm in a cabinet that could prepare nuclear therapy products.
Mr. Fuller attended an ACPE update to hear about the ACPE-NABP the Continuous Professional
Development project. They dont have all the answers, but the program has bee n well-constructed
and can be very helpful for pharmacists in the documentation of their continuing education. After
that he attended the Hot Law Topics program. Bill Fassett was one of the five presenters talking
about Pharmacists Responsibility in face of Recalls, Warnings, and Other Special Knowledge.
He then attended a session titled Pharmacists Responsibility with Prescribing Opioids by two
lawyers from New York and Florida . They went through a number of cases from OBRA 90 forward
to demonstrate the need for pharmacists to screen prescriptions for potential problems and
consulting with the patient or prescriber. Expressed concerns were an opioid-nave patient receiving
high-dose opioids and PMPs impact on patient care. While they indicated the phar macists legal
liability/responsibility was increasing, it is a general liability and they are often shielded. They
recognized that pharmacists are assuming greater responsibility. Pharmacists establish the standard
of care by the way they practice.
Tim also attended a session titled, The biosimilar pathway: Where will it lead us? Knowing that
biologic drugs are becoming key drivers in the prescription drug market, and that there were efforts
to set up a brand-generic process to contain costs. The presenters describe a scenario to
interchangeability that was quite different than the non-biologic drug with which we are familiar. A
comparison of data from the clinical effect is used rather than where or how the drug is made. He
concluded the meeting by attending the final House of Delegates meeting. The Washington
delegation was very active in the policy-setting.
Chief Investigator
The question of how much technical assistance and education is provided by the pharmacist
investigators. To be able to answer this Grant has started capturing the data in 2008.
March 7, 2011 Richard Morrison attended Diversion training in Tumwater in the Towne Center
3 building.
Jim Doll gave a presentation on Pharmacy Law at the Clover Park Vocational School February
3, 2011.
Welcome Elizabeth Jensen New Board Member
Al Linggi formally welcomed Elizabeth Jensen to the Board of Pharmacy and shared some
background.
The Board of Pharmacy welcomes Elizabeth Jensen to the board. Elizabeth has been a resident of the
state of Washington all her life. She went to the University of Idaho where she received her
Bachelors of Science degree in Biochemistry. During her second year of her Masters degree she
decided she wanted to work with people. She went back to school at the Washington State University
College of Pharmacy and has never regretted this decision.
Elizabeth moved to Yakima Valley during the last year of her externship for her Doctor of Pharmacy
degree. She took a job at Yakima Valley Memorial Hospital upon graduation. In 2006 after several
years of employment there she went to Yakima Valley Farm Workers Clinic in Toppenish, WA.
Elizabeth resides in Zillah, WA a small town outside of Yakima with her husband and 3 children. She
enjoys reading with her sons classroom 2 days a week. She knows many of the students in the school
because they are patients at the Yakima Valley Farm Workers Clinic in nearby Toppenish.
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Elizabeth has served on many committees. In her career she has worked at hospital, retail and
community pharmacies. She also precepts pharmacy students from Washington State University and
the University of Washington as well as technician students from Yakima Valley Community College
PRESENTATIONS
Pharmacy - Partnership with Smoking Cessation Program
Dr. Robin Corelli updated the board on the pilot project to promote pharmacy-based referral to the
tobacco cessation programs/quit lines.
Background:
Tobacco is the leading preventable cause of death
Patients who smoke require more medications
Community pharmacists are uniquely positioned to assist patients with quitting
Frequent contact with patients with chronic conditions
Primary location for sales of smoking cessation medications
Brief interventions are effective and likely are feasible for implementation in busy pharmacies
Tobacco cessation counseling, provided at no cost via telephone
Staffed by trained tobacco cessation counselors
Up to 46 personalized sessions (varies by state)
~30% success rate for patients who complete sessions
Overview of the Intervention Arms:
Mailed materials intervention:
Printed quitline materials delivered by mail
Academic detailing intervention:
Brief (15-20 min) on-site training for pharmacists and technicians
Print quitline materials that parallel the mailed materials group
Fax referral forms
DVD demonstrations of the Ask-Advise-Refer strategy
Community Pharmacy Recruitment:
The States of Washington and Connecticut were selected because:
They are geographically disparate and offer rural, suburban, and urban locations
The quitline is serviced by Free & Clear, Inc.
Seattle-based company providing quitline services to 27 states (350,000 tobacco users
served in 2010)
Services 25 health plans and > 500 employers
Research partner
1678 pharmacies: 593 in CT and 1,085 in WA
Pharmacies contacted:
84 independents, 66 chains
64 pharmacies enrolled, sampling ensured:
32 independents, 32 chains
32 in CT, 32 in WA
Recruitment success rate:
50% of eligible pharmacies
Randomization to intervention groups:
50% academic detailing, 50% mailed materials
Intervention Materials:
All pharmacies
1-page description of quitline services
Quitline cards and brochures with pharmacy ID number
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Plastic counter-top display to house cards and brochures

Ready to Quit? I can help buttons
Quitline stickers for Rx bags:
State-specific, New Years, July 4
Quitline posters (2 versions)
Counseling resources for pharmacists:
Pharmacologic Product Guide
Drug Interactions Table
Intervention Materials:
Academic detailing pharmacies only
On-site visit with academic detailer
Fax referral forms
Relevant published literature
Video vignettes provided on DVD:
Brief, 1-2 minutes (Ask-Advise-Refer)
Setting: independent community pharmacy
Pharmacist:
Ready to quit (fax referral)
Not ready to quit (quitline card)
Technician:
Ready to quit (refer to pharmacist for fax referral)
Not ready to quit (quitline card)
Data collected by Free & Clear:

Number of calls to the quitline originating from pharmacies
Data collected on-site by study team:
Number of quitline referral cards and brochures provided to patients
Surveys of pharmacists and technicians:
Frequency of tobacco cessation counseling activities
Number of patients referred to the quitline (past month)
Preliminary Conclusions:
High rates of pharmacy participation and survey completion
Increased frequency of calls to the quitline
Self-reported counseling activities are increased
Ongoing analysis of mailed materials versus academic detailing
Preliminary data suggest higher proportion of calls from academic detailing group
Board Member Orientation
Joyce Roper, Assistant Attorney General gave a presentation to the board on the Roles and
Responsibilities of Board Members; the Executive Ethics Act; and Open Government.
DISCUSSIONS
Rules Update.
Doreen Beebe provided an update to the board on the rules workload .
Electronic tracking of pseudoephedrine, ephedrine, phenylpropanolamine: Doreen Beebe is still
working on CR102.The board has approved the language. The significant analysis will be started next
and then there will be a hearing at the August board meeting. Susan is working on memorandum of
understanding (MOU).
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Correctional Pharmacies: The board did approve language. On December 2010 the Department of
Corrections came to the board and asked to re-open rule making. There is an internal meeting
scheduled next week to look at language to see if this needs to be re-opened or not.
Update Animal Control Agency and Humane Society Rules (petition): This is in the CR 102 stage. The
humane society and animal control agency issue has flared up . New investigators are finding there
may be euthanasia programs that may not be approved.
Synthetic Marijuana Spice: Filed emergency rules January 22, 2011 which will expire on April 26,
2011. The board is e issuing an emergency rule to extend the emergency rule timeframe. There is a
CR101 for permanent rules.
Delegation of authority to initiate investigations: CR105 filed to repeal this rule was put out to the
public. There was no comment to oppose this rule.
Doreen Beebe is asking the board to consider adoption of the proposal to repeal WAC 246-856-030
Delegation of Authority to Initiate Investigations.
MOTION: Dan Connolly moved that the board repeal WAC 246-856-030 Delegation of Authority
to Initiate Investigations. Rebecca Hille second. MOTION CARRIED: 6-0.
Doreen Beebe asked the board if they had any questions on the rules workload. These rules are under
the rules moratorium which ends December 2011. There were no questions or concerns.
Rulemaking to Ban Chemical Marketed as Bath Salts
Susan Teil Boyer provided the board with some background. The board was asked to consider rulemaking
options for bath salts that appear to present
a growing drug problem. These products contain

mephedrone and MDPV, chemicals that produce symptoms similar to methamphetamine and cocaine.
Bath Salts Substituted Cathinones:

Cathinone and methcathinone: Federal (DEA) Schedule 1 controlled substances since early
90s
In recent years, various functional group substitutions on the cathinone structure have created a
new class of designer drugs

o Snorted, swallowed, injected, vaporized
o available via head shops and the Internet
The Federal Analog Act doesnt apply since they are marketed as bath salts and pond
cleaner and not for human consumption
National and Washington State Poison Center data shows increasing ingestion exposures
50 percent of these are Emergency Room calls to the Poison Center
National poison centers have reported:
o 2010 total of 298 cases
o 2011 as of March 21 total of 1,196 cases
Washington State Poison Center - 27 cases in 2011
Most research is from UK and is survey-based
Other States
Idaho has banned the substance in law and Oregon in rule
In response to this emerging threat, several states including Hawaii, Michigan, Louisiana, Kentucky,
Florida and North Dakota, have introduced legislation to ban these products.
Symptoms of ingestion:
These products can induce rapid heart rate, visual hallucinations, paranoia and psychosis, as
well as suicidal or homicidal thoughts
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The psychosis can cause extreme violent and combative behavior. Self-injurious behavior is
also common. There are reports of self mutilation, suicides, and homicides linked to bath
salts highs
These substances create a dependence and craving immediately
The effects of bath salts are long lasting and the psychotic/combative behavior may last even
after the substance is eliminated from the body.
Treatment for ingestion:

Activated charcoal is not routinely recommended unless a large amount was consumed orally
very recently.
Supportive care such as fluids and benzodiazepines for chemical sedation or physical restraints
for severe combativeness, agitation, and hallucinations are recommended.
The patients heart rate and blood pressure should be closely monitored as
they are expected to
be elevated.
Elevated creatine phosphokinase (CPK), hypokalemia, and myoclonus have also been
observed.
Hallucinations can last for days.
Psychiatric monitoring is recommended until the hallucinations and suicidal or homicidal
thoughts pass.
Pharmacology:
Substituted Cathinones are stimulant, similar to amphetamine
different by only a ketone

o From the khat plant (catha edulis) native to East Africa and the Arabian peninsula
o Reported to cause psycho-stimulant effects
Many substitutions to functional groups can be made to result in various affinity and specificity
for serotonin, norepinephrine, and dopamine transporters
Schedule I Test Chapter 69.50.203 RCW:

These substances have a high potential for abuse
Have no currently accepted medical use in treatment in the United States
Lack accepted safety for use
MOTION: Dan Connolly moved that the board approve emergency rule making and permanent rule
making for the 5 identified substances and chemicals indicated. Kim Ekker second. MOTION
CARRIED: 6-0.
Naloxone Collaborative Drug Therapy Agreement
Pharmacist Consultant, Tim Fuller highlighted an approved Naloxone collaborative drug therapy
agreement submitted by Dean Webb. Dean Webb from Public Health Seattle King County (PHSKC)
shared a power point with the board to provide more information and background.
Prescribing:
Annual receipt of at least one Rx for opioids
Adults 19%
13-17 year olds 10%
Long term opioid use for chronic pain increasing.
From 2% to 4% of adults from 1997 to 2005
o Group Health and Kaiser
Higher rates of prescribing among those with substance abuse or depression, prevalence
increases with age
Substantial minority also prescribed medicines like Xanax and Valium
Naloxone/Narcan:
PHSKC has seed money to distribute ~1,000 rescue kits
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o 2 doses of intra-nasal naloxone

o Protocols under development
May be prescribed to those at elevated risk for overdose at area clinics, jail
Naloxone- steps to widen Rx & dispensing:
In order for a pharmacist to prescribe, an entity needs to submit a Collaborative Drug Therapy
Agreement to the Board of Pharmacy (BOP)
o PHSKC developing
o Some chain pharmacies expressing interest
Distribution by non-licensed health educators, e.g. needle exchange staff. Protocols being
developed will be shared w/ Medical Quality Assurance Committee (MQAC).
o Discussions have begun these issues between PHSKC, University of Washington UW,
and Department of Health (DOH), BOP, MQAC
Evaluation of a Public Health Law to Support Intervening in Drug Overdoses:

This RWJ funded study will examine the legal intent, implementation and outcomes of a new
Washington state law to support intervening in drug overdoses.
Evaluation will be conducted on the development of the legislation and the impact of the law
on Seattle area heroin users , bystanders, and emergency responders during overdoses as well as
the impacts on community health outcomes.
Principal Investigators
o Caleb Banta-Green PhD MPH MSW (UW)
o Patricia Kuszler MD JD (UW)
Co-Investigator
o Phillip Coffin MD MIA (UW)
Acetaminophen Prescriptions
Cathy Williams asked the board to table this topic until the June meeting when Christopher Barry will
be present. Mr. Barry initiated this topic. The boards response to the FDAs Drug Safety
Communication requesting that drug manufacturers limit the amount of acetaminophen in prescription
drug products to 325mg.
The board was asked to consider adopting the American Council on Pharmaceutical Education (ACPE)
Accredited Professional Programs of Colleges and Schools of Pharmacy as the official list of approved
pharmacy programs.
MOTION: Gary Harris moved that the board reaffirm policy/procedure #3, which recognizes ACPE
accredited schools and colleges of pharmacy as approved by the board for meeting the educational
requirements for licensure as a pharmacist . Kim Ekker second. MOTION CARRIED: 6-0.
Review of Board Procedure for Canadian Pharmacy School Graduates after January 1994
The board was asked to consider renewing the procedure to allow Canadian Graduates of Canadian
Council for Accreditation of Pharmacy Programs (CCAPP) to sit for the National Pharmacists
Licensure Examination without obtaining a certificate from the Foreign Pharmacist Graduate
Examination Committee.
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MOTION: Rebecca Hille moved that the board require all foreign graduates to meet the same
requirements as stated in WAC 246-863-040. Kim Ekker second . Dan Connolly opposes. MOTION
CARRIED: 5-1.
EXECUTIVE SESSION
CASE PRESENTATIONS
Rules Hearing
Proposal Rule amends WAC 246-870-060. The proposed rule change will amend WAC 246-870060(6) to require the prescriber to manually sign the hard copy of a prescription printed from an
electronic prescription transmission system. The change will make the rule language consistent with
the tamper-resistant prescription law (RCW 18.64.500). The proposed rule was filed with the Code
Revisers office on February 16, 2011. Notice was published in the Washington State Register as
WSR # 11-05-094.
Al Linggi asked the public if anyone would like to speak. There were no comments. Doreen Beebe
provided some background . After the background the floor was opened up for questions from the
board. Doreen shared the comment that she received.
MOTION: Rebecca Hille moved that the board accept the revised version of WAC 246-870-060 as
printed to require the prescriber to manually sign the hard copy of a prescription printed from an
electronic prescription transmission system . Gary Harris second. MOTION CARRIED: 6-0.
2011 Legislation Updates
Kristy Weeks, Director of Legal Services and HSQA Legislative Liaison updated the board on
legislative activities.
Bills still alive in Legislation:

SHB 1304 Health Care Assistants: A licensed health practitioner may delegate certain functions to the
health care assistant such as administering skin tests, injections, and performing blood withdrawals.
Only category C or E health care assistants may administer over-the-counter drugs and legend
drugs (as opposed to "oral" over-the-counter and legend drugs).
HB 1353 Pharmacy Technicians: Certified pharmacy technicians must complete continuing education
requirements established by the Board of Pharmacy.
HB 1486 ARNP Prescriptions: Allows Washington pharmacies to honor the prescriptions of out-ofstate advanced registered nurse practitioners with respect to controlled substances.
SHB 1311 Health care collaborative: Membership includes: health carriers, third party administrators,
health maintenance organizations, national health carriers, physicians, hospital-physician groups, selffunded purchasers, state-purchased health care programs, and the Puget Sound Health Alliance. The
Collaborative is required to add members or establish clinical committees to acquire clinical expertise
regarding the service under review. The proceedings of the Collaborative must be open to the public
and notice of the meetings must be provided to the public.
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The substitute bill authorizes the Collaborative to identify data collection and reporting requirements to
measure the impacts of the strategies that minimize cost and administrative efforts and include the use
of existing data resources.
2SHB 1507 Crimes Against Pharmacies: A person is guilty of Robbery in the first degree if he or she
commits robbery of a pharmacy. The bill clarifies only the portion of a building or store that is licensed
by the Board of Pharmacy constitutes a "pharmacy" for purposes of Robbery in the First Degree
SB 5005 & HB 1015 Immunization Exemption: The form used to exempt a child from school
immunization requirements must include a statement, to be signed by a health care practitioner, that
information about the benefits and risks of immunization was provided to the parent or legal guardian
signing the immunization exemption. A health care practitioner is defined as a licensed physician,
licensed naturopath, licensed physician assistant, or a licensed advanced registered nurse practitioner.
SB 5073 Medical marijuana: The bill would license dispensaries by the department of health and
create a registry of those authorized to receive medical marijuana. The department of agriculture will
have oversight of grow operations.
HB 2006 Board of Pharmacy-managed Drug Take Back Bill: This bill establishes a statewide drug
take back program under the board and places a collection site in all counties and towns. The waste
material must be separated from the drugs; the board must contract for collection, trucking and
disposal. The bill is funded by an increase in the B&O tax on drug wholesalers and will add staff to
the board to manage. The cost is estimated over $1.5M.
SSB 5394 Primary Care Health Homes: The bill states primary care health homes are for children and
adults, and that health homes are encouraged to collaborate with other providers currently outside the
medical insurance model, such as dental providers and senior service providers. The terms and
conditions are tightened up to reflect the terms used in the Affordable Care Act (ACA): primary care
health homes is changed to health homes; chronic condition definition mirrors the federal ACA
language; the health care team is defined following ACA language and now includes most health
professions; the primary care provider definition removes references to physician assistants and
specialists, however they remain part of the health care team.
Bills that have died:

HB1285 & SB5101 Regulating Synthetic Cannabinoids
HB1370/SB5234 & HB2006 Disposal of Unwanted Medicines
HB1496 & SB5632 Disposal of Residential Sharps Waste
HB1550 & SB5998 Regulating Cannabis
SB5279 Changing the Definition of Controlled Substance
Planning Session, Budget and Credential Fees
Susan Teil Boyer led the discussion with the board going over preliminary goals and objectives for the
August business planning session. The board was given updates on the future budget issues and
proposed fee increases.
Meeting Dates and Upcoming Conference/Training
Doreen Beebe led the discussion with the board to finalize the board business-meeting calendar for
th
2012. The board was asked to name the voting delegate to the 107 Annual National Boards of
Pharmacy meeting and discuss 2011/2012 attendance for priority conferences and/or trainings.
MOTION: Kim Ekker moved that the board accept 2012 meeting dates as purposed by board and
staff. Rebecca Hille second. MOTION CARRIED: 6-0.
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MOTION: Dan Connolly moved that the board delegate Susan Teil Boyer as the official voting
th
delegate at the 107 Annual National Boards of Pharmacy meeting and Al Linggi as the alternate
delegate. Elizabeth Jensen second. Rebecca Hille abstained. MOTION CARRIED: 6-0.
MOTION: Rebecca Hille moved that the board accept the tentative 2011/2012 travel and training
schedule as purposed by board staff if the travel restriction is lifted. Kim Ekker second. MOTION
CARRIED: 6-0.
Department of Health/BOP Operating Agreement
Susan Teil Boyer and Melissa Burke-Cain led the discussion regarding the draft operating agreement
on administrative procedures per RCW 43.70.240 with the board.
Each board member was given an opportunity to share their opinions and concerns on the draft
agreement after Melissa and Susan went over each section of the agreement. There will be more work
on the draft and it will be brought before the board again.
Correspondence
The board discussed the correspondence sent and received.
WRAPP Quarterly Report
DOH News Release
Death with Dignity-Annual

ASHP Daily Briefing March 15, 2011
report
Letter to Senator Kline and Representative Ladenburg

pharmacies
Letter to InfuSource
Extension of
supporting 2SHB1507 crimes against
License Exemption
Prescription Monitoring Program Update

Letter to PSC Environmental Services, LLC- licensing requirement
Washington Post Article- Drug Labels
Email regarding Medical Marijuana
Letter from Representative Green and Cody
Medication Assistants
OPEN FORUM
Monica Clemmens University of Washington Pharmacy student shared with the board information
regarding a fundraiser being held by the University of Washington students who are raising money for
32 pharmacy students who will be going to Honduras for a week.
Colin Conway from Group Health asked the board how they will they interact with the process at state
level with the federal law that was passed regarding pharmacist role in health reform. How will the
board be proactive with this issue? Will this be a part o f the strategic planning session?
Jeff Rochon from the Washington State Pharmacy Association (WSPA) shared that the WSPA does
oppose the increase in license fees. Jeff also read a letter written to Al Linggi and the rest of the board
responding to a newsletter article that was written in April NABP Newsletter Requirements of a
Faxed Prescription. The WSPA is asking that the board reconsider and recall the newsletter article.
This article conflates concerns expressed by the Drug Enforcement Agency for controlled substances
with procedures for issuing prescription, refill authorizations, or other clarifications for legend drugs.

CLOSED SESSION
Case presentations
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April 8, 2011 9:30 a.m. Cancelled
_______________________________
Approved on June 8, 2011
_______________________________
Al Linggi, Chair
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STATE OF WASHINGTON
WASHINGTON STATE
MEETING MINUTES
April 7, 2014
Special Meeting
Teleconference
CONVENE
The telephonic meeting was called to order by the Commission Chair Chris Barry. .
Commission Members present by telephone:
Chris Barry R.Ph, Chair
Elizabeth Jensen, Pharm.D, Vice-Chair
Gary Harris, R.Ph
Steve Anderson, R.Ph.
Nancy Hecox, Pharm.D.
Tim Lynch, Pharm.D.
Sepi Soleimanpour, R.Ph., MBA-HA
Commission Members absent:

Emma Zavala-Suarez, J.D., Public Member
Albert Linggi, R.Ph., MBA
Joyce Roper, AAG (by phone)
Chris Humberson, R.Ph, Executive Director
Gordon MacDonald, Supervising Pharmacist
Investigator
A special meeting of the Washington State Pharmacy Quality Assurance Commission was held at 6:30
p.m. on Monday, April 7, 2014 . The public was invited to hear the discussion by dialing into a
conference bridge. The Commission met to discuss and draft language amending WAC 246-873-060
Emergency Outpatient Medications under the provisions of RCW 34.05.350 for emergency adoption. The
Commission had determined that the rule amendment was necessary for the preservation of public health,
safety, or general welfare, and that observing the time requirements of notice and opportunity to comment
upon adoption of a permanent rule would be contrary to public interest.
The Commission, represented by a quorum, discussed in detail the provisions of the critical access
hospital designations and the potential need to expand the exceptions written in WAC 246-873-060 for
the emergency dispensing/delivery of outpatient medications. The rule currently provides an exception for
ten named hospitals to allow registered nurses to deliver controlled substance prescriptions to patients .
The commission voted to adopt emergency rules to update and expand the exception.
Dr. Tim Lynch moved that the Commission adopt amendments to WAC 246-873-060 and file emergency
rules. The motion was second by Dr. Nancy Hecox. The approval of the emergency rule was unanimous.
The following is the amended language for WAC 246-873-060:
Subsection 1 and 3
technical changes converting numbers into words.

72 hours seventy-two hours
24-hourstwenty-four hours
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Subsection 7:
Strike the word rural
and all text following the word hospitals ending in a colon.
Add subsections (a) A hospital qualified and designated as a critical access hospital under state and
federal criteria established in WAC 182-550-2598 and 42 CFR 485; or (b) A hospital that maintains no
more than fifty inpatient beds and is located more than a thirty-five mile radius from any outpatient
hospital or other licensed pharmacy providing 24-hour outpatient or retail pharmacy services.
There being no further business, the Commission adjourned at 7:34 p.m. The Pharmacy Quality
Assurance Commission hold a planning session on April 16 at the Lake Washington Rowing Club. The
next business meeting is April 17 at Highline Community College.
_______________________________
Chris Barry, Chair
Washington State Pharmacy Quality Assurance Commission
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STATE OF WASHINGTON

Meeting Minutes
April 11, 2013
310 Israel Rd SE
Tumwater WA 98501
CONVENE
Chair Christopher Barry called the meeting to order at 9:07 a.m., April 11, 2013
Board Members:
Guest / Presenters:
Rudy Leighton, Providence Infusion
Hospital Services
Cindy Chan, Providence Infusion
Hospital Services
Gail Bunker, Pharmacy Manager for
MultiCare Medical Center
Doug Thompson, Director of Clinical Services
for Columbia Basin Health Association
Linda Higginson, Director of Pharmacy
for Providence Centralia
Karen Bright, Director of Pharmacy for
Olympic Medical Center

UW PharmD Students
BridgetteLorenzen
Mikalla Cheney
Thomas Gorlin
Elize Knutzen
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Staff Members:
Joyce Roper, AAG
1.1
1.2
1.3

Approval of the February 21, 2013 Business Meeting Minutes
MOTION: Donna Feild moves that the board approves 1.1, 1.2, and 1.3. Elizabeth Jensen second.
CONSENT AGENDA
1) NPLEx Monthly Report Acceptance
2) Pharmacies and Other Firm Application Approval
3) Pharmacy Tech Training Program Approval
a. Kelley-Ross Pharmacy
4) Ancillary Utilization Plan Approval
a. Providence St Mary Medical Technicians Taking Med Lists
b. Central Washington Hospital Inpatient Pharmacy Technicians
a. GHC Olympia
b. GHC Tacoma Medical Center
a. Rx 30 Transaction Data Systems
b. Rx3000 Pharmacy Computer Services Inc
8) Sample Drug Distribution Approval
a. HealthPoint Pharmacies
9) Household Pharmaceutical Waste Take Back Program Approval
10) Tamper Resistant Prescription Paper/Pads Approval
taking Med Lists
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Items listed under the consent agenda are considered routine agency matters and will be approved by
a single motion of the board without separate discussion. If separate discussion is desired, that item
will be removed from the consent agenda and placed on the regular business agenda. Items 4, 9,
and 10 were deleted from the agenda.
MOTION: Donna Feild moved that the board approve items 1, 2, 3,5,6,7 (a), and 8. Item 7 (b) was
pulled from the consent agenda. Elizabeth Jensen second.
REPORTS
Board Member
Elizabeth went to the senate for her confirmation hearing. She found it to be very interesting.
She felt the planning session held April 10, 2013 was productive and appreciated the format.
Emma Zavala-Suarez reported:
She also went to the senate for her confirmation. She felt the questions being asked were
interesting and all in all it was an exciting experience.
Donna announced she has taking a new position in North Carolina and will be leaving the
board. She shared that she has enjoyed being on the board and finds it to be a privilege.
Executive Director
Addressed WSPA Pharmacy Legislative day with Tim Fuller with Students from UW on Feb
th
25 .
Attended several hearings and helped prepare testimony for DOH representatives for WA.
House and Senate Health Care Committees ( more in Leg report)
Attended the Veterinary Board of Governors meeting on March 4
th
in Kent to discuss
pharmacist responsibility in filling/counseling prescriptions for pets.
Spent morning of March 12
th
at Oregon Pharmacy Board planning session to gain perspective
on their work on compounding rules, technology rules, strategic planning and business practice
rules recently.
Submitted articles for Veterinary Newsletter on Pharmacist-Veterinarian relationships and

finding common ground and on pharmacist prescription responsibility.
Attended second WSPA WSU student Legislative day in Olympia on March 25
th
to speak to
students.
st
Attended National Drug Abuse Summit in Orlando for DOH for week of April 1 to learn
about efforts to reduce opioid abuse and listen to national speakers and programs on the issues.
Working with WSPA to include a CE on Veterinary medicine in Idaho Meeting in June 2013.
Speaking on October 4
th
to Veterinary Association on Prescription Medication issues.

3
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A decision came out of the District Court in New York to make Plan B available over the
counter for all ages the Federal Government has thirty days to appeal. We have been looking at
it from the perspective of the Stormans Case on behalf of the board and what implications there
are. Keep in mind the Stormans Case involves Plan B and Ella not just Plan B. We will keep
track of what is going on and see what the Federal Government does with any appeal.
Hosting UW Extern Svetlana Nozdrina and WSU Extern Robin Seagrove. These students
contributed a great deal while they were at the board. In addition to their field experiences with
the Pharmacist investigators, they spent time in the board office developing and completing
projects and reduced my very large backlog of collaborative drug therapy agreements. They
used their knowledge, communication skills, and confidence to revise agreements with
requestors. I have never had externs do this before.
Presented with Chris Humberson to the UW students on Pharmacy legislative day.
Attended Hazard Drug Advisory Committee meeting: see Handling of Hazardous Drugs
Exposure Risk Algorithm (attached). Algorithm needs to be supported training, transport,
administration, policies and procedures, amount and frequency.
Participated in Local Health Jurisdiction-Pharmacy Template MOU Operation Plan Work

Group meeting.
Attended FDA Cascadia Conference to share current activities among 5 states and 2 provinces.
Participated in federal review of the DOH Receipt, Stage, and Store operation with a particular
focus on medication repackaging.

The pharmacist investigators are finding that there are many pharmacies which are involved in
take back programs not approved by the board and are not disposing of the drugs they collect
appropriately. The investigators have found bags of unsecured legend drugs, some with
controlled substances, in pharmacies. The investigators are educating the pharmacists on the
proper handling of returned drugs.
Bill Kristin participated at the WSU Pharmacy Class March 28, 2013.
Pharmacists in the field are continuing to have problems with their workload.
Tina Lacey and Grace Cheung participated in the NABP/ MPJE exam writing March 21-22,
2013.
Greg Lang reported:
The investigators enjoyed working with the externs and felt they were able to provide the
externs with a great overall experience.
PRESENTATIONS
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Providence Report to the Board - Preparing Non-Patient Specific Products

Rudy Leighton and Cindy Chan from Providence Infusion and Pharmacy Services provided the board a
six-month status report on its practice of preparing non-patient specific products within a hospital
system.
Compounding Resumed November 2012, Non-Patient Specific
Servicing Providence Hospitals in Washington

Sterile-to-sterile compounding
Currently preparing four products
Three additional products in testing
Highest Quality Sterile Environment

PIPS has achieved and continues to maintain a state of environmental control that
meets or exceeds USP 797 Standards
Internal monthly environmental testing

Air sampling
Surface sampling
Continuous temperature and humidity monitoring
Semi-annual environmental testing by Technical Safety Services which provides

independent USP 797 compliant testing
Air sampling
Surface sampling
Temperature, humidity and room differential pressure monitoring
Quality Assurance
Simplifi 797 software application

Tracks all tasks, processes, and competencies required for USP 797 compliance:
Daily inspection, cleaning, sanitizing of IV hoods, pumps, scales to
maintain sterility.
Monthly cleaning of ISO environments
Monthly drug outdate checks
Temperature, humidity, and pressure monitoring
Sterility testing
Annual training for pharmacists and technicians
QCU - Dedicated Quality Control Unit
End-Product Sterility Testing

Pharmacy Technician Training Program
Media Fills, Gloved Fingertip Sampling

Observed Competencies, Written Exams
Critical Point online competencies
Competencies specific for batching technicians
Total average initial training time per pharmacy technician:
(without batching): 677 HOURS. Total average initial training time per pharmacy
technician: (with batching): 904 HOURS. Annual Training per Pharmacy Technician: 55
HOURS.
Pharmacist Training Program
Media Fills
5
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Observed Competencies
Hands-on clean room training
Critical Point online competencies
Total training time initially and annually per pharmacist: +40 hours
Rudy Leighton invited anyone from the board to come visit his facility. There was not much discussion
regarding this update presentation.
MultiCare Report to the Board- Telepharmacy
Tim Fuller introduced Gail Bunker, Pharmacy Manager for MultiCare Medical Center. Gail provided
the board a six-month status report on its use of telepharmacy technology:
1) To provide after hours services to Covington ED Nursing staff sterile medication
preparation for administered medications in the Emergency Department; and
2) To verify patients own medications at five MultiCare Sleep Centers.
Tele-Pharmacy: Covington ED Nurse Preparation of High Risk Medications
Covington ED does not have 24 hour Pharmacy Services, trained RNs prepare IV admixtures
when the pharmacy is closed. Tacoma General pharmacists observe nurse preparation of high
risk IV admixtures via tele-pharmacy conferencing. Pharmacists document double check of
admixture prepared in EPIC ED Notes.
Tele-Pharmacy Calls of High Risk Admixture Preparation

Pharmacists staff the Covington ED from 12:00 noon to 7:00 pm daily.
After hours order verification is supported by TG pharmacists due to their pediatric training.
Select High Risk IV admixtures prepared after hours require pharmacist tele-pharmacy
observation
An average of 6/month High Risk IV admixtures are prepared after hours
Tele-Pharmacy: Verification of Patient Own Medications in Sleep Centers
MultiCare has six Sleep Centers located at Auburn, Covington, Gig Harbor, Good Samaritan,
South Hill and Tacoma General.
Joint Commission requires pharmacy oversight of medication administration.
Pharmacy remotely verifies patients own medications via high resolution camera.
Tele-Pharmacy: Verification of Patient Own Medications in Sleep Centers

In August 2012 there was a one month pilot of pharmacist verification of patient own
medications from the Tacoma General Sleep Center.
104 medications of 41 patients were verified by tele-pharmacy
There was an average of 2.5 medications per patient
Pharmacists spent an average of 30 minutes per day verifying sleep center patient own
medications at Tacoma General Sleep Center
It was projected that verification of patient own medications at all MultiCare Sleep Centers
would take approximately 3 hours of pharmacist time per day
Staffs working at the Sleep Centers are non-licensed staff that is not authorized to administer
medication. Tele-conferencing was also being used by nursing staff to observe medication
administration.
The sleep center project is currently on hold until resources can be allocated for pharmacy and
nursing staff.
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MultiCare Health Systems (MHS) Centralized Pharmacy Practice

Gale Bunker from MultiCare presented a proposal for four centralized pharmacy services to support
multiple MHS facilities, services to include:
1) Centralized Repackaging of Oral Solids
2) Centralized Repackaging of Non-Sterile Compounded Oral Liquids and Topicals
3) Centralized Batching of Compounded Sterile Products
4) Pyxis Central Fill
Overview:
MultiCare Pharmacy Services supports five hospitals, seven surgical centers, one free standing
Emergency Department, five outpatient oncology clinics, ten retail pharmacies and over one hundred
physician offices.
Centralized Services: Four Proposals across MultiCare Facilities
MHS has grown to include several medical campuses with unique populations and varied
workloads. The BOP request is to provide specific centralizing functions through a
Manufacturing License.
Goals:
1. Ensure all medications within MultiCare have a readable barcode.
2. Improve efficiency and optimize care at all MultiCare facilities.
Specific programs requested include:
1. Proposal 1: Centralized Repackaging of Oral Solids
2. Proposal 2: Centralized Repackaging of Non-Sterile Compounded Oral Liquids and
Topicals
3. Proposal 3: Centralized Batching of Compounded Sterile Products
4. Proposal 4: Pyxis Central Fill
Applicable laws:
1. RCW 18.64.045 Manufacturers License
2. WAC 246-895-010 Pharmacy Good Manufacturing Practice
3. WAC 246-871 Pharmaceutical Parenteral Products
Proposal 1: Manufacturing License for Oral Solid Centralized Packaging
MultiCare Pharmacy Services will continue to purchase unit dose packaging whenever
possible.
Controlled substances will not be provided by centralized packaging.
Tacoma General and Good Samaritan Hospital Pharmacies to provide oral solid bulk
repackaging for other MultiCare facilities.
Centralized packaging of oral solids will occur when:
Unit dose form is unavailable
The manufacturer unit dose form has an unreadable barcode

Autopak
Oral solid non-narcotic bulk repackaging to be performed on AutoPak machine.
AutoPak places a viable barcode on each package.
AutoPak expiration date is one year from packaging unless expires sooner
Biohazard and highly allergenic medications will not be packaged in the AutoPak machine due
to contact contamination. These items may still be packaged for central distribution using the
7
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Euclid or bubble pack packaging methods; these packages will also require a viable barcode for
centralized distribution.
Distribution
Packaging requests will be sent to Tacoma General or Good Samaritan Hospitals for
processing.
Proposal 2: Manufacturing License for Non-Sterile Compounded of Oral Liquid and Topicals
No Controlled Substances will be compounded for central distribution.
MultiCare sites may request a compounded medication in bulk or unit-dose. Unit-dosed
products will be packaged with viable barcode.
Distribution
Compounding requests will be sent to Tacoma General for processing.
Completed unit-dose compounds to be couriered to requesting MultiCare.
There was some confusion on the language with this proposal with respect to clarification of
compounding and manufacturing. A couple questions from the board about bar-coding.
Proposal 3: Manufacturing License for Compounded Sterile Products
Tacoma General and Good Samaritan Hospital Pharmacies to provide compounded sterile
product batch preparation for other MHS facilities.
The majority of admixtures will be prepared on site, compounded sterile product batching will
be used for:
Non-controlled substances only
High volume items such as cefazolin 2g piggybacks
Standard premixed drips unavailable due to drug shortages such as heparin infusions
Distribution
Compounded sterile product requests will be sent to Tacoma General or Good Samaritan
Hospitals for processing
Cold Chain Transportation will be using during transport
Products requiring refrigeration will be placed in an insulated container with frozen cold
packs to maintain temperature between 2-8C (35-46F)
Products requiring freezer transportation will be transported in Vaxisafe or another
approved freezer storage unit to maintain temperatures at -15C (+5F) or colder
Concerns from the board were regarding MHS following 797 rules and pharmacist competency. There
were some questions on the future of this particular type of compounding.
Proposal 4: Central Pyxis Fill

Tacoma General and Good Samaritan Hospital Pharmacies to provide central Pyxis fill for the
other MHS campuses.
Advantages of Central Pyxis Fill
Centralized decision making
Process standardization
Re-deployment of resources on more patient centric activities
Improved inventory management
Ideal for multi-location acute care facilities
Refill quantities determined by Pyxis report specific to each campus
Non Controlled Substances only
8
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Courier transports to receiving campus, chain of custody documented
Staff Training and Competency

Oral Solid Centralized Packaging:
Technician must complete Talyst and AutoPak competencies to be certified on
equipment to package oral solids.
Non-Sterile Compounded Products:
Technician must complete a non-sterile compounding competency to compound nonsterile compounds.
Compounded Sterile Products:
Technician must complete initial and annual IV certification.
Central Pyxis fill:
Technicians must complete an initial and annual Pyxis competency and be certified on
Talyst and AutoPak to perform central fill.
Technicians must be certified in the specialized Tech-Check-Tech Board of Pharmacy
approved program to check Pyxis fill.
Quality Assurance Program
Oral Solid Centralized Packaging:
Only a pharmacist can enter a new medication into the AutoPak system.
Pharmacist check of all oral solid packages.
Pharmacist to verify, medication name, strength, manufacturer, expiration date, lot and
barcode.
Non-Sterile Compounded Products:
All recipes pre-approved through Compound Assist.
Two step pharmacist check on all non-sterile compounded products including
verification of weight on pharmaceutical scale.
Compounded Sterile Products:
Pharmacist check of all compounded sterile products.
Direct inoculation sterile tests are performed on all batched compounded sterile
products with extended dating.
Central Pyxis fill :
Triple check process: double check occurs during central fill, third check occurs by
filling technician.
Quarterly Pyxis fill audits performed.
MOTION: Donna Feild moved to approve MultiCare Health Systems proposal for a Manufacturing
License for Oral Solid Centralized Packaging with the understanding that the policy and procedures are
reviewed by Tim Fuller. If there are concerns, this is no longer approved. Sepi Soleimanpour second.
Chris Barry recused himself. MOTION CARRIED: 5-0.
MOTION: Donna Feild moved to deny MultiCare Health Systems proposal for a Manufacturing
License for Non-Sterile Compounded of Oral Liquid and Topicals. The board would like to have
changes in the language differentiating between compounding and manufacturing and for the board to
review the policy and procedures. Sepi Soleimanpour. Chris Barry recused himself. MOTION
CARRIED: 5-0.
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MOTION Donna Feild moved to deny MultiCare Health Systems proposal for Manufacturing License
for Compounded Sterile Products. The board would like some additions to the policy and procedures.
1) How 797 standards rules will be followed
2) Pharmacist competency was described as overseeing the compounding by pharmacy
technicians. Multicare needs a training program for their pharmacists.
The board would like to review the policy and procedures. Sepi Soleimanpour second. Chris Barry
recused himself. MOTION CARRIED: 5-0.
MOTION: Donna Field moved to approve MultiCare Health Systems proposal for Tacoma General
and Good Samaritan Hospital Pharmacies to provide central Pyxis fill for the other MHS campuses
with the understanding the policy and procedures are reviewed by Tim Fuller. If there are concerns this
is no longer approved and must return to the board . Sepi Soleimanpour second. Chris Barry recused
himself. MOTION CARRIED: 5-0.
CONSENT AGENDA
single motion of the board without separate discussion. This item was pulled because Elizabeth Jensen
had to recuse herself. The board needed to wait until there was a quorum to vote on this item.
b.Rx3000 Pharmacy Computer Services Inc
MOTION: Donna Feild moved that the board approve items 7 (b) that was pulled from the consent
agenda. Emma Zavala-Suarez second. Elizabeth Jensen recused herself. MOTION CARRIED: 5-0.
Columbia Basin Health Association (CBHA) Othello Family Clinic Pharmacy Role Based Pharmacy
Technician Ratio Proposal
Cathy Williams introduced Doug Thompson, Director of Clinical Services for CBHA who presented
the proposal to utilize pharmacy technicians and technicians-in-training based on assigned work role to
maintain the standard ratio of three technicians to one pharmacist (3:1) when there are fluctuations in
pharmacist staffing levels.
Columbia Basin Health Association
Serving the medical needs of Othello and the surrounding area for 40 years.
JCHO certified Community Health Center.
Provide a single so urce
27,000 patients, 150,000 visits in 2012.

90% of patients below 200% of poverty
+50% Spanish translation
Safetynet provider: medical and dental services without regard to ability to pay.
Provides low cost 340B medication.

Health Home
for all of a patients primary care needs.

10
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All services are provided in English and Spanish.
14th Avenue Medical Center (Medical, Social Services)
Single Electronic Dental Record (EDR) linked to Electronic Medical Record (EMR).
Single medical chart shared by all providers.
Single patient history for all CBHA pharmacies.

CBHA Locations
Othello
Othello Family Clinic (Medical, Dental, Optometry, Social Services)
Mattawa
Wahluke Family Health Center (Medical, Dental, Optometry, Social Services)
Connell
Connell Family Clinic (Medical, Dental, Optometry, Social Services)

Telepharmacy (Othello Family Clinic Pharmacy) (2012)
Othello Family Clinic Pharmacy (OFCP)
Staffing
Pharmacy Director (RPhD): 1
Pharmacists: 3
Pharmacy technicians: 5.5 (+1 at telepharmacy)
Pharmacy assistants: 6.5
Volume: 696 Rx/day YTD 2013
SureScripts ePrescriptions
Robotics (ScriptPro SP200 fill 45% of Rxs)
Scriptpro SP200 robotic filling (45% of prescriptions)
Barcode controlled workflow (Etreby)

Technology
Pharmacy Management System (Etreby by Cerner)
Patient profile, billing, inventory, etc.
Workflow controlled by barcodes and login IDs
Point of Sale system
Pill counter (Eyecon optical counter)
Electronic Medical Record
Accessible to pharmacists and technicians
Why OFCP?
Covers pharmacist absence at WFCP.

Covers technician absence at WFCP and Connell telepharmacy.
Safetynet: literacy, language, transportation
High volume (690 Rx/day)
Established color coded uniform policy.
Established Role based software security.
No front end retail cashiers.
Extreme difficulty recruiting bilingual technicians.

Services Provided
OFCP functions
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Collaborative practice agreements

Medication dispensing
Patient consultation
Provider consultation
MTM reviews
Limited compounding (<0.1% of Rx)
How it will work
When fully staffed
When short pharmacists

Select techs will change to red uniforms and have security level changed to
All technicians will wear black uniforms and have RxTechnician security level.
RxAssistant.
Red techs will be assigned to assistant roles; insurance
calls, refill calls, cashier, etc.
Governance
Visibility
Red vested staff currently not allowed to perform certain duties, this would not change.
Pharmacists and managers responsible for enforcement.
Technology
Security is set in Etreby by role, not by individual .
Staff members role can be changed quickly.

Reporting available to investigate suspected violations.
Benefits
Open Every Day
With more techs on staff OFCP can cover sick days at all 3 locations.
Recruiting/Retention
Ability to offer advancement to top performers.
Patient Safety
Technicians performing all filling operations.
Patient Service
Never having to send home support staff.
Summary
Limited to OFCP.
No increase of the 3:1 ration.
Technician count by role rather than licensure.
Roles identified by colored uniforms.
Roles restricted by software security levels.
Managers and staff pharmacists to insure compliance.
This is a topic that the board and investigators have a lot of concerns about. There was plenty of
discussion and questions. Main concerns were pharmacist workload, technicians doing technician work
when they are working as an assistant. How is that prevented and are there sufficient documentation
showing who is working as what role and when? Once a prescription is processed, who fills it? Having
pharmacist checking so many prescriptions per day is an unsafe practice. The pharmacist workload
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seems to be an issue. Some of the board members feel this seems to be an issue of needing another
pharmacist.
MOTION: Donna Feild moved that the board table this proposal until July and allow Tyler Varnum
visit the site to observe this practice. The board would like Tyler to provide feedback. They would like
him to look at the log audit feature and how it is track able, receive some input from the staff
pharmacists on the workload issue. Also this would give CBHA an opportunity to look into resources
to find a pharmacist that could fix this issue all together. Elizabeth Jensen second. MOTION
CARRIED: 6-0.
Providence Centralia - Remote Medication Order Processing
Cathy Williams led this presentation by introducing Karen Bright, Pharmacy Director for Olympic
Medical Memorial Hospital and Linda Higginson, Pharmacy Director for Centralia. They presented the
proposal for Providence Centralia to provide remote medication order processing services to Olympic
Memorial Hospital.
Providence Centralia Hospital (PCH)
Rural not for profit Catholic Health Care
Rural Public Hospital-Sole community
OMH is affiliated with Swedish HealthServices
PCH to provide Remote Order Processing to OMH 23:30 to 05:30
Computerized Physician Order Entry
Licensed 128 bed

Centralia, Washington
Pharmacy Hours 24/7/365
EPIC Electronic Health Record

Olympic Medical Hospital (OMH)
Licensed 80 beds
Port Angeles, Washington
Pharmacy Hours 0530-2400 daily
May 2013 EPIC - EHR

PCH OMH Relationship
Sublicense of the Providence EPIC Electronic
Health Record is a component of our Providence
Swedish affiliation
OMH and PCH utilized the same ElectronicHealth Record build

Contract Agreement Summary
Agreement renewed annually, may terminate by either party without cause 60 days notice
Common EPIC build will provide seamless order verification process
PCH available phone consultation to OMH staff for clinical questions
OMH to provide onsite orientation

Policy and Procedure Overview
OMH staff clarify unclear orders
PCH pharmacists trained OMC CPAs

OMH standardize formulary, IV concentrations with PCH to reduce variation
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PCH Pharmacist
1) Verify Orders
2) Perform Drug Regimen reviews Manages Alerts
3) Interprets clinical data
4) Performs Therapeutic Interventions
5) Provides drug information
OMH
1)
2)
3)
4)
On-Call Pharmacist available for urgent referrals

Drug unavailable outside of normal channels
Drug storage drug requiring special mixing procedures
Unique clinical situations
Procedures related to another service line
OMH
1)
2)
3)
4)
Designated Nurse Supervisor

Coordinate and direct medication access
Access to After Hours automated dispensing cabinet
Coordinate communication with PCH pharmacist
Coordinate communication with OMH on-call pharmacist
Automated Dispensing Cabinets

1) Profiled
2) Override list approved by OMH medical, nursing and pharmacy staff
3) Overrides available only in urgent/emergent situations where delay may cause patient
harm
Quality Assurance
Conducted routinely by OMH and PCH management
1. Adverse Drug Events tracked & investigated by OMH Director and reported to PCH
Director for follow up
2. Compliance with CPAs and Policy/Procedures reviewed monthly by OMH Director
3. Monthly parameters monitored to include, variances in timeliness of order and any
variations outside of policy
4. Volumes and timeliness of order verification
5. Availability of PCH Pharmacists for routine clinical questions
6. Performance feedback from OHM staff
7. Daily retrospective review by OMH all medications removed on override
MOTION: Donna Feild moved that the board approve the proposal for Providence Centralia to
provide remote medication order processing services to Olympic Memorial Hospital as presented and
to report back after six months after started. With this report the board would like them to include
quality data and the opinions from the hospital staff being served . Second. MOTION CARRIED: 6-0.
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DISCUSSIONS
SHB 1155 modifies RCW 69.41 and RCW 69.50 to allow electronic transfer of schedule II controlled
substances and standardizes language. Substitute bill standardizes language in RCW 69.41 and RCW
69.50. Companion bill SB 5416
Crossed over to senate, executive action taken on 03/21/13 by Health Care committee, passed to rules
nd
committee for 2 reading.
SHB 1182 adds pharmacists to RCW 69.41.030 as a practitioner with CDTA; we are already in RCW
69.50. Crossed over to senate, executive action taken on 03/21/13 by Health Care committee, passed to
rules committee for 2nd reading.
SHB 1382 allows drug manufacturers, drug wholesalers, hospitals, pharmacies, nursing homes,
boarding homes, adult family homes and medical clinics, to donate (return) drugs in an original sealed
and tamper evident package, or open package, if it contains a single unit doses that remain intact
(excluding controlled substances and with at least 6 month remaining on the expiration date). These
donations may be made to a pharmacy for redistribution without compensation or the expectation of
compensation. The pharmacy may redistribute the drugs to another pharmacy, pharmacist, prescribing
practitioner for use to treat uninsured and low income individuals . Companion bill to SSB 5148.
Crossed over to senate, in Health Care committee, scheduled for public hearing on 03/14/13.
HB 1609 renames the Board of Pharmacy to Pharmacy Quality Assurance Commission, increasing
membership from 7 to 15 members (10 pharmacists, 4 public, 1 technician).
Crossed over to senate, executive action taken on 03/21/13 by Health Care committee, passed to rules
committee for 2nd reading.
HB 1800 allows the compounding of medications for physician offices, ambulatory surgical centers, or
ambulatory surgical facilities to be used by a physician for ophthalmic purposes for non-specific
patients. Crossed over to senate, first reading, referred to Health Care committee, scheduled for public
hearing on 03/27/13 at 5:30 PM.
HB 1808 addresses the situation where a legal amount of marijuana is found at a retail store that holds
a pharmacy license. The store manager or employee must promptly notify the local law enforcement
agency, after notification to law enforcement the store manager or employee must properly dispose of
the marijuana.
Crossed over to senate, first reading, referred to Health Care committee, scheduled for public hearing
on 03/27/13 at 5:30 PM.
ESB 5104 places epinephrine auto-injectors in schools, companion bill to HB 1578.
Crossed over to house, executive action taken on 03/26/13 by House Committee on Education should
pass to rules committee on 03/27/13.
SSB 5148 allows drug manufacturers, drug wholesalers, hospitals, pharmacies, nursing homes,
boarding homes, adult family homes and medical clinics, to donate (return) drugs in an original sealed
and tamper evident package, or open package, if it contains a single unit doses that remain intact
(excluding controlled substances and with at least 6 month remaining on the expiration date). These
donations may be made to a pharmacy for redistribution without compensation or the expectation of
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compensation. The pharmacy may redistribute the drugs to another pharmacy, pharmacist, prescribing
practitioner for use to treat uninsured and low income individuals. Companion bill to HB 1382.
Crossed over to house, in Health Care and Wellness committee scheduled for executive session on
03/28-29/13.
SB 5149 Concerning crimes against pharmacies, creates a one year sentencing enhancement for a
person convicted of a robbery offense committed against a pharmacy.
Crossed over to house, in House Committee on Public Safety, scheduled for public hearing on
03/20/13.
2SSB 5213 requires managed care plans contracting with Medicaid to require that any patient with five
or more prescriptions be place in an automatic review process with a primary care provider to ensure
appropriateness and screen for drug interactions at least annually.
Crossed over to house, in Health Care and Wellness committee scheduled for executive session on
03/28-29/13.
SSB 5416 modifies RCW 69.41 and RCW 69.50 to allow electronic transfer of schedule II controlled
substances and standardizes language. Substitute bill standardizes language in RCW 69.41 and RCW
69.50. Companion bill HB 1155
Crossed over to house, executive action taken by Health Care and Wellness committee on 03/26/13
should pass to rules committee on 03/27/13.
SSB 5459 under certain circumstances, a pharmacist is allowed to dispense up to a 90 day supply if the
valid prescription specified an initial quantity of less than a 90-day supply followed by refills. The
pharmacist must notify the prescriber if dispensing an increase in dose units. See HB 1583.
SB 5524 authorizes Washington pharmacies to fill prescriptions written by physician assistants in other
states. Companion bill to HB 1596.
Rules and Planning Session

Christopher Humberson, Executive Director and Doreen Beebe led the update on the rules and the
planning session.
April 10, 2013 the Board of Pharmacy had a planning session. The majority of the time was spent
talking about what was done at the January board meeting. At that meeting the board had decided to
open rules on four particular areas. Which were Compounding, Pharmacy Technology, Pharmacy
Business Practices, and Pharmacist Interns and Preceptors. Being in Legislation Session and looking
to hire someone in Kitty Slatters rules position. Doreen has been working on the CR101 on
Compounding. The CR101 draft has been entered into the DOH Rules Management System. We are
hoping to start holding stake holder meetings at the end May if the CR101 gets filed.
2013 NABP Meeting

th
The board was asked to review and provide input on meeting resolutions for consideration at the 109
NABP Annual Meeting in St. Louis MO on May 18- 21.
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District 1
RESOLUTION Pharmacy Compounding Sterile Products
Whereas the demand for compounded medication has increased and the need for pharmacies to
provide the best quality to their patients by producing a high quality compound is required; and
Whereas, supply shortages of critical, lifesaving prescription medication may increase the demand for
compounded medications; and
Whereas, pharmacies engaging in sterile compounding must meet or exceed United States
Pharmacopeia high quality standards; and
Whereas, pharmacies engaging in high risk sterile compounding imposes a greater risk to patient s
safety; and
Whereas, patient safety if the primary mission of the state boards of pharmacy and the National
Association of Boards of Pharmacy (NABP);
Therefore, be it resolved that NABP encourage Boards of Pharmacy who license compounding
pharmacies that engage in sterile compounding to require accreditation through a nationally recognized
accreditation body, such as Pharmacy Compounding Accreditation Board (PCAB) or similar
accreditation body approved by the board.
Be it further resolved that NABP review and, if necessary, propose amendments to the Model State
Pharmacy State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy to
address appropriate regulation requiring accreditation of pharmacies engaging in sterile compounding.
District 2
RESOLUTION #1
Whereas despite great strides in securing our drug distribution system from adulterated, misbranded
and counterfeit drugs, problems remain, and
Whereas contemporary systems allow for receiving medications in a timely and efficient fashion, and
Whereas federal and state provisions allow for intra-company transfers of medications, and
Whereas properly constructed laws and regulations can allow boards of pharmacy to provide waivers
to cover emergency disruptions in our drug delivery systems,
Therefore, be it resolved that the National Associations of Boards of Pharmacy (NABP) urge its
member boards of pharmacy to prohibit pharmacies from utilizing the 5% wholesaler transfer
allowance to introduce drugs for resale, with the exception of emergency situations declared by the
board and except the legitimate return of drugs to the manufacturer or wholesaler from whom the drugs
had been purchased.
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MOTION: Dan Rubin moved that the board support District 2 resolution #1. Donna Feild second.
RESOLUTION #2 Pharmacy Compounding Sterile Products
District 2 was approached by District 1 to support and co-sponsor their resolution titled: Pharmacy
Compounding Sterile Products .
The seven states of District 2 present at the business session fully endorsed the concept of the D1
resolution, but with the one minor grammatical correction (line 4: impose vs. imposes) and the striking
of the wording .such as the Pharmacy Compounding Accreditation Board (PCAB) or similar
accreditation body.
It was suggested that as D1 had already approved the resolution as written, that the proper course of
action would be for D2 to submit the same resolution with the above listed change/correction, as the
two documents would be harmonized via the NABP Resolutions Committee process.
It was therefore agreed (vote of 6-1) to submit the amended wording of the D1 resolution noted above
as a separate D2 resolution.
MOTION: Dan Rubin moved that the board support District 2 resolution as improvement of District 1
resolution and support District 2 compounding sterile products resolution and District 7 task force on
compounding reconstitution of drug infusion in medical clinics resolutions. We support all as stated.
Donna Feild second. MOTION CARRIED: 6-0.
District 3
RESOLUTION - Concerning PBM Model for States
th
Whereas, the member boards of NABP adopted resolution #108-6-12 at the 108
annual meeting of
the association acknowledging the need for state regulations of PBMs and utilization of the NABP
model state pharmacy act and model rules as a starting point for states to develop and implement
regulations for the PBMs; and
Whereas, State Boards of Pharmacy are charged with the responsibility of protecting the patients or
applicable citizenry as it relates to patient safety, patient health and patient services through Pharmacy;
and
Whereas, the practices, decisions or rules of PBMs directly affect patient safety, patient health and
patient services; and
Whereas, the regulations of PBMs extend beyond individual state borders, and requires cooperation
and communication among the state boards of pharmacy; and
Whereas, there is a need to determine the status of PBM regulations in the states in order to revise the
NABP model act, model to provide a cohesive strategy for revising and reviewing these model
regulations.
Therefore to be resolved that NABP convene a task force to review the status of PBM regulations in all
of the states, further cooperation and collaboration among the states regarding the regulations of PBMs
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and reviewing and revising the PBM model act to provide a cohesive and current guideline for states to
utilize in developing regulations.
MOTION: Dan Rubin moved that the board support District 3 resolution with the suggestion that they
involve state insurance regulatory entities as well as a pharmacy regulatory entity. Donna Feild second.
District 4 -Co-supports two district resolutions proposed
1. Co-supports District 2 Pharmacy Compounding Sterile Products
2. Co-supports District 8 Proposal for the alternate delivery of mandatory Patient Package
Information (PPI) in the interest of environmental concerns and protection of patient privacy.
District 5 No Substantive Resolutions Proposed

District 6 No Resolutions Proposed
District 7
RESOLUTION #1 - Definition of Pharmacy Compounding
Whereas pharmacy compounding has been a traditional part of pharmacy practice and continues
to be practiced by many pharmacists; and,
Whereas pharmacy compounding is regulated by the state boards of pharmacy; and,
Whereas pharmaceutical manufacturing is primarily regulated by the United States Food and
Drug Administration (FDA); and,
Whereas a lack of clarity in the definitions of and the distinctions between pharmacy compounding and
pharmaceutical manufacturing has allowed manufacturing to occur under the guise of pharmacy
compounding with tragic consequences,
Therefore be it resolved that NABP work with the FDA, the state boards of Pharmacy and other
interested parties to establish mutually agreeable definitions for pharmacy compounding and
pharmaceutical manufacturing; and,
Be it further resolved that NABP update its Model Act and Rules to reflect the new definitions.
RESOLUTION # 2 - Compounding and Reconstitution of Drugs for Infusion

Whereas recent tragic events involving products compounded and reconstituted for infusion which
were contaminated, adulterated or misbranded have demonstrated the significant risks that exist when
drugs are compounded and reconstituted for infusion; and,
Whereas a variety of medical practices, including but not limited to, oncology, rheumatology and
gastroenterology employ nurses and pharmacy technicians, registered or unregistered, to compound
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and reconstitute sterile products for infusion in their clinics, which often involve complicated
calculation; and,
Whereas the final product of compounding and reconstitution of sterile products within a prescribe r s
office may not be checked by the prescriber prior to administering or dispensing; and,
Whereas United States Pharmacopeia (USP) guidelines for the preparation of sterile products for
Infusion may not be followed in these medical clinics, potentially leading to unsafe conditions and
unnecessary risk to patients,
Therefore be it resolved that NABP establish a multidisciplinary taskforce or other appropriate vehicle
including the Federation of State Medical Boards and the National Council of State Boards of Nursing
to address the compounding and reconstitution of sterile products for infusion in medical clinics or
other establishments without pharmacist oversight; and,
Be it further resolved that NABP work through the taskforce or other appropriate vehicle to establish
consensus that the compounding and reconstitution of sterile products for infusion in medical clinics is
considered to be pharmacy compounding which must be performed only by or in consultation with a
licensed pharmacist and must comply with the USP Chapter 797 guidelines for the preparation of
sterile products.
RESOLUTION # 3 - Performance Metrics and Quotas in the practice of Pharmacy

Whereas when the Institute for Safe Medicine Practice (ISMP) surveyed 673 pharmacists, 83%
believed that distractions due to performance metrics or measured wait times contributed to dispensing
errors and 49% felt specific time measurements was a significant contributing factor; and,
Whereas Performance metrics, defined as the measurement of speed and efficiency of prescription
work flow by measuring parameters, including but not limited to, prescription wait times, percentage of
prescriptions filled within a specific time period, number of prescriptions verified per pharmacist and
the number of immunizations given per pharmacist shift, may distract pharmacists and impede
professional judgment; and,
Whereas the practice of applying performance metrics or quotas to pharmacists in the practice of
pharmacy may cause distractions that decrease the pharmacist s ability to perform Drug Utilization
Review, decrease interaction with patients, decrease attention to detail and lead to unsafe conditions in
the pharmacy; and,
Whereas the ISMP is advocating for change or elimination in the use of performance metrics and
quotas in pharmacies,
Therefore be it resolved that NABP assist the state boards of pharmacy to regulate, restrict or prohibit
the use of performance metrics or quotas in pharmacies and,
Be it further resolved that NABP review and propose amendments to the Model Act and Rules to
address the regulation or prohibition of the application of performance metrics and quotas to
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pharmacists in the practice of pharmacy in order to protect the health and safety of pharmacy
customers and pharmacy employees.
MOTION: Donna Feild moved that the board support District 7 resolution #3. Dan Rubin second.
Sepi Soleimanpour recused herself. MOTION CARRIED: 5-0.
District 8
Resolution - Proposal for the alternate delivery of mandatory Patient Package Information (PPI)
in the interest of environmental concerns and protection of patient privacy
Whereas there are many tons of unread and discarded PPI deposited in virtually every pharmacy trash
receptacle and,
Whereas the electronic world offers acceptable alternative ways for the patient to access PPI and,
Whereas patients often request and may prefer receiving PPI via electronic means:
Therefore be it resolved that NABP explore discussing with the FDA and state Boards of Pharmacy
regarding the feasibility of allowing patients the choice of accessing mandatory PPI through electronic
means.
MOTION: Donna Feild moved that the board support District 8 resolution Dan Rubin second.
CriticalPoints Sterile Compounding Boot Camp

Chris Humberson, Executive Director asked the board to consider approving funds for a pharmacist
investigator to participate in a program on current sterile compounding best practices. The intention
would be to send one or two investigators. These investigators will then train the others and then use
videos and other means of education (train the trainer). The one or two who attended the boot camp
will be the main resource for others. Also after returning they will be asked to present to the board.
MOTION: Donna Feild moved that the board approve funds for a pharmacist investigator to
participate in a program on current sterile compounding best practices. Elizabeth Jensen second.
New Board of Pharmacy Vice-Chair

MOTION: Donna Feild moved that Elizabeth Jensen take the position of Vice Chair for the Board of
Pharmacy. Sepi Soleimanpour second. . MOTION CARRIED: 6-0.
Continuing Education (CE) Approval

Cathy Williams asked the board to consider approving CE recognized by another state board of
pharmacy in lieu of an independent review and approval. WAC 246-861- 040(5) states, The board of
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pharmacy may accept comparable continuing education units which have been approved by other
boards of pharmacy.
MOTION: Donna Feild moved that the board approve CE recognized by another state board of
pharmacy in lieu of an independent review and approval. MOTION CARRIED: 6-0.

The board was asked to consider reaffirming its recognition of the American Council on Pharmacy
Education (ACPE) accredited professional programs of colleges and schools of pharmacy as the
official list of approved pharmacy programs.
MOTION: Donna Feild moved that the board recognize the American Council on Pharmacy
Education (ACPE) accredited professional programs of colleges and schools of pharmacy as the
official list of approved pharmacy programs. MOTION CARRIED: 6-0.
Correspondence
The board may discuss any correspondence received or distributed.
Citizens' Petition to BOP 3-27-13 - Attachment 1

Citizens' Petition to BOP 3-27-13 - without Attachments
Reponse to Fluoride Petition
University of Washington Pharmacy Students Law Presentation

Dr. Thomas Hazlet, University of Washington Pharmacy Students introduced the PharmD students.
Each group of student presented their pharmacy law projects to the board on these topics.
Increasing Accessibility of Hormonal Birth Control
Mikalla Cheney, Thomas A. Gorlin, Elise B. Knutzen
Safe Pharmacy Work Environment: Amendment to Ensure Safe Pharmacy Practice

Bridgette Lorenzen, Christine Chan, Ivan Huang, Sumin Lee, Michelle Lin, Kris Martinson, Brian
Muller, Sheeva Panahinia, Hana Sperling, Mary Slate Williams
Presented by: Bridgette Lorenzen
OPEN FORUM
Jenny Arnold from the Washington State Pharmacy Association shared that WSPA will be hosting a
webinar May 16, 2013 from 9:30 a.m.-10:30 a.m. There will be an email sent out as a reminder.
22
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CLOSED SESSION
Next scheduled business meetings: May 30, 2013 9:00 a.m.
310 Israel Rd SE
Tumwater WA 98501

Approved on May 30, 2013

23
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STATE OF WASHINGTON
April 30, 2015
Amended Meeting Minutes
Best Western Plus
Lakeway Inn & Conference Center
Mt. Baker Room
714 Lakeway Drive
Bellingham, WA 98229
CONVENE
Chair Al Linggi called the meeting to order March 12, 2015.
Commission Members:
Al Linggi, RPh, MBA
Gary Harris, RPh,
Steve Anderson, RPh
Tim Lynch, PharmD
Absent Commission Member

Nancy Hecox, PharmD
Guest / Presenters:
Dr . Andy Kim, Senior Medical Science
Liaison at Shire US Inc.
Mark Lenker, Director, US Government
Relations & Public Policy at Shire US
Jeffrey Gombosky, Public Affairs
Consultant for Shire US Inc.
Glen Adam, Pharmacy Director
for Confluence Health
DR. Peter Rutherford, CEO of Confluence
Dr . Julie Smith, Oncology Infusion
Manager for Confluence Health
Mary Gunkel, Director of Oncology
for Confluence Health
Craig Pedersen, Pharmacy Manager
Carol Sue Janes, Attorney for Confluence
Staff Members:
Lilia Lopez, AAG
Guest / Presenters(continued)
Brad Dykstra, Pharmacy Investigator
Lannay Turay, Pharmacy Director for
Jefferson Hospital
Cathy Williams, R.Ph, Pharmacist Consultant
Cliff Richards, PharmD Othello
Community Hospital
Gordon MacDonald, R.Ph, Chief Investigator
Absent Staff
Joyce Roper, AAG
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CALL TO ORDER
1.2 Approval of March 12, 2015 Meeting Minutes .
MOTION: Chris Barry moved that the commission approve 1.1. Gary Harris second.
MOTION: Chris Barry moved that the commission approve 1.2 with suggested
CONSENT AGENDA - Items listed under the consent agenda are considered routine
commission matters and will be approved by a single motion of the Commission without
separate discussion. If separate discussion is desired, that item will be removed from the
consent agenda and placed on the regular business agenda.
March 2015
a. Bob Johnson Pharmacy
b. International Academy of Merchandising and Design dba SanfordBrown College
c. Rite Aid renewal
d. Walgreens renewal
e. Wasems, Inc.
f. Island Drug
a. Cascade Medical
b. FairFax Behavioral Health
c. Jefferson Healthcare Surgical Associates Health Care Entity
d. Propac Pharmacy Fort Vancouver Convalescent Center
e. Kelley Ross Pharmacy skilled nursing facilities
PharmacyRx e-prescribing system
2.7 Sample Drug Distribution Approval
2.8 Tamper Resistant Prescription Paper/Pads Approval
2.9 Pharmaceutical Take-back Program
San Juan County Friday Harbor Drug, Lopez Pharmacy, and Rays
Pharmacy
Sepi Soleimanpour recused herself from Item 2. 3 (d).
MOTION: Elizabeth Jensen moved that the commission pull items 2.3 (b, c, d & f) for
further discussion. Dan Rubin second. MOTION CARRIED: 9-0.
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MOTION: Chris Barry moved that the commission approve items 2.1, 2.2, 2.3 (a & e),
2.5, 2.6 & 2.9 on the consent agenda. Steve Anderson second. MOTION CARRIED:
9-0.
REPORTS
Commission Members
Tim Lynch reported:
Met with Al to talk about some issues related to interpretations of WACs

concerning non hospitalized patients it was a great discussion. Tim wanted to bring
this forward to the commission for further discussion and consideration. How the
current WACs are being interpreted and applied to some patients underneath the
hospital licensure but being viewed as non-hospitalized patients . This has the
potential to impact the quality and safety of care provided to our patients. The goal
would be to get the commission to understand the ramifications of these
interpretations.
He will be one of the facilitators at the Leadership session for ASHP in October .
He attended the ASPHP Pharmacy Business Manager Advisory Group.
Tim participated in the creation of WSPA Hospital Pharmacy Leadership Meeting

next month.
He attended a Business Practice Committee Webinar March 30 and April 15.
Steve took and passed the Michigan MPJE and is now licensed in Alabama .
On April 2 Steve attended the UW Strategic Planning Committee Meeting

Steve flew to Alabama for a license interview. Steve delivered a message from the
Alabama Board of Pharmacy to our commission saying, Hello.
Sepi participated in the Business Practice Committee Webinars.
She also participated in the Business Practice Committee Webinars.
Dan Rubin reported:
He has been spending a significant amount of time on the Business Practice

Committee.
Dan shared he has spent a considerable amount of time with a friend who is dying.
He expressed his appreciation for the team work in Palliative Care that occurs in
many hospitals. His friend was so grateful to have honest discussion about how is
life was going to end.
Al Linggi reported:
He attended the UW P-3 Policy & Strategy Meeting for the UW School of
Pharmacy.
He also attended the UW School of Pharmacy Facility and Curricula Meeting.

He receives a considerable amount of dialogue and phone calls regarding some of
the issues the commission is working on, specifically with the business of process.
For the most part the concern is based upon prioritization, regulation of some of the
particular issues.
Kingsbury0472
For the July Planning Session Al suggested the commission work on a complete
prioritization with input on all the rules and regulations. Prioritization of the work
that needs to be done with milestones and timing. The commission needs to take a
look at our existing staff and help make recommendations to the Executive Director
on prioritization and utilization of current staff so we can meet timelines we outline
for prioritized issues that we need to work on.
He attended the UW Strategic Planning Committee Meeting.
Gary is Co-Chair for the UW School of Pharmacy campaign takes place through
the summer until next year.
Gary also participated in the Business Practice Committee Webinar.

He participated in the UW School of Pharmacy Alumni Association board meeting
to pick the two pharmacist of the year the awards that will be given out at the
Kattermans Lecture . For the first time this year they will be giving a lifetime
achievement award.
Executive Director
Attended a 50 state FDA meeting in Maryland for Washington State to discuss

sterile compounding issues and related inspection formats for states to utilize.
Attended National Drug Abuse Summit meeting in Atlanta representing

Washington State and DOH.
Participated in business practice committee meetings
Lisa Roberts and I met with Senator Parlette, Reps Harris, Cody, Schmick and their
staffs to provide technical assistance regarding issues concerning bio-similar
legislation.
Over the course of the legislative session, Lisa Roberts, Doreen Beebe, and I work
on 35-bill analysis for the department. You should be proud of the quality of their
work.
Working with Cathy, Irina and LeAnn, we were able to implement and completely
resolve the CDTA backlog that existed at the office as of six weeks ago. Leann?
We posted the rules coordinator position and have not found a suitable candidate to
date to succeed Peggy Crain.
Participated in quarterly UPWG

Met twice with WSHA representatives on SB 5460 and other related issues
Met with Long Term Care stakeholders in Kent
Met with Senators Becker and Parlette and DOH staff re: pharmacy commission
activity.
USP 797/ Sterile Compounding Training Review

Gordon MacDonald, Chief Pharmacist Investigator and Brad Dykstra and Julie Faun
Pharmacist Investigators shared a presentation to the commission regarding the
Compounding Boot Camp.
Background
Regulatory Change
January 1, 2004 USP 797 first published

2004 NIOSH Alert published
2008 USP 797 revised
2013 the Drug Quality and Security Act becomes law
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June 2013, USP 797 adopted as minimum standard in Washington

Current Law RCW 18.64.270(2)
Any medicinal products that are compounded for patient administration or

distribution to a licensed practitioner for patient use or administration shall, at a
minimum, meet the standards of the official United States pharmacopeia as it
applies to nonsterile products and sterile administered products .
RCW 18.64.270 (2)
1998 California - 11 children become ill with bloodstream infections associated

with contaminated prefilled saline syringes.
2001Missouri - 4 children contract Enterobacter cloacae infection from IV

ranitidine compounded in hospital pharmacy.
2002 North Carolina - 5 patients develop Exophiala infection from contaminated

methylprednisolone, 1 died
2004 Several states - 36 patients develop Pseudomonas from contaminated heparin

syringes.
2007 Washington, Oregon - 3 patients die after receiving IV colchicine

compounded at high concentration.
2011 California, Florida, Tennessee - 16 patients develop severe eye infection after
contaminated Avastin.
Failure to meet minimum standards for sterile compounding may result in criminal
liability RCW 18.64.270 (3)
Historical Negative Events
2011 Alabama - 19 patients develop serratia marcescens infections after receiving

contaminated TPNs. 9 died.
Landmark Event
2012 - New England Compounding Center (NECC) Pharmacy

751 people had documented infections
64 deaths
NECC was licensed in Washington
USP 797 was adopted by Mass prior to NECC fall out
NECC was doing surface sampling, air sampling, glove tip sampling,
media fill test, maintained cleaning logs (They just ignored results)
Subsequent Negative Events
2013 New Jersey Compounding pharmacy closed and all drugs recalled after mold
found in bags of mag sulfate.
March 25, 2015 North Carolina All sterile and non-sterile drugs from compounding
pharmacy recalled nationwide .
FDA Action
Section 503A Traditional compounding pursuant to a prescription
Section 503B Outsourcing facilities (not pursuant to patient specific prescriptions)

must follow stricter standards (cGMPs). 51 registrants to date.
Form 483: An FDA Form 483 is issued to firm management at the
conclusion of an inspection when an investigator(s) has observed any
conditions that in their judgement may constitute violations of the Food
Drug and Cosmetic (FD&C) Act and related Acts. Higher level of
scrutiny
Compounding Boot Camp Review
USP 797 has been a minimum standard since 2004
Learning a State of Control
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The hands-on training is critical to understanding the entire concept of USP 797
and sterility.
You cant pick and choose parts of compliance because theyre all inter related..
Specific Focus Lessons of Class
Review of USP 797

Low risk, medium risk, high risk
Primary engineering controls

Secondary engineering controls
Training Take Aways
Engineering control and certificate analysis

Jim Wagner (president Controlled Environment Consulting, on USP expert
committee) reviewed a certification that is common to Washington pharmacies
and found it deficient
Interactive exercises
Performed glove tip sampling
Smoke studies
Particle Counts
Developing a cleaning program
Beyond use dates

Recognizes the possibility of contamination
Developing policies and procedures

Critical part of USP 797 compliance
Must involve all employees in the system
Without them, employees cannot be expected to understand what to do
Establish acceptable ranges
Environmental sampling
Allows for early detection
Monitors State of Control
After the presentation the commission was able to ask Brad Dykstra and Julie Faun about
their opinions and what they felt about the program.
A couple suggestions from the commissions were that there should be some
communication out to the stakeholders making them aware of what they are engaging in
and what the standards are in compounding. Elizabeth suggested that the investigators start
doing some sort of CE that educates the stakeholders on what they have learned in this
Boot Camp.
Challenges faced by stakeholders:
Financial
Engage with certifiers and have commission communicate with certifiers letting
them know of any different expectations.
Guidance from investigators and what they are going to look for.
The selection of the hoods, no guidance to address the iso-hoods / glove box and
how they relate to 797 and what environment they need to be in.
The commission asked the investigators to provide this information to
the stakeholders/commission members .
Note: All of these guidelines and recommendations and any other information are
published in the USP 797. Investigators ask as part of the process that pharmacist in charge
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or whoever should be well read on 797 it is a 38 page document that is what the
investigators are looking for.
LEGISLATION, RULEMAKING, AND POLICY DEVELOPMENT
Rulemaking Petition
Cathy Williams introduced the team from Shire US Inc. to allow them to provide some
background to the commission about the petition to amend WAC 246-887-040 Designation
of non-narcotic stimulant drugs for purposes of RCW 69.50.402, and WAC-246-887-045
Prescribing, dispensing, or administering of Schedule II nonnarcotic stimulants.
Shire US Inc, aka Shire Pharmaceuticals or Shire, is a pharmaceutical company and the
patent holder for a newer nonnarcotic stimulant, name Vyvanse (Lisdexamfetamine
Dimesylate). Vyvanse is indicated for both the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) in patients six years and older, and as of January 30, 2015, Binge Eating
Disorder in adults. Vyvanse was approved by the FDA for the treatment of ADHD,
effective February 26, 2007.
The active ingredient in Vyvanse, Lisdexamfetamine Dimesylate, is listed as a Schedule II
stimulant in RCW 69.50.206(d)(5). Lisdexamefetamine was added to the list of Schedule II
stimulants in 2010. Under RCW 69.50.402(1)(c), it is unlawful (a Class C felony) for a
practitioner to prescribe, order, dispense, administer, supply, or give to any person.
The legislature has granted the commission the authority to add medical conditions for
which Schedule II nonnarcotic controlled substances may be prescribed by rule adoption,
in consultation with the Medical Commission and the Osteopathic Board. The issuance of a
letter or a newsletter article would have no effect on the language in RCW 69.50.402. To
the extent that prescribers are unwilling to prescribe Vyvanse due to concern that doing so
is a violation of RCW 69.50.402, which could subject them to criminal enforcement, a
letter or an article in the newsletter would not have any force or effect on the application
of that statute.
MOTION: Dan Rubin moved the commission reject the petition to amend WAC 246-887040 Designation of non-narcotic stimulant drugs for purposes of RCW 69.50.402, and
WAC-246-887-045 Prescribing, dispensing, or administering of Schedule II nonnarcotic
stimulants. The reason for the rejection is the statute about petitions sets such extraordinary
timelines and it is not felt it is consistent with the commissions overall priorities.
Dan also moved that the commission work on a possible broader approach to this issue
based on indications not names of drugs at the planning session. Gary Harris second.
PRESENTATIONS
Confluence Follow-up
Chris Humberson led the discussion of the follow-up on Confluences request for a
demonstration project approval for remote infusion services at Moses Lake and Omak.
Glenn Adams introduced his team from Confluence Health. Mr. Humberson provided a
brief background on the ongoing request and to reach a conclusion to the matter of their
request for a pilot program approval at their Omak Clinic and the continuation of the pilot
program at their Moses Lake Clinic facility, where in both cases they wish to utilize a
pharmacy technician for sterile compounding that will be remotely supervised by a
pharmacist located off site in Wenatchee.
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Background
Confluence came to the Pharmacy board in November 2012 to request a pilot

program at their Moses Lake clinic to utilize remote pharmacist supervision of a
technician in preparing parenteral solutions, including chemotherapy medications .
At the time they stated in a memo provided to the board that they were following
USP 797 as a matter of hospital policy. The basis of this approval was the concern
of patients access to medications being provided by the nursing staff at the clinic.
The board approved this pilot program without being provided information on
WACs 246-878 or 246-871 regarding the requirement of a pharmacist to be on site
in this case.
In September 2014, the commission was approached about extending this pilot
program to their Omak clinic. The commission provided tentative approval which
they rescinded in October 2014 after learning that a pharmacist was on site in the
Omak facility and that access was not a central issue.
In November 2014, Tyler Varnum and Commissioner Hecox visited both Moses
Lake and Omak facilities and found several operational concerns. This information
was provided to the commission and Confluence in December 2014.
January 29 ,2015 , the commission voted to provide Confluence with technical
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assistance to assess both their facilities in Moses Lake and Omak for compliance
with Washington State statutes regarding minimum requirements for pharmacy
sterile compounding by April 30, 2015. Inspectors again made visits to both
facilities to provide technical assistance and assist with improving their operational
capabilities.
The last site visit was on April 13
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provided n the report to the commission which outlines
the ongoing issues. Safety still remains a concern for the patients at these facilities.
There is legislation that the Department of Health and WSHA worked on that needs some
clarification on the interpretation of it and will it pass or not. The underlying question is do
these two facilities need to be licensed to practice pharmacy. This is still an issue that
needs to be addressed.
Mary Gunkel from Confluence Health, Oncology nurse feels that the safety of our patients
and the safety of compounding would be compromised if nurses go back to compounding.
A nurses training is not dedicated to compounding. Dr. Peter Rutherford, CEO of
Confluence feels that the initial focus has been lost in the discussion regarding all the other
issues. He is committed to providing safe high quality care to patients. At this point
Confluence doesnt have a funding issue they are not going to go cheap on this but they
do need to keep the lights on. He assured that Confluence will not attempt to do anything
that is not safe that is not appropriate, this is his community. The commission members
took turns asking the Confluence team questions and sharing their concerns with the team.
MOTION: Dan Rubin moved the commission take no action on the Moses Lake pilot as is
and Omak pilot with pharmacist as is. Steve Anderson second. Elizabeth Jensen opposed.
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This continues to be a hot topic with over an hour of detailed discussion. If you would like
more details, staff can provide further information.
OPEN FORUM
Jeff West shared some issues he has concerns he has as a Quality Improvement Consultant
working specifically on reducing adverse drug events to his knowledge there is not reliable
accurate adverse drug event incident prevalence data at the community level. He is
looking for an accurate report to reduce adverse drug events. Along with the lack of reports
for medication reconciliation that directly affects adverse events.

Legislation Report
Passed:
SHB 1625 providing drugs to ambulances
Delivered to Governor for signature
ESHB 1671 opioid overdose medications
SSB 5268 eye drop refills
Governor signed. Chapter 85, Laws of 2015, effective 07-24-15
ESSB 5441 patient med coordination
ESSB 5460 prepackaged ER meds
(Title is now pharmacy services in hospital emergency rooms and hospital clinics)
ESB 5577 pharmaceutical waste
(PQAC was support only)
SB 5935 biologics III
Appear to be DEAD:
SB 5557 services provided by pharmacists
SHB 1369 student volunteers
HB 1675 biologics I
HB 1679 biologics II
HB 1719 pharmacy asst. registration/discipline (agency request bill)
HB 1732 meal/rest breaks & mandatory OT for certain healthcare workers
HB 1765 marijuana authorized only in Rx pill form
ESHB 1845 pharmaceutical waste
SB 5291 epi auto-injectors for authorized entities
SB 5434 synthetic cannabimimetics
SB 5493 cannabis health & beauty aids
(companion bill HB 1753 introduced Jan 28)
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SB 5549 pharmacy asst. registration/discipline (agency request bill)

SB 5695 insurance coverage for opioid reversal drugs
SB 5815 naturopath Rx authority
SB 5821 updating pharmacy provisions I
SB 5822 updating pharmacy provisions II
SB 5857 pharmacy benefit managers
(Note: Small independent pharmacies testified they would be out of business by years
end lacking the provisions in the amendment; issue is PBM failure to reimburse
pharmacies for their cost for drugs)
Compounding Rules Update

Chris Humberson updated the commission on the Compounding rule. The second working
draft is proceeding more slowly without a Rules Coordinator to facilitate the redraft. I
personally have read all 129 pages of comments and anticipate the second working draft to
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be released for comment period on June 15 .

AL Linggi gave the commission an update on the Technology Committee . There was a
request sent out on listserv asking stakeholders to volunteer to be on a sub-committee to
review and give input to the committee. We have about 12 volunteers to date. There has
been data pulled on some technology arenas . Once we get someone to coordinate some
dates and times we are ready to move forward.

Dan Rubin updated the commission on the work the Business Practice Committee has
done.
March 19, 2015 the committee mapped a plan for arriving at the point of
identifying high-level action options in key areas (trial balloons) by the planned
April 30 meeting (1) staffing and workload, (2) performance metrics and quotas;
and (3) breaks.
March 30, 2015 Steve Anderson presented an overview of other states regulations
related to the environment/space for clinical services. Gordon MacDonald also
presented on the most frequent issues that arise in inspections, and the committee
had a preliminary discussion of some issues related to the commissions planned
exploration of whether to move toward a Notice of Deficiency/Plan of Correction
approach to inspections . Dan Rubin provided an overview of the stronger published
research literature brought to the committees attention in relation to its scope, with
focus on a couple of literature reviews and those sources using endpoints related to
quality and safety. There is meaningful evidence that high workload, interruptions,
distractions and inadequate lighting increase occurrence of dispensing errors .
April 15, 2015 Joseph Clifton and Sarah Butterbaugh presented a slightly updated
version of the presentation on prescription transfer incentives that a group of UW
PharmD students originally presented to the commission.
Chris Humberson distributed a compendium of the most relevant current

Washington rule (WAC) sections, and these will be cited and attached as relevant to
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each issue assessment.
Steve Anderson also very briefly summarized the range of other states rules related
to Quality Improvement, Assurance and Control.
Nursing/Pharmacy Taskforce Update re: Students Access to Automated Drug Distribution

Devices
Cathy Williams updated the commission on the Nursing Taskforce. There were 8 out of 50
Pharmacy Boards shared that they did not prevent access to nursing students. We are
looking for more input from the stakeholders. The next Taskforce meeting is May 13 and
the nursing commission will summarize the information they gathered from the four
questions they sent out.
Long-Term Care Pharmacy Workgroup Update

Chris Humberson led the update to the commission.
Electronic storage of orders -The discussion revolved around how prescription

information sent from the nursing facility to the long term care pharmacy was
stored at the pharmacy location.
Electronic signatures of orders/verification issues-The concern regarding how these

orders are signed and verified by the pharmacist and the process or such. Most
physicians do not visit a facility but every thirty days per CMS and thus may be
signing orders/prescriptions at that time.
Nurses/agents faxing prescription orders/prescriptions -Discussion of the standard

of practice of sending orders with multiple medications via a fax machine rather
than sending as a prescription that meets all the elements of a prescription.
Prescriptions verses orders in closed door setting -Discussion of how settings are
different and that long term care pharmacy operations are more like a hospital than
a retail pharmacy operation since they accept no walk in clientele .
NABP Model rules on LTC pharmacy operations -Discussion around the adoption
of the NABP model rules and the determinations that they reached about LTC
practice of pharmacy.
Faxing of orders and prescriptions -A major concern of stakeholders, who believe

that in a LTC setting that processing orders is no different than a hospital setting
and that to compare to a retail pharmacy operation is not accurate.
E-RX verses CPOE - prescriptions not in patients hands.
Proposed Resolutions
Christopher Humberson led the discussion with the commission on their position regarding
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resolutions for consideration at the 111 Annual NABP Meeting on May 16-19.
Submitted by District 1
Resolution #1 Draft Resolution for Technicians (Co-supported by District 2)
WHEREAS, the pharmacists scope of responsibility is expanding and should be
expanded further to ensure the provision of current and additional patient care services
surrounding medication therapy and
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WHEREAS, technicians assist in the practice of pharmacy and, under the supervision
of a pharmacist, can perform prescription entry and validation tasks that would further
assist the pharmacist and
WHEREAS, the current education of technicians in relation to this expanded role has
not been determined
THEREFORE BE IT RESOLVED that NABP work with PTCB and other
stakeholders to study the current status of technician education and what future
educational processes and requirements that may be needed to support the expanded role
and regulation of technicians assisting in the practice of pharmacy.
MOTION: Chris Barry moved that the commission support this resolution. Tim Lynch
Resolution #2 Pharmacist Use of the Prescription Drug Monitoring Program (MA)
(Co-supported by Districts 2 & 4)
WHEREAS prescription drug abuse is the fastest growing drug problem in the
United States,
WHEREAS the unintentional drug overdose death rates in recent years has been
driven by increased use of opioid analgesics,
WHEREAS the pharmacist is often the last line of defense in preventing
prescription drug abuse,
THEREFORE BE I T RESOLVED that National Association of Boards of
Pharmacy (NABP) encourage state boards of pharmacy to educate pharmacists on the
use of the prescription drug monitoring program (PMP) and to develop best
practices to guide pharmacists when to access the PMP to include when a pharmacist
becomes aware of a person currently, including but not limited to the following;
(1) Receiving controlled substances from multiple prescribers;
(2) Receiving controlled substances for more than twelve consecutive w e eks;
(3) Abusing or misusing controlled substances (i.e. over-utilization, early refills,
appears overly sedated or intoxicated upon presenting a prescription for a
controlled substance, or an unfamiliar patient requesting a controlled substance
by specific name, str e e t name, color, or identifying marks);
(4) Requesting the dispensing of controlled substances from a prescription issu e d
by a prescriber with whom the pharmacist is unfamiliar (i.e. prescriber is located
out-of-state or
prescriber is outside the usual pharmacy geographic prescriber care area); or
(5) Presenting a prescription or controlled substances w hen the patient resid es
outside the usual pharmacy geographic patient population.
THEREFORE IT BE FURTHER RESOLVED that NABP collaborate with the

appropriate s takeholders to facilitate pharm acist access to PMP data and
seam lessly integrate P MP data in pharmacy workflow.
Resolution #3 Prescriber Use of the Prescription Monitoring Program (MA)
(Co-Supported by Districts 2 & 4)
WHEREAS prescription drug abuse is the fastest growing drug problem in the
United States,
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WHEREAS the unintentional drug overdose death rates in recent years has been
driven by increased use of opioid analgesics,
WHEREAS the prescriber is often the first line of defense in preventing
prescription drug abuse,
THEREFORE BE I T RESOLVED that National Association of Boards of
Pharmacy (NABP) work with The Federation of State Medical Boards (FSMB) and
prescriber stakeholders groups to educate prescribers about Prescription Drug
M onitoring Programs (PMP) and encourage the adoption of legislation/regulations
requiring the prescriber to access the PMP prior to the issuance and authorization of
a controlled substance prescriptions to a patient for the first tim e.
Resolution #1 (NJ) (Co-supported by District 1)
WHEREAS, by 2030 there will be 75 million people over the age of 65 which is a 40%
increase over current population; and
WHEREAS, there is a critical shortage of primary care practitioners in our country; and
WHEREAS, pharmacists are the most accessible health care professionals and
providers in the community;
THEREFORE BE IT RESOLVED that NABP convenes a taskforce with other key
healthcare stakeholders to explore the feasibility and practicality of granting pharmacists
limited prescriptive authority to meet patient needs.
Resolution #2- (NJ) (Co-supported by District 1)
WHEREAS, by 2030 there will be 75 million people over the age of 65 which is a 40%
increase over current population; and
WHEREAS, there is a critical shortage of primary care practitioners in our country; and
WHEREAS, pharmacists are the most accessible health care professionals and
providers in the community;
THEREFORE BE IT RESOLVED that NABP collaborate with interested
stakeholders to develop an informational program to educate the public and other health
care professionals about the role of pharmacists in the health care continuum, including
information on pharmacist care services such as medication therapy management,
counseling on prescription drug usage, and providing immunizations.
Resolution #1 Draft Resolution for Technicians
WHEREAS, the pharmacists scope of responsibility is expanding and should be
expanded further to ensure the provision of current and additional patient care services
surrounding medication therapy and
WHEREAS, technicians assist in the practice of pharmacy and, under the supervision
of a pharmacist, can perform prescription entry and validation tasks that would further
assist the pharmacist and
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WHEREAS, the current education of technicians in relation to this expanded role has
not been determined
THEREFORE BE IT RESOLVED that NABP work with PTAC and other
stakeholders to study the current status of technician education and what future
educational processes and requirements that may be needed to support the expanded role
and regulation of technicians assisting in the practice of pharmacy.
Resolution #2
WHEREAS Congress has enacted the Drug Quality and Security Act;
WHEREAS certain portions of the Compounding Quality Act remain unclear;
THEREFORE, BE IT RESOLVED that NABP update model law accordingly and
collaborate with the FDA to clarify conflicting and/or ambiguous language.
MOTION: Chris Barry moved that the commission does not support this resolution. Tim
Resolution #3
WHEREAS Drug Supply Chain Security Act substantially changes wholesale
distribution law, including certain preemption of state law and changes in licensure;
WHEREAS the Act becomes effective periodically over the next decade;
WHEREAS the Act requires regulation promulgation periodically over the next decade;
THEREFORE, BE IT RESOLVED that NABP update model law until all provisions
of the
Act and its regulations have become effective.
THEREFORE, BE IT FURTHER RESOLVED that NABP provide public comment
during regulation promulgation as necessary.
PENDING - Resolution #1 Ensure Public Confidence in NABP and its Member
Pharmacy Boards (MN)
WHEREAS, NABP is an independent, impartial professional organization that supports
and assists its member state boards of pharmacy in protecting the public health;
WHEREAS, a primary mission of NABP's member pharmacy boards is to protect the
public by licensing, regulating, and when necessary, disciplining individuals and entities
licensed and regulated by member pharmacy boards; and
WHEREAS, to ensure public confidence that NABP and its member pharmacy boards
are free from an appearance of conflict of interest or bias in the execution of their duties
that may be created by sponsorships, grants and other financial support at NABP annual
meetings by individuals and entities who are licensed and regulated by member
pharmacy boards;
THEREFORE BE IT RESOLVED, that NABP will not accept sponsorships, grants or
other financial support for any event or activities at NABP's annual meetings from
individuals and entities who are licensed or regulated by member pharmacy boards.
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Resolution #1 (Co-supported by District 7 & 8)
WHEREAS there is a national and state movement to obtain provider status for
pharmacists; WHEREAS provider status is important to the advancement of the
pharmacy profession;
THEREFORE BE IT RESOLVED that NABP follow/adopt APhA provider status
model THEREFORE BE IT RESOLVED that NABP work collaboratively with
APhA and other pharmacy organizations to have a cohesive message to driver provider
status recognition nationally; Therefore be it further resolved that NABP develop a task
force to create model act language to assist boards in oversight and regulation of
independent providers in pharmacy practice.
MOTION: Chris Barry moved that the commission does not support this resolution. Tim
Resolution #2 (Co-supported by District 7)
WHEREAS there is diversity among states regarding pre-licensure experience
requirements;
WHEREAS this diversity in pre-licensure experience requirements may negatively
impact new graduates seeking licensure in states other than where they graduated from;
THEREFORE BE IT RESOLVED that NABP encourages states to accept ACPE
accredited pre-licensure experience as satisfying preliminary licensure requirements;
THEREFORE BE IT ALSO RESOLVED that NABP encourages states to adopt the
use of a centralized NABP database to confirm graduation of new graduates.
Resolution #1 (ID) (Co-supported by Districts 6 & 8)
WHEREAS Congress has enacted the Drug Quality and Security Act; WHEREAS
certain portions of the Compounding Quality Act remain unclear; THEREFORE, BE
IT RESOLVED that NABP convene a task force to update model law accordingly and
to collaborate with the FDA to clarify conflicting and/or ambiguous language.
Resolution #2 (ID) (Co-supported by Districts 6 & 8)
WHEREAS Drug Supply Chain Security Act substantially changes wholesale
distribution law, including certain preemption of state law and changes in licensure;
WHEREAS the Act becomes effective periodically over the next decade;
WHEREAS the Act requires regulation promulgation periodically over the next decade;
THEREFORE, BE IT RESOLVED that NABP convene an ongoing task force to
update model law until all provisions of the Act and its regulations have become
effective.
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THEREFORE, BE IT FURTHER RESOLVED that the task force provide public

comment during regulation promulgation as necessary.
Submitted by Minnesota
PENDING Ensure Public Confidence in NABP and its Member Pharmacy Boards
WHEREAS, NABP is an independent, impartial professional organization supporting
and assisting its member state boards of pharmacy in protecting the public health; and
WHEREAS, a primary purpose of NABP's member pharmacy boards is to protect the
public by licensing, regulating, and when necessary, disciplining individuals and entities
licensed and regulated by member pharmacy boards; and
WHEREAS, NABP and its member pharmacy boards are vigilant of the obligation to
be free from conflicts and the appearance of conflicts of interest or bias in the execution
of their assistance and duties, respectively; and
WHEREAS, sponsorships, grants and other financial support at NABP annual meetings
by individuals and entities who are licensed and regulated by member pharmacy boards
could be interpreted as a conflict or the perception of a conflict of interest despite the
fact that the support is in the form of unrestricted grants and appropriately overseen both
by internal controls and the approval of NABP as a provider of continuing pharmacy
education by the Accreditation Council of Pharmacy Education (ACPE);
THEREFORE BE IT RESOLVED, that NABP commission a task force to review the
present practice and policies for accepting sponsorships and grants for the Annual
Meeting and provide recommendations to the NABP Executive Committee to replace
such sponsorships and grants with other means of support in order to continue to
maintain the high quality of the Annual Meeting as well as NABPs objectivity and
unbiased presentations and activities at the Annual Meeting.
PRESENTATIONS
Jefferson Hospital
Lisa Roberts introduced Lanny Turay the Pharmacy Director for Jefferson Hospital . He is
here to provide a presentation to the commission asking for approval for Jefferson
Hospitals remote medication order processing.
Background:
Jefferson Hospital (Jefferson Healthcare) is a critical access hospital located in Port

Townsend, Washington.
25 critical access bed hospital they see about 15 patients a day.

2.4 pharmacists a week.
Jefferson Hospital Pharmacy is open Monday through Friday 0630 to 1800 and
0730 to 1630 weekends and holidays.
They currently utilize CPOE with EPIC software .

They are currently using Medication Review as their outside pharmacy vendor and
have been doing so for approximately two years .
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The pharmacys policies and procedures are in accordance with the WA State
Pharmacy Quality Assurance Commissions current guidelines.
During a recent hospital pharmacy inspection, it was discovered that this pharmacy
was utilizing remote order processing but did not have Pharmacy Commission
approval for Remote Processing of Medication Orders .
MOTION: Chris Barry moved that the commission approve Jefferson Hospitals remote
medication order processing services, Medication Review. Elizabeth Jensen second.
DISCUSSION
Pass Assured
Irina Tiginyanu introduced David Dubose, President and CEO of Pass Assured On-line
technician training program asked the commission for approval of his program.
PassAssured Program Structure
300 Hours of course content

Self-paced instruction for high school seniors or adults
Teacher facilitates
Tutor when necessary
Encourages completion
Delivery formats
Class within a class
Self-contained
Independent study
Distance learning
PassAssured Program Capabilities
Online course content:
Organized:
Addendums:
Contains: Pronunciations of Brand/Generic Drug Names, Drug Images/PAs Top

200 Drugs/Classifications/Drug Use
Testing System:
1,000+ questions
Random Test Generation
Videos and Learn Files (text) Course content caters to the visual and audio type
learners
There are six sections with forty-four subsections (Medical Review Section is
organized by classifications of drugs.)
Study Aids, Interview, Effective Communication, HIPAA Regulations, Virtual Rx
Electronic flash cards (Study Aids)
5 Levels:
Subsection Quiz
Section Test
Tutored Exam
Final Exam
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Exit Exam
Separate 1,000 question test bank

Educator must give student access
125 Questions
3 Hour Time Limit
Once accessed, must complete Automated grade book / Student progress

monitored by Facilitator
All Tests Retrievable for review via ECP

PassAssureds PTTP
All Future Technicians must also complete

WA State Pharmacy law
Aids / HIV
MOTION: Dan Rubin moved to reject as a stand-alone program but approves this as a
potential didactic training. Chris Barry second.
Dan Rubin rescinded his motion.
MOTION: Dan Rubin moved that the commission reject as an all-encompassing

pharmacy technician training program but may be used in conjunction with an approved
pharmacy technician program that includes pharmacist oversight. Elizabeth Jensen second.
Maureen Sparks recused herself. Chris Barry abstained. Steve Anderson and Sepi
Soleimanpour opposed. MOTION CARRIED: 5-2.
CONSENT AGENDA
b) International Academy of Merchandising and Design dba SanfordBrown College
Elizabeth Jensen asked if this can be approved with no pharmacy manager. They are
opening up a new school that is why there is no pharmacy manager.
MOTION: Elizabeth Jensen moved that the commission deny this Pharmacy Tech
Program they can come back when they have a pharmacy manager. Chris Barry second..
c) Rite Aid renewal
Elizabeth Jensen was concerned about a question and answer on a form about licensure.
MOTION: Elizabeth Jensen moved that the commission approve the Rite Aid Pharmacy
Tech Program. Maureen Sparks second. MOTION CARRIED: 9-0.
d) Walgreens renewal
The training portion was missing in the documents submitted by the pharmacy consultant
to the commission. The documents were retrieved so the commission executive director
could review could review and provide further information to the commission.
MOTION: Steve Anderson moved that the commission approve the Walgreen Tech
Program. Tim Lynch second. Sepi Soleimanpour recused herself. MOTION CARRIED:
8-0.
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f) Island Drug
There was not an initial effective date given to Island Drug and the commission was asked
to back date the effective date by the pharmacist consultant.
MOTION: Chris Barry moved that the commission approve Island Drug Pharmacy Tech
Training Program effective as of today. Steve Anderson second. MOTION CARRIED:
9-0.
Route of Licensure for Foreign Trained Pharmacist completing Non-traditional PharmD program.
This was tabled until the June 2015 meeting.
Correspondence
The commission discussed correspondence received or distributed
a. Prescription Pricing Letter from Consumer
b. Need for Broader Access to Pharmacy Services Letter from
Consumer/Practitioner
c. DEA News Release Fentanyl Alert
d. CNEWS Council on Nursing Education in Washington State = Nursing
Students Access to Automated Drug Dispensing Devices (ADDDs)/
e. Swedish Medical Center support student nurses access to ADDDs
f. Long-term Care Workshop Stakeholder comment
g. CTG, Inc. Compliance to Pharmacy Compounding Regulations and
Standards
h. NABP Mailbag April 2015
STATUS REPORTS
PeaceHealth Southwest Medical Center
Cathy Williams shared some background the written document provided by Victoria Tamis
who was unable to attend the meeting. PeaceHealth was asked to provide a letter with the
data the commission asked for after they were given approval for their specialized
function: Technicians checking the work of other technicians in stocking emergency
medication boxes/trays and automated dispensing cabinets .
Assessment/Data and Outcomes:
We had 16 technicians that started the process for ADC checking. All completed
the didactic training between April 24th and July 3rd, 2014. All passed the initial
written examination with a score of 93% or greater. One technician failed the first
attempt at finding the 3 errors hidden in the fill. The technician subsequently passed
the following attempts successfully.
The program had to be discontinued for a timeframe when the pharmacy resident
had departed the organization and pharmacy management was transitioning.
Pharmacists resumed checking the ADC and box fills during that time frame until
the monthly checks were completed. When the program was resumed, all
subsequent monthly and quarterly check resulted in 100% accuracy.
We had three technicians that completed the code tray and box checking process .
They each received an additional 8 hours of didactic learning. All passed the
written exam with a result of 90.5% or greater. They then had to check 10 trays or
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boxes to find 3 errors in the trays or boxes. The three technicians then had trays
checked by a pharmacist for accuracy. The monthly fill had an expected accuracy
of greater than 99%. Three initial monthly tray and box 'fills" were required. After
this, the trays and boxes are checked quarterly. All fills, trays and boxes that were
checked by the pharmacist were completed at a 100% accuracy rate.
Hours the project freed up pharmacists to perform other patient care:
There are 13 ADC fills per day that require approximately 15 minutes per fill to
check; hourly stock outs require approximately 5 minutes to check. Checking of
these fills require approximately 315 minutes or 5 hours and 15 minutes to
complete daily.
There are approximate 15 anesthesia trays that are checked daily utilizing the tech
check tech program; time to complete the checks is approximately two minutes per
tray. There are approximately three Rapid Sequence Intubation (RSI) boxes that
require checking daily; time to complete is approximately four minutes per box.
Time spent per day is about 42 minutes to check trays and boxes.
It is estimated that the pharmacy department is saving nearly six hours per day in
pharmacist time having the technicians check each other. This adds up to over one
full time pharmacist over the past year (2190 hours). We have reallocated
pharmacist staff in the department over the past several months to provide an
additional transitional care pharmacist service to address medication education
issues and access to mediations on discharge. This service has been very well
accepted by hospital administration and providers . Central distribution pharmacists
are spending more time managing medication protocols that do not require a
decentralized presence to manage.
Lessons learned from staff and supervision:
We have learned that technicians that complete these tasks on a daily basis can be
more efficient than pharmacists that rotate through distributive functions and are
subject to multiple interruptions for drug information needs . Drug shortages and
inventory issues for the products in the ADCs, trays and boxes are addressed more
completely. The technicians work directly with the pharmacy purchasing team to
manage inventory; pharmacists are only interrupted for unresolvable concerns
related to utilizing alternate medications. Technicians are having more of an impact
on patient care and the feel more empowered as a caregiver.
Report Back for Othello Hospital

Cathy Williams introduced Cliff Richards, responsible pharmacy manager for Othello
Hospital. He presented via teleconference to report back the use of remote medication
order processing services by Medication Review to the commission.
Cliff shared data on the medication refill/restock requests for first six months of use.
1305 medications were reviewed

Technicians were remotely monitored on 48 different days, the other days
pharmacist was working.
No errors filling the machine

14 items were marked as deficient
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Average time for Medication Review pharmacist to review the ADDD refill
contents is 18.8
This has been a great and has enhanced the ability to get patients medication in a
timely manner
Scanning Function is required

Input from technician and Medication Review is going well and is still being finetuned.
MOTION: Tim Lynch moved that the commission approve the continuation of the
demonstration project . Elizabeth Jensen second. Chris Barry recused himself. MOTION
CARRIED: 8-0.
OPEN FORUM


Approved June 11, 2015
Al Linggi, Chair
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STATE OF WASHINGTON

MEETING AGENDA
April 12, 2007
Point Plaza East Rooms 152-153
310 Israel Road
Tumwater WA 98501
CONVENE
Chair Rebecca Hille convened the meeting at 9:00 a.m. on April 12, 2007
Gary Harris, RPh Vice Chair
George Roe, RPh
Rosemarie Duffy, RN
Dan Connolly , RPh
Jim Doll, Pharmacist Investigator
Cheryl Christensen, Office Assistant 3
Guest present:
Andrew Bennett, WSU Pharmacist Extern
Andy Fernando, DOH Regulatory Affairs Manager
Karl Hohen, HPQA Legal Services Manager
Laurie Jinkins, Assistant Secretary
Bonnie King, HPQA Director
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RULES HEARING DELIBERATIONS

The Board continued its deliberation regarding the proposed rules for Pharmacists Professional
Responsibilities WAC 246-863-095 and Pharmacies Responsibilities WAC 246-869-010. The
Board did not take public comments or answer questions from the audience during this agenda
item.
Lisa Salmi provided background on the Boards activity to date regarding the proposed rules.
She stated that the Board heard testimony from 91 stakeholders and the public at the rules
hearing on March 29, 2007. Of the testimony, 46 supported the rules as written and 45 opposed .
The intent of the proposed rules is to promote patient safety and access to health care by
emphasizing pharmacist and pharmacies responsibilities . On March 30, the Board met and
discussed the testimony and supporting documents . The Board directed staff to make changes to
the Small Business Economic Impact Statement (SBEIS) and Significant Analysis (SA).
Rebecca Hille read the vision and mission statements of the Board . The Board confirmed receipt
and review of the revised SBEIS and SA. The Board confirmed receipt and review of all
materials from the rules hearings. Board members Gary Harris and Vandana Slatter, who were
not present during the hearing or deliberation on March 30, confirmed that they have reviewed
all materials and have no questions at this time.
Tim Fuller summarized the changes made to the SBEIS, a directed by the Board. Mr. Fullers
presentation was followed by Andy Fernandos summary of changes to the Significant Analysis.
Changes requested by the Board consisted of clarifying the explanation of potential costs and
benefits in both documents.
Gary Harris confirmed, as stated in the SA, that the rules are needed to minimize barriers to
health care and to reduce risks for a patients health when there may be an emergent need for a
prescribed drug or device or a timely preventative use is essential to drug efficacy.
Madame Chair Hille asked if there is a consensus among the Board that the changes and
information contained in the SBEIS and SA meet the direction of the Board. All agreed.
Following the approval of the SBEIS and the SA the Board was asked to discuss the proposed
rule language.
Dan Connolly expressed the challenges and thoughtful work that went into crafting these rules,
and acknowledges that it is difficult to craft rules that would satisfy all parties. He went on to
state that the Board represents the people of the state of Washington and is charged with
protecting their health and safety and ensure access to health care. The proposed rules will meet
this requirement. George Roe concurred.
Vandana Slatter stated that this is a very complex issue and wished to acknowledge the
compassion and commitment of the citizens of Washington in their active participation/interest
in their health care.
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Susan Teil Boyer acknowledges that it has been a difficult process, but also felt the proposed
rules were well crafted and protecting patients is what the Board does. Ms. Teil-Boyer stated
that the first line of WAC 246-863- 095 is the key statement a pharmacist s primary
responsibility is to ensure patients receive safe and appropriate medication therapy. She stated
that pharmacists will need to adjust to this rule.
Gary Harris stated that the Board members have read a tremendous amount of information and
stakeholder input over the past sixteen months related to these rules. Mr. Harris declared that the
Board has made a good effort to draft the best rule it can.
Mr. Harris also stated that it is not the intent of the Board or the rule to expect every pharmacy to
stock every drug , in every strength, for every medical condition. There are many options
available in this new rule that would allow a pharmacist to provide service to patients.
Rosemarie Duffy also acknowledged how challenging this process was and commended the
Board for its professionalism and staff for their work.
ACTION: Gary Harris moved that the Board accept WAC 246-863-095 Pharmacists
Professional Responsibilities as it is currently amended. George Roe second. MOTION
CARRIED 6-0.
ACTION: George Roe moved that the Board accept WAC 246-869-010 Pharmacies
Responsibilities . Vandana Slatter second. MOTION CARRIED 6-0.
The adopted rules will become effective 31 days after filing with the Code Revisers office.
anticipated effective date is mid-June and all interested parties will be notified .
The
CONSENT AGENDA
1.2
Pharmaceutical Firms New and Closed 2/11/07-3/13/07

Lake Chelan Community Hospital
1.4
Coulee Community Hospital

TLC Integrative Pharmacy
Republic Drug Store
Shiraz Specialty Pharmacy
Toledo Pharmacy
University of Medicine of Pharmacy Bucuresti Romania
Ionela Todoran
Apollo College - Bosie ID
Jennifer Benger
Western Career College Emeryville CA Maninder Kaur
Allied College St Louis MO Melissa Fagan
University of Montana-Missoula Shannon Beadle
San Antonio College of Medical & Dental Assistants San Antonia TX Rebecca Ortiz
San Joaquin Valley College Visalia CA Ronald K. Johnson
United Education Institute San Diego CA Joseph G. Quintella
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Pines City Colleges Baguio City Philippines - Vanelli G. Ignacio

Inpatient Medication
1.5
1.8
Virginia Mason Various

Cascade Valley Hospital/Clinics - Various
Refills/Initiating or Continuing Drug Therapy Community Health Centers Snohomish
County Various
Board Minute Approval March 1, 2007
Anticoagulation
Items 1.1 Pharmacist License Application Approval; 1.3 Pharmacy Technician Application
Approval; 1.6 Automated Drug Dispensing Device Acceptance; and 1.7 Sample Distribution
Requests were deleted from the consent agenda. ACTION: George Roe moved that the Board
approve 1.2, 1.4, 1.5, and 1.8 of the consent agenda. Susan Teil-Boyer second. MOTION
CARRIED 6-0.
REPORTS
Performance Auditors continue to meet with credentialing and investigative staff and
we expect they will be in the building through April . The final report to the
legislature is due in July.
Staff continues to serve on committees to plan for the conversion to the new licensing
program, eLicense. Doreen Beebe and Janelle Teachman participated in intensive
training on the system in March. The will serve as trainers for staff members. The
implementation date of the new licensing program is February 2008.
Grace Cheung and Ms. Salmi are participating in the HSQA Organization Review
workgroups -Inspection and Compliance Workgroup and Customer Service
Workgroup, respectively. Judy Haenke, Program Manager for the Veterinary and
Optometry Boards, is on the Health Professions and Facilities Workgroup.
The Food and Drug Administration recently visited several compounding pharmacies
in the state to request voluntary samples of compounded products. The products will
be tested for sterility and to analyze the contents. We have heard that Senator
Kennedy is working on a bill to bring compounded products under stronger regulation
by the FDA and add limits to their distribution. State pharmacy boards currently
regulate compounding pharmacies at the state level. Under Senator Kennedys

proposal, primary oversight for compounded products would shift to the FDA.
Quarterly Investigator meeting was held on March 7-8. Susan Teil-Boyer represented
the Board at these meetings.
The waiver request to DEA asking permission for the PH:ARM pilot project to
collect controlled substances was sent in March. The waiver request received support
from numerous state and private agencies including the Governor, Attorney General,
Mary Selecky and the Department of Ecology. To date, there have been 2
incinerations.
The Department has granted the Board authorization to purchase new computers for
field investigators.
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Met with representatives of the DOH Trauma Program to prepare for a briefing to
Mary Selecky on strategies to reduce poisoning deaths in Washington State.
Washington State is seeing an epidemic of poisoning deaths from unintentional drug
overdoses. The high risk groups include males 35-45 years of age. Washington State
data and national data suggest the increase is due to intentional abuse of prescription
drugs, especially pain medications.
Tim Fuller and Ms. Salmi will meet with representatives of Facilities Services and
Licensing and the Executive Director of the program that administers the Health Care
Assistance Program to discuss issues concerning the scope of practice of Health Care
Assistants. Currently, HCA are only allowed to administer injectable drugs (e. g.,
vaccines and numerous other injectable meds); but not the oral ancillary medications
ordered by the provider (e.g., the Tylenol that goes with the vaccination). A Seattle
hospital has asked the Department to grant an exemption to allow Health Care
Assistants to administer oral meds as well .
Stakeholder work will begin soon on establishing rules for pharmaceutical services in
correctional facilities.
Currently recruiting for four positions; credentialing manager, support staff for
discipline, pharmacy investigator, and the Executive Director. The application
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deadline for the Executive Director position is April 30 .
The NABP Annual Meeting will be held May 19-22 in Portland, Oregon. Susan TeilBoyer, Gary Harris, Rebecca Hille and George Roe will represent the Board. Doreen
Beebe, the investigative staff and Ms. Salmi will also attend.
Tim Fuller, Jim Doll and Ms. Salmi will be participating in this year's Strategic
National Stockpile Reception Storage and Staging annual full-scale exercise
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(WASABE 9 2007) on October 30 in Spokane.
Upcoming meetings: HPQA Annual Leadership Conference - May 14, Radisson

Hotel in Seattle; HPQA Annual Board/Commission and Committee Conference
September 27-28, Renton Holiday Inn in Renton; Citizen Advocacy Center Meeting
October 31-November 2, Edgewater Hotel in Seattle.
.
Board Member Reports:
George Roe accompanied Jim Doll on an inspection of the Yakima Valley Farm Workers
Clinic Call center. (Representatives of YVFWC were unable to attend. this agenda
report has been deferred to a future meeting. )
Commented on the Washington State Pharmacy Associations webpage encouraging

patients to take an active role in their health care by helping their physicians and
pharmacists to prevent medication errors by carrying a list of their medications and to
question anything if it doesnt appear right.

Susan Teil-Boyer spoke briefly about medication reconciliations a new requirement by
the Joint Commission on Accreditation of Health Care Organizations and Hospitals.
Ms. Teil-Boyer attended the quarterly Investigators Meeting held in March. She
congratulated the Investigators and the Chief Investigator for their great work!
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Gary Harris commented on the March 1 stakeholder meeting regarding SOMA and his
role as Board sponsor.
Joyce Roper updated the status of the Ongom Case regarding the standard of evidence in
health practitioners disciplinary cases. A petition for review of the Washington s court
ruling has been filed with the US Supreme Court. The Association of Nursing Boards and
a patient advocacy group have signed on to the petition as amicus curiae (friends of the
court) which may increase the chances the court will review the lower court s ruling. The
Federation of State Medical Boards and CLEAR may sign onto the petition as well.
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Deadline for amicus curiae petitions is April 18 .
Consultant/Investigator Pharmacists
Activities of Washington State University Pharmacy Extern Andrew Bennett. Mr.

Bennett is in his third week and has been in the field conducting inspections, case
management team meetings and various other functions.
Mr. Mecca will be holding an electronic stakeholder comment period regarding the
petition for rulemaking requesting the placement of carisoprodol in schedule IV of the
Uniformed Controlled Substance Act. He will update the Board on the comments
received at the May meeting.
Attended the Washington State Patient Safety Coalition Conference held at SeaTac on
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March 22 . The keynote speaker was Don Berwick, the co-founder and CEO of the
Institute for Healthcare Improvement, which has the 5 Million Lives campaign. Topics
included patients perspective of medication errors, systems approach to medication
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error, etc. On April 5 attended a meeting regarding the Opioid Guidelines for chronic
and ongoing pain management. Guidelines are written and they are starting an
educational pilot program to get information out.
He confirmed with Buck Stevens of PDX-Rx systems that faxing a copy of the original
prescription will meet the Boards intent that the central fill final check pharmacist has
the ability to view an image of the prescription .
Mr. Fuller indicated that the Emergency Response Strategic National Stockpile is
planning its first full scale exercise to be held in Eastern Washington in Spokane. He
acknowledged that there will be challenges in terms of logistics and recruiting volunteers .
Mr. Fuller shared that he recently visited the Bellegrove/Stilliguamish tribe telepharmacy
operation. He indicated that the video transmission satellite systems they were using is
inadequate and will provide follow-up to the Board at a future meeting.
Chief Investigator
Grace Cheung distributed copies of the Chief Investigators report which highlighted
investigations and inspections for the month of February. Ms. Cheung also briefed the Board on
the failed recruitment efforts for the Central Washington Investigator. Staff has broadened the
recruitment efforts by posted notices in the Spokesman Review. The Board asked if part-time or
job sharing should be considered.
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Tim Fuller, Andy Mecca, Dick Morrison and Kelly McLean assisted with the Pharm 440
class at the University of Washington. Pharm 440 focuses on how communication
influences the pharmacist's activities in designing, delivering, and managing patientfocused pharmaceutical care e.g. smoking cessation programs.
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On March 10 , Stan Jeppesen and Andy Mecca will help out with the UW Law Class.
Staff is conducting a law book index review for the development of an electronic law book
(CD).
Investigators Meetings
June 6/7 Dan Connolly
September 12/13 George Roe
December 5/6 Vandana Slatter
Due to workload challenges Board Investigators will decline doing the Consumer Safety
Product inspections.
Ms. Cheung acknowledged Lisa Salmi for negotiating funds for new equipment for the
investigators and approval to attend the NABP annual conference.
Program Manager
Attended Train the Trainer training the 3 rd week of March for eLicensing.
The
implementation is planned for early 2008 and will show multiple credentials on one
screen. It should be helpful with our restructure.
The Office Assistant 3 position has been filled by Cheryl Christensen, who transferred
from the Department of Social and Health Services.
EXECUTIVE SESSION
The Board adjourned at 12:00 p.m . for the Executive Session to discuss personnel issues and
pending litigation.
The Board reconvened at 1:05 p.m. for Presentations and Discussions.
PRESENTATIONS
Presentation of the Secretary of Healths Sanction Guidelines.
PowerPoint and handouts

facilitated by Karl Hoehn, Health Prof Sec 2, HSQA. Mr. Hoehn indicated that the Secretary
adopted the guidelines on May 31, 2006 for use in the professions she regulates. Mr. Hoehn
stated public protection is paramount consideration for the guidelines which provide framework
for discipline with consistency and ensures connection between the conduct and sanction. The
guidelines involve 5 steps which include 7 categories of conduct. If more that one conduct is
under review, they are prioritized with the additional charges as aggravating. We are largely
compliant with the guidelines already. ACTION: Vandana Slatter moved that the Board adopt
the guidelines with the understanding that it is still in the development process. Dan Connolly
second. MOTION CARRIED 6-0.
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Board Goals
2007/2009.
Tim Fuller provided an overview of the Current Rules Workload.
Complete Rule Process for the Top Five Rule Priorities

Correctional Facilities stakeholder meetings should begin to occur within the next 6
weeks
Pharmacy Technician National Standardized Examination will need to revamp the

technician education. Susan Teil-Boyer and Rosemarie Duffy volunteered themselves as
sponsors.
Precursor Suspicious Transaction
Update Wholesaler Rules the regulations need to be looked at and may require
legislation. Per Andy Mecca, with SOMA and Correctional Facilities, probably fall at
the earliest (or early next year). Pedigree need AAG opinion on whether we have
authority to require electronic pedigree -- (federal authorized distributor of record
other areas in our regulations that needs to be further flushed out security, storage etc).
Update Animal Control Agency and Humane Society Rules Doreen Beebe stated the
guidelines have been drafted but have not been distributed to stakeholders yet. There will
be a review in July 2007.
Increase Communication & Awareness to the Profession and Public

Acknowledge Boards Accomplishments
has been pushed back to July 2007.
Add SOMA to CSA the next step is electronic stakeholder meetings and will report
back at next Board meeting.
Communicate Boards Mission & Vision

Frequently Asked Questions
For Public Safety Retaining Pharmacist Investigators
Establish Continuing Education Credit for Attending Board Meetings

Communicate Information via Email to Washington Pharmacists
Reorganization/Restructure. Laurie Jinkins, Assistant Secretary of Health Systems Quality

Assurance, distributed a current organizational chart which includes the following offices:
Facilities and Services Licensing
over 7,000 facilities

Emergency Medical Services & Trauma System Access to Trauma care system
throughout the state of Washington and injury prevention
Community and Rural Health
recruit Healthcare practitioners in rural areas hospitals

Health Professions Quality Assurance Health Professions 57 professions regulated by
DOH or in combination with Boards and Commissions 2007 Legislation will create 3
new professions
Ms. Jinkins continued to explain that in December 2005 the division undertook a Strategic Plan
to address concerns by the public and legislators on how responsive we are and if we are
structured in a way best to ensure safe and appropriate healthcare; and improving public
confidence. The plan s priorities are:
The development of a single complaint process

Establishing common business practices throughout the department
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Enhancing data management

Utilizing technology and enhancing/updating our data and systems
Improving workforce diversity, competency and satisfaction
Under the Office of the Assistant Secretary, five new functional offices have been proposed:
Inspection and Compliance to include investigators and inspectors for more consistency
and a systems based approach to workload management
Legal Services
wont change very much, remain similar to current

Customer Service initial point of contact public/credential holder contact .
Community Health Systems to include EMS & Trauma and Community and Rural
Health - Office designed to link communities with the health care they need, ensuring
access.
Health Professions and Facilities Support for Boards and Commissions, rules
development and education of practitioners prevention oriented.
The Office of the Assistant Secretary anticipates additions of a Human Resource Workforce
Analyst and Communications Consultant. Anticipated implementation in the Fall 2007.
Board members expressed their belief that maintaining expertise in the field investigators is
critical in achieving the goals of the Board through inspections, investigations and providing
technical assistance to the profession.
Ms. Jinkins indicated that she would not anticipate that non-pharmacists would be doing
inspections or pharmacy related investigations unless appropriate. Ms. Jinkins invited Board
members to either call or email her if they have any questions. She also mentioned the RIP
(Rumors In Progress) page on the DOH website; which is updated weekly in efforts to keep lines
of communication open and transparent.
Bonnie King, Director of Health Professions Quality Assurance, provided an update on the
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recruitment for the Executive Director position for HPS4. The recruitment closes on April 30
and interviews will be conducted mid-May. The Board will be involved in the interview process
and must confirm the Secretary s selection. Ms. King complimented Lisa Salmi on her role as
Acting Executive Director.
DISCUSSION
ESSB 6032 Medical use of marijuana - this bill looks like it will pass. The department
will have to adopt the new rules by January 1, 2008. The bill allows patients to have a 60
day supply and helps to ensure that the marijuana is received from a safe, consistent
source. However, marijuana obtained under this bill is still federally illegal.
SHB1553 - Prescription Monitoring Program this bill has died but the PMP program
has been added to the Blue Ribbon Commission bill, which is still alive, but has transfers
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the program back and forth from the Washington State Health Care Authority to the
Board of Pharmacy.
2SHB1103 contains language transferring the authority to investigate to the Secretary

this bill has died.
SHB1300 Agency Request Legislation

added.
EHB1667 Health Professions Licensing Fees this bill has changed multiple times . It
calls for a three tier fee structure based on the type of credential license/registration/certification .
HB1331/SB5485/SSB5485 - Vet technician
appears to still be alive; 2 other bills
have been
New Professions Animal massage practitioner, Dental Assistants Registration, Athletic

Trainers, and Physical Therapy Assistants

There being no further business, the Board adjourned at 4:05 p.m. The Board of Pharmacy will
meet again on May 17 18 in Vancouver, Washington.
_______________________________
Cheryl Christensen, Board Staff
_______________________________
Board of Pharmacy
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STATE OF WASHINGTON

Special Meeting Agenda
April 16, 2013
Town Center Two Room 145
111 Israel Rd SE
Tumwater WA 98501
Chair Chris Barry called the meeting to order at 9:00 a.m. on April 16, 2013. Board members present
by telephone:
Board members
By telephone:
Donna Feild, R.Ph., MBA, Vice-Chair
Elizabeth Jensen, Pharm.D.
Emma Zavala-Suarez, J.D., Public
Member
In Tumwater:
Staff/Presenters in Tumwater
Gerald Steel, PE Attorney for the Petitioners
Chris Humberson, Executive Director
Cathy Williams, Pharmacists Consultant
Open Session Business Meeting

April 16, 2013
9:00 a.m.
The Board was convened to consider a petition for rule making filed by the King County Citizens
Against Fluoridation and Washington Action for Safe Water to amend:
(a) WAC 246-883- 020(2) by changing the reference of legend drugs to prescription drugs,
because the federal law refers to prescription drugs, not legend drugs;
(b) WAC 246-883- 020 by adding the phrase, are restricted to use by practitioners only,
because the federal rules include over-the-counter (OTC) drugs, which are restricted to use by
practitioners only and those drugs should be legend or prescription drugs under
Washingtons legend drug act, chapter 69.41 RCW;
(c) WAC 246- 883-020 by incorporating a reference to WAC 246-879-010(9) because the latter
rule, which is contained in the pharmaceutical wholesaler rules, includes a reference to
prescription drugs, consistent with the FDAs rules, rather than referring to legend drugs;
and
(d) WAC 246-883- 020
by changing the conjunction and to or on the premise that the

reference to legend drugs would be changed to prescription drugs as requested in (a)
above, then the term or would reflect that the public would then have notice that the Red
Book referenced in the rule are legend drugs under chapter 69.41 RCW.
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Mr. Gerald Steel PE, attorney for the petitioners, presented materials in support of rule making and
augments in opposition of the Petition Summary, written by Joyce Roper, and provided to the board
and Mr. Steel in advance of the meeting. Ms. Roper responded to the issues brought forward in Mr.
Steel's presentation, which was followed by a period of questions and answers by the members.
ACTION: Dan Rubin moved that the board deny the petition on the basis that there is no distinction
between the term legend drugs or prescription drugs under the state and federal drug laws.
Donna Feild seconded the motion. MOTION CARRIED. Vote: 5-0.
The board also clarified that it considers the drugs restricted to practitioners only to be addressed in
current rules, which incorporates the federal Food and Drug Administration rules for drugs requiring a
prescription and the Red Book addressing drugs restricted to practitioners only.
The Board informed advised Mr. Steel that it is currently in the process of reviewing and updating all
of the Boards rules, which will include a review of WAC 246-883-020. The process for reviewing and
updating the rules will occur over the next several years. Although we cannot predict at this time when
chapter 246-883 WAC will be review, the board welcomes public comments during the review
process.
There being no further business, the board adjourned at 9:46 a.m. The Board of Pharmacy will meet
again on May 30, 2013 for its regularly scheduled business meeting in Tumwater, Washington
*****

Chris Barry, Chair

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STATE OF WASHINGTON

April 17, 2014
Mt. Constance
2400 South St.
CONVENE
Chair Christopher Barry called the meeting to order April 17, 2014.
Commission Members:
Gary Harris, RPh,
Steve Anderson, RPh
Nancy Hecox, PharmD
AL Linggi, RPh, MBA
Tim Lynch, PharmD
Guest / Presenters:
Al Carter, PharmD for Walgreens
Heidi Bragg, RPh for Cardinal Health
Andrew Albanese, PharmD for PeaceHealth
Southwest Medical Center
Marella Hopkins, RPh for Lincoln Hospital
Glenn Adams, BS Pharm, PharmD, Corporate
Director for Confluence
Nicole Eddins, PharmD for Mason General
Hospital
Staff Members:
Joyce Roper, AAG

1.2 Approval of March 6, 2014 Meeting Minutes.
1.3 Approval of April 7, 2014 Special Meeting Minutes
MOTION: Elizabeth Jensen moved that the commission approve 1.1. Maureen Sparks second.
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MOTION: Dan Rubin moved that the commission approve 1.2 with suggested changes. Tim Lynch
MOTION: Nancy Hecox moved that the commission approve 1. 3 with suggested changes. Elizabeth
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be approved
by a single motion of the Commission without separate discussion. If separate discussion is desired,
that item will be removed from the consent agenda and placed on the regular business agenda.
Jan March 2014
a. Mega Pharmacy
a. Olympic Medical Center
a. CAPS-pharmacy e-prescribing system
b. Siemens Medical Solutions
c. QS_1 Data Systems
be removed from the consent agenda and placed on the regular business agenda. Items 2.4, 2.6, 2.8 and
2.9 were deleted from the agenda.
MOTION: Dan Rubin requested to remove 2.3 (a) from the consent agenda for further discussion.
Dan Rubin moved that the commission approve items 2.1, 2.2, 2.5 (b), and 2.7. Gary Harris second.
Christopher Barry introduced Jenny Arnold Chair of the Immunization Action Coalition. Jenny Arnold
presented Nancy Hecox with a reward. Nancy was recognized for her outstanding work with vaccines.
Nancy has established with Yakima Public Health a vaccine for adults program. They provide free
vaccines for uninsured and under insured adults in their area.
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REPORTS
Commission Members
Chris Barry gave a two hour lecture to second year pharmacy students about the Washington
State Pharmacy Quality Assurance Commission.
Sepi attended a NACDS conference in March it was flattering because they proposed
pharmacists as a providers. They then met with different congressman to speak with them and
have a positive influence how to step forward as pharmacist to be providers.
Tim Lynch reported:
Tim Lynch continues to operate as Chair with ASHP section advisory group on pharmacy
practice management and moving forward with initiatives on that.
Also working with Jenny Arnold and WSPA in terms of organizing hospital leadership coming
up in May.
Elizabeth sat in on the emergency meeting on April 7, 2014.
Nancy Hecox went on a ride along with Tyler Varnum and Elizabeth Jensen to a telepharmacy
inspection it was very interesting and very eye opening.
In the process of taking a new certification course offered by the University of Florida called the
Pharmacy Regulatory Specialist. It is available online and is offered by Dave Brushwood. It is
very relative to what commission is doing here.
Al Linggi reported:
Al attended the University of Washington School of Pharmacy curriculum committee. The

committee is adopting new curricula for compounding and handling of hazardous drugs along
with a number of other things to make them more contemporary with the practice of pharmacy
today.
He was on a panel to interview nine candidates for director of customer service at Department
of Health.
Executive Director
Presented with Gordon MacDonald at New Laws new at New Rules for WSPA in Spokane on
th
April 6
Attended an FDA Intergovernmental working meeting on Compounding in Maryland March 19st

21
Attended the Oregon Pharmacy Board Planning Session on March 11
th
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Attended the Dental Commission meeting regarding Dentists prescribing for maxillofacial
surgery
Continued participation in the Compounding rules workgroup

Attended MQAC meeting on April 4
th
Participated in Lean Project 5S process for Pharmacy Commission staff

Joyce sat in for Attorney General Bob Ferguson on a National Association of Attorneys General
(NAAG) phone call with the FDA about the medication Zohydro. The FDA requested this
phone call because of the letter signed by many states Attorneys General which asked FDA to
not approve Zohydro due to concerns with its high potential for abuse. The FDA representatives
explained that the FDA approved Zohydro after making a decision that there is a medical need
for this medication, even though its advisory committee had voted against approval of this drug.
The Attorneys General, who participated in the telephone call, continued to express concern
about this non-tamperproof formulation of an extended release hydrocodone.
The Attorney Generals Office organized an E- cigarettes Workgroup after identifying that
attorneys in several divisions were addressing issues about e-cigarettes. The workgroup is
looking at the multiple issues concerning e-cigarettes, including the health and public safety
concerns about them.
Participated in two meetings of the Commission subcommittee on cdtas.

Participated in a chronic pain Webinar.
He
was Leaned in several ways.
Tim participated in a teleconference regarding the Varian electronic prescription system.

Attended the UW Katterman lecture and UW Deans
reception.
Participated in a RSS exercise of the Emergency Preparedness and Response program.
Program Manager
Doreen Beebe reported we had our first candidate that came to the Tumwater office to take the PARE
exam. Unfortunately, there were some technical difficulties the test was postponed.
CONSENT AGENDA
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b. Mega Pharmacy
There were some questions regarding the review of the consultant.
MOTION: Tim Lynch moved that the commission approve Consent Agenda Item 2.4 Mega Pharmacy
Tech Training Program. Gary Harris second. MOTION CARRIED: 11-0.
PRESENTATIONS
Christopher Humberson introduced Al Carter, Pharm.D. for Walgreens. Al presented its
electronic prescription recordkeeping system for reconsideration by the commission.
Stickerless
Overview:
Stickerless Pharmacy Environment
Virtualization: Acknowledgement of the Electronic Record as being the Official Record
All information required to be on the prescription hard copy record is now contained and
referenced on the electronic patient medication record :
Patient Information (Name, address, allergies, health conditions)

Prescription number
Directions for use as prescribed by the prescriber
All dispensing and refill information
Identification of the pharmacy team member(s) responsible for dispensing
Prescribers contact information including DEA and any special instructions

provided by prescribing physician
The physical prescription hard copy is still maintained at store level and is readily retrievable
for WA Pharmacy Quality Commission inspections and audit purposes, filed by date.
Audit/Board of Pharmacy Inspection Report
Image of hard copy prescription both front and back
Complete recap of the prescription dispensing information containing date, time,

location and identity of individual who:
Scanned Rx
Entered Rx
Data Reviewed Rx
Filled Rx
Product Review of Finished Rx
Time and Date Sold
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MOTION: Dan Rubi n moved that the commission deny Walgreens stickerless electronic
prescription recordkeeping system . The commission does not expecting retroactive change that is
creation of stickers, papers and prescription files and provide Walgreens a reasonable amount to
implement the reversion of the Stickerless program. Nancy Hecox second. Sepi Soleimanpour
recused herself . MOTION CARRIED: 8-2.
Cardinal Health
Tim Fuller introduced Heidi Bragg from Cardinal Health. Cardinal Health requested approval from the
commission of its policies and procedures to provide remote medication order entry/telepharmacy
services to interested Washington State Hospitals.
Background:
Cardinal Health has been in the remote order business for over 10 years.
Review of Cardinal Healths current policies and procedures show tremendous improvement
The Pharma cy QA Commissions Guidelines for Remote Medication Order Entry were
established in 2004 following a Cardinal Health remote order request.
from ten years ago.
The computer systems support an extensive audit trail of pharmacy order entry. A number of the
hospitals requirements are part of the remote order entry program.
The hospital is responsible for clear, accurate, and legible medication orders.
Medication documentation is kept at the hospital.
The hospital also determines medication dispensing quantities and dosage forms. The
telepharmacists work very closely with the hospital nurses to insure medication safety.
Cardinal Health has greater than 50 pages of policies and procedures that define the roles of the
telepharmacist.
Facts Bearing on the Problem:
Patient information and documents will be treated confidentially.
The telepharmacists will perform direct order entry when the hospital pharmacist is not
available.
Cardinal Health Telepharmacy will record variances including medication errors and order entry
process errors.
Each telepharmacy vendor must be licensed as a pharmacy in Washington State
The telepharmacy vendor will have adequate access to the hospital computer information
system.
Assumptions:
Cardinal Health Telepharmacy can deliver the services they describe.
Cardinal Health telepharmacists will be licensed in Washington State.
Cardinal Health Telepharmacy would establish effective collaborations with pharmacies in

hospitals
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Heidi briefly provided the commission an overview of the policy and procedures and then allowed time
for questions.
MOTION: Tim Lynch moved that the commission approve the policy and procedures from Cardinal
Health to provide remote medication order entry/telepharmacy services to Washington Hospitals. Dan
Rubin seconded. Al Linggi recused himself. MOTION CARRIED: 10-0.
PeaceHealth Southwest Medical Center

Cathy Williams introduced Andrew Albanese for PeaceHealth Southwest Medical Center. He requested
approval of policies and procedures for their pharmacy technician specialized-function program to train
technicians to check the work of other technicians stocking emergency medication boxes/trays and
automated dispensing cabinets.
Purpose
To assure that emergency medication boxes/trays and ADCs are accurately filled, verified,
and ready in a timely manner
Create a thorough ongoing QA program
Allow pharmacists to have more time to make an impact on patient medication use
Background
15 states have versions of TCT programs
Studies have shown technicians to have similar accuracy compared to pharmacists
Adams et al. review of 11 studies
Technician 99.6% 0.55% versus Pharmacist 99.3% 0.68%
Format and structure of program based on:
Approved Washington programs
Iowa TCT programs and pharmacy state law
Pharmacy Society of Wisconsin TCT Toolkit
Minimum Requirements
Minimum of 1 year of experience as a licensed pharmacy technician employed at PHSW
Successful completion of the PHSW TCT training program, competencies, and
examinations
0.6 FTE
Form 2.D TCT ADD Training Validation
Pyxis ADC Initial Validation

Pharmacist must verify technician is able to check 50 ADC medication pockets on three
separate occasions
3 errors introduced
Score of 99% required
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Documentation
Form 2.D TCT ADDD Training Validation
Pyxis ADC QA Audits
Monthly x 3 months and then quarterly quality assurance audits

At least 50% of the unit-dose medications for an ADC refill in a 24 hour period
99% accuracy requirement
Form 3.A TCT Emergency Box /Tray and ADDD Quality Assurance Documentation
Initial Verification Requirements
Trays and boxes that are filled and verified by technicians will be checked by a
pharmacist:
A pharmacist will randomly select a minimum of 10 boxes or trays checked by a
technician on 3 separate occasions within the first week after completion of the TCT
training, competencies, and examination
3 different occasions, introduction of at least 3 errors
A 99% or greater accuracy rate will be achieved
Form 1.D TCT Emergency Medication Training Validation Form
Conclusion
Evidence supports that technicians are able to accurately check medications
Our goal is to equip PHSW technicians with the skills necessary to accurately check
emergency medication boxes and trays
PHSW will implement an ongoing TCT quality assurance program Patient safety is top
priority
Allows for the redirection and optimization of pharmacist patient care services
Amended MOTION: Al Linggi moved that the commission conditionally approved the policy and
procedures for PeaceHealth Southwest Medical Centers pharmacy technician specialized-function

program to train technicians to check the work of other technicians stocking emergency medication
boxes/trays and automated dispensing cabinets as a demonstration project. They are to report back in
one year. The report back is to include data accuracy, error rate and the amount of hours the pharmacist
is freed up to provide more patient care. Maureen Sparks second. MOTION CARRIED: 10-1.
OPEN FORUM
Ajay Sinah, Director of Pharmacy for Skagit Regional Health. His concern is access to medication in
our clinics by medical assistants (MA). In our last inspection it was brought to our attention that the
MA is allowed to administer the medications but they are not to retrieve the medication from the
medication rooms. This affects the workflow of all clinics. Ajay was asking for direction regarding this
matter. The commission suggested that there needs to be changes to MA scope of practice .
8
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PRESENTATIONS Contd
Lincoln Hospital
Tim Fuller introduced Marella Hopkins, RPh from Lincoln Hospital. Lincoln Hospital asked the
commission to approve its policies and procedures for the use of Medication Reviews remote
medication order entry /telepharmacy services.
Lincoln Hospital District
25 Bed Critical Access Hospital
2003: SHMC and Larry Bettesworth
Telepharmacy - Pharmacy order entry
One pharmacist on site approximately 30 hours per week (4 days/week) and as needed on
weekends.
One surgeon on site full time
15 of our beds are Transitional Care

Busy Emergency Department
Outpatient Services
Lincoln Hospital Telepharmacy History
2009: Envision Telepharmacy
2011-Present: Medication Review Spokane, WA

Patient Safety Systems In Place
PYXIS
Located on all units in Profile Mode (units were purchased in 2003 with a grant)
Meditech EMar
Meditech Bedside Medication Verification
Meditech - Computerized Physician Order Entry in the Emergency Department
Preparing for a PYXIS upgrade as well as expansion with anesthesia units

Staffing
One part-time pharmacy technician 24 hours per week

Telepharmacy Services: General
Provide remote order entry when pharmacist not on site

Answer clinical questions of nursing staff and provide dosing calculations prn. Accessible via
phone or instant messaging.
Remote Order Entry Summary

Telepharmacy remote order entry is not an option any more
it is a necessity for our facility.

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Order entry is the first step in the line of patient safety systems we have put into place over the
years.
Without 24/7 pharmacy order entry, systems could not be utilized to their potential.
Having in house pharmacists 24/7 is not a viable alternative for us at this time.
MOTION: Dan Rubin moved that the commission approve Lincoln Hospital policies and procedures
for the use of Medication Reviews remote medication order entry and for the use of their Pyxis
machine as long as the access to the pharmacy issue gets resolved. Elizabeth Jensen second. MOTION
CARRIED: 11-0.
Confluence Health
Tim Fuller introduced Glenn Adams, Corporate Director of Pharmacy for Confluence. Mr. Adams
asked the commission to approve its policies and procedures for the use of remote medication order
entry /telepharmacy services.
The request is for Central Washington Hospital to provide Wenatchee Valley Hospital with remote
medication supervision and order entry. They will not be providing services for anyone else. Glenn
Adams provided a brief background to the commission and then allowed time for questions.
Advantages:
Internal control
Contract with PipelineRx
Operate with the same policies

Operate with the same automation
Pharmacists know the physician group

Current Remote Medication Supervision and Order Entry:
After hours
Emergency staffing needs
MOTION: Dan Rubin moved that the commission approve Central Washington Hospital to provide
Wenatchee Valley Hospital with remote medication supervision and order entry . Gary Harris second.
Mason General Hospital

Nicole Eddins, PharmD from Mason General Hospital requested approval from the commission of its
policies and procedures for the use of PipelineRxs remote medication order entry /telepharmacy
services.
Background:
10
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Located in Shelton, WA
25 Bed critical access hospital
OR, ED, MSP, Birth Center, ICU
11 ambulatory clinics
Tele-pharmacy History:
2011 with Envision
Written orders scanned in
Different systems (ED vs. inpatient)
January 13, 2014 changed to PipelineRx
100% CPOE
Fully integrated EMR
After hours dispensing:
House Supervisor is the only staff on site able to access IV room and pharmacy.
House Supervisors go through extra sterility compound training, to include media fill
tests
All medications pulled from the pharmacy require a log entry along with the copy of the
order according to WAC 246-873-050
Pharmacy has badge access readers and cameras for auditing.
Medication Errors:
Electronic error reporting tool (SafetyZone)
Communicated to Pipeline/MGH via email and conference calls
Plan of action expected to be performed within 1 week
Computer Downtime:
Written orders are faxed to Pipeline
7/24 access
Pipeline inputs orders when system comes back up
Nurses document administration after order is input
Amended MOTION: Dan Rubin moved that the commission approve Mason General Hospitals
policies and procedures for the use of PipelineRxs remote medication order entry /telepharmacy
services with the requirement that a letter is written to PQAC stating that an annual review is put in
place in their policy and procedures. Steve Anderson second.
RULE MAKING
Sterile Compounding Rules Update
Peggy Crain provided the commission some background and an update on the Sterile Compounding
Rule and went briefly went through the timeline.
11
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During the 2013 legislative session HB 1800, an act relating to compounding of medications
was adopted into law.
On May 20, 2013 a CR-101 was filed to initiate the rule making process for sterile and nonsterile compounding. Subsequent to filing the CR-101 meetings were held in June, July and
September of 2013 to obtain input from stakeholders regarding the compounding rules.
Late in 2014 the process began to develop rules for sterile compounding. An analysis was done
looking at USP and administrative rules from several other states. An internal committee
comprised of pharmacy staff and pharmacy investigators have met throughout the past few
months to develop draft rules.
Peggy asked the commission to appoint a sub-committee to assist in the Sterile Compounding Rule . It
was noted that the Compounding sub-committee was comprised of Christopher Barry, Gary Harris, and
Maureen Sparks, in addition to staff.
Electronic Communication Using Computer Systems

December 2013 Peggy came before the commission and asked approval and was granted to move
forward with the CR102 using the Expedited process. After meeting with internal policy staff it was
determined that additional language changes are needed to make the rules more understandable. This
will take the rule out of the expedited process and into the regular process of rulemaking. Peggy asked
the commission to consider opening the CR101 WAC Chapter 246-870 Electronic Transmission
Prescription Information and WAC Chapter 246-887 Uniform Controlled Substances Act using the
regular rule adoption process . After further discussion the commission decided to move forward with
the CR102.
Rulemaking Petition
The commission discussed the petition for rulemaking presented by University of Washington Students
in March to prohibit the use of financial awards or offers of other benefits for prescription transfers,
which incentivize patients to transfer prescription from one pharmacy to another .
MOTION: Dan Rubin moved that the commission deny the petition by University of Washington
Students in March to prohibit the use of financial awards or offers of other benefits for prescription
transfers, which incentivize patients to transfer prescription from one pharmacy to another . The
alternate means would be to include this issue within a broader rulemaking in pharmacy business
practices. The reason for the denial is to preserve the ability to move on a group of issues that interrelate. Nancy Hecox second. MOTION CARRIED: 10-1.
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Tramadol
Christopher Humberson led the discussion with the commission on the process to be used to develop
recommendation to add Tramadol to the list of medications tracked by the Prescription Monitoring
Program.
Procedurally the commission makes recommendation to the DOH to add drugs of concern to the PMP.
It is then the DOH that makes the changes to their PMP rules. A letter is not adequate for changing a
rule. There needs to be more research to provide data that proves this is a drug that should be added to
the PMP. The
MOTION: Nancy Hecox moved that the commission moves forward on gathering more data on
Tramadol. Maureen Sparks second. MOTION CARRIED: 11-0.
OTHER
Lists and Label Request
A panel was chosen to hear the request from Washington State Pharmacy Association to be recognized
as a professional association and educational organization to receive contact lists for pharmacists and
pharmacy technicians.
MOTION: Steve Anderson moved that the panel recognize Washington State Pharmacy Association as
a professional association and educational organization to receive contact lists for pharmacists and
pharmacy technicians. Gary Harris second. MOTION CARRIED: 6-0.

Christopher Humberson led the continued discussion and review of draft bylaws to provide a
framework for commission operations and management not covered in law or rule. After some further
discussion it was realized that the most recently updated version was not handed out. Chris will send
out the updated version and they will be re-visited in May.
Continuing Education (CE) Approval

Cathy Williams asked the commission to revisit their decision at December 2013 meeting regarding
recognition of CE approved by other state board of pharmacy in lieu of an independent review and
approval.
13
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MOTION: Dan Rubin moved that the commission rescind the motion passed at the December 2013
meeting that restricted approval of out of state CE . Steve Anderson second. MOTION CARRIED: 110.
MOTION: Tim Lynch moved that the commission rescind the motion made April 2014 and go back to
the rule regarding reviewing and approving CEs. Steve Anderson second. MOTION CARRIED: 110.
Proposed Resolutions
Christopher Humberson led the discussion with the commission on their position regarding resolutions
th
for consideration at the 110 National Association of Boards of Pharmacy Annual Meeting. May 17-20,
2014 in Phoenix, AZ.
District 2
RESOLUTION #1 Permitting Residents to Obtain Drugs from Sources outside the US
WHEREAS, Maine has enacted a law allowing residents to obtain prescription drugs from
sources outside the United States, and
WHEREAS, these drugs are not FDA-approved drugs and therefore, may not be safe and
efficacious, and
WHEREAS, pharmacies located within the United States must be licensed by their resident
Board of Pharmacy and may only dispense FDA-approved drugs, and
WHEREAS, NABP's research indicates 97 percent of the internet sites do not conform with
federal and state laws, often dispensing counterfeit drugs, and
WHEREAS, there is potential for imminent patient harm with no regulatory oversight from the
United States and accountability,
THEREFORE BE IT RESOLVED, that NABP continue its efforts in educating state policy makers
and the public in the danger of obtaining prescription drugs from sources outside of the United States
without federal and state oversight
MOTION: Elizabeth Jensen moved that the commission support this resolution. Tim Lynch second.
Dan Rubin abstained. MOTION CARRIED: 10-0.
RESOLUTION #2 Pharmacy Robberies and Thefts
WHEREAS, in recent years, there has been an increase in armed robberies and internal and
external thefts of controlled substances in pharmacies, and
WHEREAS, armed robberies have resulted in injury and death and continue to pose a
significant threat to pharmacy personnel and the public through bodily harm and the illicit use of the
stolen controlled substances, and
WHEREAS, the risk of armed robberies and thefts will potentially continue due to the national
14
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epidemic of prescription drug abuse and current economic conditions, and

WHEREAS, the Boards of Pharmacy are responsible for establishing minimum criteria for the
control and safeguards against diversion of drugs and protecting public health and safety,
THEREFORE BE IT RESOLVED that NABP establish a taskforce to review actions taken by
member boards to thwart the loss of controlled substances by armed robberies and internal and external
thefts of pharmacies and mitigate potential harm to pharmacy personnel and the public, and
recommend amendments to the minimum security standards in the Model Act, if necessary.
MOTION: Al Linggi moved that the commission support this resolution. Dan Rubin second.
RESOLUTION #3 Pharmacies Selling Tobacco Products
WHEREAS, In the United States, tobacco use is responsible for nearly 1 in 5 deaths; this equals about
443,000 early deaths each year (Source: Cancer Facts & Figures 2013), and
WHEREAS, state boards of pharmacy are charged with protecting the public health, safety and
welfare as related to services provided by pharmacies and pharmacists; and
WHEREAS, it is an inherent conflict of interest for pharmacies to dispense the medications that treat
heart disease, lung disease, and cancer -- and then also sell tobacco, encouraging pharmacies to stop
selling tobacco products and work toward a Smoke Free Society
THEREFORE BE IT RESOLVED, that the National Association of Boards of Pharmacy reaffirm
its existing policy encouraging pharmacies to stop selling tobacco products and work toward a
Smoke Free Society.
MOTION: Tim Lynch moved that the commission support this resolution. Elizabeth Jensen second.
District 3
No Resolutions Proposed
District 4
Co-supports three district resolutions proposed:
District 2: Permitting Residents to Obtain Drugs from Sources outside the US

District 7: Standards for use of PDMP Data
District 7: Veterinary Pharmacy Education
District 5
No Substantive Resolutions Proposed
District 6
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Co-supports two resolutions proposed by District 7:
Standards for use of PDMP Data

Veterinary Pharmacy Education
District 7
RESOLUTION #1 Standards for use of PDMP Data
WHEREAS, certain state legislatures have enacted law requiring various forms of mandatory
Prescription Monitoring Program (PMP) access prior to the prescribing of controlled substances.
WHEREAS, certain pharmacies have enacted policy that includes mandatory PMP access prior to
dispensing certain prescriptions in order to satisfy the pharmacist s corresponding liability.
WHEREAS, PMPs often contain a subset of controlled substance data that is missing from state
Health Data Exchanges.
WHEREAS, a need exists to streamline PMP data, including across state lines.
THEREFORE BE IT RESOLVED that NABP convene a task force to develop standards to ensure
regular, consistent, and appropriate use of PDMP data and to increase utilization that has not occurred
as a result of initiatives to encourage voluntary usage.
AND BE IT FURTHER RESOLVED that NABP facilitates cooperation between state PDMPs and
state Health Data exchanges.
AND BE IT FURTHER RESOLVED that NABP encourages the use of NABP PMP
Interconnect and NAR XCHECK.
MOTION: Tim Lynch moved that the commission not support this resolution. Nancy Hecox second.
RESOLUTION #2 Veterinary Pharmacy Education
WHEREAS, Pharmacists are recognized as the experts in pharmacology and appropriate drug
therapy; and,
WHEREAS, evolving pharmacist practice includes providing medication therapy for both
human and veterinary patients; and,
WHEREAS, a substantial opportunity exists for increasing veterinary pharmacy care and
education in pharmacy practice,
THEREFORE BE IT RESOLVED; that NABP encourage the development and availability of
veterinary pharmacology education at colleges and schools of pharmacy in collaboration with the
schools of veterinary medicine.
MOTION: Elizabeth Jensen moved that the commission support this resolution. Nancy Hecox second.
District 8
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Co-supports two resolutions proposed b y District 7:
Standards for use of PDMP Data

Veterinary Pharmacy Education
Correspondence
The commission discussed all correspondence received or distributed.
-WAC 246-873-060 Rewrite to Pharmacy Commission - WSHA
-Response Julie Akers CDTA
-Response Kloepping - CDTA
OPEN FORUM
Grant Chester in January he asked about a dashboard for CE, AUP and CDTA programs and havent
heard anything back on that and was wondering if there was any progress on that.
He had also asked the commission how they would enforce USP797 Standards in Hospitals he has
concerns that investigators will enforce this before there were rules.
Grant referred to the last newsletter regarding exempt narcotics it didnt touch at all on the exempt
narcotic rules. He would like something from the commission as to whether the exempt narcotic rule is
still in effect or determination that they are no longer in effect.
Executive Director Humberson replied:
Regarding the dashboard during our value streaming lean project that will be constructing a
dashboard for those.
As far as USP 797 you are correct, there will be some additional stake holdering. there will
be phase in process to give facilities an opportunity to prepare for capital expenditures.
Joyce will need to look closer at the wording to this rule on the question of exempt narcotic
sales.


Time:
May 29, 2014

9:00 a.m.
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Location:
Red Lion Hotel At the Park

303 W. N. River Dr.
Spokane, WA 99201


18
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STATE OF WASHINGTON

MEETING MINUTES
April 19, 2012
CONVENE
Chair Christopher Barry called the meeting to order at 9:04 a.m., April 19, 2012
Board Members:
Gary Harris, RPh,
Guest / Presenters:
Will Rhodes, WRAPP Monitoring Program Manager
Will Barnes, Multi-Care Pharmacy Administrator
Gale Bunker, Multi-Care Pharmacy Manager
Dave Rose, HealthPoint Director of Pharmacy
Tim McCrea, Safeway Pharmacy Manager
Greg Horochi, Safeway Regional Pharmacy Manager
Doug Pratt, Pharmacy Director for PharmMerica
Staff Members:
Joyce Roper, AAG
Steven Saxe, Acting Executive Director
CONSENT AGENDA
1.1
Business Meeting Agenda Approval April 19, 2012
1.2
1.4
o ADDD Yakima Valley Memorial Hospital
1.8
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March 8, 2012
be removed from the consent agenda and placed on the regular business agenda. Items 1.3, 1.5, 1.6
were deleted from the agenda.
MOTION: Gary Harris moved that the board approve items 1. 1, 1.2, 1.4 and 1.8. Sepi Soleimanpour
REPORTS
Board Member
Mr. Harris was unable to attend the Washington State University for his annual Ethics and Law
class for the students due to weather conditions and the plane could not land. He was really
disappointed.

Steve Saxe re introduced himself and shared that he is standing in as Acting Executive Director
for Board of Pharmacy during the recruitment for a Board of Pharmacy Executive Director
Throughout all government agencies a program called Lean Performance Improvement System
is being started this includes Department of Health. Within our division the Lean Project will
be working on Pharmacy credentialing Donna Field will be a part of this program with Mr.
Saxe.
Doreen Beebe was instrumental in a project that was recently recognized for the work that was
done for the Statewide Methamphetamine Precursor Electronic Tracking Systems. She gave n
excellent presentation at the agency about this project.
Legislature implementation that impact the Board of Pharmacy

ARNP out of state prescribing, a plan of communication is being worked on
Military spouses, if they are deployed Department of Health can make these licenses
inactive.
May 1, 2012 there will be an Orientation held for new board members.
June 18, 2012 the Annual Board/Commission Meeting will be held.
Whooping cough is still an ongoing serious problem in the state Department of Health strongly
encourages getting immunized. Pharmacies and collaborative agreements can play a big part in
immunizations.
The agency will be moving to a new web format and lay out starting May 1, 2012. Hard work
is being done to make sure all links will work to redirect users to the new format.
Health Professions and Facilities started providing quarterly webinars for all boards and
commissions. These are held during the lunch hour.
There has been a lot of work to recruit for the Board of Pharmacy Executive Director position.
Sepi Soleimanpour and Elizabeth Jensen are a part of the recruitment panel.
Kingsbury0531
Mary Selecky has asked Steve Saxe to present on her behalf at the Association of State and
Territorial Health Officers. This will be related to prescription opioid overdose problem that is
happening nationally.
Mr. Saxe will also be attending the NABP Annual Meeting in May along with Christopher
Barry
Pharmacy Technician online renewal is one of the first groups to finish a process called proof
of concept testing. There will be 6 other professions rolling out. The goal is to have online
renewal for all professions by fall.

Since the last meeting the Attorney Generals office filed an appeal in the Stormans vs Selecky
case. There was some media coverage about the appeal to the 9
th
Circuit Court of Appeals.
Subsequent to the appeal, Plaintiffs filed their motion for their attorneys fees and expenses.
These expenses and fees total a little more than 2.7 million. We are preparing a response to the
attorneys fees motion on behalf of the Board and the Department.

Each year the Federal government requires a thorough review of the state Public Health
Emergency Preparedness and Response Program. It is called a TAR or Technical Assistance
Review. When completed the state receives a grade, not unlike pharmacy inspections. Tims
involvement is medication handling from receipt and preparation to storage to distribution and
documentation. It is a two day event.
Tim Fuller, Greg Lang and Tyler Varnum presented at the annual New Drugs New Laws 2012
program in Seattle and Spokane. Attendance was good and the pharmacist audiences had lots
of questions.
Pharmacies that accept out of state prescriptions in Washington are an issue. On June 7
Washington pharmacies will be able to accept out-of-state controlled substance prescriptions
from nurse practitioners as a result of legislation. The status of prescriptions from out-of-state
physician assistants is less clear. If the out-of-state physician assistant is also licensed in
Washington, you would expect (and this has occurred for some time) that Washington
pharmacies could accept their prescriptions. Unfortunately, the Medical QA Commission has
some clarification to do with many of Washington licensed physicians assistants. Unless the
out of state physician assistant also has a practice location in Washington State, the DEA says
Washington pharmacists cannot accept out-of-state controlled substance prescriptions from
physician assistants.
Last week Tim presented An update on Washington pharmacy law to the Northwest
Pharmacy Council in Portland. He followed a pharmacy Inspector/Investigator from the
Oregon Board of Pharmacy who did an update on Oregon pharmacy law. The audience was
pharmacy directors from Oregon and Washington who belong to the Amerinet purchasing
group.
With the help of Greg Lang and Grace Cheung, Tim has successfully reduced the number of
medication in the after hours Pyxis
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Planning Session Update, Strategy 2: Review trends in inspections to identify gaps in rules
areas where there currently are not rules in place to address issues which impact patient safety.
Ongoing
Action Steps:
o By October 2011, develop a method to identify and track inspector identified, currently
unregulated, patient safety issues seen in the field.
Method: A field investigator presents a report to the Board at their regularly

scheduled meetings detailing any currently unregulated, patient safety issues seen in
the field.
By March 2012, develop method for coordination and communication between the
pharmacy inspectors (IIO) and the Board of Pharmacy members.
Method: The Board of Pharmacy has a directory listing all of the pharmacist
investigators and the pharmacist investigators have a listing of all Board of Pharmacy
members. The Pharmacist Supervisor of the pharmacist investigators attends each
Board of Pharmacy meeting and staff planning sessions. NOTE: Investigators cannot
discuss ongoing cases except with the reviewing board member.
Pam Sanders and Jim Doll presented on the subject of Laws for Technicians March 13, 2012.
Tina shared an over view and answered questions about her participation in Item Writing for
the NABP-MPJE Law Exam.
Greg Lang presented New Laws and Drugs with Tim Fuller in Seattle March 25, 2012.
Tyler Varnum presented New Laws and Drugs with Mr. Fuller in Spokane April 1, 2012.
Tina Lacey participated in a NABP-MPJE Item Writing Workshop March 22-23, 2012.
Tina Lacey reported:
PRESENTATIONS
Washington Recovery Assistance Program for Pharmacy (WRAPP)
Will Rhodes, WRAPP Monitoring Program Manager provided an overview and update on WRAPP
activities.

Providing confidential, professional assistance to the profession of pharmacy:
"WRAPP serves to protect the health and safety of the public while acting as a health resource
and support of rehabilitation to the impaired pharmacist ."
Why Call WRAPP?
A pharmacist who is unable to practice pharmacy with judgment, skill, competency and safety
to the public, due to chemical dependence on alcohol or other drugs, emotional illness, the
aging process or loss of mental or motor skills is an IMPAIRED PHARMACIST. In the past,
the only way of dealing with an impaired pharmacist had been through disciplinary measures of
the Washington State Board of Pharmacy.
In 1983, the Washington State Pharmacists Association, in cooperation with the Washington
State Society of Hospital Pharmacists established WRAPP. This program provides a
CONFIDENTIAL, caring and non-coercive resource to assist in the identification, referral to
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treatment, recovery support and rehabilitation of the impaired pharmacist so that they can
return to, or continue to practice pharmacy.
WRAPP gives the pharmacist and the Board an alternative to disciplinary action.
Is There A Charge For Services?
There is no fee for referral, recovery assistance or rehabilitation support services offered by
WRAPP. When a referral is made for evaluation and treatment, the cost of treatment services,
including drug screening, will be the responsibility of the individual participant. Most of these
services are reimbursable through health insurance plans.
How Do I Get Help?

Call WRAPP at (800) 446-7220 and ask to speak to a WRAPP representative. Your call will be
promptly returned. All requests for information and assistance are held in strict confidentiality
in accordance with state and federal law. The caller will be asked to identify him or herself and
give specific reasons for believing that a problem exists.
The identity of the caller will be held in STRICT CONFIDENCE. A WRAPP representative
will make arrangements to examine the information further, arrange intervention assistance or
schedule the individual to meet with a licensed professional who will make a confidential
evaluation and suggest an appropriate treatment plan. If there is no apparent problem or if
insufficient information is available, the case will be closed.
If treatment is necessary, WRAPP will monitor the individual's progress according to terms
stipulated in a contract between WRAPP and the individual. WRAPP will also provide
assistance and monitoring to individuals who are referred through the Washington State Board
of Pharmacy.
Who Provides WRAPP Services?
WRAPP utilizes a variety of qualified professionals to assist in initial evaluation and approved
treatment facilities to provide inpatient or outpatient treatment. In addition, a cadre of
pharmacists has been trained to serve as interveners and to function as a support network for
recovering participants in WRAPP.
How Does WRAPP Work?
When a pharmacist, friend, family member, colleague or employee seeks assistance from
WRAPP, they will encounter a trained member of WRAPP. Voluntary calls are held in
confidence from the Board at this point.
WRAPP may assist in any or all of the following:

Intervention services to persuade the impaired pharmacist to recognize the problem and seek
treatment.
Referral for evaluation services and appropriate treatment facilities, programs, or professionals.
Monitoring the impaired pharmacist's treatment, aftercare, rehabilitation and re-entry into the
profession.
Referral to the Pharmacists Support Group meetings in which pharmacists may safely discuss
licensure issues, drug diversion, return-to-work and other issues related to recovery
Who Does WRAPP Help?
CONFIDENTIAL assistance will be provided to all pharmacists, pharmacy technicians,

assistants and students (interns and externs).
Is The State Board of Pharmacy Involved?

The answer to this question will vary according to individual circumstances . Following are the
three scenarios most frequently encountered.
1. An individual who voluntarily seeks assistance from WRAPP is held in strict confidence
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from the Washington State Board of Pharmacy as long as that individual is in compliance with
the monitored treatment program.
2. An individual who involuntarily seeks assistance from WRAPP (after a concerned individual
has intervened) may also be held in strict confidence from the State Board of Pharmacy as long
as that individual is in compliance with the monitored treatment program. However, if
knowledge of the individual's substance abuse was also linked to a drug theft, the individual's
identity may be reported to the Board.
3. An individual who may be seeking assistance from WRAPP, but who has also been
identified by the State Board of Pharmacy will be asked to cooperate with the Board. Pharmacy
Board licensees and certificate holders are subject to the provisions of the Uniform Disciplinary
Act (UDA). Under the UDA, the Board has the authority to allow licensees and certificate
holders to participate in a voluntary substance abuse monitoring program in lieu of disciplinary
action.
If a member of the Board determines that the licensee shall be referred to WRAPP, WRAPP
will execute a contract with the licensee or certificate holder. If the licensee/certificate holder
successfully completes the contract, no disciplinary action is taken and their participation is the
program is kept confidential.
If the licensee/certificate holder does not consent to being referred to WRAPP or fails to
comply with their contract, the Board can take disciplinary action. If the Board Member
determines that a licensee shall not be referred to the voluntary substance abuse program, the
Board will issue a Statement of Charges, prepared by an Assistant Attorney General (AAG). At
this point, WRAPP will no longer serve as an advocate for the individual, although the Board
may ask WRAPP to monitor compliance with the Board-ordered rehabilitation program.
The board heard a proposal by MultiCare Medical Center to use telepharmacy technology:
1) To provide after hours services to Covington ED Nursing staff sterile medication
preparation for administered medications in the Emergency Department; and
2) To verification of patients own medications at five MultiCare Sleep Centers.
Tele-Pharmacy across MultiCare Facilities
MultiCare provides Pharmacy Services to four hospitals, seven surgical centers, five outpatient
oncology clinics, seven retail pharmacies and several physician offices.
MultiCare Informatics Systems
Inpatient Computer System: EPIC

o CPOE implemented in 2008
Automated Dispensing Cabinets: CareFusion (Pyxis)

o 3500 Model
o At TG since 1998, implemented at Good Sam in 2010
o Anesthesia Carts (A-Carts) at TG, Good Samaritan, Covington and Gig Harbor
Carousel: Talyst
o Bedside Barcoding implemented 2009-2010
Tele-Pharmacy across MultiCare Facilities
Objectives:
o To provide safe and effective pharmaceutical care through pharmacist review and
verification of orders
o To normalize workload on the hospital campuses
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o
o
o
o
o
To normalize workload in the ambulatory areas

To provide after hours support to the off-site areas
To monitor and evaluate the quality and appropriateness of patient care provided by
remote order verification
To monitor accurate preparation of select high risk admixtures at the off-site areas
To verify patient own medications for self-administration at MultiCare Sleep Centers
Remote Processing of Medication Orders
Remote Processing of Medication Orders

MultiCare Facilities are under a single corporate structure
MultiCare uses a standard electronic medical record (EPIC also known as MultiCare Connect)
MultiCare uses standard order sets across all facilities.
Remote Medication Order Processing to include:
o Receiving, interpreting, clarifying and verifying medication orders
o Performing drug regimen review
o Interpreting clinical data
o Therapeutic interchange
o Providing drug information
Policies and Procedures

o MultiCare System Level Policies and Pharmacy Services Policies for all facilities are
available electronically through the MultiCare Intranet
o Policies are reviewed and approved annually
Pharmacist Practice
o All MultiCare pharmacists are licensed in Washington State
o Pharmacists can access EPIC from any MultiCare Facilities
o EPIC records are stored indefinitely which allows concurrent and retroactive audits of
performance
o Pharmacists are trained on pharmacy policies and procedures related to medication
order processing
Remote Order Verification between Allenmore and Tacoma General Hospitals
BOP approval for remote order verification for MultiCare on October 20, 2011
Phase I December 12, 2011 involved order verification of three med-surg nursing units at
Tacoma General, lessons learned
o Patient own meds to be processed on site
o Vasotec prepared differently at TG (admixture) vs. Allenmore (vial sent)
o STAT orders to IV Room to have custom label entered to call attention to the order
Phase II January 11, 2012 added verification of orders from Women and Newborn and Birth
Center, no issues identified
Phase III
Covington ED opened on April 3, 2012
Allenmore Hospital (AH) night pharmacists cross trained at Tacoma General in November
2011
February 22, 2012 added verification
of orders from ICU, no issues identified
AH pharmacists verify 20-40 orders at Tacoma General each night

After Hours Pharmacist Order Verification at Covington Emergency Department (ED)
Covington patient demographics includes many young families with children
Covington ED pharmacists staffs from 12:00 noon to 7:00 p.m. daily
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After hours order verification supported by TG pharmacists due to their pediatric training,
Covington ED is also staffed by the same physician group that supports TG
Average number of orders = 200/day
RN prepares admixtures when pharmacy closed
STAT drips such as Vasopressin are prepared in kits to ensure accurate preparation
MultiCare Health System has 5 Sleep Centers located at Tacoma General, Good Samaritan,
Covington, South Hill and Gig Harbor
Sleep Centers are Hospital Based Services which are surveyed under Joint Commission
Sleep Center Self-Medication Workflow

o Physician authorizes medication for self-administration, only medically necessary
medications are authorized during the Sleep Center stay
o Patient brings medications for self-administration to Sleep Center
o Sleep Center technician faxes medication list to pharmacy
o Sleep Center technician calls pharmacy via Tele-Pharmacy conferencing and has the
patient show the medications to pharmacy to verify medication identification
o Pharmacist enters orders for self-medication into EPIC
o Nurse observes the patient taking the medication via Tele-conferencing
o Nurse documents medication administration via EPIC
Less than 5% will require remote verification

Covington ED after Hours Pharmacist Observation of IV Admixture Preparation
RN completes an initial IV admixture competency with twice yearly renewals
Covington IV Admixture reference book utilized by RNs for admixture preparation
RN barcodes EPIC label and each ingredient added to admixture
Select High Risk medications require TG pharmacist to observe IV preparation via telepharmacy conferencing
Pharmacists are available for questions at all times for Covington staff
Pharmacist document double check of admixtures prepared in EPIC ED Notes

Sleep Center Tele-Pharmacy Workflow
Joint Commission requires pharmacy oversight of medication administration

Staff working at the Sleep Centers are non-licensed staff, who are not authorized to administer
medication
MOTION: Donna Feild moved to approve the proposal by MultiCare to provide after hours services
via telepharmacy to Covington Emergency Room nursing staff in the preparation of sterile IV
admixtures and report back in one year. Gary Harris seconded. MOTION CARRIED: 6-0.
MOTION: Donna Feild moved to approve the proposal by MultiCare to use telepharmacy technology
to identify patients own medications at the Multicare Sleep Centers and report back in one year.
Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
MOTION: Donna Feild moved to approve the extension on the use of remote medication order
processing for MultiCare hospitals and clinics authorized in October 2011 and approval additional sites
without 24 hour pharmacies. Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
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Central Fill Pharmacy Proposal

The board was asked to consider a proposal by HealthPoint community Health Clinic Pharmacies for
centralized prescription processing and filling. Cathy Williams introduced Dave Rose Director of
Pharmacy for HealthPoint who provided the board with a power point.
Overview:
Patient calls into HealthPoint (HP) retail pharmacy/telepharmacy

o Retail pharmacy
Faxed request to Central Fill Pharmacy
Phone request transferred to Central Fill IVR/refill line
Call transferred to central refill line
Walk-in. request dispensed or recorded on refill log and faxed to CFP
o HP clinic
Refill request transferred to refill IVR line or Auburn pharmacy
Patient calls into HP retail pharmacy/telepharmacy

o Retail pharmacy
Faxed request to Central Fill Pharmacy
Phone request transferred to Central Fill IVR/refill line
Call transferred to central refill line
Walk-in. request dispensed or recorded on refill log and faxed to CFP
o HP clinic
Refill request transferred to refill IVR line or Auburn pharmacy
o Telepharmacies
Refill requests faxed to Central Fill pharmacy
Phones requests from telepharmacy transferred to CFP/IVR line
Walk-in refill requests sent to CF pharmacy or dispensed if patient out of med
and approved by pharmacist.
If dispensed from telepharmacy, remote pharmacist will authorize technician to
release medication from tele-machine and counsel patient via telepharmacy
webcam.
Central Fill Pharmacy

o All refill requests-Technician processing
Telepharmacy Blue bins- requests should be in separate bin & processed
IVR- Retail pharmacy requests on QS1 pharmacy software system
Retail pharmacy refill log- faxed to CFP & placed in separate bin & processed
CFP phone recorder refill requests processed.
Refill requests are processed by:
Technician will log into QS1 pharmacy software system
o HP retail pharmacy request: Rx transferred to CFP and dispensed.
Technician will process refill and print label from CFP printer.
Remove label from printer and fill med from pharmacy inventory stock
or RxMedic ADS (Automatic Dispensing Machine, See attached P&P).
Place filled medication, label and ancillary label into colored site bin for
final approval by pharmacist
Refill Center Pharmacy

o Pharmacist
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Telepharmacies approve final med, place meds in bag, seal bag, sign seal and
place bag in appropriate telepharmacy site bin.
HP Retail Pharmacy approve final med, place meds in bag, seal bag, sign seal
and place bag in designated retail pharmacy site bin.
Central Fill Pharmacist

o Per refill protocol:
Authorize refills for telepharmacies and HP retail pharmacies refill requests
Log onto NextGen EMR to review medical record for authorizing refill requests
per protocol guidelines
Place authorized refills in appropriate bin for dispensing by technician
Denied refills
o Let provider know via NextGen of denied Rx
o Call patient if before 6:00pm of denied refill and reason. If after 6:00 pm day shift
pharmacist must call patient.
o Remind patient to request refill again when appropriate
Courier delivery procedures

o Pharmacy courier matches finished med receipt (stapled to outside of pharmacy bag),
with dispensed refill log sheet for each delivery site.
o Each site, (telepharmacy, pharmacy) will review delivered refills with refill log sheet
and sign for received meds. Any discrepancies or missing items will be addressed to
Kent pharmacist prior to courier leaving site.
Courier delivery procedure

o Each site will fax signed delivery refill log to CFP pharmacy to compare with end of
day refilled prescriptions dispense report.
Patient Pick-up at Telepharmacy

o When patient comes to telepharmacy to pick-up refilled prescription.
o Technician will show pharmacist, via webcam and telephone, the med bag and signature
of pharmacist.
o The pharmacist will counsel the patient via telephone and webcam.
o Patient may refuse counsel and pharmacist notes refusal.
o Technician has patient sign for med pickup and collects payment.
Patient Pick-up at HP Retail pharmacy

o When patient pickup refill med at HP retail pharmacy
o Technician will show pharmacist medication bag and signature of pharmacist.
o Pharmacist will counsel patient at pharmacy counter.
o Patient may refuse counsel, pharmacist notes counsel refusal.
o Technician has patient sign for pick-up and collects payment.
MOTION: Emma Zavala-Suarez moved to approve the proposal by HealthPoint to provide central fill
pharmacy practice. Sepi Soleimanpour seconded. MOTION CARRIED: 6-0.
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PRESENTATIONs Contd
Safeway Call Center.
Tim McCrea, Pharmacy Manager and Greg Horochi, Regional Manager for Safeway provided the
board a presentation on Safeway providing services through the use of a Call Center to improve
pharmacy flow, allow more time for pharmacist to focus on patient care, and increase patient
satisfaction.
Seattle Division Call Center

Overview of responsibilities:
Resource for Patient Information
o Answer questions that may be posed by patients that cant reach their pharmacy.
Transfer and Process prescription to include Phone forwarding if needed.

o For hard to staff pharmacies
-Bad weather
-Sick Tech (Unable to physically staff)
o Have calls forwarded to call center as needed
-New prescriptions
-Refills
-Patient questions
-Third party billing issues
o Process prescriptions in the refill queue and e-scripts for pharmacies as needed.
Outcomes/MTM
Assist pharmacy with calling and scheduling interventions
Be a resource for pharmacists on MTM issues.
Immunizations
Assist
Assist
Assist
Assist
in
in
in
in
review of recommended immunizations

review and processing of third party billing
identification of potential patents
vaccine allocations
Acquisition
o Transfer prescriptions out: to other pharmacies to allows the pharmacy staff to on their
customers in the store.
o concentrate Inform patients about promotions and services before transferring
Policy and Procedure Transfer Prescriptions
Customers interested in transferring their prescription to Safeway will have access to our
national 1-866 transfer line. The call will go to the Arizona Safeway call center data switch.
The call will then be automatically routed to the Seattle Division call center based on the
customers area code (example: 206, 253, 425, 360, 509, etc).
The Washington State licensed pharmacy technicians/pharmacist will answer the routed calls
assist in the transfer process by completing a transfer and patient information form. Assist
customer in determining the most convenient Safeway pharmacy and time to pick-up their
prescription and note the desired pick-up times on transfer request form and prioritize
appropriately.
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The call center staff will then enter the data into the appropriate pharmacys data base via Putty
and/or ZOC5. The prescription will be placed on- hold or filled per patients request. Desired
pick-up times will be placed in comment field .
The DUR will be performed by the call center pharmacist and overrides provided as needed.
Prescriptions will be checked and filled at the pharmacy in accordance with establish Safeway
policy and procedures. Transfer request will then be placed in daily transfer file for quality
assurance review by a Washington State registered pharmacist . Then all PHI will be placed in a
secure shred bin.
Pharmacists and Technicians doing MTM

Overview:

o Comprehensive Medication Reviews (CMR)
o Physician Consultations
o Patient Compliance Consultations
o Patient Education & Monitoring (most common)
o TIPs*
Simply put, pharmacists are able to bill for services they are currently uncompensated for, such
as calls placed to a prescriber for formulary reasons, unsafe doses or interactions, and even
o Example: Medication A is not covered by patients insurance formulary. Action:

pharmacist consults with physician and medication is changed to B. Pharmacist provides
and educates patient on medication B. Patient receives a follow-up call in 3 days to
monitor satisfaction with medication B.
Billable services: $20 for calling doctor and $10 for counseling and monitoring the patient.
Two different claim submissions for the same prescription!
Adjudication Edits in PDX will notify you of which patients are eligible for Outcomes
Services. This is not a universal program, it applies to a select group of individuals that are
MOTION: Donna Feild moved to approve the load shifting proposal by Safeway for a Call Center.
The Call Center must first be licensed as a pharmacy, stock no medications, and obey all laws and
rules related to a pharmacy including tech to pharmacist ratio. Report back in 6 months for board
questions and concerns. Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
DISCUSSION
EZ Mar Electronic Prescription Transmission System
The board was asked, by staff, to reconsider its approval of EZ Mar electronic Rx system the
application was incomplete as presented to the board in March. Douglas Pratt, Pharmacy Director for
PharMerica was asked to come back and answer some questions and give the board a more complete
presentation.
MOTION: Dan Rubin moved to reconsider the boards decision from March reapproving the EZ Mar
Electronic Prescription Transmission System. Donna Feild seconded. MOTION CARRIED: 6-0.
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Sara Kirschenman from Office of Legal Services provided the board some back ground on
PharMerica/ EZ Mar proposal that was given at the March 2012 meeting. When PharMerica was up to
get re approval there was an open complaint and since Mr. Pratt was the responsible pharmacist he was
the respondent. This limited on what was able to be disposed to the board when they were presenting
for re approval. The complaint has now been closed and there was not action or discipline taken
against Mr. Pratt or PharMerica. The issue had to do with PharMerica using a non prescriber to enter
prescriptions into the system.
There was some discussion on the definition of agent of prescriber . Ez Mar provided a list to the
board of other systems used by nursing homes in the same manner. This is a system used in a nursing
home exclusively. The board and staff will needs to look at other systems, some past proposals
specifically in nursing homes. There were a lot of questions and concerns from the board. The board
decided they would like some input from other agencies and commissions.
The board was asked what is the status was of the two systems already operating until this is resolved.
Mr. Pratt was advised to operate with full consideration of the boards concerns.
MOTION: Elizabeth Jensen moved to table this discussion until the next meeting and that EZ Mar
continue to operate with consideration of the boards concerns. The board requested more information
from staff. Dan Rubin seconded. Donna Feild and Gary Harris abstained. Sepi Soleimanpour opposed.
(4 Approve; 2 Abstain; and 1 Opposed) MOTION CARRIED: 4-1-2.
Inspection Process Review

Grant Chester asked the board to review and make recommendations on the updated Inspection Report
and Process. The review was based on input from the field investigators . The board was asked to
authorize a pilot project to test the design and functionality of the new form.
MOTION: Gary Harris moved to accept the changes to the inspection report/process and authorize a
pilot to test the design. Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
2013 Meeting Dates and Travel Priorities

The Doreen Beebe led the discussion with the board to finalize the board business-meeting dates and
locations for 2013 along with future travel and training priorities.
After some discussion the board requested to move meeting dates from Oct 31 thru December up one
week. The adjusted calendar will be distributed to the members for individual comments to do Doreen
Beebe. The 2013 calendar will be revisited at the June 7, 2012 meeting.
th
108 Annual NABP Meeting

Doreen Beebe asked the board to choose an alternate voting delegate to the 108th Annual National
Boards of Pharmacy meeting.
MOTION: Donna Feild moved to approve appointing Steven Saxe as alternate voting delegate at the
th
108 NABP Annual meeting. Sepi Soleimanpour seconded. MOTION CARRIED: 6-0.
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Organizational Overview
Steven Saxe, Acting Executive Director and Grant Chester, Chief Investigator led the discussion to
explain the organizational structure of the Department of Health (DOH) and Health Systems Quality
Assurance Division (HSQA).
Office of Health Professions and Facilities
Supports Boards, Commissions and Secretary to regulate 80 professions and over 7000
facilities
Professional regulation include:

o Regulations for credentials and standards of practice
o Enforcement of regulations
Board Staff Responsibilities
Executive Director
o Pharmacist requirement
o Leader and liaison for board and DOH
Board Program Manager

o Daily board operations manager
o Rules development manager
o Expert resource to public, pharmacists for laws, rules
o Reviewers for proposals to board
Rules Coordinator
o Rule writing and support
Office of Investigation and Inspections

Pharmacist Investigator Responsibilities
Promote public safety by conducting inspections and investigations. Evaluate compliance with
regulations and when appropriate identify areas for improvement during inspections.
o Investigate allegations relating to drug laws and pharmacy practice violations providing
results to a reviewing Board member.
Promote public health by providing professional and technical expertise relating to pharmacy
and presentations.
o Answering phone calls, emails, and letters promptly.
o Presentations to professional groups.
o Participation in National Association Boards of Pharmacy activities and Board of
Pharmacy activities.
o Presentations to schools.
Completing routine firm inspections within a 24 months . (BOP Requirement)

Complete inspections of 5 jails for pharmaceutical services each year. (Law)
Completing routine investigations within 170 days . (DOH Requirement)
Complaint Process
Intake (phone, letter, email etc.)

o We prefer written complaints (we do not want to restate the complaint in a different
context)
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Case Management Team (CMT) review

o Reviewed by team with three board members to determine whether to investigate
complaint
CMT may decide to investigate complaint or close with no action
Assigned to Investigator
Complaint is investigated
The findings are reviewed by the chief investigator and sent to a Reviewing Board Member
Outcome/Penalty Phase
https://fortress.wa.gov/doh/hpqa1/documents/Sanction_Guidelines.pdf
Rules and Planning Session Update

Doreen Beebe provided the board a key point rules overview for the new board members to get a bit of
an understanding of the rules process. The new board members will be attending a board member
Orientation where they will receive detailed information and presentations on all processes they will be
a part of.
Kitty Slater-Einert updated the board that she will be taking over the lead on the Rules Rewrite project
R2P2. The acronym chosen for the Rules Rewrite Project will be R2P2 Rules Rewrite Project for
Pharmacy.
Correctional Pharmacies: are on hold right now.

Internship Rules: writing an exception request.
Continuing Education for Pharmacy Technician: rules hearing June 7, 2012.
Update Animal Control Agency and Humane Society Rules (petition): Rules Hearing
Scheduled for June 7, 2012. Pending CR102 filing.
Correspondence
The board discussed all correspondence received or distributed.
a) Letter from Providence re: Compounding in a Pharmacy/Clarification of Law
b) NABP urges ICANN to take action against Internet.bs
c) Article: FDA Works to Lessen Drug Shortage Impact
d) Article: Use Only as Directed Isnt Easy
There will be a follow to the Letter from Providence at the June 7, 2012 meeting.
OPEN FORUM
CLOSED SESSION
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August 16, 2012

310 Israel Road SE
Room 152/153
Tumwater WA 98501
_______________________________

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MEETING MINUTES
April 20 21, 2006
Red Lion Inn
Yakima Center
607 E. Yakima Ave.
Yakima WA 98901
CONVENE
Board Chair Asaad Awan called the meeting to order at 11:30 a.m. on April 20, 2006.Board
Members present:
Donna Dockter, RPh
Gary Harris, RPh
George Roe, RPh
Rosemarie Duffy
April 20, 2006
Open Meeting
CONSENT AGENDA
1.2
1.3
1.4
1.5
1.8

Closed & New Pharmaceutical Firms Report 2/13/2005 thru 04/07/2006
Pharmacy Technician Application Approval
Kentucky Tech-Central Campus in Lexington KY\Gladwyne Reed
Tehran University of Medical Services\Negar Golchin
Draughons Junior College in Clarksville TN\Teresa Lewis
Pharmacy Technician Training Program
Nebraska Medical Center/Justin Gripp
Valu Drug Montesano WA
Nancy Hecox Fred Meyer/Antibiotic Treatment
Prescriber Leslie Miller-Various/3-month Bridging Study
Steven Wanaka Childrens Hospital/Total Parenteral Nutrition
Tom Engel Northwest Prescriptions & Medical Supply/Anticoagulation
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March 10, 2006 meeting minutes
Items 1.1-Pharmacist License Application Approval; 1.6 Automated Drug Dispensing Devise
Acceptance; and 1.7- Sample Distribution Requests were deleted from the consent agenda.
MOTION: Vice-Chair Rebecca Hille moved to accept the consent agenda items 1.2; 1.3; 1.4;
1.5; and 1.8 with the correction to the spelling of Ms. Hilles name on page 6 of the March
meeting minutes. MOTION CARRIED.
REPORTS
Optometry Board held its continuing education two day seminar with approximately
650 attendees.
Work continues with the Governors office for appointments to the Veterinary Board
of Governors. A public member was recently appointed; however there are still
several vacant positions.
Mr. Saxe attended the American College Healthcare Executives as the state
representative for Washington. The meeting focused on ethics, personal and
professional growth, and networking. This is Mr. Saxes last year of his elected 3year term.
Mr. Saxe and George Roe attended the National Association of Boards of Pharmacy
(NABP) annual meeting. The meeting provided an opportunity to network with other
state boards and executive directors.
Board Chair Asaad Awan and Vice Chair Rebecca Hille will be attending the
Department of Health (DOH) Board & Commission Leadership Conference on April
th
26 .
Chief Investigator Grace Cheung, Board Investigators Stan Jeppesen and Tim Fuller
will be attending a forum hosted by the federal Drug Enforcement Agency (DEA) and
the Oregon Board of Pharmacy later this month looking at the issue of drug disposal .
The issue relates well with the Washington Board of Pharmacys activities with drug
disposal pilot projects and is specifically focused on the disposal of controlled
substances, which is difficult complying with both ecology and drug rules. The
meeting will be attended by representative from the states of Washington, Oregon,
Wyoming, Idaho and Montana.
DOH Health Systems Quality Assurance is further developing organizational
changes based on functionality similarities throughout the division. The Board
requests that Laurie Jinkins, HSQA Assistant Secretary or Bonnie King, HPQA
Director be invited to speak at a future meeting.
Reporter Michael Behrens of the Seattle Times will be releasing a report based on a
culmination of research reviewing the departments disciplinary process focusing
primarily on sexual misconduct. The first of a four part series will be published April
nd
22 .
BOARD MEMBERS
Gary Harris is involved in a project with Washington Association of Diabetes Educators and
several pharmacy chains Fred Meyer, Bartell Drugs and Rite Aid in developing diabetes
curriculum for retail pharmacist. The project is in its initial planning stages, formation of a
committee to develop the curriculum is expected to be completed in July, with classes held in
September.
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George Roe attended NABP Annual Meeting and was appointed a delegate to the Resolutions
Committee. This Committee is tasked with reviewing and declaring which resolutions are
passed, withdrawn or moved forward with no recommendations . Resolutions passed or moved
forward go before the whole delegation for vote. Highlights included the former Secretary of
U.S. Health & Human Services, Tommy Thompson who spoke on the issue of Medicare.
Mr. Roe also attended a class on communications which included discussed how to manage
media interviews and getting your message out by using short headline type of statements. In
addition, discussions included participation in the Katrina disaster and the problems encountered
related to pharmacy practices; such as, the authority of out-of-state pharmacies to dispense,
checking and maintaining the quality of drugs, control of drug abuse, patients not knowing the
drugs they are prescribed, no electricity, and lack of access to tools pharmacists typically uses
stationary, etc.
Susan Teil-Boyer referred to the American Pharmaceutical Association (APhA) conference
where Bruce Canaday, the new president of APhA and former president of American Society of
Health System Pharmacists (ASHP) gave an address about the future of the pharmacy profession
and the use of technician, and technology. Ms. Teil-Boyer suggested that this discussion be
considered for the Boards strategic planning session.
Ms. Boyer shared with the Board that Good Samaritan Hospital participated in emergency
management drill held by Pierce County. It was a valuable learning experience in identifying
what went well and the deficiencies in the process in taking care of community needs during an
emergency.
Donna Dockter - also attended the APHA conference.
CONSULTANT PHARMACISTS
th
On April 5 the state held its second emergency preparedness drill in Pierce County
called the Tacoma Resilience. Board staff Tim Fuller, Lisa Salmi, Jim Doll, and Jackie
Stockdale participated in the receiving and distributing antibiotics related to a biological
agent emergency. The warehousing exercise went very well. Issues identified locating
delivery points, software problems and additional need for pharmacists in specific
locations.
Met with Department of Health Facility and Licensing Construction Review staff
regarding questions on USP797 (Regulations for the Compounding of Sterile
Preparations) requirements and the Boards position.
Presented background on controlled substances laws to the Bastyr College Naturopathy
law class.
Provided support to the Nursing Care Quality Assurance Commission on issues related to
legislation for school nurses and access to asthma medications.
Working on rules using the new electronic system for filing. Rules currently in progress
include; the Automated Distribution Devise rules, Pharmacist Responsibility, Pharmacy
Technician, Long-term Care, etc. Mr. Fuller acknowledged support provided by Tami
Thompson, DOH HPQA Policy Coordinator.
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Andy Mecca indicated that he has received several questions from doctors offices asking for
interpretations on laws related to dispensing medications to their patients and methadone
treatment. He advised them of the requirements for office dispensing such as labeling,
recordkeeping, etc.
Mr. Mecca updated the Board on the interagency committees working on establishing opiod
st
dosing guidelines. The committees next meeting is May 1 .
CHIEF INVESTIGATOR
Presented with Andy Mecca to the Spokane area pharmacists on April 9th. The
presentation was part of the New Laws, New Drugs continuing education program
sponsored by the University of Washington (UW) and the Washington State Pharmacy
Association (WSPA).
On March 8th, Investigator Jim Lewis provided the Clark College Technician class with
an overview of Pharmacy Law relevant to the role of the pharmacy technician.
Investigators Joseph Honda and Dick Morrison gave a presentation to a group of Seattleth
area researchers on March 15 . The goal of the presentation was to promote voluntary
compliance of laws and rules by providing information regarding Pharmacy Board
inspection process for researchers, controlled substance recordkeeping requirements,
DOH/Board expectations, and answer questions .
Ms. Cheung and several of the investigators will assist the instructors at the UW Pharm
440 communications lab classes in April and May. This activity provides the Board a
unique opportunity to impress upon the students, many of whom are interns, the
importance of patient counseling.
On April 6, Investigator Dick Morrison gave a lecture on pharmacy law to Bartell Drug
technicians-in training.
On April 17th Investigator Bill Kristin provided an overview of pharmacy law to the
Pharmacy Technician class at Spokane Community College.
Rosemarie Duffy will attend the June Investigators meeting in Tumwater.
PROGRAM MANAGER
Doreen Beebe reported on the following:
Unofficial offer for a new support person has been submitted for approval. The person
will be on board before the June Board meeting.
New Board Orientation scheduled for May 31 st.
PRESENTATIONS
Yakima Valley Farm Workers Clinic
Tim Fuller provided an introduction to a presentation by the Yakima Valley Farm Workers
Clinic. YVFWC has requested approval to establish a Call Center off-site from the pharmacy
and staffed by trained agents not credentialed by the Board.
Presenters: Patrick Bucknum, Director of Operations; Brandy White, Pharmacy Manager
Yakima; Dan Scott, Pharmacy Manager Grandview; and Leon Wilde, Pharmacist Consultant
Key Points
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Provides services to the un-served or underserved patients.

YVFWC is an approved 340B drug pricing program.
YVFWC is (JCAHO) Joint Commission of Accreditation for Healthcare Organizations
accredited since 2000.
IVA system creates unique challenges for YVFWCs patients such as language barriers.
YVFWCs pharmacies currently receive per pharmacy approximately 100 refill calls in
an 8 hour business day.
Operates 5 pharmacies Yakima, Toppenish, Grandview, Walla Walla and Spokane.
Call Center Functions
o Similar to IVA system but staffed by live call-center agent.
o Verify refills are available through pharmacy system by refill number.
o Ability to queue refill request at the appropriate pharmacy.
o Ability to connect patient to pharmacy/provider
o Answer non-pharmacy related inquiries location, time of operation, etc.
o Access to patients records HIPAA and confidentiality training Patients
registered in the YVFWC system signs agreement to allow access to records by
YVFWC staff.
Key Issues/Concerns
Non-credentialed staff with access to pharmacy/clinic system
o No Board oversight of call-center agents
o Misfills
o Dosing Issues
o Limit access to refill information not complete patient records
Off-site from pharmacy without a pharmacists direct supervision
Diversion
Policies and Procedures Quality Assurance
MOTION: Donna Dockter moved to approve the proposal by the Yakima Valley Farm Works
Clinic Pharmacy Call-Center provided that the Call Center is located in the same building as a
licensed YVFWCs pharmacy and the Call Center has implement written policies and procedures
to monitor calls for quality assurance. All Call Center staff must be registered as pharmacy
assistants and shall receive appropriate training. YVFWC will provide an update to the Board on
the progress of the Call Center in six months after implementation. MOTION CARRIED with
6 supporting the motion and 1 opposed (George Roe). AMENDED MOTION: Chair Asaad
Awan moved that the motion is amended to restrict the approval to 340B approved programs.
MOTION CARRIED.
DISCUSSION
Rules Update
A spreadsheet of current rules in process was distributed to the Board. Steve Saxe updated the
Board on their status.
Automated Drug Distributing Devices lead Tim Fuller CR 102 package submitted and up
for hearing July 2006.
Suspicious Transactions CR102 submitted and waiting comments for the departments
economist on the Significant Bill Analysis and Significant Small Business Economic Impact
Statement.
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Long-Term Care Facilities Destruction of Controlled Substances

Adding Soma to CSA proposed by UW students this proposal has been withdrawn at this
time and projected for re-filing.
Wholesaler Rules - working on CR101 package.
Sexual Misconduct Rules CR101 package filed. Stakeholder meeting set for July in
tandem with the Veterinary Board of Governors. Plans are being finalized for the July
stakeholder meeting to be held in Tumwater and via teleconference in Spokane.
Pharmacist Responsibilities - stakeholder meeting held April 19 and 20.
Technician National Examination stakeholder meeting April 20.
2007 Legislative Input

Steve Saxe updated the Board on 2007 suggested legislation for agency consideration. He also
asked the Board if they had any concerns or additional suggests.
Wholesaler Rules
Prescription Monitoring
Methamphetamine Legislation State Law comparison to Federal Regulations
MOTION: Vice-Chair Rebecca Hille moved that the Board support the suggested 2007
legislation for wholesaler rules, prescription monitoring and methamphetamine proposals for
agency approval. MOTION CARRIED.
GMAP Government Management Accountability and Performance
Grace Cheung provided the Board with an overview of the pharmacy inspection and
investigations GMAP report. She shared with the Board the difficulty they are having in pulling
out the data necessary in creating the GMAP report from our current computer systems. The
report itself was not distributed due to problems with the data. Instead, Ms. Cheung provided an
overview of the information the report is designed to capture and the duties not reflected in the
report. Investigators have five main duties investigations, inspections, education, consultant and
practice reviews. Practice reviews may or may not be linked to discipline orders . GMAP will
report investigations and inspections only.
Inspections include canine handlers, researchers, pharmacies, etc.
Each Investigator has an average of 300 locations.
The goal is to inspect each location every 24 months (locations over 24 month goal are
considered pending).
Monthly Data reported identifies the number of pending locations compared to
inspections completed.
Inspections include: routine, new, relocations, re-inspection (location previously failed).
System does not account for the different types of inspections and therefore the data is
flawed.
The investigators are currently keeping manual logs to record time spent doing activities that
will need to be documented in the GMAP report. Pharmacist Investigator Jim Doll has been
assisting in the task of attaining meaningful data. Ms. Cheung hopes to develop a baseline by
which to plan and set performance goals. She wants to illustrate the dissimilarities in inspection
workloads of various pharmacy practices that may not be reflected solely in the total number
completed.
Steve Saxe added that our current databases capture the data, but do not provide a method for
tracking and/or monitoring investigators daily activities. In addition, these systems are not
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supported by our Information Technology staff. We may be looking at purchasing an off-theshelf system that can interface with the ILRS system (new licensing system) and is supported by
our IT staff. The proposal for a pharmacy inspection system will move forward as a budget
request for the next fiscal year.
Operating Agreement
The Board reviewed the proposed operating agreement and addendum with the Department of
Health regarding administrative matters . The Board requested to take a look at the last
agreement signed on June 7, 1990. Concerns include budget development and personnel issues.
The Board questioned whether or not the Secretary would be willing to consider modifications to
the agreement template. Note: the addendum addresses the programs unique circumstances that
have a statutory basis.
Joyce Roper expressed a possible conflict of interest in advising the Board in this matter.
The Board is postponing a decision on this agenda item and requests additional information and
legal counsel. It was suggested that the Board extend an invitation to a future meeting to a
former Board member for historical background.
Correspondence
The Board reviewed and discussed correspondence addressed to the Board from NABP
regarding:
Requests for volunteers to serve on the Associations committees and task forces in 20062007.
Foreign Pharmacy Graduate Equivalency Examinations administered in New York,
Chicago and San Francisco in June 2006.
Revisions to the Foreign Pharmacy Graduate Examination Committee policy for
eligibility for FPGEC Certification.
Additional proposed resolutions for consideration at NABPs 102nd Annual Meeting.
To improve processing times for FPGEC Certification, NABP has partnered with
Educational Credential Evaluators. As a result, the fee for evaluation of applications has
increased.
Results of a national survey of prescription drug repository program (donation of unused
prescriptions). This issue did come up during the 2006 legislation.
Report of the 2005-2006 Task Force on Model Regulation for Long Term Care for
institutional pharmacies.
Standards 2007 new standards and guidelines for the Doctor of Pharmacy Degree,
effective July 1, 2007.
Report of 2005-2006 Task Force on Standards for Compounding.
Pharmacist reports a request for pharmacys NABP ID number.
Board members were asked to review correspondence and request staff to add items to future
board agendas.
Notice of Corrections (NOC) & Stipulation to Information Disposition (STID)
Kristy Weeks, staff attorney provided a brief overview on Statement of Allegations, Stipulation
to Informal Disposition and Notices of Corrections.
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Notice of Correction is not issued under the Uniformed Disciplinary Act . It is issued under
another section of the RCWs that authorizes their use when in the course of an inspection or
investigation the investigator finds a clear violation of a technical rule or law. Because they are
not under the UDA we can not issue sanctions. It does become part of their professional record
and is available by public disclosure request. NOCs are not reported to the National Practitioner
Date Bank and is not included on the DOH website provider credential look-up. A statement of
appropriate corrective action should be provided during the investigation and before a decision to
issue a NOC.
Notice of Correction
Can NOT be issued for:
Can be issued for:
standard of care issue
Often used for a misfill where a
unclear violation of technical rule- it
pharmacist has taken corrective action
either is or it isnt
Clear violation of technical rule e.g.
violation is denied (no right to appeal)
ancillary staff failing to wear name
badges
Statement of Allegations This document states the allegation and the evidence. This is not
formal discipline and is accompanied by an STID (see below).
Stipulations to Informal Disposition (STID) This document reiterates the allegation, states that
no finding has been entered and no admission required; however conditions are imposed.
STIDs are reported to the National Practitioner Databank and included on the DOH credential
look-up. A STID may be issued anytime prior to issuing a Statement of Charges. A STID has
the same evidentiary standards as an SOC. A STID is generally not open to negotiation.
Stipulations to Informal Disposition

What sanctions can not be imposed:
What sanctions can be imposed:
Suspend
Cost recovery up to $1000 per
Revoke
allegation
Fine
Probation
Censure or reprimand
May be appropriate when:
May not be appropriate when:
First Offense
Anticipate compliance issue
Lesser offense
Denying responsibility
Respondent has taken responsibility
Disadvantage
Advantage
Non-compliance with conditions can
Quicker and cheaper
not be fast tracked.
Open Forum
No comments provided.
Meeting adjourned at 5:00 pm.
April 21, 2006
Open Meeting
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Chair Asaad Awan called the meeting to order at approximately 9:00 am. All board members
and staff from the previous day were present. The Board assembled to review comments from
stakeholder workshops held on April 19 and 20 and to discuss the next steps.
Wendy Fraser, the facilitator contracted to assist the Board in this process, acknowledged that
last night the Board received copies of letters, and notes and comments from both stakeholder
workshops related to a pharmacists responsibilities. In addition, all 4800 letters, emails and
written telephone messages received were available for the further Boards inspection.
Following Chair Asaad Awan and Vice-Chair Rebecca Hille summary of the events and public
th
comments received on April 19 , the Chair called for an executive session to consult with
counsel regarding possible litigation.
The Board reconvened approximately 35 minutes later.
Ms. Fraser asked the Board to consider issues and concerns surrounding the matter of a
pharmacists responsibilities when presented with a lawful prescription. The Boards discussion
centered on the four questions asked at the earlier stakeholder workshops.
1. What are a pharmacists professional responsibilities when presented with a lawful
prescription?
2. Under what circumstances may a pharmacist/pharmacy refuse to fill a prescription?
3. What expectations should patients have when seeking professional services from a
pharmacy?
4. What would characterize unprofessional conduct by a pharmacist?
Unprofessional Conduct - identified by the Board (facilitators poster paper notes)
Giving wrong information
Verbal or non-verbal harassment
Doing something that is not in the best interest of the patient (e.g. destroying a legal
prescription)
Not obeying the law
Fraud
Changing the prescription without attempts to contact the provider
Unauthorized altering of a prescription
Practicing under the influence
Not filling a prescription (e.g. long weekend)
No attempt to ensure care
MOTION: Vice-Chair Rebecca Hille moved that the Board start the rule making process to
further define unprofessional conduct. MOTION CARRIED.
The Board provided staff with direction to develop a rough draft and requested that the draft be
nd
rewritten in rule language and brought before the Board on May 2 for further discussion.
Meeting adjourned 12:10 p.m.
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CLOSED SESSION Case Presentation

Adjournment
There being no further business, the Board adjourned at 2:00 p.m. They will meet again on May
2, 2006 in Kent Washington for a special meeting and on June 1 & 2, 2006 in Tumwater,
Washington for its regularly scheduled meeting.

__________________________________________
_________________________________________
Board of Pharmacy
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STATE OF WASHINGTON
MEETING MINUTES
April 29, 2010
12401 SE 320th St
CONVENE
Chair Gary Harris called the meeting to order at 9:04 a.m., April 29, 2010.
Dan Connolly, RPh
Guest / Presenters:
Steve Freng, Psy.D., MSW
Kristin Mansfield, DVM, MPVM of
Washington Department of Fish and Wildlife
Bhavani Bharathi Sangameshwar, Pharmacist Intern
Melissa Burke-Cain, ATG

Michael Tribble, AAG
Tyler Varnum, Investigator
New Member Introduction

Kim Ekker was appointed to the Board of Pharmacy as a public member March 2, 2010. She was
born and raised in Hood River, Oregon. Kim graduated from the Oregon State University in
1980 with a bachelor science degree in US History and Political Science.
Kim is now a resident in Kent, Washington with her husband Tom. She says her degree in
history has led her directly into the electronic world where she has spent the last 25 years. Kim is
excited to be a part of the Board of Pharmacy. Welcome Kim to the board.
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CONSENT AGENDA
1.1
1.3
Closed Pharmaceutical Firms 02/16/2010- 04/19/2010

1.5
Snoqualmie Valley Hospital

Board Minute Approval. (March 11, 2009)
MOTION: Dan Connolly moved that the board approve items 1. 1, 1.3 and 1.5. Vandana Slatter
REPORTS
Board Member
Vandana Slatter reported:
Vandana attended the Kick up Your Heels event at the Governors
was to recognize women in government and public service.
mansion. This event
Al Linggi Reported:
Mr. Linggi has been working with Washington Recovery Addiction Program for
Pharmacy (WRAPP) on an Algorithm for the board to be more consistent with
disciplinary actions given to those participants who become non compliant while in the
WRAPP program.
Al is also working with American Society of Health System Pharmacists (ASHP) on the
Pharmacy Practice Initiative (PPI). They are looking at renewing Hilton Head meeting
held a decade ago. Two weeks ago Al met with forty stakeholders that are going to help
formulate the foundation for the pharmacy practice initiative sponsored by ASHP. 140
pharmacy practitioners will be invited to the PPI conference in Texas . PPI will outline
the future practice of hospital pharmacy for years to come.
Kim Ekker reported:
She is fascinated and excited for the opportunity to serve on this board. Kim is eager to
learn and participate in all aspects of the Board of Pharmacy.
Gary attended the second Task Force Meeting that Attorney General McKenna had
convened on Prescription Monitoring Program (PMP). Joyce Roper and Melissa BurkeCain were present at this meeting. Gary is going to be on the sub-committee to look for
funding for PMP.
He will participate in the upcoming Boards and Commissions meeting.
Gary will take part on a panel with Patrick Hanley and a health law judge for a
presentation in Olympia next month.
Mr. Harris gave a two hour presentation at Washington State University for Keith
Campbell s class. He had a great time.
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Executive Director
The Washington State Board of Pharmacy April Newsletter reports the implementation of
Tamper Resistant Prescription Pad (TRPP) in July 2010. The Newsletter is distributed
quarterly to the Board of Pharmacy listserv.
Pharmacists must only dispense written prescriptions written on board
approved prescription paper.
Pharmacist may dispense emergency medication if written on an unapproved
form.
Prescriptions sent electronically are not required to be on board approved
TRPP.
The board seal of approval (a security feature in thermochromic ink) should
always appear in the bottom right corner of the prescription form.
A sample of the board approved prescription format and seal are available on
the TRPP webpage www.doh.w.gov/hsqa/trpp.
Lisa Hodgson submitted a grant to the Bureau of Justice for Prescription Monitoring
Program. There should be a decision in September 2010.
The Board and Commission Member Meeting Videoconference/Webinar waswere held
April 26, 2010 from 12 noon to 1pm.
Susan has been talking with other states and has decided that the Washington State Board
of Pharmacy will host the Region 7 and 8 NABP District meeting October 2011.
The Department of Health is still faced with budget challenges.
Pain Management Rules Development (Medical, Nursing, Podiatry, Osteo and Dental
Commissions). The Board of Pharmacy will participate in support and with technical
assistance.
Nursing Commission agrees with Board of Pharmacy on Spokane County Jail request to
disallow nurses from identifying and validating medications brought from home. A letter
in response has been sent to the Spokane County Jail.
Controlled Substance Act bill signed by the Governor. Tim Fuller, Doreen Beebe and
Susan attended the signing.
The Food and Drug Administration regional leaders met with pharmacy board staff to
discuss mutual items of interest.
Tim Fuller and Susan Boyer were recognized for work with H1N1Vaccine and Pan Flu
Planning.
Tim spent a considerable amount of time focusing on the implementation of two bills
passed by the 2010 legislature.
The first bill authorizes Washington pharmacies to accept out-of-state
prescriptions from ARNPs. The legislation did not authorize acceptance of
controlled substance prescriptions. In addition the laws have not been
amended to be compatible with changes in the practice acts of osteopathic
assistants, physician assistants, and pharmacists.
The second piece of legislation concerns a bill designed to prevent opiate
overdoses with naloxone. The bill provides protections for all of the people
involved and states that a family member, friend, or other person may obtain,
possess, and administer naloxone (injection or inhalation) for opiate overdose.
A number of major cities around the U.S. have naloxone programs. Some use
standing orders and some do not. Susan Teil Boyer and Tim were able to get
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Dr. George Heye, MD, and the Medical Quality Assurance Commission
involved. There is some precedent for patients to receive medication without
being seen by a health professional in the STD Partner Program.
With Leann Georges help Tim was able to eliminate the backlog of collaborative drug
therapy agreements. Tim and Leann continue to work with Customer Service to
standardize the process and obtain reports.
Tim and Susan Teil Boyer have had several conferences calls with the organizers of the
Washington State Pharmacy Association (WSPA) Hospital Pharmacist meeting at Valley
Medical Center on Friday, April 29, 2010. They have been planning the first hospital
pharmacy rule stakeholders meeting. There is lots of interest and enthusiasm among
hospital pharmacist. Several communications have been sent out to pharmacists and
some have already submitted material.
May 1, 2010 a refresher training course was held for the Receiving Storing and Shipping
(RSS) volunteers. Jim Doll and Tim participated representing the quality assurance
program. They are still waiting for an appropriate antiviral storage facility in the
Tumwater area.
May 20, 2010, Pharmacy Leadership Summit: Worked with Janice Rahman, the Clinical
and Pharmacy Operations Program Manager, Preparedness Section / Public HealthSeattle & King County during the CE (continuing education) approval process for the
event.
April 21, 2010, Washington P&T Committee meeting handout: Making it Work a
report by Dr. Jeff Thompson, Chief Medical Officer for Medicaid, on Medicaids
Generics First program that was recently rolled out. HB5892 created this initiative to
increase the use of generics by prescribers. Key points are: patients can continue on their
currents meds; providers can still prescribe their choice of drug based on medical
necessity; outlier prescribers utilizing DAW are identified and provided information on
their prescribing practices to help effect changes in their prescribing patterns.
April 28, 2010 Conference Call with Clover Park Technical College and Spokane
Community College Pharmacy Technician Training Programs: These programs are
keenly interested in developing online pharmacy tech programs, much like what the
North Dakota Board of Pharmacy has successfully been involved with. The programs
were contacted by COL Peter Bulatao, Chief, Pharmacy Branch, of the AMEDD Center
& School at Fort Sam Houston . He is interested in coordinating in this endeavor with
both of the programs. Stay tuned for more information!
Chief Investigator
Month and Year
Completed
New
March
109
2010
Inspections
Open Completed
20
67
Investigations
20
April 25, 2010 Grant gave a law update presentation in Spokane, WA.
April 20, 2010 Grant and the other investigators attended the Investigation and Inspection
Office (IIO) All Staff Meeting in Shoreline. A pharmacy investigators meeting was held
in the afternoon after the all staff meeting.
Grant shared other information with the board regarding.
DEA Requirements for CS Automated Dispensing System in Long Term Care
Facilities, 21CFR1301.27
NABP Advisory Committee on Examinations Meeting Memo (03/18/10)
NCPA Web Page RE: Prescription Disposal Program Toolkit .
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PRESENTATIONS
Washington State Rx Watch
Doreen Beebe introduced Dr. Steve Freng, Psy.D., MSW from the Greater Spokane Substance
Abuse Council. Dr. Freng presented: How Rx abuse is affecting your community to the board.
This program educates communities on prescription abuse. The goal is to raise public awareness
of prescription abuse and its effects on the communities. Covering topics such as:
Commonly Abused Prescription Drugs
Current Trends
Street Use/Pill Mills
Pharmacy Burglaries
Addiction vs. Dependence
Prenatal Prescription Drug Use
Prevention
MOTION: Vandana Slatter moved that the board acknowledges the value and endorses the idea
of the Washington State Rx Watch program. Dan Connolly second. MOTION CARRIED: 6-0.

The board was asked to consider a petition requesting that the board engage in rulemaking to
amend WAC 246-887-280 to add additional controlled substances for use by the Washington
Department of Fish and Wildlife for chemical capture.
The Board of Pharmacy does not have authority to add Sodium pentobarbital euthanasia
solutions to WAC 246-887-280.
MOTION: Al Linggi moved that the board initiate expedited rulemaking to add Butorphanol,
Midazolam, Fentanyl to WAC 246-887-280 for use by the Washington Department of Fish and
Wildlife for chemical capture. This will not include Sodium pentobarbital. Dan Connolly second.
Electronic/Web Pharmacy Law Book

Leann George demonstrated the new printable and searchable law book featured on the Board of
Pharmacys website.
NAPLEX Study Plan

Bhavani Bharathi Sangameshwar a pharmacist intern presented a study plan for consideration by a
panel of the board. She is requesting authorization from the board to re-take the North American
Pharmacist License Examination.
MOTION: Christopher Barry moved to allow Bhavani Bharathi Sangameshwar a pharmacist intern
one more opportunity to re-take the North American Pharmacist License Examination . Vandana Slatter
DISCUSSION
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2010 Legislative Session Report

Susan Teil Boyer updated the board on the 2010 Legislative Session.
Legislative bills affecting pharmacy and health care.
o Uniform Controlled Substances Act 2443
Incorporates carisoprodol as schedule IV.
This bill aligns and conforms the states CSA to the Federal CSA.
o Electronic tracking of pseudoephedrine, phenylpropanolamine 2961
rulemaking and implementation of the program statewide.
Implementation planning .
o Out of state ARNP prescribers
On June 10, 2010 Pharmacists will be able to accept legend drug
prescriptions written from out of state ARNPs. Controlled substances are
not approved. Out of state ARNPs were not included in the CSA.
o Boards and Commissions 2617
Eliminates 4 boards/committees including the EMS Licensing Advisory
Committee and 3 Environmental Health Committees .
Encourages fee based boards to reduce travel and other costs.
o Naloxone distribution
The bill authorizes any person to obtain and utilize naloxone and
administer naloxone to a person suffering an opiate overdose. All parties
are granted protection from prosecution.
Follow laws/rules for prescribing and dispensing.
Work in progress with UW, King County Public Health, King County
Corrections.
o Pain Management Education for prescribers-chronic, non-cancer pain 2876
Rules will be developed for prescribers by five boards and commissions
including Medical Commission, Osteopathic Board, Podiatry Board,
Nursing Commission and Dental Commission. A workgroup will be
formed by these boards to create a model rule.
The internal HSQA steering committee met April 19 and all agreed we
need to have a pharmacist/pharmacy board and staff member participating.
o Expands prescribers who can recommend medical marijuana 5798
o On Line License Renewals by July 2012 6444 .
o Washington Vaccine Association 2551 .
Restores childhood vaccines to all children in the state. Insurers are
assessed to support costs.

Susan Teil Boyer led the discussion with the board to review 2009 - 2011 initiatives, goals, and
strategies. Susan focused on the steps being taken for the board s first goal.
Goal #1: Adopt a process/tool to evaluate rules using criteria based priorities . There continues
to be challenges with the number of rules and the resources to do this. We are making strides on
getting help with this process. We have been able to utilize some Department staff for support to
move forward.
Susan passed out a quadrant that organizes the rules in sections of urgency. This would be a tool
to use for time management. She asked the board for the input on this tool.
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Goal #2: Safe drug delivery system. Dan Connolly was added as a board lead to this goal . Gary
Harris will be attending another Attorney Generals Task Force Meeting.

Goal #3 : Develop a proactive approach to defining and responding to the future of pharmacy . Al
Linggi is prepared to initiate discussions with University of Washington and other colleges.
Scheduling Board Meetings

Doreen Beebe and Susan Teil Boyer presented scheduling options for board business meetings in
2011. Doreen put together a schedule to hold board meetings every six weeks and another one
for every eight weeks.
Christopher Barry shared his concern regarding the second day usually held for disciplinary
hearings. His concern is the board members schedule this day for these hearings and they are
usually cancelled. Could this day be used for other board business meeting items?
MOTION: Vandana Slatter moved the board accept the eight week schedule with a reevaluation after the April 2011 meeting to make sure the board is satisfied with their
commitment to the public, with consideration to include Spokane by using available technology.
With an amendment to use second day to handle discipline and more board business if there is
not a disciplinary hearing. The board members will be rotated to participate on the second day.
Kim Ekker second. MOTION CARRIED: 6-0.
MOTION: Kim Ekker moved that the board skip the business meeting August5, 2010. Motion
was withdrawn to be tabled for discussion at the June 17, 2010 meeting.
EXECUTIVE SESSION
CASE PRESENTATION
DISCUSSION contd
Operating Agreement
Melissa Burke-Cain, ATG and Susan Teil Boyer continued the discussion regarding the draft
operating agreement and addendum between the Board of Pharmacy and the Department of
Health. Each addendum was discussed and the board had many questions and concerns.
MOTION: Christopher Barry moved that the board form a subcommittee to review the draft
Operating Agreement proposed by the Department of Health and draft response language. Once
the response language has been drafted it will be brought back to the board for further
discussion. The board members that volunteered for the subcommittee were Al Linggi,
Christopher Barry and Gary Harris. This will be coordinated through Susan Teil Boyer. Dan
Connolly second. MOTION CARRIED: 5-0.
Guidelines for Pharmacy Technicians Taking Patient Medication Lists
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Tim Fuller asked the board to consider for approval the training standards that have been added
to the Guidelines for Pharmacy Technicians Taking Patient Medication Lists. After further
discussion and questions the board suggested that Tim include more detail in these guidelines .
The board tabled this request until the June board meeting for further discussion.
Disposal of Controlled Substances in Extended Care Facilities Rule Process.

Tim Fuller asked the board to approve the withdrawal of the CR101 amendments to WAC 246865-060 subsection of Pharmaceutical Services Extended Care Facility Rules.
MOTION: Christopher Barry moved that the board withdraw the CR101 to WAC 246-865-060.
Stake holder work was done quite some time ago and there are concerns that stake holder input
may be out dated. Al Linggi second. MOTION CARRIED: 5-0.

Doreen Beebe led the discussion with the board asking them to consider initiating rule making to
issue a temporary practice permit to pharmacy interns and technicians that holds an unrestricted,
active license in another state and are waiting for fingerprint-based national background checks
to be completed.
Doreen provided the board with some back ground along with information from the National
Association of Boards of Pharmacy (NABP) survey of law. This information was provided for
the board to get a feel of what the requirements are for pharmacy technicians and pharmacy
interns. These professions were discussed with the board separately.
MOTION: Christopher Barry moved that the temporary practice permit for pharmacy interns be
addressed in the update of the internship rules to meet Accreditation Council for Pharmacy
Education (ACPE) standards . Christopher Barry moved that the board deny the request to initiate
rulemaking for temporary practice permits for pharmacy technicians. Dan Connolly second.
Rules Update
Doreen Beebe discussed and reviewed the proposed rulemaking workload with the board.
Tamper Resistant: Final stages of being approved. Will be put on the public comment
page in May. This rule is on track.
Electronic Tracking of Pseudoephedrine: Just in the beginning stage. This is legislative
mandate rule and will be top priority. Dan Connolly volunteered to be the board member
assigned to this rule.
Hospital Pharmacy Rules: Scheduling the first stakeholder meeting in conjunction with
the WSPA Hospital Pharmacy Directors Meeting April 30, 2010, Valley Medical Center
in Renton, WA.
Correctional Pharmacies: Hearing August 2010.
Extended Care Facilities Destruction of Controlled Substances: The CR101 will be
withdrawn.
Animal Control rules: Hearing August 2010.
Impaired Pharmacist rule: CR101 is due next month.
Pharmacy Internship rules: Cathy Williams is working on the CR101.
Update Controlled Substance Act: This is an expedited process. A lot of work already
done just a few more updates.
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Temporary Practice Permit for Pharmacist: Hearing in June 2010.

Prescription Record Requirements: CR101 in process.
Veterinary Drug Wholesaler Rules: Susan Boyer is working on CR101
Telepharmacy Rules: No update.
Correspondence
NABP State News Roundup March 2010
ISMP Medication Safety Alert Community/Ambulatory Care edition-March 2010
ISMP Medication Safety Alert Safety Brief March 2010
ISMP Medication Safety Alert Safety Brief April 8, 2010
DEA published new rules in the Federal Register - Electronic Prescriptions for
Controlled Substances
Letter from Spokane Pharmacy Association
Spokane County Jail - response by Nursing Care Quality Assurance Commission
and Board of Pharmacy
NAPB State News Roundup April 2010
ISMP Medication Safety Alert Safety Brief April 22, 2010
OPEN FORUM
EXECUTIVE SESSION
The board met in Executive Session to consult with legal counsel matters relating to enforcement
actions.
CLOSED SESSION
Case presentations
______
April 20, 2010_9:00 a.m.
_______________________________
_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON

MEETING AGENDA
May 17, 2007
Heathman Lodge
7801 NE Greenwood Drive
Vancouver, Washington 98662
CONVENE
Chair Rebecca Hille convened the meeting at 9:01 a.m. on May 17, 2007.
Gary Harris, RPh, Vice Chair
George Roe, RPh
Rosemarie Duffy, RN
Dan Connolly, RPh
Gail Yu, Assistant Attorney General
Guest(s) present:
Steve Singer, Bellegrove Pharmacy
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CONSENT AGENDA:
1.2

Pharmaceutical Firms New and Closed 3/13/07 thru 4/26/07
1.4
1.5
PIMA Medical Institute, Denver CO
Daniela Stamenova
Gabrielle Mones
University of Santo Tomas, Manila Philippines Mignonette Dael
Cairo University, Cairo Egypt Adel Guirguis
University of the Punjab, Pakistan Asrar Haq
Olympia Career Training Institute, Grand Rapids MI Phoebe Nguyen
Manila Central University, Manila Philippines
1.8
Ilwaco, Long Beach, and Ocean Park Pharmacies
Childrens Hospital Dose Rounding

Childrens Hospital Therapeutic Interchange
St John Medical Center Heparin IV Dosing/Anticoagulation
St John Medical Center Medication Refill
April 12, 2007
Items 1.1 Pharmacist License Application Approval; 1.3 Pharmacy Technician Application
Approval; 1.6 Automated Drug Dispensing Device Acceptance; and 1.7 Sample Distribution
Requests were deleted from the consent agenda. ACTION: George Roe moved that the Board
approve 1.2, 1.4, 1.5 and 1.8 of the consent agenda . Gary Harris second. Susan Teil-Boyer
requested 1.5 be deleted; Tim Fuller clarified the issues. Ms. Boyer then moved to approve 1.5.
George Roe second. MOTION CARRIED 6-0.
REPORTS:
Received inquired from media on colchicine deaths; two patients were from Oregon
and one from Washington. It appears the drug was prepared by a pharmacy in Texas
and was shipped to Oregon. The drug was brought into Washington State by a
relative of the deceased patient. At this time, there is no evidence that the pharmacy
shipped directly to Washington State. The Annual Department of Health
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Board/Commission Leadership Meeting was held on May 14 . Rebecca Hille
represented the Board. Topics discussed included: Interagency Guidelines on Opioid
Dosing, Reorganization Update, HealthMap, Performance Guidelines, Legislative
Update and the Performance Audit.
Grace Cheung and Ms. Salmi continue to participate in the HSQA Organizational
Review workgroups.
The Quarterly Investigator meeting will be held on June 6 in Tumwater. Dan

Connolly will represent the Board.
Continue to meet with representatives of the DOH Injury Prevention Program to

prepare for a briefing to Mary Selecky on strategies to reduce poisoning deaths from
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unintentional drug overdoses. The high risk groups include males 35-45 years of age.
Washington State data and national data suggest the increase is due to intentional
abuse of prescription drugs, especially with pain medications.
The Department has contracted with Sterling Associates to conduct a workload

standards study required by SHB 2974. Focus is on disciplinary activities. Goal is to
develop a comprehensive and sustainable measure for allocating workload to respond
to changes in case priorities. Data collection will occur during August, with the final
report due in December.
We anticipate filing the Pharmacist/Pharmacies Responsibilities rules in early June.

A copy of the rules will be sent to all pharmacists and pharmacies.
Will be attending the DEA Annual Conference on June 4-7. The agenda includes
Methadone mortality, pain policy panel discussion, pharmacy theft and scheduling
updates.
The NABP Annual Meeting is May 19-22 in Portland, Oregon. Susan Teil-Boyer,
Gary Harris, Rebecca Hille and George Roe will represent the Board.
Upcoming meetings: Board/Commission/Committee September 27-28, Renton

Holiday Inn; Citizen Advocacy Center Meeting October 31-November 2,
Edgewater Hotel in Seattle.
Staffing Updates:
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Joan Benderson assumed the Credentialing Manager position effective May 7 .
We are currently recruiting for four investigator positions: Central Washington, East
King County, overhire and the precursor investigator. We anticipate holding
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interviews during the week of June 11 .
We are re-allocating the Chief Investigator position to a Pharmacy Supervisor

position to address salary disparities and anticipate opening the recruitment period in
the middle of June.
Interviews for the Executive Director position will be held on May 23 . Rebecca
Hille, Dan Connolly and George Roe are members of the interview panel.
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Interviews for the disciplinary support position were held on May 16 . We hope to
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have the position filled by June 4 .
rd
Rebecca Hille presented plaque to Lisa Salmi in recognition of her leadership as Acting
Executive Director. Lisa thanked the Board and gave recognition to staff.
George Roe attended the Oregon Society of Health-System Pharmacists in Sunriver,
Oregon.
Gary Harris attended the Katterman Lecture for UW alumni pharmacists in Seattle. He
informed them about the electronic newsletter and encouraged sign up.
Dan Connolly represented Bartell Drugs at a conference in Boston.
Rebecca Hille commented on administering the Oath of the Pharmacist to 96 pharmacy
candidates at Washington State University. She also reported on her attendance at the
DOH Leadership Meeting. The Department will have six new license credentials:
registered dental assistants; licensed dental access auxiliaries; certified animal massage
practitioners; licensed athletic trainers; physical therapist assistants; and veterinary
technicians (credential changed from registered to licensed). Dr. Gary Franklin, Labor
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and Industries Medical Director, spoke on the Opioid Guidelines developed by the
Agency Medical Directors Group. Dr. Franklin also shared information on the use of
opioids to treat chronic pain. Laurie Jinkins gave an update on the Health Systems
Quality Assurance reorganization and the performance audit. The company conducting
the audit was impressed by the cooperation of the Department.
Lisa Salmi stated that two of the new professions will be in our section; animal massage
practitioners and the Veterinary Technician.
Gail Yu, attended on behalf of Joyce Roper. Ms. Yu had nothing to report at this time.
Consultant Pharmacist
He will be going to the Wenatchee region to make a presentation to emergency

response personnel on pharmaceutical issues.
The Emergency Response Strategic National Stockpile is still planning on its first full
scale statewide exercise in Spokane later on this year in late October. He
acknowledged challenges still exist in terms of logistics and recruiting volunteers.
Attended a meeting with Nursing Quality Assurance Commission staff regarding

automated distribution devices in nursing home situations. A number of issues were
identified and a task force has been set up to deal with the issues.
Chief Investigator
Grace Cheung distributed copies of the Chief Investigators report highlighting
investigations and inspections for the March and April 2007 and on-going projects.
PH:ARM Pharmaceuticals from Households: A Return Mechanism - Recently

had a third burn and the project is moving forward.
We continue to participate in the Pharm 440 classes at the University of

Washington (UW) School of Pharmacy.
Stan Jeppesen provided a lecture to the Pharmacy Communications class at the

UW regarding dispensing errors.
Bill Kristin recently taught a class in the Spokane area for technicians.
Recognized Jim Doll for his hard work, carrying an extra load and acting in the
capacity of 1.5 FTEs.
Acknowledged that the entire investigative staff has been working hard .
Investigators Meetings
o
June 6/7
Dan Connolly
September 12/13
December 5/6
George Roe
Vandana Slatter
Rebecca Hill e and Dan Connolly both recognized Jim Dolls
efforts and excellent work as well.
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Program Manager
After the last board meeting, she contacted the WSPA and exchanged email address lists. Due to
this, the electronic newsletter has over 4,800 names and addresses in the distribution list and
continues to grow.
GENERAL DISCUSSION
Lisa Salmi reported that next months budget report will show we will be overspent, but we have
the revenue to cover expenses . Received approval to purchase equipment for the investigators
and office equipment. Dan Connolly stated that he distributed a report on abuse of narcotics in
Washington State to all of his pharmacies and feels that it should be distributed to all pharmacies
and pharmacy staff in this state as well . At this time, we are not able to do so, but as the name
and address data base for the electronic newsletter continues to grow, that may become a
possibility. Gary Harris commented on the Katterman Lecture and suggested that the Board
attend every other year.
PRESENTATIONS
Review of Pharmacy Guidelines: Tim Fuller provided the Board with reference materials to aid
in the discussion on the similarities and differences in Remote Order Processing; Central Fill
Pharmacies; Telepharmacy Operations.
Highlights
Central Fill Pharmacies do not provide services to walkup patients. Unless there is
common ownership, the central fill pharmacy must deliver the filled prescription to the
originating pharmacy.
Remote Order Processing of medication orders does not include dispensing the
prescription. Remote order processing occurs from pharmacy to pharmacy; pharmacy to
pharmacist (off-site); pharmacy to hospital; hospital to pharmacist (off-site) and hospital
to hospital. The remote location must have access to the information necessary or
required to process a medication order. Non-resident pharmacies providing remote order
processing must be licensed in Washington. Security of confidential patient information
is paramount.
Question: Is a Washington pharmacist license required for non-resident
pharmacists providing remote order processing from an off-site location?
Telepharmacies operate under the license of the main or central pharmacy and utilize electronic
prescription transmission systems and automated drug distribution devices. The Board does not
have a guideline or set of policies/procedures for telepharmacies primary issues are around
storage and recordkeeping.
ACTION: Susan Teil-Boyer moved that staff create guidelines for telepharmacy operations
and appropriate changes/amendments to the central fill and remote order processing guidelines.
Rosemarie Duffy second. Dan Connolly is assigned as Board Sponsor. MOTION CARRIED
6-0.
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Rule Making Update

Substance Act
Placement of Carisoprodol in Schedule
IV of the Uniformed Controlled
st
Andy Mecca reported that as a follow-up to the March 1 stakeholder meeting an electronic
st
request for comments was sent out on May 1 . Of the five comments the Board received three
supporting the scheduling of carisoprodol based on experience. The Washington State Pharmacy
Association sent notices to membership to coordinate response to the Board. WSPA received 40
comments in support and 1 opposed.
ACTION: Gary Harris moved that the Board postpone its decision on moving forward with the
rules process until the next meeting to allow time to gather additional information. Susan TeilBoyer second. MOTION CARRIED 6-0.
Methamphetamine Workgroup Update:
Jim Doll updated the Board on the activities of the Methamphetamine Workgroup.
The workgroup consists of two retail representatives (Dan Connolly and Lee Worthy), and
representation from the Washington State Patrol (Richard Beghtol), Attorney Generals office
(Chris Johnson) , Pierce County Prosecutors Office (Mark Lindquist), Washington Association
of Sheriffs and Police Chiefs (Scott Smith, Mountlake Terrace Police Chief), and a board
appointed member (Donna Dockter) . The workgroup is drafting a report due to the legislature by
November 2007 to answer 5 key questions regarding the transaction logs used to capture sales of
products containing ephedrine, pseuoephedrine and phenylpropanolamine (EPP) in Washington
State.
1. Is the transaction log or other means of recording a transaction an effective law
enforcement tool?
2. What information is needed to make logs or other means of recording a
transaction a useful deterrent to criminal activity?
3. What is the most effective method of obtaining, recording, and storing log or
other electronic data in the least intrusive manner available?
4. How long should the information recorded in the logs or other means of recording
transactions be maintained?
5. How can logs or other means of recording a transaction be most effectively
transmitted to law enforcement and the state board of pharmacy?
The transaction logs have been an effective tool. They have played a part in the significant
decline on meth labs in Washington State. Has it been a deterrent? It has been a balancing act in
that there has not been a decrease in the use of meth. There has bee n a decrease in mom and
pop operations, however the new source of meth now seems to be Mexican meth.
Several members of the Oregon Board of Pharmacy were in attendance, including Gary
Schnabel, R.N., R.Ph., Executive Director, Ann Zweber, R.Ph., Vice President and Bernie
Foster, Public Member. Mr. Schnabel stated that in Oregon, pseudoephedrine is a prescription
item, not over-the-counter (OTC). He also commented there has been a 95% decrease in meth
labs; they went from 200 per month down to one. Resources once directed to combat the
manufacturing labs and dangerous dumpsites are now directed to combat meth usage.
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Mr. Schnable stated that most people are now buying over the counter products that have been
reformulated and do not contain pseudoephedrine; Oregon is seeing very few prescriptions
written for the pseudoephedrine .
Jim Doll commented that Oregons experience is clearly related to the restrictions on
pseuophedrine sales. The Federal Drug Enforcement Administration mandated that the logs be
retained for two-years, but the issue is how to effectively transmit the logs to law enforcement.
In most cases, counties dont have the staff to go from store to store to collect the data.
Additional issues include legibility and completeness of the logs.
A report is being drafted to show that the vast majority of non-pharmacy shopkeepers have
gotten quit selling pseudoephedrine. Out of 175 shopkeepers, 10 are still selling EPP products.
The Workgroup is considering five options to present to the legislature:
1. Make it a prescription/legend drug
2. Restrict EPP sales to pharmacy only
3. Rescind our Washington law and follow the federal mandates allowing consistency
among the states
4. Require a real-time online electronic log
5. Do nothing (labs are down, the logs have worked and going electronic is expensive)
Mr. Lewis stated that labs are down approximately 80%, but Mexican meth has taken up the
slack. Lisa Salmi spoke briefly about Substitute House Bill 1797 (Title of original bill:
Automating the reporting requirements for ephedrine, pseudoephedrine, and
phenylpropanolamine sales by establishing a state repository) sponsored by Representative Tom
Campbell, who is very interested in this issue .
EXECUTIVE SESSION
The Board adjourned at 11:45 a .m. for the Executive Session to discuss personnel issues and
pending litigation. The Board reconvened at 1:05 p.m. for Presentations and Discussion.
PRESENTATIONS Contd
Bellegrove Pharmacy - The application for remote pharmacy services provided to the
Stillaguamish Tribal Clinic by Bellegrove Pharmacy was approved by the board in April
2005. The Board requested a one year report following the startup of the operations.
Investigators Tim Fuller, Dick Morris and Kelly McLane visited the facility a few months
ago. Mr. Fuller spoke briefly regarding the inadequacy of the camera phone, and then
introduced Steve Singer from Bellegrove Pharmacy for a presentation.
Steve Singer reported that their primary clients are methadone patients, but they do not
dispense methadone. The pharmacy deals primarily in taking care of the other
pharmaceutical needs of the patients.
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Mr. Singer concurred with Tim Fuller that the videophone is inadequate and provides
grainy pictures. The pharmacy is evaluating the internet and web based connections and
pursuing MSN Messenger technology. The videophone has not been replaced, but they
are in the process of acquiring a monitor and speakers within the next 4-6 weeks and are
working on installing a webcam. He stated the phone has never really worked well, but
has been adequate. There have been no dispensing errors with this operation. Before any
prescription is handed out, the label and bottle are scanned, and there is an audio/visual
check. A patient packet insert (PPI) is automatically printed for all new prescriptions,
which accounts for 25% of all prescriptions processed. Their goal is to develop a system
to provide service to significantly rural parts of the state. Dan Connolly questioned at
what point do you need a pharmacist on staff and Susan Teil-Boyer was concerned with
critical access. Mr. Singer stated there are areas where this type of service makes perfect
sense and they are more than happy to work with Tim Fuller on this. ACTION:
Rosemarie Duffy moved to accept the report. Susan Teil-Boyer second. George Roe
opposed it. MOTION CARRIED 5-1.
DISCUSSION
Review Enacted Legislation
HB1103 bills did not pass. This legislation would transfer certain discipline
decision making from Boards & Commissions to the Secretary.
The Department as acquired 6 new professions, and we are getting 2 in our

section.
The Prescription Monitoring Programs discussions continue.
Legislation was passed to assess health care practitioners a $25.00 fee to support
the UW Online Resource Center. Pharmacy was successful in being removed
from this legislation.
DOH will be regulating ambulatory surgical centers and establishing licensing

requirements.
Medical Quality Assurance Commission is doing a study on the source and

distribution of medicinal marijuana and trying to establish what is a 60-day
supply.
The 2008 legislature is a short session and it is undecided at this point if the Department will
have any request bills.
Questions from Field Investigators
Question 1
Can a pharmacy technician compound a prescription when supervised by a pharmacist?
In the Pharmacist Responsibility rules the language permits a pharmacist to allow a technician to
perform bulk compounding from a formula but not pursuant to a prescription. However, the Drug
Compounding Controls subsection of the Good Compounding Practices chapter suggests that a
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technician may compound pursuant to a prescription. This rule requires a pharmacist to check
and recheck at each stage of the process to ensure each weight or measure is correct as stated in
the written compounding procedures. The responsibility and accountability lies with the
pharmacist.
The Board acknowledges that the Pharmacist Responsibility prohibition does not reflect current
practice. ACTION: Vandana Slatter moved that staff develop an interpretive statement for
review and approval by the Board to include definitions of supervision while we pursue the rule
making process for pharmacy technicians compounding extemporaneous compounds. Susan
Teil-Boyer second. MOTION CARRIED 6-0
Question 2
Does the ratio of one pharmacist to three pharmacy technicians still apply if the pharmacy
utilizes an additional technician that is not doing technician duties?
Simply recording on the work schedule which technicians are performing non-technician duties
and when would be challenging for inspectors to assess whether a pharmacy is exceeding the
ratio. There is a provision in the rules where the Board may approve a pharmacys pharmacy
service plan and allow an exception to the 1 to 3 ratio. To promote public health and safety the
Board believes that the 1 to 3 ratio is important. However if there is a reason that a pharmacy
requires an exception to the standard ratio the pharmacy may submit a request to the Board. The
Board finds that minimal overlap of the third and fourth technician meets the intent and spirit of
the law.
Question 3
Can a pharmacy remain open during the prolonged absence of the pharmacist
break?
Not permitted by rule.
example lunch
Request for Public Disclosure Lists and Labels

ACTION: Gary Harris moved that the Board postpone its decision to approve or deny the public
disclosure request by the Washington State Health Care Employees Union SEIU 1199NW until
the Boards regularly appointed AAG is able to provide guidance. Susan Teil-Boyer second.
MOTION CARRIED 6-0. National Association of Boards of Pharmacy Proposed Resolutions
rd
The board discussed proposed resolutions for consideration at the 103 NABP Annual Meeting.
The results are as follows:
Resolution 1:
ACTION: Rosemarie Duffy moved to accept. Susan-Teil Boyer second. MOTION
CARRIED 6-0.
Resolution 2:
ACTION: George Roe moved to accept. Susan Teil-Boyer second. MOTION CARRIED 6-0.
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Resolution 3:
ACTION: Rosemarie Duffy moved to accept. Susan Teil-Boyer second. MOTION
CARRIED 6-0.
Resolution 4:
ACTION: Rosemarie Duffy moved not to accept the resolution due to lack of clarity on how
pharmacists will verify bona fide patient/physician relationships. Vandana Slatter second.
MOTION CARRIED 6-0.
Resolution 5:
ACTION: Susan Teil-Boyer moved to accept. George Roe second. MOTION CARRIED 6-
0.
Mission Statement
The original and proposed mission statements were discussed. The proposed statement
essentially divides the single sentence into two sentences. The first sentence would include the
addition of the word and. The second sentence would include the addition of The Board of
Pharmacy will educate. ACTION: Rosemarie Duffy moved to accept the revised mission
statement. Susan Teil-Boyer second. MOTION CARRIED 6-0.
2008 Meeting Dates
The board discussed establishing meeting dates for 2008 and whether to hold business meetings
on Friday. ACTION: Rosemarie Duffy moved to continue business meetings on Thursdays and
disciplinary hearings on Fridays. George Roe second. MOTION CARRIED 6-0.
ACTION: Vandana Slatter moved to accept the 2008 dates. Rosemarie Duffy second.
MOTION CARRIED 6-0.
ACTION: Vandana Slatter moved to accept March 5
Roe second. MOTION CARRIED 6-0.
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as the planning session date. George
Rosemarie Duffy requested recommendations on other meeting locations throughout the state.
OPEN FORUM
Doug Beeman from Group Health Cooperative addressed the Board on several issues.
Washington Recovery Assistance Program for Pharmacy (WRAPP):
Leon Alzola is the new chair for WRAPP .
There have been 3 incinerations so far and it is going well. GHC is accepting
medications from non-GHC subscribers as well .
New revised brochure will be available soon.
A WRAPP Orientation Continuing Education program has been scheduled for June 22,
2007, in the Department of Health office in Tumwater from 9:00 a.m. -noon.
PH:ARM Project:
10
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Pharmaceutical waste burn programs (similar to the Washington consumer

pharmaceutical waste collection project) and discussion on possible reuse of hospice
program medications were highlighted National Council of Prescription Drug Programs .
General:
Group Health will be requesting a second license to comply with the requirements by
Centers for Medicare and Medicaid Services (CMS) for its mail order pharmacy.
Mr. Beeman has concerns that on the Department of Healths website statement of
charges are listed. He has no concerns regarding the final statement of charges being
listed at the conclusion of the hearing.
Mr. Beeman requested an update on the September 7, 2006, federal register of a DEA proposed
rule revision on Schedule II multiple refills. Andy Mecca said he checked with the DEA a few
days ago and there was no action on the proposed rule.

meet again on July 26-27 in Kent, Washington.
_______________________________
Approved on July 26, 2007
_______________________________
Board of Pharmacy
11
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STATE OF WASHINGTON

May 29, 2014
Red Lion Hotel at the Park
303 W. N. River Dr
Spokane, WA 99201
CONVENE
Chair Christopher Barry called the meeting to order May 29, 2014.
Commission Members:
Gary Harris, RPh,
Steven Anderson, RPh
Nancy Hecox, PharmD
AL Linggi, RPh, MBA
Tim Lynch, PharmD
Staff Members:
Joyce Roper, AAG
Christopher Humberson,
Executive Director
Eleanor Carbett, Pharmacy Investigator
Edina Morgan, WSU Pharmacy Extern
Guest / Presenters:
Jim Hansfield, Clark County Sustainability
and Outreach
Cheryl Pell, Pharmacist in Charge at
Klickitat Valley Hospital,
Prosser Memorial Hospital,
and Quincy Valley Medical Center.
Tracy Clark, Pharmacist in Charge at
Our Lady of Lourdes Hospital
Tommy Simpson, Department of Health,
Military Education Program Manager
Scott Mihulka, PharmD, Pharmacy
Manager Bartell Drugs #59
Billy Chow, RPh, Director of Pharmacy
Operations & Clinical Services
Denis Jason, Compliance Officer at Genoa
Leslie Sherrard, PIC at Genoa in Yakima
Tim Shields, Clinical Psychologist and Director
of Bridges
Sandi Tschritter, Director of the Pharmacy
Technician Training Program at
Spokane Community College
Announcement by Chris Barry:

Tim Fuller is retiring; hes been with the Board/Commission for 22 years and has only missed 2
meetings in that time. We truly appreciate all the work that he has done and will miss him. Thank you
Tim and congratulations!
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1.2 Approval April 17, 2014 Meeting Minutes.
MOTION: Tim Lynch moved that the commission approves 1.2. Steve Anderson second. MOTION
CARRIED: 10-0
MOTION: Steve A moved that the commission approve 1.1. Dan Rubin second.
CONSENT AGENDA
single motion of the commission without separate discussion. If separate discussion is desired, that
item will be removed from the consent agenda and placed on the regular business agenda. Items 2.3,
2.4, 2.5, 2.8 and 2.9 were deleted from the agenda.
April 2014

a. Harrison Medical Center
b. Cascade Behavioral Hospital
a. DocLinks by LIN Software
b. Cardinal Health Radio Pharmaceutical
Dan Rubin moved 2.6 to regular agenda
Tim Lynch recused himself from items under 2.6
MOTION: Dan Rubin requested to remove 2.6 from the consent agenda for further discussion.
Nancy H moved that the commission approve items 2.1, 2.2, and 2.7. Steve Anderson second.
REPORTS
Commission Members
Al Linggi reported:
Al attended the University of Washington practice advisory board; they are looking for a
new Dean.
o University of Washington School of Pharmacy is considering adopting and
publishing a policy concerning the sale of tobacco in Licensed Pharmacies; same
resolution passed by NABP.
Al attended UW curriculum advisory board. Integrating ethics & law classes and redoing
other classes to bring them up to contemporary standards
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Al attended NABP Annual Meeting in Phoenix AZ with Chris H and Steve A. . Pearls on
regulatory affairs.
Elizabeth participated in CDTA discussion on May 27, 2014.
Maureen attended an International conference on Teaching and Learning in Excellence in

Austin, TX. She was awarded an Excellence in Teaching award.
Maureen completed an Austin Community College and ACPE course to become an Instructor in
sterile admixtures, awarded Instructor Credential by ACPE.
Dan Rubin reported:
Dan participated in CDTA discussion on May 27, 2014.
Gary attended University of Washington Annual Katterman Lecture Event.
Sepi participated in CDTA discussion on May 27, 2014.
Kristina Logsdon had nothing to report

Steve attended NABP meeting in Phoenix AZ with AL and Chris H.

o
At NABP, Steve went over 2016 draft proposals with ACPE
Tim Lynch reported:
Tim presented a lecture on Medication Reconciliation at UW for IPPE class
Tim is the chair of the CDTA subcommittee.
Tim chairs the advisory group at ASHP for business development.
Tim assisted in Hospital Leadership Meeting for Pharmacy coordination. Chris H, Don, and
Gordon attended to talk about current inspection process.
Nancy published a paper called CDTA topics for Washington State Pharmacists moving from
dispensing of pills to managing ills that was inspired by the 600+ CDTAs she read.
Executive Director
Attended National Drug Abuse Summit in Atlanta Georgia. 3 day conference involving Law
Enforcement, PMP, Treatment Programs, and Pharmacy. FDA was there.
o
Pearl: 99% of Global production of Hydrocodone & Vicodin is used in the United
States.
Participated in CDTA discussion on May 27, 2014
Point person for the Unintentional Poisoning Workgroup at DOH. Quarterly meeting was at the
end of March. Currently working on ways to reduce opioid abuse, over-dose, and death. Over
600 deaths in Washington State in 2012 related to opioid and heroin use.
Participating in the ongoing compounding rules development sessions
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Participated in Dont Ask, Dont Tell conference with assistant secretary Martin Wheeler on
opioid poisoning.
Attended the Hospital Leadership Meeting for Pharmacy in Renton, WA.
Attended a Naturopathic meeting on May 16 .
Attended NABP meeting in Phoenix, AZ with Al and Steve.
Working to find a successor for Tim Fuller position.
th

Joyce was asked to sit in on Pfizer meeting with a member of the attorney generals policy
office. Pfizer is interested in legislation for next session that will prohibit pharmacy substitution
of non-tamper resistant long-acting opioid products for tamper resistant medication. Pfizer is
expressing concern about the opioid overdoses and believes that non-tamper resistant drugs
should not be substituted for tamper resistant opioid medications.
Joyce sat in on a National Association of Attorneys General (NAAG) phone call with the FDA
about the medication Zohydro. The next NAAG phone call will be with the Zohydro
manufacturer, who asked to be invited to a phone conference with the NAAG substance abuse
th
workgroup. The call is scheduled for June 11 .

Introduced Edina Morgan, WSU Intern working with PQAC for 6 weeks.
Participating in the LEAN process.

Participated in CDTA subcommittee meeting on May 27, 2014.
Participated in a chronic pain Webinar.
Participating in the LEAN process.
Attended the Katterman Lecture and Deans Reception.
Participated in RSS Reception Storage and Shipping Response group exercise.
Supervising Pharmacist Investigator

Participated in CDTA subcommittee meeting on May 27, 2014.
Presented at WSPA Hospital Board of directors meeting with Don and Chris H.
Helping the Staff Committee work on compounding rules .

Eleanor Carbett reported:
Inspecting facilities in Spokane.
Participated in April Teleconference on CDTA. WSU provided the satellite site and is willing to
do so in the future.
CONSENT AGENDA
c. Harrison Medical Center
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d. Cascade Behavioral Hospital
It was recommended that each facility reduce their override medications by 25%.
Both facilities need to address employee termination and time limit to terminate personnel
access to medications. Supervisors (i.e. Charge Nurse) cans give and remove access. Standard
patient care is to remove access within 12 hours.
o
o
This is a condition of approval.
It is on the check list of requirements.

This is a condition of approval.
Concern was expressed about the Medication Restock with no witness required.
MOTION: Dan Rubin moved that the commission approve Consent Agenda Item 2.6 Automated Drug
Distribution Device Approval provided that the above conditions are met. Elizabeth second.
MOTION CARRIED: 10-0
PRESENTATIONS
Military Education and Training Crosswalk
Chris Humberson introduced Tommy Simpson, former Army Master Sargent and current DOH Military
Education Program Manager. Tommy did an informative presentation about crosswalk and assisting
military personnel with their transition to civilian health professional licenses.
Overview
Military to civilian health professions crosswalk document identifies the training received in
each military branch and compares them to the health professions a crossed the state. From this
comparison the military experience and training that equates to the civilian education and
training is established and credentialing is done.
The goal was to streamline the veterans transition to the civilian workforce. This is geared
toward the enlisted individuals, who gained their education and experience while in military
service. The crosswalk document does not address officers, those who gained their education
and training through an accredited college or university.
Only two pharmacy positions are addressed: pharmacy technician and Pharmacy assistant
o
All pharmacy military positions exceed the required standards of their position.
Pharmacy technicians are required to have their national certification through the
PTCB to be duty qualified.
16 weeks of didactic training and 8 months of on the job training.

Pharmacy assistant is a registration that gets on the job training under a licensed
pharmacist.
Presentation is to say thank you for your support and your assistance with the veteran transition.
Washington ranks 10 in the country for military bases and outposts. There are 25 military
installations in Washington. The largest footprint is the Coast Guard, they have 13 posts .
Background checks would only show off-post incidences unless they have lost their credential
through military disciplinary action.
th
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o
o
The reason why milder crimes on-post are not reported is because it is viewed as double
jeopardy. The individual goes through retraining and discipline through the military & if
these mild infractions are reported to the state or DOH then the individual is disciplined
twice.
DT 214 discharge paperwork that says anything other than honorable needs a double
check. This could be an indication of a problem .
Pharmacies are audited on a monthly basis and Tommy has never found a pharmacy
technician to be diverting medication. Usually that is a problem on the provider level.
Telepharmacy Services
Tim Fuller introduced Cheryl Pell, PIC at Klickitat Valley Hospital, Prosser Memorial Hospital, and
Quincy Valley Medical Center. These smaller Eastern Washington Hospitals operate in very similar
ways and all work with Medication Review.
List of Telepharmacies
a. Columbia Basin
b. Coulee Medical Center
c. East Adams Rural
d. Klickitat Valley
e. North Valley
f. Odessa Memorial Healthcare Center
g. Prosser Memorial
h. Quincy Valley
a-1. Our Lady of Lourdes
Overview
Eight small critical care telepharmacy hospitals in Eastern Washington seek to become
approved by the Pharmacy QA Commission. They all are supported by Medication Review
Inc., telepharmacy services vendor. Each hospital provided a description of their operation
including a
A Telepharmacy Hospital Annual Summary Information Form;
Policies and procedures that describe operations with the telepharmacy services vendor
including electronic patient records and scanning between the telepharmacy hospital and
the telepharmacy services vendor
Use of ADDDs;
Electronic supervision of pharmacy technicians, if any: and
Continuous quality im provem ent program s.
There is one other new telepharmacy hospital that seeks approval, Lourdes Medical
Center; Lourdes uses the same telepharmacy services vendor and very similar policies
and procedures.
The increased involvement by the Pharmacy QA Commission with hospital telepharmacies
will provide greater assurance to the Commission that public health is being maintained.
The e i gh t plus one hospital telepharmacies operate in the essentially the same manner.
The electronic supervision of pharmacy technicians needs camera and bar code support.
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MOTION: Tim Lynch moved that the commission approve the remote order entry process as proposed
for 6 months Demonstration Project with provision that immediate supervision by video camera is in
place when pharmacist is not physically on site and development of policy which states what activities
a technician will perform when pharmacist is not physically present. Nurses will double check cabinet
stocked by technician when pharmacist is not on site and in the absence of barcode verification for
stocking medication. Report back on aggregate data - error reporting. Nancy Hecox second. MOTION
CARRIED: 11-0.
Our Lady Lourdes Hospital in Pasco WA
MOTION: Tim Lynch moved that the commission approve the proposal for Our Lady of Lourdes Hospital to
use remote order entry policies and procedures for services by Medication Review during the hours the pharmacy is
closed. Nancy Hecox second. MOTION CARRIED: 11-0.
Clark County Waste Medication Collection

Tim Fuller introduced Jim Hansfield who is presenting a proposal by Clark County to allow pharmacies
to participate in a voluntary program to get unused and unwanted medications out of homes and off the
street. If this program is approved pharmacies can come to the commission for individual approval to
participate.
Background
This program started in April of 2003; it involved pharmacies and sheriff departments in Clark County.
DEA approval was received for the police department take back involvement for controlled
medications. Medications were collected and placed in a box . When the box was full pharmacies
contacted Jim, who sent FedEx out to their site to transport the box of medications to Clark County
Hazardous Waste Vendor. This vendor would see that the boxes were incinerated at a federally
approved facility. Over 42,000 pounds of medication has been collected and destroyed. Program is
grant funded. This year Jim was notified of problems concerning the take back program.
Overview
o Each pharmacy will submit a modification of this protocol to the Pharmacy QA
Commission
o Participating pharmacies will only accept Non-Controlled Substances delivered to the
pharmacies in their original container by Clark County residents.

o No pharmaceutical waste generated in connection with any business activity,
including pharmaceutical samples, will be accepted by this program.

o Medication take-back relies on the use of a locked secure container located in the
participating pharmacies.
o All medications will be secured during collection and tracked in bulk from collection through
to ultimate destruction.
o All reasonable efforts will be taken to eliminate any opportunity for diversion.
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o Controlled substances, sharps, business generated pharmaceuticals and hazardous
materials will not be collected.

This is an opt-in program. Pharmacies may choose to participate but they must present their
policies and procedures to the commission for individual approval.
Concern was express about erecting too many barriers because pharmacies will choose
not to participate in the program.
Want to compare any proposed protocols to Stan Jeppesen Take-Back Protocol.
o Concern was expressed that the proposed system may not be a one-way system if not used
correctly.
Acceptable containers/systems will be approved by the Commission.
o
o
o
The system requires two people to empty a full box.

Which medications are accepted and how the line is drawn.
Controlled substances cannot be collected at the pharmacies. However, if a patient will
take these medications to a law enforcement office in Clark County, they can accept
them.
Only patient owned non-controlled medications may be collected at the pharmacy.
Commercial waste or assisted living medications or similar non-patient specific
medications will not be accepted.
MOTION: Al Linggi moved that the commission accept the protocol for Clark County Take-Back
program with the exception that 2c be modified. Where it reads if container is behind the counter,
shall be totally stricken. And where it reads if the container is in a retail area, staff will open, strike
if the container is in a retail area and begin with staff will open lock and customers will place the
bag in the container. Gary seconded. MOTION CARRIED: 10-0. Elizabeth abstained.
OPEN FORUM
Grant Follow up on Healthcare Entities and concerns about the medical assistants (MA) and
investigators enforcement/interpretation of rules . Who can have access to the drugs? Grant referred to
Ajay Sinah question from the April 17, 2014 meeting about MA scope of practice.
Response DOH is recommending that if a facility has drugs that they get a healthcare entity license.
But there are specifics to who can have access to medications and the Commission is working on
MAs can administer drugs but they cannot go to a cabinet and choose the medication to give.
This is part of the scope of practice.
Grant The exempt narcotic, did we found out about that?

Response DOH has not had a chance to look at it since the last meeting.
EXECUTIVE SESSION
Closed Session.
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CDTA Subcommittee proposal

Tim Lynch Read the recommendation of the subcommittee to be approved at the July meeting.
Summary
Stress that CDTAs are portable documents and it goes with the pharmacist until the pharmacist
or provider involved decide to cancel it or the CDTA expires without renewal.
o
o
CDTAs are not approved by the commission they are only reviewed, accepted, and kept on file.
o
A CDTA is valid as soon as it is signed by both the pharmacist and the authorizing
provider with prescriptive authority.
If a signature or vital piece of information is missing the Commission can request it.
Continually updated means every time a pharmacist is added or removed the list will
reflect that change.
The provider shall set any limits they feel necessary.

However, an employer through policy may limit the implementation of a pharmacists
CDTA within their setting.
The expiration date shall not be more than 2 years after the date the CDTA was signed by the
provider.
o If stated in the CDTA, the expiration date may be shorter than 2 years.
The commission will review and discuss the recommendation for possible approval at the July meeting.
Reporting Tramadol to the PMP

Chris Humberson filled in for Chris Baumgartner for this presentation to the commission. They were
asked to review information to determine whether the evidence supports a potential for abuse in
prescribing or dispensing of Tramadol by licensed practitioners and move forward in the process to
recommend tracking by the Prescription Monitoring Program.
Under RCW 70.225.020

The department shall establish and maintain a prescription monitoring program to
monitor the prescribing and dispensing of all Schedules II, III, IV, and V controlled
substances and any additional drugs identified by the pharmacy quality assurance
commission as demonstrating a potential for abuse by all professionals licensed to
prescribe or dispense such substances in this state
Under WAC 246-470-020
Pursuant to RCW 70.225.020, the pharmacy quality assurance commission may add
additional drugs to the list of drugs being monitored by the program by requesting the
department amend these rules
Overview
Tramadol was approved for marketing as a non-controlled analgesic in 1995 under the trade
name of Ultram. Although the company initially claimed that this substance produced only very
weak narcotic effects, recent data demonstrate that opioid activity is the overriding contributor
to the drugs pharmacological activity. Because of inadequate product labeling and lack of
established abuse potential, many physicians felt this drug was safe to prescribe to recovering
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narcotic addicts and to known narcotic abusers . As a consequence, numerous reports of abuse
and dependence have been received.
Federal government may be looking to re-schedule this med. The DEA is concerned about the
abuse of tramadol.
PMP can choose to change rules to track Tramadol prescriptions for monitoring to occur.
Most internet pharmacies are illegal. Top 3 sellers for Internet sales are Tramadol, Viagra, and
Soma.
Want to draft a letter on behalf of the Commission to encourage the DEA to schedule Tramadol .
After further discussion the commission asked Chris Humberson to draft a letter to DEA to express the
concerns about Tramadol. There will be continued discussion on this issue.
Bartell Drugs Call Center

Cathy Williams introduced Scott Mihulka and Billy Chow who requested that they be allowed to add a
call center to office headquarters in west Seattle. They want to centralize some universal workflow
items to free up pharmacists time and allow the pharmacists to participate in more patient safety
activities.
Al Linggi and Steve Anderson Recused themselves .
Purpose of Proposal
Our purpose is to establish a licensed, but non-dispensing pharmacy call center, located at the
Bartell Drugs Corporate Headquarters, 4025 Delridge Way SW Suite 400, Seattle, WA 98106.
Todays economic climate has made it very challenging for any community retail pharmacy to
remain viable and relevant. Reimbursement rates continue to decline, third party audits grow
increasingly more aggressive and the demands for pharmacies to adopt additional innovative
clinical initiatives that will help payor plans achieve better ratings according to the CMS
guidelines by way of improved patient outcomes has made it critically important for community
pharmacies to seek better efficiencies and afford pharmacists more time to deliver these clinical
services.
Our goal is to centralize the more time consuming and labor intensive pharmacy processing
tasks so as to afford our pharmacists more time to spend on patient centric activities.
EnterpriseRx System
EnterpriseRx is a secure and hosted, workflow-based system that utilizes a centralized
database and allows pharmacists to redistribute tasks and prioritize fulfillment according to
patient expectations in order to help the pharmacist to focus on clinical care related activities.
A key feature of EnterpriseRx is the ability to reassign workload or also known as load
balancing.
Load Balancing
Load balancing is a feature that enables a group of pharmacies to share workload amongst themselves.
With load balancing, you can remotely select and process prescription queues for other pharmacies.
The following are some scenarios where load balancing can be used to share work:
Users at remote facilities can help process queue prescriptions for pharmacies with staffing
shortages.
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Users at 24-hour facilities can help process queue prescriptions during non-peak hours for
pharmacies that are closed in the early morning hours .
Disaster recovery program (extended outage or disruption)
Unusual Rx Volume increases or spikes due to seasonality changes like insurance changes or
public health related outbreak concerns
Adverse weather related events (snow or flooding)
Shared employee expertise such as insurance adjudication related matters
Users can process queue prescriptions from a remote location (e.g., call center)
Benefits of Call Center

Some of the benefits of a call center may include the following aspects:
1) Patient Safety - More time spent on prescription verification/counseling
2) Improved efficiency of existing staff
Enables pharmacist to engage in more patient centric services (i.e. MTMs,
immunizations, travel consultations, CMRs, biometric screenings, counseling)
3) Use of technology driven solutions to assist our facilities without traveling on-site
4) Reduced customer wait times
5) Enhanced overall patient satisfaction and wellness
Establishment of Bartell Drugs Call Center
Functions of the call center will include the following pharmacy practice initiatives:
1) Facilitate processing of new prescriptions, refills and prescription transfer requests
2) Scheduling and/or completion of MTM related activities (by pharmacists, technicians or interns)
as deemed appropriate and allowable by current pharmacy practice rules and guidelines utilizing
both Mirixa or Outcomes MTM platforms.
3) Resource for patient information (i.e. drug related questions) provided by pharmacist or
pharmacy intern under supervision of a credentialed precepting pharmacist .
4) Scheduling for clinical services or compliance/adherence programs (by pharmacist, pharmacy
intern or pharmacy technician as appropriate).
5) Resolving 3rd Party Claims related adjudication and prior authorization issues
These functions will be tracked in a continuous quality improvement program that measures workload
volume in each pharmacy prior to call center induction as well as evaluating the effects of the call
center following implementation (decreased workload as it relates to increased clinical care services).
This was tabled until the July meeting so commission has an opportunity to review Bartells AUP and
Bartells can work on the Q & A issues, whether or not the preverification can be turned on at the call
center site or not. The commission would like to hear more detail on what the pharmacist will be doing
with extra time.
Genoa Emergency Drug Kit

Cathy Williams provided the background on Comprehensive Mental Health, Bridges is a 16 bed facility
that opened in February 2014. Cathy Williams introduced Denise Jason, Leslie Sherrard, and Tim
Shields. Genoa is seeking to stock the Bridges RTF automated dispensing devices for emergent need
only. There are no 24 hour pharmacies in Yakima so Bridges has no other option than to stock
medication for emergency patients because hospitals wont take them.
Background:
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Comprehensive has taken over the mental health care for Yakima Valley Hospital . Memorial
Hospital has 4 mental health hospital beds reserved for co-occurrence medical and psych
patients. Comprehensive will cover all emergency mental health for Yakima County. Bridges is
licensed as a residential treatment facility (RTF) certified by the department of mental health
through DSHS. The policies and procedures follow the DSHS & PQAC medication rules.
Genoa wants to stock medications in two automated dispensing devices and to reconcile their
usages for billing and restocking purposes . More details are located in the presentation. Genoa
does not own the devices located in Bridges RTF but they do service the devices. This proposal
is for when Genoa is closed in the evenings and the weekends. Policies and procedures that
were submitted were developed mostly by the bridges medical director. Genoa will explain how
the P&T process works.
The commission granted a conditional exception for patient care and safety was granted while Bridges
& Genoa works with the commission to find a solution to care for the patients . This will be discussed
further at the July meeting.
Technician Training Program

Cathy Williams led the discussion of the components required in a commission-approved training
program. No State requirement of delineation. ASHP requires experience in the different areas.
After some discussion the commission felt it may be necessary to update the guidelines to include this.
On-line Technician Training

Cathy Williams introduce Sandi Tschritter, Director of the Pharmacy Technician Training Program at
Spokane Community College. This program is ASHP accredited, this was completely voluntary. This is
an informational presentation.
Background
Program became effective in 1998. It is a 3 credit program with 25 students per class because of
the limited Spokane hospital training sites. This program requires 300 didactic hours and 66 lab
hours, which will be changing to 80 hours because of an ASHP accreditation requirement
change. Students are also required to get 352 hours of extern training. ASHP accreditation was
granted in 2002.
Current online program has 13 students and 2 at with our new partner in Olympic College at the
Bremerton WA campus. These online students attend their course classes at Olympic College
and then complete their pharmacy class online with SCC. These students listen to the SCC
lectures via the Tegrity program. This way Olympic College didnt have to get its own
accreditation and the students will graduate from 2 colleges. These students will do their clinical
sites in that area, they dont come to Spokane to do that .
Online students have 3-2-1 Health online course requirements along with other online course
requirements. There is an interactive pharmacology program called mind tap. The students
also view and study from the ACPE and ASHP sterile compounding videos. These students are
required to go to the school for 32 hours of hands on training, 16 hours community and 16 hours
hospital.
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Exams are in proctored area using 2 programs. These programs allow for monitoring and
question shuffling.
Lab competencies of required. Online students must come to SCC for these and maintain sterile
requirements while mixing IVs and breaking ampules.
Spokane Community College Pharmacy Technician Cohort Program
The Pharmacy Technician Program at Spokane Community College is a three-quarter certificate

program consisting of classroom instruction, laboratory practice, and clinical pharmacy training.
The purpose of the program is to provide educational opportunities to individuals that will
enable them to obtain the knowledge and skills to prepare the student to function in alliance
with pharmacists, nurses, and health care providers to offer the best possible care of the patient.
We provide educational opportunities regardless of race, color, national origin, religion, sex,
age, physical challenge, academic dis advantage, or economic status.
Training
Students are trained in all phases of the pharmacy field such as drug products, calculations,
dosages, dispensing techniques, inventory management, and Washington State law. Graduates
will be prepared to work in community, hospital, or a home health care setting.
Students will demonstrate knowledge of legal requirements regarding technician vs. pharmacist
within a pharmacy setting. The program strives to provide theoretical instruction and practical
application in job skill fundamentals. Our objective is to instruct the student in attaining your
goals of acquiring more knowledge, and greater skills to become as asset to the pharmacy
technician profession.
The school stresses skills development, acceptable work attitudes and ethics, proper work habit
and job appreciations, which contributes to a successful and continued employment as well as
satisfying productive life.
Each student is required to complete 176 clinical hours in community and hospital or home
health care for a total of 352 hours.
Completion
After completion of the program, students are required to take and pass the National
Certification Exam before applying for a Pharmacy Technician license issued by Washington
State Board of Pharmacy, which must be renewed each year on their birthday. As of January,
2013, pharmacy technicians in the State of Washington are required to maintain 10 continuous
education credits with one of them being in Washington law.
Graduates
Graduates of the Pharmacy Technician Program will demonstrate accountability regarding drug
identification in a professional matter as well as principles of aseptic technique in regard to safety in the
pharmacy setting.

A panel was chosen to hear James Babb request list and labels for multiple professions including
pharmacist, and pharmacy technicians for statistical analysis and licensed verification.
MOTION: Kristina moved to deny the request . Dan Rubin second. MOTION CARRIED: 6-0
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Chris Humberson led the discussion and review of draft bylaws to provide a framework for commission
operations and management not covered in law or rule.
MOTION: Al Linggi moved that the commission accept the amended draft for the PQAC bylaws as
amended by commission members and Joyce Roper. Steve Anderson. MOTION CARRIED: 10-0
Exception Application Matrix
The commission was asked to consider developing/adopting a tool to use to evaluate applicants with
criminal convictions for investigation, conditions, and issuance. The biggest concern is that the
commission is consistent with at the disciplinary actions they use.
Al Linggi will work with Joyce and someone from legal staff to prepare a matrix that the commission
can approve by the September 11, 2014 meeting.
Correspondence
Response to UW Students' Rulemaking Petition
Fresenius-Foster Pepper PLLC
OPEN FORUM
Billy Chow Healthcare Entity Pharmacy License Question referring to the Bartells Clinics. Will
this Healthcare Entity License affect Bartells Pharmacy facility license? The Clinics will provide
vaccinations and do some point-of-care testing. Wants clarification on how the Commission would
delineate between the two entities if they have the same physical address.
Response The Commission hasnt dealt with this problem before, but the pharmacy license is
separate from the Healthcare entity license
Billy Chow Upon inspection, the investigators will inspect exclusively one area of the other?
Response The clinic would have to order from Bartells Warehouses. One license inspection will
not affect the other.

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16
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STATE OF WASHINGTON

May 30, 2013
310 Israel Rd SE
Tumwater WA 98501
CONVENE
Chair Christopher Barry called the meeting to order at 9:04 a.m. May 30, 2013
Board Members:
Gary Harris, RPh,
Staff Members:
Joyce Roper, AAG
Pamela Sanders, Pharmacy Investigator
Guest / Presenters:
Josh Bolin, NABP Government Affairs Director
Thomas West, M.S., RPh, Pharmacy Operations
for PharmaSyn, LLC
Karen Headlee, Director of Shelter Operations for
the Wenatchee Valley Humane Society
Elizabeth Vincenzi, DVM Washington Federation of
Animal Care and Control Agencies
Howard Crabtree RPh, CEO Seattle Pharmacy Relief
Beverly Schaefer, RPh for Katterman s Sand Point
Sara Mcelroy, PharmD
Carlos Lara, TypeHaus, Inc
Chase Ferguson, Care Pharmacy of the West
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Approval of the April 11, 2013 Business Meeting Minutes
Approval of the April 16, 2013 Special Meeting Minutes
1.1
1.2
1.3
MOTION: Elizabeth Jensen moved that the board approves 1.1 and 1.2. Gary Harris second.
MOTION: Elizabeth Jensen moved that the board approves 1.3. Dan Rubin second. MOTION
CARRIED: 6-0.
CONSENT AGENDA
1)
2)
3)
4)
5)

Ancillary Utilization Plan Approval
(a) Evergreen Hospital and Medical Center Renewal
(b) Ottersen s Pharmaceutical Services Renewal
(c) Swedish Medical Center

(a) Kaye-Smith Enterprises, Inc.
be removed from the consent agenda and placed on the regular business agenda. Items 3, 4, 6, 7, 8,
and 9 were deleted from the agenda.
MOTION: Elizabeth Jensen moved that the board approve items 1, 2, and 5, and remove Item 10
for discussion. Dan Rubin second. MOTION CARRIED: 6-0.
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(b) Kaye-Smith Enterprises, Inc.
Elizabeth Jensen asked about the process for verifying that someone is valid to order paper.
Vendors retain a copy of a person ordering papers license. Doreen Beebe clarified that they are
asked to take reasonable steps to verify that the person ordering has a legal right to order the paper.
There are no rules that establish a specific process. Through legal advice we were advised that we
are approving the paper not the vendor. There is the expectation that the vendor is taking steps to
verify the purchaser. Dan Rubin wanted clarification that this consent agenda item had no
connection to the presentation regarding tamper resistant paper later on the agenda. Doreen Beebe
assured him it was two very separate items.
MOTION: Dan Rubin moved that the board approve items 10. Sepi Soleimanpour second.
REPORTS
Board Member
Dan Rubin reported:
Dan will be going to the Utah School for alcoholism and other drug abuse. He invited other
board members and staff to share issues with him regarding how to handle disciplinary matters
such as; court action, investigations and anything else regarding drug use and treatment.
Gary Harris attended Katterman s lecture and The University of Washington Deans reception a
while back he saw a lot of colleagues there.
He wanted to share what a privilege and what a great time its been serving on the Board of
Pharmacy.
She attended the NABP Annual Meeting what a great opportunity to meet a lot of people. The
topics were very current pharmacy issues. There were a lot of really interesting CE topics
provided at this meeting.
A great topic was about compounding versus manufacturing. The Executive Director of the
Iowa Board of Pharmacy spoke of investigations he has been doing at compound pharmacies.
One CE topic that Elizabeth found interesting was regarding Online Pharmacies and how to
distinguish legitimate from illegitimate sites. Only 2 to 3 percent are legitimate pharmacies. It
is really tough to distinguish the difference.
Another topic was about veterinary pharmacy issues this is big and will get bigger. There was
discussion about helping Pharmacy schools add this to the program to educate our future
pharmacists.
3
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Been reviewing cases that are involved with gray market he feels will be great to have more
discussion regarding the gray market.
Executive Director
th
The regular legislative session ended April 28 and they are now in special session. Sixteen
pharmacy related bills were introduced with several passed into law. More on that in our
legislative update session .
Chris attended the WSPA Hospital Leadership Conference at Valley Medical in Renton to
participate in discussions related to hospital pharmacy issues and fielded questions from the
audience.
He spoke at the WSPA New Drugs/New Laws session in Spokane on April 21 ; a well attended
session and will be attending the Northwest pharmacy Conference in Idaho this coming
weekend to speak on Sunday. Worked with WSPA, the Veterinary Board of Governors and
WSPA to include a CE on veterinary medicine related to pharmacy practice on the program on
Friday morning.
Chris attended two bill signings on behalf of the Board of Pharmacy, on HB 1800
Compounding of Medications and HB 1155, Electronic Transmission of Prescription
information. At the bill signing Chris was also introduced to Senator Randy Becker, Chair of
the Senate Health Care Committee who is looking forward to working with the Pharmacy
Commission.
After the initial posting and response, none of the candidates who applied for the rules position
were suitable, so we are reposting the position to cast a wider net of qualified candidates,
meanwhile Doreen is doing her usual fantastic job in managing this area for the board.
Chris attended the NABP National Meeting in St. Louis with Elizabeth Jensen as the official
board delegate. Elections for officers were held and seven resolutions were offered and passed
after discussion, including Compounding, PBM accountability, Medical Office Compounding
and one supporting the restriction or elimination of Quotas and Metrics being used in a
pharmacy business setting. Oregon was awarded the Fred T. Mehaffey Award for their work on
Business/Drug Outlet rules and the support of NABP to work with all boards of pharmacy
nationwide was confirmed.
Several interesting programs were presented on Pharmacy Compounding, Veterinary Pharmacy

Issues and supply chain variations, Internet Pharmacy issues, Virtual Wholesalers and
Distributors, Biosimilar Drugs, as well as the business meetings to discuss and vote on
measures and elect officers.
He have been assisting in any way possible regarding the OII search for a new Chief Pharmacy
Inspector and we will be involved in the interviewing process for this critical hire.
PQAC Update: Been busy speaking to interested parties regarding the application process for a
seat on the Pharmacy Commission, with the goal of having a packet of candidates to submit to
st
st
Governor Inslees office by July 1 for appointment. These would include a successor to
Donnas seat, as well as five other pharmacist members, two public members, and one
pharmacy technician member. We have been assured that we will have some in place by our
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September 5
business.
th
meeting in Spokane as eight members will be required for a quorum to do
There have been a number of Emergency Planning and response activities and one was a full
scale exercise last week.
Also related to Emergency Planning we are developing operational plan between local health
jurisdiction and pharmacies .

Grant completed our six month (December 2012 May2013) Pharmacy Inspection Customer
Satisfaction Survey which is part of the information packet you have already received. The
averages for Items 1 thru 6 have had a slight drop over the past 2 years which I believe is
partially due to the influx of new pharmacist investigators. Customers that were very satisfied
or satisfied dropped from 98.9% to 98.2%.
The Board of Pharmacy s disciplinary summary for the past four and half biennium. The
number of complaints has risen and at the current rate will exceed 900 for the 2011-2013
biennium. Typically we close 77% of all complaints either before or after investigations.
About 16% of complaints receive either informal or formal discipline and about 7% receive
Notice of Corrections.
Pam Sanders reported:
Compounding course online training target is for investigators to complete the course by the
end of July. This course is a very interesting, intense training.
She will be attending the Utah School of Alcoholism and other drug dependencies.
Pam has been participating in the Emergency Response Planning activities .
PRESENTATIONS
National Association of Boards of Pharmacy Compounding Action Plan and
Pharmacy eProfiles
Chris Humberson introduced Josh Bolin, NABP Government Affairs Direct who presented this plan to
the board.
Overview:
Current Nonresident Pharmacy Regulatory Structure
Existing NABP Infrastructure
Enhancement of Existing Services
Developing a Unified Resource
Assistance from Member Boards
Nonresident Pharmacy Licensure Process Prior to NECC:
Submit application and fee to the board
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Provide proof of licensure from state of domicile

Submit copy of inspection or proof of inspection
Some states require on initial application, but not renewals
Problems with Current Nonresident System:

Boards rely on resident state board s oversight and inspection processes
Boards differ in their oversight due to differences in
Regulatory Structures
Human Resources
Fiscal Resources
Inspection Processes
Boards have had to make licensing decisions without complete information
Due to varying resources, the weakest link breaks the entire system
Existing NABP Infrastructure:
License Verification Services
Disciplinary Clearinghouse HIPDB reporting
License Transfer for Pharmacists
Accreditation Programs
Contracted State Inspection Services
Resident Nonresident
Solution: Enhance Existing Infrastructure Verified Pharmacy Program (VPP):
Extrapolate the successes of the Electronic Licensure Transfer Program and apply it to
nonresident pharmacies and facilities
Create an e-Profile for each pharmacy and link to e-Profiles for key pharmacy personnel
Verify that a qualified inspection has occurred and include this data within the pharmacy
e-Profile
Need Assistance from Member Boards:
In order to make this work, we need to
Establish and identify uniform inspection standards that will satisfy all states
USP 797/795
Routine Inspections
Establish these uniform inspection standards similar to competency assessment and

accreditation programs
Share license status changes and disciplinary actions in real time (NABP existing technology)
VPP A Unified Resource for States:

Verify pharmacy licenses (resident/nonresident)
Verify pharmacist-in-charge licenses (resident/nonresident)
Verify that a qualified inspection has occurred, either by NABP or the resident state in
accordance with the established uniform standards
Report any disciplinary action by another state
All information will be packaged through VPP, within the Board e-Profile Connect interface
Josh Bolin asked the board members to provide him feedback on what he has presented. NABP wants
the boards to be engaged. The goal is to have a qualifie d inspection for these pharmacies. To reach
this goal NABP is again asking that board members provide their thoughts and feedback on what
pieces would make a qualified inspection.
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PharmaSync Remote Order Entry

Tim Fuller led this presentation and introduced Thomas West, M.S., R.Ph, V.P. Pharmacy Operations
for PharmaSyn, LLC. He presented the proposal to provide remote prescription processing services
from its pharmacy in Spokane, WA to its licensed pharmacy in Milwaukie, Oregon.
Overview:
PharmaSync, an Oregon LTC pharmacy, wishes to utilize a facility in Spokane to supplement

their current prescription processing operations at the PharmaSync pharmacy in Milwaukie,
Oregon. The orders processed would only be for the Oregon pharmacy. The pharmacy
technicians at the Spokane operation will be supervised by a pharmacist and a three technician
to one pharmacist ratio will be maintained. All pharmacy technicians and the pharmacist will
be licensed in Washington State. A pharmacy license is being processed for the Washington
facility.
The requestors state that they have been unable to find pharmacy technicians in Oregon who
have the skills to operate their new LTC Framework computer. That is the reason to utilize
pharmacy technicians in Spokane.
The Washington PharmaSynch facility will operate according to the following criteria.
1) No storefront retail pharmacy operation will be established in Washington.
2) No prescriptions for WA residents will be processed in this facility.
3) The purpose of the facility is to supplement pharmacy data entry functions through remote
order processing securely linked to the PharmaSync pharmacy system in Oregon.
4) The Spokane facility will be drugless and will not have drugs or equipment for processing
prescriptions.
They have licensed the Milwaukie, Oregon pharmacy. They will license the Spokane facility
as a nonresident retail pharmacy. The Oregon Board is about to post several new rules
concerning Central Pharmacies, Central or Remote Processing, and Workload Balancing.
Expect adoption by August.
The PharmaSync request is for approval of the PharmaSynch Spokane facility to remotely
process LTC medication orders. The request provides policies and procedures (included) that
satisfy the Washington State Board Guidelines for Remote Processing of Medication Orders.
After listening to the presentation the board had some concerns. The plan seemed to change and the
information they provide d didnt match the presentation. They also did not have a utilization plan.
The board tabled this presentation until the July 18, 2013 meeting. They would like to see updated
documents on what exactly they are asking and a utilization plan.
Karen Headlee, Director of Shelter Operations for the Wenatchee Valley Humane Society presented
the euthanasia-training program and supplemental training materials for board approval.
Course Outline:
Training shall consist of two parts; lecture and practical training.
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It will be taught by Karen Headlee, Director of Shelter Operations. ( The first class will be
instructed by Dr. Jerry Winters DVM in which Karen Headlee will attend, then Karen will teach all
subsequent classes thereafter )
There will be a minimum of a 3 hour lecture to go over the Wenatchee Valley Humane Society
Training Manual and 1 hour demonstration and hands on practice of techniques. If the materials
cannot be covered sufficiently in the allotted four hours, additional time will be scheduled. Each
Employee of the WVHS will have to log 3 dogs and 3 cat euthanasias with the Director of Shelter
Operations before getting their certification.
Trainees will be required to have and read the training manual developed by the Wenatchee Valley
Humane Society. They will also have access to The Humane Society of the United States
Euthanasia Training Manual by Rebecca H. Rhoads, DVM
The details in these references shall be the basis for the training lecture.
Verbalized questions will focus on safety issues and what will be done if something goes wrong.
After training is completed, a certificate will be awarded: Certificate of Successful Completion of
Washington State Board of Pharmacy Approved Euthanasia Training Course .
The Wenatchee Valley Humane Society will keep a log of all people certified through this course
and keep the record for 2 years after certification.
After completion of the training program, the student must pass a written test with a passing score
of 75% or greater and pass a practical test consisting of euthanasia of a dog and a cat. The student
will explain the complete process step-by-step while performing the procedure.
MOTION: Dan Rubin moved that the board approve Shelter Operations for the Wenatchee Valley
Humane Society s euthanasia-training program and supplemental training materials. Gary Harris
Elizabeth Vincenzi, DVM presented the Washington Federation of Animal Care and Control Agencies
euthanasia-training program for board approval .
GOALS OF TRAINING
Develop understanding of how to perform euthanasia correctly and humanely
Washington State laws
What is euthanasia
Drugs used
Injection techniques
Addressing problems
Verifying death
Developing protocols
Creating a space for euthanasia
Protecting yourself physically and emotionally
Record keeping requirements
AVMA PANEL ON EUTHANASIA
IV injection of barbituates (sodium pentobarbital) is the preferred method for dogs, cats, small
animals, and horses.
Sodium pentobarbital is the only controlled substance allowed by Washington State Law for
registered shelters to order and use. Can only be used for euthanasia.
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SITE SECURITY FOR CONTROLLED SUBSTANCES

Controlled substances (and legend drugs) must be stored in a substantially constructed, locked
cabinet or drawer.
If controlled substances are to be carried in a vehicle, field supply should be kept in locked
metal box securely attached to inside of vehicle.
Access to the drug supply should be limited to supervisors, veterinarians, and CETs
Appropriate logs recording:
Main inventory
In-use inventory
Every 6 months inventory - WA
Biennial (every 2 years) inventory - DEA
EUTHANASIA CRITERIA
Community expectations of animal shelters have changed over time
Shelters should create criteria and protocols to address ways of increasing adoptions, reducing
the number of unwanted animals, and selecting animals for euthanasia.
Documentation of numbers can help educate the community on overpopulations and spur
community action
Age, health, temperament, physical condition, behavior, available space, breed
Is there hope for alleviating pain or distress?
In the present condition, does the animal pose a health or safety risk to other animals or people?
OVERVIEW OF EUTHANASIA
Reason for euthanasia

Behavior/medical issues to know about?
Confirm that you have the right animal
Scan for microchip
Choose injection site
Choose restraint method appropriate for the animal and injection site
Perform euthanasia
Confirm death
MOTION: Elizabeth Jensen moved that the board approve the Washington Federation of Animal
Care and Control Agencies euthanasia-training program. Sepi Soleimanpour second. MOTION
CARRIED: 6-0.
NAPLEX Study Plan

The pharmacy intern requesting authorization to re-take the North American Pharmacist License
Examination was not able to make it to the board meeting so this item was postponed.
Non-Routine Collaborative Drug Therapy Agreements
Collaborative Drug Therapy Agreement (CDTA) Background:
Collaborative drug therapy agreements (CDTAs) must comply with RCW 18.64.011(23) definition of
the practice of pharmacy and WAC 246-863-100 pharmacist prescriptive authorityprior notification
of written guideline or protocol required (included).
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Many years ago the CDTA were pharmacy-based with a contact pharmacist for each pharmacy having
a CDTA. Ten years ago the board defined the pharmacist CDTAs as individual credentials. DOH
staff set up a credentialing system to document the agreements for the individual pharmacists .
CDTAs of individual pharmacist collaborative agreements are recorded in the DOH credentialing
computer. To process the greatly increasing numbers of CDTAs, however, the staff has worked with
corporate entities and large pharmacies to help manage the paperwork associated with the credentialing
process. Corporate management or pharmacy owners have now assumed control of pharmacist
collaborative agreements from the individual pharmacist and have used the pharmacist CDTAs to
implement questionable practices that could negatively impact public health and safety. Pharmacists
have complained to the board staff that they are coerced to meet quotas without the resources needed.
Communication with the CDTA authorizing physician is managed by the corporation or owner and the
individual.
Seattle Relief Agency Immunization Agreement

Seattle Pharmacy Relief (SPR) provides temporary pharmacists as needed by pharmacies. The CEO
Howard Crabtree wants the relief pharmacists to have immunization agreements so the relief
pharmacists can maintain immunization services at the pharmacies. Howard submitted his
immunization agreement to include the relief pharmacists. With a few minor changes the submitted
immunization collaborative agreement is acceptable. The issue that has arisen is who owns the
immunization collaborative drug therapy agreement?
After further discussion the board has concerns that this has become a corporate to prescriber
agreement not a pharmacist to prescriber agreement. Tim Fuller and Chris Humberson will work with
Howard Crabtree on how to resolve this. Agreements will go back to individual pharmacist and
prescriber relationship. It was suggested that Howard ask his prescriber to develop a CDTA with each
pharmacists at the relief pharmacy.
Treatment of Minor Ailments in an Ambulatory Setting

Beverly Schaefer, RPh for Kattermans Sand Point Pharmacy shared a power point presentation with
the board regarding her proposal for the board to accept this non- routine CDTA.
History of Project
FDA consideration of 3 rd class of drugs
Background
Testimony March 2012
Results no opinion!
How can we move forward locally?
Infrastructure: CDTA in Washington
Need: Develop list of potential drugs that pharmacists can use to treat minor ailments
Infrastructure + Need = Action!
Overarching Goals
Increase access to health care using pharmacists clinical skills
Decrease cost to the health care system
Create additional revenue sources for pharmacists and WSPA
First Steps
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Identify unmet needs

Minor ailments
Patients in gray area of health care system
Experience in pharmacy/working with patients
Utilize relationship with providers
Floated clinical pharmacist idea to several area MDs
Listened for MD concerns about pharmacist ability to initiate patient care
For the Patient

Develop Patient Handout
Disease-state focused
Symptoms
Causes
Self-care
Treatments
Prevention
When to see provider
Increase patient awareness of pharmacist clinical consultation
Revenue Stream
Individual Pharmacist
Charge for the services at selected market price
WSPA
Charge for certificate training program
Next Steps
Pharmacists in WA
Utilize educational opportunities
Confer with practitioner of choice for CDTAs
Use the CDTA list as a starting point
Outcomes Measurement
Publication
Share model with others
Beverly Schaefer, 1 st Clinical Community Pharmacist
Expand program
MOTION: Elizabeth Jensen moved that the board accept Katterman s Sand Point Pharmacys
Treatment of Minor Ailments in an Ambulatory Setting. They are asked to report back after a year
and provide the board with an update. Dan Rubin second. MOTION CARRIED: 6-0.
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PRES E NTATI ONS Cont d

Tamper Resistant Prescription Pads/Paper
Carlos Lara, representing TypeHaus, Inc. demonstrated FormJet Prescription Secure, and a printing
system intended to meet the tamper resistant security features required in RCW18.64.500.
About TypeHaus
Developer of printing solutions for small, medium and enterprise business.
Solution and technology partner with major printer manufacturers.
Tamper resistant paper cost an average of $0.14 to $0.20 per page.
Avoid costly thermal printers.
Designed to prevent unauthorized copying of a completed prescription.
Maximize detection in order to minimize fraud.
Resides between host application and the printer.
Simplify enterprise wide deployment.
Niche expertise in PCL5 (printer command language) print stream transformation and
manipulation.
Custom & ready-to-ship solutions: 1D and 2D barcodes, electronic forms, secure check
printing, prescription printing and other elements to extend printing capabilities .
Reduce Costs
Tamper Resistant Paper
Security risk with potential theft of tamper resistant paper.
Blank paper cost: $0.001

Printer Hardware and Toner
Use cost effective printer hardware.
Eliminate costly specialty toner.
Increase printer utilization.
Eliminate tray locks.

Overview:
Designed to prevent the erasure or modification of information written on the prescription
Designed to prevent the use of counterfeit prescriptions.

AuthentiGrid Security
Taking security one step further.
FormJet PRO
FormJet solutions arrives pre-programmed.
Regular printing is not affected.
No third party software is required.
Device is printer specific .
Recalibration process (new printer)
FormJet PRO adds security features as necessary and passes print job to the printer
Quick and easy installation.

FormJet Enterprise
Centralizing configuration and management.
Easily supports over 100 printers.
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New prescription printers can be added on the fly.

Small form factor PC.
Yearly license model (per printer).
No third party software required.
All support provided by TypeHaus.
The board had serious concerns regarding the security of this printing system. This is on plain paper
and there is no thermo chromatic ink. Some board members felt this could be confusing for
pharmacists.
MOTION: Gary Harris moved that the board deny the proposal for TypeHaus Incs. use of
FormJet Prescription Secure, printing system. Elizabeth Jensen second. Emma Zavala-Suarez
abstained. MOTION CARRIED: 5-0.
Automated Drug Distribution Devise Approval

Chase Ferguson for Senior Care Pharmacy of the West presented a proposal for the non-resident
pharmacy to provide services to multiple Avalon Health Centers located throughout the state via
ADDDs.
The Need
More demands for care givers time has created a greater need for pharmacies to have more
medications readily available.
Automated dispensing cabinets serve as a bridge between pharmacy and nursing to help
overcome this issue.
Why does this need extend beyond hospitals?
First generation cabinets have stationary/open pockets.
Is it practical in long term care?

The Problem
This means very little security.
Chance for miss-placement of drugs.
Pharmacy labor moving to machine site for stocking.

The Solution:
Pyxis CUBIE System
SEPERATION OF DUTY
Licensed pharmacy personnel stock the CUBIE in the pharmacy, using the CUBIE
Replenishing station.
Nursing staff load the CUBIE into the Pyxis machine.
They can t load it incorrectly.
They can t touch the medication.
SECURITY
The CUBIE allows the medications to be securely transported.
A barcode on the CUBIE used with the Pyxis machine means the right drug gets
stored in the right place.
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Once a nurse appropriately authenticates her logon and requests the pre-approved dose,
he/she will only have access to the right drug.
MOTION: Elizabeth Jensen moved that the board approve the proposal from Senior Care Pharmacy of
the West, the non-resident pharmacy to provide services to multiple Avalon Health Centers located
throughout the state via ADDDs with the amendments suggested by the board. The amendments are; to
clarify for emergency use only, terminate users and patients no longer at the facility within 12 hours
and change authorized users to licensed pharmacist and pharmacist s technicians. Gary Harris second.
DISCUSSIONS
2013 Legislative Wrap-up and Rules Update
The board discussed implementation of legislation and updates on rulemaking activities.
SHB 1182
Adds pharmacists to RCW 69.41.030 as a practitioner with CDTA; we are already in
RCW 69.50 effective July 28, 2013.
HB 1609
Renames the Board of Pharmacy to Pharmacy Quality Assurance Commission,
increasing membership from 7 to 15 members. (10 pharmacists, 4 public, 1 technician)
effective date 07/28/13 except section 45 (UDA) which becomes effective on 07/01/16.
EHB 1538
Allows a registered nurse who is licensed under chapter 18.79 RCW and who is an
employee of a local health department or district or a clinic or facility under contract
with a local health department or district, may dispense a drug or device for purposes of
prevention or treatment of a communicable disease or family planning. Reintroduced
HB 1800
EHB 1808
HB 2022
and retained in present status in senate Rules Committee for 2nd reading on
05/13/13.
Allows the compounding of medications for physician offices, ambulatory surgical
centers, or ambulatory surgical facilities to be used by a physician for ophthalmic
purposes for non-specific patients effective 05/07/13.
Addresses the situation where a legal amount of marijuana is found at a retail store that
holds a pharmacy license. The store manager or employee must promptly notify the
local law enforcement agency, after notification to law enforcement the store manager
or employee must properly dispose of the marijuana effective 07/28/13.
Requires pharmacies and insurers to pay for up to one years supply of birth control
medications at a time. Reintroduced and retained in present status in house Rules
nd
ESB 5104
SSB 5148
Committee for 2 reading on 05/13/13.

Places epinephrine auto-injectors in schools, companion bill to HB 1578 effective
07/28/13.
Allows drug manufacturers, drug wholesalers, hospitals, pharmacies, nursing homes,
boarding homes, adult family homes and medical clinics, to donate (return) drugs in an
original sealed and tamper evident package, or open package, if it contains a single unit
doses that remain intact (excluding controlled substances and with at least 6 month
remaining on the expiration date). These donations may be made to a pharmacy for
redistribution without compensation or the expectation of compensation. The pharmacy
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SB 5149
2SSB 5213
SSB 5416
SB 5459
SSB 5524
SB5934
may redistribute the drugs to another pharmacy, pharmacist, prescribing practitioner for
use to treat uninsured and low income individuals effective on 07/01/14.
Concerning crimes against pharmacies, creates a one year sentencing enhancement for a
person convicted of a robbery offense committed against a pharmacy effective on
07/28/13.
Requires managed care plans contracting with Medicaid to require that any patient with
five or more prescriptions be place in an automatic review process with a primary care
provider to ensure appropriateness and screen for drug interactions at least annually
effective on 07/28/13.
Modifies RCW 69.41 and RCW 69.50 to allow electronic transfer of schedule II
controlled substances and standardizes language. Substitute bill standardizes language
in RCW 69.41 and RCW 69.50 effective 0728/13.
Under certain circumstances, a pharmacist is allowed to dispense up to a 90 day supply
if the valid prescription specified an initial quantity of less than a 90-day supply
followed by refills. The pharmacist must notify the prescriber if dispensing an increase
in dose units. Companion bill HB 1583 effective 07/28/13.
Authorizes Washington pharmacies to fill prescriptions written by physician assistants
in other states. Companion bill HB 1596 effective date 07/28/13.
Recognizes limitation on individual pharmacy providers and allows for facilitated
referral. Referred to senate Health Care Committee on 05/15/13.
Next major legislative date is June 11, 2013 which is the last day allowed for this special session.
Delegation of Authority
The board reviewed and discussed delegation of signature authority to department staff and delegation
of decision-making under RCW 18.130.050(8) to act on behalf of the board on summary actions when
a respondent is prohibited from practicing in another state due to unprofessional conduct .
MOTION: Dan Rubin moved that the board renew its delegation of signature authority to department
staff and delegation of decision-making under RCW 18.130.050(8) to act on behalf of the board on
summary actions when a respondent is prohibited from practicing in another state due to
unprofessional conduct. Emma Zavala-Suarez second. MOTION CARRIED: 6-0.
Correspondence
a) Letter requesting clarification of patient counseling requirements.
b) Just Culture Transformation PowerPoint
c) Response to Petition Gerald Steel, PE King Co Citizens Against Fluoridation, and
WA Action for Safe Water
OPEN FORUM
The purpose of the open forum is to provide the public an opportunity to address the board on issues of
significance to or affecting the practice of pharmacy that are not related to topics for which a hearing
has or will be scheduled.
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CLOSED SESSION
Next scheduled business meetings: July 18, 2013 9:00 a.m.

Blackriver Training and Conf Center
Puyallup Room
Renton, WA 98057
Respectfully Submitted by: Leann
George, Program Support


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MEETING MINUTES
June 1, 2006
Point Plaza East Conference Rm 152/153
310 Israel Road SE
Tumwater, WA 98501
(360) 236-4825
CONVENE
Chair Asaad Awan convened the meeting at 9:03 a.m. on June 1, 2006. Board Members present:
Donna Dockter, RPh
Gary Harris, RPh
Rosemarie Duffy, RN
Absent Member:
George Roe, RPh
Jennifer Wells, Program Support
June 1, 2006
Open Meeting
CONSENT AGENDA
1.2
Report of opened and closed pharmacy firms from 04/08/06 thru 06/15/06
1.3
Lorna R. Mayo
1.4
Kmart Pharmacy
1.5
Scott White/Anti-Malarial Prophylaxis
Scott White/Altitude Sickness
Scott White/Epi-Pen
Scott White/Motion Sickness
Jennifer Matin/Anti-Malarial Prophylaxis
Jennifer Matin/Travelers Diarrhea
Jennifer Matin/Altitude Sickness
Jennifer Matin/Epi-Pen
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Jennifer Matin/Motion Sickness

Roger Woolf/Anemia
Items 1.1- Pharmacist License Application Approval; 1.6- Automated Drug Dispensing Device
Acceptance; and 1.7- Sample Distribution Requests were deleted from the consent agenda.
MOTION: Rebecca Hille moved to accept 1.2, 1.3, 1.4, 1.5, and 1.8, with correction to page 3,
Susan Teil-Boyer made reference to the American Pharmaceutical Association (APhA) conference.
MOTION CARRIED.
REPORTS
Executive Director Steven Saxe reported on the following:
Tim Alden was reappointed to the Dispensing Optician Examination Committee.
Dr. William Keatts was appointed by Governor Gregoire on May 5, 2006, to
serve on the Veterinary Board of Governors.
In 2005, methamphetamine precursor law ESHB2266 required the establishment
of a task force comprised of representatives from the Board of Pharmacy, legal,
law enforcement, and retail industries to evaluate the efficiency of the retail
transaction logs for products containing ephedrine, pseudoephedrine, or
phenylpropanolamine as a deterrent for methamphetamine production. A report
to the legislature is due November 2007. On April 25, 2006, representatives of
the retail businesses tasked with maintaining these logs selected two
representatives to the Methamphetamine Work Group. The Work Group had its
first meeting scheduled for June 13. Members include: Donna Dockter, Board of
Pharmacy; Chris Johnson, Attorney Generals Office; Mark Lindquist, WA Assoc
of Prosecuting Attorneys; Gary Gasseling, Washington State Patrol; Scott Smith,
WA Assoc of Sheriff and Police Chiefs; Lee Worthy, Safeway; and Dan
Connolly, Bartell for retail.
BOARD MEMBERS
Rebecca Hille and Asaad Awan attended the Board and Commission Leadership Forum on April
th
26 . The discussion included roles and relationships, disciplinary sanctions, sexual
abuse/misconduct, etc. Ms. Hille has requested to participate on a task force developing
recommendations for revisions to the Uniform Discipline Act (UDA).
Donna Dockter attended a University of Washington town hall meeting in which the guest speaker, a
pharmacist from Oregon, discussed the states Death with Dignity laws and related dispensing
issues.
CONSULTANT PHARMACISTS
Tim Fuller provided an update on the Drug Disposal meeting sponsored by the DEA.
Mr. Fuller presented at a meeting in Spokane Region 9, regarding emergency response. He attended
a course on Clear Rule Writing. Grace Cheung, Tim Fuller, and Andy Mecca attended the State
Investigator Training course.
Andy Mecca updated the Board on the collaborative work being done by the Department of Health,
Labor and Industries, Department of Corrections, and other agencies in establishing opioid dosing
guidelines. Meetings are still progressing. This group is working on developing guidelines to ensure
the safe use of opioid pain relievers for treatment of non-cancer pain. A guideline has been drafted
and continues to be refined. Final guideline will be reported to the Board.
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CHIEF INVESTIGATOR
Along with Tim Fuller and Stan Jeppesen, Ms. Cheung attended the Drug Disposal Meeting
in Portland, OR. They participated in discussions regarding the appropriate disposal of drugs
in the community setting. Participants included: the Drug Enforcement Administration,
representatives of the Oregon and Montana Boards of Pharmacy, and various environmental
agencies from the northwest region.
Weekly participation in the University of Washington (UW) Pharm 440 communications lab
class is coming to a close. The investigators involved this year include Tim Fuller, Stan
Jeppesen, Kelly McLean, Andy Mecca, Dick Morrison, and Grace Cheung. This class
provided investigators with an avenue to share the Boards expectations with current and
future pharmacists who work with these students/interns.
On May 4, 2006, Steven Saxe, Andy Mecca and Ms. Cheung met with UW and Washington
State University instructors to discuss Internship and Preceptor issues.
Stan Jeppesen gave a lecture to UW pharmacy students regarding implementation of Quality
Improvement Methods in the Retail Pharmacy Environment on May 8, 2006. This lecture
was aimed at ways of reducing dispensing errors.
On May 8, 2006, Jim Doll provided a joint presentation with Pierce County Prosecutor on
prescription forgeries and the legal consequences at Multicare Medical Center, Tacoma.
On May 18, 2006, Jim Doll provided a joint presentation with Pierce County Pharmacy
Association entitled, Update on pending pharmacy rules.
From May 19th to 21st, 2006, Ms. Cheung and Dick Morrison drafted new law exam
questions to be introduced into the Washington state pool of questions for the Multi-state
Jurisprudence Exam (MPJE). Dick was one of a few MPJE Review Committee members
who were tasked to assist representatives from each state in drafting quality questions.
PROGRAM MANAGER
Doreen Beebe reported on the following:
Introduced Jennifer Wells, who was appointed to the new Board/Committee support position
th
on May 15 .
A New Board Member Orientation was held on May 31, 2006. This is a great source of
information for new board members to learn about their role and responsibilities as members
of a gubernatorial board.
There is an upcoming Rules Hearing on July 20 th regarding Automatic Drug Distribution
Devices.
May 2006 Budget reports were distributed for members to review.
PRESENTATIONS
eClinicalWorks
Tim Fuller provided an introduction to a presentation by eClinicalWorks. Mr. Bhavin Shah
presented an online demonstration of eClinicalWorks electronic prescription transmission system to
the board for approval. The demonstration highlighted the required elements. eClinicalWorks will
add to its fax transmission the name or logo of the electronic system.
Key Points
System includes list of all medications available on the market today.
Gives an alert to the doctor when prescribing a medication from the same family of
products as the previously prescribed medication. (Alerts of duplication)
Will allow input of weight-based medications.
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Will alert of interactions, gives the prescriber a list of options to choose from of
interactions and the prescriber can review the interactions (drug-drug, drug-food, etc .)
Has option to show no substitute , generic prescription name, can add coversheet, and
prescriber can add comments.
Prescriptions are faxed only, each fax shows who prepared the prescription and adds a
unique transaction identifier.
Prescriber can input patients preferred pharmacy, or any pharmacy of the patients
choice.
System prints DEA# and License # on prescription, and can also add new signature to
prescription other than one saved in the system for each provider.
System keeps a log and copies of each fax.
The system stores all sent faxes infinitely.
Has ability to search prescription history by date or by patient.
MOTION: Susan Teil-Boyer moved to approve the electronic prescription transmission system by
eClinicalWorks. MOTION CARRIED.
Design Clinicals LLC
Tim Fuller provided an introduction to a presentation by Design Clinicals LLC. Design Clinicals
LLC has requested approval to establish an Electronic Prescription Transmission System.
Dr. Charles Butler, MD, (Valley Medical Center) provided an introduction to his business which is
comprised of 4 partners, of which, 2 are physicians. They began their business in August 2005 with
the idea of improving communication with MedsTracker between physicians and patients in regards
to tracking and prescribing medications.
Key Points
Web-based, extracts list of medications downloaded from Electronic Medical
Records software by McKesson.
Currently prints prescriptions for faxing or delivering to pharmacy. This program is
not currently an electronic sending system, although it possibly will be in the future.
Provides security by ensuring unique user identification with encrypted passwords.
User IDs associated with specific roles.
Has audit function to record the date, time, and user that accessed the system.
Has login timeout of 3 minutes.
Has a user self audit for verification of usage. Allows user to ensure account was not
used by anyone other than the user themselves.
Has detailed keystroke auditing showing each step the user took.
All data is reviewable.
NCPDP Basic Guidelines compliant.
Shows medication history, dosage, usage, and timelines.
Patient drug profiles.
Compliant with controlled substance regulations.
Drug use review, medication error, quality assurance.
Allows history search.
Key Concerns
Does the system allow the prescriber to select non-formulary drugs?
MOTION: Donna Dockter moved to approve the electronic prescription transmission system by
Design Clinicals, LLC. MOTION CARRIED.
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DISCUSSION
Pharmacist Responsibilities Draft Rule Language
nd
The Board discussed the draft rules from the May 2 meeting and reviewed Washington laws related
to conscience clauses and discrimination. In addition, they referenced other states regulations and a
list provided to Donna Dockter by other pharmacists of non-clinical situations when a pharmacist
may choose not to dispense.
The Board discussed which draft rule version to adopt and each Board member stated their
preference of the two drafts. MOTION: Rosemarie Duffy moved to accept the first draft rule
nd
language (Draft 1) from the May 2 Meeting. MOTION FAILED with a vote of 2 (Duffy, Harris)3 (Docktor, Hille, Teil-Boyer), the Board Chair did not vote.
The Board adjourned for a 15 minute closed session to discuss potential litigation.
The Board amended both rule language drafts and developed a third draft.
Subsection (1) reads: Pharmacists and ancillary personnel shall not obstruct a patient in
obtaining a lawfully prescribed drug or device .
Add: Second sentence of Draft 2 omitting stocked
Add: (1)a, b, c and d of Draft 2; and (4)a and c of Draft 1.
Delete: all words following professional responsibilities from subsection (2)
Add: to subsection (3) after payment of their usual and customary or contracted
charge.
Remove: subsection (4)
Remove: subsection (7)
MOTION: Rebecca Hille moved to accept the new draft. MOTION CARRIED with an affirmative
vote of 5-0, the Board Chair did not vote.
Service Recognition
The Board recognized 24 Pharmacists who have been licensed in the state of Washington for 50
rd
years. The honorees will also be recognized at the 3 Annual Northwest Pharmacy Conference in
Spokane.
Administration of Medication in Schools
Tim Fuller provided a request for information from the Office of Superintendent of Public Instruction
(OSPI), asking for input to update their policy regarding administration of medication in schools.
This policy will be distributed to schools concerning immediate access to medications and providing
required medications to students when medications stored in a locked cabinet may not be easily
accessible.
There was concern that if students were on a field trip or in a sporting event away from school, how
they would have access to their medications if the medications are in a locked cabinet at the school.
There was discussion of self-administration, or having a teacher, bus driver, or coach carry the
prescription medication in case of emergencies.
Paula Meyer, Executive Director of the Nursing Commission, voiced her concerns about maintaining
safety for all children while providing immediate access for the child in need. She was concerned if
that meant allowing the child to carry their own medication. There was also concern about controlled
substances. If a child needs a different medication, should that child be able to carry a controlled
substance as well.
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It was concluded that the Board of Pharmacy will work with the Nursing Commission to develop and
provide input to OSPI for distribution to schools regarding safekeeping and administration of
medications for students.
Offsite Pharmacy Practice
Andy Mecca presented two requests for approval to permit pharmacists to engage in the practice of
pharmacy at a location other than a pharmacy. The first letter was from Medco, stating they have
implemented programs in a number of states in which pharmacists are practicing their profession in
alternative settings, primarily their residence or a separate private office under their control.
The second request is from Sarah Benator, of Foley & Lardner LLP, Attorneys at Law, who have a
client providing a service where individuals can email questions to a pharmacist, and get a response
via email with general medication information about prescription medications, non-prescription
medications, and dietary supplements. Depending on the question the individual asks, the pharmacist
may also guide him or her to appropriate sources of medication and medical information. When
appropriate, the pharmacist will recommend the individual contact their physician. The pharmacist
does not recommend specific prescription medications or diagnose medical conditions, and the
service is not an online pharmacy.
The questions are: (1) does an email as described above constitute the practice of pharmacy under
Washington law, and (2) is a pharmacist who resides outside of Washington and who answers an
email from a Washington resident required to be licensed in Washington.
The Board agreed they would need more information from Ms. Benator to further address her
questions.
Joyce Roper noted that nothing states that pharmacy practice is restricted to a pharmacy. Some
pharmacists practice outside of a conventional pharmacy, such as in clinics and other non-dispensing
facilities.
Prescription Legibility Legislation
Andy Mecca distributed a draft of the notice to be mailed to all practitioners with prescriptive
authority, pharmacies and pharmacists regarding 2SHB 2292. The law, which is effective June 7,
2006, further defines a legible prescription by stating, a prescription must be hand-printed,
typewritten, or electronically generated.
Susan Teil-Boyer expressed that in hospitals this bill will improve patient safety and reduce errors.
There was an expressed concern from the audience that a prescription written in cursive is not a legal
prescription. The Board determined that the law addressed the definition of a legible prescription
and that a prescription written in cursive will be considered illegible, not illegal.
Executive Director Saxe stated that staff will be working with the other boards and commissions
within the Department of Health in the technical assistance of practitioners. At this juncture the staff
has been directed to take an educational approach to this new law.
The Board discussed a petition filed by Adam Karp, an animal rights attorney. Mr. Karp provided
the Board with clarification of his petition and answered questions from the Board. The petition
requests that the Board adopt rules regarding the administration, recordkeeping, and public disclosure
Kingsbury0635
of logbooks relating to the use of sodium pentobarbital and legend drugs by animal control agencies
and humane societies in the performance of humane euthanasia.
Donna Dockter expressed her concern that the current rules arent being followed and that
inspections have primarily focused on storage, access, and inventory of the drug supply. The Board
discussed the need for developing guidelines to address the concerns raised in the petition rather than
pursuing the rulemaking process.
MOTION: Donna Dockter moved to develop guidelines describing what is sufficient detail to
include, at a minimum; weight, dose, and method of administration. MOTION CARRIED. Joyce
Roper reminded the Board that guidelines are not enforceable. MOTION: Donna Dockter moved to
open the rulemaking process regarding the administration and recordkeeping requirements for animal
control agencies and humane societies. MOTION CARRIED.
The Board discussed a petition submitted by a Washington pharmacist requesting the Board adopt
rules making ephedrine and pseudoephedrine prescription only. The Legislature has included
provisions for the over-the-counter sale of ephedrine and pseudoephedrine (RCW 69.43); therefore,
the Board does not have the authority to move forward on this request. The legislature also
addressed various options during the 2005 legislative session and asked the Board to create rules
requiring a sales transaction log. A work group is required to evaluate the effectiveness of the log
and report to the legislature by November 2007.
MOTION: Rebecca Hille moved to deny the petition for rule making. MOTION CARRIED.
MOTION: Rosemarie Duffy moved to postpone Agenda Items 3.8 and 3.9 to a future meeting.
MOTION CARRIED.
OPEN FORUM
No comments provided.
CLOSED SESSION Case Presentations.
Adjournment
There being no further business, the Board adjourned at 5:00 p.m. They will meet again on July 20,
2006 in Tumwater, Washington.

__________________________________________
Jennifer L. Wells, Program Staff
_________________________________________
Board of Pharmacy
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STATE OF WASHINGTON
MEETING MINUTES
June 7, 2012
CONVENE
Chair Christopher Barry called the meeting to order at 9:04 a.m., June 7, 2012
Board Members:
Gary Harris, RPh,
Guest / Presenters:
Jeffrey Roberts, President, CEO of Majestic Aerotech, Inc
Rudy Leighton, RPh Operations Manager for Providence
Infusion and Pharmacy Services
Doug Thompson, Director of Clinical Services for
Columbia basin Health Association
Glenn Adams, PharmD Central Washington Hospital

Staff Members:
Joyce Roper, AAG
CONSENT AGENDA
1.1
Business Meeting Agenda Approval June 7, 2012
1.2
New and Closed Firms April 14 - May 22, 2012
1.3
NPLEx Monthly Report Acceptance.
1.9
April 19, 2012
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be removed from the consent agenda and placed on the regular business agenda. Items 1.4, 1.5, 1.6,
1.7 and 1.8 were deleted from the agenda.
MOTION: Donna Feild moved that the board approve items 1. 1, 1.2, 1.3 and 1.9. Elizabeth Jensen
REPORTS
Board Member
She attended the New Board Member Orientation May 1, 2012. She felt it was very
informative.
He attended The NABP Annual Meeting in Philadelphia. Chris thought it was an excellent
meeting a lot of discussions on issues all the boards are facing such as drug shortages. There
were a number of excellent presentations at this meeting.
Dan Rubin reported:
Mr. Rubin thanked staff for providing him with a couple different pharmacy tours.
He also attended the New Board Member Orientation May 1, 2012.

Steve Saxe reported:
Steve has attended the following meetings.
Steve represented Mary Selecky at the Association of State and Territorial Health Officers.
This was related to prescription opioid overdose problem that is happening nationally.
He also attended the NABP Annual Meeting in Philadelphia along with Christopher Barry. Gil
Kickowsky, Director of Office of National Drug Controlled Policy was great talked about their
plan. Other presentation included drug shortages and some of the causes behind it and along
with some activity trying to address this problem, methamphetamine precursors and others.
Northwest Convention: Steve provided an update from the board and received feedback on a
couple issues we are working on such as, pharmacy tech ratio and the inspection process.
Department of Health has now converted to a new website.


th
The brief to the 9 circuit was due at the end of the month. The defendant- intervenors asked for a 45
th
day extension. In response to that the plaintiffs also asked for an extension. Our brief to the 9 circuit
is now due August 13, 2012. There has not been a decision from the Distr ict Court on plaintiffs
motion for attorneys fees.
Kingsbury0638
PharMerica and EZ MAR Francis Floyd, attorney for PharMerica, asked to a delay until the
August Board of Pharmacy meeting due to his schedule. Mr. Floyd reported that Doug Pratt,
PIC, is no longer with the PharMerica pharmacy. Tim and Dan Rubin met to discuss how to
strategically resolve the issues with the long term care software called EZ MAR.
Labor and Industries has formed a Hazardous Drug Advisory Committee Charter to discuss
issues that arise from implementation of the hazardous drug handling rule. After discussing two
models, Labor and Industries put forward a relatively small group representing employer and
employee representatives of the health care industry and affected agencies. The Department of
Health was mentioned specifically. The Charter serves as a document to define the
organization, operation, and governance of the Advisory Committee.
He developed a decision paper concerning the licensure of the freight forwarding sites of
healthcare waste which would include medication wastage and be stored until there was a
sufficient amount to truck to the Philips Service Corporation (PSC) disposal facility. This
decision paper will also be scheduled for the August Board of Pharmacy meeting.
During the first week of May the Board of Pharmacy staff moved from the third floor of PPE to
the first floor of TC2.
Tim consulted along with Construction Review on the rebuild of an independent Oncology
Clinic becoming part of Overlake Hospital. The rebuild includes a unique intravenous
oncology preparation area.
Mr. Fuller worked with Radiation Safety to determine the licensure status of a
radiopharmaceutical producer.
Employee Survey Response Activities: His focus is managing workload. Looking for help with
administrative details like formatting documents.
Seeking or using employee feedback for process or other improvements
Employee recognition
Milestones that progress us towards online transactions or increase ILRS performance
Efforts to help manage workloads
Training and development, formal or informal

Office of Investigation and Inspections is also in the process of moving from PPE to TC2.
Mr. Chester provided the board data on how the investigators spend a typical 8 hour day.
After some question about the MPJE questions Grant provided the board a National
Association Boards of Pharmacy, Multistate Pharmacy Jurisprudence Examination fact sheet
and the new competency statements, which took effect January 25, 2012. The questions are
multiple choice (only one answer) or multiple response (more than one answer) item formats.
If you would like to write questions for the MPJE please contact investigators Grace Cheung or
Tina Lacey for assistance. We need questions in the following competencies: 1.03.01; 1.03.06;
1.04.01; 1.04.12; 1.05.02; 1.07.03; 2.01.02; 2.01.03; and 2.02.05 .

Technician / Assistant Dual license Tech Ratio manipulations BOP is interested to look
into this further asked staff to place on agenda for future meeting for discussion.
2007 BOP clarified that all Technicians on site at the pharmacy are counted in the 1:3
pharmacist to technician ratio.
3
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Investigators have observed pharmacies having the Technician staff obtain an Assistant
Registration so to circumvent the ratio.
Original intent and purpose of having a ratio is ultimately for patient safety; how many
Ancillary Personnel can one pharmacist safely supervise?
Some questions arise such as:
How reasonable is it to expect a Technician to not
perform a Technician task when the

opportunity arises?
Scenario, Technician who is also registered as an Assistant is the scheduled Cashier. It is
usually not in the Ancillary Personnels nature to stand idle when there is work to be
done. How likely is this person going to NOT help out and perform Tech duties?
e.g. select drug from stock for counting.
Does the Ancillary Staff have two name tags and switch off depending on their shift and
assignment?
Do they hang their appropriate license depending on the day/shift? Perhaps they could
have two sided licenses!
How does the pharmacist on duty keep track of how to supervise the Ancillary Staff
especially when they are not the scheduler or is a float pharmacist?
General Pharmacy Staffing concerns
Reducing Pharmacist hours/ changing from hourly to salary - Combine this with the
Tech/Asst concern above leads one to ask the question of whether this is setting up an
environment that may be conducive to negative out comes?
Interesting OR BOP Survey
concerns are similar to what we hear from
pharmacists
during inspections
Patient safety
Coupons /guaranteed maximum wait time
Chain performance metrics/measurement systems
Workload /job quality
Immunizations
PRESENTATIONS
Rule Making Petition Export Wholesaler
Kitty Slater-Einert presented a petition for the board to consider. The petition was for rule making filed
by Jeffrey Roberts, President and CEO of Majestic Aerotech, Inc. to amend WAC 246-879-090 to
allow an exception to subsection 2, which limits the export wholesaler to exporting non-controlled
drugs.
Majestic Aerotech Inc is a licensed pharmaceutical wholesaler. Majestic is requesting an exemption to
export controlled medication in emergency medical kits to Copa Panamanian Airlines.
After further discussion with Joyce Roper, AAG and staff the petitioner Jeffrey Roberts agreed to table
the petition until the next meeting. The board feels that the export of drugs is the authority of the Drug
Enforcement Agency.
MOTION: Donna Feild moved that the board draft a letter saying the authority to regulate foreign
export of controlled substances was with the Drug Enforcement Agency. Elizabeth Jensen seconded.
MOTION CARRIED: 4 -0.
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Jeffrey Roberts consented to agree to table this petition.
Hospital Pharmacy Preparing Non-Patient Specific Products

The board discussed a request by Providence Infusion and Pharmacy Services for clarification whether
the practice of preparing non-patient specific products within a hospital system is in the scope of the
hospital pharmacy license or if a manufacturers license is required. Tim Fuller provided the board
with some background.
Background:
For the past several years, hospitals have aligned under health-system management and
ownership. Large systems such as Swedish/Providence, Franciscan, Multicare, and UW health
systems each own and operate several hospitals within their system. Pharmacy departments in
the hospitals have sought efficiencies within these health-systems. For example, they have
changed from preparing certain sterile products pursuant to a physician order at each hospital to
using one site to prepare these sterile products for several hospitals. The drug shortage has
encouraged this shift to optimally manage limited supplies of a drug within a health system.
Providence Infusion and Pharmacy Services (PIPS) have requested that the Board of Pharmacy
(BOP) clarify Washington State rules that require regulation of a drug compounding operation
as a drug manufacturer. An evaluation of laws and regulations regarding compounding and
manufacturing in hospital pharmacies found inconsistencies in the definitions of pharmacy
practice (does not mention manufacturing) and hospital pharmacies (does include
manufacturing in definition). Other descriptors are too vague.
Federal regulators have opposing interpretations . The FDA in Section 510 of the Federal
FD&C Act considers a hospital pharmacy that compounds medication for inpatient dispensing,
outpatient dispensing, mailing to a patient, or for other units (nee hospitals) in a centralized
system of care are compounding medications and are exempt from additional licensure. This
exemption is lost if the compounding pharmacy supplies pharmacies outside of its system.
The Drug Enforcement Agency (DEA) states that compounding a controlled substance is an act
of manufacturing 21 USC 802(15) and manufacturing requires a separate DEA registration. A
DEA registered pharmacy is exempted from having to register as a manufacturer only when it
compounds a controlled substance pursuant to a valid patient specific prescription and
dispenses the prescription directly to ultimate user or family member. There are other
centralized pharmacy services that prepare drug products for hospitals in their systems. These
pharmacies will watch to see if the decision will impact their licensure. As mentioned
repackaging pharmacies have previously appeared before the BOP and have been required to
obtain a manufacturer license because they prepared non-patient specific drugs distributed to
other locations
MOTION: Gary Harris moved that the board recognize the practice for non-patient specific products
within a hospital system as within the scope of the hospital pharmacy license. With the understanding
they need to get a hospital pharmacy license and come back in six months. Elizabeth Jensen seconded.
Christopher Barry recused himself. MOTION CARRIED: 4 -0.
5
Kingsbury0641
The board considered a proposal by Othello Family Clinic Pharmacy to use telepharmacy technology
to provide pharmaceutical services to Connell Family Clinic Columbia Basin Health Association.
Tim Fuller briefed the board then introduced Doug Thompson, Director of Clinical Services.
Overview:
Columbia Basin Health Association (CBHA)
Serving the medical needs of Othello and the surrounding area for 40 years.
7 dental operatories staffed Mon-Friday (7:30 AM
Patient Benefits assistance Mon-Friday (8 AM
Initiated dental services in Connell in September 2008.

Initiated medical services to Connell December 2011.
Expanding medical services in Connell August 2012.

Connell Family Clinic
5:30 PM).
6 PM).
2 medical providers staffed Mon-Friday (8 AM

1 optometrist staffed 2 days per week (10 Am
Tele-pharmacy staffed Mon-Friday (10 AM
o Upon approval
6 PM).
6PM).
6 PM).
CBHA has a pending application with the state to provide WIC services in Franklin
County.
Health Home
Provide a single source for all of a patients primary care needs.
All services provided by OFC pharmacy staff.
Medication history available at all CBHA pharmacies.
Single Electronic Dental Record (EDR) linked to Electronic Medical Record (EMR).
Single medical chart shared by all providers.
Single medication list reconciled to the EMR .
Single patient history for all CBHA pharmacies

Benefits of Telepharmacy
Provide pharmacy services in Spanish and English.
Many safety net patients do not have a valid mailing address.
Provide low cost medication to safety net patients.
Provide medication at the time of medical visit for those with limited access to
transportation.
IMPROVED PATIENT COMPLIANCE.

Othello Family Clinic Pharmacy (OFC)
Wholly owned and operated by Columbia Basin Health Association.

Also owns and operates the Connell Family Clinic.
Current hours of operation (M-F: 9-6).

Serves over 1,100 patients from Connell .
5 full time PharmD s on staff.

Pharmacist Oversight
Monthly site visit:

Observe technician practices.
Inspect dispensing environment.
Consult with medical providers
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MOTION: Gary Harris moved that the board accept the proposal from Othello Family Clinic
Pharmacy to use telepharmacy technology to provide pharmaceutical services to Connell Family Clinic
Columbia Basin Health Association. The board asked that there be a patient poll taken and a report
back in one year regarding the report. Elizabeth Jensen seconded. MOTION CARRIED: 5 -0.
Tim Fuller asked the board to consider a proposal by Central Washington Hospital Pharmacy to use
telepharmacy technology to provide pharmaceutical services to Royal City. Glenn Adams provided
background on the history of this telepharmacy that was already approved the only thing being
changed here is the name of the system.
Background:
Royal City is a remote community in Central Washington that lost its pharmacy. Nearest
pharmacy is 60 miles. A few years ago the board approved Bellegrove Pharmacy to operate a
telepharmacy there. Subsequently, Bellegrove stopped its telepharmacy services and Moses
Lake Clinic Pharmacy was approved to continue the telepharmacy to Royal City.
Now Moses Lake Clinic Pharmacy is closing and Central Washington Hospital-The
Professional Pharmacy-Wenatchee Valley Clinic would like to request approval to provide
Royal City with telepharmacy service.
People of Royal City would have to travel approximately 120 miles roundtrip to obtain
prescriptions from the nearest pharmacy. Medication treatment could be delayed or
prescriptions could go unfilled.
Policy and Procedures

Identical to Moses Lake Retail Pharmacy
TCI equipment
Inventory
Board of Pharmacy Telepharmacy Guidelines and Requirements document
Staff training
MOTION: Donna Feild moved that the board accept the proposal from Central Washington Hospital
Pharmacy to use telepharmacy technology to provide pharmaceutical services to Royal City. The board
asked that the language authorized personnel be changed to authorized pharmacy personnel.
Elizabeth Jensen seconded. MOTION CARRIED: 5 -0.

The board was asked to consider a request by to use remote medication order processing services to
cover after-hour operations and staff shortages at Kindred Hospital Seattle-Northgate and First Hill.
Tim Fuller provided some background regarding this proposal.
MOTION: Elizabeth Jensen moved that the board table this item until there is a pharmacist to answer
board questions. Donna Feild seconded. MOTION CARRIED: 5 -0.
7
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Central Fill Pharmacy Guidelines

Cathy Williams asked the board to review and consider approving the updated guidelines for
centralized prescription processing.
History/Background:
The DEA published a final rule on central fill practices in 2003 titled Allowing Central Fill
Pharmacies and Retail pharmacies to Fill Prescriptions for Controlled Substances on Behalf of
Retail Pharmacies . That year the National Association of Boards of Pharmacy (NABP) Task
Force on Centralized Prescription Filling released a report providing guidance to state boards of
pharmacy on the topic.
The boards current central fill guideline was developed in 2004 by Tim Fuller. Since then,
additional proposals have come before the board and brought a greater understanding of
centralized prescription filling functions. Other centralized prescription functions have also
been identified in other practice settings. These will not be addressed in this current review,
but represent considerations for future guidelines.
As the practice of pharmacy continues to advance toward more integrated patient centered
models, there will be a greater focus on streamlining operations in support of centralizing
specific functions.
The revised central fill guideline does not create additional requirements. The guideline was
reorganized and some of the language was emphasized. Clarification of terminology and what
isnt included in the guideline were also noted. The final guideline will need to be published on
the boards website. Presenters of proposals that were previously approved will need to be
provided with the new guideline.
MOTION: Donna Feild moved these be looked at together as a sub group in an open meeting and
make a recommendation to the board at the September or November board meeting. Sepi
Soleimanpour and Dan Rubin volunteered to participate in the sub group. Elizabeth Jensen seconded.

Christopher Barry chose a panel for these requests Gary Harris, Elizabeth Jensen and Dan Rubin .
A board panel considered requests for recognition as an educational organization and/or professional
association permitting the requester to receive contact lists of credential holders.
(a) U.S. Navy
(b) University of Washington
MOTION: Dan Rubin moved to deny the request from the Navy to be recognized as an educational
organization and/or professional association permitting them to receive contact lists of credential
holders. Elizabeth Jensen seconded. MOTION CARRIED: 3 -0.
8
Kingsbury0644
MOTION: Gary Harris moved to deny the request from the University of Washington to be
recognized as an educational organization and/or professional association permitting them to receive
contact lists of credential holders. Elizabeth Jensen seconded. Dan Rubin abstained. MOTION
CARRIED: 2 -0.
Inspection Process Review

Grace Cheung led the discussion on the results of the inspection pilot project and specifies its
recommendations on the revised inspection process.
Pilot Project/Results:
The most significant change in point values are reflecting the emphasis on the practice of pharmacy
relating to patient safety issues. On the current form, any deficiencies found under the general category
of Patient Med Record may be assessed a maximum of 5 points deduction. Deficiencies that fall under
this category include:
Failure to maintain allergy information;

Failure to maintain current significant chronic conditions;
Computer system failing to perform appropriate Drug Utilization Review alerts.

In the proposed form, these three subcategories are separated out and each is assigned a 5-point value.
The Pharmacist Investigators performed a total of 23 inspections where the proposed form was used
alongside the current form to provide some data for analysis . It should be noted that certain items were
moved from one category to another (e.g. Poison Requirements was moved from Section B to A)
affecting the point deduction differences between the two forms.
The following are observations made when reviewing the data provided by the 23 inspections:
13 inspections resulted in the same total score.
2 of the 9 inspections that resulted in a lower score were due to the new point value assessed
for number of outdates (5-9 outdated meds is assessed a 2 point deduction)
Sections A and D point deductions were virtually identical on both forms (except that the total
point values of those two sections were reduced in the new form).
Section C point deductions were identical between the two forms (except that the total point
value was increased by 5 points for this section in the new form) .
Section B had the greatest difference as expected for those pharmacies with deficiencies in the
maintenance of patient profiles (allergy and significant chronic conditions information).
9 inspections resulted in a lower score.

1 inspection resulted in a score that was higher.
7 of the 9 inspections that resulted in a lower score were due to the Section B changes to the
allergy and chronic conditions deficiencies.
MOTION: Donna Feild moved to expand the subcommittee and get input from the Executive
Director, legal advice and stakeholders. The subcommittee will bring recommendations to the board on
Kingsbury0645
how to move forward with updating the inspection process/form. Elizabeth Jensen seconded.
Joyce Roper shared with the board that there will be a review and discussion regarding the delegation
of authority to department staff. The reviews will examine the statutory language to see if the statutes
and delegations are consistent with the Seymour decision, so the Board can make a decision on the
delegation weighing the risks, if there are any.
Board Approved Technician Training Program Review

Cathy Williams led the review and discussion of the criteria used for evaluating technician training and
education. She shared the recent review form used and some background with board.
There was some discussion and opinions shared with the board members. Topics discussed were online
programs being accepted as an accredited component along with the process. After further discussion
the board and staff seems to feel that this process seems to be working for now but can be looked into
for future changes.
Verification of Internship Hours

Kitty Slater-Einert asked the board to consider adopting an interim procedure for accepting internship
hours reported from by the out-of-state accredited school or college of pharmacy in lieu of verification
by the resident state board.
MOTION: Gary Harris moved to adopt the interim procedure for accepting internship hours reported
from by the out-of-state accredited school or college of pharmacy in lieu of verification by the resident
state board without revisions. Elizabeth Jensen seconded. MOTION CARRIED: 5 -0.
2013 Meeting Dates

The board considered to approve the amended 2013 business/disciplinary meeting calendar and discuss
meeting locations.
MOTION: Dan Rubin moved to approve the amended 2013 business/disciplinary meeting calendar to
a later date in January 2013. Elizabeth Jensen seconded. MOTION CARRIED: 5 -0.
Rules Hearing
The purpose of the proposed rule is to implement Chapter 71, Laws of 2011 (HB1353), which requires
the Board of Pharmacy to develop rules to establish continuing education requirements for pharmacy
technicians. The proposed rule was filed with the Code Revisers office on May 2, 2012. Notice was
published in the Washington State Registry as WSR # 12-10-082.
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Before taking public comments Kitty Slater-Einert summarized the proposed rule. She presented
information with power point slides in support of this proposed rule. Kitty followed her presentation by
answering any questions from the board.
During the second segment of the hearing the board heard from those who were signed up to comment
on the rule. Christopher Barry then read the comments that were sent in writing to the Department of
Health.
Mr. Barry read comments sent to the Department of Health. The board members responded to all the
comments given during the hearing.
MOTION: Elizabeth Jensen made a motion to approve Chapter 71, Laws of 2011 (HB1353), which
requires the Board of Pharmacy to develop rules to establish continuing education requirements for
pharmacy technicians as written with the recommended change, Continuing Education Provider to
Continuing Education Course. Gary Harris second. MOTION CARRIED: 5-0.
DISCUSSION Contd
Rules Update
Kitty Slater-Einert led the discussion and review proposed rulemaking workload with the board.
Kitty Slater-Einert requested board provide approval to withdraw the CR-101, Preproposal
statement of inquiry, that was filed July 5, 2007, to add a new chapter to WAC 246-874. The
rule was proposed to protect public health and safety by establishing enforceable standards
specific to the practice of pharmacy in correctional facilities. The Board of Pharmacy (BOP)
has the authority to regulate the practice of pharmacy in correctional facilities, but does not
have specific standards to evaluate these services. Currently, the BOP applies retail pharmacy
standards (rules), which do not adequately evaluate services provided in correctional facilities.
MOTION: Elizabeth Jensen made a motion to approve the withdrawal of the CR-101, Preproposal
statement of inquiry, which was filed July 5, 2007, to add a new chapter to WAC 246-874. Donna
Feild second. MOTION CARRIED: 5-0.
Correspondence
Letter to Representative Waxman re RxTEC Proposal

NABP Federal Legislation to Amend Distributor Requirements
PDSA Bill
Constitutional Amendments w background
Bylaws Amendments w background
AWARxE Facebook Page
11
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Internet Drug Outlets_Not Recommended_30Mar2012

NABP Article on State Drug Re-Dispensing
NABP Internet Drug Outlet Report_April 2012_final
News from DEA, 4th Annual Takeback Event
Pharmacists Reluctantce to Fill Rx
SurescriptsEPCSUpdate5.16.12
Practice Exam Launch
OPEN FORUM
Jeff Rochon from the Washington State Pharmacist Association (WSPA) shared there are a number of
interested stakeholders within the community pharmacy compounding community that plan to get
together to discuss the role of community pharmacy compounders in light of recent investigations and
the proposal that was approved for Providence earlier today. They would be interested in plan to share
this at the next board meeting.
There is a WSPA workgroup that has been put together regarding the Technician to Pharmacist Ratio.
This workgroup is putting together a proposal to utilize the Ancillary Utilization Plans and to integrate
a continuous quality improvement component that would provide a mechanism for the board to control
safe practices and allow for better staff utilization .
WSPA has had many complaints concerning the approval of Continuing Education and the delay of
these courses being approved. WSPA has ACPE accreditation status and, if granted the permission of
the board, could use similar parameters to help to take some of the burden of the board and staff.
Gary Harris shared with the board that he was listening to the national news and bath salts came up
talking about the abuse and how out of control this is. Gary gave the board a pat on the back for getting
the Bath Salts Rule through.

CLOSED SESSION
Next scheduled business meetings: September 27, 2012

Point Plaza East Room 152/153
310 Israel Rd SE
Tumwater WA 98501
12
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_______________________________
Approved on August 16, 2012

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STATE OF WASHINGTON

MEETING MINUTES
June 8, 2011
Point Plaza East
310 Israel Rd SE Room 152/153
Tumwater WA 98501
CONVENE
Chair Al Linggi called the meeting to order at 9:04 a.m., June 8, 2011
Gary Harris, RPh,
Guest / Presenters:
William Rhodes, WRAPP Monitoring Program Manager
Diane T. Young, Dept of Health, Credentialing Manager
Jennie Hong, RPh, Swedish Medical Pharmacy Manager
Stacey Price, Animal Welfare Director for Kitsap
Humane Society
John Worthington, American Alliance Medical Cannibis
Steve Sarich, CANNACARE
Rachel Kurtz (acting on behalf of Steve Fager), Cannabis
Defense Coalition
Laura Farris, Dept of Health, Senior Health Law Judge

Joyce Roper, AAG
Melissa Burke-Cain, AAG (by phone)
CONSENT AGENDA
1.1
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New Pharmaceutical Firms - March 18 - May 16, 2011
The Custom Prescription Shoppe

Board Minute Approval. (April 7, 2011)
1.3
1.6
Closed Pharmaceutical Firms March 17, 2011- may 6, 2011

will be removed from the consent agenda and placed on the regular business agenda. Items 1.2, 1.4,
MOTION: Gary Harris moved that the board approve items 1. 1, 1.3, and 1.6. Rebecca Hille second.
Christopher Barry asked that Tim Fuller follow-up to get some clarity for Item 1.3 to be approved.
Welcome Donna Feild New Board Member
Al Linggi formally welcomed Donna Feild to the Board of Pharmacy and shared some background.
The Board of Pharmacy welcomes Donna Feild to the board. Donna graduated from the University of
Georgia, School of Pharmacy in 1983. Ten years later she earned her MBA. Donna has been a
licensed pharmacist since 1984. She has been married for 25 years this May 17, 2011 and has 4 boys.
Mrs. Feild has been practicing at SW Washington Medical Center as Director of Pharmacy and Cancer
Services since Jan 2005.
REPORTS
Board Member
Christopher attended the Washington State Pharmacy Association (WSPA) meeting where Tim
Fuller presented. This was a well attended meeting.
She attended the WSPA meeting as well.
Mr. Harris attended the initial Prescription Monitoring Program Forum.
He also had the opportunity to listen in by phone at the last Attorney Generals Prescription
Drug Task Force Meeting.
Rebecca Hille reported:
She had the privilege of being invited to attend the Capstone Presentation of the third
professional year of Washington State University Pharmacy Students. The presentations were
on innovative pharmacy services.
Executive Director
Welcome to our new board members Elizabeth Jensen and Donna Feild.
Legislative Session 2011: Two successful bills in 2011 were CE for Pharmacy Technicians and
Regulating the Handling of Hazardous drugs. Many bills were not successful including the
Medical Marijuana Dispensaries, Crimes against pharmacies, out of state ARNPs prescribing
CS, and the Drug Take Back bill.
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o We have met with L and Is John Furman who will be coordinating rule writing for the
Safe Handling of Hazardous Drugs bill.
NABP (National Assn Boards of Pharmacy) Annual Meeting: Executive Director and Chair,
board of pharmacy attended the annual meeting in San Antonio in May. Four business
resolutions were approved by the delegates:
o Establish a task force to review the current use of technology systems in pharmacy
practice and recommend revisions to the Model State Pharmacy Act and Rules of
NABP.
o Support the development and implementation of an interconnect hub by NABP to
facilitate data sharing among state prescription monitoring programs
o Establish a task force to recommend revisions to the Model Act to address the
responsibility of pharmacies and pharmacists to maintain control over prescription
medications and provide examples of controls and monitoring measures that can be
used to prevent, detect and investigate losses of drugs.
o Encourage efforts by the profession to study primary health care activities in which
pharmacists can be engaged and methods by which pharmacists can be incorporated
into the medical home model and the potential for pharmacists to engage in primary
health care activities.
DEA registration number on CII prescriptions: The board will clarify this conflicting topic
today.
Hospital Pharmacy directors meeting May 6: Tim presented the new Handling Hazardous
Drugs legislation and Susan gave a board update.
UW School of Pharmacy Practice Advisory Board; Susan Teil Boyer was appointed to the
board where a wide ranging set of topics is discussed to strengthen the UW community
relationships.
Jail medication management review: Board staff met to discuss the legislative mandate to
inspect 5 jails annually. Susan contacted WASPC to determine which jails to inspect, however,
WASPC deferred to the board investigators to determine.
Statewide Electronic Tracking of Methamphetamine Precursor Products Legislation: The

Memorandum of Understanding has been signed with the Board/DOH and Appriss, the
software company providing the tracking service. Rulemaking and training for pharmacists
and pharmacies and other sellers will start soon with go live planned for September.
Appriss/NPLEX stakeholder kickoff meeting was held May 18, 2011 to implement statewide
electronic tracking of methamphetamine precursor products.
Prescription Monitoring Program: The PMP rules hearing is scheduled June 27 at 1:30pm in
Tumwater. The new rules will be effective in August with data collection using the system
October 2011. Reporting from the system will begin in early 2012.
will go into effect October 2011. We will discuss this further in the Planning Session agenda
item.
Pain Management Rules: The Medical Commission and 4 other prescribing boards have written
pain management rules. The Medical Commission rules are effective the end of June. There
will be an Interpretive Statement developed and FAQs as well to help understand the changes
expected. You can find the rules on the department website.

Board and Commission Leader meeting planned for June 14 from 1p to 4p.
Board investigative staff meeting is planned for June 14 and 15. Al Linggi and Susan Boyer
will attend.
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Stormans case update: The plaintiff called and asked if we would agree to amend the complaint which
we declined. The interveners agreed to the amendment of plaintif fs complaint. The amendment
proposed to add the drug Ella specifically to the named drugs concern in the lawsuit and their equal
protection claim would be changed to a substantive due process claim . We opposed the request. The
judge ruled in the plaintiff s favor and allowed them to amend the complaint.
April
Mr. Fuller provided Ruth Carter of Seattle Drug Enforcement Agency with the
definition of collaborative drug therapy.
May
o
o
Tim Fuller welcomed University of Washington pharmacy extern, Erin Davis.

He presented to Washington State Pharmacy Association Academy of Hospital
Pharmacist, Hazardous Drugs Legislation

o Attend CHITA Conference on Meaningful Use
o Can local health jurisdictions return antivirals to DOH?
o Prophylaxis of responders/intrastructure staff .
June
o
o
Tim provided a presentation on collaborative drug therapy agreements with pharmacists

to Medical Quality Assurance Committee Policy Committee.
He also made a Washington Law Update presentation at the NW Pharmacy
Conference.
Followed up on the point Susan Teil Boyer made regarding the pain management rules.
Chief Investigator
Presentations:
April
Washington State Pharmacy Law Update - Grant Chester provided the presentation.
The Clover Park Pharmacy law presentation was given by Jim Doll.
Stan Jeppesen presented at the University of Washington Pharmacy Class 590.
Dick Morrison and Gregory Lang presented at the King County EMS Drug Diversion in
Seattle.
Attendance:
April:
Pam Sanders and Jim Doll attended the She riffs
Precursor Conference on Meth and More.
Stan Jeppesen attended the Neighborcare Regulations, the SEA MAR regulations and the
University of Washington Drug Distribution meetings in Seattle, WA.
June:
Jim Doll attended the Meth Precursor Retail Sales meeting in Renton, WA.
PRESENTATIONS
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William Rhodes, WRAPP Monitoring Program Manager, gave the board an orientation and update on
the activities provided by the program.
How does WRAPP Work?

When a pharmacist, friend, family member, colleague or employer seeks assistance from
WRAPP, they will encounter a trained member of WRAPP.
Voluntary calls are held in strict confidence . WRAPP may assist in the following:
Interventio n services to persuade the impaired pharmacist to recognize the problem and seek
treatment
Referral for evaluation services and appropriate treatment facilities, programs or professionals
Monitoring the impaired pharmacists treatment, aftercare, rehabilitation and re-entry into the
profession
Working with the pharmacist, family, employer and the Board of Pharmacy (if necessary) to
provide support of recovery
Referral to the pharmacists support group meetings in which pharmacists may safely discuss
licensure issues, drug diversion, return-to-work and other issues related to recovery
Who provides WRAPP services?
WRAPP does not provide any direct counseling, treatment of aftercare
WRAPP utilizes a variety of qualified professionals to assist in initial evaluation and to provide
inpatient or outpatient treatment in facilities approved by the Washington State Department of
Alcohol and Substance Abuse Services (DASA) and the Washington Department of Health
In addition, a cadre of pharmacists have been trained to serve as interveners and to function as a
support network for recovering participants in WRAPP
Is there a charge for services?
There is no fee for referral, recovery assistance or rehabilitation support services through
WRAPP
When a referral is made for evaluation and treatment, the cost of treatment services, including
drug screening, will be the responsibility of the individual participant. Many of these services
are reimbursable through health insurance plans.
How does a pharmacy professional get help through WRAPP?
Call WRAPP at (800)446-7220 and ask to speak to a WRAPP representative. Your call will be
promptly returned.
All requests for information and assistance are held in STRICT CONFIDENCE in accordance
with state and federal law
The caller will be asked to identify him or herself and give specific reasons for believing that a
problem exists. This is done to minimize crank calls. The identity of the caller will be held in
strict confidence.
Information must be factual and well-documented
A WRAPP representative will make arrangements to examine the information further, arrange
for intervention assistance or schedule the individual to meet with a licensed professional who
will make a confidential evaluation and suggest an appropriate treatment plan.
If treatment is necessary, WRAPP will monitor the individuals progress according to terms
stipulated in a contract between WRAPP and the individual.

WRAPP will also provide assistance and monitoring to individuals who are referred through
the Washington State Board of Pharmacy
WRAPP monitoring process

WRAPP suggests temporary removal from pharmacy practice and refers the individual for
assessment and evaluation.
If assessment determines that the individual is chemically dependent, or otherwise impaired,
the individual is asked to sign a WRAPP Monitoring Contract.
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The individual enters and completes an approved substance abuse (and/or other) treatment
program.
The treatment provider provides WRAPP with the following information:
Diagnosis of any medical, psychiatric, behavioral or emotional-related conditions
Diagnosis of alcohol or drug-related conditions
Prognosis of conditions identified
Assessment of success in treatment and likelihood of continued abstinence
Recommendations for continuing care
Assessment of ability to return to work
Recommendation of restrictions that should be placed upon the practice of pharmacy
Random Urinalysis Drug Screening Program:
Positive urinalysis will be reported to the Board of Pharmacy within 24 hours, with followup to the client. WRAPP must provide the Board with the reason for the positive urinalysis report.
WRAPP must notify the Board if an individual does not report for urinalysis.
Twelve Step meeting attendance two meetings per week must be affirmatively reported by
the individual.
Documentation of employment in a health-related field or any entity licensed by the Board of
Pharmacy
A written job description must be submitted within 30 days of employment or signing
of a WRAPP Monitoring Contract
Employer must submit written documentation of awareness of terms of the employees
Monitoring Contract
Individual must submit quarterly declarations of compliance with terms of the Monitoring
Contract
Supervising Pharmacist (Employer) must submit quarterly report
WRAPP Monitoring Program Manager provides immediate feedback to the individual
regarding compliance
Non-compliance will be reported to the Board of Pharmacy
Length of WRAPP Monitoring Contract Five (5) years of uninterrupted sobriety and
compliance with the terms of the Monitoring Contract (May be extended in Board of
Pharmacy-referred cases).
Office of Customer Service Credentialing

Diane T. Young, Credentialing Manager, provided the board with an overview of the pharmacy
programs credentialing performance in relation to established targets. She shared graphs and
explanations of credentialing performance. Diane also went through the credentialing process step by
step.
Limited Manufacturing License
Dr. Jennie Hong, First Hill Pharmacy Manager for Swedish Medical Center presented a request for a
limited manufacturing license for centralized bar coded unit dose medications packaging program.
5 Rights Project:
Right Patient
Right Delivery Method
Right Dosage
Right Time
Right Medication
Why?
Safety is predicated on all medications having an accurate & readable barcode
A uniform format for the Swedish system
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Centrally controlled database
What?
Continue to purchase in unit dose packaging whenever possible

Pre-Packing Oral Solids Only
If unavailable in unit dose form
If unit dose form on back order
If the manufacture unit dose form has an unreadable barcode
No Controlled Substances
Distribution Process:
Packaging hospital will receive medication packaging requests from the other Swedish
campuses.
Packaging hospital will pack and distribute the medications requested by the other campus .
An invoice will be provided with each order
Drug name, strength, Lot#, EXP date, & quantity
QA Process:
TCGRx ATP System
Verification by NDC
Technician Refill
Pharmacist Verification
Medication Canisters are calibrated and coded by NDC
MOTION: Christopher Barry moved that the board accept and approve the request from Swedish
Medical Center for a manufacturing license. Gary Harris second. Al Linggi recused. MOTION
CARRIED: 5-1.
Doreen Beebe provided the board some background on Kitsap Humane Societys (KHS) euthanasia
Training Program. Stacey Price, KHS Animal Welfare Director asked the board to consider a request
for approval of their euthanasia training program . The board was given some documentation on this
program and Stacey Price answered any questions and concerns the board had.
MOTION: Gary Harris moved that the board approve Kitsap Humane
Program. Rebecca Hille second . MOTION CARRIED: 6-0.
Societys Euthanasia Training
Rule Making Petition to Repeal Rule

Steve Sarich, Steve Fager, and John Worthington asked the board to consider the petition filed to
amend the existing rule. The purpose of the petition is to repeal marijuana from Washington State
Schedule I designation in WAC 246-887-100 stating conflicts with Chapter 69.51A RCW Medical
Marijuana.
MOTION: Christopher Barry moved that the board not open rule making and reject the petition to
amend WAC 246-887-100 based on section (b) of RCW 69.5.203 . Rebecca Hille second. MOTION
CARRIED: 6-0.
Rule Making Petition to Repeal Rule

The board was asked to consider a petition filed to repeal existing rule. The purpose of the petition is
stated to repeal Ibogaine from Washington State Schedule I designation in WAC 246-887-100(d) (13).
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Steve Sarich, John Worthington and Rachel Kurtz (acting on behalf of Steve Fager) asked to with
withdraw the petition during the business meeting to the board. The board granted the request and
removed the item from the business meeting.
EXECUTIVE SESSION

CASE PRESENTATIONS
DISCUSSIONS
2011 Legislation
Updates
2011 Legislature Bills Session law effective July 22, 2011
E2SSB 5073 Medical use of cannabis passed
HB 1353 Continuing education for pharmacy technicians passed
o Authorizes the board to write rules
HB 1486 Authorizing Washington pharmacists to fill CS prescriptions written by out of state
ARNPs did not pass
ESSB 5594 Hazardous drug handling Department of Labor and Industries to write rules based
on National Institute for Occupational Safety and Health (NIOSH) standards
ESSB 5307 Evaluate Military training and experience to qualify for pharmacy technician
licensing
SHB 1304 Administration of drugs by an HCA (health care assistant)
Narrows to two categories of HCA previously certified to give injections
Schedule II Prescription Requirement DEA Registration Number

Susan Teil Boyer shared background to clarify the recent confusion around CII controlled substance
prescriptions and prescriber DEA registration numbers.
DEA published in November 2007 in the Federal Register the Final Rule entitled Issuance of Multiple
Prescriptions for Schedule II Controlled Substances. In the preamble to that rule, the DEA stated, the
essential elements of a Schedule II prescription written by the practitioner such as the name of the
controlled substance, strength, dosage form, and quantity prescribed may not be modified orally.
The instructions in the rules preamble are in opposition to DEAs previous policy which permitted the
same changes a pharmacist may make to schedules III-V controlled substance prescriptions after oral
consultation with the prescriber.
A policy letter, written in October 2008 by Joe Rannazzisi, DEA Deputy Chief of Operations, Office
of Diversion Control states, DEA recognizes the resultant confusion regarding this conflict and plans
to resolve this matter through future rulemaking. Until that time, pharmacists are instructed to adhere
to state regulations or policy regarding those changes that a pharmacist may make to a schedule II
prescription after oral consultation with the prescriber.
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The October 2008 policy letter remains in effect. Nothing has changed regarding the DEA numbers
and other required information on CS prescriptions since the issuance of the October 2008 letter. This
instruction applies until the rule is updated and a notice is issued by the DEA.
MOTION: Christopher Barry moved that the board approve the policy statement that is in response to
the questions about the DEAs interpretation of CII controlled substance prescriptions and prescriber
DEA registration numbers. The DEA headquarters will be sent the Board of Pharmacys interpretation
requesting a response. Donna Field second. MOTION CARRIED: 6-0.
Acetaminophen Prescriptions
Cathy Williams led the discussion with the board in response to the FDAs Drug Safety
Communication requesting that drug manufacturers limit the amount of acetaminophen in prescription
drug products to 325mg.
MOTION: Rebecca Hille moved that Christopher Barry, Cathy Williams coordinate a newsletter
article for informational and educational purposes with the Washington State Pharmacy Association .
Donna Feild second . MOTION CARRIED: 6-0.
National Association of Boards of Pharmacy Continuing Pharmacy Education (CPE) Monitoring

Program
Susan Teil Boyer shared update with the board about the NABP launching a new CPE monitoring
system for pharmacists and technicians.
Pharmacists and pharmacy technicians will receive a unique ID after setting up their e-Profile with
NABP. Beginning in the latter part of 2011, they will provide their NABP e-Profile ID and date of
birth to the ACPE-accredited provider when they register for CPE or submit a request for credit. The
system will then direct electronic data from ACPE-accredited providers to ACPE and then to NABP,
ensuring that CPE credit is officially verified by the providers. Once information is received by NABP,
pharmacists and pharmacy technicians will be able to log in to access information about their
completed CPE activities. After a transition period, ACPE-accredited CPE providers will no longer be
required to distribute statements of credit .
Rules Update
Doreen Beebe and Kitty Slatter discussed and reviewed rule making activities with the board
1. Chapter 246-889 WAC Electronic sales tracking of pseudoephedrine,
ephedrine, phenylpropanolamine products Proposed changes to approved
language. There will be a rules hearing August 12, 2011.
MOTION: Rebecca Hille moved that the board accept WAC 246-889 as amended. Elizabeth Jensen
2. WAC 246-887-100 Synthetic Cannabinoids Spice and Bath Salts Extension
of Emergency Rules will be in effect until August 13, 2011.
3. WAC 246-887-100 Synthetic Cannabinoids Spice and Bath Salts - consider
proposed rule making language that adds certain synthetic cannabinoids
(marijuana) and substituted cathinones to the Schedule 1 controlled substance
list. There will be a rules hearing August 12, 2011.
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MOTION: Gary Harris moved that the board approve amended proposed rule language to WAC 246887-100. Donna Feild second . MOTION CARRIED: 6-0.
4. Chapter 246-874 Correctional Pharmacies Will be starting the stakeholder
process.
5. Chapter 246-886 WAC & WAC 246-887-050 thru 080 Animal Control and
Humane Society Rules hearing in October 2011 .
6. Chapter 246-901 WAC Ancillary Personnel Pharmacy Technician Continuing
Education Legislation takes effect July 22, 2011 in the process of drafting
language.

Susan Teil Boyer and Melissa Burke-Cain continued the discussion with the board on the draft
operating agreement on administrative procedures per RCW 43.70.240.
MOTION: Rebecca Hille moved that the discussion be tabled until the next meeting so the new board
members could be brought up to date on the dialogue of the Operating Agreement. Al Linggi moved
for a friendly amendment that a meeting be set up with the new board members for this update.
Christopher Barry second. MOTION CARRIED: 6-0.
Signature Delegation
The board reviewed delegation of signature authority related to credentialing, rulemaking and
disciplinary functions for the 2011 2013 biennium.
MOTION: Gary Harris moved that the board approve signature delegation for the 2011-2013
biennium as proposed by board staff. Rebecca Hille second. MOTION CARRIED: 6-0.
Correspondence
The board discussed the correspondence sent and received.
Emergency Rules Banning Spice & Bath Salts

Pharmacy Statistics FY10.xlsx
The WRAPP-UP April 2011

The board was asked to consider a request from IMS Health for access to a mailing lists and labels of
pharmacists to assist companies and professional in the pharmaceutical and health care industry for
educational purposes, sampling and legal compliance.
MOTION: Donna Feild moved to deny the request from IMS Health for access to a mailing lists and
labels of pharmacist to assist companies and professionals in the pharmaceutical and health care
industry for educational purposes, sampling and legal compliance. Rebecca Hille second. MOTION
CARRIED: 3-0.
OPEN FORUM
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Dan Connolly a former boarder member, Bartell Drug pharmacist shared his concern that the board
would have to do rule making for the National Association of Boards of Pharmacy Continuing
Pharmacy Education (CPE) Monitoring Program. Mr. Connolly asked when the hearing for Electronic
sales tracking of pseudoephedrine, ephedrine, phenylpropanolamine products would be held.
Jeff Rochon from the Washington State Pharmacy Association (WSPA) shared that the topic of
whether a Pharmacy Assistant would be counted in the ratio of Pharmacist to Pharmacy Technicians.
This causes a concern if they are counted in the ratio that it could limit training.
MEMBER ORIENTATION:
Disciplinary Process
Laura Farris, Senior Health Law Judge provided an orientation on the roles of the Health Law Judge
and Board Members in the disciplinary process.
CLOSED SESSION
Case presentations
DISCIPLINARY HEARING
JUNE 9, 2011 CANCELLED
_______________________________
_______________________________
Al Linggi, Chair
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STATE OF WASHINGTON
MEETING MINUTES
June 17, 2010
310 Israel Road SE Room 153
Tumwater, WA 98501
Board Office: (360) 236-4946
Video Conference Location
16201 E. Indiana Ave

Suite 1500 (Rm 112
Spokane, WA 99216
(9 am 3:30 pm)
CONVENE
Chair Gary Harris called the meeting to order at 9:04 a.m., June 17, 2010.
Dan Connolly, RPh

Joyce Roper, AAG
Jim Lewis, Investigator
Guest / Presenters:
Dan Luce,RPh, MBA
National Director, Pharmacy Affairs Walgreens
Sue Merk, VP of Business Development and
Product Management of OneHealthPort
David Doane, Talyst VP of Pharmacy Services
Jason Spears, LTC Market Director for Talyst
Holly Whitcomb Henry, Pres., CEO
Rxtracare, Inc.
Glen Adams, Director of Pharmacy,
Wenatchee Valley Clinic
Kristen Vedder, RPh
Steve Wanaka, RPH, Director of Pharmacy,
Seattle Childr ens
Will Barnes MPH, BCPS
Christian Hamm PharmD, BCPS
John Swenson, RPh for
Central Washington Hospital
Jin-Kyung Lisa Yang, PharmD
Colin Conway, PharmD, Group Health
Katherine Bergman, RPh, Group Health
Shirley Reitz, PharmD, BCPS, Group Health
Guest / Presenter continued:
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Tom Colleran, Director of Pharmacy Operations

& Systems, Group Health Cooperative Pharmacy
Michaelene (Micki) Kedzierski, RPh, CDP
WRAPP
William Rhodes, MSW, CDP, MHP
WRAPP Monitoring Program Manager
CONSENT AGENDA
1.1
New Pharmaceutical Firms - April 19- June 2, 2010
1.3
Closed Pharmaceutical Firms April 21- May 31, 2010

Chesterfield
Mercury Pharmacy Services
1.5
Navos Pharmacy
Board Minute Approval. (April 29, 2009)
MOTION: Dan Connolly moved that the board approve items 1. 1, 1.3 and 1.5. Kim Ekker
Service Award plaque to Retiring Pharmacist Investigator

Jim Lewis, Board of Pharmacy Investigator started working for Washington State January 4,
1993 after retiring from the Navy. He first served the people of Washington State as a pharmacist
for Department of Correction for 9 years. Jim became a Board of Pharmacy Investigator October
21, 2002. He has been a well respected investigator in the southwest region of Washington State.
Thank you for your service to the citizens of Washington State. Mr. Lewis was given a plaque
for recognition of his services.
REPORTS
Board Member
Christopher Barry attended the Tri-State Pharmacy meeting in Idaho.
Al Linggi reported:
In May Mr. Linggi attended the National Association Boards of Pharmacy meeting in
Anaheim, CA.
This was a great opportunity to network with board members from other states.
This helped understand a little bit about the challenges that other states are faced
with.
The biggest take a way is that all states are having budgetary challenges.
We are still one of the few states without the Prescription Monitoring Program.
Other states are considering Carisoprodol as a scheduled drug.
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Al is on the University of Washington School of Pharmacy practice council. They met

May 27, 2010 to discuss how the University of Washington can change their agenda or
curricula to better meet practice needs throughout the state for pharmacy.
June 14, 2010 Gary Harris, Susan Boyer, Tim Fuller and Steve Saxe attended the Pain
Management Workgroup.
Executive Director
NABP Annual Meeting May 22 to 25, 2010. Several resolutions were passed including:
Support of a multistate licensure concept study
Standardization of registration of pharmacy interns
Expansion of pharmacist immunization services
National practice standards
Uniform disciplinary guidelines
Review and revise the CSA
Standardize technician education and training
Pharmacist access to complete patient profile data
Labeling of sample medications and encourage vouchers.
Susan attended the Washington State Pharmacist Association Northwest Pharmacy
Conference. A Board of Pharmacy update was provided to the General Membership
meeting. Susan also gave an update to the Hospital Pharmacy Academy. A hot topic
underway is pursuing provider status for pharmacists .
She participated in the King County Public Health Pharmacy Leadership Summit. The
focus was emergency preparedness, especially related to vaccinations, and how
collaboration between public health departments and pharmacists can improve response
to the needs of the community. There was a keynote by a CDC Senior Policy Advisor.
Legislation:
Tamper Resistant Prescription paper/pads legislation effective July 2010
HCA expansion of scope of practice
Statewide electronic tracking system for PSE products
Out of State ARNPs can write prescriptions for legend drugs
Physician Assistants and ARNPs can recommend medical marijuana
A person acting in good faith may receive a naloxone prescription, possess
naloxone, and administer naloxone to an individual suffering from an apparent
opiate-related overdose
Conforming the uniform controlled substances act to existing state and federal
law. (Updates the State CSA, RCW 69.50)
Pain Management Standards. Five DOH boards and commissions must develop
pain management standards in rule. The Medical Quality Assurance Commission
(MQAC), Board of Osteopathic Medicine and Surgery (BOMS), Nursing Care
Quality Assurance Commission (NCQAC), Dental Quality Assurance
Commission (DQAC), and the Podiatric Medical Board (PMB) must adopt rules
by June 30, 2011. Gary Harris, Tim Fuller and Susan Boyer are participating on
the workgroup.
Gary, Tim and Susan attended the Pain Management Workgroup Meeting June 14, 2010
meeting in Kent. The need for improved prescribing of opiates is compelling. 500 deaths
due to opiate overdose in Medicaid patients occurred in Washington State in 2008. The
law passed during 2010 includes requirements for a dosage trigger to get a consultation
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from a pain specialist and requires continuing education for prescribers and focuses on
developing an outcome tracking tool for prescribers to use in treating these patients.
A meeting was held with the Board of Pharmacy and the Drug Enforcement Agency
(DEA). The DEA clarified that e-kits including controlled substances must be stored in
an automated drug distribution device (ADS) controlled by the Pharmacy servicing that
facility and the ADS must be registered with the DEA. A communication has been sent
to all RTFs and Pharmacies in the state to come into compliance by December 31, 2010.
The district court heard the state and intervenor s summary judgment motions regarding
the Stormans case. The judge ruled against the state and intervenor s. In his ruling, the
judge indicated that he sees this case being decided by the appellate courts, potentially
reaching even the Supreme Court, and it was his intent to have the appeal proceed on a
full record. The trial will begin July 26, 2010 and is scheduled for ten days .
On April 6, 2010 for the first time in more than a decade, the American Society of
Anesthesiologists Task Force on Chronic Pain Management has updated its chronic pain
guidelines. The new guidelines appear in the April issue of Anesthesiology. The 12member task force consists of anesthesiologists in both private and academic practice
from various parts of the United States. The group also worked with members of the
American Society of Regional Anesthesia and Pain Medicine.
th
Attended the Pharmacy Leadership Summit on May 20 . Hosted by the Seattle/King

County Public Health Department and Dean Webb. A great forum for raising the issues
of public-private collaborations on emergency preparedness endeavors and other
community wide initiatives . The concept of collaborative drug therapy agreements was
hailed as the boilerplate for this type of outreach to the community.
On May 20, 2010 Tim participated in the Public Health-Seattle King County-Pharmacy
Leadership Invitational Summit meeting in Seattle. The focus was emergency
preparedness and how collaboration between public health departments and pharmacies
can improve response to the needs of the community.
Tim anticipated similar excitement on June 1, 2010 when he will participate on
conference call about pharmacy provider status. The call is to pull together several
current efforts to have pharmacists paid for services as a provider.
He has been appointed to the Department of Health (DOH) Pain Workgroup that has been
formed to satisfy ESHB 2876 Pain Management. A response to the legislation is to draft
model set of rules can be developed collaboratively for the boards/commission to use.
On May 13 Tim attended a meeting HITECH and Health Information Exchange (HIE)
in Washington State sponsored by CHITA (Community Health Information Technology
Alliance). These are the people who have to get the electronic health communications to
work together. There was a status report from the federal Office of the National
Coordinator, the Washington State Health IT Coordinator, and the CEO of
OneHealthPort, the lead HIE organization for the state. References to ePrescribing were
frequent. The ARRA (Obama) funds are just the start of what is needed.
The DOH Emergency Response group met with a team from the Government Accounting
Office (GAO) to review the H1N1 pandemic as we experienced it . Washington was the
first of five states to be visited. Their interest was what went well and what didnt, in
particular the federal help the state received.
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Chief Investigator
The DEA has formed a Tactical Diversion Group which focuses on the diversion of
prescription controlled substances. They ask that the pharmacy obtain photo ID of the
person presenting the prescription for controlled substances and write the ID number on
the prescription.
Grant has received permission to fill the SW Washington pharmacist investigator position
when Jim Lewis retires on August 1, 2010. Along with permission to fill a permanent
part-time (0.6) pharmacist investigator position located in western Washington. This
position was last filled in 2008. He is working with personnel to have the positions posted
st
and advertised on July 1 and filled by the end of August.
PRESENTATIONS
NAPLEX Study Plan
Glenda Posadas a pharmacist intern presented a study plan for consideration by a panel of the
board. She is requesting authorization from the board to re-take the North American Pharmacist
License Examination.
MOTION: Vandana Slatter moved to allow Glenda Posadas a pharmacist intern one more
opportunity to re-take the North American Pharmacist License Examination . Christopher Barry
Maria Orencia a pharmacist intern presented a study plan for consideration by a panel of the
board. She is requesting authorization from the board to re-take the North American Pharmacist
License Examination.
MOTION: Christopher Barry moved to allow Maria Orencia a pharmacist intern one more
opportunity to re-take the North American Pharmacist License Examination . Vandana Slatter second.
Walgreens Report to the Board- Workload Balancing

Dan Luce, National Director of Pharmacy Affairs for Walgreens will provide an update on their
InterCom Plus system used to balance pharmacy workload through remote order entry.
Traditional Retail Store Overview

Currently, at the store:
Refills requested by phone or walk in
New scripts presented, image created
Data entry
Data review
Product prepared
Product verification occurs
Patients counseled
Scripts are sold
Workload Balancing Store Overview
Less distractions means better patient care.
Real times help when I need it.
The same steps occur each time a prescription is processed .
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Common database allows:

Shared data entry
Shared data review
Benefits
Less distractions - help when you need it
Pharmacy staff will be able to spend more time with patients
More reliable and user friendly refill options thanks to advanced technology
Increased time to counsel patients on complex medication therapies (my work does not
back up).
Increased Pharmacist interaction on OTC selections
Workload Balancing
The steps in the filling process are the same whether one or more stores perform the steps
Common ownership
Standard operating procedures and policies
Approved in 46 states, tens of millions of prescriptions processed
Operational since June 2004
Proven patient safety advantage
All activity occurs in Washington at Washington licensed facilities
Audit trail accountability (we track and record each step)
Presentation: Washington State Health Information Exchange

Susan Boyer introduced Sue Merk, VP of Business Development and Product Management of
OneHealthPort. Sue Merk presented information on the Washington Health Information
Exchange.
Background SSB 5346

Bill enacted by WA Legislature in 2009
Applies to public/private payers and providers, priorities:
Enhanced eligibility transaction, claims coding, pre-auth, others
Credentialing: a uniform electronic process for provider credentialing/privileging
data collection; for all payers/hospitals
Uses voluntary adoption model, if voluntary adoption fails Insurance Commissioner
(OIC) can regulate
OIC directed to designate private sector org to lead implementation pro bono, no
public money
OIC designated WA Healthcare Forum and OneHealthPort
Provider Data Management Value Prop
The Problem
Practitioners fill out multiple forms for health plans and hospitals
15/practitioner, costs $80,000/yr for 10 MD group
Data elements largely the same across plans, hospitals, much of the info available
online
Same info repeatedly entered/verified by credentialing entities, cost can reach
$100 - $500 per practitioner
Process is usually static, not real time, increases risk
The Solution
Provider fills out initial application once
Continuously update/verify data in shared data base
Credentialing entities access shared data and apply as needed
Timelines
ProviderSource data collection application goes live in June/July
Hospitals and health plans start requesting data records in July/August
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Measure voluntary adoption for Legislative report in September/October

Very fast timeline for statewide activity
SSB 5501
WA State Legislature instructed the Health Care Authority to appoint a private sector
Lead Organization to design, implement and operate a Statewide Health Information
Exchange using the HIE Federal funds of the HITECH and ARRA grants.
OneHealthPort volunteered for this pro-bono work based on funding from the
OneHealthPort owners.
History managing collaborative projects
Has run a Federated Security Service for 8 years
ePrescribing Focus
During 2011practitioners have an opportunity to earn meaningful use bonus dollars
based on doing real electronic transactions.

E-Prescribing is a major player in this first wave and beyond.
Must use a CCHIT certified application
Most will connect to RxHUB/SureScripts to get medication history and formulary
information on patients when available (200 million insured lives)
Our HIE Design Assumptions

Modest central capability and cost
Limited enterprise $ for HIE, many have already made HIT investments, HIE has
to link and leverage, not replace
Enterprises are the change agents, HIE is just an enabler
HIE must scale as interest and participation evolves
Industry is in early stages of readiness
Flexibility to serve diverse trading partner combinations
Enterprises at different points, with different priorities and needs and it takes at
least two to trade
Blend public and private interests and requirements
Market interest is key, but cant ignore public sector

Role of the HIE
Simplify secure connections
Meet security requirements of HIE
Set community standards for all trading partners
Assist practitioners in meeting meaningful use requirements audit log of electronic
transactions
Provide patient and provider databases to simplify finding this information
Opted not to store clinical data or offer applications that require clinical data
Emerging Security Requirements
ONC is emphasizing the need to make sure security is at a high level for all participants.
HIE will need to:
Set standards
Certify trading partners
Manage a secure data center
Monitor transactions
Audit transactions (to and from not content)
Enforce encryption requirements
Authentication of users/systems
Digital certificate management
Board of Pharmacy Role
Increasingly harder to distinguish who and what you should certify as ePrescribing
becomes more layered:
Application itself vendor builds application level security and privacy features
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Outsourced security service that manages second factor authentication

Health Information Exchange offering network connectivity
Health Information Organization local community offering that connects the
practice to the HIE
Talyst Automated Drug Distribution Device

Tim Fuller introduced David Doane, VP of Pharmacy Services, Jason Spears, LTC market
Director for Talyst and Holly Whitcomb Henry President, CEO of Rxtracare, Inc. and. Jason
Spears provided an informational presentation to the board on the new Automated Drug
Distribution Device (ADDD) technology.
What is Remote Dispensing in LTC?

Remote dispensing site a site located within an institutional facility or a clinic
that utilizes an automated pharmacy system and that is electronically linked to the
coordinating pharmacy via a computer system and/or a video/auditory
communication system approved by the board.
Coordinating pharmacy is the pharmacy responsible for the practice of
telepharmacy performed at remote pharmacies and remote dispensing sites.
One or more dispensing systems are located onsite at the LTC facility
The remote dispensing systems are considered an extension of the pharmacy
Nurses have access to pharmacist-approved medications 24x7
Patient-specific medications are dispensed on-demand and only when needed.
Medications are delivered in pharmacist-verified, tamper-evident canisters that
use microchip technology to ensure accuracy
Benefits to the Facility
Provides access to medications 24x7
Emergency / STAT doses
First doses for new admissions (esp. late night/weekend)
Reduces medication errors and prep/pass time
Virtually eliminates medication waste
Reduces inventory on the med cart
Eliminates narcotics count at shift change
Increases accountability and reduces diversion
Allows nurses more time with patients
Benefits to the Pharmacy
Increases accuracy (5 rights)
Provides better inventory control
Reduces delivery costs
Reduces fill labor costs
Provides better service to remote facilities
Eliminates returns and drug destruction costs
Allows pharmacists to focus on clinical functions
Benefits to the State
Virtually eliminates medication waste
Provides cost savings to Medicaid
Dual eligibles
Part D excluded drugs
Doughnut hole
Reduces environmental impacts
Prevents diversion of controlled substances
Policies and Procedures
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Responsibility of the Pharmacy

Medication Dispensing/Distribution
Medication Labels
Medication Administration
Controlled Substances
Medication Security
Medication Inventory
System Access, Data Management, Information Security
Reporting
Malfunction, Downtime and Emergency Procedures
Inspections, Installation Requirements, and Maintenance
Quality Assurance / Improvement and Training
Moses Lake Clinical Pharmacy Telepharmacy

Tim Fuller introduced Glen Adams, Director of Pharmacy of Wenatchee Valley Clinic to
the board. The board was asked to consider a proposal from Moses Lake Clinical
Pharmacy to provide remote order entry services to the Royal City Medical Clinic.
Glen Adams shared with the board some information on why they would like to provide remote
order entry services to the Royal City Medical Clinic. The clinic was struggling to survive due to
the lack of a provider and pharmacy services which were some distance from the community.
Glen was able to work with Steve Singer to provide telepharmacy services to the Royal City
Medical Clinic
Bellegrove pharmacy was approved by the board in September 2007 and used its extensive
telepharmacy policies and procedures, specialized equipment, and a pharmacy technician to
provide pharmacy services to the Royal City Medical Clinic. Steve Singer provided specific
information about the geography, patient population, and nearest medical and pharmacy service.
Now Bellegrove Pharmacy has changed course and will no longer be providing telepharmacy
services. Once again Bellegrove has worked with Wenatchee Valley Clinic (WVC). The
telepharmacy services will be provided from WVCs Moses Lake Clinic. The equipment and
extensive telepharmacy policies and procedures have been adapted to the new central pharmacy.
MOTION: Christopher Barry moved to approve the request for Moses Lake Clinical Pharmacy
to provide remote order entry to the Royal City Medical Clinic . Moses Lake Clinical Pharmacy
must report back to the board in one year. Dan Connolly second. MOTION CARRIED: 5-0.
Seattle Childrens Hospital Remote Order Entry

The board was asked to consider a proposal by Seattle Childrens Hospital to provide
remote processing of medication orders for Bellevue Clinic and Surgery Center . Steve
Wanaka, Director of Pharmacy, Seattle Childrens Hospital provided the presentation to
the board.
Medication Order Process:

The Medication Order Process will include:
Receiving, interpreting or clarifying medication orders
Data entry and transferring of medication order information
Performing drug regimen review
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Providing drug information concerning medication orders or drugs
Pharmacists:
The training includes:
How to: Verify an order in Med Manager
How to: Process Non Formulary Medication Orders
How to: Update Backordered Medications (Drug Shortages)
General Medication Administration
Medication Ordering and Transcription
Order Reconciliation
Challenging Medication Orders
Telephone/Verbal/Electronic Messaging Orders
Medication Approval and Procurement
Adverse Drug Reactions (ADR)
Dangerous Abbreviations and Decimal Use
Information System:
Records:
They manage medical records and coding information for patient visits, reimbursement and
research. Their mission is to support the mission of Children's Hospital in providing excellent
pediatric care by:
Ensuring health information is complete and available to legitimate users.
Protecting patient privacy and providing information security
Providing patient records for clinic and research in a timely manner
Accurately coding and classifying data for reimbursement and research needs
Complying with standards and regulations regarding health information
Licensing:
Policy and Procedures:
At a minimum, the Policy and Procedures included in the Manual will include:
Patient confidentiality and integrity protection information
A policy to maintain an accurate list of possible pharmacists, including initials and ID
codes, that will perform Remote Order Processing
Any policies that outline compliance with federal and state laws and regulations
Any policies involving quality care or improvement
The review of each Policy & Procedure annually; each to be signed and dated upon
review.
MOTION: Dan Connolly moved to approve the request from Seattle Childrens Hospital to
provide remote processing of medication orders to Bellevue Clinic and Surgery Center. Al
Linggi second. MOTION CARRIED: 5-0.
EXECUTIVE SESSION
CASE PRESENTATION
PRESENTATIONS Contd
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Pharmacy Technicians Taking Patient Medication Lists

MultiCare Health System presented a follow-up report on its process for using specially trained
pharmacy technicians to obtain medication lists for emergency department patients. Christian
Hamm Pharm.D., BCPS provided the update to the board on their take back program that was
approved in 2009.
Program Summary
Implemented in Tacoma General Hospital ED on August 2009
Initial support provided by one 8 hour technician position from 1500-2330 M-F
Currently providing 15 hours of technician coverage (0800-2300), 7 days/week
Focus and priority is on patients that are planned to be admitted from the ED
Number of techs completing training and competency program: 10
Feedback Physicians
Improved accuracy of med lists
Improved accuracy of order entry
Extra efforts by pharmacy techs to find patients home med list; contacting MD office or
retail pharmacy
Improved trust in the med list obtained by Pharmacy
Saves time for the providers
Improves efficiency of the admitting process
Saves time and improves accuracy of the discharge reconciliation process
Next Steps
Improve the process in getting to the patient before the MD
Get to all ED patients that are being admitted
Determine the best workflow to discontinue PTA meds that the patient is no longer taking
Notification of decentralized pharmacist if PTA medication history not fully complete in
ED
Expand to 24 hour coverage and non-ED admits
Central Washington Hospital

Central Washington Hospital will present a follow-up report on the success of its proposal for
expanded roles for specialized function pharmacy technicians. Tim Fuller introduced John
Swenson and Jin-Kyung Lisa Yang. The presentation was given by Jin-Kyung Lisa Yang.
Methods:
Phase I: Collecting data from pharmacists checking technicians
Phase II: Training and testing qualified technicians
Phase III: Collecting data from technicians checking technicians, evaluating the data, and
then presenting the data
Quality Assurance:
In the first year after becoming certified technicians will undergo quarterly quality
assurance audits for anesthesia/sedation boxes and batch pre-mixed intravenous
medications and then annually thereafter
For emergency crash carts technicians will undergo bi-annual audits for the first year and
then annually thereafter
Technicians mu st have an accuracy rate of 99% for all audits
Additional audits if deemed necessary by the Pharmacy Manager
Results:
There was a total of 12 pharmacists who participated in the
o phase I data collection period
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A total of 2262 items were checked

A total of 3 mistakes were found
Overall time spent = 220 minutes
Overall accuracy rate for the pharmacist was 99.87%
There were three technicians who participated in the new program
All three technicians completed the eight hour training and passed all three exams
There was a total of 2915 items checked
There was only 1 mistake found
Overall time spent = 295 minutes
Overall accuracy rate for technicians was 99.97%
There is no statistically significant difference between pharmacist and technicians when it
comes to checking anesthesia/sedation boxes, emergency crash cart, and pre-mixed
intravenous medications (non first-dose)
Discussion:
Our study is focusing on CWH policies and procedures which may not be the same as
other institutions.
CWH has many safety measures implemented like patient bar-coding
The Norris Center and RKDP pharmacy have an expanded technician check technician
program
Further studies to assess quality assurance program and the impact of the new program to
CWH
Conclusion
Technicians who have been trained in a supervised program which includes measures for
quality assurance can safely and accurately check anesthesia/sedation boxes, emergency
crash carts, and pre-mixed intravenous medications (non-first dose) at Central
Washington Hospital
MOTION: Vandana Slater moved that the board approve the continuation of Central
Washington Hospitals expanded roles for specialized function pharmacy technicians program.
Dan Connolly second. MOTION CARRIED: 5-0.
Group Health Cooperative (GHC) Take Back Program

Grant Chester introduced Shirley Reitz, from Group Health Cooperative . The board is being
asked to consider their request for continuation of their drug disposal take back program.
Take Back Program Overview

Pilot project at Group Health ran from Oct 2006 through end of 2008 which collected and
disposed of 15,134 lbs of unwanted medications
Starting in 2009, Group Health has continued to provide this service
Findings from pilot presented to Board of Pharmacy in June 2009; asked to come back in
a year. Group Health hired 0.5 FTE technician and 0.2 FTE Pharmacist to manage the
program
Protocol and processes were simplified (post-pilot project) for better flow in pharmacy
warehouse and to utilize space more efficiently
Additional warehouse staff were trained to manage the day-to-day work of logging
buckets as well as in the bi-weekly screening process
Continued to work with Mike Lafferty as new owner of PS Industries, Inc. for
transportation of materials for destruction
In 2009, Group Health:
o collected 2,022 5-gallon buckets of material,
o condensed it to 658 containers for shipping, and
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incinerated 14, 206 pounds material

Data from a UW study show that on average, about 25% of the weight consists of
packaging, so approximately 10,650 lbs of medication was destroyed.
All 25 WA state Group Health clinics continued to participate in 2009.
Total costs for Group Health in 2009:
$30,683
o Labor:
o Supplies:
$500
o Incineration: $35,515 (includes transportation costs)
$66,698
o Total
As of May 2010, we have collected and disposed of 6,138 lbs of material
o average of 72 5-gal buckets are screened every 2 weeks;
o approximately 5% are empty pill bottles,
o <1% of material is removed per protocol (sharps, batteries, aerosols, mercury,
iodine products)
During 2010, all GHC sites will be audited for compliance with protocol
o 6 have been completed to date (see attached form)
o All locations have been in full compliance
o Staff feedback has been very positive and most frequent request is for bigger
disposal containers.
From 2006 through 2008, the state of Maine piloted a mail back medication return
program that started in 11 and then expanded to 150 pharmacies. During that time, they
disposed of 2,300 lbs of medications from 3,926 returned envelopes at a cost of $18.79
per unit mailer.
MOTION: Christopher Barry moved that the board approve the continuation of Group Health
Cooperatives Take Back Program for two more years. Vandana Slater second. MOTION
CARRIED: 5-0.
Group Health Cooperative - Pharmacist to Technician Ratio

Katherine Bergman from Group Health Cooperative (GHC) was introduced by Grant Chester.
The board is being asked to consider a request by Group Health Cooperative to increase the
pharmacy technician to pharmacist ratio.
Currently pharmacies are restricted to a 3:1 technician - pharmacist ratio unless they
receive board approval. GHC is requesting board approval to utilize a 4:1 ratio in their
Ambulatory Refill Pharmacy Pharmacy Contact Center in Tukwila. The technicians
would be involved in non-distributive pharmacy activities in the Call Center.
GHC has provided a pharmacy services plan.
GHC will monitor the technicians work using a Quality Assurance call monitoring
program and by performing regular audits of standard work over time. GHC will provide
a follow-up presentation to the board in one year.
While we could choose to use Pharmacy Assistants or non-pharmacy personnel to perform many
of these duties, we feel that pharmacy technicians perform these duties with a higher degree
knowledge and expertise with resulting excellent quality in the care provided to our members.
We believe that expanding the role of technicians in our innovative pharmacy practice will
ultimately allow pharmacists to more fully engage in provision of high quality, accurate and safe
pharmaceutical care to our members.
MOTION: Vandana Slater moved that the board defer the decision on the request from Group
Health to increase pharmacist technician to pharmacist ratio. The board needs to gather and
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review more information on past actions to similar requests that were approved. Kim Ekker
second. Al Linggi opposed. MOTION CARRIED: 4-1.
GHC - Computer Upgrade

Grant Chester introduced Tom Colleran who updated the board about the GHC pharmacy
computer software. The board was asked to consider a request for an exemption to counsel on all
new prescription numbers for certain refill prescriptions .
Mr. Colleran shared with the board the issues and the resolutions to Group Health Cooperatives
computer system. Stan Jeppesen performed an inspection June 15, 2010 on GHCs computer
system and found that these issues were fixed.
MOTION: Christopher Barry moved that the board deny the request from Group Health for an
exemption to counsel on all new prescription numbers for certain refill prescriptions. GHC
pharmacists are to continue to counsel on all prescriptions . Dan Connelly second. MOTION
CARRIED: 5-0.
DISCUSSION
Delegation of Authority to Initiate an Investigation
Bill Kellington, Director of the Office of Legal Services for the Department of Health presented
a proposal asking the board to consider withdrawing the rules to delegate authority case
management to initiate investigations.
MOTION: Al Linggi moved that the board repeal Chapter WAC 246-856-030 by expedition.
This rule delegates authority to the case management team to initiate and investigation. Vandana
Slatter second. MOTION CARRIED: 5-0.
Substance Abuse/ Decision-Tree Algorithm

Al Linggi led the discussion with the board regarding the draft algorithm developed to provide
the board guidance for considering cases of diversion and substance abuse. William Rhodes and
Micki Kedzierski from Washington Recovery Addiction Program for Pharmacy (WRAPP) went
over the draft algorithm with the board. After further discussion and review the board asked that
the algorithm be reformatted so the board can better understand this. The board asked for more
education regarding the process WRAPP takes to discipline those who are non compliant to the
program.
U.S. Congress H.R. 1191, the Safe Drug Disposal Act of 2009
The board was asked by Susan Teil Boyer to consider sending a letter of support to the U.S.
House Energy and Commerce Committee in support of Congressman Ins lees bill.
MOTION: Vandana Slatter moved that the board send a letter of support to the U.S. House
Energy and Commerce Committee in support of Congress Inslees bill. Dan Connolly second.
Changes to Scheduled Business Meetings
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Susan Teil Boyer asked the board to consider cancelling the August 2010 business meeting due
to the budget constraints.
MOTION: Christopher Barry moved that the board cancel the August 2010 business meeting
and that the board will reconvene September 2010 . Kim Ekker second. MOTION CARRIED:
5-0.
Rules Update.
Doreen Beebe and Susan Teil Boyer led the discussion on the proposed rulemaking workload.
Each rule was reviewed by staff and the board. There was an update on the Animal Control
Agency and Humane Society Rules Al Linggi volunteered to be the Champion Board Member to
support the staff with this rule.
Correspondence
The board discussed correspondence received/sent.
Medication Safety Alert June 3, 2010

Notice of Stakeholder Workgroup Pain Management
Proposed Rule Making Amending Scope of Practice for Health Care

Assistants/SHB1414
Letter from board to all Pharmacies/Residential Treatment Facilities Controlled
Substances
WRAPP Quarterly report Wrap-Up & Workload Statistics
OPEN FORUM
EXECUTIVE SESSION
Board met in Executive Session to consult with legal counsel matters relating to enforcement
actions.
CLOSED SESSION
Case presentations

There being no further business, the board adjourned at 5:00 p.m. The Board of Pharmacy will
meet again on September 16, 2010 for its regularly scheduled business meeting in Renton,
Washington.
______
June 18, 2010_9:00 a.m.
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_______________________________
Approved on September 16, 2010
_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON
MEETING MINUTES
June 29, 2010
Special Meeting
Teleconference
CONVENE
The telephonic meeting was called to order by the Board Chair Gary Harris.
Board Members present by telephone:
Gary Harris, R.Ph, Chair
Albert Linggi, R.Ph, Vice-Chair
Vandana Slatter, Pharm.D.
Christopher Barry, R.Ph.
Rebecca Hille, BA, Public Member

Dan Connolly, R.Ph.
Joyce Roper, AAG (by phone)
Susan Teil Boyer, R.Ph, Executive Director
A special meeting of the Washington State Board of Pharmacy was scheduled to begin at 3:30 p.m. on Tuesday,
June 29. The public was invited to hear the discussion at the Department of Health, 111 Israel Rd SE Room 158
in Tumwater. The meeting was held to allow the board to consider whether to initiate rule making to amend its
rule(s) to require facilitated referral when a facilitated referral will provide more timely access of medications to
patients when pharmacies do not have the medications and when pharmacists do not dispense the medications.
The board, represented by a quorum, discussed that a facilitated referral is consistent with current practice and with
the changes occurring in the practice of pharmacy with the newer pharmaceuticals, including but not limited to
biologics. They acknowledged that in many instances a facilitated referral will benefit patients in assuring more
timely access to a variety of medications. They also discussed how telepharmacy services might also promote
patient access to medications, particularly in the rural area, and acknowledged that rule-making on telepharmacy
services is already on their rule-making list.
Al Linggi moved that the Board initiate rulemaking to amend rules to require facilitated referral and instructed staff
to file a CR101 in the state registry. The motion was seconded by Kim Ekker . Five members voted in favor of the
motion and zero opposed. Note: the Chair does not vote unless to break a tie.

There being no further business, the board adjourned at 3:55 p.m. The Board of Pharmacy will meet again on
September 16 for its regularly scheduled business meeting location to be determined.
_______________________________
Approved on ________
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_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON

CONVENE
Chair Christopher Barry called the meeting to order July 10, 2014.
Commission Members:
Guest / Presenters:

Gary Harris, RPh,
Sally Logan, RPh, KPNW Outpatient Pharmacy

Quality Coordinator

Steve Anderson, RPh
Nancy Hecox, PharmD
Tim Lynch, PharmD
Jay Rho, RPh, KPNW National ePIMS Deployment

Lead
Carolyn Luettgerodt, RPh, KPNW Pharmacy Area
Director & National ePIMS Training Lead
Sandra Dahl, RPh, KPNW Pharmacy Area Director
Scott Mihulka, PharmD, Pharmacy Manager Bartell Drugs
Billy Chow, R.Ph., Director of Rx Operations
Cecelia Smiley-Adams, Regulatory and QA Manager for
Mark Steltz, CEO of ePharmPro
Lloyd Stever, PharmD, Director of Pharmacy for
Samaritan Health
Michael Li, PharmD, Supervisor Pharmacy Services for

Al Linggi, RPh, MBA
Highline Medical Center

Staff Members:
Joyce Roper, AAG
Christopher Humberson R.Ph., Executive Director
Gordon MacDonald R.Ph., Chief Investigator
Grace Cheung R.Ph., Pharmacy Investigator
Cathy Williams R.Ph., Pharmacist Consultant

1.2 Approval of May 29, 2014 Meeting Minutes.
MOTION: Steve Anderson moved that the commission approve 1.1. Nancy Hecox second. MOTION
CARRIED: 9-0.
MOTION: Dan Rubin moved that the commission approve 1.2. Steve Anderson second. MOTION
CARRIED: 9-0.
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CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be approved by
a single motion of the commission without separate discussion. If separate discussion is desired, that item
May 2014

Shiraz Pharmacy
Village Pharmacy
Omnicare of Spokane Columbia Crest Care & Rehabilitation
Omnicare of Spokane Lifecare Center of Kennewick
Omnicare of Spokane Regency at the Park

CVS E-system
MOTION: Dan Rubin requested to remove 2.3 (a & b) and 2.6 (a) from the consent agenda for
further discussion. Dan Rubin moved that the commission approve items 2.1, 2.2, and 2.5. Sepi
Soleimanpour second. MOTION CARRIED: 9-0.
REPORTS
Commission Members
He participated in a compounding conference call.

Kristina Logsdon reported:
Kristina attended the WRAPP Training June 29, 2014.

Nancy wrote an article/paper on Collaborative Drug Therapy Agreements has been accepted for
publication in two journals.
Her course for pharmacy regulatory specialist will be completed after she takes her final exam.
He also attended the WRAPP Training June 27, 2014
Steve took the MPJE in Arkansas he passed it and met with Board of Pharmacy.
Dan Rubin reported:
He spent quite a bit of time on the prepping for the Pharmacy Business Practices Committee take
off.
Following this meeting there will be a brief meeting of the Pharmacy Business Practices
Committee of the Commission to deal with procedural issues exclusively.
Tim Lynch reported:
Tim attended the WRAPP Training on June 27, 2014.
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He chaired the section advisory committee for business pharmacy practice management for
ASHP. The final meeting was last month.
Completed a CE event at ASHP on bedside medication.
Chris attended the Boards and Commission Leadership Meeting June 13, 2014 at Department of
Health (DOH). This includes members of all board and commission. There was a legislative
update. Topics of discussion were tele medicine, medical marijuana, and potential alternatives to
discipline.
Executive Director
Met with Compounding Sub-Committee to continue progress on Sterile Compounding rules

development.
Met with both Chairs of Business and Technology Committees to determine path forward.
Attended the Idaho Northwest Pharmacy Conference (5/30-6/1 ) and presented on New Rules and
Laws on June 1st, 2014
Follow up meetings with Department of Corrections on their Pharmacy Centralization proposal.
Participated in meetings to provide Citrix access to B/C members for secure e-mailing of
documents and files.
Assisted with Sunrise review for Naturopathic Board/DOH to evaluate prescriptive scope with
controlled drugs for naturopathic providers. Currently, they can only write for products
containing codeine and testosterone.
Completed LEAN Visual board project and now have daily stand-ups to increase accountability
and project management completion by staff. Implemented SBAR decision paper format.
Attended DOH Boards and Commissions Leadership Meeting with Chris Barry at DOH
Tumwater.
Got approved and posted a HSC2 Pharmacy Technician Analyst position to handle consultant
workload on routine applications and processes. Job posting closed June 30 and have 22
applicants. Hope to have the position hired by September 1st.
Participated in meetings and provided documents/decision papers on Pharmacy Commission

requests for 2015 legislation through DOH.
Finalized Pharmacist/Technician Survey that will be going out August 1st and available for 6
weeks. More to follow later in the meeting.
Participated in department meetings on Residential Treatment Facilities and use of ADD devices
and EMS services and statutes/regulations on purchasing medication.

The Supreme Court issued its decision on Hobby Lobby. That particular decision has
th
implications for the commission in respect to the Stormans litigation. The 9 Circuit put a
hold on the Stormans litigation pending the outcome of the Hobby Lobby decision. The
th
afternoon of the decision the 9 Circuit notified all parties that they wanted supplemental
briefing, due July 28, on the question of the impact, if any, of the Hobby Lobby decision
on the issues in the Stormans case. The Hobby Lobby decision was based exclusively on
a federal law that only applies to other federal laws, such as the Affordable Care Act.
From the States perspective, the Hobby Lobby decision has no impact on the Stormans
case.
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Lisa Roberts introduction

Lisa Roberts is a 1997 graduate of the University Of Washington School Of Pharmacy. She received both
her Bachelor of Science in Pharmacy and her Doctor of Pharmacy degree from the University of
Washington. Prior to taking the Pharmacist Consultant position with the WA State Pharmacy Quality
Assurance Commission, she was the Director of Pharmacy at Willapa Harbor Hospital. Previously, Lisa
spent twelve years working as a clinical inpatient pharmacist between Providence St. Peter Hospital and
Grays Harbor Community Hospital. She also has three years of experience working as a clinical provider
for Providence St. Peter Anticoagulation Clinic. She holds her Anticoagulation Therapy Management
Certificate from the University of Southern Indiana. Lisas earlier pharmacy experiences include working
retail, outpatient and independent pharmacy. She was Director of Pharmacy at Stafford Creek
Correctional Center for two years as well. Lisa is married and currently resides in Cosmopolis with her
husband and son.
Cathy welcomed Lisa Roberts, Pharmacist Consultant who was hired to fill Tim Fullers position.

Pharmacist Investigator Grace Cheung attended the Multistate Pharmacy Jurisprudence Exam
(MPJE) Review Committee (MRC) annual meeting held at the NABP office from June 11-13,
2014. Grace has been serving on this committee since 2008; she was reappointed by the NABP
Executive Committee to serve her third three-year term.
Amongst other duties, the MRC is tasked to review all newly composed questions from each state
to ensure that they meet standards for inclusion into the exam test pool. Members review
questions for content feasibility as well as format. This year the committee reviewed & edited
1000 law questions submitted from over 50 states. Additionally, the MRC members discussed the
blueprint of the MPJE as part of their ongoing review of the applicability of competencies.
Pharmacist Investigators Greg Lang and Tina Lacey attended CriticalPoints Sterile Compounding
Boot Camp for State Board Inspectors held June 17th-19th in Englewood, Co... Along with
Inspectors from other states, Greg and Tina were presented information to assist them in assessing
cleanroom principles and practices that comply with USP <797> as well as industry best practices.
The most common deficiencies noted in routine pharmacy inspections continue to include the
lack of updated patient medical records including chronic medical conditions and allergies as well
as the presence of outdated or deteriorated stock in the pharmacy. Of special note, these
violations have increasingly been repeat violations that were noted on a previous routine
inspection and have continued to remain uncorrected by the pharmacy.
Pharmacist Investigators continue to provide technical assistance to pharmacists regarding the

importance of maintaining current patient medication records and removal of expired or
deteriorated stock from the pharmacy in addition to making appropriate and consistent point
deductions on inspections.
PRESENTATIONS
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Kaiser Permanente Northwest Workload Balancing

Christopher Humberson introduced Sally Logan, KPNW Outpatient Pharmacy Quality Coordinator she
was requesting approval of the PDX-EPS (Enterprise Pharmacy System) a remote pharmacy dispensing
system for use to assist other Washington licensed locations KPNW.
Proposal
Kaiser Permanente Northwest (KPNW) is implementing the PDX-EPS pharmacy dispensing system and
is requesting the Washington State Pharmacy Quality Assurance Commission (PQAC) approval of a
Workload Balancing prescription process for KPNW Washington licensed Pharmacies utilizing
Washington licensed staff.
Similar to other Workload Balancing programs, this would allow Washington licensed
pharmacists and technicians at multiple Washington licensed pharmacy locations to remotely
assist one another in processing prescription orders.
The purpose is to maximize staff resources, create efficiencies, and maintain patient safety.
About the System
PDX-EPS Retail Pharmacy Management System platform, known as the Kaiser Permanente
enterprise Pharmacy Information Management System (ePIMS), includes a few program
enhancements to accommodate the interface with KP HealthConnect our electronic medical
record system, Central Fill and Mail Order Pharmacy systems
ePIMS retains all the regulatory compliant functions of the PDX-EPS Retail Pharmacy
Management System
The basic prescription dispensing work flow of ePIMS is the same as the PDX-EPS system work
flow
ePIMS uses a common patient data base.
Prescription Work Load Balancing
What it is:
o
Distributing the work across all appropriate pharmacy locations (depending on location
licensure and staff licensure) at the appropriate times while not exceeding the 3:1
technician to pharmacist ratio.
This is work that does not require direct contact with the patient or physical handling of
the medication.
Staff at a low volume or slow pharmacy location can remotely access orders at a busier
location to assist in processing those orders.
What it is not:
o
It is not counseling
It is not the physical manipulation of medication products or the act of filling the
prescription (preparing medication for dispensing or labeling)
It is not doing the final verification of the filled prescription (checking for right drug with
right label on the bottle)
The purpose
Improves efficient use of pharmacy staff resources by preparing (includes Order Entry,
Data Entry, Data Verification, and DUR) the prescription order for fill at a location
pharmacy.
Leverages the use of the common patient database which keeps the patient profiles whole.
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The pharmacy systems automated prioritization function allows a high volume pharmacy
environment to better manage their incoming prescription orders with the assistance of
Workload Balancing and the Central Fill Pharmacy.
Reduces stress in the work environment due to high incoming prescription order volume.
Assists to maintain a high level of patient safety by allowing staff more time to better focus
on the needs of those patients present at the pharmacy.
Quality Indicators
Expected decrease in Drug Furnishing Irregularities
Sentinel events are explored through Root Cause Analysis (extremely rare)by a multi-
Pharmacy is closely partnered with Regional Quality Resource Management, Risk
disciplinary team
Management, Regional Compliance, and National Compliance and regularly reviews
patient safety issues
ePIMS Quality Assurance
The ePIMS system tracks each individual who performs each task of the prescription
processing work flow from start to finish which can be audited for quality
Specific tasks in the prescription process are enabled in the system based on the scope of
practice of the user (technician and pharmacist as dictated by State pharmacy
rules/regulations)
Any notations made on a prescription are done electronically and are retained with the
prescription record. Example: the remote RPh can add notes for the counseling RPh to act
on
Besides being required to comply with the KPNW organizational quality and patient safety
policies and procedures, the KPNW pharmacy department also maintains pharmacy
specific quality assurance programs to ensure medication and patient safety.
All pharmacist involved are licensed in Washington. Christopher Barry suggested that order
entry portion in the policies and procedures be taken out since it isnt being used. There is a
regional quality assurance committee that reviews all incidents. The pharmacist would be held
responsible for an error is usually based on a case by case investigation.
MOTION: Tim Lynch moved to approve the PDX-EPS (Enterprise Pharmacy System) a remote
pharmacy dispensing system for use to assist other Washington licensed locations KPNW. They must
report back at end of year one and year two of results of programs to include documentation of
documented amount of increased pharmacist time with patients, increases in MTM/counseling time
spent with patients, error/ QI comparative reports for first year of program and what improvements
were made during first year, how many pharmacy technicians are working before the ePIMS system was
put in place and how many after . Sepi Soleimanpour second. MOTION CARRIED: 9-0.
CONSENT AGENDA
a.
Shiraz Pharmacy
MOTION: Tim Lynch moved that the Shiraz Pharmacy Technician Training Program approval be tabled
until more information is provided. Nancy Hecox second. MOTION CARRIED: 9-0
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b.
Village Pharmacy
Some commission members are concerned about all the exams being oral.
o
There isnt a requirement that we see scores, our requirement is that they pass the
national certification exam, and that they have the specific training.
MOTION: Gary Harris moved that the commission approve the Village Pharmacy Technician Training
Program. Tim Lynch second. Elizabeth Jensen abstained. MOTION CARRIED: 7-1
The commission wanted some clarification regarding the 128 bit encryption whether it was
needed or not. CVS is saying they dont need it because they dont send anything through a
public domain.
o
128 bit encryption is required in Washington State.
It is a federal law they are required to have 128 bit encryption.
MOTION: Gary Harris moved that the commission deny CVS electronic prescription transmission
system until they prove that they have 128 bit encryption. Tim Lynch second. MOTION CARRIED: 9-0
Gary Harris rescinded his motion.
MOTION: Dan Rubin moved that the commission approve CVS electronic prescription transmission
system conditional on a confirmation that the procedure complies with federal law. Steve Anderson
second. Gary Harris and Sepi Soleimanpour opposed. MOTION CARRIED: 7-2.
Bartell Drugs Call Center

Cathy Williams led the presentation that was tabled at the May 2014 meeting. To give Bartell Drugs time
to address the quality assurance concerns and strategies around the pre-verification function issue; review
the technician ancillary utilization plan; and detail how pharmacists will have more time for clinical
activities. Billy Chow, RPh, Director of Rx Operations and Christie Cummins from McKesson answered
commission concerns.
Christin Cummins explained how the pre verification works. Pre verification can be turned on from a
store perspective but not the way Bartell Drugs wants to set up call center. ( no documentation was
provided ) .Call center will be using load balancing functionality to be able to remote into individual
stores to help with workflow. If the individual store doesnt have the pre verification turned on than they
wouldnt be able to access that queue. The call center doesnt own the prescriptions, the stores will keep
ownership of the prescriptions so if the store doesnt have that queue turned on than the call center
wouldnt be able to access that queue.
Load Balancing
Inbound Communications
Collection of electronic images and electronic prescriptions

Reception
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Repository for paper hard copies received by the pharmacy after scanning an image (before
patient is assigned)
Contact Manager
Lists all outbound communication regarding refill requests, prescription clarifications and prior
authorizations
Data Entry
Primary component of workflow; melds prescriptions from Inbound Communications, Reception

or Contact Manager
Adjudication Exception
Third Party rejections
Pre-Verification
Displays DUR for pharmacist approval and image with typed information (patient, prescriber, sig,
quantity, etc.) for pharmacist to verify prescription accuracy
Benefits of Call Center

Some of the benefits of a call center may include the following aspects:
Patient Safety - More time spent on prescription verification/counseling
Improved efficiency of existing staff
Enables pharmacist to engage in more patient centric services (i.e. MTMs, immunizations, travel
Use of technology driven solutions to assist our facilities without traveling on-site
Reduced customer wait times
Enhanced overall patient satisfaction and wellness
consultations, CMRs, biometric screenings, counseling)
BDCC Policies and Procedures Manual

The BDCC P&P manual shall contain but not limited to the following:
BDCC requirements and staff qualifications
Quality Assurance Program
BDCC staff responsibilities
Pharmacist functions
BDCC prescription transfer procedures
BDCC new prescription procedures
BDCC refill prescription procedures
MTM policies and procedures
The BDCC policy and procedures manual shall be reviewed annually and shall record
documentation of such reviews
A more comprehensive version of the policies and procedures manual has been submitted for
your review.
BDCC Pharmacy Technician Utilization Plan

The BDCC will be utilizing Pharmacy Technicians within limitations, for the various functions listed
below.
Prescription Order Processing
Record keeping
Handling of nonprofessional telephone calls to/from BDCC
Housekeeping tasks
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MOTION: Tim Lynch moved to approve Baretll Drugs Call Center as presented and they must report
back in one year. Sepi Soleimanpour second. Steve Anderson recused himself. Gary Harris opposed.
HealthFirst Acquisition Company, LLC

Cathy Williams provided a very brief background to the commission. Ron Friedman, JD presented an
overview prior to the presentation. Cecelia Smiley-Adams, Regulatory and QA Manager presented the
proposal to transfer business practice from Texas to Washington refurbishing emergency medical kits for
use on board U.S. commercial airlines.
Overview
Passenger-carrying commercial aviation is a critical part of our national transportation

infrastructure, as 644,000,000 people are transported for business and pleasure each year. A
recent study found that on average there is one in-flight medical emergency for every 604 flights,
which translates to approximately 14,510 in-flight medical emergencies each year.
The Federal Aviation Administration is charged with passenger safety and requires every
passenger-laden flight to carry an emergency medical kit (EMK) with a specific set of
medications to treat the most common in-flight ailments. These FAA-mandated EMKs are a nofly item and passenger-carrying planes cannot liftoff without them onboard.
Banyan International is located in Abilene, Texas and was founded over 40 years ago as the first
provider of emergency medical kits to office-based physicians.
Banyan manufactures and maintains EMKs for nearly half of all US domestic flights and is one of
two companies in the country that can provide this mission-critical service.
Banyan International is the sister company of HF Acquisition Co LLC (HealthFirst brand)

located in Mountlake Terrace, Washington.
The companies have the same ownership and management structure and the businesses are being
merged in Q2 2014. Both the HealthFirst and Banyan brands will be sold out of the Mountlake
Terrace facility (which is currently licensed by the Washington Board of Pharmacy, the DEA,
FDA, and 48 state boards of pharmacy and accredited by the NABP).
We understand the Boards concerns regarding the nuances of the commercial aviation business
model (i.e., the airline kits are returned for refurbishment with unused medications inside). We
have created numerous preventative measures to ensure returned medications are not diverted or
inadvertently placed back into active inventory.
physical segregation of returned medications and immediate disposal
time-temperature tags to ensure medication efficacy
separate production area for airlines
strenuous recordkeeping procedures)
MOTION: Tim Lynch moved to approve HealthFirst Acquisition Company, LLC s proposal to transfer
business practice from Texas to Washington refurbishing emergency medical kits for use on board U.S.
commercial airlines. Sepi Soleimanpour second. MOTION CARRIED: 9-0.
Medication for Disposal Take-Back Programs

The commission was asked to review and re approve the policies and procedures for City of Bellingham
Household Take-Back Administration Program for potential collection sites in pharmacies. This was
already approved the commission members were provided all documents for review. There was little
discussion on this since it has been approved. There was discussion regarding the location of the box.
The location of the box is outside of the pharmacy if anything happens to the box the Pharmacist in Charge
(PIC) would be held responsible.
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MOTION: Dan Rubin moved that the commission re approve the City of Bellingham Household Takeback Administration Program for potential collection sites in pharmacies for five years. Gary Harris
OPEN FORUM
Charmaine Sanders thanked the commission for approving her request to re- take the MPJE. She now has
a better understanding for Pharmacy Law in Washington State. She has been networking since she has
received her license. This has allowed her to enhance her education in Pharmacy even more. Charmaine
thanked her mentor Jenny Arnold.
Lis Houchen with NACDS thanked the CDTA sub-committee for all the hard work regarding the CDTA
process. She offered copies of the letter that she had sent to the commission with some recommendations.
Lis also shared that she hopes the new process proposal gets approved soon.
Jeff Rochon with Washington State Pharmacy Association (WSPA) wanted to publicly thank the CDTA
sub-committee for extending an additional stake holder meeting so a number of stake holders had another
opportunity to express concerns and viewpoints that possibly added to the sub-committees end product.
Jeff thanked Chris Humberson for attending and the Pharmacy Convention. He extended a thank you to
Chris Humberson, Gordon MacDonald, and Don Painter for attending Health Systems Leadership
Meeting and meeting with a number of Health Systems leaders. WSPA truly values stake holder
opportunities and he is hopeful that there continues to be an open dialogue between WSPA and Pharmacy
Commission. Jeff offered an open invitation to all commission members to attend a WSPA Meeting
anytime.
Grant Chester shared some concerns he has:
Currently there are 3 commission members whose terms expire in 2016 and 3 commission
members whose terms expire in 2018. Has anything being done to correct the problem?
These meetings are currently regular scheduled public meetings. The public is provided with an
agenda before each meeting. I have three concerns:
Even with the agenda it is difficult to follow the items because none of the information on
the agenda is disseminated to the public prior to or at the meeting which makes it difficult
for the public audience to follow. Request that since the commission meetings are public,
a copy of the commission documents be available either by CD or paper at or before
the meetings for the public.
Not everything brought up at the meeting is captured in the minutes. None of the topics
presented during open forum have been entered into the minutes. Request that everything
brought up at the commission meetings be captured by the minutes.
Minutes of the prior commission meeting are routinely approved at the next
commission meeting. However, it can take up to 4 or 5 weeks for them to be
disseminated to the interested public. Request that approved meeting minutes be
disseminated closer to the time they are approved.
Thomas Schilling asked for assistance from the commission to help pharmacist be recognized as
prescribers so they can access that HEALWA site.
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PRESENTATIONS Contd.
ePharmPro, LLC Telepharmacy Telepharmacy/Remote Pharmacy Services
Chris Humberson introduced Mark Steltz, CEO of ePharmPro. Mr. Steltz shared a power point
presentation of the ePharmPro, LLC Telepharmacy to the commission for approval.
Overview:
Variance Reporting
Direct link into your hospitals reporting system.
We follow your P&Ps in regards to variance reporting.
You will receive monthly variance reports and quarterly safety reports.
Information tracked by our Safety Officer.
These reports create internal educational initiatives for our pharmacist teams.
Continuous Quality Improvement Process
Continuous customer satisfaction review beginning on day one, and ongoing.
Communication System links Hospital Staff to e-PharmPro Staff.
If you clarify with one- You educate all.
Constant communication used to clarify and update all processes and policies.
After the 90 day start up, all TRUE Medical and Profiling Variances can be charged back to ePharmPro.
The goal of the e-PharmPro Quality Improvement Process is to educate our staff so that your
Pharmacy will have trust our e-PharmPro
Pharmacists and consider them as an integrated part of your pharmacy practice.
Advantage
Seamless with Hospitals Internal Processes.
Strong Nursing Perspective.
Calls from your nurses go directly to your dedicated e-PharmPro pharmacists.
Primary Pharmacist Model.
No Technicians and no retail pharmacists
Continuous Process Improvement Program.
100% up Time Guarantee.
24 Hour IT Support.
All pharmacist Have Greater Than 5 Years of RECENT Hospital Experience.
We work in a True Virtual Pharmacy Community.
Integrated Web Based Reporting System.
Custom Reports on Customer Defined Benchmarks.
Benefits Realized
Pharmacist review of medication orders.
Pharmacist clinical interventions.
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Pharmacist as a clinical resource.
Enhanced medication safety.
TJC and HIPAA compliance
Nursing supervisors have more time to focus on patient care.
Nursing staff has a clinical resource available 24 hours a day.
Enables optimization and future application of technology to enhance patient care and minimize
medication errors.
Implementation Guidelines
Establish time table to implement e-PharmPro service.
Weekly 10 minute meetings.
On-site training.
Gather clinical and operational information.
Create joint policy and procedure manual.
Establish communication plan for document management and order processing.
Coordinate with IT to establish connectivity to your pharmacy computer system.
Phone and fax set up to reach after hours pharmacists.
MOTION: Dan Rubin moved that the commission approve ePharmPro, LLC Telepharmacy for one year
or sooner if there is substantive guidance emerging from the technology committee . Tim Lynch second.
Samaritan Health Telepharmacy/Remote Pharmacy Services
Lloyd Stever, PharmD, Director of Pharmacy for Samaritan Health asked the commission to approve its
policies and procedures to use ePharmPro, LLC to provide remote pharmacy services.
MOTION: Elizabeth Jensen moved that the commission approve ePharmPro, LLC Telepharmacy for one
year or sooner if there is substantive guidance emerging from the technology committee . Gary Harris
Highline Medical CenterTelepharmacy/Remote Pharmacy Services

Cathy Williams provided some brief background to the commission. She then introduced Michael Li,
PharmD, Supervisor of Pharmacy Services for Highline Medical Center. He requested approval to
provide remote order entry after hour services for Highline Specialty Campus.
Proposal
To consider a request for Highline Medical Center pharmacy to provide remote order entry for
Highline Specialty Campus, after hours
Highline Specialty campus provides long-term acute care services 24/7
Long term plan:
Highline specialty campus will be moving back to the Highline Medical Center campus in Oct
2014
Training
HMC and HSC share many policies and procedures
HMC and HSC staff are oriented to both campuses; both belong to HMC pharmacy staff
Training includes but is not limited to
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Abbreviations, administration times, automatic stop orders, substitution, formulary

compliance
Policy and procedures are shared through a common HMC portal
Policies are reviewed annually
Remote Order Verification

HMC pharmacists order verification includes:
Review for appropriateness, completeness, and conformance to facility policies
Interpreting and clarifying orders
Drug regimen review
**Because HMC/HSC utilize EPIC CPOE, there is no order entry, only order verification
Each order is reviewed for:
Appropriate dose, route, duration, frequency, indication
Unapproved abbreviations
Identified medication/food allergies and sensitivities
Drug-drug interactions
Duplicate therapy
Therapeutic appropriateness
Appropriateness to medication stop policy
Quality assurance
Monthly, 10 orders from HSC will be reviewed by HMC pharmacy leadership for the following
Time to order verification
Order verification appropriateness
When error or delay is identified, the order will be investigated

HSC providers will be contacted for:
Incomplete orders
Inappropriate abbreviations
Clinically inappropriate orders
These orders will not be verified until clarified

Once orders are processed in EPIC, RNs will have access to medications via Pyxis
MOTION: Dan Rubin moved that the commission approve the proposal for Highline Medical Center
pharmacy to provide remote order entry for Highline Specialty Campus, after hours. Nancy Hecox
second. Tim Lynch recused himself . MOTION CARRIED: 8-0.

CDTA Sub-Committee
Tim Lynch the chair of the CDTA Sub-Committee presented the amended proposal from the May 29,
2014 meeting. After several stake holder meetings, sub-committee meetings and work a draft proposal
was presented at the May 20, 2014 meeting. Tim lynch did acknowledge and thank the NACDS for the
letter of recommendations that they submitted. There were few minor grammatical changes made. Tim
Lynch and the sub-committee asked the commission members for approval of this amended proposal.
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MOTION: Steve Anderson moved that the commission approve the proposal for submitting CDTAs.
Nancy Hecox second. Tim Lynch recused himself . MOTION CARRIED: 8-0.
Business Practice
Sub-committee process discussion
Dan Rubin reported other members are Steve Anderson, Gary Harris and Elizabeth Jensen. I developed
this recommendation in consultation with commission staff over the past month.
History
In fall of 2011 the then- Board of Pharmacy began a pharmacy rules rewrite project. Over the
following year members and staff participated in a rule scan and gap analysis process to identify
areas that likely need revision. This rule scan was input to a Board Planning Session on
November 9, 2012. Four workgroups were formed, including an Operations Workgroup (name
later modified to Business Practices). In January 2013 the Board adopted resolutions authorizing
filing a CR-101 for this area of rule-making (along with resolutions covering three other rulemaking. Soon after this a moratorium was placed on non-essential rule-making, leading to
interruption of planned work sessions with stakeholder input. The priority areas were reviewed
again at the April 16, 2014 Commission Planning Session without formal change and
membership of the committee was reaffirmed except for the appointment of Steven Anderson to
replace Emma Zavala-Suarez, who had left the Commission. Dan Rubin was named chair at this
point.
Scope of Issues to be considered
Official scope of rule-making will be stated in a CR-101 that needs to be filed to initiate the
formal rule-making process under the state Administrative Procedures Act (APA).
Based on work through the conclusion of the November 2012 Planning Session, priority topics
related to Pharmacy Business Practices were identified
During the Commissions April 16, 2014 Planning Session. No official modifications were made
in the priority topics but I believe a brief period should be provided for further input on the scope
of Pharmacy Business Practice rulemaking by both Commission members and interested parties
before filing a CR-101.
Process
Immediately after todays business meeting, the Pharmacy Business Practices Committee will
convene to agree on a process for the committees work (Committee Meeting 1). The door will be
open to modification of process later based on experience and/or further input.
Dans goal is for the CR-101 identifying general scope of consideration for rulemaking to be
issued by the end of August at latest.
Chris Humberson shared, in beginning the work of the Business Practice Committee; we are rolling out a
survey for pharmacists and pharmacy technicians in Washington State.
Survey Process:
Looking at the initial Oregon pharmacy workplace survey and the subsequent B.C. survey, we
constructed the PQAC survey using both the Oregon survey questions for continuity for future
data collaboration and added questions from the AHRQ/Westat Community Pharmacy Survey
on Patient Safety. Those additional questions were drawn from a scientifically developed
national survey instrument sponsored by Agency for Healthcare Research and Quality that would
apply to several practice settings that add questions on quality improvement processes currently
in use.
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The survey will take about ten minutes to complete with about 20 questions along with a place
for additional comments. The survey requires no identification and will be confidential, with a
link
on the PQAC web site and a return to the site when complete.
Our goal is to publicize thru List Serve, email and direct mailings. The survey will run from
th
August 1 until September 18 .
Compounding Rules process
We had a document prepared for distribution in early June but decided to wait for Tina Lacey
and Greg Lange to complete their training at Critical Points Compounding Boot camp in
Colorado in June. During that training we had discussions that our body of work needed some
additional tweaking in organizational structure and there was an opportunity for the Critical
Points experts
to review the document and make suggested changes based upon USP 797 standards and work
they have done with other states. We felt this offer to the commission at no charge was
valuable and subsequently will have the restructured document to their staff the week of July
th
14 for a weeklong review and report on suggested changes to make. Once returned, we plan
on reviewing/modifying the document before releasing the draft for comment. We hope to
finally have that done by end of July 2014.
Emergency Outpatient Dispensing Emergency Rules
After our March commission meeting, the Commission responded to requests from Island
Hospital in Anacortes and the WSHA to hold a special meeting to authorize emergency
rulemaking to expand WAC 246-873-060 to increase the number of critical access hospitals
that could have nurses dispense controlled medications when the pharmacy was closed.
The action of the commission at that meeting was to increase the number of hospitals to fit
the criteria of 50 beds or less and a distance of 35 miles or more from a 24 hour pharmacy
service, expanding the current number of hospitals from ten to over forty.
The decision was immediately challenged as not inclusive of all hospitals that might be in need
but did not fit the criteria. So the rulemaking process was delayed as staff attempted to resolve
issues with how the criteria were selected. With no resolution and the 1989 rule still in effect, it
is the recommendation of the staff to rescind the emergency rule and proceed to authorize a
CR101 on the rule and proceed down the traditional rules process
MOTION: Tim Lynch moved that the commission rescind the CR103 emergency rule, proceed with
CR101 rule making process and for staff to notify impacted facilities that may have assumed
approval. Steve Anderson second. Dan Rubin and Kristina Logsdon abstained. MOTION
CARRIED: 7-0.
Staff will draft a procedural document after it is put together it will be brought to the commission
for approval.
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Medical Assistant Dispensing
There is no granted scope that allows for dispensing of medications or selection of medications
to be administered.
R.C.W 18.360.050 Authorized duties.
As a body the Pharmacy Commission does not have authority over the Medical Assistants (MA). After further
discussion the commission suggested that pharmacist discuss with physician that they should select medication
for the MA to administer until there is a resolution regarding this matter. The medications can only be within that
health care entity and NO controlled substances. Staff will work with Brett Cain, Blake Maresh, Joyce Roper,
MQAC and NQAC to do more research on this matter and see if there needs to be a legislative change.
Department of Health staff will work towards getting a communication out to those who are impacted and or will
be impacted.
Unlicensed staff transporting drugs from pharmacy

The question has been raised, can an unlicensed person transport medications from the pharmacy to
another location within a hospital?
69.41.030 Sale, delivery, or possession of legend drug without prescription or

order prohibited Exceptions Penalty.
It shall be unlawful for any person to sell, deliver, or possess any legend drug except upon
the order or prescription of a physician under chapter 18.71 RCW, an osteopathic physician
and surgeon under chapter 18.57 RCW, an optometrist licensed under chapter 18.53 RCW
who is certified by the optometry board under RCW 18.53.010, a dentist under chapter 18.32
RCW, a podiatric physician and surgeon under chapter 18.22 RCW, a veterinarian under
chapter 18.92
RCW, a commissioned medical or dental officer in the United States armed forces or public
health service in the discharge of his or her official duties, a duly licensed physician or
dentist
employed by the veterans administration in the discharge of his or her official duties, a
registered nurse or advanced registered nurse practitioner under chapter 18.79 RCW when
authorized by the
nursing care quality assurance commission, a pharmacist licensed under chapter 18.64 RCW to
the extent permitted by drug therapy guidelines or protocols established under RCW 18.64.011
and authorized by the *board of pharmacy and approved by a practitioner authorized to
prescribe
drugs, an osteopathic physician assistant under chapter 18.57A RCW when authorized by
the board of osteopathic medicine and surgery, a physician assistant under chapter 18.71A
RCW
when authorized by the medical quality assurance commission, or any of the following
professionals in any province of Canada that shares a common border with the state of
Washington or in any state of the United States: A physician licensed to practice medicine
and
surgery or a physician licensed to practice osteopathic medicine and surgery, a dentist licensed
to practice dentistry, a podiatric physician and surgeon licensed to practice podiatric medicine
and
16
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surgery, a licensed advanced registered nurse practitioner, a licensed physician assistant,

a licensed osteopathic physician assistant, or a veterinarian licensed to practice
veterinary medicine: PROVIDED, HOWEVER, That the above provisions shall not
apply to sale,
delivery, or possession by drug wholesalers or drug manufacturers, or their agents or
employees, or to any practitioner acting within the scope of his or her license, or to a
common or contract carrier or warehouse operator, or any employee thereof, whose
possession of any legend drug is in the usual course of business or employment:
PROVIDED FURTHER, That nothing in this chapter or chapter 18.64 RCW shall prevent a
family planning clinic that is under contract with the health care authority from selling,
delivering, possessing, and dispensing commercially prepackaged oral contraceptives prescribed
by authorized, licensed health care practitioners.
Schedule V prescription exemption
Questions remain regarding: Why did the commission issue the communication last year to
discontinue the sale of class 5 cough medications without prescription by signing a
registry?
Chris Humberson, At this time I would like to publically waive the client confidentially
with AAG Joyce Roper on this topic for the basis of a full and complete conversation
regarding the communications with her and DOH/ BOP employees on this subject.
Cont When on May 17, 2013, passage of SUBSTITUTE SENATE BILL 5416 occurred, I
had discussions with the former Chief Pharmacy Investigator regarding the effect of the
passage of
the bill on the purchase of codeine containing cough syrups without a prescription, at which
point he contacted AAG Roper for her opinion. After that discussion with her, it was determined
that
the bill would not permit the activity and we then researched those pharmacy operations that were still
using a registry to contact them regarding the change. I believe there were less than 30 of the
1450 pharmacy operations still doing this. We sent out a letter stating that this practice would
no longer be allowed.
Tramadol
The DEA classifies Tramadol as Schedule IV controlled substance to be effective August

18,
2014.
MOTION: Nancy Hecox moved that the commission authorize CR105 for Tramadol. Gary
Harris second. MOTION CARRIED: 9-0.
OTHER
Veeva a Professional Association Request to receive list/labels
A panel was chosen to hear the request from Veeva to be recognized as a

professional association to receive list/labels .
17
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MOTION: Kristina Logsdon moved that the panel deny Veeva to be recognized as a
professional association on the grounds that they do not meet the definition of a professional
organization. Gary Harris second. MOTION CARRIED: 6-0.
2015 Meeting dates and fiscal year travel plans
MOTION: Elizabeth Jensen moved that the commission change the meeting from December 18,
2014 to December 11, 2014. Steve Anderson second. MOTION CARRIED: 9-0.
MOTION: Tim Lynch moved that the commission adopt the 2015 meeting dates as proposed.
Steve Anderson second. MOTION CARRIED: 9-0.
MOTION: Christopher Barry moved that the commission send Chris Humberson to the 2014
NABP District 6, 7, & 8 Meeting. Tim Lynch second. MOTION CARRIED: 9-0.
Review of the commissions delegation of signature authority

Doreen led the discussion regarding the commissions delegation of signature authority to
department staff. In addition, the commission will review its delegation of decision-making under
RCW
18.130.050(8) to act on behalf of the board on summary actions when a respondent is prohibited
from practicing in another state due to unprofessional conduct.
MOTION: Dan Rubin move that the commission approve the delegation of signature
authority to department staff to remain as is. Tim Lynch second. MOTION CARRIED: 9-0.
Re-affirm the commissions recognition of accreditation by the American Council on Pharmacy

Education Accreditation (ACPE).
MOTION: Tim Lynch moved that the commission recognize the accreditation by the American
Council on Pharmacy Education Accreditation. Steve Anderson second. MOTION CARRIED:
9-0.
Correspondence
Health Care Entity (HCE) / Ambulatory Surgery Facility (ASF) Information
Pharmacy Quality Assurance Commission (PQAC) Powers and Duties of Pharmacist

Investigators
OPEN FORUM
Billy Chow inquired about WAC 246.869 child resistance caps. Does there need to be a box on a form for
the patient to mark whether or not they want child resistant caps or not? And is there an issue if
18
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there happens to be two colored pens on the form?
Joyce Roper said there is nothing stating anything about different color pens on a form. There
are three ways to capture a patients request for non-child resistance caps.
Jeff Rochon with WSPA stated that the new format of commission meetings seem to be difficult
for public to give comments that may be helpful to the commission for making decisions. Maybe
the commission can accept comments from the public before a vote.
The legend drug act doesnt seem to designate who can have a possession of a drug.
A couple things with CDTA process that we would like clarification in writing. The process
for getting acknowledgment from the commission for Yellow Fever Stamp approval seems to
be difficult. He asked to have that process clarified. And the lack of recognition of multiple
prescribers.


The committee met following the business meeting to agree on a process for the committees work


19
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sion
20
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STATE OF WASHINGTON

Meeting Minutes
July 17, 2008
310 Israel Road SE Room 152/153
Tumwater, WA 98501
Board Office: (360) 236-4825
PRE MEETING PANEL

Pre-meeting Panel: Board members Gary Harris, Dr. Slatter, George Roe met prior to the
business meeting to consider two requests submitted by pharmacy intern applicants. The panel
approved:
Special internship hours for Connie M. Remsberg for her participation in pharmaceutical
research conducted at the University of Washington under the direction of Dr. Neal
Davies. Hours not to exceed 840.
The study plan proposed by Marlene M. Zaky Saleeb. Authorizing her to retake the
Multistate Pharmacy Jurisprudence Examination.
CONVENE
Chair Rebecca Hille called the meeting to order at 9:00 a.m., July 17, 2008.
Rebecca Hille, BA-Public Member, Chair

Albert Linggi, RPh
Lisa Hodgson, Executive Manager
Dan Connolly, RPh

Rosemarie Duffy, RN, MA, MSN, Public Member
George Roe, RPh
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Steve Saxe, Executive Director (Acting)
Joyce Roper, AAG
Grace Cheung, Investigator
Cheryl Christensen, Administrative Assistant
Mission Statement
The mission of the Board of Pharmacy is to achieve the highest standards in the practice of
pharmacy and promote public health and safety and to effectively communicate with the
Governor, Legislature, the Department of Health, the public and profession.
Vision Statement
The Washington State Board of Pharmacy leads in creating a climate for the patient-focused
practice of pharmacy.
We support and encourage our pharmacists to inform, educate, consult, manage drug therapy and
provide products as an integral part of an accessible, quality based health care system.
CONSENT AGENDA
1.1
1.2
1.4
1.5

Connie M. Remsberg Intern Hours for Pharmaceutical Research
A & H Pharmacy
Duplicate (this is the same as #1)
Brooke Bakogeorge Vancouver Community College BC Canada
Suzanne Lee Hinton Payless Drug and Save-On Drugs in Las Vegas NV
Zhanna Culbertson Zaporazhs State Medical University, Ukraine
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Community Health Service of Spokane (CHAS)- Hypertension Various

Pharmacists
Community Health Service of Spokane (CHAS)- Lipid Treatment Various
Pharmacists
Howards Drug and Medical Supply OTC Various Pharmacists
Howards Drug and Medical Supply Refills Various Pharmacists
Howards Drug and Medical Supply Immunizations and Epinephrine
Various Pharmacists
Liberty Bay Internal Medicine Hypertension Nicholas David Wyatt
Liberty Bay Internal Medicine General Protocol Nicholas David Wyatt
Swedish Medical Center Anemia/Pre-surgery Various Pharmacists
Odessa Memorial Healthcare Center Pyxis
Skyline Hospital Pharmacy MDG System
Evergreen Pharmaceutical LLC - Omnicell
1.6
1.8
May 29, 2008 Board Minute Approval
Items listed under the consent agenda are considered routine matters and will be approved by a
single motion of the board without separate discussion. Items 1.3, 1.7 were deleted from the
agenda. MOTION: George Roe moved that the board approve items 1.1, 1.2, 1.4, 1.5, 1.6, 1.8.
Rosemarie Duffy second. MOTION CARRIED: 5-0.
REPORTS
Executive Director
Attended the Northwest Pharmacy Convention.
o I1000 Initiative Death with Dignity.
Budget preparation time staff busy preparing to go before the legislature.
The Integrated Licensing and Regulatory System (ILRS) continuing to work out some
of the bugs. Better way to access/cross reference cases. Multiple license facilities.
Attended the Unintentional Poisoning workshop with Dan Connolly. Rising
unintentional incidents of death relating to prescription drugs.
Attended NW Patient Safety Conference regarding the prevention of medical and
medication errors.
Attended the Rural Hospital Conference discussed some issues around patient safety.
Represented Health Systems Quality Assurance Division at the Hospital Acquired
Infections Workgroup.
A formal offer has been extended to an applicant to head the Prescription Monitoring
Program (PMP) and will hopefully be on staff by August 1, 2008. The PMP currently is
funded for one year and we are working on ongoing funding and awaiting approval on a
federal grant.
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Bonnie King, Director of Health Professions Quality Assurance office has officially
retired and this marked the formal change from Facilities and Licensing Services to
Health Professions and Facilities effective July 1, 2008.
The Executive Director position for the Board of Pharmacy will be posted shortly. Board
members will be involved in the hiring process for this position.
Board Members
George Roe reported:
He is a member of the committee tasked with drafting sanctioning guidelines. The
committee has met twice. The committees recommendations are due to the Secretarys
office by November 15, 2008, and if adopted will take effect on January 1, 2009.
Secretary Selecky will present a report to the Legislature by January 15, 2009. An
informational handout was passed out to board staff then he asked for their comments.
Attended the Pharmacy Investigators Quarterly Meeting on June 11, 2008. He stated he
felt the meeting was filled with good, positive energy. Some of the discussion at the
meeting included issues with ILRS and the sharing of possible solutions.
Asked that when the board is doing case reviews, to please be mindful that they are
completed in a timely manner.
Dan Connelly reported:
He attended the University of Utah School on Alcoholism and Other Drug Dependencies
from June 15-20th. He stated he went to numerous meetings and feels that the program is
very spiritual. This program helped him understand addiction problems. He mentioned
that Bartells will fund two scholarships each year that will qualify for 2 hours continuing
education credits.
June 9, 2008 he represented the board at a Prescription and Drug Overdose meeting
another great experience. He feels the Prescription Monitoring Program is essential to
helping to eliminate drug diversion.
Attended the Microsoft Health Vault Conference in Bellevue regarding internet record
keeping.
He handed out samples of a product that was produced for the Seattle Medic 1 program
called Vial of Life. It is a prescription vial that is placed in your refrigerator to be
filled with information regarding an individuals medications, doses. Also includes door
stickers, magnets and a card for your wallet. It is planned that the program will extend
throughout the state.
On July 8, 2008 the 9th Circuit Court of Appeals heard arguments in the case of Stormans
vs. Selecky. The argument was whether or not to lift the injunction that was issued by
Judge Ronald B. Leighton of the U.S. District Court pending trial in April 2009. .
Kingsbury0738
We have continued to work with the Department of Health (DOH) on what constitutes a
sixty-day supply of medical marijuana. The draft has been filed for public comment.
DOH involved in development of guidelines. We have taken no position.
Attended the American Society of Health System Pharmacist (ASHP) Summer Meeting.
Enjoyed all the vendors with software programs, physician order entry, robotic arms, and
barcodes for patients and their drugs.
On the Patient Safety Coalitions work on the Medication Safety Initiative to improve
medication safety by focusing on the prevention of error via improved communication
between prescribers, pharmacists, and patients. The group will met on August 5, to
brainstorm ideas, seek advice from media experts and strategize how to promote the use
of medication lists.
Attended the Washington Pharmacy and Therapeutic Committee Meeting with the
healthcare authority.
Chief Investigator
Mr. Randy Flett left state service on June 30, 08 after working for a year as a time
Pharmacist Investigator. Mr. Joseph Hondas appointment ends Sept. 15, 2008.
Compliments to Judy Haenke and her staff for doing an outstanding job with ILRS
challenges around pharmacy firms and license expiration dates.
We have been working with the Yakima Valley Farm Workers Clinic (YVFMC) since
November to improve their understanding of the Call Center requirements and to ensure
compliance with their agreement with the Board of Pharmacy. Tyler Varnum, Pharmacist
Investigator and Amy Amerein, Responsible Pharmacist Manager for YVFMC were able
to resolve all concerns except one. This related to Call Center services for their Oregon
pharmacy. YVFWC will presentation at the September board meeting in Yakima. The
YVFWC was inspected on June 24, 2008 and received an A grade.
The Investigators Quarterly Meeting is scheduled for September 11, 2008. Rosemarie
Duffy will attend with the possibility of Dan Connelly attending also.
PRESENTATION
National Standardized Examination for Pharmacy Technician
The board was tasked with identifying the criteria it will use to approve a national standardized
certification exam. Based on the rules adopted in May all new applicants for pharmacy
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technician must pass a board-approved national standardized exam in addition to other

requirements. The board reviewed many recommendations for criteria submitted by the National
Association of Boards of Pharmacy, the Washington State Pharmacy Association and two
national pharmacy technician certification programs. . A teleconference presentation was given
by Jim Kendzel, Executive Director of the National Organization for Competency Assurance
(NOCA) and the National Commission for Certifying Agencies (NCCA).
NCCA currently accredits both national exams PTCE and ExCPT.
Rosemarie Duffy read into record letters from the American Society of Health-System
Pharmacist; National Association of Chain Drug Stores, and Group Health Cooperative.
Following the presentation, the board asked questions and received comments from
representatives of both national examinations Dr. Kenneth Schafermeyer, Director of Education, Institute for the Certification of
Pharmacy Technicians (ICPT) and
Jeanie Barkett, representing, the Pharmacy Technician Certification Board.
MOTION: Dan Connolly moved the board accept accredited NCCA certified tests as boardapproved Pharmacy Technician examinations. Rosemarie Duffy amended that they need to
show proof of accreditation for NCCA as necessary. Vandana Slatter second. MOTION
CARRIED: 5-0.
University of Washington (UW), School of Pharmacys Medication Therapy Management
Pharmacy
Don Downing, UW, gave an overview of the program with the following highlights:
More people are asking for this service and willing to pay.
The capacity to provide care for those who come to us has not been built yet.
In order to be paid, we have to be able to provide positive outcomes.
The UW is collaborating with Washington State University (WSU).
A drugless pharmacy has been opened at the UW, but does not want to make pharmacy
students obsolete.
The first year of training for PharmD students will be practicing on scheduling and taking
medication history and billing. Years two and three the students will work using teaching
cases and standardized patients. The fourth year would be regular Medication Therapy
Management clerkship at the University of Washington working in a pharmacy with live
cases with faculty preceptors.
He has received overwhelmingly positive results from pharmacies.
Rod Shaffer, Executive Director of the Washington State Pharmacy Association, stated his
support for the program and thanked the board for their support.
Madhu Panchapagesan, PharmD Candidate commented that this is the future of pharmacy and a
wonderful experience she can carry over to her practices.
Joyce Roper, AAG, made it clear that the board has not endorsed the program.
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Request for Lists and Labels

ACTION: Rosemarie moved that the board select a panel to consider the request by Edward Via
Virginia College of Osteopathic Medicine /The National Center for Analysis of Healthcare Data
to be recognized as an educational organization. Vandana Slatter second. MOTION CARRIED:
5-0.
Vandana Slatter, Gary Harris and George Roe were chosen to be part of the panel.
Following the panels discussion, Gary Harris suggested that before making a decision the panel
needs more information.
MOTION: George Roe moved that an inquiry should be made as to the background of the
association, its relationship to the college and the nature of the academic research.
Documentation needed. Dr.Vandana Slatter second. MOTION CARRIED: 3-0 pending more
information.
Tim Fuller introduced Lance Muncey, of Holy Family Hospital. Mr. Muncey presented a
proposal to allow Holy Family Hospital in Spokane to provide remote prescription order
processing for St. Josephs Hospital in Chewelah and Mount Carmel Hospital in Colville when
their pharmacists are not present. The hospitals have a common order entry program and drug
dictionary. Their clinical documentation is the same program, but not shared. It is estimated that
20 prescriptions per evening will be remotely processed.
MOTION: Rosemarie Duffy moved to allow Holy Family Hospital to provide remote order
processing to the hospitals. Dr. Vandana Slatter second. MOTION CARRIED: 5-0.
DISCUSSION
John Worthington presented a proposal to adopt rules to reschedule industrial cannabis hemp.
Joyce Roper, AAG, advised the board that industrial hemp is not a scheduled drug by the DEA
or at state level. The board does not have the authority over industrial hemp regardless of the
THC level. She also said that the legislature made it clear that industrial hemp is not a controlled
substance, under our state statute, not a legend drug and the board has no authority to schedule.
MOTION: George Roe moved to deny the petition since it doesnt fall under the boards
authority. Dan Connolly second. MOTION CARRIED: 5-0.
Delegation of Signature Authority for Credentialing
T. Diane Young asked the board to approve a change of signature delegation for approval of
routine credentialing applications. She requested that signature delegation get transferred to the
following people:
T. Diane Young Credentialing Supervisor
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Karen Stricklett, Pharmacy Credentialing Supervisor

Kay Normand, Credentialing Lead
Shannon Beigert, Director, Customer Services Office
Shannon McMillan, Credentialing Supervisor
Jennifer Herbrand, Credentialing Lead
Shamim Bachelani, Credentialing Supervisor
Cindy Morris, Credentialing Lead
Josh Shipe Manager, Call Center
Diana Ehri, Manager, Operations
MOTION: Dr. Vandana Slatter moved to update the credentialing approval list. Rosemarie
Duffy second. George Roe amended that the list should be updated on an annual basis.
Mandatory Report Rules
Margaret Gilbert, Senior Staff Attorney, DOH HSQA, gave a presentation on how the
Mandatory Reporting Rules, adopted in April 2008, apply to the practice of pharmacy. Ms.
Gilbert said the rules are about what you have to do and what you are going to do when you have
to review a file. Joyce Roper commented that the boards rules extend a little beyond these rules.
Doug Beeman, Washington Recovery Assistance Program for Pharmacy (WRAPP) Advisory
Board member said he had concerns about the rules and feels that there is a presumption of
guilty until proved innocent. He also said his concerns about the future of impaired practitioner
programs are at risk with these rules.
Joyce clarified that a report is required if there is a patient harmed. A report does not determine
or mandate that the board take action.
2009 Meeting Dates
The board discussed and finalized the meeting calendar for 2009.
Business & Disciplinary Hearing
Planning Session
January 22 & 23, 2009

March 11, 2009
March 12 13, 2009
May 7 & 8, 2009
June 18 & 19, 2009
July 29 & 30, 2009
September 17 & 18, 2009
October 29 & 30, 2009
December 10 & 11, 2009
King Co
King Co
King Co
Spokane
Tumwater
Kent
Yakima
Tumwater
Kent
MOTION: Rosemarie Duffy moved to approve the meeting dates. Gary Harris second.
MOTION CARRIED: 5-0
2008 09 Travel Plans.
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The Board discussed and designated members and staff to attend priority conferences and
trainings for the 08-09 fiscal year.
September 17-20,
2008
October 21-25,
2008
May 16-19, 2009
June 21-26, 2009
June- TBD
District 6,7,& 8
NABP Meeting
Annual NASCSA
Conference
NABP 105th
Annual Meeting
University of Utah
School of Alcohol
and Other Drug
Dependencies
DEA Annual
Meeting
Park City, UT
Fort Lauderdale,
FL
Miami, FL
Salt Lake City, UT
Steve Saxe
George Roe
Steve Saxe
Steve Saxe
Gary Harris
Rosemarie Duffy
Greg Lang Pharmacist Investigator
TBD
MOTION: Dan Connolly moved to approve the designated travel plans. Gary Harris second.
Rulemaking Carisoprodol
Tim Fuller provided a brief summary. The board then considered the information presented at
the May 29th stakeholder meeting in its decision on whether to proceed in scheduling
carisoprodol hearing. MOTION: George Roe reaffirmed to move forward to reschedule. Dan
Stakeholder Meeting Update
Dan Connolly updated the board on the last correctional pharmacies stakeholder meeting held
July 10, 2008. He presented the concerns of the attendees at that meeting by passing out a
handout.
Model Policies and Procedures Animal Control Agencies/Humane Societies
Doreen Beebe provided some background on the model policies and procedure. The board then
considered the adoption of model guidelines for the administration and recordkeeping of legend
drugs.
MOTION: Rosemarie Duffy moved to accept the Model Policies and Procedures with the
clarification of the strength of Sodium Pentobarbital, 390mg/ml per 10lbs. George Roe second.
CORRESPONDENCE
The following correspondence was reviewed and discussed by the board.
The DEA has proposed rules for electronic prescription transmittals of controlled
substances ACTION: Tim Fuller and Cathy Williams have been asked to draft a
response for the board to review September 4, 2008.The response to the proposal must be
submitted by September 25, 2008.
NABP State News Roundup.
NABP Pharmacist Self-Assessment Mechanism.
NABP 3-News.
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Press Release ASHP Advises Washington State on Requirements for Pharmacy

Technician Training, Certification.
News from ICPT Exam for Certification of Pharmacy Technicians receives
distinguished NCCA Accreditation
Group healths Medicine Return Program will receive two awards.
California E-Pedigree.
Patient Safety & Clinical Pharmacy Services Collaborative.
DOH News Releases #08-099, 08-100, and 08-101.
OPEN FORUM
There were no comments.
There being no further business, the board adjourned at 4:15 p.m. The Board of Pharmacy will
meet again on September 4, 2008 for its regularly scheduled business meeting in Yakima,
Washington.
CLOSED SESSION
Case presentations
_______________________________
_______________________________
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STATE OF WASHINGTON

July 18, 2013
Blackriver Training and Conf Center
Puyallup Room
Renton, WA 98057
CONVENE
Chair Christopher Barry called the meeting to order at 9:05 a.m. July 18, 2013
Board Members:
Gary Harris, RPh,
Absent Members:
Staff Members:
Joyce Roper, AAG
Don Painter, Chief Investigator
Stan Moore, Pharmacy Investigator
Diane Young, Credentialing Manager
Guest / Presenters:
Sally Abbott, RN, MSN, Medical Surge and Healthcare
Coalition Coordinator for the Department of Healths Public

Health Emergency Preparedness and Response program
Hein Tran, Pharmacy Supervisor for Ambulatory Pharmacy
Service / Multicare Health Sytsem
Heidi Bragg, MBA, RPh, Director of Regulatory Compliance
for Cardinal Health
Annette Adkins, RPh, Interim Director of Pharmacy for
Whidbey General Hospital
Thomas H. Gallagher, MD
Alyson R. Kohl, MA
Carol Hooven, Ph.D
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Approval of May 30, 2013 Meeting Minutes
1.1
1.2
1.3
MOTION: Elizabeth Jensen moved that the board approves 1.1 and 1.2. Gary Harris second. MOTION
CARRIED: 5-0.
CONSENT AGENDA
motion of the Board without separate discussion. If separate discussion is desired, that item will be removed
from the consent agenda and placed on the regular business agenda.
1)
2)
3)

a) Care Health Solutions LLC
b) Owl Pharmacy
4) Ancillary Utilization Plan Approval
a) Fairfax Hospital
motion of the board without separate discussion. If separate discussion is desired, that item will be removed
from the consent agenda and placed on the regular business agenda. Items 4, 5, 7, 8, 9 and 10 were deleted
from the agenda.
MOTION: Dan Rubin moved that the board approve items 1, 2, 3(b) and 6, and remove Item 3(a) for
discussion. Elizabeth Jensen second. MOTION CARRIED: 5-0.
REPORTS
Board Member
Dan Rubin reported:
He attended the Utah School of Alcohol and Substance abuse he found this to be extremely valuable. It
includes a real accurate view of what treatment is like for a participant. There were approximately 650
participants and over 300 of them were pharmacists and 250 were pharmacy students. This can be a very
emotional program for those who have gone through this with a family member or someone close. Dan
Rubin made an honorary PQAC ceramic plaque.
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July 17, 2013 Elizabeth attended the stakeholder meeting in Kent regarding compounding. She felt the
meeting helped give her really understand how important it is to rewrite this rule and what the
stakeholder concerns are.

Gary Harris attended the UW Deans Club alumni event baseball game. He saw a number of old friends
along with Don Williams, the past Executive Director for the Board of Pharmacy.
Christopher Barry Reported:
He also participated at the compounding stakeholder meeting held in Kent. Chris felt this provided great
information and seemed a bit more focused than the previous stakeholder meeting.
Executive Director
Executive Director Report:
Attended Northwest Pharmacy Conference in Coeur dAlene Idaho on May 31 st thru June 2nd. Sat in on
Lecture on Veterinary Pharmacology to advance pharmacist knowledge of veterinary drugs being
dispensed and emphasis on the responsibility of proper counseling, dispensing per provider instructions,
and pharmacists having adequate resources/ references in the pharmacy on veterinary medications.
nd
Presented on Pharmacy Law and Board updates for 90 minutes on Sunday the 2 .
Had opportunity to network with both UW and WSU faculty and students on behalf of the board to
facilitate closer working relationship with each school .
Continued networking and recruiting interest in Pharmacy Quality Assurance Commission board seats
Rules Workshops: Hosted two stakeholder meetings in Kent, Tumwater and Spokane concurrently to
discuss relevant issues on formulating new rules relative to HB 1800 on Compounding. Great
participation with several insightful ideas to provide direction as we begin the rule writing process
New Rules Coordinator: Allow me to introduce to the board and audience Peggy Crane, who is our new
rules coordinator and comes to us with a great deal of experience in rules writing and development over
several years in both DOH and Fish and Wildlife and a great deal of management experience that will
be a great asset to the board/ Commission in the coming years, so please join me in welcoming Peggy.
The commission recruitment has gone very well, with to date 6 public member applications, 5
technician applicants, and 34 pharmacist applications thus far. So thank you to those who have be
gracious enough to apply to serve the people of Washington in this capacity and the next steps of
reviewing applications and making staff recommendations to Governor Inslees office by August 5 th to
allow time for their internal review as they make their choices. To review, there are a total of ten
pharmacist seats, four public member seats, and one technician seat on the PQAC that enacts into law
th
on July 29 , 2013. There will be ten total appointments to be filled, one a two year pharmacist term to
complete Donna Fields seat and one to replace Gary Harriss seat. It is possible that the appointments
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will be made in stages to allow for business quorum for September 5 meeting, and then completing the
appointments thereafter.
I am quite pleased to report to those of you that have not heard, that our chairman, Chris Barry was
appointed to a second four-year term last month by Governor Inslee. His leadership and experience, in
conjunction with the other current members, will be critical to the success of the work we do going
forward to serve all Washingtonians. I am so pleased that I get to work with him for several more years.
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As many of you know, Grant Chester retired as of June 30 after several years of dedicated service to
the pharmacy program and in this formal setting I wanted to express again my thanks to him for his
assistance to me and his work on behalf of the board and DOH.
Finally I want to thank everyone at DOH and within the pharmacy program, in particular Steve Saxe,
Doreen Beebe and Grant Chester for helping out during the period of time I have been away mending
from my accident. While everyone has been wonderfully supportive as I recover from my escapade on
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June 22 , Doreen has continued to be the rock of this program in keeping things running smoothly and I
want all in this room to know how fortunate you are ( and I am ) to have Doreen as the program
manager.
A new lawsuit has been filed, asking the Thurston County Superior Court for a declaratory ruling. The
lawsuit was filed by two groups, King County Citizens Against Fluoridation, and Washington Action
for Safe Water. This lawsuit arises from the Boards denial of a petition to amend the legend drug act,
which attorney Gerald Steel presented to the Board. Joyce has filed a motion to dismiss.
The Pierce County Prosecuting Attorney s Office served subpoenas on some Department of Health staff
regarding the bath salts rule. Steve Saxe and Donn Moyer were interviewed by prosecutor and the
defendants attorney, in expectation that they would be called to testify in a criminal case.
Joyce received a letter sent by a representative of the Washington State Medical Association about
pharmacists asking for more information about prescriptions for Controlled Substances. The letter
claimed that some patients are not timely receiving their pain medications due to these inquiries . This
letter was also sent to the DEA, asking whether the DEA had changed policies or procedures to make
these additional questions necessary. DEA responded that there are no new requirements. If patients are
not timely receiving their pain medications, the Board may conclude that these inquiries resulted in a
violation of the pharmacies responsibilities rules.

MOTION: Elizabeth Jensen pull together a stake holder meeting with WSPA, Medical Board, Wholesalers and
Chain stores to see what we can do about pharmacist that are asking for more information about prescriptions
for Controlled Substances. Some patients are being denied. This is a patient access issue and patient safety. Sepi
Soleimanpour second. MOTION CARRIED: 5-0.
Little to report as I have been using use it or lose it leave for three weeks.
Tim has been working with PHEPR (Emergency Preparation and Response) on a MOU with Dept of
Agriculture, State Veterinarian to distribute drugs from the National Veterinary Stockpile by use of the
DOH RSS facility. There are several drug and licensure issues to resolve.

Don Painter reported:
Don painter interim Chief Pharmacy Investigat or has

this position.
The pharmacy inspection survey reports have been turned in. Overall everything seems to be the same
except slightly down in customer satisfaction.
There has been an offer made for
been learning a lot of things he didnt realize about
the Grant Chesters position of Chief Pharmacy Investigator.

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Stan Moore reported:
Investigators would like to put together a policy and procedure for chronic illness in a
patients file at a pharmacy so they are not being denied prescriptions. Then possibly prepare
a letter for distribution so there is an understanding on what is expected in these situations.
Chris Barry suggested that investigators draft a letter and bring back to the commission for further
review.
Diane Young reported:
She reported to the board that the credentialing team was able to get 100% of the Pharmacy Firm
renewals processed before the expiration deadline of May 31.
PRESENTATIONS
Crisis Standards of Care: Update on Washington Planning
The board heard a presentation by Sally Abbott, RN, MSN, Medical Surge and Healthcare Coalition
Coordinator for the Department of Healths Public Health Emergency Preparedness and Response program. Ms.
Abbott spoke about how a medical response to a disaster or public health emergency could overwhelm our
healthcare system.
Medical Surge
Ability to provide adequate medical evaluation and care during events that exceed the limits of the
normal medical infrastructure of an affected community
Encompasses the ability of the healthcare system to survive an event and maintain or rapidly recover
operations that were compromised
Regional Coalition Planning Activities

Hospital: expand bed capacity using common space; rapid discharge of non-critical patients
Ambulatory care facilities: destination for less severely injured
Home Care: increasing caseload during response, care for hospital discharge patients
Alternate Care Sites: schools, hotels, tents
DOH Patient Movement Coordination
Disaster Response
All hazards: natural and manmade
All disasters are local
State and federal resources support local response
Public Health and Medical-part of Emergency Support Function #8 US Dept of Health and Human
Resources
Crisis Standards of Care
Defined as a substantial change in usual healthcare operations and the level of care it is possible to
deliver; necessary by a pervasive or catastrophic disaster
Justified by specific circumstances
Formally declared by a state government
Enables specific legal/regulatory powers & protection for healthcare providers
Defined as a substantial change in usual healthcare operations and the level of care it is possible to
deliver; necessary by a pervasive or catastrophic disaster
Justified by specific circumstances
Formally declared by a state government
Enables specific legal/regulatory powers & protection for healthcare providers
Department Activities
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Follow up: 2009 WA State Altered Standards of Care Project Recommendations

Internal planning with HSQA: e.g. out of state professional licensure
Convened legal workgroup: hospitals, ambulatory care, EMS
Evaluate need for medical advisory group for clinical decisions regarding
care with scarce
resources
Pharmacy Issues
Sending medications to alternate care facility
Points of Dispensing: non-pharmacists
Scarce supply of pharmaceuticals
Medications for chronic illness during disaster response (e.g. insulin, narcotics, mental health)
Suicide Prevention Training Study Update and Presentation

A representative from the Department of Health and the program consultants from the University of Washington
provided a presentation and update on the Suicide Prevention Training Study required by Chapter 181, Laws of
2012 ESHB2366.
Goals is to provided for review literature on suicide training and rates

There is not a specific health care profession that this training is relevant .
Yes it does help to train health care professionals.
The literature search and communication out in the health care field, confirmed that there was not a
particular profession. We then surveyed the professions in health care and over 200 folks in the pharmacy
profession responded to survey. Pharmacists were among the highest level of responders.
Provider behavior statistics determined knowing how to respond is within their scope of practice
and a large percentage wanted to have more training. 50% did not or cannot remember having this type of
training.
The overall evidence from pr feedback that this training has positive outcome that is well received and this
allows those with this training to feel more confident in addressing these issues if they see the need.
DISCUSSION ITEMS
Multicare Proposal for Centralized Pharmacy Services.
Tim Fuller provided the board an update on the April proposal presented by Multicare Health Systems to
implement centralized services including repackaging of non-sterile compounded oral liquids and topicals; and
batching of compounded sterile products as it relates to House Bill 1800.
Background:
On April 11, 2013 Multicare Healthcare present four proposals for centralizing packaging and
compounding operations. One site would serve several of Multicares health facilities. See the original
decision paper.
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Then May 7 , 2013 the Washington State legislature passed and the Governor signed House Bill 1800,
The Compounding of Medications. It went into force immediately due to the concerns about non-sterile
and sterile pharmacy compounding. The bill clarifies that a drug compounder must meet minimum
compendia standards for both non-sterile and sterile pharmacy compounding. It also defines what is
considered manufacturing and those functions that are not considered manufacturing. The new state
law allows a compounded drug product from a licensed pharmacy to be distributed to other
appropriately licensed entities under common ownership or control of the compounding facilities and
no longer requires a manufacturing license.

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In light of this recent legislation the two Multicare compounded product requests, Centralized Batching
of Compounded Sterile Products and Centralized Repackaging of Non-Sterile Compounded Oral
Liquids and Topicals, no longer require Board of Pharmacy approval.
The boards April 11, 2013 is modified by the passage of HB 1800 The Compounding of Medications.
The board requirements are reduced to:
Multicare shall submit policies and procedures for the centralized repacking or
oral solids and
the Pyxis/Talyst central fill operations.. MultiCare submitted the policies and procedures and
I found them acceptable. This satisfies the Board of Pharmacys April 11, 20 13 decision.
I have been promised the board requirement Multicare will provide the board with a copy of a
pharmacist competency training program for sterile products that include pharmacy technician
supervision will be provided.
Columbia Basin Health Association Othello Family Clinic Pharmacy
Role Based Pharmacy Technician Ratio
Proposal Revisited
The board discussed
the CBHAs technician ratio proposal that was tabled until the on-site demonstration to
DOH Pharmacist Investigator. The board discussed the concerns they had when this proposal was initially
brought before them. They felt that the outcome of Tyler Varnums report from his visit to CBHA that these
concerns were not addressed. There was no way to assure that a pharmacy technician that was working as an
assistant could not continue to do technician work, therefore would lead to a higher pharmacist to technician
ratio.
MOTION: Elizabeth Jensen moved that the board deny the technician ratio proposal by Columbia Basin health
Association Othello Family Clinic Pharmacy. Gary Harris second. MOTION CARRIED: 5-0.
CONSENT AGENDA Item 3(a)

Pharmacy Tech Training Program Approval from Care Health Solutions LLC was pulled from the Consent
Agenda for further discussion.
This technician program was letting students through although it was expired as of June 2012. This is a
high priority issue and affects quite a few students. Some have licenses pending, some have already
been licensed, and some have just finished hours. Each of these situations may need be handled
differently.
Some of these students didnt receive all their hours from this particular pharmacy. The teaching of
these students varies all across the board. The training in this program is very inconsistent along with
the quality of the training. Also the program that has been being used is very outdated.
Does the board have the authority to license these students if they have not gone through an approved
program? What is the ability of the board? What authority does the board have to remedy this situation
and those involved?
There are concerns with the renewal application for this pharmacy technician training program that was
just submitted July 10, 2013
MOTION: Dan Rubin moved that the board disapprove the pharmacy technician training program submitted by
Care Health Solutions LLC. Gary Harris second. MOTION CARRIED: 5-0.
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Christopher Humberson, Executive Director will take the lead on how to handle this situation and report back at
the September meeting.
Remote Order Entry

The board heard an update on the implementation of pharmacy remote order entry services provided to Whidbey
General Hospital by Cardinal Health.
Agenda overview:
Company background
Solution overview
Process overview
Results
Implementation
Quality assurance
Pharmacist training
ROES center Policy and Procedure
Questions
Solution:
A seamless part of the hospital team
Off-site pharmacists review and enter all medication orders into hospitals pharmacy
information system
Pharmacist review prior to administration
Resolution of all incomplete or questionable orders by our pharmacists

Relief for on-call pharmacists
Our pharmacists are available via a toll-free number to provide information and clinical support
to hospital and medical staff

Identify safety, clinical and operational improvements
Provides clinical intervention tracking and reporting
Results to date:
Measurable results
Over 7 million order lines processed annually
Clinical intervention rate averages 3-5% of order volume
49% of interventions identify potential patient safety risks

Nation-wide service
Eight regional service centers; operational in 41 states
WA non-resident site license and 5 pharmacist licensed
Over 250 hospital clients

Employs over 100 pharmacy personnel
Operates with over 22 different pharmacy information systems

Implementation:
Training
Pharmacists are trained on each hospitals policies, procedures, and protocols prior to initiation
of the service.
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Hospital pharmacys policies and procedures are stored electronically in a proprietary
technology system accessed by the Pharmacy Service Center to enable quick key-word
searching capabilities by the pharmacist during order entry.
Pharmacy Service Center is staffed with pharmacists experienced in hospital pharmacy.
Recordkeeping
System is able to identify each individual who processes an order and all activity related to the
order.
Measurements and Reports
Pharmacy Service Center staff document all order entry variances and interventions such as
interaction avoidance, illegible order clarification, incomplete order clarifications, dosing

changes, therapy duration changes, drug information provided, adverse drug reaction reporting,
therapeutic interchange, etc.
Daily and monthly reports are accessible via a secure, web-based client reporting portal .
Confidentiality and Security

Remote access to hospital pharmacy computer system is through a secure, virtual private
network.
Pharmacy Service Center enters into a Business Associate agreement with hospital and is in full
compliance with HIPAA and state privacy laws.
Quality assurance:
Hospital specific policy and procedure compliance
Proprietary technology maintains >50 pages of P&P documentation per hospital
Accessible by remote and customer on-site pharmacy personnel
Web-based to enable real time updates and alerting when information changes
Quick key word searching capabilities during order entry process
Quarterly P&P maintenance check up
Variance reporting program
Variance form created based on ISMP guidelines
Confirmation of receipt to hospital

Appropriate communication and feedback to hospital
Internal communication with Pharmacy Service Center leadership and pharmacist involved
Internal documentation and variance filing

Internal evaluation of variances
Daily at Pharmacy Service Center level
Monthly for centralized trigger point review
Quarterly by QA focus team for overall results analysis
Variance data and reports accessible by hospital

Prospective quality auditing program
Focus on patient 5 rights and hospital policy compliance
Audits reviewed centrally on a monthly basis
Quarterly findings drive focused improvement plan
Targeted for entire service and/or personnel specific

Individual or hospital performance improvement plan initiated real time as necessary
Audits communicated to designated hospital personnel

Pharmacist training:
Internal training and documentation
Competency testing upon employment and annually
Minimum of 11 ASHP competencies

Hospital specific competencies
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Pharmacist transcripts provided annually

Video and on-line training for proprietary and hospital specific technology
Currently support >22 pharmacy information systems
Dedicated due diligence team for internal and hospital specific training
Customer pharmacy
Monthly complimentary webinars hosted by Cardinal Health clinical experts
Hot industry clinical topics

Accreditation updates and news
Regulatory updates and news
Medication safety initiatives

Training videos provided upon request
Policies and Procedures Manual:

Maintain manual for operations within centers.
Completely reviewed annually. Individual policies updated between formal reviews on an as needed
basis.
Addresses topics including personnel, order processing, quality assurance and confidentiality.
MOTION: Gary Harris moved that the board approve implementation of pharmacy remote order entry services
provided to Whidbey General Hospital by Cardinal Health. The board request that they come back for a one
year update with more detailed information. Dan Rubin second. MOTION CARRIED: 5-0.
Rules and Legislation Implementation Update

Doreen Beebe updated the board.
We have been working on renaming board to commission and recruitment for new members. We are
expediting a packet to change the name from board to commission in our rules.
Peggy Crain is our new rules coordinator agency. We decided that the best rule for her to get stated on
was the agency request legislation that talks about electronic transmission and controlled substance
prescriptions
We have had a couple Stakeholder meetings for the compounding rules.

We still have our rules rewrite project. We need to work on the Legislation Implementation rules first.
PRESENTATIONS Contd
Immunization Training Program
The board was asked to consider for approval an in-house pharmacist immunization certification/training
program proposed by Ambulatory Pharmacy Service / Multicare Health System.
Background:
Multicare is an integrated health care system serving the South Puget Sound. We consist of 5 hospitals
and over 100 clinics. Many of these clinics offer immunizations on site, but many do not. Physicians
have asked for additional access points to serve their patients. Community pharmacies and
anticoagulation clinics are an opportunity for us to provide those access points.
At the current time we would propose a relatively small number of locations to provide this service: 7
community pharmacies and 4 anticoagulation clinics. All of these locations are located within our
hospital campuses or within our clinics.
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The purpose of having an in house training program is to ensure quality of care, standard of care and be
able to utilize our own expert resources. Our pharmacists will be trained and certified for Multicare
purposes only and we are not looking for national certification at this time.
Overview:
Provide a map of all the sites where pharmacists will be operating under the CDTA in relation to your clinics
and hospitals.
All of our proposed sites will be located within our hospital campuses or within our clinics.
How will any changes in the CDC, AICP, etc recommendations/requirements be routinely monitored and
incorporated?
As standard operating procedure, CDC updates will be monitored by our trainers and information will
be
communicated to our team. Additionally, all certified pharmacists will maintain an account with the CDC for
current updates. Pharmacists will also have an annual teleconference for update review.
How are drug recalls and other FDA alerts handled?

Drug recalls and other FDA alerts will be handled according to standard Multicare operating procedure as
outlined in the attached procedure document .
What is your CQI program for this training and monitoring of outcomes/pharmacists/interventions?
1. Vaccine Adverse Event Reporting System (VAERS)
2. Vaccine Errors- Institute for Safe Medication Practices
3. We have an internal reporting system as well. The MeQuim process requires we report any adverse event.
Time, dates, persons involved, physicians are all documented to completion and follow up is performed as
needed.
What information is provided to patients and how are they assessed by the pharmacists?
Each patient is provided a Vaccine Information Statement (VIS) and given a MHS Adult Immunization
Consent/Screening Form. As an additional check, the pharmacist will go over the screening form/checklist
question by question as well as verify in EPIC and the Washington State Immunization Registry for pertinent
clinical information/records. We will also consult with the CDC immunization schedule for recommended
vaccination schedule. We will provide a verbal vaccination education and question/answer period for the patient.
How is your P&T Committee involved?

Our collaborative practice agreement will be vetted through the Multicare P&T committee. We will take in their
input and will not proceed without their full support.
What volume of immunizations are you planning for?

We do not expect a high volume practice. Most of our immunization will be based on physician referral. We
anticipate no more than 2-3 immunizations per week, per site, with potential for more for seasonal demand.
It is not the role of the board to approve these collaborative agreements. The advice of the board is to make sure
that the agreement is between provider and the pharmacist.
Transforming Communication in Healthcare

The board heard an update from Dr. Thomas Gallagher, (M.D.) on a project to enhance the culture of health care
communication in order to improve patient safety and decrease medical malpractice liability.
Communicating to Prevent and Respond to Medical Injury Update:

Background:
Medical injuries common
Poor team communication as cause of many injuries
Communication with patient often deficient in response to injuries
Disclosure often fails to meet patient expectations
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Difficult for injured patients to receive fast, fair compensation

A decades emphasis on disclosing unanticipated outcomes to patients has brought limited change
Increasingly disclosure programs being coupled with early efforts at resolution
Communicating with patients after unanticipated outcome now recognized as:
Institutional responsibility
Critical part of quality, not solely risk management
Overview:
2010-2014
Components
Team communication training to
prevent errors
respond after errors
Pilot disclosure and resolution program (DRP)
Milestones:
HealthPact Forum @ Sea-Tac Hilton
1-31-12: Transforming Communication in Health Care
5-14-12: Promoting Accountability to Washington Patients Following Medical Injuries
Keynotes:
Strong representation from patient advisors, attorneys, other stakeholders
Next HealthPact meeting planned for 9/24/13
HealthPact Patient Advisor Panel formed
TeamSTEPPS training of sites change teams

Train the trainer coaching
Disclosure training developed

Disclosure coach training developed
Provider support/second victim training developed
What is accountability after medical injury?
Healthcare institutions and providers:
Recognize that event has occurred
Disclose it effectively to the patient
Proactively make the patient whole
Learn from what happened
Discuss the event across colleagues, institutions
In a healthcare delivery environment that:
Prospectively monitors quality of care
Identifies unsafe providers and employs effective remediation
Spreads learning across institutions
Quality of Actual Disclosures:

COPIC
3Rs program for disclosure and compensation, 2007-2009
837 Events
445 patient surveys (55% response rate)
705 physician surveys (84% response rate)
Just Culture Principles:
Errors are inevitable.
Errors are opportunities for learning and system improvement.
Non punitive reporting of errors is essential for learning.
All staff are accountable for their behaviors.
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Most errors are caused by system problems. Organizational leadership is accountable for developing
systems that reduce risk.
We are all accountable for correcting system flaws that raise the probability that error will occur.
What is the DRP?

Be candid and transparent about unanticipated care outcomes
Conduct a rapid investigation, offer a full explanation, and apologize as appropriate
Where appropriate, provide for the familys financial needs without requiring recourse to litigation
Build systematic patient safety analysis and improvement into risk management
DRP Partners:
Physicians Insurance A Mutual Company
Providence Sacred Heart Medical Center and Childrens Hospital

Providence Regional Medical Center, Everett
The Everett Clinic
The PolyClinic
The Vancouver Clinic
Benefits for Clinicians:

Provider support
Engagement from beginning in event analysis, disclosure, resolution
Disclosure coaching
Improved patient safety
Possible reduction in likelihood of being sued, outcome if lawsuit is filed
Myths: The DRP is not:
A rush to judgment
A rush to settlement
Mandatory
Telling the patient absolutely everything known about an adverse event
Paying patients when care was reasonable
Business as usual
Progress to Date:
DRP designed
Pilot sites recruited
Providence Everett, Sacred Heart, St. Mary; Everett Clinic; Polyclinic; Vancouver Clinic;
Physicians Insurance
Extensive physician outreach
Close collaboration with sites
Accelerating Results:
DRP Events starting to progress through process
Enhanced Providence-PI collaboration
Physicians Insurance Provider Support program launched 6/1/2013
Sites reaching out to affiliated physician groups
Training scheduled 8/20 for Walla Walla Clinic
Ongoing collaboration with Radia, Inland Imaging, other physician groups highlights positive
collaboration and interest
Exploring MQAC collaboration
Implementation Barriers:
Physician fear of adverse event reporting
MD education underway
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Work with sites around Just Culture

Lack of trust among key stakeholders
Incremental improvement as DRP events progress through system
Ongoing outreach to key physician groups affiliates with DRP sites
Time constraints for quality/safety/risk leaders
Physician concern about NPDB, MQAC, peer review
Certification Concept:
Provider fear of punitive action deterrent to early event reporting
Hard to ensure learning after adverse events
Early collaboration with MQAC around concept for DRP Certification to promote patient safety
Ongoing collaboration- DRP Certified Events
for those events being handled through DRP Process:
MQAC would agree to put investigation on hold
If at conclusion of DRP process event meets criteria for DRP Certification, MQAC
would likely close case
Cases of unprofessional conduct, willful or reckless conduct are not eligible for DRP
certification
Process would be available to all Washington physicians. Expanding to include pharmacists
would be ideal
Long term vision-create WPHP-like program for handling medical error
NASCSA Annual Conference

The board was asked to designate an attendee for the 2013 National Association of State Controlled Substances
Authorities.
MOTION: Elizabeth Jensen moved that Christopher Humberson attend the 2013 National Association of State
Controlled Substances Authorities and if he is unable to attend that we designate the chief investigator to attend
in his place. Gary Harris second. MOTION CARRIED: 5-0.
MOTION: Gary Harris moved that board authorize two spots to attend the Regional NABP meeting. There will
be further discussion with Christopher Humberson. Elizabeth Jensen second. MOTION CARRIED: 5-0.
Correspondence
There was no correspondence for the board to discuss .
OPEN FORUM
Grant Chester asked that the board think about modifying the rule so that pharmacy technicians can give
immunizations.
Jeff Rochon from WSPA wanted to thank the board for the past couple stakeholder meetings regarding
compounding. He feels these went well and appreciates the work the board does .
Elizabeth Jensen asked that there be a link to Yakima for the next stakeholder meeting on compounding.

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CLOSED SESSION

Approved on December 5, 2013
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MEETING MINUTES
July 20, 2006
Department of Labor and Industries
7273 Linderson Way
Tumwater, WA 98501
(360) 236-4825
CONVENE
Chair Asaad Awan convened the meeting at 9:10 a.m. on July 20, 2006. Board Members
present:
Donna Dockter, RPh
Gary Harris, RPh
Rosemarie Duffy, RN
Board members present via telephone:
George Roe, RPh
James Lewis, Pharmacist Investigator
Jennifer Wells, Program Support
July 20, 2006
Open Meeting
CONSENT AGENDA
1.1
1.2
1.3

Hawkins Defrance Application for Nuclear Pharmacist
Robin Pardun Application for Nuclear Pharmacist
Mandip Kalar
Kimberly A. Bradbury
Elizabeth Ann Fisher
Nipaporn Manivong
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1.4
1.5
Jacqueline A. Breau-Cohoon
Erika L. Borg
Riverpoint Pharmacy
David West/Anticoagulation
Legacy Salmon Creek Hospital/Anticoagulation
Items 1.6 Automated Drug Dispensing Device Acceptance; and 1.7- Sample Distribution
Requests were deleted from the consent agenda. MOTION: George Roe moved to accept 1.1,
1.2, 1.3, 1.4, and 1.5. Teil-Boyer second. MOTION CARRIED 6-0.
Item 1.8 Board Minute Approval. MOTION: Susan Teil-Boyer moved to accept the meeting
minutes with changes, removing the second sentence from the second paragraph on page 5.
Dockter second. MOTION CARRIED 6-0.
REPORTS
Executive Director
Executive Director Saxe reported on the following:
Health Professions Section Four:
The Prescription Legibility law went into effect on June 7, 2006. Notices were sent
to all licensees that have prescribing or dispensing authority. The department put out
a press release to encourage communication on the subject and received numerous
calls from the media.
The Board of Optometry received notice of a petition to the Joint Administrative
Rules Review Committee (JARRC). The petition requested that rules describing
approved drugs an optometrist may prescribe be listed individually and not by
category. These rules were developed in consultation with the Board of Pharmacy.
The petition was denied by JARRC.
The Veterinary Board of Governors is still recruiting for three (3) Veterinary
members and one (1) public member.
Mr. Saxe has continued to participate with other department staff on a patient safety
coalition. There are a wide group of organizations involved. The coalition is looking
for ways to reduce medication errors.
Mr. Saxe presented at a Northwest Pharmacy Association Convention.
The Dispensing Optician group is evaluating whether to change their state written
current examination to a national examination developed under contract.
At the last meeting the Board of Pharmacy reviewed a petition by Adam Karp, who
also petitioned the Veterinary Board of Governors. The Veterinary Board decided to
begin rulemaking on some of the issues in his petition, but declined on others.
Veterinary Board staff can provide a list of the specific results.
The National Association of Boards of Pharmacy (NABP) and the American
Association of Colleges of Pharmacy (AACP), District 7 meeting is scheduled for
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October 4 through 7 in Anaheim, California. In the past, the Executive Director
has attended with a Board member. This year the new Executive Director will attend
with George Roe.
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Board Members
Donna Dockter attended a WSPA meeting in June in which I was part of a presentation on
Medication Error Prevention.
Donna Dockter also attended the methamphetamine work group meeting in which they discussed
differences between Washington regulations and federal regulations. During this meeting they
received substantial feedback from law enforcement.
Gary Harris, along with Donna Dockter, attended the stakeholder meeting held on July 19, 2006,
at the Department of Health, Point Plaza East building, which was to begin development of rules
regarding sexual misconduct. This meeting was to look at language and discuss ways to make
the language more appropriate for pharmacy. The current rules are very broad and need to be
more specific toward the pharmacy profession.
Tim Fuller met with the Nursing Commission regarding the Office of the Superintendent of
Public Instructions (OSPI) request for changes to the oral medication policy. These changes are
necessary to meet the new asthma law. Issues include storage requirements. Their goal is to
bring their recommendations to the next Board meeting. Paula Meyer is setting up another
meeting with OSPI to finalize the plan.
Mr. Fuller attended the Northwest Pharmacy Convention and was involved in three
presentations; one of which was regarding electronic prescription systems .
Mr. Fuller also presented in Vancouver about emergency response drug caches for hospitals,
providing the background from the Department of Health perspective. He will likely be
presenting a few more times on the subject.
Andy Mecca updated the Board on the new prescription legibility law. He mentioned that one of
the largest questions received was what role this law plays in hospitals.
Mr. Mecca also updated the Board on the progress of the opioid dosing guidelines. There are
more meetings scheduled to address the development of the guidelines and implementation. The
Department of Labor and Industries is currently making rounds to update professions and answer
questions. They have already met with the nursing and dental commissions.
Chief Investigator
Inspection Statistics
May 2006
87
Investigations closed:
27

June 2006

Investigation Statistics
May 2006
70
100%
42
100%
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June 2006
77
Investigations closed:
33
The Quarterly Investigators Meeting was June 7 and 8 , 2006. Investigators met
to be updated on current events and to share field observations. Board member
Dockter joined the investigators on the first day and also attended an all staff
meeting.
On June 8, 2006, Investigator Stan Jeppesen was invited to the DEA Annual
Meeting in Texas to make a presentation on Pharmaceuticals from Households, a
Return Mechanism and Pilot Proposal
On June 13, 2006, Steve Saxe, Andy Mecca, and Grace Cheung attended the first
Methamphetamine Precursor Log Work Group meeting along with Board
Member Donna Dockter. Other attendees included:
o Chris Johnson (Attorney General Office), Gary Gasseling (Washington
State Patrol), Scott Smith (WA Association of Sheriffs and Police Chiefs),
Mark Lundquist (WA Association of Prosecuting Attorneys) as well as
two retail members Dan Connolly (Bartells) and Lee Worthy (Safeway).
From June 17 to 24 , 2006, Investigator Jim Lewis attended the University of

Utah School on Alcoholism and Other Drug Dependencies.
Staffing issues Central Washington investigator position remains vacant and

nd
Randy Flett will be retiring on August 2 , 2006. Jim Doll is assuming the
responsibility of the Pseudoephedrine related issues in addition to his current
workload.
Future Investigators Meeting dates are as follows:

o September 6-7
o December 6-7

Activities
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DISCUSSION
Pharmacists Responsibilities
Executive Director Saxe provided an update on the status of this rule making process. At the
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June 1 meeting there was discussion and a vote on draft 1, which failed. The Board approved
an alternative draft. Provided in the Board meeting notebook was feedback on contacts received,
notes from the facilitator discussion at Yakima meeting and a copy of each draft rule language
starting with the Yakima meeting. There have been over 2,250 contacts, including legislators on
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this issue since the June 1 meeting with the majority not in support of the current draft.
Board staff have not filed the CR-102 rules package with the Office of the Code Reviser, since
some members of the Board have expressed a desire to have further discussions. Given that the
rules hearing was tenatively scheduled for August 31, 2006, and that this date has been publicly
announced, the Board decided to postpone discussion regarding the draft until that date. In
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addition, recent stakeholder work on the draft will be shared at the August 31 meeting.
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Board member Donna Dockter along with Don Downing, Assistant Professor of Pharmacy at the
University of Washington, met with Christina Hulet, Governor Office Health Policy Adviser and
Governor Gregoire.
Given public input and the desire to have more discussion than the meeting agenda would allow,
it was recommended that the staff not file the current draft rule with the Code Reviser.
MOTION: George Roe moved to instruct staff to not file the current draft rule and to postpone
further discussion of this agenda item until the meeting on August 31, 2006, and to ensure filing
at the appropriate time. Duffy second. MOTION CARRIED 6-0.
Donna Dockter recommended that the Board make a statement to ensure the other side of this
current draft rule information is understood by the public. She recommended the Board read a
statement into record. This item was postponed until the conclusion of the Automated Drug
Dispensing Devices rules hearing.
RULES HEARING
Automated Drug Distribution Devices
The Board solicited comments and discussion for adoption of the proposed new section for WAC
Chapter 246-872, establishing uniform standards for the use of automated drug distribution
devices.
Comments:
Dean Webb, Chief of Pharmacy, King County Community Health Services Division
o Where can these devices reside? Can a pharmacy at one site manage a
device at another site that does not have a pharmacy present?
Lannie Turay, Pharmacy Manager, Swedish Medical System, Seattle

o Wants to make sure the Board addresses Article b, relative to controlled
substance counting. Mr. Turay hopes the Board will be progressive in
allowing blind counting. Mr. Turay wanted to make sure the Board
updates approved policies and procedures on controlled substances .
Rob Taymans, MTS Medication Technologies

o Mr. Taymans attended to answer questions as they relate to stocking. A
pharmacy goes through the process of assigning a bar code to medication
which allows for accountability. With this system, there is an electronic
log of the medications; bar codes track the location, quantity, and which
responsible person is dispensing each drug.
Beverly Sheridan, RPh, Assistant Director, Harborview Medical Center, Department

of Pharmacy
o Ms. Sheridan noted that WAC 246-873-080 7(h) says controlled
substances schedule II and III shall be inventoried at the end of each shift.
Because security of inventory on these automated drug distribution
devices, its not very realistic to perform an inventory count at the end of
each shift.
MOTION: Susan Teil-Boyer moved to entertain a rules hearing continuance, and Joyce Roper
and Tim Fuller will determine which of the suggested rule changes are substantive. Roe second.
MOTION CARRIED 6-0.
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DISCUSSION (contd)
Continuation of Pharmacists Responsibilities
Donna Dockter requested to read into record a statement she wrote to educate the public on the
professional judgments used in the practice of pharmacy.
MOTION: Gary Harris moved to delay reading of the statement into the official record and to
postpone the discussion to a future meeting after the Board has had time to evaluate the proposed
rule language. Roe second. MOTION CARRIED. (Vote: 4 (Roe, Harris, Duffy, Hille) to 2
(Teil-Boyer, Dockter))
Executive Director Status Report
Steven Saxe has accepted a new appointment as Office Director of Facilities and Services
Licensing, an office within the division of Health Systems Quality Assurance. MOTION:
Susan Teil-Boyer moved to support the appointment of Lisa Salmi as Acting Executive Director
of the Board of Pharmacy. Dockter second. MOTION CARRIED 6-0.
Mr. Saxe publicly thanked the Board for the last 2 years. He said its been an exciting and busy
time and that he has learned a lot. The Board will continue to have a great support staff. Lisa
Salmi reported that the search for a replacement has been posted and is open until the end of
July. Asaad Awan and Rebecca Hille will be involved in the interview process with Bonnie
King, HPQA Director.
Offsite Pharmacy Practice
The Board discussed a request for approval to allow pharmacists to engage in the practice of
pharmacy at offsite locations. This request was continued from the June Board meeting. Two
questions that arose were 1) does the location need to be licensed as a pharmacy, and 2) is the
location able to be licensed as a pharmacy.
Attorney Sara Benator and Dr. Emily Thomas, representing Kaiser Permanente Northwest,
joined the conversation via telephone. Susan Teil-Boyer asked if the off-site location is a
pharmacy or independently contracted pharmacists providing drug information. Ms. Benator
stated that the offsite pharmacist provides general medication information by email to members
of Kaiser Permanente in Washington and Oregon. All the pharmacists providing this
information are licensed in the state of Oregon, which is the state of their residence and location
of their workplace, as employees of Kaiser Permanente.
Andy Mecca questioned the authority the Board would potentially have over an out of state,
offsite practicing pharmacist, who is not licensed in Washington. Donna Dockter noted that in
the case of mail order pharmacies, the Board doesnt require their pharmacists to be licensed in
Washington, but the mail order pharmacy does need to be licensed.
Rosemarie Duffy felt that a pharmacist in Oregon, which isnt licensed in the state of
Washington, gives the Board no recourse in protecting the patients in Washington State. Dr.
Thomas wanted to ensure that the Board knew that the information these pharmacists are giving
is general information that could be found on a website; and that they arent giving out advice.
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Dr. Thomas added that all staff is under the direct supervision of the Kaiser Permanente
Northwest Director of Clinical Pharmacy, who is a licensed pharmacist in the state of
Washington.
Grace Cheung addressed that it is the Boards decision to decide whether the individual
practitioner is able to practice pharmacy. Historically, the Board has licensed the location and
not each individual pharmacist dispensing each medication out of state. Joyce Roper stated that
the non-resident pharmacy statute addresses the dispensing of medication to a patient in
Washington, and this separate group, which provides advice and counseling but no medications
to patients, is not recognized in the statute.
Mr. Don Williams said the non-resident pharmacy law is quite explicit. It requires pharmacies
out of state to deliver prescriptions to patients in Washington. It doesnt require them to
dispense in the state of Washington. The definition of practice of pharmacy is the monitoring of
drug therapy. As the state tries to expand its authority to other states, how would they know
who is calling who; or would they have any success in requiring that pharmacist to be licensed in
Washington.
MOTION: Rosemarie Duffy moved to approve to allow this request for pharmacists to engage
in the practice of pharmacy as long as the pharmacist works for a pharmacy licensed in
Washington. Dockter second. MOTION CARRIED.
Board of Pharmacy Newsletter/Law book
The Board discussed electronic media for distribution/access of the Pharmacy quarterly
newsletters and law books.
Currently, the Board along with NAPB produces a quarterly newsletter which is distributed to
pharmacists, interns, and technicians. This newsletter is an important tool used to update the
profession on rule and law changes, providing technical assistance and information on national
issues. Staff requests transition to an electronic newsletter, in which NABP would continue to
format.
In addition, the Board publishes a hard copy law book that is distributed to pharmacists and
pharmacies. Staff requests the Board consider producing the Pharmacy law book in electronic
format.
Gary Harris commented that this has been done with other newsletters hes been involved with
and it works very well. The electronic documents may create a minor hardship for those without
computer access; however, there are many copy centers that have the capability of print out the
documents if desired. Steven Saxe mentioned that producing the law book on CD will be more
cost effective and provide a more efficient means of keeping the information updated rather than
re-printing an entire law book.
MOTION: Rosemarie Duffy moved to further explore the discussion of electronic media for
distribution/access of quarterly newsletter and/or law books . Teil-Boyer second. MOTION
CARRIED.
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Washington Methamphetamine Precursor Rules

The Board reviewed and discussed differences in the newly adopted federal regulations and
Washington States rules and laws regarding the sale of products containing ephedrine,
pseudoephedrine, or phenylpropanolamine.
Andy Mecca provided an update on the methamphetamine task force workgroup which held its
first meeting on June 13, 2006. The group requested staff examine and compare the differences
between the state and federal transaction log requirements.
Policy Review
The Board reviewed the status of assorted board adopted policies . (The Governors office has
been looking at the discipline process. The decision was made to put the Department of Health
first in the process for the State Auditors Office to perform a performance audit. There are a lot
of policies that are old and out of date which needed to be reviewed.)
Policy Number 2 Police Powers .
Donna Dockter wanted to clarify that some RCWs might conflict with what the Department of
Health is recommending when it comes to these policies.
Policy Number 5 Warning Notice.
Donna Dockter questioned if the Board needs to address the use of a notice of correction. There
has been confusion about what is expected of a pharmacist.
Policy Number 11 Phone Calls for Pharmacy Assistants (Ancillary Personnel).
Donna Dockter questioned if this policy is covered in regulation. Lisa Salmi mentioned that staff
felt there was still value in this policy and that Board still receives questions pertaining to this
issue.
Joyce Roper recommended that this policy be an interpretive guideline. These policies are not
directed toward pharmacy personnel. She recommended rescinding this policy and creating an
interpretive guideline.
Policy Number 24 Criteria for Random Biological Fluid Testing. Rescind Incorporate
discussion with WRAPP.
Lisa Salmi stated that certain policies guiding the Board of Pharmacy are no longer needed and
covered under Department of Health policies.
MOTION: Donna Dockter moved to remove policies 2, 5, 11, 13, and 24 for further
examination and take staff recommendations for the remainder of the policies . Duffy second.
MOTION CARRIED.
Electronic Prescription Transmission Systems
MOTION: Donna Dockter moved to delegate approval of standard Electronic Prescription
Transmission systems to staff. Teil-Boyer second. MOTION CARRIED.
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Mail Order Pharmacy Operating Procedures

The Board considered the operating procedures of BCWA, a Washington licensed pharmacy and
its use of an order processing center in Surrey, BC.
Grace Cheung presented the request submitted by BCWA Health Services LLC (Custom
Prescription Shoppe) located in Bellingham asking the Board make a ruling on its practice of
dispensing prescriptions that have been mailed by customers to an affiliate Canadian pharmacy
and subsequently routed to BCWA in the United States .
Kevin Farris, the Responsible Pharmacy Manager for BCWA, was in attendance to answer
questions from the Board. He wanted to assure the Board that a U.S. physician gives the
prescription to the patient and the patient then, in turn, mails the prescription to the Canadian
pharmacy. The pharmacy in Surrey receives the prescription, if the prescription is cheaper to fill
in Canada, they will fill it. If the prescription is more expensive in Canada, they will send the
prescription on to the Bellingham pharmacy, where it will be filled and then mailed to the
patient.
Donna Dockter mentioned that in the past, the FDA has closed down pharmacies for facilitation
of prescriptions from Canada. Assistant Attorney General Joyce Roper advised the Board that
this is a business practice and that the Board would not have the authority to make a ruling. Mr.
Farris was also advised to contact the FDA for clarification of any potential Federal Law issues.
Grace Cheung informed the Board that Mr. Farris was asked to come before the Board because
this was a new practice and the current laws and rules did not anticipate this practice. The
pharmacy in Bellingham was not initially receiving the original prescription, but was receiving a
faxed copy sent by the Canadian pharmacist but has since changed its practice and are receiving
the hard copy from the Canadian pharmacy..
Gael Reedy from Managed Pharmacy Care was concerned about mail order taking place between
the U.S. and Canada.
Donna Dockter questioned that if a pharmacist practicing in Washington is violating federal law,
does the Board have the authority to make the determination of the violation. AAG Joyce Roper
informed the Board that they do not have the authority if it is a federal law.
The Board decided it was not within their jurisdiction to make a ruling on this request.
Health Systems Quality Assurance Organizational Restructure
Laurie Jinkins, Assistant Secretary, Department of Health, presented the Organizational Review
results which are planned to be implemented for Health Systems Quality Assurance and
entertained questions from Board members. Board members were provided a short survey form
and asked to provide feedback.
Several Board members expressed their concerns with what the re-organization meant for the
pharmacist investigative staff. They emphasized the importance of the requirement that
investigative staff be licensed pharmacists . Assistant Secretary Jinkins responded by stating that
she did not anticipate making changes to that requirement but thought that it was important to
utilizing the pharmacist staff effectively.
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Chief Investigator Grace Cheung added that it is important to remember that the investigators do
more than investigate complaints . The investigators also perform a great deal of preventive work
through their inspections, technical assistance, providing educational presentations and they also
provide Board support.
PRESENTATIONS
Tim Fuller introduced Per-Se Technologies and the Condor Pharmacy System for approval by
the Board.
Warren Williams, of Per-Se Technologies, presented the Condor Pharmacy System which is an
pharmacy electronic prescription receiving system through SureScripts. This program is
designed to accept and process electronic prescriptions.
After the presentation, Susan Teil-Boyer questioned if there was a specific location for allergy
information. Mr. Williams noted there was no specific field for allergy information, but there is
a comments field. Ms. Teil-Boyer also noted the field that showing DAW 1/0 does not explicitly
indicate of whether a therapeutically equivalent generic drug may be substituted. She suggested
the use of Y or N instead of 1 or 0.
Donna Dockter recommended using a different format, removing the information that isnt
necessary to each prescription. MOTION: Susan Teil-Boyer moved to approve Condor
Pharmacy System with the recommended changes. Donna Dockter seconded the motion.
MOTION CARRIED.
Beth DeLaHunt of Achieve Health Care Technologies presented the Achieve Matrix System for
approval by the Board.
MOTION: Donna Dockter moved to approve Achieve Matrix System. Susan Teil-Boyer
seconded the motion. MOTION CARRIED.
The Board considered a request from Robert D. Ashley to adopt rules changing the prescription
refill and expiration limitations from one to two years and eliminate the re-numbering of expired
re-authorized prescriptions with no changes. The proposed regulation would be similar to other
states including Kansas, Iowa, Oregon, Missouri, Rhode Island, and South Carolina.
Susan Teil-Boyer wanted to know the experience Oregon has had with their two-year rule.
Grace Cheung informed the Board that the main challenge the Oregon Board faced was the
PRN (as needed) refills piece. When a doctor wrote PRN, it meant the prescription was
good for one year, which caused a lot of confusion because a designated number of refills were
valid for two years. Initially it was a very challenging rule. After time, pharmacists became
accustomed to the two-year and one-year PRN refill exception. The rationale behind the Oregon
Boards decision was that it is reasonable for patients to be able to obtain maintenance drug
therapy refills beyond one years time. An example: allergy season comes once a year and they
felt it was necessary to have two-year expiration to help patients acquire their prescriptions the
following year if theyve had their allergies year after year.
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Donna Dockter noted that she understands the value of not changing the prescription number
each year, but she doesnt see a lot of benefit to a two year expiration date unless its coordinated
with prescribers. If the Board simply said a pharmacy doesnt have to update the prescription
number each time, there are a lot of examples where the pharmacist would still have to get
authorization to refill a prescription.
Gary Harris had questions and/or concerns with this issue also. Some concerns can be dealt with
patient education and counseling. If the pharmacist ensures the customer knows they are on a
new strength and instructs them to throw away their old prescription information, ensuring they
know their new dosage and instructions . He also expressed concern that human nature for a lot
of patients would tell them they dont have to see the doctor for two years, and there would be
less continuity of care.
Robert Ashley noted a good example is a person who had a heart attack. A prescriber wouldnt
give them a years worth of refills for their initial medications. Once a person moves from acute
to maintenance medications, you can then allow them two years refills. Mr. Ashley expressed
they dont want to obstruct those patients from getting their prescriptions if they see their doctor
regularly.
MOTION: Donna Dockter moved to grant this petition for rule-making regarding two-year
prescription expiration and re-numbering of prescription refills .
DISCUSSION: Gary Harris was concerned some pharmacists arent asking the right questions
of patients about their dosages and if they had recently been seen by their practitioner. Joyce
Roper, having worked with payer systems, was concerned if this will become a standard and that
patients will not have to pay an office visit fee every year, and they can have their prescriptions
for two years without ever seeing their doctor.
Rebecca Hille had a comment from a dermatologist which asked why there is a one-year limit if
a patient is on a medication perpetually.
Doug Beeman from Group Health Cooperative, for years has been advising that the Board
eliminate prescription numbers . He feels that they carry over from the past, that prescription
profiles are much cleaner. To go to a two-, three-, or four year period when updating the
prescription number would provide a cleaner view of the prescription history for the patient. The
pharmacies will have a lot of data duplicated in their systems having to change prescription
numbers each year. At some point, he feels moving to a system of medication management that
can do tracking without a prescription number would better suit pharmacies.
Robert Ashley noted that there are situations in cases of allergy medications that require less
frequent visits, but there are medications that will require more frequent visits.
Investigator Jim Lewis mentioned that the Board should consider this for the validity of
management of records and data. If a physician is going to have a relationship for therapy, it
isnt going to depend on the duration of the prescription.
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Concerns/Discussion:
Less sophisticated pharmacy record systems may not allow ease of monitoring
management of pharmacy patient profiles
Pharmacy systems do not drive medical care
Doctor/patient relationships are not enhanced or guaranteed by a prescriptions expiration
date
No expiration date for controlled substances imposed by the Drug Enforcement Agency
(DEA)
MOTION: Donna Dockter moved to start the rule making process for 2-year prescriptions as
well as re-numbering of prescriptions. Susan Teil-Boyer seconded the motion. MOTION
CARRIED. Vote 3(Susan Teil-Boyer, Gary Harris, Donna Dockter) 2(George Roe, Rebecca
Hille).
Item 4.4 Correspondence was deleted from the agenda.
OPEN FORUM
No comments were provided.
Adjournment
There being no further business, the Board adjourned at 4:20 p.m. They will meet again on
August 31, 2006, in Kent, Washington.

__________________________________________
_________________________________________
Board of Pharmacy
12
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STATE OF WASHINGTON
Special Meeting Agenda
July 25, 2011
Town Center Two Room 158
111 Israel Rd SE
Tumwater WA 98501
Chair Al Linggi convened the meeting at 12:37 p.m. on July 25, 2011. Board members present by
telephone:
Board members by telephone :
Donna Feild, R.Ph., MBA
Rebecca Hille, Public Member
Staff members present :

Lilia Lopez, Assistant Attorney General (by phone)
Steven Saxe, Director, Office of Professions &Facilities
Susan Teil-Boyer, Executive Director
Kitty Slater-Einert, Health Services Consultant
Open Session
July 25, 2011 12:30 p.m.

Business Meeting
Before the Chair spoke to the business item on todays agenda, Mr. Linggi asked the AAG to speak to
the email received from Mr. David Keller dated July 25, 2011. In the email, Mr. Keller petitioned the
board to cancel this meeting for lack of reasonable notice. Ms. Lopez affirmed that she did review Mr.
Kellers email. She also verified that the meeting notice, distributed on July 20, 2011 via email to the
public listserv, complies with the requirements of the Open Public Meetings Act (RCW 42.30.080) for
this type of meeting.
Emergency Rules.
The board is asked to consider filing a CR103E to extend the emergency ban of synthetic cannabinoids
and substituted cathinones. The current emergency rule will expire on August 13, 2011. The board is
currently in the process of permanent rulemaking to consider adding synthetic cannabinoids known as
Spice, K2 and other names, and substituted cathinones, marketed as bath salts and sold under names
like Ivory, Purple Wave, Red Dove, Blue Silk, and Zoom to Schedule I of the Uniform Controlled
Substances Act, chapter 246-887 WAC.
ACTION: Elizabeth Jensen moved that the board file a new CR103E emergency rule to extend the
ban of synthetic cannabinoids and substituted cathinones. Rebecca Hille seconded the motion.
MOTION CARRIED. 4-0.
The Chair opened the meeting for public comment . A Detective from the DEA-Tactical Diversion
Squad of the Washington State Patrol shared his support for the continuation and ultimate adoption of
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rules to banning these products. He highlighted the dangers and recent events in Washington
associated with bath salts.

*****
There being no further business, the board adjourned at 12:53 p.m. The Board of Pharmacy will meet
again on August 12, 2011 for its regularly scheduled business meeting in Renton, Washington
___________________
Albert Linggi, Chair

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STATE OF WASHINGTON

MEETING AGENDA
July 26, 2007
Marketing Center Creekside Three at CenterPoint
nd
20435 72 Ave S, Suite 200
CONVENE
Chair Rebecca Hille convened the meeting at 9:00 a.m. on July 26, 2007.
Gary Harris, RPh, Vice Chair
George Roe, RPh
Rosemarie Duffy, RN
Dan Connolly, RPh
Tyler Varnum, Pharmacist Investigator
Guest(s) Present:
Bonnie King, Director, Health Professions Quality Assurance
Tami Thompson, HPQA Policy Manager
Jennifer Sabel, Epidemiologist, Injury Prevention Program
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CONSENT AGENDA:
1.2
1.4
1.5
1.8

Opened and Closed Pharmacy Firms April 26 July 1, 2007
Southern Careers Institute in San Antonio TX Priscilla Guzman
Care Health Solutions LLC
Lidgerwood Owl Pharmacy
Medical Lake Owl Pharmacy
Periyar College of Pharmaceutical Sciences for Girls in Trichy Madras
Rajalakshmi Karthikeyau Yuvaraj
Career Centers of Texas in El Paso TX Maria Gomez
High Tech Institute in Las Vegas NV Kara Kinas
Houston Community College System in Houston TX Erica Gomez
Cerritos College in Norwalk CA Asmeret Gebremichael
Costco Pharmacy in Brandon FL Sandra Fernandez
Ogden-Weber Applied Technology College in Utah Gwen Santisteban
Abram Friedman Occupational Center in Los Angeles CA Octavia Smith
The Tamil Nadu DR. MGR Medical University in Chennai Tamil Nadu, India
Deepthi Nitta
St Johnss Medical Center Peacehealth Warfarin Various
Childrens Hospital Surgical Antimicrobial Various
The Everett Clinic Immunization & Travel Medication Various
Board Minute Approval May 17, 2007
Items 1.1 Pharmacist License Application Approval; 1.3 Pharmacy Technician

Application Approval; 1.6 Automated Drug Dispensing Device Acceptance; and 1.7
Sample Distribution Requests were deleted from the consent agenda. ACTION:
Rosemarie Duffy moved that the Board approve 1.2, 1.4, 1.5 and 1.8 of the consent
agenda. Gary Harris second. MOTION CARRIED 6-0.
REPORTS:
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Quarterly Investigator meeting was held on June 6 in Tumwater. Dan

Connolly represented the Board. Bonnie King met with the investigators to
discuss the restructure of Health Systems Quality Assurance.
Work continues on the HSQA Organizational Restructure. Workgroups have

been preparing functional org charts for each office. Workgroups will present
st
proposals to Assistant Secretary Laurie Jinkins on July 31 . Ms Jinkins will
then brief Secretary Selecky. Implementation is projected for November or
December 2007.
HSQA is developing a new 2007-2009 Strategic Action Plan.

The preliminary report on the Performance Audit has been received. The
Department of Health is working on a response and the audit has not been
made public.
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Workloads Standards Study has begun. Investigators, program managers and

disciplinary staff are participating in the study. Participants wear pagers and
are alerted during the day and must record their activities at the time of the
alert. The study is required by Substitute House Bill 2974 and the focus is on
disciplinary activities. The goal is to develop a comprehensive and
sustainable measure for allocating workload to respond to changes in case
priorities. Study will assist the Department in determining the resources
necessary to perform specific activities for specific types of cases. The study
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is in a pilot phase this week. Data will be collected from August 1 through
st
the 31 . Final report is due to the legislature in December.
The Pharmacist s /Pharmacies Responsibilities rules become effective July

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26 . To assist pharmacies and pharmacists in complying with the rule a
guidance document has been developed and distributed. These rules continue
to receive media interest.
Attended the Drug Enforcement Administration (DEA) Annual Conference on

June 4-7. The agenda included discussions on methadone mortality, pain
policies, pharmacy theft and scheduling updates. DEA hopes to propose rules
to schedule carisoprodol in September.
There are ongoing discussions with Department of Social and Health Services
(DSHS) about federal legislation that requires all outpatient Medicaid
prescriptions be written on tamper proof prescription pads. Centers for
Medicare and Medicaid Services has not provided a definition of tamper
proof. Faxes, phone, and electronic prescriptions are exempt.
The Methamphetamine Workgroup report for the Legislature had been drafted
and it will be circulated to the department for comments.
The Medical Quality Assurance Commission will be holding stakeholder

meetings during the next few months to determine what constitutes a 60-day
supply of marijuana for approved conditions.
2007-09 Budgets due out July 31 .
Tyler Varnum joined our staff on July 18th as a Pharmacist Investigator and is
assigned to the Central Washington region and is based out of Yakima. He
received his PharmD degree from WSU and has served in the U.S. Navy.
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Upcoming Meetings/Conferences:
o The NABP District VII & VIII October 3-6 in Ashland, Oregon.
September 27-28 DOH Board/Commission/Committee Conference,
Renton Holiday Inn
October 31-November 2 Citizen Advocacy Center Meeting,
Edgewater Hotel, Seattle to be attended by Dan Connolly and
Vandana Slatter (tentative)
Staffing Updates:

George Roe attended the NABP Annual Meeting held in Portland, Oregon on May 19th22nd.
Kingsbury0776
Dan Connolly attended the following:

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Investigator Meeting on June 6 in Tumwater. He commented how impressed

he was with the quality of the investigators.
On June 7-10 , he represented the board at the Tri-State Convention.
The Methamphetamine Workgroup meeting held June 20
WRAPP Meeting on June 22 . Mr. Connolly remarked how impressed he is

with the organization and would like to be on the committee. He suggested
that WRAPP present to the board at least once per year.
th
th
nd
Rosemarie Duffy had the opportunity to go out with Investigator Bill Kristen and
considered it a good experience.
th
Gary Harris attended the NABP Annual Meeting held in Portland, Oregon on May 19 nd
22 . He also had the opportunity to attend the Utah School of Alcoholism and
Other Drug Dependencies.
th
Rebecca Hille also attended the NABP Annual Meeting in Portland, Oregon on May 19 nd
22 and found many of the presentations quite educational. She also attended the
nd
WRAPP Meeting on June 22 and feels it is a great program.
ACTION: Rosemarie Duffy motioned to adjourn the Board at 9:15 a.m. to conduct the
Rules Hearing, WAC 246-889-050. Susan Teil Boyer second. MOTION CARRIED 60.
RULES HEARING, WAC 246-889-050
Jim Doll, Pharmacist Investigator, presented a brief background and summary of WAC
246-889-050. A revision of the WAC was mandated by the legislature in 2004,
Engrossed Substitute Senate Bill 6478 to further restrict the sale of pseudoephedrine by
wholesalers and manufacturers.
The Rules Hearing was divided into two portions: Question/Answer Session and the
Public Hearing. There were no questions from the board members.
Mr. Doll read into record a public comment posted to the Department of Healths Public
Rules Comment web page that questioned the effectiveness of the rule and the workload
impact to Board staff. Mr. Doll explained that the number of over-the-counter drug
wholesalers in the state have decrease significantly and many that continue to sell
pseudoephedrine products have incorporated computer software that identifies and
restricts excessive sales.
The Chair opened the hearing to public testimony
none was given.
ACTION: Dan Connolly moved that the Board adopted the revised rule. Gary Harris
Chair Rebecca Hille reconvened the meeting at 9:30 a.m. on July 26, 2007
Kingsbury0777

Joyce Roper stated that the Department of Health was served with legal pleading
filed by Ralphs Thriftway challenging the Pharmacies Responsibility Rule.

Consultant Pharmacist
Attended a Nursing Care Quality Commission meeting where the Commission

discussed the issue of personnel using standing orders to dispense drugs. The
Commission approved a request by Snohomish County Community Health Care
to automate this process allowing nurses to renew medication orders. The
Commissions approval was based on DOH attorneys definitions of protocol and
stand orders.
Attended the Utah School of Alcoholism and Other Drug Dependencies .
As a member of the Emergency Response Group begin planning the Reception

Staging Storing processes. A full scale exercise is scheduled for October 31,
2007.
Chief Investigator
Dick Morrison received a letter from University of Washington promoting Mr.

Morrison to Clinical Associate Professor effective July 1st.
We are currently recruiting for the Chief Investigator position. The duties of
Chief Investigator have been divided among investigator staff until a replacement
is hired.
Inspection statistics were provided via a handout for May and June 2007.
Interviews were held on June 12 for two vacant Investigator positions. Grace
Cheung has been selected for the King County position and Tyler Varnum was
selected for the Central Washington Region. We continue to recruit for an
additional investigator for Western Washington.
Interviews were held on July 11 for the vacant Pharmacist Consultant position
and the position has been informally offered and accepted.
Randy Flett has returned to the Department to work part-time concentrating on

inspection backlog.
Presentations and meetings attended by Investigative staff included:
th
th
Stan Jeppesen gave a presentation to the UW School of Pharmacy

and the Childrens Medical Center Research Institute on federal and
state laws regarding the use of controlled substance and research and
licensing requirements on July 17th.
Dick Morrison participated in the Human Behavior and

th
Communications class at the UW on May 29 .
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Stan Jeppesen gave a presentation to the UW Hospital Pharmacy staff

on Pain Addiction in Professional Healthcare Workers.
In June, Grace Cheung and Dick Morrison participated in the National

Association of Boards of Pharmacy Multi-state Pharmacy
Jurisprudence Exam Writing Workshop.
Program Manager
th
Citizens Advocacy Center registration is open until September 28
New Board Member Orientation will be held on Wednesday, August

th
8 in Tumwater and it will be attended by Vandana Slatter and Dan
Connolly.
DISCUSSION
Request by Group Health to Utilize One Pharmacy Inventory for Two Pharmacies
Tim Fuller briefed the Board on the proposal by Group Health Cooperative to utilize one
inventory for two pharmacies located in the same facility. The CMS is requiring a
separate National Center for Prescription Drug Program ID number (NCPDP) used for
third-party billing for mail order prescriptions.
Dick Morrison, Board Investigator shared concerns not related to GHCs operations,
which tracks its inventory electronically, but that the Boards approval may establish a
standard for other practices that do not have an adequate tracking system.
Group Health Cooperative purchases drugs at special pricing under the Robinson
Pattman Act for its own use, but not for mail order. GHC will pursue a waiver or
exception from the CMS.
Board staff will research whether there are other options should CMS deny GHC
an exception/waiver. ACTION: George Roe moved that the Board postpone this
decision for additional information/research . Vandana Slatter second. MOTION
CARRIED 6-0.
Request by SEIU District 1199NW for Public Disclosure
The 1199NW Service Employees International Union request for a list of all practitioners
credentialed by the Board of Pharmacy was deferred from the May meeting. ACTION:
Rosemarie Duffy moved that the Board deny the request as SEIU are not recognized as
professional association by the Board. SEIU represent the economic interests of the
union and do not represent the issues of the pharmacy profession(s) and do not develop
criteria or standards. George Roe second. MOTION CARRIED 6-0.
Malleys Pharmacy Requests Extension of Technician Training Program

The board members a greed that they all had the chance to review Malleys Pharmacy
request to extend the training of a pharmacy technician beyond one year due to mitigating
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circumstances. ACTION: Dan Connolly moved to approve the request. Vandana Slatter
second. MOTION CARRIED: 6-0
Seattle Childrens Hospital - Requests Intern Registration for Foreign Graduate

The Board reviewed the proposal by Seattle Childrens Hospital and Regional Medical
Center to allow Ms. Ying-Jung Chen a pharmacist from Taiwan to serve as an Intern at
the hospital and participate in pediatric general medicine and infectious disease rotations .
The proposal met the criteria established in Board procedure #31. ACTION: Dan
Connolly moved that the Board accept the request by Childrens Hospital. Rosemarie
Duffy second. MOTION CARRIED 6-0.
Delegation of Signature Authority
Each biennium the Board must update delegation of signature authority for credentialing,
disciplinary, and rules.
ACTION: Vandana Slatter moved that the Board approve the delegation of signature
authority for disciplinary documents, credentialing applications and rules as follows:
Signature Authority to Doreen Beebe for the CR-101, CR-102 and that the CR103 continue to be signed by the Board chair.
Signature Delegation Authority for Disciplinary Documents to Janelle Teachman,

Section 4 Disciplinary Manager.
Delegate Signature Authority to Judy Haenke, who will become the Acting
Executive Director for Section 4, for credentialing matters for approval of routine
credentialing applications. Any exceptional applications would have to come
before the Board.
Gary Harris second. MOTION CARRIED: 6-0
Citizen Advocacy Centers Conference

The CAC Conference is being co-hosted by the Department of Health. The conference is
local, making it a great opportunity for the Board Members to attend. Registration was
included in the 2007-09 budget. Dan Connolly has confirmed and a tentative
confirmation from Vandana Slatter.
PH:ARM Project Update
The PH:ARM (Pharmaceuticals from Households: A Return Mechanism) program is a
pilot project that the Board of Pharmacy authorized to take back household consumer
pharmaceutical waste.
Stan Jeppesen updated the Board on the status of the PH:ARM Project:
Three additional collection sites have been added since the last update, bringing
the current total to 11.
Over 1,800 pounds have been collected and incinerated, however we need a more
efficient manner to do so. The current rate of collection is higher than the
anticipated forecast.
Currently using two proto-type containers and would like to begin using them at
Bartell Drugs with the Boards approval.
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Statewide implementation could result in collection of 700,000 pounds.
Secretary Mary Selecky and Governor Gregoire have written letters of support to
the DEA.
Pilot funding is primarily from grants, Pacific Northwest Pollution Prevention

Resource Center and the Russell Foundation.
DEA waiver necessary to utilize disposal sites outside of Washington State.
A presentation on the pilot has been done to Laurie Jinkins, HSQA Assistant
Secretary.
ACTION: Susan Teil Boyer moved that the Board draft another letter to the DEA
requesting a waiver for the collection of controlled substances . That the program seek
additional support from other sources and send a proposal to NABP for consideration by
its Board at the district meeting. George Roe second. MOTION CARRIED 6-0.
ACTION: Rosemarie Duffy moved that the Board approve participation by Bartell
Drugs in the PH:ARM pilot. Susan Teil Boyer second. MOTION CARRIED 6-0.
Dispensing Error Prevention Guidelines

Grace Cheung asked the Board for its views/philosophy regarding dispensing error to
help develop uniform and appropriate sanctions guidelines. What Board action is
appropriate; and how might the Boards decisions influence errors in the future.
Factors for Consideration
Frequency
Degree
Input Error
New or Refill Prescription
Patient Counseling
Quality Action Plan for first dispensing error
Quality Assurance Program Board needs to take the lead in developing a model
QA program. Joyce Roper suggests that the Board contact the DOH Coordinated
Quality Improvement Program for sample programs. The CQIP approves Quality
Improvement plans submitted by health care providers by verifying plans met the
minimum requirements for complying with related laws and rules.
Severity
Generic or Brand
MedGuides
Further research would be necessary to determine whether the Board has the
authority to mandate a QA program in pharmacies other than hospitals. Hospitals
currently have a requirement for QA programs in its licensing requirements.
Patient Outcomes
System Related Issues
Grace Cheung and Kristi Weeks will work on formatting a grid for the Board to use in
developing a sanction guideline for dispensing errors.
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The Board expressed an interest in gathering more information to further define a tool to
evaluate appropriate sanctions and uniformity in its disciplinary actions. Staff will make
appropriate contacts as suggested. Dan Connolly, George Roe and Gary Harris have
volunteered to participate on the sub-committee tasked with looking at dispensing errors
sanction guidelines.
ACTION: Susan Teil Boyer moved that the Board establish a sub-committee/task force
to include development of guidelines for dispensing errors prevention and appropriate
discipline sanctions to bring back to a future meeting. Rosemarie Duffy second.
MOTION CARRIED 6-0.
Delegation for Approval of Continuing Education Audits

The Department of Health audits 2 percent of all practitioners renewing their credentials
each month for compliance with CE requirements. The Board was asked to consider
delegating to staff the authority to determine if practitioners have met the CE
requirements.
ACTION: Susan Teil Boyer moved that the Board delegate approval of CE audit
requirements to credential manager. Rosemarie Duffy second. MOTION CARRIED
6-0.
Update on Organizational Changes

Lisa Salmi announced she has accepted a position as the Executive Manager of the
Accommodations and Residential Care Survey Program and will report to Steve Saxe.
Mr. Saxe will be the Acting Pharmacy Board Director in the interim until the position is
filled. The Pharmacist Consultants and the Chief Pharmacy Investigator will report to
Byron Plan. The Pharmacist Field Investigators will continue to report to the Chief
Investigator. The Credentialing and Disciplinary Manager will remain in HPQA Section
4 and will report to Judy Haenke. This is an interim step towards the HSQA
reorganization. It will also mean more involvement for Doreen Beebe with the Board.
Bonnie King stated she doesnt think the Board will see a change.
PRESENTATIONS
Accidental Poisonings
Jennifer Sabel
Jennifer Sabel of the Department of Health Injury Prevention Program gave a

presentation on Poisoning & Drug Overdose Deaths. Dr. Sabel shared national and
local data to show an increase in unintentional poisoning deaths and spoke about
prevention strategies.
Next spring, the Department of Health in conjunction with Labor & Industries
will be putting on a conference on this issue.
The Attorney Generals office has a new program for high school students called
Dont Meth Around.
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Rules Workshop
Tami Thompson, HPQA Policy Manager provided a brief overview of the administrative
rules process including what is a rule, what triggers a rule and the guiding principles for
rule development.
Carisoprodol
The decision to move forward on with rule development regarding Carisoprodol was
postponed at the May meeting to allow stakeholders to review and provide input on
comments received during the electronic stakeholder process. All comments have been
shared with the Board.
A support scheduling verses opposed scheduling presentation was provided by Board
Sponsor Gary Harris and Pharmacist Consultant Tim Fuller. The subject of the
interaction was whether the Board should move forward in the rule making processes by
proposing rules to schedule Carisoprodol.
MedPoint representatives Cliff Webster, and Kinsey Reagan, Legal Counsel for
MedPoint Pharmaceuticals, and Richard Spivy, Senior Vice President of Research and
Development for MedPoint Pharmaceuticals were present during this discussion. FDA
labeling changes on carisoprodol products were shared with the Board.
ACTION: Susan Teil Boyer moved that the Board proposed an amendment to the rule to
schedule carisoprodol and move forward with filing a CR102 . George Roe second.
MOTION CARRIED. 4 to 2 (Vandana Slatter and Rosemarie Duffy opposed)
Extended Care Facilities
ACTION: Rosemarie Duffy moved that the Board proposed version 2 of the amended
rule language and move forward with filing a CR102. Susan Teil-Boyer second.
MOTION CARRIED 6-0.
Pharmacy Technicians National Standardized Examination

The Board reviewed and approved survey questions to gather information on the possible
disproportionate financial impact the proposed rule may have on small businesses with
Board approved pharmacy technician training programs. ACTION: Gary Harris moved
to approve the survey for mailing. Vandana Slatter second. MOTION CARRIED: 6-0
OPEN FORUM
Rosemarie Duffy requested an update on the Correctional Facilities CR-101 filed in June
and the Stakeholder meetings. Doreen Beebe stated the CR-101 went through the review
process and was approved in early July and we are in the process of scheduling
Stakeholder meetings.
Dick Morrison stated that he was really pleased for Lisa Salmi accepting a new position.
He feels that no individual is more dedicated than Lisa and she will be genuinely missed.
Tim Fuller gave kudos to Investigators Jim Doll and Bill Kristen for helping answer
telephone calls on Mondays and Fridays. He said that since the other Pharmacist
Consultant accepted another position, this has helped him manage his current workload.
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Doug Beeman, Group Health Cooperative, asked the Board for information regarding the
requirement that all Medicare prescription must be on tamper resistant paper. This
requirement is effective October 1, 2007. Lisa Salmi stated it is a federal rule and we are
working with DSHS to ensure the information is distributed. The Board has not received
information defining a tamper proof prescription pad. Legislation has been introduced to
limit it to Schedule II and Washington State Pharmacy Association is campaigning to
extend the implementation date . Once we receive information as to what constitutes a
tamper proof prescription pad, the department will work to get that information out .
Mr. Beeman also requested clarification regarding a new format for licenses issued by the
department. Lisa Salmi stated that license numbers will not change, but there will most
likely be a change in the look of licenses. The new licensing system is currently
scheduled to go fully live in February 2008, but it is her understanding that Pharmacy
will come on in October 2007.
Dan Connolly requested an update on the Prescription Monitoring Program . Lisa Salmi
requesting support
stated we still dont have funding and a letter to Secretary Selecky

has been drafted for Rebecca Hilles signature.

There being no further business, the Board adjourned at 4:49 p.m. The Board of
Pharmacy will meet again on September 6-7 in Spokane, Washington.
_______________________________
_______________________________
Board of Pharmacy
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State of Washington

July 30, 2015
Renton, WA 98057
CONVENE
Vice Chair Dan Rubin called the meeting to order at 9:10 a.m.
Commission Members:
Guest / Presenters:
Paul Thompson, Pharmacy Director
for Navos Hospital
Steve Anderson, RPh
James Hall, PharmD for ReliantRx
Patrick OConnor, Pharmacy Director
Tim Lynch, PharmD
for TCH
Ponce Bautista, Director of Pharmacy
Nancy Hecox, PharmD
for Premier Long Term Care
Gary Harris, RPh,
Al Linggi, RPh, MBA, Chair
Sepi Soleimanpour
Staff Members:
Joyce Roper, AAG
CALL TO ORDER
1.2 Approval of June 11, 2015 Meeting Minutes .
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MOTION: Gary Harris moved that the commission approve 1.1; Nancy Hecox second.
MOTION: Steve Anderson moved that the commission approve 1.2; Matthew Ronayne
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will
be approved by a single motion of the commission without separate discussion. If separate
June 2015
st
a. 1 Ave Pharmacy
b. Fairway
c. Native Project Pharmacy
d. Skagit Valley College
e. Yakima Valley Farm Workers Clinic
a.
Holy Family Hospital Tech check Tech; IV admixture preparation;
and Taking Medication List
b.
Providence Centralia Hospital Medication Lists
c.
Skagit Valley Hospital Tech check Tech
d.
Yakima Valley Memorial Hospital Tech check Tech
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Items 2.7 and 2.8 were deleted from the consent agenda.
The commission requested that Items 2.3 (a, b, c, d & e), 2.4 (a & b), 2.5 & 2.6 be
pulled from the Consent Agenda for further discussion.
MOTION: Chris Barry moved that the commission approve items 2.1, 2.2, & 2.4 (c &
d) on the consent agenda. Steve Anderson second. MOTION CARRIED: 13-0.
REPORTS
Commission Members
Spent the month of June in Africa

He has participated in business practice meetings via teleconference calls.
Mr. Harris attended a meeting of the University of Washington Pharmacy Alumni
Association as its current president.
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He gave a lecture last week to a pharmacy technician training program at a North

Seattle Community College.
Gary attended a Deans Club Event the last week of July 2015.
She has participated in all 3 rules committees; Business practices, Sterile

Compounding and Pharmacy Technology.
Nancy went out with Tyler Varnum and Eleanor Carbett last week on a hospital
inspection, which was an eye opener.
Tim Lynch reported:
Participated in Pharmacy Technology committee
Participating on a work group regarding the pharmacy inspection process
Working with ASHP on their leadership conference and a mid-year conference in

December 2015.
Olgy Diaz reported:
Completed the new commission member orientation.

she will be going along on a pharmacy inspection on July 30th.
Cheryl Adams reported:
Participated in phone conference with Tim Lynchs work group regarding

pharmacy inspections .
Since the last meeting Cheryl has been reading past meeting minutes and
newsletters to catch up on hot topics. Also, she has reached out to representatives of
stakeholders in our pharmacy world, WSHA, WSPA, and Senator Linda Parlette.
Dan Rubin reported:
July 20 he participated in a leadership meeting of members of boards and

commission with some of the DOH management.
A system called Citrix is being rolled out to commission members
and a specific email will be provided to members instead of using
personal emails along with providing access to certain documents .
A process improvement manager will be provided at the division
level. There also will be more focus on analytics and metrics to
explore sources of health care errors from available data, which
might be valuable to the Commission
Models are being developed for voluntary engagement between
people who have been injured and those who assume responsibility
(practitioners). This initially focused on medical doctors and will
expand over time, initially focusing on a single profession at a time.
There was an update on interstate licensing compacts with Nursing
as a prime example. This is relevant to our work related to both
pharmacists and pharmacies.
Many Critical Access Hospitals are struggling and at the DOH level
there is an effort to try to find other ways to look at regulatory status.
There was a brief discussion of new procedures for FBI fingerprint
checks, which allows for updates if the individual has subsequent
criminal justice "hits" after the initial request so long as there is an
ongoing purpose for the information such as licensing.
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Last Friday Al and Dan met with a consultant hired by DOH to examine
stakeholder perceptions of many areas of our communications. The report was
only available to them late last week and will be shared with the Commission at a
later meeting.
Monday and Tuesday also went with Tyler Varnum and Eleanor Carbett for
inspections. Elizabeth recommended that all commission members participate in
these if given the opportunity.
She participated in two Business Practice meetings since the last commission
meeting.
Elizabeth attended the Planning Session in Tacoma July 29, 2015.
Arun Sambataro reported:
As a new member, Arun has been reading newsletters so she can get up to speed
and be an effective commission member.
He attended the Business Practice in Kent on June 30, 2015.

Steve had knee surgery July 10, 2015.
He participated in the Business Practice meeting via teleconference July 16, 2015.
He passed the Oklahoma MPJE July 22, 2015
He also attended the Business Practice meeting in Tacoma July 28, 2015.
Along with commission members and staff attended the Planning Session July 29,
2015.
On July 8, 2015 she attended the Pharmacy Technician Educators Council Meeting
in New Orleans.
While there heard a report from someone from the USP 797 expert panel.
Talk from Pharmacy Technician Certification Board regarding the 2020
initiative where all technicians that sit for the national certification test must
graduate from an ASHP accredited program.
She participated in a discussion with ASHP publication manager who is
looking to publish a new book on sterile compounding for technicians.
She participated in conference call with other members on inspection processes .

Judy went on an inspection with Brad Dykstra to a long term facility. This was a
great experience.
Executive Director
Chris attended several sessions to organize the planning session
On July 16, 2015 Chris held a Spokane Long Term Care Stakeholder meeting
He received and shared the report on recommendations for improving

communications
Some are within the control of the commission/ others are with DOH
(e.g. PQAC web site improvements / Listserve and functionality )
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He attended a Seattle Meeting with stakeholders and legislators as follow up to

Opioid overdose legislation from 2015.
Chris attended a UPWG quarterly meeting: They are considering updating their
charter and pursuing recent legislation on Naloxone deployment.
Chris is lead on HPF Office Morale Improvement Program for:

Telecommuting
Flex schedules

On July 23, 2015 the Ninth Circuit issued its ruling in the Stormans case and
reversed the ruling of Judge Leighton and said the Pharmacy Commissions rules
were neutral and generally applicable . The Ninth Circuit said the rules did not
target the religious beliefs of the Stormans Corporation and the two individual
pharmacists who filed the lawsuit. These rules did not violate the First Amendment
of the Constitution. The two million dollar judgment for Plaintiffs attorneys fees
and costs is no longer pending against the Pharmacy Commission. However, the
Plaintiffs attorneys have notified the States attorneys that they will seek review of
this decision.
Lisa accompanied Brad Dykstra on two inspections. Being on the other side of the
inspection was a very different perspective.
Aside from routine duties, she has coordinated two pharmacy technology rules
meetings on June 25 and July 24, 2015. There are approximately 40 people split
into six working groups .

Last month we started inviting the commission members to attend inspections with
the PharmacyInspectors . It would be very valuable for commissioners to see how
inspections are done currently.
Inspection team is continuing to work on a CE program regarding sterile

compounding for licensees.
Gordon attended all subcommittee meeting in pharmacy technology and business

practice meetings.
He has been working with DOH EMS program helping them with some
implementation questions regarding hospital supplying drugs to to EMS and
Ambulance services as well as residential treatment facilities who obtain Health
Care Entity licenses.

Final Legislation Update
Passed Bills with Legislative Implementation Plans:
SHB 1625 Ambulances & aid, drugs
HB 1637 Tribes/ Prescription Monitoring
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ESHB 1671 Opioid overdose medications

SSB 5027 Prescription Drug Monitoring
SSB 5268 Eye drop prescription refills
ESSB 5460 Prepackaged emergency medications in ER
ESSB 5557 Services provided by pharmacists
ESB 5577 Pharmaceutical waste
ESB 5935 Biological products
ESSB 6052 Sect. 219(11) Operating budget PQAC developing proposed statutory
language regarding long-term care pharmacies for the legislature by Nov 15, 2015.
Planning Session Debrief

Dan Rubin updated the public on some of the discussion at the planning session on July 29,
2015. The commission and staff met in an open meeting discussed priorities in our sizable
rule making list and a number of areas of our own operational process in developing rules
and other matters. Briefly discussed whether or not we had the best frequency and duration
of meetings. Rule priorities:
a) Sterile compounding
b) Pharmacy technology
c) Business practices, except rest and lunch breaks for pharmacists
d) Inspection process
e) A petition we accepted to do emergency rulemaking regarding the drug Vyvanse
for binge eating.
We looked at the nature of our agenda process and streamlined the presentations. We will
minimalize live presentations during a meeting since the commission has already read the
material. This will allow the commission to focus more on their questions/concerns during
dicussion.
Committee Updates
a) Pharmacy Business Practice
Dan Rubin provided a brief update on the Business Practice work done. The Business
Practice Committee met June 30 and July 28, 2015. They completed the review through the
content areas related to share accountability between PIC and business entities. At this
point, the committee is beginning process of drafting rule ideas. That will be discussed
with interested parties before any language is sent out.
b) Technology
Lisa updated the commission on the Technology rules. The workgroup has 35-40 members.
They decided to divide the workgroup into 6 categories . They have met twice June 25 and
July 24, 2015. After the July meeting, each group from all 6 categories came up with some
preliminary material together. We are hoping to put that up on our website for public to
see. The workgroup has a week to provide input on where/when they would like the next
meeting.
c) Long-Term Care Workgroup/Rules
Chris Humberson provided an update on the Long Term Care. The 2015 legislature
requested that the commission provide stakeholder-focused recommendations for any
needed statutory changes in a report by November 15th, 2105. This report will be based
upon the completed stakeholder work already conducted and additional stakeholder work
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scheduled in August of 2015 with focus specifically on any statutory recommendations by

the commissions work with stakeholders .
Three stakeholder meetings were held in Kent, Washington, Vancouver, Washington and
Spokane, Washington from March 2015 to July 2015. The meetings were two hours in
length in the evenings and were facilitated as a conversation regarding issues of concern to
scope the problems and opportunities currently present in Long Term Care pharmacy
operations. An average of forty people attended each of the sessions. In the final meeting in
Spokane, the NABP Long Term Care pharmacy model rules were discussed as part of a
discussion on options for rule development, as well as the legislative action requesting
stakeholder input on any recommended statutory changes in LTC pharmacy that the
commission would suggest. With two additional stakeholder meetings planned, we expect
to have active participation to reach consensus .
d) Inspection process committee
Tim Lynch provided an update on inspection process committee. The committee met
earlier in July just to discuss the inspection process. Discussion was based around the
process of these inspections. There will be another meeting held in a couple weeks about
the investigators to discuss how to provide investigators interpretive guidance. With the
outdated rules puts investigators in a difficult situation with the way things are being done
now. We will be focused on patient safety issues as a priority.
Approved Rulemaking Activities Updates

a) Electronic Prescription Communication Rules
Doreen Beebe updated the commission on Electronic transmission prescription. When the
commission first proceeded with the process to incorporate the changes required from
legislation law into the WACs, it was recognized that this would not be easy to meet the
criteria for abbreviated rulemaking. So now the CR101 is being prepared for filing and
could be in the review stages within DOH rules process.
b) Pharmaceutical Compounding Rules (Sterile)
Chris Humberson gave an update to the commission on the Sterile Compounding rules.
The second draft is done it is being vetted with the members of the committee should be
out in a week for a comment period between 6-8 weeks .. It has been dialed back with
regard to taking out USP 800 streamline and making sure elements we have specifically
address gray areas in 797. We are hoping to bring this to the commission in the fall after
the comment period.
c) Inspection Process Rules Update

Chris Humberson gave a quick update on the purpose of the Inspection Committee . This
process is to try and determine how and if we should move from the point system to
another type of system with a plan of correction. Brittany Mahung scheduled a meeting in
Kent August 4, 2015 to get a base line and scope this out as to where the commission needs
to go. We havent talked about agenda yet.
Petition for Emergency Rulemaking

Chris Humberson gave a brief background to the commission regarding Shire US Inc., is
asking the commission to consider emergency rule making to amend WAC 246-887-040
Designation of nonnarcotic stimulant drugs for purposes of RCW 69.50.402 (1)(c) and
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WAC 246-887-045 Prescribing, dispensing, or administering of Schedule II nonnarcotic

stimulants.
Background:
The commission first heard a non-emergency request for this action at the April 2015
Commission meeting in Bellingham Washington. At that time, the commissions decision
was to deny the petition and defer to future rule work in the general area, given the quantity
of rulemaking processes now under way.
In June 2015, the commission was asked to reconsider their request, given a raised level of
awareness of this issue legislatively. The commission decided to open the section of
rulemaking in this area in the regular rulemaking process, which is in process.
A bill was introduced late in the 2015 session to change the RCW to include binge eating
disorder within the existing language. A legislative request for official AGO review of the
current RCW governing this class of medications has also been made.
The regular rulemaking process is proceeding. Since there is only the addition of the
condition of binge eating disorder to the WAC, a more timely process appears to be
possible than the standard 12-18 months .
MOTION: Chris Barry moved the commission deny the request for emergency rule
making to amend WAC 246-887-040 Designation of nonnarcotic stimulant drugs for
purposes of RCW 69.50.402 (1)(c) and WAC 246-887-045 Prescribing, dispensing, or
administering of Schedule II nonnarcotic stimulants because the request does not meet
statutory requirements for emergency rule making. Gary Harris second. MOTION
CARRIED: 13-0.
Emergency Disaster Rules

Chris Humberson led this discussion asking the commission to consider rulemaking to
adopt standards to address patients access to medications during governor declared
emergencies.
Last year when Carlton Complex fire erupted, the commission and staff were challenged
how to provide medication to those that are displaced in these situations. Gordon, Lisa,
Doreen and Joyce Roper were able to quickly put together draft guidance in consult with
the DEA on what would be required to provide people with a certain amount of
medication. When we looked at this draft this year, it was really imperative that we need to
address it in an emergency rule instead of just a letter of guidance.
The commission and staff looked at the language provided and went through it to add
suggested amendment to the language. This is tabled until later in the meeting after
suggested language is added for action.
CONSENT AGENDA
st
a) 1 Ave pharmacy
b) Fairway
c) Native Project Pharmacy
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d) Skagit Valley College

Cheryl Adams had questions about the forms and procedural questions for the reviewer.
There were no other concerns. This will be improved per the request of the commission
member.
MOTION: Nancy Hecox moved to approve 2.3 (a, b, c, d). The commission would like a
report back on 2.3(b). Steve Anderson second. MOTION CARRIED: 13-0.
e) Yakima Valley Farm Workers Clinic
Same procedural concern here. Elizabeth Jensen recused herself.
MOTION: Steve Anderson moved to approve 2.3 (e). Nancy Hecox second. Elizabeth
Jensen recused herself. MOTION CARRIED: 13-0.
a) Holy Family Hospital Tech check Tech; IV admixture preparation; and
Taking Medication List
Cheryl Adams had more concerns about the form and the reviewing process. Chris
Humberson suggested Cheryl work with Irina and Maureen to update the form.
b) Providence Centralia Hospital Medication Lists
MOTION: Elizabeth Jensen moved to approve 2.4 (a & b). Gary Harris second. Cheryl
Adams abstained. MOTION CARRIED: 12-0.
Gary Harris had concerns about the override list and a nurses ability to control or access
the ADDD. This hospital has an older device. This is an all or nothing regarding the
overrides. It is a constraint within the device. Lisa spoke to him directly and nurses know
that they must wait for order to be populated on a screen on overrides unless it is an
emergency and there is a daily and monthly review of these actions.
MOTION: Nancy Hecox moved to approve 2.5. Steve Anderson second. MOTION
CARRIED: 13-0.
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Chris Barry we have 118 electronic transmission systems that are not approved he would
like to recommend this be denied and ask them to come to the commission and tell us why
they have waited to come to the commission for approval. Elizabeth Jensen suggested that
Joyce Roper draft a letter to these outstanding systems. Joyce said this was discussed at the
Planning session on how to move forward on reviewing these outstanding ADDDs request
for approval. Receive a list of these vendors send out a communication to them on the
requirements and let them come forward for approval.
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MOTION: Steve Anderson moved to approve 2.6. Gary Harris second. MOTION
CARRIED: 13-0.
OPEN FORUM
Lauri St. Ours, for Director of government relations for the Washington Health Care
Association. They represent 80% of the skilled nursing centers and 70% of assisted living
facilities. I am here to affirm our commitment to the work on Long Term Care Pharmacy
regulations. We believe our pharmacist and our Long Term Care Pharmacies are one of the
keys to quality in long term care services. I have been working closely with Chris over the
past few months. Had the opportunity to tour with him in a LTC to show him how things
work. Laurie invited any of the commission members to visit a LTC.
Dennis McAllister for Express Scripts he wanted to follow up on Maureen Sparks comment
regarding the changes on ACPE, ASHP and PTCB on pharmacy technician education.
Very few states have level of oversight Washington does regarding pharmacy technician
education. These rules are written to catch the bad guys. This was something that was to
protect students with no over sight so they are attending schools that are legit and provide
them the education they need to move forward in their career. This is a bigger deal for
other states not so much Washington because of the over sight provided in this state.
Mike for ReliantRx. He spoke on behalf of his independent LTC pharmacy. His concern is
there doesnt seem to be much representation of true LTC on the commission. He urged the
commission to visit a LTC facility. He invited the commission to his LTC pharmacy
anytime.
DISCUSSION
Doreen Beebe led the discussion to the panel that was asked to consider granting
recognition to Postgraduate Healthcare Education, LLC as an approved educational
organization allowing it to received lists of pharmacist, technicians, and pharmacy interns .
MOTION: Chris Barry moved to grant recognition to Postgraduate Healthcare Education,
LLC as an approved educational organization. Tim Lynch second. MOTION CARRIED:
4-0.
Notice of Required Evaluation

Marlee ONeal supervising staff attorney and Diana Staley led the discussion about the
process for requiring applicants, under certain circumstances, to obtain a substance use
evaluation prior to licensure. There seems to be gaps in our process and we really need a
new more efficient way of doing this. We started this new program Notice of Required
Evaluation (NRE) as a pilot that has been going on for one year and still has a few things to
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work out. There are about 48 applicants, however there continues to be more applicants
entering this program. Some have refused to enter this program and not get their
credential, some needed monitoring and some didnt. It has been a very successful pilot
program up to date. This pilot program is an option not mandatory and works closely with
WRAPP.
The commission asked to table this until the next meeting asking for more formalized
information.
Santo Daime Churchs

Chris Humberson and the commission received a letter from Gary Schnabel, who is now
working as a consultant after his retirement from the Oregon Board of Pharmacy, regarding
the Santo Daime Churchs use of a Schedule 1 drug, DMT, in the Churchs sacramental
tea. This church has parishes in Oregon and recently opened a parish in Washington. The
Church is asking the commission to authorize its use of DMT in its sacramental tea and
declare that this use is not a violation of the controlled substance act. The Oregon Board
apparently issued such a letter authorizing the Churchs use of DMT in its sacramental tea.
This church also filed a lawsuit against the federal government to allow the use of DMT
under the federal controlled substances act, and the federal courts ruled in the Churchs
favor because the federal government is subject to the Restoration of Religious Freedom
Act, a federal law. Joyce is asking the Commission to authorize her to include Deputy
Solicitor General Alan Copsey to assist in this request.
MOTION: Maureen Sparks moved to approve Alan Copsey and Joyce to research and
advise the Commission on the Santo Daime Churchs request. Judy Guenther second.
Emergency Disaster Rules (continued)
Chris Humberson continued leading this discussion from the amendments that were
suggested in the morning when this was initially discussed. The commission had a chance
to go through and add the suggested amendments . They made a few more changes to
update WAC 246-869-105.
MOTION: Steve Anderson moved that the commission adopt the amendments to the
Emergency Disaster Rule WAC 246-869-105 as an emergency rule under CR-103E. Nancy
Hecox second. MOTION CARRIED: 13-0.
MOTION: Maureen Sparks moved to file a CR-101 for the regular rulemaking for the
same language this will be put up for comment. Matthew Ronayne second . MOTION
CARRIED: 13-0.
Business Meeting Calendar

Doreen Beebe led the discussion with the commission asking them to approve the 2016
business meetings calendar. There was a discussion regarding different meeting schedules.
MOTION: Chris Barry moved that the commission meetings stay on a six week schedule
and that the planning session be tentatively planned May 25, 2015. Matthew Ronayne
second . MOTION CARRIED: 13-0.
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Doreen Beebe asked the commission to consider renewing its delegation of signature
authority and decision making delegation regarding specific adjudicative proceedings. In
addition, the commission was asked to consider delegating authority to approve requests
for lists and label request made by entities accredited as a continuing education provider by
the Accreditation Council for Pharmacy Education (ACPE) .
MOTION: Steve Anderson moved that the commission renew its delegation of signature
authority and decision making -delegation to the health law judge regarding specific
adjudicative proceedings. Matthew Ronayne second . MOTION CARRIED: 13-0.
MOTION: Steve Anderson moved that the commission delegate decision making
authority to the default order. Elizabeth Jensen. Elizabeth Jensen second . MOTION
CARRIED: 13-0.
MOTION: Steve Anderson moved that the commission delegate the authority to approve
requests for lists and label request made by entities accredited as a continuing education
provider by the Accreditation Council for Pharmacy Education (ACPE) only. Chris Barry
second. Elizabeth Jensen abstained . MOTION CARRIED: 12-0.
Correspondence
The commission discussed correspondence received or distributed on its behalf.
Thank you letter from Greg Hovander
PRESENTATIONS
Navos Hospital
Cathy Williams introduced Paul Thompson, Pharmacy Director from Navos Hospital
asking them to consider a request for retrospective approval of its policies and procedures
allowing home based pharmacists to perform remote medication order processing services
after hours.
Overview
Navos Hospital is licensed as a 70-bed acute care psychiatric hospital that provides
inpatient mental health services to children and adults .
The hospital is located in West Seattle and is open 24/7.
Nurses are staffed 24/7.
This was raised as a significant safety concern that could could be resolved with
off-site, remote order entry and remote verification by the pharmacist.
Concerns by hospital and pharmacy administration and the medical staffed lead to
the implementation of a RMOP process for handling these after hours medication
orders.
This was not submitted until April of 2015 that the proposal was submitted for
review.
Daily staffing of physicians is from 9am to 3p and of pharmacists from 7:30am to

3:30pm.
During a pharmacy inspection in May of 2013, the pharmacy inspectors noted that a
significant volume of medication orders occurred when pharmacy services were not
available after hours and these orders were administered to patients prior to being
reviewed by a pharmacist.
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The RMOP service is provided by staff pharmacists from their homes in accordance
with security requirements that specify password-protected and encrypted access to
the hospitals server and protection of all HIPAA information in the home setting.
This occurs via an encrypted (authenticated) gateway, or VPN.
Remote processing is scheduled to occur every 3-4 hours prior to the scheduled
medication passes during the time when medication orders are more likely to be
created. RMOP is initiated and concluded during a specified time frame, meaning
that each complete log-in and log-off is cyclical. Override medications are used for
emergency situations .
The commission members share a concern that these and other proposals are not coming
for approval before being used. There was a discussion on reporting back, what to report
back who to report back in person or via a letter providing required information.
Mr. Thompson was able to answer any questions from the commission regarding security,
where these pharmacists will be working from and Navos quality assurance.
MOTION: Nancy Hecox moved the commission approve Navos Hospital policies and
procedures allowing home based pharmacists to perform remote medication order
processing services after hours. Navos Hospital must provide a written report in one year
with specific information. Steve Anderson second . Chris Barry abstained. MOTION
CARRIED: 12-0.
ReliantRx
Cathy Williams led this presentation and introduced The Commission will consider for
approval policies and procedures submitted by ReliantRx to provide remote order
processing and workload balancing services .
Overview
Long term care pharmacy serving over 6,000 patients in multiple states
Other services:
Compounding
Medical supplies
Mobile immunizations and antipsychotic injections
Why
Timely access to medication is of utmost importance to ReliantRx
Receiving, interpreting, and clarifying medication orders
Medication errors related to non-specialty packaged medications
In the patients best interest to have a single pharmacy dispensing to critically

analyze drug interactions, contraindications, and appropriateness of all medications
Currently operating 2 separate pharmacies under common ownership
Spokane
70 employees
24 hours
Richland
3 employees
M-F 8-5
Remote order processing (RMOP): Ability for each pharmacy to remotely
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DOES NOT count in pharmacist/technician ratio at remote location
Each pharmacy location shares a centralized computer server
Providing drug information concerning medication orders or drugs

Supplemental workload balancing
Both pharmacies operate within legal 3:1 ratio
DOES NOT allow dispensing without a licensed pharmacist present
DOES NOT include final prescription verification
DOES NOT include supervision of technicians at remote location

Logistics and information security
All information is sent over an encrypted virtual private network (VPN)
Pharmacy software (Framework) can run multiple pharmacies
Retains ability to audit all activity
Prescriptions records will be held at each location if RMOP is utilized in
dispensing.
All staff trained in HIPPA

Patient Safety and Quality Assurance
All staff performing RMOP will be fully trained and follow policy and procedures
Volume and timeliness of orders will also be evaluated
LTC patients will benefit from timely access to medications
LTC patients will benefit from reduced medication administration errors
Medication errors and near misses will be tracked objectively

Responsible managers implement action plans monthly in response to any errors
All staff participating in supplemental workload balancing and RMOP will review
all errors
Policies and procedures will be reviewed annually

Conclusion
LTC patients will benefit from accurate Drug Utilization Review (DUR) that
accounts for all chronic conditions and potentially interacting medications
MOTION: Steve Anderson moved that the commission approve the policies and
procedures submitted by ReliantRx to provide remote order processing and workload
balancing services.
Elizabeth Jensen second. MOTION CARRIED: 13-0.
Toppenish Community Hospital
Lisa Roberts led the presentation and introduced Patrick OConnor from Toppenish
Community Hospital . Mr. OConnor asked the commission to consider their policies and
procedures to receive remote medication order processing services for approval.
Overview:
Toppenish Community Hospital
Rural for-profit hospital

Toppenish, Washington, Yakima County
Owned by Community Health Systems
Licensed 62 bed, average census 15
MAP Electronic Health Record
Pharmacy hours: M-Sat 7:30 am to 4:00 pm, closed Sunday
1 FTE pharmacist
2 FTE technicians
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4 per diem pharmacists (average 24 hrs/wk)
Urban for-profit hospital
Common ownership by CHS
Shared EHR, pharmacy management system, CPOE, lab, radiology, eMAR and
Outlook account allows for seamless order entry and ensures secure access.
YRMCC pharmacists have access to and are trained on all the policies and
procedures of TCH pharmacy.
YRMCC pharmacists are made aware of changes to the policies and procedures via
email communication by the TCH Director of Pharmacy.
TCH Designated House Supervisor (RN) on-site 24/7
There will be no remote supervision of technicians .
The YRMCC pharmacist will access the TCH EHR to gather information to
complete order entry when needed.
The YRMCC pharmacist will be available for consultation with TCH staff should
they call.
The YRMCC pharmacist will call TCH staff to clarify any questions that arise
during their coverage.
Upon arriving to work, the TCH pharmacist will review the hand-off
communications and resolve any issues.
Orders entered remotely by YRMCC pharmacists are saved in a queue and are
available for review by the TCH pharmacist if needed.
2 per diem technicians

Located on the Yakama Indian Reservation in Yakima County, Central Washington
20 miles from Yakima

Yakima Regional Medical and Cardiac Center
Yakima, Washington, Yakima County
Owned by Community Health Systems
Licensed 214 bed, average census 60
MAP Electronic Health Record
Pharmacy hours: 24/7/365
7 FTE pharmacists
7 FTE technicians
4 Per diem pharmacists
3 Per diem technicians

Relationship
Share the same Mission and Vision
Both use HMM pharmacy management system and MAP electronic medical record
Common lab, eMAR, CPOE, etc
Several pharmacists and technicians have or currently work at both facilities

Summary
TCH pharmacist on-call 24/7 for urgent on-site needs not fulfilled by RMOE.
Quality issues will be investigated and dealt with by the Directors of Pharmacy of
TCH and YRMCC.
The Process
TCH pharmacist will notify YRMCC pharmacy when they are transferring services .
YRMCC pharmacist will access TCH orders via a secured VPN connection.
YRMCC pharmacist will process written and CPOE medication orders as per the
policies and procedures and pharmacy manual provided by TCH.
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In the case that power or network connection is lost at YRMCC, the pharmacist will
notify TCH nursing supervisor and the hospitals will follow their respective downtime procedures. Acudoses will go on override.
In the case that power or network connection is lost at TCH, the nurse supervisor
will notify YRMCC pharmacy and the hospitals will follow their respective downtime procedures. Acudoses will go on override.
Request
Yakima Regional Medical & Cardiac Center (YRMCC) seeks approval to provide
Remote Medication Order Entry services to Toppenish Community Hospital (TCH)
between the hours of 16:00 to 07:30 M-Sat and all day on Sunday.
TCH seeks approval to receive Remote Medication Order Entry services from
YRMCC during the above mentioned hours.
Period of 1 year with automatic renewal, may be terminated by either party without
cause with appropriate notice.
During the presentation the commission discussed the security about faxing prescriptions
via Outlook. Concerns related to encryption of prescriptions in PDF format in e-mails in
their closed system. This is not acceptable for the commission at all. Mr. OConnor is
asked to go back and find alternatives to fix this problem.
MOTION: Tim Lynch moved to delay this request for approval for 4- 6 weeks to allow
time for Patrick OConnor to research and provide information on security of this way of
faxing prescriptions or to find an alternative . Steve Anderson second. Nancy Hecox and
Elizabeth Jensen recused themselves . MOTION CARRIED: 11-0.
Yakima Regional Medical and Cardiac Center
The commission was asked to consider for approval policies and procedures submitted by
Yakima Regional Medical and Cardiac Center to provide remote medication order
processing to Toppenish Community Hospital .
This is the second portion to the Toppenish Community Hospital request.
MOTION: Matthew Ronayne moved that this be tabled for 4-6 weeks as well. Gary Harris
second. Nancy Hecox and Elizabeth Jensen recused themselves . MOTION CARRIED:
11-0.
Premier LTC Pharmacy

Lisa Roberts provided some brief background of Premier LTC Pharmacy. The commission
was asked to consider approving the policies and procedures submitted by Premier LTC
Pharmacy for use of MedDispense an automated drug distribution devise at Park West
Skilled Care Facility.
Background
Premier LTC Pharmacy recently acquired Park West Skilled Care Facility in
Seattle, Washington, from Mercury Pharmacy.
This automated device had previously been placed in the skilled nursing facility
without approval by the prior pharmacy.
The Pharmacy Director at Premier was informed by his pharmacy inspector that he
needed to obtain Pharmacy Commission approval to be operating an ADDDs at this
long-term-care facility. The Pharmacy Director has included pictures demonstrating
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he has currently taped off the device with signs posted that the device cannot be
used until proper commission approval is received.
Premier LTC Pharmacy currently services four long-term-care facilities; however,

Park West Skilled Care Facility is the only facility utilizing an automated drug
distribution device.
The Pharmacy Director has stated that he has purchased an interface between their
pharmacy software (QS1) and the automated device (MedDispense).
The interface is scheduled to arrive by the end of July 2015.
Pharmacy hours are as follows: Monday Friday 0930 to 1800 and Weekends
0900-1700.
There is a pharmacist on call when the pharmacy is closed.
Current policy states that with the interface, patient names will populate into the
device, and the pharmacists will be prospectively reviewing orders during
pharmacy hours of operation.
The pharmacy currently employs 2-3 pharmacists and 6-9 pharmacy technicians
daily.
MOTION: Tim Lynch moved to approve the policies and procedures submitted by
Premier LTC Pharmacy for use of MedDispense, an automated drug distribution devise at
Park West Skilled Care Facility. Steve Anderson second. Dan Rubin and Gary Harris
recused themselves. MOTION CARRIED: 11-0.
STATUS REPORTS
Cathy Williams introduced Cheryl Pell, Director of Operations for Medication Review who
provided a power point presentation to the commission for an update on the use of remote
medication order entry services/telepharmacy services provided by Medication Review at
the pharmacies listed below. These were approved in May 2014.
a. Columbia Basin
b. Coulee Medical Center
c. East Adams Rural
d. Klickitat Valley
e. North Valley
f. Odessa Memorial Healthcare Center
g. Prosser Memorial
h. Quincy Valley
The power point presentation showed graphs of how many prescriptions were processed
using the services along with any deficiencies, reasons why there were deficiencies and
how these were handled. She answered all the questions the commission had specifically
are the pharmacy technicians being monitored. Yes, there are cameras in every pharmacy
and all data is archived. Yes, the pharmacy technicians are being monitored. There were
some questions regarding the duties of these technicians. There was zero misfills from the
system.
MOTION: Tim Lynch moved that the commission extend the remote supervision of
pharmacy technician demonstration project for the another year with a report back with
specific data. Steve Anderson second. Nancy Hecox abstained, Elizabeth Jensen opposed .
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OPEN FORUM
Jeff Rochon from WSPA had a couple questions that came to him. There was a segment in
the last newsletter regarding ancillary pharmacy staff and specialized functions he would
like some clarification. If there is no communication from DOH staff after submitting an
AUP what does that mean? There has also been questions regarding the commission and
the direction with rules work? Is there a formal process to gain a clarification of a WAC?
Jeff asked if there are updates please let him know so he can share with members who are
asking clarification.


Approved September 17, 2015
Dan Rubin, Vice-Chair

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STATE OF WASHINGTON

MEETING MINUTES
August 12, 2011
Renton, Washington
CONVENE
Chair Al Linggi called the Rules hearing to order at 9:04 a.m., August 12, 2011
Gary Harris, RPh,
Guest / Presenters:
Drew Zimmerman RPh for Costless Senior
Services
Jason Spears, Market Director for Talyst
Chris Baumgartner, PMP Program Director
Philip Burgess, R .Ph, NCPA, Sharps Compliance
Chuck Cumiskey, Department of Health Nursing Consultant
Kristi Weeks, Director of Office of Legal Services
Kim ONeal, Supervising AG for Prosecuting
Attorneys

Lilia Lopez, AAG
Rules Hearing
The purpose of the proposed changes to chapter 246-889 WAC is to implement Engrossed Second
Substitute House Bill 2961, laws related to establishing a statewide real-time electronic
methamphetamine precursor tracking system for the retail sales of over-the-counter or nonprescription
medications containing ephedrine, pseudoephedrine, or phenylpropanolamine . The proposed rule was
filed with the Code Revisers office on June 28, 2010. Notice was published in the Washington State
Registry as WSR # 11-14-048.
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There were two suggested changes in the language that would not hold up the filing of the rule. The
first is to change dispenser to retailer and to change record purchase to record incident.
Al Linggi asked the public if anyone would like to speak. There were no comments. Doreen Beebe
provided some background on this rule. After the background the floor was opened for questions from
the board. Doreen shared the comments that she had received.
MOTION: Rebecca Hille moved that the board adopt the rule as written with the two minor changes.
Gary Harris seconded. MOTION CARRIED: 5-0.
The rules hearing adjourned at 9:29am
Chair Al Linggi called the meeting to order at 9:30 a.m., August 12, 2011
CONSENT AGENDA
1.1
1.6
Closed Firms March 18 - June 3, 2011

Opened Firms March 18 - July 21,2011
Board Minute Approval (June 8, 2011)
MOTION: Gary Harris moved that the board approve items 1. 1 and 1.6. Elizabeth Jensen seconded.
PRESENTATIONS
Automated Drug Distribution Device (ADDD) Approval
The board was asked to consider a proposal by Correctional Healthcare Companies (CHC) Pharmacy
Services, a licensed non-resident pharmacy, to provide pharmaceutical services by ADDD at the South
Correctional Entity (SCORE) a multijurisdictional jail.
Tim Fuller provided the board some background explaining that the request was changed from CHC to
Costless Senior Services. Tim introduced Drew Zimmerman a pharmacist from Costless Senior
Services who shared a presentation with the board.
The Companies involved:

South Correctional Entity Multijurisdictional Misdemeanant Jail (SCORE)
New jail in Des Moines, WA opening in late 2011
RFP for healthcare included pharmacy services using ADDD
Correctional Healthcare Companies (CHC)
National healthcare management firm located in Colorado
Recently awarded bid for providing healthcare to SCORE
Cost Less Senior Services
Washington States preferred pharmacy for over 11 years servicing over 20 correctional
institutions in Washington State.
Subcontractor to CHC for pharmacy services at SCORE
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Who does what?

CHC provides overall healthcare management to SCORE
The ADDD will be located at the SCORE Jail
CHC staff located at the jail will operate the ADDD
Cost Less will provide all pharmacy services to SCORE
Cost Less will review and approve all prescription orders, including those not in the ADDD
Cost Less will purchase, own, monitor and replenish medication inventory in the ADDD
Cost Less will contract with another pharmacy to provided backup services when the pharmacy
is closed
What is the InSite ADDD?
The InSite system is located onsite at the Correctional facility
The InSite system is considered an extension of the pharmacy
Nurses have 24x7 on-demand access to patient-specific, pharmacist-approved medications
Medications are delivered in pharmacist-verified, tamper-evident canisters with microchip
technology
System Safeguards
The system is in a locked med room only accessible to licensed healthcare professionals
designated by the PIC
The system is the ultimate responsibility of the PIC
The PIC is responsible for access to the system
Only pharmacist-approved, patient-specific medications are dispensed
Canisters are tested and verified by a pharmacist
Canisters are tamper-evident and use microchip technology to ensure accuracy and eliminate
diversion
MOTION: Donna Feild moved that the board approve the request from Costless Senior Services to
provide pharmaceutical services by ADDD at the South Correctional Entity (SCORE) a
multijurisdictional jail with the revisions that designee title be spelled out and that there is an
inspection before opening. Rebecca Hille seconded. MOTION CARRIED: 3-0. Gary Harris opposed,
Al Linggi recused himself.
National Drug Disposal Program

The board was asked to consider a proposal by National Community Pharmacy Association (NCPA) to
approve its national drug disposal program. Philip Burgess, R.Ph., a pharmacy consultant to Sharps
Compliance and a member of the Illinois Board of Pharmacy, described the TAKEAWAY system of
envelopes and boxes for the return of unused medications.
Sharps Compliance Overview:

Founded in 1994
Publicly traded
In-depth industry experience
National reach
Leading developer and supplier of superior solutions for improving patient safety and the
environment
Meets or exceeds all applicable regulations
Fully vertically integrated supplier from design to treatment
On-staff experts
Complete fulfillment services
Full data services
TakeAway Environmental Return System Envelope Features:
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Items accepted for return include over-the-counter medications, non-controlled prescription

medications and liquid medications (4oz or less).
Controlled prescriptions are not accepted.
Unique operational agreement with USPS
Tracked, validated and measurable results
Sustainable costs
Production:
Handled by licensed law enforcement officials at treatment facility
Securely stored (packaging is never opened)
Weight and date stamped
Witnessed and assured destruction
Online data warehouse of production
TakeAway Environmental Return System 10 and 20-Gallon Drop-Off Systems

1.
Secure, one-way opening for depositing medications
2.
Tamper-resistant, secure box closure for safe return and disposal
3.
Unique identification number and bar code on each container
4.
Tracking of shipment through SharpsTracer online program
5.
Data program delivery of sender information, content weight, and confirmation of receipt at
disposal facility
SharpsTracer Tracking Capabilities:

Secure, proprietary online data warehouse, unique for each client.
Outbound inventory
Returned inventory
Date of return
Condition of return
Weight of return
Current status of return (stored)
Date of destruction
Effectiveness check
Number of scripts returned
7/24 access
Availability of customized reporting
MOTION: Elizabeth Jensen moved that the board approve the National Community Pharmacy
Association (NCPA) national drug disposal program to be used in Washington pharmacies. Gary
Harris seconded. MOTION CARRIED: 5-0.
Prescription Monitoring Program

Chris Baumgartner updated the board on the implementation of the Prescription Monitoring Program .
DOHs Goals for Washingtons PMP

To give prescribers an added tool in patient care
To allow prescribers and dispensers to have more information at their disposal for making
decisions
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Rules Schedule
DOH Review
Completed: April to May 2011
Public Hearing
Completed: June 27, 2011
Rule Adoption
Completed: July 27, 2011
Rule Effective Date
Goal: August 27, 2011
Implementation Update
Begin Hardware/Software Setup July 6
Create Security Specifications July 6
Kickoff Meeting July 20
Focus Group Meeting July 21
Mail Registration Notifications August 1
Begin Testing Process September 14
Begin Data Collection October 1
Begin Mandatory Reporting October 7
Begin DOH/PMP Staff/Licensing Board Access October 26
Begin Oversight Agencies Access November 15
Begin Pilot Data Requestor Access December 1
Begin Data Requestor Access January 4
Begin Law Enforcement/Prosecutorial Agencies Access January 4
Begin Medical Examiners/Coroners Access February 1
Operations, Maintenance, Enhancements ongoing
Who isnt required to submit data?
Practitioners who directly administer a drug
A licensed wholesale distributor or manufacturer
Prescriptions provided to patients receiving inpatient care at hospitals
Pharmacies operated by the Department of Corrections
VA or other Federally operated pharmacies
Canadian pharmacies that are not licensed to dispense in Washington
Who Has Access
Prescribers & dispensers - in regards to their patients
Licensing boards in regards to investigations
Individuals in regards to any prescription dispensed to them
DOH/Vendor in regards to program operation
Law Enforcement/Prosecutor for bona fide specific investigations
Medical Examiner cause of death determination
HCA (Medicaid), L&I (Workers Comp), DOC (Offenders)

De-identified information may be provided for research and education
Future Enhancements
Share data with other State PMPs
Interface with the Emergency Department Information Exchange
Education programs
Health information exchange
Outcome evaluation
50 Year Certificates
Al Linggi announced and recognized Pharmacists who have been licensed in Washington for 50 years.
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Board Panel
MOTION: Rebecca Hille moved that the delegated board be Donna Feild, Christopher Barry and
Elizabeth Jensen for the NAPLEX Study Plan and the List and Labels Request presentations . Gary
Harris seconded. MOTION CARRIED: 5-0.
NAPLEX Study Plan
Pharmacist Intern Ahmad Amin Jazaeri presented a study plan for consideration by a panel of the
board. The Intern is requesting authorization to re-take the North American Pharmacist License
Examination.
MOTION: Donna Feild approved the authorization for Amin Jazaeri to re-take the North American
Pharmacist License Examination based on policy. The policy is for Intern to work 750 intern hours in a
different environment, take a required course and wait one year before taking the test. Christopher
Barry seconded. MOTION CARRIED: 2-0. Elizabeth Jensen abstained.
The panel of the board was asked to recognize The Pharmacist Letter Therapeutic Research Center as
an educational organization permitting them to receive contact lists of credential holders. An
education organization is an accredited or approved institution or entity, which either prepares
professionals for initial licensure or provides continuing education.
MOTION: Donna Feild moved that the board recognize The Pharmacist Letter Therapeutic Research
Center as an educational organization permitting them to receive contact lists of credential holders .
Elizabeth Jensen seconded . MOTION CARRIED: 3-0.
EXECUTIVE SESSION

CASE PRESENTATIONS
REPORTS
Board Member
Al Linggi reported:
Al Linggi attended the Boards and Commission Leader Meeting and also attended the
Investigators Meeting.
Executive Director
New board member orientation scheduled: On September 15, 2011, the office of health
professions will host a new board member orientation in Tumwater to discuss the functions and
processes of the board including credentialing, discipline, investigations and more. The
meeting is also available by webinar.
Statewide Electronic Tracking of Methamphetamine Precursor Products Legislation: All

pharmacies received their first letter from the Board of Pharmacy and Appriss (software
company) the end of June notifying them of the project and its intent and timelines. The
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second pharmacy/retailer letter is finalized and will be mailed in August with account
information, training and support information. Law Enforcement also will receive a letter
regarding training details. All pharmacy accounts are now loaded into the system and training
dates defined.
Legislative Session 2011: Two successful bills in 2011 were CE for Pharmacy Technicians and
Regulating the Handling of Hazardous drugs. The rule process is underway for developing
requirements for CE for Pharmacy Technicians. The rulemaking process for Handling of
Hazardous drugs is managed by Labor and Industries and their second stakeholder meeting is
scheduled for August 31 at L&I.
WRAPP (Washington Recovery Assistance for Pharmacy Program) Training: Several board
staff and staff attorneys attended WRAPP Training Friday, July 15, 2011. Will Rhodes,
WRAPP manager and Micki Kedzierski, UW professor and WRAPP board member, provided
the history and content and led the training.
Pharmacist investigator meeting: Board chair Al Linggi and I attended the investigator meeting
th
th
the morning of June 14 . The topics covered June 14 were current rulemaking, FDA
investigations, and DEA issues.
Board and Commission Leader Meeting: Al and I attended the B/C leader meeting June 14 .
Topics included a budget update, legislative, licensing, investigations and legal update.
Prescription Monitoring Program: Chris Baumgartner will present an update today to the
board.
will go into effect November 1, 2011. The filing date for the CR-102 rule package is now
projected for Aug. 3. The fee rule hearing is tentatively scheduled for Sept. 7, 2:00, at PPE
152/153.
King County Public Health Pharmacy Summit: The pharmacy community was well
represented at this second annual pharmacy summit to discuss collaboration and planning in the
event of a disaster.
th
Tim Fuller was invited to speak to the nurse practitioners in Shoreline at an annual meeting
they have. His topic was electronic transimition of controlled substance and he got to follow
Ruth Carter from the DEA.
The King County Pharmacy Summit reached beyond King County.

Stan Jeppesen announced his retirement the end of July with his first day of retirement being
August 1, 2011.
Richard Morrison has also announced his retirement at the end of September with his first day
of retirement being October 1, 2011
Pharmacist Investigator Positions Grant was notified by the Office of Investigations and
Inspections (OII) Director, David Magby, that he would be authorized to hire a replacement for
Stan. Mr. Magby also informed him that the OII Decision Paper for 2011, which was just
approved, had authorizations for 1.4 pharmacist investigator positions in addition to our current
8.6. Pam Sanders, our part time investigator, will go to full time September 1, 2011. A full
time position will be added to the current pharmacist investigator staff which will bring the
total number of field pharmacist investigators up to 10 excluding the supervisor. The new
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investigative area will include Okanogan, Chelan, Douglas, Kittitas, and most of King County
east of I-405.
Grant has started recruitment for all 3 positions and would anticipate the new investigators
st.
starting work October 1 or later this year.
Greg Lang and Pamela Sanders reported concerns out in the field:
Surplus of Pharmacists and Pharmacy Technicians due to changes in the economy, decreases in
staffing levels to cut costs, changes in staffing plans due to workload balancing, remote order
processing, central fill and automation without any real regulation of such processes.
Concerns by Pharmacists that they are being stretched too thin in some settings (for the above
mentioned reasons) and that this is directly impacting patient safety and their ability to fulfill their
obligations to properly check prescriptions and counsel patients.
Concerns that in some settings the overuse of Pharmacy Technicians (including Pharmacy
Technicians in Training) and Pharmacy Assistants in an attempt to cut costs is resulting in errors.
Lack of timely legislative changes supporting MTM.
Concerns about physician dispensing.
Concerns/Questions about the PMP.

Concerns/Questions about the Precursor Tracking program.
Concerns about employers not being held responsible for policy that prevents/hinders compliance
with the law.
DISCUSSION
The board discussed the draft operating agreement on administrative procedures per RCW 43.70.240.
Susan Teil Boyer led the discussion sharing that she and Steve Saxe had met with the new board
members separately to answer questions and discuss the Operating Agreement. The floor was open for
more discussion within the board about their concerns and what they would like to see to agree to sign
the Operating Agreement.
MOTION: Donna Feild moved that the board reject the Operating Agreement as written . Rebecca
Hille seconded. MOTION CARRIED: 5-0.
Al Linggi asked for 3 board members to volunteer to put a matrix together of what the board members
would like to put in the operating agreement within 3 weeks. Donna Feild, Al Linggi and Elizabeth
Jensen volunteered.
Medication Assistant Nursing Commission

The board discussed the department of health s sunrise review regarding the regulation and the scope of
practice of medical assistants. Susan Teil Boyer introduced Chuck Cumiskey, Department of Health
Nursing Consultant. Chuck provided the board a brief overview.
Purpose-Present Current Evidence:

The Medication Assistant (MA) role and utilization
Rationale for MA role in skilled nursing facilities (SNF)
Preparation of MAs
Medication error rates of MAs compared to RNs and LPNs
Perceptions of licensed nurses working with MAs in LTC facilities
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Substitution of MAs for licensed nurses

Parameters other states have applied to MA scope of practice
Implications for policy development and evaluation in Washington State
Medication Assistant Role:

Varies across states: job descriptions, training, testing, credentialing and supervision
Practice acts for licensed nurses (RNs and LPNs) include responsibility for medication
administration.
While licensed nurses (LNs) may delegate selected tasks of medication administration to MAs,
the MA cannot replace the LNs role in exercising their judgment when administering
medications, such as assessing clients; as evaluating the need for, or response to, medication;
educating the patient; and performing the conversions or calculations of drug dosages whenever
necessary. (NCSBN, 2007)
Rationales: use of Medication Assistants in Skilled Nursing Facilities:

Staffing flexibility
To focus valuable LN resource on most complex nursing functions; free LN staff for other
essential functions
Nursing shortage: use of facility-oriented MAs to reduce use of outside agency staff unfamiliar
with facility residents
To control costs (reduce outside agency use and optimize limited LN resource)
May provide a career ladder for CNAs
Preparation of Medication Assistants:
NCSBN (2007) suggested minimal admission requirements:
Able to read, speak and write English
Competent in basic mathematics skills
Earned HS diploma or GED and CPR certification
Certified Nursing Assistant (CNA)
18 years or older
NCSBN (2007) Model Curriculum
100 hr curriculum: 60 hrs didactic including skill/sim lab; 40 hrs supervised clinical
practice
Training models vary by state: state-based standards, testing & certification to
institution/facility-based models
Most states require formal coursework; NA registry status; regulatory oversight by DOH;
specific admission, progression & teacher requirements
Medication errors: measurement:
Barker (2002) reports 4 methods to measure med errors:
Observation
Self-report (such as incident report)
Testing
Physical evidence (such as audits; document review)
Flynn(2002) compared three med detection methods:
Observation (found 456 errors in 2557 doses)
Incident reports (found 1 error in same doses)
Chart review (found 34 errors in same doses)
IOM (2007) also recommends this nave observation as valid, efficient & accurate
medication error measure- the gold standard
This method uses trained observers (nurses, pharmacists) that are trained to be objective,
unobtrusive & nonjudgmental.
CMS requires this observation method for SNF surveys and determination of F-322 CitationMedication error rate of >5%
Perceptions of licensed nurses working with MAs in SNFs:
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By end of AZ pilot, participants viewed MA role favorably with reported increase in

LN role satisfaction
Initial LN reluctance turned to positive satisfaction with being freed up to work
directly with residents to meet needs & complete higher level tasks (assessment)
Challenges in implementing MA role at facility level: staff turnover & limited
financial/human resources
Conclusions:
No reduction in QOC with MAs as part of team
Efficient use of MAs requires careful planning of complimentary MA/LN roles
that support effective resident care without compromising cost-effectiveness
Nurse job satisfaction & stress and the Medication Assistants role:
Mixed methods, LN sample: 20 interviews; 91 surveys
No significant differences between the two groups on quantitative measures (JSS and PSS)
Qualitative (interview) findings supported hypothesis of correlation between MA role and
perceived nurse satisfaction and stress:
Less stress with LN staffing vacancies but more supervision of MA required
MA role improved the work environment
Without MA, situations more stressful relative to both monitoring care & administering
meds
Substitution of Medication Assistants for Licensed Nurses:
Findings (SNFs with vs. without MAs):
With more likely to be larger, for-profit
With had lower staffing overall (CNAs and RNs/LPNs per 100 beds)
With more likely to have med error rate at least 5% documented in survey (10 % with
vs. 7.3% without MAs)
With also more likely to have been cited as not meeting minimum pharmacy services
requirement
Conclusions/Implications:
Beware of substitution
Importance of MA supervision and adequate LN staffing
Survey sent to 43 BONs believed to be using MAs in their state; 69% response rate (N=30)
Were CNAs or LPN/LVNs experiencing job losses as a result of MAs being introduced into
LTC facilities?
Findings:
20 states reported currently using MAs in LTC facilities
17 states reported no job losses
3 states reported they did not know because the info was not maintained by BON
Limitation: Not known how he 17 states verified their reported conclusion about no job loss
Conclusions:
Medication administration involves 2 categories of activities:
The repetitive psychomotor skill of drug administration
The higher level clinical judgment required for monitoring drug response and decision
making
Evidence supports that MAs are as safe as LNs in the first category
As LNs perform both sets of functions simultaneously, they are often initially opposed to MA
roles.
Evidence shows that this perception changes to one of satisfaction with the MA role as LNs
adjust their roles to MA supervision and emphasis on the higher level clinical judgment skills
Regardless of staff role mix involved in medication administration, continuing development of
better medication administration systems, team approaches to medication safety, and a culture
of safety in medication practice is needed.
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Al Linggi suggested that board staff draft a letter on the board s behalf to the Nursing Commission in
support of licensed RNs and LPNs managing medication administration for patient safety.
Disciplinary Sanctions for Pharmaceutical Firms

The board will review its authority to sanction pharmaceutical firms . Susan Teil Boyer introduced
Kristi Weeks, Director of Office of Legal Services and Kim ONeal, Supervising AG for Prosecuting
Attorneys in the AGs office.

Based on the statute there is room for argument that because pharmacies are licensed by the board of
pharmacy under chapter 18.64 RCW, they are subject to the UDA. There is, however, a rule in
statutory interpretation that the specific outweighs the general. The language is general in that it
speaks generally about all professions. The specific law relating to the practice of pharmacy is in
chapter 18.64 RCW, which includes the following provisions:
RCW 18.64.163 Uniform Disciplinary Act. The Uniform Disciplinary Act, chapter 18.130 RCW,
governs unlicensed practice, the issuance and denial of licenses of pharmacists and pharmacy
interns, and the discipline of licensed pharmacists and pharmacy interns under this chapter.
18.64.165 Refusal, suspension, and revocation of other licenses. The board shall have the
power to refuse, suspend, or revoke the license of any manufacturer, wholesaler, pharmacy,
shopkeeper, itinerant vendor, peddler, poison distributor, health care entity, or precursor
chemical distributor upon proof that:
(1) The license was procured through fraud, misrepresentation, or deceit;
(2) The licensee has violated or has permitted any employee to violate any of the laws of
this state or the United States relating to drugs, controlled substances, cosmetics, or
nonprescription drugs, or has violated any of the rules and regulations of the board of pharmacy
or has been convicted of a felony.
These two sections of the law specific to the practice of pharmacy indicate a clear intent for
pharmacists and pharmacy interns to be subject to the UDA, whereas pharmacies and other firms are
subject only to license refusal, suspension or revocation, and only for very limited offenses. Therefore,
requiring a fine does not appear to be an option against a pharmacy.
An option that may be available to the board without closing down a facility might be to issue a
statement of charges with suspension as the sanction but then negotiate a settlement for a stayed
suspension on the condition that they obey all laws, rules and regulations of the board. Or to negotiate
for a fine in lieu of a suspension (a licensee can agree to a fine in settlement even though we cannot
require it). This assumes that the conduct determined is a violation of a law, rule or regulation of the
board.
Drug Repackaging/Reuse Balancing Cost with Safety
Grant Chester asked the board to consider adopting the United States Pharmacopeia 31, Chapter <681>
Repackaging into Single-Unit Container, and Unit-Dose Containers for Non-sterile Solid and liquid
Dosage Forms as the boards interpretive guideline and consider future rule making on the subject.
The pharmacist investigators have noticed that some pharmacies, primarily long term care (LTC)
pharmacies, are interpreting WAC 246-869-130 to allow them to accept the return of unit-dose,
modified unit-dose, and med-packs for repackaging using the pharmacists professional judgment.
Recent inspections of LTC pharmacies discovered that some pharmacies have been accepting legend
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drugs (including controlled substances) back from the facilities they serve (nursing homes, assisted
living facilities, adult family homes), and were repackaging these drugs untold numbers of times.
MOTION: Christopher Barry moved that the board defer this until more information is provided.
Rebecca Hille seconded. MOTION CARRIED: 5-0.
Special vs. Regular Meetings

The board will consider the advantages and disadvantages for holding special meetings versus regular
meetings filed with the Code Revisers Office. Lilia Lopez (?) explained the difference between special
meetings and regular meeting.
MOTION: Donna Field moved that the board change to regular meetings in six week intervals
effective January 2012. Elizabeth Jensen seconded. MOTION CARRIED: 4-0. Rebecca Hille
abstained.
Rules Update
Doreen Beebe and Kitty Slater-Einert updated the board on rule making activities.
Update Animal Control Agency and Humane Society Rules (petition) 102 still being worked on.
Synthetic Marijuana Spice and Bath Salts Board voted on July 25, 2011 to authorize staff to file
new emergency rule to extend ban which was filed August 12, 2011 the CR102 Filed July 27, 2011
th
rules hearing scheduled for Sept 8 .
Continuing Education for Pharmacy Technician CR101 scheduled for filing on August 24, 2011 .
Correctional Pharmacies we were working on this rule but based on the Strategic Planning we are
going in a different direction.
Medical Assistants Sunrise Report

Susan Teil Boyer led the discussion with the board on the Department of Healths sunrise review
regarding the regulation and the scope of practice of medical assistants. This will provide the board an
opportunity to comment and provide input to the Department of Healths sunrise review for licensing a
new profession, Medical Assistants.
Kristi Weeks, Director of Office of Legal Services asked the board to think about what they believe a
Medical Assistant should do and please submit their ideas to her by August 29, 2011.
Pharmacy Technician Ratio/Techs in Training

The board was asked to discuss the ratio of pharmacy technicians to pharmacists and its relation to
technicians in training. Cathy Williams and Greg Lang provided the board some concerns that the
investigators are having out in the field regarding the pharmacy technicians to pharmacists ratio.
Through recent inspections it has been established by Pharmacist Investigators that an increasing
number of pharmacies are utilizing Pharmacy Technicians in Training to perform Pharmacy

Technician functions. However, many of these pharmacies are not including these Pharmacy
Technicians in Traini ng in the 3:1 Pharmacy Technician to Pharmacist ratio.
In some circumstances, this results in the pharmacy exceeding the established 3:1 Pharmacy
Technician to Pharmacist ratio resulting in a state of non-compliance.
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MOTION: Christopher Barry moved that the investigators follow the law as written that pharmacy
technicians in training are counted in the 3:1 ratio. Gary Harris seconded. MOTION CARRIED: 50.
Correspondence
FDA plan to require pedigree 07 2011
Rule Petition Withdrawn
ISMP Warns That Emphasizing Speed in Community Pharmacy RX Dispensing...

NABP Internet Drug Outlet Report_July2011
NABP State News Roundup June 2011
Petition for cancellation of July 25 2011 Special Meeting due to noncompliance with notice
requirements of meeting
Ibogaine
WA Poison Center Director's Update July 2011

WSBOP Answer to 2011 Petition _ Marijuana
WSPA PMP Article 20110715
OPEN FORUM:
Howard Crabtree asked the board to further discuss having a licensed technician be a book keeper
some places do as long as it is clear the technician is not moving around doing technician duties.
Jenny Arnold asked that the board evaluate WAC 246 901 100 and discuss this at a future meeting. She
also urged that the board come up with and support the scope of practice for a Medical Assistant.

CLOSED SESSION
_______________________________
Approved on October 20, 2011
______________
_________________
Al Linggi, Chair
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STATE OF WASHINGTON
Meeting Minutes
August 16, 2012
310 Israel Rd SE
Tumwater WA 98501
CONVENE
Chair Christopher Barry called the meeting to order at 9:04 a.m., August 16, 2012
Board Members:
Gary Harris, RPh,
Guest / Presenters:
Diem Pham, RPh, PSPharm, PharmD,
Pharmacy Director, Northgate Campus
Nancy Tran, RPh, PharmD
Pharmacy Director, First Hill Campus
Brad Hanna, Costco Northwest Pharmacy Regional
Costco NW Pharmacy Regional Supervisor
Catherine Zimmer, MS, BSMT, PSC Healthcare Svcs
Industry Leader, Regulatory & Technical Affairs
Staff Members:
Lilia Lopez, AAG
CONSENT AGENDA
1.1
Business Meeting Agenda Approval August 16, 2012
1.2
New & Closed Pharmaceutical Firms May 23 thru August 1, 2012
1.3
June and July 2012 Transaction Summary & Dashboard Reports
1.5
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1.7
1.9
UW and Northwest Hospital changes

Franciscan Hospice and Palliative Care
Skagit Valley Hospital: Mt Vernon and Arlington
Walla Walla General Hospital
Pharmaceutical Waste Take Back Programs.
City of Ferndale - Haggen Pharmacy
June 7, 2012
be removed from the consent agenda and placed on the regular business agenda. Items 1.4, 1.6, and
Donna Feild requested that 1.5 be pulled from the Consent Agenda for further discussion.
Elizabeth Jensen requested that 1.7 be pulled from the Consent Agenda for further discussion.
MOTION: Donna Feild moved that the board approve items 1.1, 1.2, 1.3 and 1.9. Elizabeth Jensen
Item 1.5
UW and Northwest Hospital: During the review of this application Tim Fuller would like to
ask the board should this system be looked at as a system used in several locations or do we look at
each location using the system.
MOTION: Donna Feild moved that Tim Fuller reviews this as a system as long as the policy and
procedures are the same. Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
Franciscan Hospice and Palliative Care: Mr. Fullers concern here was the rule states that a
patient must be removed from a device within 12 hours. This location is asking that they be
exempt from this because patients released during hours where there is no one there to
remove them from the system they would like to be given 24 hours.
This request was denied there are plenty of ways to comply with the rule. Tim Fuller will
contact them and assist them so they are able to comply with the rules.
Skagit Valley Hospital: Mt Vernon and Arlington: The concern here is can nurses fill the
machines? Pharmacists are doing this most of the time but nurses are covering if they need
to. Tim shared some background on this issue. The outcome on this discussion is the Board
of Pharmacy does not have authority over nurses.
Walla Walla General Hospital there were some issues during Tim Fuller reviews.
Everything was worked on but his concern was overriding and how this is done.
board was comfortable with Walla Wal las process.
The
Item 1.7
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City of Ferndale - Haggen Pharmacy Pharmaceutical Waste Take Back Program: Elizabeth
Jensen was concerned that with this box a person could actually go back into that box.
There was not a lock or anything on it. There are approved programs that are the same,
such as Group Health and Bartell Drug.
Rules Hearing
Chair Christopher Barry called the hearing to order at 9:53 a.m., August 16, 2012
Board of Pharmacy has filed proposed rule changes to Chapter 246-886 WAC Animal Control legend
drug and WACs 246-887-050, 060, and 070 rules regulating the possession, administration and storage
of sodium pentobarbital for euthanasia by registered animal control agencies and humane societies.
The proposed rules update current requirements for training personnel, and the administration and
recordkeeping of legend drugs. In addition, the amended rule will standardize training and
recordkeeping requirement s for sodium pentobarbital, a controlled substance, mirroring the
requirements established for approved legend drugs used in euthanizing animals. The proposed rule
was filed with the Code Revisers office on July 3, 2012. Notice was published in the Washington
State Registry as WSR # 12-14-105.
Before taking public comments Doreen Beebe summarized the proposed rule and shared the
background then answered questions from the board.
During the second segment of the hearing the board heard from those who were signed up to comment
on the rule. Christopher Barry then read the comments that were sent in writing to the Department of
Health.
MOTION: Gary Harris moved that the board adopt changes to Chapter 246-886 WAC Animal
Control legend drug and WACs 246-887-050, 060, and 070 rules regulating the possession,
administration and storage of sodium pentobarbital for euthanasia by registered animal control
agencies and humane societies as currently written. Elizabeth Jensen second. MOTION CARRIED:
6-0.
The hearing was adjourned at 10:13 a.m., August 16, 2012.
REPORTS
Board Member
Donna participated in the Value Stream Mapping Event for the Pharmacist Credentialing
Process. She felt this was an excellent opportunity and was thankful for being a part of it.
She also attended the University of Utah on Alcoholism and Drug Abuse. She was very ill
during this and had to come home part way through. What she was able to participate in was an
excellent program.
Kingsbury0834
Elizabeth took part in the end portion of the in the Value Stream Mapping Event for the
Pharmacist Credentialing Process.
She was on the panel to interview applicants for the Executive Director position.
There have been a lot of Friday disciplinary calls.

Emma attended the WRAPP training. Her opinion was that training is invaluable and has
helped with her perspective on Friday calls.
He believes that WRAPP Training should be mandatory as a board member within a year of
appointment.

Steve had an opportunity to participate in the Syringe Access Consultation this is related to the
Syringe Exchange Programs. The funding for these types of programs is becoming more
restrictive. The Department of Health (DOH) has gathered stake holders and wanted
participation from the Board of Pharmacy so Mr. Saxe attended. They are looking to get key
partners to brainstorm on the future of these programs. These programs help prevent HIV and
Hepatitis C from being spread.
There was a press release and an article regarding NPLEx System and. There was plenty of
positive feedback. Doreen Beebe did a great job at crafting that and staying in touch with our
communication folks
Pharmacist license can now be renewed online.
Steve had an opportunity to present the Prescription Monitoring Program at the Rural Hospital
Meeting.
In May we held a New Board Member Orientation. There is another on scheduled for sometime
in September.
He reminded everyone that whooping cough is still out there.
There has been a lot of work on Legislative Implementation from last session. If you are
interested join the listserv.
There will be a National Association of Boards of Pharmacy (NABP) triathlon starting in

September. There will be three meetings held starting in September. Chris Barry will be
attending the meeting in September. Steve suggested the board designate the new Executive
Director to attend the October meeting. November will also be a meeting sometime in
November.
Motion: Elizabeth Jensen moved board designate Chris Barry to attend the NABP meeting held in
September and to designate the new Executive Director for the meeting that will be held in November.
Donna Feild second. Motion Carried. 6-0
Lilia Lopez reported:
The States Attorneys are working on a request for a two week extension for the briefings because of a
scheduling conflict.
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Received a second collaborative drug therapy agreement on Nalaxone.

Looking at the long term care area as far as pharmaceutical services. Both short term and long
term. Our rules need to be updated in this area.

Pam Sanders reported:
She shared the issue most faced with is dual licensure. Pharmacy Technicians also licensed as
Pharmacy Assistants. This seems to cause confusion on who is playing what role. This is a way
around the Pharmacy Technician to Pharmacist Ratio.
Drug Shortage Wholesalers are limiting distribution to pharmacies of drugs on the shortage
lists. Some pharmacies are taking advantage of this and ordering shortage drugs they do not
need. The pharmacies then mark up the price and resell them to other pharmacies and/or
wholesalers for resale.
Greg Lang attended the University of Utah School on Alcoholism and Substance Abuse.
As mentioned in March 2012 there is a conflict in the Code of Federal Regulations between the
Consumer Product Safety Commission (CPSC) position relating to the use of non-child
resistant prescription containers and our rule. Our rule mandates a signature in a permanent
record while the federal rule does not . CPSC staff recommend a signature be obtained and
suggest that a prudent pharmacist should periodically check with all patients. Another concern
was the wording on most point of sale devices is unclear and sometimes confusing. A patient
could be signing for: (1) counseling (Y/N); (2) non- CRC caps; (3) insurance; and (4) credit
card if not paying for cash during the same transaction. Grant checked with Mr. John Vece, the
Deputy Director of Field Investigation Western Branch, US Consumer Products Safety
Commission Office of Compliance to find out if the point of sale signature would meet the
standards of the CPSC. Mr. Vece checked with his superiors and said they would
(Attachment).
Grant asked the board to consider that pharmacies which use a point of sale device to capture
the signature for non-child resistant closures be considered as meeting the requirements of
WAC 246-869-230. Signatures must be retrievable within 72 hours per WAC 246-875-060.
Steve suggested we take questions and issues and table this until the September meeting
for further discussion.
DISCUSSION
Rules Update. The board will discuss/review proposed rulemaking workload and agency request
legislation.
Pharmacy Technician Continuing Education the CR103 as filed July 31. Notices will be
sent out January 2013 and the requirement to report will begin in 2014.
Hospital Pharmacy Rules Update Chapter 246-873 WAC the CR101 has been withdrawn
the update will be done in the rules re write R2P2.
Wholesale Rules Exemption for the distribution of bulk drugs for herds directly to
livestock farmers (end-user), pursuant to an order written by a veterinarian, if the
Kingsbury0836
pharmaceutical is to be administered to an animal raised for the purpose of producing an

agricultural product. WAC 246-879-060 will also be updated in the news re write R2P2.
Agency Request Legislation electronic communication of Schedule II thru V controlled
substance prescriptions. There will be another draft written to the agency before the
legislation.
Prescription Drug Shortages

Steve Saxe led the discussion and shared some update and information with the board to discuss
growing concerns regarding drug shortages.
There has been significant increase in attention to the issue of drug shortages. Some of the significant
shortages involve drugs used to treat cancer or involved in emergency care.
There are multiple reasons that have been identified for these drug shortages, product quality issues,
product discontinuation, production Capacity issues, unavailability of raw material, loss of site,
unavailability of other components, and other drug shortages .
Drug shortages have several impacts on patient care. Pharmacy staff, nurses and physicians have
reported spending more time away from patient care dealing with issues caused by drug shortages.
Other reported impacts included delayed treatment, less effective drug alternatives, incomplete or
missed treatment and adverse outcomes.
There is action being done at the national level to address the issue. The GAO found the FDA was
constrained in its lack of authority to require manufactures to provide information on shortages to the
FDA or public. The FDA is working with stakeholders to prevent, identify and resolve drug shortages.
The Department of Health and Human Services is analyzing some of the economic factors involved in
shortages. There is also legislation being considered to help address the drug shortage issue.
Department of Health and the Board of Pharmacy are trying to help patients and healthcare providers
in addressing the shortage issue while weighing any negative impact on patient safety. This includes
ensuring compliance with laws that protect the public related to drug wholesalers, manufacturers,
healthcare professionals and facilities.
Correspondence
12-114-MethTrackingSystem
American Veterinary Medical Association
Jeffrey Roberts Majestic Aerotech 20120628
MEMO-Forum Survey_080212
Swedish TAKEAWAY drug disposal system
Verification of Internship Hours

Doreen Beebe asked the board to consider revisions to board policy #41, an interim procedure for
accepting out-of-state internship hours in lieu of verification by the resident state board.
Kingsbury0837
Motion: Donna Feild moved board designate Chris accept the revisions to board policy #41as an
interim procedure for accepting out-of-state internship hours in lieu of verification by the resident state
board. Elizabeth Jensen second. Motion Carried. 6-0
PRESENTATIONS
The board was asked to consider a request to use remote medication order processing services to cover
after-hour operations and staff shortages at Kindred Hospital Seattle-Northgate and First Hill.
Pharmacy Services
Provided by PharMerica
Each pharmacy is independently licensed
Shared pharmacy staff between campuses
Remote order application is for our two inpatient pharmacies only

Purpose
To provide better care to our patients by facilitating prospective timely review of medication orders
during regular pharmacy hours of operation when one pharmacist is on-site at one
hospital and not the other
Main use: early in the morning, late evenings or weekends
staff shortages, during emergencies such as codes, IT maintenance

Two campuses as one
Identical Services and Support

Shared nursing staff, resources and services
Patient preference dictate hospital site/location
Pharmacy staff work at both inpatient pharmacies

Ultimate impact
Timely verification of medical orders would benefit patients at both hospital campuses
prospective review and monitoring

avoid delays in receiving medications
better management of patients medications by nurses

More clinical support from pharmacists
Concerns
Lack of patient information because pharmacist is not physically present
Pharmacist is physically at one campus

Pharmacists have access to patients electronic medical records on- and off-site
Other pharmacists and DOPs available as resource
Nurses and medical staff are available to consult
Remote order entry would not be used to limit staffing, but to enable assistance should the
pharmacy not sufficiently staffed.
MOTION: Elizabeth Jensen moved that the board approve the request to use remote medication order
processing services to cover after-hour operations and staff shortages at Kindred Hospital SeattleNorthgate and First Hill. They must report back after six months. Gary Harris seconded. MOTION
CARRIED: 6-0.
Kingsbury0838

Cathy Williams led the presentation asking the board to consider a request to use remote medication order
processing services by Costco Call Center. Bard Hanna shared a power point with the board to show the
flow of the Call Center.
Costco Pharmacy Call Center (PCC)
Located in Issaquah, WA
Licensed by the WA State DOH
Handles incoming calls for Costco Mail Order Facilities in Corona, CA and Everett,
WA
Scope of Proposal
Expand hours of operation of PCC to 6am-6pm

Accept calls for new prescriptions at PCC
Transmit refill requests and receive refill approvals at PCC
Process new and refill prescriptions remotely at the PCC

Flow of Called-in New Prescription
Call would first be routed to PCC

RPh at PCC transcribes new prescription
Prescription processed for mail order facility at PCC by RPh or Technician
DUR performed and accuracy verified by PCC RPh
Prescription transmitted to Central Fill for packaging and shipment to patient
If all RPHs at PCC occupied, call would overflow to mail order
Process then exactly the same as at PCC, except takes place at mail order
Flow of Refills
When refill request is entered by patient via IVR or web, flows into Symphony system
for processing
If prescription has refills, it ultimately enters the batch queue for processing
Once prescription is accessed for processing only that technician or RPh will have
access to process it.
DUR will be performed as appropriate by RPh at PCC or Mail Order depending on the
location processed
o Only one RPh can access the prescription for DUR
Prescription transmitted to Central Fill for packaging and shipment to patient
Process then flows as above
Refills in the queue will be processed by an RPh or Technician at Mail Order or the
PCC
If patient calls for refill, the call will be taken by PCC RPh, technician, or assistant to
enter order request
If the prescription has no refills remaining, it enters a queue to request a refill
Refill request will be faxed, e-scribed, or called to prescriber by RPh, technician or
assistant at PCC or Mail Order
Approvals received will be processed per new prescription flow

Important Notes
All functions of RPhs, Technicians and Assistants are outlined in the proposal
System access limited by license or certification classification
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Additional training will be provided to PCC staff in how to access remote prescriptions
All elements of prescription processing to occur at one location
Staffing at Mail Order to remain unchanged with additional staffing added at PCC
Ratio of technicians to RPhs will be 3 to 1, just as in retail

If questions are asked outside the scope of a technician or assistant, the call will be
transferred to an RPh
MOTION: Dan Rubin moved that the board approve the request to use remote medication order
processing services by Costco Call Center . Donna Feild seconded. MOTION CARRIED: 6-0.

Christopher Barry chose Dan Rubin, Elizabeth Jensen and Gary Harris as the panel for this request.
The chosen panel was asked to consider a request of recognition as an educational organization and/or
professional association permitting the requester to receive contact lists of credential holders from Rx
Consultant.
MOTION: Elizabeth Jensen moved that the panel accept Rx Consultants request to be recognized as
an educational organization and/or professional association permitting them to contact lists of
credential holders. Dan Rubin seconded. MOTION CARRIED: 3-0.
The board adjourned for Executive Session at 12:05 p. m.

The board reconvened from Executive Session at 1:35 p.m.
PRESENTATIONS
Contd
Executive Director Recruitment - Update

The board heard an update from Steve Saxe on the potential applicants for the Board of Pharmacy
Executive Director position. Since none of the applicants had yet been notified these applicants were
discussed as numbers. The board was asked to make a recommendation of applicants.
MOTION: Elizabeth Jensen moved that the board recommend applicant #2 Chris Humberson be
offered the position as the new Board of Pharmacy Executive Director. Dan Rubin seconded. Emma
Zavala-Suarez opposed. MOTION CARRIED: 5-1.
Pharmaceutical Waste Management

Tim Fuller led this presentation asking the board if a pharmaceutical wholesaler location license is
required for transport terminals (freight forwarding sites) used by pharmaceutical waste management
companies [e.g. Phillips Services Corporation (PSC)] chapter 246-879 WAC. Catherine Zimmer the
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PSC Healthcare Services Industry Leader, Regulator & Technical Affairs was introduced to the board
she provided a power point to the board and answered many questions and concerns from the board.
Background:
Phillips Services Corporation (PSC) business operations are regulatory compliance, and
described itself as a waste disposal company. PSC collects and forwards hazardous medical
waste to its incineration facility in Washougal. As part of its collection, PSC collects unusable
waste materials including pharmaceuticals such as leftover chemotherapy in IV bags or a tablet
that was dropped and not administered.
Summary:
These materials are collected at transport terminals until there is enough to transport to the
incinerator.
PSC doesnt salvage or recondition drugs or devices for resale or distribution.
PSC transports the wastes to a secure facility, a transport terminal (also described as a transfer
station), where they are consolidated and shipped to a process/receiving facility for destruction
by incineration.
The wastes are handled by a limited number of highly trained technical staff using safe and
secure methods.
DEA requires these facilities to be continuously monitored, but does not license them.
Both are DEA registrants.
PSC collects hazardous and/or dangerous waste, including non-viable pharmaceuticals and
other medical wastes, from healthcare facilities.
PSC states that any controlled substances transactions will be between offerer/generator and the
process/receiving facilities.
The transportation terminals will not be handling controlled substances.
MOTION: Gary Harris moved that PSC Healthcare does not need a wholesaler license to transport
terminals used by pharmaceutical waste management companies. Donna Feild seconded. MOTION
CARRIED: 6-0.
Value Stream Mapping Event for the Pharmacist Credentialing Process

This presentation was led by Donna Feild, Board Member, Shannon Beigert, Director of Office of
Customer Service also the lead on this project along with many credentialing staff on this project. They
shared with the board the VSM closeout report on process improvements to reduce the number of days
it takes to complete the initial review of a pharmacist application.
The board was asked to consider some changes to the application process.
Summary:
The team identified approximately 30 recommendations to increase efficiency and quality of the initial
review step of the Pharmacist application process. Implemented, they would make the licensing
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process more meaningful to the customer, optimize and maximize resources and reduce required
documentation. The team will concentrate on the following six areas in the next 90 days.
1. Work with the Board of Pharmacy to reduce required documentation. There are many
different types of documentation the Pharmacist applicant must provide during the initial
review process. Some of the requirements are written in rule, while others are interpretation of
rule. All increase the amount of time it takes to process an application. The team identified
areas where documentation could be eliminated:
Birth certificate/passport (RCW for 18 years old)
RCW 18.64.080 (1) (a)
MOTION: Donna Field moved that the board not require a birth certificate or a passport from an
applicant. There is enough information provided from applicant. Elizabeth Jensen seconded.
o Eliminate Pharmacy Board need to approve for examination (RCW 18.64.080 (2)
This request was tabled.
o
Accept school hours to document 1500 intern hours and replace preceptor forms (WAC
246-858-020)
MOTION: Donna Field moved that the board accept intern hours from the school. Elizabeth Jensen
Allow letters of recommendation anytime in process, not before exam only (RCW
18.64.080 (1) (b)
MOTION: Elizabeth Jensen moved that the board not require a letter of recommendation from an
applicant. Donna Feild seconded. MOTION CARRIED: 6-0.
Waive requirements for official transcripts for reciprocity applicants (RCW 18.64.080
(5)
MOTION: Elizabeth Jensen moved that the board not require official transcripts for reciprocity.
2. Finish scanning software installation and complete training. A streamlined process for
scanning all documents received from an applicant will reduce approximately 57 handoffs in
the process, from 106 to 49 handoffs, and the time to complete the initial review step.
3. Integrate and enhance web pages. Updating the Web and paper application instructions,
including helpful hints, FAQ, and expected timeframes will address customer concerns brought
to our attention through the Value Stream Mapping process.
4. Training. Providing web training to applicants on the application process will significantly
reduce wait times for required documentation.
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5. Office processes. Staff will reduce processing time by having ILRS generate automatic email
(deficiency) integrated with Outlook, if possible, sending outbound/auto notification through
phone system, retyping the fingerprinting instructions, and sharing helpful hints and staff
updates with program staff.
6. Customer survey. Validate with a customer survey the importance of a single point of contact
for applicants. Use the first survey as a baseline of customer satisfaction with the Pharmacist
application process and follow up after improvement.
Prescription Monitoring Program Presentation (PMP) Update

Chris Baumgartner, Prescription Monitoring Program Director provided the board an update on how
the PMP is doing.
Washington Claim Record Distribution

223,911 Newly Uploaded Claim Records
27 Records Pending Standardized Address Update from Centrus
10,229,379 Standardized Claim Records that have Completed Stat Building
10,453,317 Total Claim Records
Registrations
Pharmacist 1,977 of 9,415 (21%)
Provider Requests
As of July 20, 2012
Over 210,000 patient history requests
Over 3,600 prescriber history requests
More stats provided
List of top drugs
How many prescriptions written
Total quantity
Total days supply
Recipient Ranking of Scheduled Drugs CIIs-CIVs
Individuals with at least on prescription by age decade
Unsolicited Reports
DOH can review data and proactively alert providers about patients with concerning dispensing
patterns
1/01/12 to 3/31/12 with 5 prescribers & 5 pharmacies
867 patients identified
Ex: 25 year old, 35 scripts, 715 total quantity, 22 pharmacies, 25 prescribers
Ex: 46 year old, 42 scripts, 2,514 total quantity, 11 pharmacies, 18 prescribers
PMP Funding
The program currently has operational funding through June 2013.
There are currently no other federal grants available that the department can apply for to cover
operational costs.
Any future BJA grant the program may apply for now has to be enhancement oriented.
NASPER was not funded.
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2012 Awarded Grants

NASCSA Grant Awarded to fund development of video tutorials ($18,000)
Goal is to post these videos online so users can access training when it best meets their
schedule
Plan is to have short videos that cover each feature of the program so users can watch
just the segments they need
New Grant Applications
Prescription drug misuse activities do not end at the state border.
To continue to red uce prescription drug misuse, access to more than just one states data is
needed.
Hub services have been created to allow state PMPs to exchange data across state borders.
This allows users to only need one account.
Evaluation Study: Primary Aims
1) Test whether, and how, the implementation of a PMP impacts individual prescriber
behavior, and 2) determine the impacts on both probable appropriate and inappropriate
(e.g. excessive prescriptions or multiple prescribers) individual patient prescription
utilization behavior. One of the study designs to be used is a series of case-comparison
studies of providers who do and do not utilize the PMP and patients whose providers
who do and do not utilize PMP .
OPEN FORUM
Donna Feild asked if the board has formal approval for the Rules Re Write R2P2.
Jeff Rochon shared that Washington State Pharmacy Association (WSPA) is working on ways to help
get funding for the Prescription Monitoring Program.
WSPA has been doing a lot of work preparing for the next legislative session.
WSPA will be meeting August 22, 2012 to work on their strategic plan.

CASE PRESENTATION Closed Session
_______________________________
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MEETING MINUTES
August 31, 2006
CenterPoint Corporate Park Conference Center
nd
20809 72 Ave South
Kent, WA 98032
CONVENE
Chair Asaad Awan convened the meeting at 9:02 a.m. on August 31, 2006.
Donna Dockter, RPh
Gary Harris, RPh
Rosemarie Duffy, RN
George Roe, RPh
Greg Rice, Program Support
August 31, 2006
Open Meeting
CONSENT AGENDA
1.2
1.5
1.7

Suk Pui To Anti-Malarial Medication
Suk Pui To Motion Sickness
Suk Pui To Altitude Sickness
Sample Distribution Request
Peninsula Community Health Services Bremerton
Items 1.1- Pharmacist License Application Approval; 1.4- Pharmacy Tech Training Program
Approval were deleted from the consent agenda. MOTION: George Roe moved to accept 1.2, and
1.7, Rebecca Hille second. MOTION CARRIED 7-0.
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Item 1.3 Pharmacy Technician Training Program Requests from Ericka Borg and Elizabeth Fisher
were removed from consideration. Their technician training programs were approved at the July
business meeting. MOTION: Gary Harris moved to approve technician training programs for
Theresa R Hagen
Jargriti Gupta
Carlotta Causey
Item 1.5 Collaborative Drug Therapy Agreement Acceptance. MOTION: Donna Dockter moved to
accept Collaborative Drug Agreements stipulating that the agreements apply to the specific
pharmacist named in the protocols. Susan Teil-Boyer second. MOTION CARRIED 7-0.
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Item 1.8 Board Minute Approval. The following changes requested to the July 20 business meeting
minutes.
1. Correction: Offsite Pharmacy Practice Motion to read: stipulated practice approved to allow
pharmacists to engage in the practice of pharmacy as long as the pharmacist works for a
pharmacy licensed in Washington State .
2. Correction: Board Reports Donna Dockter attended a Washington State Pharmacy Association
meeting in which she participated in a presentation on medication error prevention.
3. Electronic Prescription Transmission System Condor Pharmacy System strike from page 10
She also questioned what ICD9 is. Donna Dockter requested Condor Pharmacy Systems to
remove ICD9 and/or add a statement of purpose on the electronic prescription form.
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MOTION: Susan Teil Boyer move for the approval of the July 20 meeting minutes with the above
reference changes. Rebecca Hille second. MOTION CARRIED 7-0.
Automated Drug Distribution Devices

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Tim Fuller summarized the suggested changes presented to the Board at the July 20 Rules Hearing
regarding WAC 246-865-060 Automated Drug Distribution Devices. Mr. Fuller highlighted the
changes focusing on those that were identified as substantive. A copy of the original language and
the proposed rule with changes were reviewed by the Board. No public comments will be accepted
during this agenda item.
The Boards options were:
Adopt the rule as proposed;
Adopt the rule with housekeeping edits (non-substantive);
Adopt the rule with all edits including substantive changes (substantive changes may be
challenged within 60 days; or
File a continuance to hold a 2nd hearing to receive additional public comments.
Amended language offers clarity, provides reference to existing rules defining health care and
medical facilities (substantive), further characterizes a pharmacists oversight, requires standards for
medication waste (substantive); and verification of controlled substances to include security support
systems (substantive).
Stocking in nursing homes concerns were raised that other health professionals needed to
participate in the stocking of these machines, which is limited to pharmacy personnel only [(WAC
246-872-030 (5)]. Joyce Roper offered that this discussion should be coordinated with the Nursing
Care Quality Assurance Commission (NCQAC).
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Susan Teil Boyer stated that the Board has been working on this rule for sometime and that the
current rules on the books are insufficient and for the majority of situations (hospitals) the proposed
rules are a good fit.
MOTION: Susan Teil Boyer moves for approval of the rule language as presented with all
suggested changes and acknowledges the need to coordinate discussions with the NCQAC regarding
the issue of nursing home facilities and long-term care pharmacies. Donna Dockter second.
MOTION CARRIED 7-0.
REPORTS
Lisa Salmi reported on the following:
The Department of Health will host the Annual Board/Commission/Committee Meeting on

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September 28 -29, 2006. The afternoon of the 28 is for leadership. The dinner and evening
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session on the 28 is open to all Board Members, as well as the meeting on September 29 .
The focus of this meeting is patient safety.
Tim Fuller and Ms. Salmi met with the representative of the Department of Health (DOH)
Immunization Program, to discuss including pharmacists in the Departments Vaccines for
Childrens Program, and the Childs Profile System. Also met with representatives of
Department of Social and Health Services to discuss pharmacists involvement in
administering immunizations and vaccinations, and obtaining reimbursement for these
services. Discussed reimbursing pharmacists for Tuberculosis testing.
Pharmacy Investigator Bill Kristin and Joe Honda recently completed inspections of
pharmacies to assess compliance with the Poison Prevention Packaging Act. The inspections
resulted in an examination of 1371 prescriptions, and found 30 that were in violation of the
Poison Packaging Act requirements. The US Consumer Product Safety Commission will
follow up on all the prescriptions that were in violation.
Staff has been meeting with representatives of the CAVU Corporation. The DOH has
contacted CAVU for a new licensing system. We are currently discussing issues around data
conversion.
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Interviews for the Executive Director position were held on August 30 . Three candidates
applied for the position. The interview panel consisted of Asaad Awan, Rebecca Hille,
George Roe, Bonnie King, Steve Saxe and Lisa Salmi.
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The quarterly Investigators Meeting is scheduled for September 6 and 7 , in Tumwater.
Rosemarie Duffy will be in attendance.
The next meeting of the Methamphetamine Workgroup will be held on October 18th, in
Tumwater. Donna Dockter is the Board representative to the Workgroup. The agenda for
this meeting should be out soon.
The recruitment for the Central Washington Investigators Position will be open during the
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week of the 28 . Anticipate holding interviews during the last week of September.
Bob Horner will be filling the Section 4 Credentialing Manager Position on a non-permanent
appointment for one year.
The Precursor Investigators Position will be temporarily filled by Jim Doll, until we a
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permanent replacement is hired. Randy Flett retired from state service on August 2 . Jim
Doll is also managing the activities of the Methamphetamine Workgroup. Anticipate
recruiting for this part time position will be in mid-September.
Jennifer Wells has promoted to another department within state service. Greg Rice has been
hired as a temporary employee until a permanent employee is hired.
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Consultant Pharmacist/Investigators
Tim Fuller reported on the following:
NCQAC Executive Director, Paula Meyers, and a nurse from the Superintendent of the
Public Instruction (SPI) and Mr. Fuller met to discuss revisions of SPIs oral medication
guidelines to comply with new asthma law. The real change was in terms of looking at an
alternative to secure substantially constructed place for medications to be stored. Mr. Fuller
will update the Board
Andy Mecca reported on the following:

Mr. Mecca will begin scheduling stakeholder meeting to discuss scheduling SOMA as a C4.
Mr. Mecca will present information on law changes and history on prescription legibility at
the Health Professions Quality Assurance Boards, Commissions and Committees conference
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on September 29 .
Chief Investigator
Grace Cheung reported on personnel issues and activities that may impact the number of inspections
completed by the investigative staff. She will also set the schedule for the quarterly investigators
meetings for 2007 once the Board identifies its meeting dates for next year.
PRESENTATIONS
Disciplinary Sanction Guidelines and HB2974
Karl Hoehn, Health Professions Quality Assurance (HPQA) Legal Services Manager presented to the
Board the Secretary of the Department of Healths Disciplinary Sanction Guidelines and discussed
implementation of House Bill 2974 Mandatory Summary Suspension. Disciplinary Process Update
Mr. Hoehn updated the Board on three major topics regarding disciplinary processes and process
improvements.
1. Update on non-compliance procedures.
2. Sanction guidelines in effect for all Secretary authority health professions.
3. Developments with HB2974, which changes parts of the Uniform Disciplinary Act (UDA).
Non-Compliance
Mr. Hoehn acknowledged that the Board of Pharmacy was the first Board to adopt the new noncompliance process last year. The process simplified and expedited the course of action when
someone is out of compliance with an order. The process was intended to eliminate duplicate steps
without jeopardizing due process. When there is substantial non-compliance with an order this
process can be used to fast track hearings (within 4 weeks) and put the license on suspension if they
fail to comply.
Non-compliance with fines or cost recovery may now be assigned to a debt collection agency. The
compliance officer will monitor compliance. Issues of non-compliance will be presented to the
Board for determination if the fast track process is to be used.
No longer restricted to orders issued after May 2005.
Sanction Guidelines
The guidelines consider broad categories of conduct rather than specific legal violations. Sanctions
are based on severity of conduct and consider aggravating and mitigating factors.
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Seven Conduct Categories:

1. Sexual Misconduct
2. Abuse of Patients Emotional or Physical
3. Drug Diversion
4. Felonies
5. Practice Below Standards
6. Misuse of Drugs
7. Non-Compliance
The worksheet provides the Reviewer an opportunity to document type and severity of conduct,
aggravating and mitigating factors, prior disciplinary history, recommendation and additional
conditions. Mr. Hoehn asked that the Board review the guidelines and provide feedback on how these
compare with what the Board uses and what they feel is appropriate action in various cases. He
suggested that the Board might consider using closed cases and see how these guidelines would be
applied.
HB2974
Mandatory Reporting
Persons prohibited in another jurisdiction cannot be licensed here.
Mandatory Summary Suspension for persons prohibited in another jurisdiction for conduct
that would be substantially similar to unprofessional conduct in WA, they must be summarily
suspended until the issue can be fully considered. An inter-disciplinary Case Management
Team reviews these cases with participation from a member of the Board.
Opioid Presentation
Andy Mecca provided background information on the interagency work group formed in 2005 to
development of opioid dosing guidelines for chronic non-cancer pain. The draft guideline was
provided for Board review. Dr. George Heye from the Medical Quality Assurance Commission and
Andy Mecca served as liaisons for the Department of Health and the work group. The goal of the
presentation is to provide information to Health Boards and Commissions and elicit their comments
to assist with the future direction of the guidelines.
Dr. Jamie Mai, Pharmacist Consultant with the Department of Labor and Industries (L&I) reiterated
that the guidelines are still a draft and would not be finalized until early 2007.
L&I, in managing worker compensation claims, began to receive reports of opioid related deaths.
They discovered that there was an increase in opioid related deaths after 1996 and daily doses on
average increased from 83 mg per day to 132 mg in 2002. This appeared to be a nationwide trend.
The guidelines are designed to give provider guidance to ensure that treatment with opioids is safe
and effective. Dr. Mai stated that once the guidelines are published the goal is to provide education
for a year before taking more restrictive action.
DISCUSSIONS
Pseudoephedrine Packaging Exemption Request
Lisa Salmi presented the request from Leiner Healthcare for a waiver to the 3 grams per package
limit. An exemption to the packaging limits is permitted per RCW 69.43.130 if the product meets
specific requirements listed in the law. The Leiner Healthcare products associated with this request
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do meet these requirements. Staff recommends that the Board approve the exemption. Approval
does not violate the new federal law.
MOTION: George Roe moves to grant exemption requested by Leiner Healthcare. Donna Dockter
2007 Disciplinary Hearing/Business Meeting Schedule and 06-07 Travel
2007 Meeting Dates
January 25th and 26th - Tumwater
February 28th (Planning Meeting) - Kent
March 1st and 2nd* - Kent
April 12th and 13th* - Tumwater
May 17th and 18th* - Vancouver WA
July 26th and 27th* - Kent
September 6th and 7th* Spokane, if budget permits
October 25th and 26th* - Kent
December 13th and 14th* - Kent
*Disciplinary Hearing Dates
Note: Washington State Pharmacy Association Tri-State meeting in June 2007 coordinate with
WSPA proposed attendance by Chair and Vice-Chair.
MOTION: Rebecca Hille moved to approve meeting dates for 2007 (as documented above). Susan
Teil-Boyer second. MOTION CARRIED 7-0.
Travel Plans 2006-2007
November 4 5, 2006 NABP --- George Roe, Lisa Salmi & Grace Cheung
May 19-22, 2007 - NABP ---Not considered out-of-state travel
June 24-27, 2007 University of Utah School of Alcoholism & Other Drug Dependencies --Rosemarie Duffy & Gary Harris
DEA To be announced
Correspondence
Board reviews the National Association of Boards of Pharmacy report of the 2005-2006 Committee
on law Enforcement Legislation.
Pharmacy Technicians National Standardized Certification Exam Draft Rule Proposal
The Board discussed proposed amendments to WAC 246-901-030 and 060 and reviewed stakeholder
comments regarding exam requirements for pharmacy technician certification.
Tim Fuller provided background and a summary of issues discussed the stakeholder meetings held in
Kent and Spokane earlier this year.
Highlights
Two national standardized certification exams available ExCPT & PTCB exam
Access to exams issue for Pharmacy Technician applicants.
90% -average scores of Washington Pharmacy Technicians taking PTCE national average
80%.
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PTCB exam taken by over 250,000 pharmacy technicians.

ExCPT taken by over 20,000 pharmacy technician.
Grandfathering clause proposed for existing WA certified pharmacy technicians.
Mr. Fuller asked the Board if they wish to approve more than one exam and if they wished to name
the exams in the rule or approved that language as Board-approved national standardized
certification examination.
Donna Dockter questioned the need to include the word certification in the proposed rule language
as part of the identifier of the requirement for a Board-approved national standardized exam. Ms.
Dockter was concerned that this may limit the Boards ability to approve national standardized
exams in the future if the word certification is not included in the title. Ms. Teil-Boyer and Ms.
Duffy felt the word certification clarifies the purpose of the exam.
MOTION: Rosemarie Duffy moved to approve the proposed rule language for WAC 246-901-030
and 060 as submitted. Susan Teil-Boyer second. MOTION CARRIED 7-0.
Joyce Roper suggested that the effective date of the rule could be established at the time of the
hearing/adoption of the rule.

Representatives Ruther Kerschbaum, Doug Beeman, Leon Alzola and Rod Shafer, CEO of WSPA
appeared before the Board to propose a budget increase for the WRAPP program for services
provided under a four year contract with the Department signed in June 2005. The program
requested $40,576 increase - $10,000 per year increase over a four-year period to cover expenses for
salary, program management, satisfaction surveys, audits and increase education of clients. A copy
of WRAPPs budget was distributed.
Ms. Kerschbaum expressed concerns about the hardship of passing on the costs of the WRAPP
monitoring program to clients, specifically pharmacy technician. Clients currently pay for urine
analysis and their treatment programs. WRAPP currently has 66 clients 47 pharmacists and 19
pharmacy technicians. Approximately $1000 per year cost to the Board for each participant.
The Board acknowledges that the WRAPP program has been successful and well managed. The cost
of the program is relatively small compared to the services provided to the state, pharmacists and
public safety.
Lisa Salmi explained that to grant the proposed increase the Board will need to cut discretionary
spending; such as salaries, travel, meeting room expenses, etc.
Donna Dockter suggested that clients pay an annual fee with the understanding that technicians
should pay no fee or a reduced fee to prevent any barriers to their participation in the program.
Ms. Salmi reminded the Board that we will be developing a new biennium budget in July 2007 and
could consider increasing the WRAPP budget at that time as well. The
Information Requested by the Board
Legislative Request for Dedicated Funds
Delineation of WRAPP budget
Review discretionary spending for cuts
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MOTION: Rebecca Hille moved to postpone the decision until the October Board meeting. Susan
Teil-Boyer second. MOTION CARRIED 7-0.
Executive Session Closed Session
The Board adjourned for Executive Session at 12:00 p.m. to discuss Emergency Preparedness and
Response, including items exempt from public disclosure under RCW 42.56.420, and personnel
issues.
Pharmacist Responsibilities Proposed Rule Language

The Board discussed the proposed language regarding a pharmacists responsibilities when presented
with a lawful prescription and the next steps. No public comments were accepted during this agenda
item.
Chair Asaad Awan invited Christine Hulet, the Governors Health Policy Advisor and Marty Brown,
the Governors Legislative Director to update the Board on the stakeholder work in which they
facilitated and present alternative rule language.
Ms. Hulet thanked the Board for allowing them to speak on behalf of Governor Gregoire. Marty
Brown and Ms. Hulet acknowledged the Boards efforts and the volume of constituent and media
interest in the rule. Ms. Hulet briefly discussed the negotiations with Dona Dockter; Don Downing,
University of Washington School of Pharmacy; representatives from Planned Parenthood,
Washington State Pharmacy Association, the Northwest Womens Law Center, the Department of
Health and other resulted in language that the Governor feels provided a balance between patient
access and it recognizes the important role of pharmacists in our health care system and patient
safety.
Christina Hulet read into record a letter from the Governor issued to the Board recommending the
approval of the alternative rule language. A copy of the alternative rule language was distributed to
members of the Board and highlighted by Ms. Hulet.
MOTION: Susan Teil-Boyer moved to reconsider the proposed rule language accepted at the June 1
meeting. Rebecca Hill second. MOTION CARRIED 7-0.
The Board was instructed by Chair Awan to have a brief discussion on the rule language provided by
the office of Governor Gregoire.
Donna Dockter shared her concerns about the proposed language. She stated that the language does
not clearly state the Boards expectation of a pharmacist when they do not dispense a legal
prescription. Ms. Dockter indicated that the list of exceptions for when a pharmacist would not
dispense is not inclusive, which she acknowledged that it would not be possible given the many
aspects of the practice of pharmacy. Donna Dockter stated that exception (1)(c) did not adequately
address the compounding of drugs that does not require specialized equipment or expertise but may
not be done for sound business reasons or special services such as filling insulin syringes.
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Donna Dockter requested clarification on the second sentence of the proposed rule which begins
Pharmacies have a duty to dispense Pharmacists dispense prescriptions not pharmacies. She
asked if approved as written who will be disciplined.
Gary Harris stated that he supports the Governors proposed language. In response to the many
examples given by Ms. Dockter, Mr. Harris felt that the Board would not pursue disciplinary action
against the pharmacist.
Susan Teil-Boyer suggested changing the word Pharmacies to Pharmacists in the second
sentence of the rule. Ms. Teil-Boyer acknowledged that this has been the toughest issue that the
Board has dealt with in her seven-years of service on the Board. She was in agreement with several
of the issues presented by Ms. Dockter; however, to move forward she stated she would support the
alternative rule language.
MOTION: George Roe moved to approve the alternative rule language changing Pharmacies to
Pharmacists in the second sentence of the rule. Rebecca Hille second. MOTION CARRIED 6-1,
Donna Dockter opposed.
Steven Saxe, DOH Director of Facilities and Services Licensing (former Board of Pharmacy
Executive Director) briefed the Board on the next steps in the rules process.
Standards of Professional Conduct Sexual Misconduct Draft Rule Proposal

Doreen Beebe provided background information on the draft rules presented for consideration by the
Board. In addition, a summary of stakeholder comments were provided to the Board for review.
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Donna Dockter shared with the Board some of the discussion from the July 20 stakeholder meeting
and the potential need for much of the language contained within the rule with the changing practice
of pharmacy.
Joyce Roper offered to work with Lisa Salmi in developing amendments to the draft language to
incorporate the Boards concerns about restricting providers from engaging in a personal relationship
with patients/clients within two years after the provider-patient/client relationship has ended. The
Board asked to focus on the abuse of patient trust and the imbalance of power/influence rather than a
defined two year time period.
MOTION: Rebecca Hille moved to approve the proposed rule language with changes made by Joyce
Roper and Lisa Salmi regarding the two year prohibition. Rosemarie Duffy second. MOTION
CARRIED 7-0.
Pharmaceuticals from Households: A Return Mechanism (PH:ARM)
Board Pharmacist Investigator Stan Jeppesen updated the Board on the PH:ARM pilot project. In
addition, the Board was asked to approve the guidelines developed for use by pharmacies in
developing policies and procedures for participation in the pilot and authorize staff to approve these
protocols.
Highlights
Model project 1st of its scope in the nation
Grant money available if the pilot begins October 1st
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No controlled substances are being collected at this time

Need protocol to state specific location of collection units
24 sites participating in project
Contracted with the Waste Division Plant in Spokane for disposal
Anticipated that the pilot will take in over 80,000 lbs of household pharmaceutical waste per
year statewide
Recommendation to change should to shall in guidelines
MOTION: Rebecca Hille moved to approve the guidelines with recommended changes. Susan TeilBoyer second. MOTION CARRIED 7-0.
OPEN FORUM
In response to an inquiry from the audience, Lisa Salmi stated Asaad Awans position on the
Board is open for recruitment. Dr. Awan is eligible to apply for a second term.
The Board received two comments regarding the pharmacist responsibilities rule both were in
support of a pharmacist choice of personal conscience.

Adjournment
There being no further business, the Board adjourned at 2:37 p.m. They will meet again on October
27, 2006 in Spokane, Washington.
September 1, 2006 Disciplinary Hearing Cancelled
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Board of Pharmacy
10
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STATE OF WASHINGTON
Special Meeting Minutes
September 8, 2011
20435 72nd Ave S, Suite 200 Rm 1
Video Connect to the Department of Health Spokane office
Board Chair Al Linggi convened the meeting at 3:34 p.m. on September 8, 2011. Board members
present by telephone or video:
Board members:
Chris Barry, R.Ph. Vice-Chair (Spokane)
Rebecca Hille, Public Member (Spokane)
Staff members present :

Joyce Roper, Assistant Attorney General (by phone)
Grant Chester, R.Ph. Chief Investigator
Bill Kristin, R.Ph. Investigator (Spokane)
Kitty Slater-Einert, Health Services Consultant
Public:
Cindy Dandoy, Pfizer (Spokane)
Wayne Clemens, Yokes Pharmacy (Spokane)
Open Session
Business Meeting
_________________
Rules Hearing The board held a public hearing to consider for adoption the proposed rule, which adds
synthetic cannabinoids and substituted cathinones to schedule I of the Controlled Substances Act . The proposed
rule was filed with the Code Revisers office on July 27, 2011. Notice was published in the Washington State
Registry as WSR # 11-16-040.
Kitty Slater-Einert summarized the proposed rule, which adds 30 substances in addition to the emergency rule
banning synthetic cannabinoids and five substituted cathinones. The three substituted cathinones placed
temporarily in schedule I by the federal Drug Enforcement Administration are included in the substances listed
in the proposed rules. Ms. Einert continued her summary by explaining that the board applied the Schedule 1
test as defined in RCW 69.50.203.
Chair Linggi summarized the public comments submitted in response to the proposed rules.
Comment: The substances added to the Schedule I listing do not meet the criteria for this type of Scheduling.
Response: The board reviewed and approved the substances as meeting the Schedule I criteria in RCW
69.50.201, Authority to change schedules of controlled substances; RCW 69.50.203, Schedule I tests; and RCW
69.50.204, Schedule I. These substances have a high potential for abuse with no medical use.
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Comment: Objection to scheduling under the Washington State Uniform Controlled Substances Act as it
violates the United States Constitutional Act protections of religious liberty. Response: The law allows the
board to schedule substances that meet the criteria in law. The rule is considered neutral and does not target any
specific religion or religious belief.
Comment: The Board of Pharmacy does not appear to be complying with RCW 34.05.270, Agency web sites
for rule making information. Response: The law requires each state agency to maintain a web site that contains
the agencys rule-making information The Department of Health maintains an agency website that provides
information on all rulemaking activities administered by department including those authorized by boards and
commissions. The website is in compliance with RCW 34.05.270.
MOTION: Chris Barry moves that the board approve the rule amendments as written. Rebecca Hille
seconded the motion. MOTION CARRIED 4-0.
NASCA Annual Meeting Due to travel restrictions and state budget cuts the board would not be sending a
representative to the National Association of State Controlled Substances Authorities annual meeting in
October. The board considered a proposal to assign Steven Saxe, Director of the Office of Health Professions
and Facilities voting rights on behalf of the board. Mr. Saxe will vote as directed by the board on the resolutions
presented at the NASCSA meeting. Mr. Saxes travel is paid by NASCSA as a presenter at the conference on
Washingtons Prescription Monitoring Program. The presentation is a requirement associated with the $20,000
grant to the PMP from NASCSA. MOTION: Rebecca Hille moved to approve Steve Saxe to represent the
board and cast votes on resolutions at the NASCSA annual meeting as directed by the board. Chris Barry
seconded the motion. MOTION CARRIED 4-0.
Resolutions:
Resolution supporting the placement of Carisoprodol into schedule IV of the Federal Controlled
Substances Act.
A resolution recommending states implement laws and/or regulations allowing for the electronic
prescribing of controlled substances pursuant to adopting Federal regulations.
A resolution recommending states implement laws and /or regulations to control pain clinic operations
in each state.
A resolution supporting the Federal governments effort to place substances marketed as Bath Salts
into schedule I of the Federal Controlled Substances Act.

A resolution encouraging the DEA and states to schedule/regulate synthetic cannabinoids contained in
products marketed as K2/Spice.
A resolution encouraging the Federal and state governments to make Salvia Divinorum a controlled
substance.
A resolution supporting Federal legislation authorizing the Dept of Defense and Dept of Veterans
Affairs to submit dispensing data to state prescription monitoring programs.
A resolution endorsing the Office of National Drug Control Policys Prescription Drug Abuse Plan to
Provide a sustained funding source for state PMPs.

*****
again on October 20, 2011 for its regularly scheduled business meeting in Tumwater, Washington
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STATE OF WASHINGTON

Regular Scheduled
Meeting Minutes
CONVENE
Chair Christopher Barry called the meeting to order September 11, 2014.
Commission Members:
Gary Harris, RPh,
Steve Anderson, RPh
Hecox, PharmD
Tim Lynch, PharmD
Al Linggi, RPh, MBA
Guest / Presenters:
Jeff Tichenor, PharmD, MHA, Pharmacy Director for
St . Anthonys Hospital
Cindy Wilson, PharmD Operations Manager within
Franciscan Health Systems
Les Hanson, Director of Pharmacy, Cascade Valley Nancy
Hospital
Ron Jennings, BPharm
Ron Cho, Pharmacy Support Center Manager for
Safeway
Glenn Adams, Corporate Director of Pharmacy,
Confluence Health
Michael Wright, RPh, Director Of Pharmacy for CAP
Seattle
Traci Mitchell, Pharmacy Services & Infection
Control Manager for Valley General Hospital
Lynn Wittwer, MD, FACEP Clark County Medical
Program Director Chair
Staff Members:
Joyce Roper, AAG
Tina Lacey R.Ph., Pharmacy Investigator
Welcome Irina Tiginyanu

Irina Tiginyanu is a nationally certified pharmacy technician that graduated from Everest College, having
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recently been with the Air National Guard and served two tours in Afghanistan. She also attended the
community college of the Air Force. Irina worked as a pharmacy technician at Pharmacy Plus, Bartell
Drugs and McKesson Online Mail Order. She is bilingual Russian and English. It is rumored she makes a
pretty mean cupcake.

1.2 Approval of July 10, 2014 Meeting Minutes.
MOTION: Elizabeth Jensen moved that the commission approve 1.1. Nancy Hecox second. MOTION
CARRIED: 10-0.
MOTION: Elizabeth Jensen moved that the commission approve 1.2 with suggested amendments . Steve
There was a discussion regarding the specific content of the minutes. Some of the commission members
felt that the minutes dont provide enough details that capture full discussions during the meeting. Joyce
Roper shared that the minutes needed to follow the Robert Rules of Order and they do at this point. Joyce
Roper and Chris Humberson suggested that staff provide a guideline / statement document that provides
more detail for some of the presentations that were hot topics and a statement in the minutes that informs
the reader there will be a document prepared.
PRESENTATIONS
Franciscan Health Systems (FHS) Barcode Verification Process for ADDD Refills
Lisa Roberts led the presentation from Franciscan Health Systems . She introduced Jeff Tichenor, Pharmacy
Director for St. Anthonys Hospital he presented FHS barcode process utilizing carousels in place of
pharmacist checks.
Background
A systematic approach to barcode verification from medication receipt to administration provides

equal or greater patient safety than the historic process of pharmacists manually reviewing every
item being placed in Pyxis
Request to invoke WAC 246-872-030 section 4.b

End to End Bar-coding Process
Receipt of medication
Pharmacy Technician receiving medication scans product barcode to verify it is in the
system and functions appropriately.
If bar-code is not in system or error results from scan the error is reported and medication
is quarantined until corrected
Adding Barcode Data to Carousel
Product arrives that is not in Carousel Database

Medication information added to Carousel database and stocking locations are assigned
with min/max, etc
One item we got out of Lisa & Pams visit was benefit of having RPh check database entry
Implementation in process
Stocking of Medication in Carousel
Actual invoice from wholesaler is loaded in Carousel and Technician works from it
Tech scans barcode and verifies correct quantity received
Carousel notes location with light and alpha-numeric labeling system
Each location is assigned to only one medication
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Removing Items from Carousel
Select item to be removed

Carousel spins to proper shelf and denotes proper location of med with red light
Technician removes medication and scans barcode

If barcode doesnt match Carousel displays error triggering review
System does not allow override
Adding to Pyxis
Technician selects refill or load options on Pyxis then scans medication barcode
Pyxis then opens proper pocket for that barcode
Technician visually inspects each item going in to pocket, verifying med,
quantity, and expiration date.
Administration to Patient
RN selects patient in ADDD
From patient profile of verified medications RN selects med that is due
ADDD opens to that location & med is removed
RN visually inspects med and record to ensure right:
Med, dose, route, time, and patient
At bedside RN scans med barcode which electronically verifies pt has order due for
selected item
MOTION: Dan Rubin moved that the commission approve Franciscan Health Systems barcode
process utilizing carousels in place of pharmacist checks subject to receipt of an acceptable AUP that
complies with all requirements. There will be no action taken against their practice. The AUP will be
considered at the October 23, 2014 meeting. Nancy Hecox second. Tim Lynch and Maureen Sparks
recused themselves. Gary Harris opposed MOTION CARRIED: 7-1.
Franciscan Health Systems Technicians Taking Patient Medication Lists

Cathy Williams was the lead on this report back from Franciscan Health System presentation. Jeff
Tichenor, Pharmacy Director for St. Anthonys Hospital presented the report back. Background
Prior to Admit (PTA) Medication List
Identifies the medications the patient was taking at last contact
May not be 100% accurate depending on time elapsed since it was last updated
Includes name, dosage, frequency, route, and last dose
Optimizing the medication record with external list of medications obtained from a patient,
hospital, outpatient pharmacy or other provider improves inpatient team knowledge of patient
medications and history.
Why We Care
Preventing medication errors and optimizing patient safety is a core goal of all health care
providers
Pharmacys core responsibility is safe medication use

These lists directly become inpatient orders!!!
They need to be correct, so the physicians have a dependable resource when diagnosing
and prescribing inpatient treatments
Lists must be: Accurate, Timely, and Complete
The Joint Commission mandates that Med Rec be completed on every inpatient
Where to Start
Review track board to see which patients are getting admitted or check in with charge RN from the
Review ED Notes for patient status and social history
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Will often tell you if the patient is from a facility, lives independently, etc
Print off PTA medication list from EPIC if available

Contact patients outpatient pharmacy (if known) to obtain a list of medications filled for the past 3
months
Interview the patient, family, or collect the medication list by alternative means if patient/family
unable to provide a list
Verify allergies and reaction

Confirm outpatient pharmacy being used with patient
Compare what patient and family describe to the lists you obtained and ask them for clarity
on any discrepancies
Follow up with outpatient physician for unexplained discrepancies
Getting outside information
Review pts insurance on face sheet to see where the second source of information can be obtained
from.
Group Health and VA are common third parties (cannot use Elysium for them)
Group Health Records can be obtained by logging into Group Health directly (preferred)
or through Care-Everywhere
Cautions in Using PBM Databases

Medications reported by PBMs do not always complete the list
PBMs only report medications that are processed through insurance
Benzodiazepines are often excluded from Medicare, therefore will not show be reported by
PBMs.
$4 generic prescriptions or other generic prescriptions that patients often choose to pay out
of pocket for might not be reported by PBMs.
OTC medications such as aspirin, docusate sodium, vitamins are not reported.
Finally, check to see if there is a medication list brought in by the patient at the RN station
If there is a medication list from home, make a copy and return the original.
You can also find MARs/Med list from Facility (SNF) here Make copies and return the original.
VA patients often carry a list from the VA (important to check the date on the list)
If patient does not carry a list, see slide 10 for phone & fax #s.
Other third parties
Reconcile outside medications or Elysium are the two electronic data

sources currently available through PBM. Limitations apply see slides 4-8
What to do when list is complete
When all information is confirmed and entered correctly mark the med list as in process and
tell the pharmacist it is ready for review by sending an inbox message to the ED Pharmacist
ED Pharmacist will check message and review patient medication list in Epic
When RPh is done with verification they will change the list from in progress to
reviewed
Franciscan asked the commission to consider approving and expansion of their Technicians Taking
Medication List program.
Overview for Medication Reconciliation Expansion
Expansion of Pharmacy Technician Medication Reconciliation Program At Franciscan

Health System:
Add Remaining Franciscan sites (St. Joseph Medical Center originally

approved)
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St Joseph Medical Center
24/7 Coverage (10 hour coverage originally approved)
Implemented board approved program in 2011 after 6 month pilot
Great success with triple check process used
17 Major Adverse Events Avoided

$~99, 000 total cost of adverse events avoided
Lack of coordination during admission process leads to variation, delay in care, and errors
in medication ordering at sites without medication reconciliation technician program
Need to standardize admission process work and have specific assigned individuals
responsible for medication reconciliation
Propose to roll out successful program at SJMC to rest of FHS sites.
MOTION: Elizabeth Jensen moved that the commission approve the expansion of Franciscan Health
Systems Technicians Taking medication Lists with a report back in one year. Gary Harris second. Tim
Lynch and Maureen Sparks recused themselves. MOTION CARRIED: 8-0.
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will be approved by a
single motion of the commission without separate discussion. If separate discussion is desired, that item
August 2014

a. Cascade Valley Hospital Technicians Taking Patient Medication Lists
b. Providence Regional Medical Center Technicians Taking Patient Medication Lists
a. Biscom, Inc. e-prescribing
b. Office Ally LLC OA-Rx e-prescribing system
Dan Rubin requested to remove 2.6 (b) Gary Harris requested to remove 2.6 (a) from the consent agenda
for further discussion.
MOTION: Al Linggi moved that the commission approve items 2.1, 2.2, and 2.4. Nancy Hecox
REPORTS
Commission Members
He took and passed two more MPJEs, Nebraska and Oregon.
She passed her Pharmacy Regulatory Certification. She highly recommends this course.
Nancy attended an addiction medicine seminar. She was asked to join the American Society of
Addiction and is now a member.
Dan Rubin reported:
He has done a fair amount of work on the Pharmacy Business Practices Committee
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She attended a few seminars on pharmacist as a provider in California and Arizona.

Sepi is working on becoming a mentor for UW pharmacy students for this academic year.
He has participated in phone calls and discussion on Pharmacy Compounding Committee and
Pharmacy Business Practices Committee.
He is now the new incoming president of the University of Washington Pharmacy Alumni
Association.
Al Linggi reported:
He has been participating on the Pharmacy Technology Committee.

He attended the UW of Washington School of Pharmacy curricula meeting.
July she attended the Pharmacy Technicians Counsel Annual Meeting.

She gave a presentation on Pharmacy Boards that have technicians serving on them.
Part of a couple Pharmacy compounding committee conference calls.
Working with Pierce County Skills Center they are interested in starting a process to start a prepharmacy technician program for juniors and seniors in high school
She was a co-surveyor on ASHP re accreditation at a Michigan College. That was a great
experience.
Tim Lynch reported:
He worked on the WSPA agenda for the upcoming Hospital Pharmacy Leadership Meeting.
Executive Director
Chris traveled to Washington D.C. in July to represent Washington State for a two day HHS
Conference on Opioids abuse.
The end of July he chaired the DOH opioid work group. This is a work group to try to reduce
opioid poisoning in Washington State.
He attended several meetings on Pharmacy Technology, Compounding and Pharmacy Business

Practices.
He also completed the work to initiate the survey which is open until September 19, 2013.
Had a some great meetings with WSPA and NCDSA with respect to pharmacy commission request
legislation and some other issues
Helped Lisa Roberts and Irina Tiginyanu get established and be a resource for them.
Doreen Beebe and Chris have a boards and commission appointment process meeting at the
Governors office.
Naturopathic board meeting and worked on their sunrise review last month.

There is an argument date in the Stormans case November 20, 2014 at 2:00 pm at the Portland, OR
Federal Courthouse
She and Lisa Roberts participated in an orientation for the DOH Emergency Response System.
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September 10, 2014 there was an all-day meeting with all of the pharmacy investigators and Chief
Investigator Don Painter. The meeting was to discuss case investigative procedures and
investigation management. The DEA attended to discuss common issues that we have with them.
Gordon introduced the investigators to the commission members.

Tina Lacey and Greg Lang represented the commission at the MPJE meeting.
Tina Lacey reported:
MPJE is a test broken into 3 different sections. She and Greg go to Chicago in September and
review every single question on the MPJE for Washington State as well as all new items that are
written by every state than time permitting they go through the rest of the scored pool to add items
on. The challenge is to develop and maintain an accurate question pool with appropriate number of
questions within each competency. Every year questions need to be eliminated from the pool for
variety of reasons. In September when questions are ready for review this allows enough time to
remove any incorrect questions and try to eliminate questions that are to similar. They review
about 1500 questions in two days.
Because of all the work this takes the Investigators would like to request that the commission take
into consideration the individual points as you contemplate proposals. The decisions that you make
actually affect potentially the ability for an incoming person who is going to be taking that license
to accurately answer the questions.
CONSENT AGENDA
2.6 Electronic Transmission Systems Approval
a.
Biscom, Inc e-prescribing
MOTION: Dan Rubin moved to table this item for further discussion until there is more information and
clarification provided. Nancy Hecox second. MOTION CARRIED: 10-0
b.
Office Ally LLC OA-Rx e-prescribing
Lisa Roberts recommended this be pulled of the Consent Agenda because some of the components
initially didnt meet our standards after working with them they were able to change these items
except for WAC 246-870-030 (8) stating the transmission of original prescriptions must include:
A place to note allergies and a notation of purpose for the drug.
o
Joyce Roper clarified that as long as there is a place to note allergies if needed it is within
our standards it doesnt need to be designated as an allergy field.
MOTION: Dan Rubin moved that the commission approve Office Ally LLC OA-Rx e-prescribing.
PRESENTATIONS
Cascade Valley Hospital Telepharmacy/Remote Pharmacy Services
Cathy Williams introduced Les Hanson, Director of Pharmacy, for Cascade Valley Hospital. He provided a
brief overview power point to the commission asking for approval of their policies and procedures to use
PipelineRx remote order entry pharmacy services.
Overview
2011 Started implementation process for:
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Use of eMAR at CVH

Bar Coding at the bedside
Both required 24/7 order entry
Needed 86 hours/week after hours coverage
Chose PipelineRx due to best fit with needs of CVH

No need for special equipment for order transmission
Dedicated PipelineRx Pharmacists
Implemented on August 29, 2011
Now in process of CPOE implementation

Also requires 24/7 order entry/verification
Benefits
24/7 Pharmacy support to CVH patients

PipelineRx has full access to the Meditech system
Ready access to pharmacist for consultation
Reduction in need for nursing supervisors to obtain medications
All orders entered or reviewed by a pharmacist
Quality Assurance:
PipelineRx pharmacists get/give report daily
CVH pharmacists review all PipelineRx orders every morning for accuracy
Issues identified immediately
Education provided as need identified
Any trends found used for systems improvement
MOTION: Tim Lynch moved that the commission approve Cascade Valley Hospital policies and
procedures to use PipelineRx remote order entry pharmacy service as written. Steve Anderson second.
Yakima Neighborhood Health Services Central Refill

Cathy Williams led this presentation with a brief background and introduced Ron Jennings, BPharm. Ron
Jennings presented a 6 month report-back on the demonstration project approved in January 2014 to
provide central refill services to its Yakima pharmacy from the Yakima Neighborhood Health Pharmacy in
Sunnyside, WA.
Background
Jan 23, presented proposal for central fill site

Were asked to look at multiple areas of error analysis
Steps we took:
Performed a pre- and post-LEAN study to look at average wait times at YNHS
Recorded errors from refill center
Surveyed customer satisfaction
Pre-and Post- LEAN Design 3* Day Time Study at YNHS
Objective: Perform a time study that would characterize average wait times at YNHS pharmacy
and reveal potential areas of improvement in the workflow and layout of the pharmacy
Methods: Pharmacy staff filled out form for all waiters coming to check-in window. Data
collected, simple statistics calculated
Overall Volume Analysis
Sunnyside: Fills ~ 90 prescriptions daily

Delivers ~ 80 to Yakima site
~ 40 scripts are returned to SS every 7-10 days
Average Number of Scripts Filled
Before: 300 scripts filled daily
Now:
210 scripts filled daily
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Less prescriptions filled at Yakima site has:

wait time for patients
Improved safety and efficiency by balancing workload of
staff
Refill Center Error Monitoring
Customer Confusion 4 incidents

Customer confusion - Some dont understand what a refill center is, or why theres two
phone numbers on the label
Needed that day- 54

Turn-around time: 24 hours, prescriptions filled and checked in SS: will be delivered to
Yakima next morning
Addressing Errors & Customer Confusion
Customer confusion
Placed education pamphlets into patient bags
Verbal education
During counseling
On phone
Delivery Errors
Called SS to resolve error(s)
The commission asked Tyler Varnum what his experience was at the last inspection. Tyler reported that it
was a very positive inspection. No concerns at this point.
MOTION: Tim Lynch moved that the commission accept the demonstration project for Yakima
Neighborhood Health Services to provide central refill services to its Yakima pharmacy from the Yakima
Neighborhood Health Pharmacy in Sunnyside, WA. Should issues arise and or any changes are made to the
process the commission must be notified and then staff can schedule a presentation. There is no
requirement for a report back in a year. Steve Anderson second. MOTION CARRIED: 10-0.
Safeway Pharmacy Call Center

Cathy Williams introduced Ron Cho, Pharmacy Support Center Manager for Safeway who provided an
update on the pharmacy call center proposal originally approved in April 2012. In January 2013, the
commission asked Safeway to return in a year to provide another update on the services provided and the
benefits to patients.
Overview of responsibilities
Provide Medication Therapy Management for all WA State Safeway customers
Transfer and Process prescription to include Phone forwarding if needed.

For hard to staff pharmacies
-Bad weather
-Sick Tech (Unable to physically staff)
Have calls forwarded to call center as needed
-New prescriptions
-Refills
-Patient questions
-Third party billing issues
Process prescriptions in the refill queue and e-scripts for pharmacies as needed.
Immunizations
-Assist
-Assist
-Assist
-Assist
Resource for Patient Information

Answer questions that may be posed by patients that cannot reach their pharmacy.
in
in
in
in
review of recommended immunizations

review and processing of third party billing
identification of patients potential needs
customer outreach
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Acquisitions
Transfer prescriptions out: to other pharmacies to allows the pharmacy staff to concentrate on
their customers in the store.
Inform patients about promotions and services before transferring
Lessons Learned From Transfers and Processing
Safeway Pharmacies
Reduce time on HOLD
Time study (2-7 mins but maybe 45-60mins)
Seasonal (snowbirds, students, mail order)
Competitor Pharmacies
No HOLD
Multiple Safeway pharmacies transfers
Acquisitions
Clearly define procedures
Customers
No phone tree
No HOLD
Customer recognitions for service excellence
Pharmacists and Technicians doing MTM

Comprehensive Medication Reviews (CMR)
Physician Consultations
Patient Compliance Consultations
Patient Education & Monitoring (most common)
Targeted Intervention Programs (TIPs)
Simply put, pharmacists are able to bill for services they are currently uncompensated for, such as
calls placed to a prescriber for formulary reasons, unsafe doses or interactions, and even
Adjudication Edits in PDX will notify you of which patients are eligible for Outcomes Services.
This is not a universal program; it applies to a select group of individuals that are
Call Center Technicians and Pharmacists:
Pulling TIPs for entire state of Washington
Telephone Skills
To pull TIPs for all of Safeway stores in our division:

Login
Click Claims on the left
Select specific division, under Pharmacy Chain
In the Claim Summary filtering criteria, under Status select Pending from the drop down
list
In the TIP drop-down menu select TIPs only
Click Search
Lessons Learned from MTMs
Patient care is TOP priority

Professionalism
Balance
Communicating with store pharmacists

Clearly define responsibilities
Benefits of remote pharmacist
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Importance of MTM services

Patients offered complete, undivided pharmacist attention
Accountability
Remembering the practice of pharmacy

Working together with prescribers
Developing meaningful relationships
Some of the follow up concerns and questions from the commission were regarding the Quality Assurance,
customer satisfaction, added value of this program. Is there any evidence on whether the response by
prescribers taking calls to resolve something is as good in the call center compared to dealing with a local
Safeway Pharmacy?
MOTION: Dan Rubin moved the commission ask for a report in one year to specifically address; impact
on dispensing pharmacists workload and feedback, evidence that this allows more time for pharmacist to
interact at the store level, accuracy of a QA process on errors during transfers, the percent of time and
volume spent on specific functions performed at the call center itself and whether that changes over time.
OPEN FORUM.
Grant Chester shared his concern regarding Schedule V Exempt Narcotics. He originally brought the
topic relating to the overreach of the PQAC in eliminating Schedule V Exempt Narcotics due to the
implementation of SSB 5416 in April 2014. At different PQAC meetings, hes received the following
responses from AAG Roper: He spoke with the DEA and it is a Schedule V. The commission has had
five months to discuss this topic and counsel has had the same amount of time to provide information.
Grant requested that PQAC publically repudiate their previous policy of not allowing pharmacies to sell
Schedule V Exempt Narcotics and to publish in the next newsletter an explanation of the pharmacist
and pharmacies' professional responsibility to sell these medications to the public as our laws and rules
require. Morning After Contraceptives and Schedule V Exempt Narcotics are treated the same under our
pharmacist professional and pharmacy responsibilities rules. Neither requires a prescription and both
had or have to be dispensed from a pharmacy.
Julie Akers, with Washington State University of College Pharmacy shared that with the Intern portion of
the rules writing that they would love to participate and get feedback so the students are provided quality
sites to earn their hours.
MOTION: Tim Lynch moved that Joyce review the information provided by Grant Chester and that this is
added as an agenda item at the next meeting for discussion, and approval or denial. Elizabeth Jensen
PRESENTATIONS
Confluence Health Remote Pharmacy Services
As lead on this presentation Lisa Roberts provided a quick overview and introduced Glenn Adams,
Corporate Director of Pharmacy, Confluence Health. Glen Adams introduced his team that attended to help
answer questions. Dr. Peter Rutherford, MD, CEO of Confluence Health, Rick Canning Executive VP of
Inpatient Services; Dr. Julie Smith, Physician Manager for Oncology add Infusion Service Line; Richard
Bennett, Senior VP for Quality & Compliance; Terry Clark, PharmD Pharmacy Manager for Confluence
Health. Glenn Adams and his team was here to ask the commission to approve the proposal for Central
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Washington Hospital to provide remote medication supervision and order entry for satellite infusions
center patients.
Background
Confluence Health in Eastern Washington currently owns two hospitals with licensed pharmacies.
One retail licensed pharmacy which performs previous PQAC approved telepharmacy to two
remote sites neither of which maintain pharmacy licenses; one home infusion licensed pharmacy;
and one infusion center licensed as a pharmacy.
Confluence owns fifteen physician clinics and two infusion centers that currently maintain no
pharmacy license..
November 8, 2012, PQAC granted Wenatchee Valley Hospital approval to perform

telepharmacy services to Moses Lake remote infusion center.
Moses Lake remote infusion center was not required to obtain a pharmacy license.
Parenteral compounding is performed by a pharmacy technician while remotely monitored by a
pharmacist at Wenatchee Valley Hospital.
Proposal
The current presentation and request is for Central Washington Infusion Center, a licensed
pharmacy owned and operated by Wenatchee, to be granted approval to perform remote
medication order processing and remote monitoring of a pharmacy technician compounding
parenteral products at Omak Infusion Center.
Omak Infusion Center does not currently hold a pharmacy license. The compounding at Omak
Infusion Center is currently performed by the nursing staff.
This is an outpatient infusion center that administers both chemotherapy and non-chemotherapy
medications.
The focus of this discussion will be regarding these two infusion centers with no pharmacy license
(Moses Lake and Omak). Please refer to the attached diagram for a visual distinction regarding
these facilities.
Policy
It is the policy of Wenatchee Valley Medical Center (WVMC) that the following procedures will
be followed when using automated dispensing cabinets (ADC) at Wenatchee Valley Hospital
(WVH) to ensure that all controlled substances that are stored in the Automated Dispensing Unit
(ADU) will be accounted for in a safe and controlled environment. The responsible pharmacist is
ultimately accountable for control of all medications stored in the ADCs at Wenatchee Valley
Medical Center.
The discussion on this proposal was focused around the legality of this location not being a licensed
pharmacy and allowing a technician to do work in a non-licensed pharmacy without an onsite pharmacist.
Unfortunately, the commission recognized that this proposal was initially approved and not consistent with
the rule. It is agreed that this is a great service but our laws and rules are out dated.
Joyce Roper was able to find an option to allow this as a conditional pilot project that allows for innovative
applications and utilizations for pharmacy technicians under WAC 246-901-100. First step will be to get
the locations licensed as pharmacies. This will require a submission of a Specialized Function Utilization
Plan.
MOTION: Nancy Hecox moved that if these two sites are licensed as pharmacies and they submit a
Specialized Function Utilization Plan by the next meeting the commission will allow for Central
Washington Hospital to continue to provide remote medication supervision and order entry for satellite
infusions center patients. Maureen Sparks second. MOTION CARRIED: 10-0
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This was a hot topic and a very serious discussion there will be a document / statement prepared by staff to
provide more details.
Central Admixture Pharmacy Services (CAPS) Central Fill Services

Christopher Humberson introduced Michael Wright, Director of Pharmacy for CAPS. CAPS asked the
commission for approval to provide centralized sterile compounded preparations services for Washington
licensed dispensing pharmacy.
Overview
Activities in the prescription filling process are performed by the central fill pharmacy (CAPS).
Order transmitted from customer via commission approved electronic transfer

Translation report is generated with any errors, allergies, incompatibilities or critical
warnings.
Fully traceable sterile compounding process with bar code capabilities (Pump and manual
adds)
Final RPh. Check

Bags are loaded in an insulated tote zip tied and sent back to the customer (pharmacy)
CAPS distributes prescriptions for patient dispensing by a licensed dispensing pharmacy

Central prescription filling of controlled substances requires compliance with the DEA regulations
allowing central fill pharmacies and retail pharmacies to fill prescriptions for controlled substances on
behalf of retail pharmacies specified in Federal Register Document 03-15912 (June 24, 2003).
The dispensing and central fill pharmacies must share common electronic files or have appropriate
technology to allow secure access to sufficient information necessary or required to dispense or process
the prescription
Information is shared through CAPSLINK or interface system as approved by BOP during

the April 2014 meeting
CAPS customers agree to perform the notification step as part of their normal admissions/pharmacy
service.
The prescription label of a centrally filled prescription must show the name and address of
both the dispensing pharmacy and the central fill pharmacy, except when there is common
ownership of the pharmacies.
All CAPS pharmacies admix in a laminar flow, ISO Class 5 zone, within an ISO Class 7 buffer zone.
Air testing for particulate and bioburden are performed weekly. Employee fingertip testing is
performed weekly. Media fill validation of compounding processes are performed semi-annually.
Clean down and line clearance is performed between every drug, every day. CAPS uses both
membrane filtration and rapid sterility testing technology as an end product test per USP<71>. Quality
Assurance reports are provided to our customers on a quarterly basis.
CAPS policy is to use FDA approved, commercially available, sterile drugs for admixing. In cases
where FDA approved sterile drug ingredients are not available, vendor qualification, including
regulatory compliance audits, are completed for any Active Pharmaceutical Ingredients (API) used in
non-sterile to sterile compounding.
All lots of API provided by qualified vendors are tested for chemical identification, impurities, heavy
metals, and endotoxin per current USP/NF standards prior to release for use in any CAPS facility.
CAPS high-risk non-sterile to sterile compounding process is validated every six months through a
media-fill validation in accordance with USP <797> and FDA Guidance.
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Each CAPS employee who participates in non-sterile to sterile compounding must complete a biannual media-fill validation.
Once the solutions are prepared from the raw materials, they are sterilized using a cold filtration
process in which they are passed through a 0.2m pharmaceutical grade sterilizing filter into the final
sterile container within an ISO Class 5 Laminar Airflow Work Station (LAFW).
All sterile solutions that are compounded from non-sterile components undergo validation testing
before a CAPS facility may use the solution.
All sterility and chemical testing procedures are validated and performed according to current
USP/NF standards.
These sterile filtered solutions are quarantined until quality assurance testing, including sterility
testing, is complete as required by CAPS Standard Operating Procedures and USP <797>.
MOTION: Al Linggi moved that the commission approve CAPS proposal to provide centralized sterile
compounded preparations services for Washington licensed dispensing pharmacies and the labels need to
be changed to say State and Federal prohibits transfer of medications to persons other than they were
prescribed. Dan Rubin second. MOTION CARRIED: 10-0
Valley General Hospital Remote Medication Order Processing

Lisa Roberts introduced Traci Mitchell, Pharmacy Services and Infection Control Manager for Valley
General Hospital. Traci presented the proposal for commission approval to utilize a Commission approved
vendor to provide continuous (24-hour a day) pharmacist services for remote order entry and verification.
Overview
To provide continuous pharmacy services, 24-hours a day, Valley General Hospital has entered into
a written contract with a Washington State Pharmacy Quality Assurance Commission approved
Remote Medication Inc. Processing Company.
The contract will be reviewed annually and may be terminated without cause by either party. The
Remote Medication Inc. Processing Company will provide pharmacists licensed in good standing
in the State of Washington who are approved to provide remote order verification and clinical
consultation.
All Remote Medication Inc. Processing pharmacists must comply with Federal and Washington
State laws and regulations.
Any out-of-state pharmacy providing Remote Medication Inc. Processing services must be
licensed as a non-resident pharmacy in the State of Washington.
The Remote Medication Inc. Processing Company will not dispense any medications and will be
responsible for the following:
Receiving, Interpreting, clarifying and remote processing of medication orders

Interpreting clinical data and making appropriate recommendations and
interventions
Performing Pharmacy & Therapeutics approved therapeutic interventions

Providing drug information and clinical information to nursing and medical staff
Providing prospective drug regimen review
Compliance with all federal and Washington State laws and regulations
Valley General Hospital will provide the Remote Medication Inc. Processing Company with secure
access to electronic patient records and the pharmacy system to allow for remote order processing.
Valley General Hospital will audit the Remote Medication Inc. Processing Companys individuals
remotely processing orders.
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The Remote Medication Inc. Processing Company will comply with all Valley General Hospital
policy and procedures including but not limited to: Pyxis policy, Valley General Hospitals
formulary, P&T Interchange program, renal dosing protocol, standard administration times and IV
concentrations.
The Remote Medication Inc. Processing Company will provide Valley General Hospital with:
A list of the name, address, telephone numbers and all license/registration numbers of
pharmacy and pharmacists involved in Valley General Hospitals remote order processing
Maintenance of appropriate records to identify the name(s), initials or identification code(s)

as well as specific activities of each pharmacist performing any medication order processing
Compliance with all federal and Washington State laws and regulations
Quality assurance tracking:
Adverse drug event tracking

Renal dose / therapeutic dose
Pharmacist clinical interventions
Volumes and timeliness of computerized order verification
Performance improvement based on feedback from Valley General Hospital
pharmacy, nursing and medical staff
Valley General Hospital has an electronic policy documentation system that records and sends
reminder emails as well as stores policy reviews and revision dates. This policy will be reviewed
and updated annually in accordance with Valley General Hospital policy guidelines.
MOTION: Dan Rubin moved that the commission approve proposal for Valley General Hospital to
utilize a vendor to provide continuous (24-hour a day) pharmacist services for remote order entry and
verification. Steve Anderson second. MOTION CARRIED: 10-0

Rulemaking Petition
Christopher Humberson provided background to the commission on WAC 246-879-010(10)(e)
definition/interpretation of for emergency medical reasons. What wholesale distributing does not
include. Lynn Wittwer, Clark County Medical Program Director, Sandra Smith-Poling, MD, Jefferson
County Medical Program Director, and Gordon Pomeroy, Fire Chief from East Jefferson Fire and Rescue
were present to answer questions and share their concerns regarding WAC 246-879-010(10)(e) and ask
for rulemaking to amend this WAC.
Background
Several EMS services in the state that were once part of hospital systems are now part of a county
ambulance district. Many of these services currently purchase through wholesalers. Those EMS
services that do not purchase through wholesalers, have been borrowing or exchanging
medications from the hospital pharmacy. This arrangement has not been legal within the
pharmacy wholesaling regulations currently established in Washington State.
Several EMS services were utilizing a DOH pilot program to carry TPA for patients because of
the cost ($5000.00 per dose). These services were also exchanging or borrowing other
medications from the hospital pharmacies and then once used, trading the used package for fresh
stock. These agreements seemingly were agreed upon by hospital administration and EMS
directors, perhaps without the pharmacy directors knowledge.
As the commission and Joyce Roper discussed this issue, they tried to come up with ways to help and
support EMS but they are not under PQAC jurisdiction to take action. Al Linggi provided suggestions on
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how they may be able to work around the WAC. The commission sympathizes with them and agreed this
is an unfortunate situation.
Sexual Misconduct Rules WAC 246-860-100
Marlee ONeill, AGG asked the commission for approval to start the CR101 to update the sexual
misconduct rule.
Department of Health is considering updating the sexual misconduct rule to establish clearer
standards of conduct for health care providers. The department's experience with investigating
and enforcing the current rule has raised the need to clarify what acts constitute sexual
misconduct by providers in health care professions under the Secretary of Health's authority listed
in RCW 18.130.040(2)(a). Updating the sexual misconduct rule will establish clearer standards of
conduct and will help the department be consistent in its enforcement activities to more fully
comply with RCW 18.130.062 and Executive Order 06-03.
MOTION: Dan Rubin moved that DOH proceed with the CR101 to update the sexual misconduct rule.
Nancy Hecox second. MOTION CARRIED: 10-0
Legislation Update Implementation and 2015 Proposals

Marlee ONeill asked the commission to vote to support the agencies request legislation regarding an
alternative to discipline for all healthcare providers under Chapter 18.130 RCW.
Background
In the 2013 legislative session, HB2139/SB 5980 was introduced by Washington State Medical
Association to allow the Medical Quality Assurance Commission to develop a pilot project for
allopathic physicians and physician assistants to enter an alternative to discipline. An alternative
to discipline would have included professional development plans. The legislature determined
this tool should not be limited to just physicians and physician assistants and should be provided
for all healthcare providers.
The pharmacy commission may close marginal cases for a variety of reasons. A STID with only
CE, results in the provider being reported to the NPDB, and this could cause removal from
insurance panels or prohibition to practice by another government agency. The alternative to
discipline is a tool for all disciplining authorities to use in cases that do not rise to the level of
warranting a statement of allegations or a statement of charges but where some remediation is
warranted to ensure the healthcare provider gets education that they need to not risk future harm
to patients.
MOTION: Tim Lynch moved that the commission support the agencies request legislation regarding an
alternative to discipline for all healthcare providers under Chapter 18.130 RCW. Steve Anderson second.
MOTION CARRIED: 10-0
Christopher Humberson gave the commission an update on legislation for 2015.
Review and increase of fee on pharmacy researchers is now being put forward to the John
Weisman for his signature and then to Governors office for approval.
Modest fee assessment to pharmacy assistance is following a similar path.

The expansion of pharmacy commission to have ultimate methods of discipline including fining
authority will also be going to John Weisman for signature and move forward to the Governors
office for approval.
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Electronic Transmission of Controlled Substance Rules

Peggy Crain updated the commission she went back re-drafted the language to use the CR102 exception
process and it will be brought forward to the commission Oct. 23, 2014 for approval on the language.
Changing the Renaming the Board to Commission
Doreen Beebe updated that originally staff was going to go with a CR 105 but there are some things that
needed to be changed so we will do a CR102 which should be a much quicker process.
Compounding Rules Committee Update
Christopher Humberson and Peggy Crain update the commission. They had hoped to have draft language
at this meeting for the commissions approval. The CriticalPoints offered to review the language so the
decision was made that there needed to be some clean up in the language so it is not ready for approval as
she had hoped. A draft will be sent out for comments Oct. 01, 2014 for 90 days. These will be brought
forward to the commission Oct. 23, 2014 for discussion.
Pharmacy Technology Rules Committee Update.
Al, Lisa Roberts and Peggy Crain had gathered telepharmacy / shared pharmacy WACs from 5 different
states that are on the forefront of telepharmacy. Just to see how they approached telepharmacy. Nothing
has been decided what so ever. They pulled information from 4 or 5 states regarding other technologies.
CR101 draft is complete and ready for review. Once it is reviewed than the process to get it filed will
begin.

Dan Rubin provided an update report to the commission members.
July 10, 2014 the full committee met following the commission meeting. The committee decided
to request public input on potential topics for consideration related to standards of
practice/operation for pharmacy businesses, to supplement the three topics already prioritized for
rule development: (1) Workload and staffing levels; (2) prescription transfer incentives and other
advertising/soliciting issues; and (3) appropriate time, space and privacy for clinical pharmacy
functions. This request for public input was formalized in an email the next day, with a comment
deadline of Friday, August 1, 2014. The committee agreed it should meet soon after the close of
comments and set a tentative date of August 7.
August 7, 2014 the full committee met telephonically from 8 to 9 am. About 20 written
comments were received by the August 1 deadline. The main agenda item was to review
comments on scope for the purpose of grouping issues into topical clusters, and to provide input
for DOH filing a CR101 form to initiate the official rule making process. Discussion did not
address substantive content of potential rule changes. Many comments supported the three predetermined topical areas (see (1), (2) and (3) in the summary of July 10 committee meeting
above); and the committee agreed these areas remain topic priorities. The committee agreed, that
two other clusters should be added based on comments: (4) accountability and contributory
responsibility of pharmacy businesses and (5) responsibilities for quality assurance and quality
improvement. A number of more specific issues mentioned in comments would fit within these
five categories. The committee acknowledged many issues cross-cut business practices and
technology; they asked that the chairs of the two committees (Dan Rubin and Al Linggi) work
together and with staff to keep work coordinated and make sure important topics do not fall off
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the plate. Finally, while issues related to ancillaries (including the technician ratio) might be more
appropriately considered in relation to a separate ancillaries committee and work process, the
committee wishes to reserve the possibility of addressing this area if it otherwise will be delayed
too long.
The committee also:
Agreed that DOH should proceed to file
a CR-101, with an opportunity for Dan Rubin
and Gary Harris to provide quick comment before a PQAC staff draft goes forward
within DOH.
Determined, based on staff
input, that DOH is unlikely to file a CR-101 until late
September.
Based on this timing, decided that the next committee meeting will be in early October,
when substantive discussion can occur in compliance with the Administrative
Procedures Act.
Agreed that the committees public process following the CR-101 should move cluster
by cluster with the three pre-designated topical areas prioritized first.
Agreed that the committees process should include opportunities for teleconference
participation as well as written and oral/telephonic input.
Agreed that comments received during the period for input on scope should also be
carried forward into the rule development phase, since many of these communications
also contain substantive comments on potential rule content which cannot be addressed
at this scoping stage of work. Likewise, some comments contain process suggestions,
which can be considered as pertinent as detailed procedures are developed.
Heard a brief staff report on the pharmacy professionals survey that
is underway. This
survey will be a source of information for rule development in more than one area.
Pharmacy Workplace Survey Update

Christopher Humberson shared that the survey closes September 19, 2014. There were over 16,000 sent
out and we have received 2,560 responses. Christopher Humberson read them all . We are working with
Neal Traven, an epidemiologist with PMP program and discussing how we are going to categorize the
comments and issues.
OTHER
Al Linggi and Marlee ONeill led this discussion asking the commission to consider adopting a process
for delegation of authority and criteria to approve or deny applicants based on standards identified in the
policy.
After minimal discussion this item was tabled for some changes and will be brought to the commission at
the October 23, 2014 meeting for further discussion or approval.
Designate Member to Represent Commission on ACPE Site Visit
Doreen Beebe asked the commission to designate or volunteer a commission member to attend the ACPE
Site Visit to represent the commission at the Washington State University by September 19, 2014.
Correspondence
CDTA Topics Paper written by Nancy Hecox

NACDS Comments Proposed Legislation
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OPEN FORUM
Ian Corbridge, WSHA is trying to get to the point to get some clarity around the HCE issue. He asked
that the commission an opportunity to put pause on enforcement in requiring a HCE License.
Jeff Rochon, WSPA shares the same concerns regarding the HCE issue and believes that clarity is
necessary.
There is a growing concern about these small clinics popping up such as Zoom Care there is no
oversight of these clinics and this really needs to be resolved.
Jeff asked the commission to prepare some sort of communication with regards to Take back
Programs in light of the DEAs announcement.
Christopher Humberson shared that Hydrocodone has been re classified to a CS2 there will be some
communication sent out in the October Newsletter.

Respectfully Submitted
by:

Christopher Barry,
Chair
Washington State Pharmacy
Quality Assurance Commission
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STATE OF WASHINGTON
Meeting Minutes
September 16- 17, 2010
Blackriver Training & Conference Center
800 Oakesdale Avenue SW
Renton, WA 98057
CONVENE
Chair Gary Harris called the meeting to order at 9:04 a.m., September 16, 2010.
Dan Connolly, RPh
Guest / Presenters:
Tim Lynch, Pharm D., MS, Regional Director of
Pharmaceutical Services Franciscan Health System
Andre Rossi, Pharm.D.,RPh, Dept. of Corrections
Mr. John Worthington
Sepideh Soleimanpour, Pharm. D., RPh, Walgreens
Dr. Giannantonio Giuliani, Inchelium Clinic
David Rose, R.Ph, Pharmacy Director

Melissa Burke-Cain, AAG
CONSENT AGENDA
1.1
New Pharmaceutical Firms - June 3- Aug 26, 2010
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1.2
Closed Pharmaceutical Firms June 1- Aug 26, 2010

1.3
Cardinal Health
Capital Medical Center Pharmacy
Costless Senior Services
Hoagland Pharmacy
Kelly-Ross LT Care Pharmacy
Medication Review Inc
1.5
North Valley Hospital Pharmacy

Board Minute Approval. (June 17, 2009)
agenda. Item 1.4 has been deleted from the agenda.
MOTION: Dan Connolly moved that the board approve items 1. 1, 1.2, 1.3 and 1.5. Vandana
Slatter second. Al Linggi recused himself. MOTION CARRIED: 4-0.
Rules Hearing
The proposed rule amends WAC 246-863-035 Temporary Permit Pharmacist. The proposed
amendments will allow for temporary practice permits to be issued to applicants applying for a
Washington Pharmacist license through the license transfer process. Applicants must meet all
requirements for licensure, but are in the process of completing a fingerprint-based national
background check. The proposed rule was filed with the Code Revisers office on July 16, 2010.
Notice was published in the Washington State Registry as WSR # 10-15-067.
Gary Harris asked the public if anyone would like to speak. There were no comments. Doreen
Beebe provided some background on this rule. After the background the floor was opened up for
questions from the board. Doreen shared the comments that she had received.
MOTION: Dan Connolly moved that the board adopt WAC 246-863-035 as proposed. The
proposed amendments will allow for temporary practice permits to be issued to applicants
applying for a Washington Pharmacist license through the license transfer process. Al Linggi
REPORTS
Board Member
She attended the Spokane Pharmacy Association board meeting. They will be holding
their annual banquet October 12, 2010. Rebecca is helping the Spokane Pharmacy
Association with this banquet. She suggested the Board of Pharmacy should put a display
out at the banquet.
Spokane Pharmacy Association s memberships have grown this year.
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Al Linggi reported:
Al will be attending the NABP District Meeting September 28-30, 2010 representing
Washington State in Albuquerque, New Mexico.
He has been selected to attend the Practice of Pharmacy Management Initiative (PPMI)
conference held by American Society of Health-System Pharmacists (ASHP).
He has had conversations with two of our
regarding Access to Medication.
senators one from each major political
party
Attended a meeting with the Non-Cancer Pain Opioid Group with Susan Teil Boyer and
Tim Fuller. The put on a short presentation for the group.
Gary also attended two meetings with the Attorney Generals Task Force. These
meetings are for finding funding for the state Prescription Monitoring Program (PMP) .
Executive Director
Pain Management Workgroup: Five prescribing boards and commissions are developing
rules for safe and effective pain management therapy for chronic non cancer pain
patients. The workgroup is setting a dose threshold (MED) for a required pain consult.
The board of pharmacy has been an active participant and has submitted rule language
content to require communication with the pharmacist when prescribing high dose opiate
therapy. Gary, Tim and I presented recommendations to the Workgroup to include the
medication indication on the prescription when prescribing high dose opiate therapy.
Presentation to Medical Commission July 15: We made a presentation to the Medical
Commission regarding Pain Management and the Prescription Monitoring Program. We
spoke to the importance of communication with the pharmacist who dispenses the high
dose opiate to the patient .
Access to Medications Rulemaking: The board of pharmacy voted to open rulemaking to
consider additions and improvements to the current pharmacy and pharmacist
responsibility rules to increase access to all medications for all patients. The board has
scheduled two stakeholder meetings September 17 at the Black River Conference Center
in Renton and September 29 at the Kent CenterPoint to gather feedback from the public.
The 2010 Legislature passed a bill to require implementation of board of pharmacy rules
and statewide electronic tracking of retail sales of pseudoephedrine, ephedrine and
phenylpropanolamine (PSE) products. These efforts will support law enforcement as it
increases its interventions with smurfing, the term for multiple purchases of these
products at pharmacies and retail stores. A stakeholder workshop was held August 26,
2010 at the department of health with excellent feedback from the public and interested
parties.
Coordinating with DEA for their National Drug Take Back Day Sept. 25
o We met with DEA and offered to support their National Drug Take Back Day.
Two of our pharmacist investigators will be on the ground assisting with this
effort on September 25.
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NABP District 6,7,8 2011 Seattle: We are beginning the planning for the NABP/AACP
Meeting to be held October 4,5,6, 2011 at the Edgewater Hotel, Seattle. Mark your
calendars!
Hospital Pharmacy Directors Stakeholder Meeting: Pharmacy board staff met with the
WSPA Hospital Pharmacy Directors planning group to prepare for the September 24,
2010 stakeholder meeting in Yakima.
Board/Commission Leadership Meeting: Gary and Al will be attending the October 4
board/commission meeting held in Kent and Tumwater with video link. Updates from
Karen Jensen on reshaping government and from Secretary Mary Selecky including
budget and legislative updates.
NABP item reviewer for Washington State MPJE (Multistate Jurisprudence Exam): We
reviewed 1200 exam questions as a member of a board of pharmacy team including Dick
Morrison and Greg Lang.
TRPP Update: Lessons learned from the implementation of tamper resistant prescription
paper include:
o Need for funding to implement a widespread change for all prescribers and
pharmacists.
o Rules with detailed requirements .
On August 30, 2010 the third DOH Chronic Pain Treatment Workgroup meeting was
held at the Black River Conference Center in Renton. The Workgroup is moving quickly
in the development of rules. Much of the discussion focused on setting a threshold for
patient referral and what is the credentialing for a pain specialist. There are a great many
chronic pain patients and few established pain specialists.
Susan Boyer, Gary Harris, and Tim presented to the Workgroup, The Pharmacy
Connection. The presentation emphasized the patient contact between chronic pain
patients and pharmacists. The pharmacists see patients on very high doses of opiates, but
do not have the medication indication or pla n for the patients treatment. We
recommended that the pharmacist be provided the indication by the prescriber writing on
the prescription chronic, non cancer pain.

Implementation of ePrescribing, electronic health records, and health information
exchanges offer a tremendous opportunity for an increased flow of patient information.
With electronic communication prescribers could obtain medication compliance
information and other medications that a patient is using. And pharmacists could access
the patient treatment plan with minimal effort.
He represented the board at a follow-up meeting with Seattle King County Public Health
(SKCPH) sponsored by the NW Center for Public Health Practice. SKCPH has an
Advanced Practice Center which is working on establishing CDTAs and MOUs with
community pharmacies for emergency response. It was a very productive meeting and
people want to keep up the momentum. The meeting was at the beautiful, new WSPA
offices.
Tim has been dealing with the growing pains of moving from paper to electronic
prescriptions. Pharmacists have difficulty determining electronic prescribers signatures.
Clinics are unsure about prescriber manual signatures and sending controlled substance
prescriptions electronically. This is the background for a major confrontation between
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HMA Inc clinics in Yakima and the pharmacies that fill their prescriptions. It was all
related to the transition to electronic prescriptions and unfortunate terminology. The
conflict is resolved by getting HMA Inc corporate management to change wording on
their prescriptions and by keeping the pharmacies in the communication loop.
Susan and Tim met with Irene Owens, Office Chief, Residential Care Services and her
colleagues to further pursue medication issues in boarding homes and adult family
homes. Irene had worked with two association representatives to develop a list of
questions. The questions require a response from the DEA rather than the BOP. Irene also
shared some DSHS rules.
Pharmacy Technician Training Programs . Cathy is working on creating a reference guide
on developing technician training programs by specific type (eg, OJT, academic/voc tech,
online). This would include a section on Washington state law review. Identify and
incorporate external resources for content development. Identify options for the
provision of the WA law review to applicants, particularly those from other states.
Ancillary Personnel Utilization Plans . Cathy is developing a reference guide tailored to
specific practice sites, eg, retail, hospital, etc. Create awareness of the importance of
these plans as living documents that can be used for employee orientation and ongoing
staff development .
Chief Investigator
We had 14 applications for the investigator positions. 11 of the applicants were
interviewed by a 3 person panel [William Dean (Investigative Service Unit Supervisor),
Karl Hoehn (Legal Service Unit, Supervising Staff Attorney), and Susan Boyer
(Executive Director, Board of Pharmacy)] with me as an alternate). Several of the
applicants applied for both positions. 10 applicants expressed an interest in a full time
position and 9 expressed an interest in the part-time position. The top 2 candidates for
each position in a very competitive field were selected, background checks were done
and at least 3 references were checked. In each instance the top candidate for each
position accepted. Tina Lacey accepted the full time position for SW Washington and
Pamela Sanders accepted the part time position for the Olympic peninsula.
PRESENTATIONS
St. Francis Hospital Remote Order Entry
The board heard a proposal from Tim Lynch the Regional Director of Pharmaceutical Services
for St. Francis Hospital in Tacoma. He would like to provide remote order entry services to
Enumclaw Regional Hospital (ERH).
Overview:
Provide after hours support for ERH
Pharmacist review of orders (PYXIS Connect)
Pharmacist order entry for ERH
o Limit access to PYXIS after order verification
o Exceptions per regional medication override list
Override list approved by FHS PT&T
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Annual review
Multidisciplinary review
Generation of labels for mixing IV products per FHS standards
Pharmacist medication information support remotely when ERH pharmacy is closed

Order Processing
o SFH pharmacist will:
Receive, interpret, clarify orders
Perform drug regimen review
Interpret clinical data
Perform therapeutic interventions
Provide drug information .
Ownership
o ERH and SFH are both owned and operated by the Franciscan Health System
Policies
o All FHS facilities use common policy and procedures
Clinical Standards
Medication Ordering and Prescribing
Medication Administration
PYXIS
Pharmacy Policy and Procedures
All policies posted on intranet that is available on all computers in each
facilities
FHS wide formulary
Pharmacists
o All employees of FHS
o All part of regional pharmacy department
o Management reports to common Director of Pharmacy
o All pharmacists licensed in Washington
Quality Assurance
o MAR Discrepancy Analysis
o IRIS Review
o Regional Medication Safety Leadership Team
o Pharmacy Operations Manager Committee
o Excellence Every Day Rounding
o BOP Inspection
Stan Jepson, BOP inspector for both SFH and ERH
MOTION: Dan Connolly moved that the board approve the proposal from St. Francis Hospital.
St. Francis Hospital in Tacoma to provide remote order entry services to Enumclaw Regional
Hospital. Rebecca Hille second. MOTION CARRIED: 5-0.
Franciscan Health System - Automated Drug Distribution Devise (ADDD) Used for Anesthesia
Trays in Operating Room.
The board was asked to consider a proposal by Franciscan Health System to allow certified
anesthesia techs to access ADDD in the OR to obtain clean anesthesia trays and used trays after a
procedure.
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Situation:
OR/PACU Support
o Anesthesia Trays
Filled by Pharmacy Technician
Clean trays placed in PYXIS Tower for removal by RN
Used trays returned to tower for restocking by pharmacy technician or RN
Tower provides limited access to medications
Tower provides enhanced medication security and tracking of user access
PYXIS Tower:
Access granted by pharmacy
Access limited by user account
o Access to specific sections of PYXIS
o Access to specific medications
Activities monitored
Date/Time tracking of user activity
Proposal:
Grant anesthesia technicians limited PYXIS access to tower only
Anesthesia technicians will remove stocked trays from tower
Anesthesia technicians will return used trays to tower
o Pharmacy technician or RN will restock trays
Advantages:
Medication Security
o Storage in PYXIS allows for secured storage
o Tracking of user activity
o Limits access to only those authorized
o Ensures medication storage and dating in compliance with BOP requirements
Avoids problems of Anesthesia Work Room
o Outdating
o Access control
o hoarding
Pharmacy control of tray stocking
Anesthesia Tech Access to only medications they are authorized to handle.
MOTION: Christopher Barry moved that the board table the proposal from St. Francis Hospital
to allow certified anesthesia techs to access ADDD in the OR to obtain clean anesthesia trays and
used trays after a procedure. The board would like more information and clarification along with
who the responsible individuals are. Al Linggi second. MOTION CARRIED: 5-0.
Department of Corrections
The board was asked to consider a proposal by Department Of Corrections to establish Health
Care Entities at Clallam Bay, Coyote Ridge, and Stafford Creek correctional facilities for use by
their clinical staff. Grant Chester introduced Andre Rossi, head pharmacist with Department of
Corrections.
Background:
Due to budget constraints DOC has removed their pharmacies from Stafford Creek and
Clallam Bay. Coyote Ridge has not had a pharmacy.
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A Health Care Entity (HCE) license would allow multiple practitioners at the facilities to
have a common supply of legend drugs and controlled substances in accordance with
approved policy and procedures.
It would also allow them to administer and dispense drugs from this supply during the
hours the HCE is staffed with a health care practitioner authorized to prescribe and
dispense.
After hours the HCE would have to be secured along with its drug stock.
These DOC facilities are not otherwise licensed by the state and while not required to be
licensed by WAC or RCW are voluntarily requesting licensing as a HCE.
MOTION: Christopher Barry recommends that the board drafts a letter to DOC in support of
automation. Vandana Slatter moved that the board approve the proposal by Department Of
Correct to establish Health Care Entities at Clallam Bay, Coyote Ridge, and Stafford Creek
correctional facilities for use by their clinical staff with the recommendation that a prescriber
must be on site. Al Linggi second. Dan Connolly opposed. MOTION CARRIED: 4-1.
Bartell Drugs Household Pharmaceutical Waste Take-Back Program
Bartell Drugs is requesting approval of changes to its Pharmaceutical Take-Back Program
protocol.
Bartell Drugs Protocol Background:

The Bartell Drugs existing protocol follows the protocols approved by the Board for the
PH:ARM pilot where waste drugs are prescreened by the pharmacy personnel for
inclusion and collected in a secure container system.
Prescreening of material to be collected has been shown to prevent the collection of
prohibited material. The Bartell program will continue to prescreen all material.
Controlled substances will continue to be excluded from collection.
Changes to the Existing Program Requested:

Bartell Drugs is requesting permission to collect screened drug material without the
prescription vial for solid pills and capsules, at the Bartell Drugs Pharmacy #67
Pharmacy on Queen Anne Avenue in Seattle. Drug material would screened by the
pharmacy personnel, and the patient or the holder of the material would then be asked to
pour the contents of the container into the secure collection container.
o The collection contain will be appropriately labeled to meet U.S . DOT shipping
requirements, and securely sealed for avoid any spillage.
Reasons for the requested changes:

This allows for the testing of the modified protocol, and procedures, to thus allow for
the collection of a greater volume of drug material in a smaller volume, when the
prescription vial is not included.
Allows for less frequent container change-outs, as a larger volume of drug material
can be collected in a single collection container.
Allows for the future recycling of prescription vial containers.
Bartell Drugs requests the addition of eight (8) additional Snohomish County
Pharmacy locations.
MOTION: Rebecca Hille moved the board accept the changes made to Bartell Drugs
Pharmaceutical Take-Back Program protocol. Vandana Slatter second. MOTION CARRIED:
5-0.
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Rule Making Petition Marijuana Scheduling

On July 6, 2010, the board received a petition filed by Mr. John Worthington requesting the
board to remove marijuana from schedule I of the Washington State Controlled Substance Act
chapter 69.50 RCW (WAC 246-887-100) and place it into schedule II. John Worthington is
asking the board to consider rule making to reschedule marijuana.
MOTION: Rebecca Hille moved the board does not find rule making necessary to move
marijuana to Schedule II under subsection (b) of RCW 69.50.30203. Melissa Burke-Cain will
draft an order on the decision made by the board. Al Linggi second. MOTION CARRIED: 5-0.
EXECUTIVE SESSION
CASE PRESENTATION
PRESENTATIONS contd
Walgreens Pharmacy Technician Training Program
The board heard a proposal by Walgreens for multistate/national board approval of its pharmacy
technician training program. Cathy Williams and Sepideh Soleimanpour, RPh for Walgreens
shared some background to the board on the Walgreen s technician training program.
Overview:
Phase One
o Cashiering/ Phones
o Customer Service
o Prescription Pick-Up
o Filling Prescriptions
o Prescription Drop-Off/ Prescription Entry
o System Navigation
Phase Two
o Third Party
Fax/Calls
Contacting Providers to resolve patient insurance issues
Resolve update third party rejects
Handle prescription covered by Workers Compensation

Prescription Processing
o Prescription Processing
o Inventory
o Goal is to stream line technicians coming
o Two phases
o Hands on training
from other states.
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Requirements:
600 hours at tech-in-training status

Complete 5 tech-in-training classes
Complete 4 self test and pass the online PTCB pre-test
High school diploma or equivalent
Complete 4 hours of HIV/AIDS training
Complete 8 hours Washington State Law study
View laminar airflow module via WAGPC
Complete communication in pharmacy letter
Complete Phase 1 & 2 of ASHP training plan
Complete Cultural Competency lecture
MOTION: Dan Connolly moved that the board approve Walgreens multistate/national board
pharmacy technician training program. Rebecca Hille second. MOTION CARRIED: 5-0.
Inchelium Clinic Pharmacy

The board was asked to consider a proposal by Inchelium Clinic Pharmacy to provide
telepharmacy services to Keller Clinic on the Colville Reservation.
Overview:
LRCHC consists of two tribal community health centers located in the rural communities
of Inchelium and Keller on the Colville Reservation.
The closest pharmacy to the Keller Clinic is in Nespelem which is 40 miles away and
only serves tribal beneficiaries. A few other pharmacies are located 25 miles away and
further.
The Lake Roosevelt Community Health Center (LRCHC) in Inchelium has a pharmacy
with all the necessary personnel and equipment to support a telepharmacy at the distant
San Poil Valley Community Health Center.
Kellar clinic has a small, secure pharmacy with keypad entry and a safe designated for
pharmacy use.
Adequate computer and ancillary equipment has been purchased for both clinics.
Indian Health Services (HIS) Resource and Patient Management System (RPMS)
pharmacy package would be utilized in lieu of alternate pharmacy.
The pharmacy in Inchelium will provide prepackaged medications, will review, enter,
and store all the prescriptions, prepare the labels for the prescriptions, and consult with
the qualified personnel and counsel the patients at Keller.
The pharmacist in Inchelium maintains control of secure access, the medication
inventory, and will audit the activities of individual users.
MOTION: Rebecca Hille moved to approve Inchelium Clinic Pharmacy to provide

telepharmacy services to Keller Clinic on the Colville Indian Reservation. Dan Connolly second.
HealthPoint
Central Refill Services
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The board will consider a proposal for a Refill Center at the HealthPoint Kent Pharmacy to
process only refills for both of the pharmacies and five telepharmacy sites.
Procedure:
HealthPoint pharmacy patients will request refill dispensing using: in person,
TeleManager IVR system, faxed requests from Auburn pharmacy, SeaTac, Federal Way,
Renton, Redmond, or Bothell tele-pharmacies, and message recorder.
Refill requests will be placed in colored bins denoting the pharmacy or telepharmacy they
are to be delivered to.
Refill Center technician will log into pharmacy or telepharmacy site FSI terminal id and
process the refill request.
Refill Center technician will print refill request prescription label onto refill center
printer.
If medication has no refill authorizations left, medication information will be tasked to
refill protocol pharmacist for refill authorization per approved protocol guidelines.
Prescription label will denote which pharmacy or telepharmacy site the medication is to
be delivered to and noting the refill was dispensed from the refill center.
Pharmacist will approve final dispensed refill medication, place medication in delivery
bag, write on refill receipt where med is to be delivered, staple receipt on outside of bag
and place auxiliary label on delivery receipt log. Place finished refilled medication in
proper site bin for delivery.
Pharmacy courier will verify each refilled medication bag with those prescriptions noted
on delivery log and have pharmacist approve final list.
Medications will be delivered to various pharmacy sites; the site technician will sign and
verify all medication on delivery log is accounted for. Any discrepancies will be reported
to Kent pharmacy and resolved prior to courier leaving pharmacy site. Signed delivery
log is faxed to Kent pharmacy to compare with pharmacy End of Day reports by
pharmacist.
Patient will pick up refilled prescription at noted pharmacy site.
MOTION: Al Linggi moved the board accept the proposal from HealthPoint for a Refill Center
at the Kent Pharmacy to process only refills for both of the pharmacies and five telepharmacy
sites as outlined, under one licensure for legend drugs only. Rebecca Hille second. Dan Connolly
opposed. MOTION CARRIED: 4-1.
SECOND MOTION: Al Linggi moved that the board create specific requirements for a dual
licensure for Refill Centers in the future based upon certain criteria. Al Linggi will work with
Cathy Williams on developing specific criteria. Dan Connolly second. MOTION CARRIED: 5-
0.
DISCUSSION
Performance Measures
The board reviewed pharmacy programs performance in relation to established parameters or
targets on discipline cases, credentialing and other key functions. Shannon Beigert and Diane
Young from Department of Health Customer Service Office shared graphs and explanations of
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credentialing performance. They answered questions and concerns from the board and the
audience. WSPA represented by Jeff Rochon shared concerns with the 128 day average to
license pharmacists. Jeff Rochon, Al Linggi and Shannon Beigert will work with the schools to
help get the students get credentialed more timely.
Signature Delegation
The board was asked to consider amending its delegation of signature authority to accept the new
format which uses delegates to specific Board and Department of Health staff by title.
MOTION: Dan Connolly moved that the board accept the new format for delegating authority
which uses delegates for specific Department of Health Staff by title for. Rebecca Hille second.
Proposed Rules Amending WAC 246-870-060

The board considered comments and adoption of rule amendments to WAC 246-870-060. The
rule change requires the prescriber to manually sign a hardcopy prescription generated from an
electronic prescription system .
MOTION: Dan Connolly moved that the prescriber must manually sign a hardcopy prescription
generated from an electronic prescription system amending WAC 246-870-060. Christopher
Operating Agreement
The board continued the discussion of the draft Operating Agreement and addendum with the
Department of Health. Susan Teil Boyer and Melissa Burke-Cain led this discussion. They
reviewed and discussed the addendum by each section.
MOTION: Rebecca Hille moved the board accept the Operating Agreement with addendum and
that the board strived to have face to face meetings with leaders of Department of Health. Al
Linggi second. MOTION CARRIED: 5-0.
Compliance Closure Codes for the Integrated Licensing and Regulatory System (ILRS )
The board heard information from Fred Garcia from the Department of Health Compliance on
new closure codes for disciplinary compliance files. This was a pilot project used to be more
consistent on closures of compliance files. The findings made closing files more efficient.
MOTION: Dan Connolly moved that the board accept the closure codes that compliance has
been using as a pilot. Al Linggi second. MOTION CARRIED: 5-0.
Service Awards
Gary Harris announced and recognized Pharmacists who have been licensed in Washington for
50 years.
Rules Update
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Board staff and the board discussed/reviewed the proposed rulemaking workload. Dan Connolly
was made board champion for the Electronic tracking of pseudoephedrine, ephedrine,
phenylpropanolamine rules.
Correspondence
Stakeholder Comments
Stakeholder Comment
WRAPP
Article
Access to Medication Rules

ACLU ESSHB2961
Quarterly WRAPP-UP
Express Prescriptions
SUPPORT BULLETIN Electronic Prescribing of Controlled Substances

Letter to Senator Keiser
NABP e-News
NABP Memo Notice Related to Dispensing of Controlled Substances to
Residents at Long-Term Care Facilities
NABP Memo - APhA Awards and Honors Program
ISMP
Medication Safety Alert - June 2010

ISMP Medication Safety Alert July 29, 2010
ISMP Medication Safety Alert August 12, 2010
ISMP Medication Safety Alert August 26, 2010
ISMP Medication Safety Alert August 2010
OPEN FORUM
There was no discussion in the Open Forum.
Panel DISCUSSION
A selected panel of the board was asked to consider the following entities request for
recognition as an educational organization permitting them to receive contact lists of credential
holders. An education organization is an accredited or approved institution or entity, which either
prepares professionals for initial licensure or provides continuing education .
MOTION: Dan Connolly moved that the board accept Medenet s request for recognition as an
educational organization permitting them to receive contact lists of credential holders. This is
accepted only for continuing education not for recruitment. Christopher Barry second. MOTION
CARRIED: 2-0.
MOTION: Dan Connol ly moved that the board accept Group 4 Quality Cares request for
recognition as an educational organization permitting them to receive contact lists of credential
holders. This is accepted only for continuing education not for recruitment. Christopher Barry
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CLOSED SESSION
Case presentations
Disciplinary Hearing _--- __________ September 17, 2010_8:00 a.m.
20435 72nd Ave S, Conference Rm 1
Kent WA 98032
Cancelled
C. L. Peckerman -- Reinstatement Hearing
Access to Medications _--- Rules Workshop__

Blackriver Training & Conference Center
800 Oakesdale Avenue SW
Renton, WA 98057
_____ September 17, 2010_1:00 p.m.
_______________________________
Approved on November 4, 2010
_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON
Amended MEETING MINUTES
September 27, 2012
310 Israel Rd SE
Tumwater WA 98501
CONVENE
Chair Christopher Barry called the meeting to order at 9:06 a.m., September 27, 2012
Board Members:
Guest / Presenters:
Gary Harris, RPh,
David Rose, Pharmacy Director for PharMerica
Shawn Moore, Attorney for PharMerica
Bill Fasset, Professor of Pharmacy and Ethics of
of Washington State University
Wendy LaRocque, from the City of Ferndale
Mindy Collins, manages the City of Bellingham
Take Back Program
Rick Johnson, Executive Director of DVM and the
Cowlitz County Humane Society
Staff Member:
Joyce Roper, AAG
Introduction: Executive Director Chris Humberson
Chris Humberson was appointed for the position of Pharmacy Executive Director that took effect
September 4, 2012. Chris has over 30 yrs retail pharmacy experience and management experience. In
addition he has several years experience in pharmaceutical sales and marketing in both hospitals and
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retailing settings. Mr. Humberson is originally from Wyoming. He graduated from the University Of
Wyoming School Of Pharmacy in 1982 with a Bachelor of Science degree. He and his wife Kelly
currently call Issaquah their home. Chris enjoys history, fine arts and music and sports.
CONSENT AGENDA
Business Meeting Agenda Approval September 27, 2012
August 16, 2012
1.1
1.2
1.3
1.9
1.7 and 1.8 were deleted from the agenda.
MOTION: Donna Feild moved that the board approve items 1.1, 1.2, 1.3 and 1.9. Elizabeth
REPORTS
Board Member
Dan Rubin reported:
He has been using personal knowledge of the philanthropy world to work on finding leads for
Prescription Monitoring Program (PMP) funding. He finds it hard to believe that the program
wont to be supported long term.

He attended the National Association of Boards of Pharmacy (NABP) Interactive Forum

September 19-20, 2012.
There was talk about the future of pharmacy regulation. It seems Washington Board of
Pharmacy is ahead as far as pharmacy technician education and continuing education.
There was discussion regarding regulations to decrease diversion and patient safety. PMP
plays a big role in this and was major part of this discussion.
Drug shortages, some states are looking at ways to extend the out date of some products
and how to use single does vials more effectively. A big piece of this discussion was
secondary versus gray market pharmacies and pharmacies selling to the gray market.
Christopher Barry did notice that there is almost no one from the west coast on the NABP
he believes the west coast should be more represented.
Executive Director
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Chris has been working on the rules re write to help and support Kitty Slater and has made
contact with Idaho Board of Pharmacy to get some input on their process of re writing the rules.
Getting up to speed on credentialing
He has reached out to Oregon and Idaho bop to contact their Executive Directors
Chris is learning where program is regarding projects
He will be attending the NABP Annual District Meeting in Little Rock, Arkansas.

There is a case involving the North Carolina Dental Board and the FTC, which might have
some implications for regulating unlicensed practice of professions. The AGs office has been
monitoring it and advising the other boards and commissions presently considering some
activity that could be implicated by the federal court decision in the North Carolina case.
Fortunately, this boards current priorities and activities are not implicated by that case. We
will continue to monitor the North Carolina case and advise the boards and commissions if
their activities may be affected by that case.
A To-Quyen an extern from Washington University will be coming next week.
Chief Investigator
There continues to be some confusion in pharmacies since the Drug Enforcement

Administration (DEA) published their new regulation allowing multiple prescriptions for
schedule II controlled substances in 2007. (21CFR1306.12(a)) In summary an individual
practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a
90 day supply of a schedule II controlled substance providing the following conditions are met:
Each separate prescription* is issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional practice;
The individual practitioner provides written instructions on each prescription
(other than the first prescription, if the prescribing practitioner intends for that
prescription to be filled immediately) indicating the earliest date on which a
pharmacy may fill each prescription;
The individual practitioner concludes that providing the patient with multiple
prescriptions in this manner does not create an undue risk of diversion or abuse;
The issuance of multiple prescriptions as described in this section is permissible
under the applicable state laws; and
The individual practitioner complies fully with all other applicable requirements
under the Act and these regulations as well as any additional requirements under
state law.
To clarify each separate prescription must be on a separate prescription blank.
While not encouraged by the DEA multiple controlled substance prescriptions may be
written on the same prescription blank only if they are all to be filled at the same time.
The most common example is a discharge prescription from a hospital.
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DISCUSSIONS
EZ Mar Electronic Prescription Transmission System
The board reviewed the proposal by PharMerica for approval of the EZ Mar system for the electronic
communication of prescription information from the long-term care facility to the pharmacy. Note, the
boards approval was reconsidered at the April meeting and postponed further discussion / decision for
a future meeting.
Background:
A pharmacist investigator inspected the PharMerica pharmacy and found they were using an
unapproved electronic prescription system initially called Paperless and now called EZ
MAR. Inspection of the applications found nurses performing order entry and the
pharmacy did not receive a copy of the original order. This was the case in a small hospital
and in two nursing homes. The small hospital operation was in violation of WAC 246-873080(5) which requires that the pharmacist to review a direct copy of the order.
The EZ MAR system is now based upon nurse order entry in one nursing home. The
pharmacy receives the electronic prescription, prints it and re-enters in to the AS400
pharmacy computer system. Procedures call for monthly Physician Order Entry sheets to
be signed by the nurse and then by the pharmacists. This was not done consistently.
Neither prescribers nor pharmacists enter medication orders into EZ MAR.
We determined that the EZ MAR system is a Medication Administration system and

PharMerica representatives agreed. Without the direct involvement of the prescriber or
the pharmacist, the EZ MAR system does not meet the definition of a system for
transmitting electronically communicated prescription information as defined in
RCW69.41.055. I t facilitates the nurses with medication administration.
PharMerica says they have adequate auditing processes to determine diversion and that the
pharmacist checks with the prescriber on all controlled substance prescriptions and some
legend drug prescriptions as well. The prescriber and the pharmacist consultant only review
orders every 30 days. PharMerica h a s b e e n a s k e d to provide the board with some
statistics on the pharmacist verification of legend drug prescriptions.asy to divert
medications with EZ MAR for a considerable length of time since.
This has been recognized that it is not an electronic prescription transmission system. The board
will not need to take action at this point .
Automated Drug Distribution Device Approval Revisited.

Tim Fuller led the discussion to the board asking them to evaluate each programs compliance with
rule (Chapter 246-872 WAC). These are revised policies and procedures for the use of automated drug
distribution devices discussed at the August meeting.
a) Franciscan Hospice and Palliative Care
MOTION: Gary Harris moved that the board approve the revised policy and procedure stating that
a patient will be removed from the system within 12 hours of being discharged or deceased.
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b) Skagit Valley Hospital: Mt Vernon and Arlington
MOTION: Gary Harris moved that the board will approve the ADDD if a change is made to the
policy and procedures to state pharmacy personnel shall do the stocking. Elizabeth Jensen
seconded. Dan Rubin abstained. MOTION CARRIED: 6-1.
c) Walla Walla General Hospital
MOTION: Donna Feild moved that the board approve this ADDD if they add a piece to the policy
and procedure. The board requires them to add a list of comprised medications that a delay in
administration can potentially cause harm to a patient. Elizabeth Jensen seconded. MOTION
CARRIED: 7-0.
d) Mason General Hospital
MOTION: Elizabeth Jensen moved to approve Mason General Hospitals

ADDD.

The board was asked to consider a request from Ann Langer, DVM and the Cowlitz County Humane
Society for approval of its euthanasia training program.
Course Outline:
Training shall consist of two parts; lecture and practical training.

It will be taught by a licensed and experienced veterinarian, Ann Langer, DVM.
There will be a minimum of 2 two hour lectures with demonstration and hands on practice of
techniques. If the materials cannot be covered sufficiently in the allotted four hours, additional
time will be scheduled.
Trainees will be required to have read The Humane Society of the United States Euthanasia
Training Manual by Rebecca H. Rhoads, DVM and the American Humane Association
Euthanasia by Injection Training Guild prior to the lecture series. These manuals shall be
the basis for the training.
The details in these references shall be the basis for the training lecture and the details within
these manuals and their pictures will be referred to directly during the lecture. Reference pages
are noted on the outline.
After completion of the training program, the student must pass a written test with a passing
score of 75% or greater and pass a practical test consisting of euthanasia of a dog and a cat.
The student will explain the complete process step-by-step while performing the procedure.
Verbalized questions will focus on safety issues and what will be done if something goes
wrong. After training is completed, a
certificate will be awarded: Certificate of Successful

Completion of Washington State Board of Pharmacy Approved Euthanasia Training Course.
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MOTION: Elizabeth Jensen moved that the board approve the DVM and the Cowlitz County Humane
Society euthanasia training program. Gary Harris seconded. MOTION CARRIED: 7-0.
City of Ferndale Household Pharmaceutical Waste Take-Back Program Revisited

The board was asked to consider for approval the City of Ferndale pharmaceutical take-back program.
The requestor, Wendy LaRocque was supported by Mindy Collins who presented the City of
Bellinghams take-back program to the board recently. They came to the answer questions, particular
those that concern the security of the take back receptacle. It seems the receptacle is opened more
times than necessary. This item was carried forward from the August meeting.
Wendy was influenced by the board approved pilot program for return of pharmaceuticals and proper
disposal. The safe removal of waste pharmaceutics is important in Ferndale to protect the environment,
reduce childhood poisonings and adverse effects, and reduce diversion and abuse of pharmaceuticals.
Overview:
Any and all unwanted pharmaceuticals from households could be taken back to any
pharmacy. For over-the-counter medications, prescription drugs, free samples, or dietary
supplements (vitamins). This would not include DEA controlled substances,
Pharmacists could accept pharmaceuticals during open hours via a mail-box-style slot or a
secured locking container near the pharmacy counter. Pharmacists would not handle or
inventory the type of pharmaceuticals being returned. Pharmaceuticals would be collected in
their packaging, and customers would be given an opportunity to remove or mark-out all
identifying information.
The waste pharmaceuticals would fall into a collection bucket, which could be serviced by the
same distributor who delivered pharmaceutical products to the pharmacy. Each secured bucket
would have tracking technology to identify and track the shipment of the material. The
distributor would consolidate waste household pharmaceuticals from all their serviced
pharmacy locations. The distributor would subsequently arrange for final disposal following
procedures approved by the Washington State Board of Pharmacy and the Washington State
Department of Ecology.
Final disposal would occur at an incinerator meeting specifications for time and temperature
requirements, and would follow air quality emission standards, irretrievable destruction, and
safety requirements.
MOTION: Dan Rubin moved that the board approve the request by the City of Ferndales
Pharmaceutical Take-Back Program . Donna Feild seconded. MOTION CARRIED: 7-0.
Authorizing the Use of Non-Child Resistant Containers

Grant Chester led the discussion asking the board to consider approving the use of electronic
technology to capture the authorizing signature of the patient or his/her agent requesting that container
used is not child-resistant (WAC 246-869-230). Grant provided the board with some brief background
and the issues that have been coming up.
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The Board of Pharmacy (BOP) has interpreted WAC 246-869-230 to allow both manual and electronic
signatures. The statement required for NCRC can be as short as yes or no in response to a question
whether NCRCs are requested. The request and waiver can be part of a series of question asked at the
same time. Since the rule is silent on the frequency with which signatures must be renewed the BOP
did not address this issue. The electronic signatures kept as part of an automated medication record
system must be retrievable within 72 hours in accordance with WAC 246-875-060. The board
recommended that staff put this interpretation into the next newsletter.
Implementation of Pharmacy Value Stream Mapping (VSM) Event Process Improvements

The board received an update on the implementation of authorized changes following the Pharmacy
VSM Event and close out report. Additional application changes for consideration include removing the
requirem ent for an applicants photo, and determining documents necessary to show an applicant is
eligible for exams.
MOTION: Donna Field moved that the board remove the requirement for an applicant to provide a
photo. Elizabeth Jensen seconded. MOTION CARRIED: 7-0.
MOTION: Elizabeth Jensen moved that the board remove the requirement that Intern hours be sent to
the board to show that an applicant is eligible for exams. Donna Feild seconded. MOTION
CARRIED: 7-0.
Joyce Roper led the discussion with the board regarding the delegation of authority to
department/program staff. Joyce did some research to see if it is appropriate for department/staff to be
delegated authority for approval of some practices.
List of items not appropriate for final approval by department/staff:
Electronic prescription transmission systems

Ancillary utilization plans
Continuing Education
Tamper Resistant Prescription Pads
Renewal of Technician Training Programs
These items can be prepared for the boards review and put in the Consent Agenda Items for the boards
review and approval.
PRESENTATIONS
Rules Update
The board will hear an update on proposed rulemaking workload and agency request legislation.
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Animal Control Rule is pending file through the Code Revisers .
Pharmacy Practice Experiences & Internships still waiting for an exemption.
Pharmacy Technician Training requirement for Continuing Education has been filed and
working on sending out letters to Pharmacists and Pharmacy Technicians.

Tim Fuller provided some information on the growing concerns regarding drug shortages. Stan Moore
shared some things the investigators see out on the field.
Correspondence
a) Ther-Rx Corp. letter re: Compounding of Hydroxyprogesterone Caproate
b) ISMP Medication Safety Alert September 6, 2012
National Association of State Controlled Substances Authority Annual Meeting

The board will discuss the NASCSA 2012 Resolutions and consider naming Steve Saxe voting delegate
for the board.
Resolutions:
1. A RESOLUTION RECOMMENDING DETAILED REPORTING BY LAW
ENFORCEMENT OF CRIMINAL OFFENSES INVOLVING CONTROLLED
SUBSTANCE.
MOTION: Dan Rubin the board does not support this resolution as written. The board
recommends more support for the Prescription Monitoring Program versus placing unfunded
additional reporting burdens on state and local criminal justice . Elizabeth Jensen seconded.
2. A RESOLUTION RECOMMENDING STATES EVALUATE AND IMPROVE STATUTES
AND REGULATIONS ENABLING THEM TO ELIMINATE ILLEGITIMATE MEDICAL
CLINICS COMMONLY KNOWN AS PILL MILLS.
MOTION: Elizabeth Jensen the board has concerns and will abstain from making a motion
until the board can have some collaboration with Nursing and Medical. There is no information
provided to make a recommendation. Sepi Soleimanpour seconded. MOTION CARRIED: 70.
3. A RESOLUTION SUPPORTING EFFORTS TO SAFEGUARD THE U.S. DRUG
SUPPLY CHAIN FROM SUBSTANDARD, INEFFECTIVE, AND COUNTERFEIT
DRUGS.
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MOTION: Elizabeth Jensen moved that the board support this resolution. The board would like
to be provided more background in the future. Donna Feild seconded. MOTION CARRIED:
7-0.
MOTION: Elizabeth Jensen moved that the board name Steve Saxe as the voting delegate for
the Washington State Board of Pharmacy at the National Association of State Controlled
Substances Authority Annual Meeting. Donna Feild seconded. MOTION CARRIED: 7-0.
OPEN FORUM
Jeff Rochon with Washington State Pharmacy Association (WSPA)

Jeff welcomed Chris Humberson
Washington State Hospital Association is working with WSPA on a Partnership for
Patients effort which is focused on two topics: anticoagulation and opioid abuse.
WSPA has been receiving a number of calls this week on the DEAs interpretation of
pharmacists sending refill requests for controlled substances. Since the DEA is saying
that the pharmacist is usually not an "agent of the prescriber", these refill authorization
forms can no longer be used. A prescriber or an agent of the prescriber must prepare the
prescription and the prescriber must sign it . WSPA has been told that a pharmacy can
send a refill request for C3-5 but a prescriber must rewrite the prescription.
He thanked Chris Humberson for attending the Labor and Industries Hazardous Drugs
Advisory Committee meeting. This Committee will be meeting monthly to guide
implementation of the new rule.

CASE PRESENTATION
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Approved on November 8, 2012

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STATE OF WASHINGTON

MEETING MINUTES
October 20, 2011
Point Plaza East
310 Israel Road SE
Tumwater WA 98501
CONVENE
Chair Al Linggi called the Rules hearing to order at 9:03 a.m., October 20, 2011
Gary Harris, RPh,
Guest / Presenters:
Kristi Weeks, Director of Office of Legal Services
Patti Rathbun, Health Policy Development
Coordinator
Jovi Swanson, Policy Coordinator
Karen Jensen, Assistant Secretary of the Health Systems
Quality Assurance Division
Kristi Weeks, Director of the Office of Legal Services
Gail Bunker, Pharmacy Manager for MultiCare Acute Care
Facilities
Meg Kilcup, PharmD Transition of Care Coordinator
for Group Health
Diane Schultz, Medication Safety Manager
for Group Health
Patrick Gallaher, RPh

Joyce Roper, AAG
Pamela Sanders, Pharmacy Investigator
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CONSENT AGENDA
1.1
Closed Firms March 18 - June 3, 2011
Evergreen Healthcare
Opened Firms March 18 - July 21,2011
1.3
1.6
Providence Holy Family Hospital

Providence Sacred Heart
Shriners Hospital for Children
Board Minute Approval (June 8, 2011)
be removed from the consent agenda and placed on the regular business agenda. Items 1.2, 1.4, and
MOTION: Christopher Barry moved that Evergreen Healthcare be pulled from Consent Agenda Item
1.3 for further discussion. Elizabeth Jensen seconded. MOTION CARRIED: 5-0.
MOTION: Donna Feild moved that the board approve items 1. 1, 1.3 and 1.6. Gary Harris seconded.
Christopher Barry stated his concern regarding Evergreen Healthcares Automated Dispensing
Device.. Tim Fuller provided more background to the board members. Mr. Fuller suggested that he re
educate all those who submit requests to use an Automated Dispensing Device System that if they
intend to expand the system they must come back to the board for approval.
MOTION: Donna Feild moved that the board approve Evergreen Healthcares request subsequent to
Tim Fuller reviewing the checklist and if there are any changes that Evergreen Healthcare must
comply with the changes. Rebecca Hille seconded. MOTION CARRIED: 5-0.
REPORTS
Board Members
She attended the NABP/AACP District Meeting.

Elizabeth attended the NABP/AACP District Meeting and felt it was very educational.
She attended the New Board Member Orientation and felt the orientation was helpful and
educational.
Also attended the Washington State Pharmacy Association meeting.

Mr. Harris attended the NABP/AACP District Meeting.
He attended a disciplinary meeting in October.

Gary attended a Prescription Monitoring Program meeting that was held in September.
He also attended several other conferences in September.

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NABP/AACP District Meeting and congratulated Al Linggi on being elected to represent

District VII at next years meeting in Arkansas.
Donna attended NBAP/AACP District Meeting and was thankful for the opportunity and
learned a lot about what other states are doing and found this to be helpful for her being new
on the board.
She attended the new board orientation and felt it helped her understand her role as a board
member.
Al Linggi reported:
Al attended the NAPB/AACP District Meeting and felt it was excellent and well organized. He
thanked the staff for doing a great job. Al thanked investigators for participating. He heard
from others that participated in the roundtables that the discussions were a delightful exchange
and good collaboration.
Mr. Linggi also attended University of Washington Advisory Board for School of Pharmacy, a
very informative meeting . They are trying to rearrange their curricula to meet the demands of
contemporary pharmacy practice.
He participated in a couple of disciplinary hearings .
Executive Director
NABP/AACP District 6, 7 & 8 Meeting: Thanks to all of you for attending the NABP meeting
and making it a special event for this board. We had 143 attendees from 20 western and
southern states. And a special thanks to Leann George, for her work in pulling the logistics
together for the meeting. And thanks to Doreen, Kitty, Grant and the pharmacist investigators
for their support of the meeting as well. It was an honor to host the meeting.
Statewide Electronic Tracking of Methamphetamine Precursor Products Legislation: Go live

for the PSE tracking system was last Saturday, October 15, 2011. As of October 13, 2011, 195
community pharmacies as well as Wal-Mart and Sams Club have not implemented the system.
Some pharmacies contacted us and will only be providing these products by prescription. We
have 1420 pharmacies licensed in the state. The pharmacist investigators are helping get the
word out to all pharmacies.
Beginning with the April 19, 2012 FPGEE administration, updated competency statements and
a blueprint will take effect for the Foreign Pharmacy Graduate Equivalency Examination
(FPGEE). The National Association of Boards of Pharmacy (NABP) has revised the content of
the FPGEE competency statements and blueprint to ensure that it remains consistent with the
entry-level doctor of pharmacy programs in the United States. The four major content areas of
the FPGEE will remain the same; however, upon evaluation the subtopics were modified. In
addition, the percentage breakdown for each content area has been adjusted as follows: Basic
Biomedical Sciences (16%), Pharmaceutical Sciences (30%), Social/Behavioral/Administrative
Sciences (22%), and Clinical Sciences (32%).
Hazardous Drug Handling Rules: Tim Fuller and I met with John Furman, RN with L and I,
who will be writing the rules, to express board concerns with the adoption of the NIOSH alert
list of 200 drugs in rule and to consider a risk based tier system. The Proposed (CR-102) Rule
Filing: October 18, 2011 and Public Hearings are scheduled November 28 in Tumwater and
December 1 in Spokane with Adoption Rule Filing: January 3, 2011.
Comprehensive Rule Scan: Board staff meets biweekly to review core pharmacist and
pharmacy rules. Under the Strategic Plan business item we will give you an update.
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Rules moratorium: Friday, October 14, 2011, the Governor announced an extension of the
rules moratorium until the end of 2012 except for public health and safety.
Lawsuit filed against the Board of Pharmacy:

On September 27, a lawsuit was filed in King County Superior court against the Board of
Pharmacy. The lawsuit is based on the boards decision to deny a petition to remove marijuana
from the states Schedule I controlled substance list. State law gives the board authority to add,
delete or reschedule a drug in rule, and allows the board to defer to the federal Schedule I list.
The board deferred to federal law and based its decision on the fact that marijuana is a
Schedule I drug in the Federal Controlled Substance Act.
WRAPP Participants: Keep in mind the continued hurdles that those in recovery are subject to
when we are dealing with the cases that come in front of us. (Letter from pharmacist
participant)
Announcement: I want to announce that I will be stepping down March 1, 2012 and want you
to know I have thoroughly enjoyed working with the board over the 11 years, both as a
member, board chair and as executive director. Thank you for all your support!

Joyce introduced two new members from the Attorney Generals Office Jason Howell and Lyn
Tran, who attended to observe a board meeting.
She also let the board and public know that the Stormans trial is on track to begin November
28, 2011 for ten days. There has been a lot of pre trial work going on right now.
There has been an appeal of the Boards most recent decision to deny the petition for
rulemaking to reschedule marijuana. Details about the case will be discussed during closed
session.

The advertisement for 3 open pharmacist investigator positions resulted in 24 applications. The
last interview was Monday, October 17, 2011. The selected individuals should receive
employment offers by the end of October, 2011.
The Department of Health is asking us to reduce our travel expenses again this year. Working
with the pharmacist investigators we use a two step approach to reduce costs:
1. Re-focused priorities on inspections and investigations starting in 2008. In 2006
time spent on inspections was 16.5% with 680 completed while in 2008 time spent
on inspections was 30.2% with 1,094 completed. (No allocation of time data is
available for 2007; an estimate would be ~15% +/- .)
2. Continuously work with the pharmacist investigators to realign inspection regions
from 2008 onward to reduce travel time and distance from investigators home
address to the firms inspected and maintaining focus on inspections and
investigations resulted in significant travel savings. As new firms come online I
work with the investigators to adjust their inspection regions to be efficient and cost
effective.
In September Jim Doll attended the Role of the Department of Health Investigators meeting.
Tina Lacey attended the Pseudoephedrine NPLEX Training September 12, 2011.
Richard Morrison attended Pharmacy Practice Requirements September 13, 2011.
September 6-9, 2011 Tina Lacey and Greg Lang attended the NABP State Specific Law
Review in Mt Prospect, IL.
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Grant Chester, Grace Cheung, Jim Doll, Tina Lacey, Greg Lang and Tyler Varnum attended the
NABP/AACP District Meeting.
Pamela Sanders reported:
Pamela reported on issues the investigators are finding out in the field.
There are no guidelines as to which references pharmacies should have on hand. The
investigators would like guidance from the board on which references that they should
require.
Physicians dispensing
The 15 minute rule
PRESENTATIONS
Coordinated Quality Improvement Program
Patti Rathbun and Jovi Swanson presented the history of the Department of Healths CQI program and
basic guidelines in creating a CQI plan to the board. Susan wanted the board to know that Pattis
program is available as a tool for a QA/CQI requirement. This is a goal the board set at the August
2011 Strategic Planning Session.
The board asked Patti and Jovi many questions during this discussion. Al Linggi recommended that
Cathy Williams sit with Patti Rathbun and Jovi Swanson to come up with some recommendations to
provide the board on how to tackle this goal.
Assistant Secretary Update

Karen Jensen, Assistant Secretary of the Health Systems Quality Assurance Division (HSQA)
provided an update to the board on relevant division/agency issues and activities. This was also an
opportunity for the board to ask questions.
Performance Metrics
Susan Boyer provided the board with some updated information and led the discussion regarding
credentialing process timelines and numbers. The board discussed the information they were provided
and asked questions. They were happy to have more detailed information and are looking forward to
hearing from Diane Young, HSQA Credentialing Manager in the beginning of next year.
Disciplinary Process
Kristi Weeks, Director of the Office of Legal Services presented an overview of the disciplinary
process including timelines.
Four stages of disciplinary action:

Intake/Assessment: 21 days
Assessment: 14 days
Investigation: 170 days
Case Disposition: 140 days
Adjudication
Cases Processed Intake/Assessment
Performance Measure:
Percent of cases in which the intake and assessment steps are completed within 21 days
Target:
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77% within 21 days

Analysis:
Pharmacy processed 108 complaints though intake/assessment during the first quarter of fiscal
year 2012.
During this time 69 percent of the cases were processed within the 21 day timeline.
During fiscal year 2011 Pharmacy processed 328 cases through intake/assessment. For the
year, 55% were within timeline.
Investigation Steps:
Percent of cases in which the investigation step is completed within 170 days
Target:
77% completed within 170 days.
Analysis:
Pharmacy completed 71 investigations during the first quarter of fiscal year 2012.
During fiscal year 2011 Pharmacy completed 187 investigations. For the year, 90% were
within timeline.
Cases Processed Case Disposition:

Percent of cases in which the case disposition step is completed within 140 days
Target:
77% completed within 140 days

Analysis:
Pharmacy processed 54 complaints though case disposition during the first quarter of fiscal
year 2012.
During fiscal year 2011 Pharmacy processed 249 cases through case disposition. For the year,
79% were within timeline.
Comparison of Legal Caseloads:

Number of completed investigations that are assigned to a staff attorney for legal review or
production of documents v. number of staff attorneys
Target:
65 cases per attorney

Analysis:
The caseload size for HSQA staff attorneys averaged 74.7 cases during fiscal year 2011.
During the first quarter of fiscal year 2012 the average was 68.1 cases.
Sanction Schedule:
Percent of Orders and STIDs that comply with the sanction schedule
Target:
93%.
Analysis:
The Department of Health issued 197 final decisions in the first quarter of fiscal year 2012.
These include:
50 for HSQA boards and commissions

What happens if a case exceeds timelines?
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Enhanced management oversight.
EXECUTIVE SESSION
MOTION: Christopher Barry moved that the board meet for a closed session to discuss personnel
issues and pending litigation. Elizabeth Jensen seconded. MOTION CARRIED: 5-0.
PRESENTATIONS Contd
2011 NABP/AACP District 6, 7, and 8 Annual Meeting
Susan Teil Boyer provided a NABP/AACP District Meeting wrap-up. She shared the District VII
resolutions.
#1 Prescriber Dispensing or Prescriber Drug Outlets

Whereas, state boards of pharmacy have long been and continue to be the sole agencies authorized by
state legislatures to regulate the dispensing and distribution of drugs in and into the state by registering
and licensing dispensers and dispensing drug outlets; and
Whereas, boards of pharmacy have become aware of an increase i n prescribing practitioners interest
in and pursuit of dispensing prescription drugs for profit outside the regulated pharmacy distribution
channels; and
Whereas, the dispensing of drugs in the absence of a pharmacist bypasses the long-standing and
traditional safeguards of drug dispensing practice routinely provided by the pharmacist and regulated
by the state boards of pharmacy including focus on appropriate drug product selection, development of
lawful procedures for acquisition, record keeping, storage, distribution and disposal of prescription
medications, evaluation, confirmation and interpretation of the prescription, drug utilization review,
patient counseling, prescriber consultation, and appropriate and necessary interventions are bypassed,
which may put the patient at significant risk of serious health consequences; and
Whereas, the dispensing and distribution of drugs on a grand scale outside the traditional drug
distribution channels arguably creates a significant public health risk;
Therefore be it resolved that NABP convene a task force, work group or other appropriate vehicle to
review this issue and assist the state boards of pharmacy to determine whether and to what extent these
prescriber dispensing activities should be regulated, restricted, or prohibited; and
Be it further resolved that the NABP review and propose amendments to the Model Act and Model
Rules to address appropriate regulation of these facilities
#2 Incentives for Patients to Change Pharmacy
Whereas, state boards of pharmacy are hearing reports from pharmacists that pharmacies are
marketing awards and incentives to patients who agree to change pharmacies; and
Whereas, boards of pharmacy are hearing reports of pharmacies offering awards and incentives to
patients and penaltie s to pharmacists for failure to meet production quotas or time deadlines; and
Whereas, the boards of pharmacy believe these incentives are inappropriate, are inconsistent with
quality patient care and may be putting unsuspecting patients at risk when they change pharmacies and
disrupt the continuity of dispensing records and profile information, or when pharmacists are pressured
to meet speed and production quotas;
Therefore be it resolved that NABP work with ISMP and other interested stakeholders to study these
practices to determine whether and to what extent these practices may be putting patients at risk and to
assist the state boards of pharmacy to determine whether and to what extent these activities should be
regulated, restricted or prohibited; and
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Rules to address appropriate regulation of these activities .
#3 Practitioner Compounding
Whereas, boards of pharmacy have become aware that some medical offices such as oncology clinics
are employing nurses, pharmacy technicians, former pharmacy technicians and ancillary personnel to
compound sterile parenteral products for administration and dispensing to their patients; and
Whereas, licensed or registered pharmacy technicians who perform these duties in a medical clinic or
facility outside a licensed or registered pharmacy may be violating pharmacy laws and rules; and
Whereas, some individuals who were licensed or registered as pharmacy technicians who are
employed in these offices and clinics let their technician license or registration lapse or are employed
in some capacity other than a pharmacy technician are not performing duties under the direct
supervision of a pharmacist in a pharmacy in compliance with the pharmacy laws and rules, which
may fall outside the jurisdiction of some state board of pharmacy; and
Whereas, boards of pharmacy are very concerned that the absence of pharmacist oversight of the
compounding of sterile parenteral products in medical offices and clinics by nurses, licensed or
registered pharmacy technicians or pharmacy technicians who have lapsed their registration or license
may be creating unnecessary health and safety risk for patients ;
Therefore be it resolved that NABP work with interested stakeholders to study these practices to
determine whether and to what extent these practices may be putting patients at risk, and to assist the
state boards of pharmacy to determine whether and to what extent these activities should be regulated,
restricted or prohibited; and
Rules to address appropriate regulation of these activities .
#4 FDA Repackaging Requirements for LTCF
Whereas, patients residing in long term care facilities often present filled prescriptions in traditional
community pharmacy containers such as capped vials; and
Whereas, the FDA has determined that transferring medications from these previously dispensed
containers to unit dose packaging is considered manufacturing; and
Whereas, in order to safely and securely manage patient care, long term care facilities require drugs to
be packaged in unit dose containers;
Therefore be it resolved that NABP work with the FDA to support model rules such as those recently
passed by the Alabama Board of Pharmacy.
#5 Drug Return Programs
Whereas, a number of state legislatures have enacted laws that allow for the return and re-use of
previously dispensed prescriptions under certain conditions; and
Whereas, many of these laws require boards of pharmacy to adopt rules to implement these return and
re-use programs; and
Whereas, boards of pharmacy are concerned that the quality and integrity of drugs previously
dispensed and returned by for re-use cannot be controlled;
Whereas, these return and re-use programs have not been widely used as expected by the state
legislatures;
Therefore be it resolved that NABP convene a task force, work group or other appropriate vehicle to
study the utility, efficacy and safety of these programs ; and
Be it further resolved that NABP develop a position statement, model rules or other appropriate
efforts to assist the state boards of pharmacy to deal with the legislative mandated programs .
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Remote Order Entry System

Tim Fuller provided the board a quick background and introduced Gail Bunker pharmacy manager for
MultiCare Acute Care Facilities. She presented a proposal to use remote order entry/medication order
verification to support pharmacy services to its inpatient facilities. MultiCare provides Pharmacy
Services to four hospitals, seven surgical centers, five outpatient oncology clinics, seven retail
pharmacies and several physician offices.
MultiCare Informatics Systems

Inpatient Computer System: EPIC
CPOE implemented in 2009
Automated Dispensing Cabinets: CareFusion (Pyxis)
3500 Model
At TG since 1998, implemented at Good Sam in 2010
Anesthesia Carts (A-Carts) at TG, Good Samaritan, Covington and Gig Harbor
Carousel: Talyst
Bedside Barcoding implemented 2009-2010
Objectives:
To provide safe and effective pharmaceutical care through pharmacist review and
verification of orders
To normalize workload on the hospital campuses
To normalize workload in the ambulatory areas
To provide after hours support to the off-site surgical centers
To monitor and evaluate the quality and appropriateness of patient care provided by
remote order verification
MultiCare Facilities are under a single corporate structure
MultiCare uses a standard electronic medical record (EPIC also known as MultiCare
Connect)
MultiCare uses standard order sets across all facilities
Remote Medication Order Processing to include:
Receiving, interpreting, clarifying and verifying medication orders
Therapeutic interchange
Policies and Procedures:
MultiCare System Level Policies and Pharmacy Services Policies for all facilities are
available electronically through the MultiCare Intranet.
Policies are reviewed and approved annually.
Pharmacist Practice:
All MultiCare pharmacists are licensed in Washington State .
Pharmacists can access EPIC from any MultiCare Facility.
EPIC records are stored indefinitely which allows concurrent and retroactive audits of
performance.
Pharmacists are trained on pharmacy policies and procedures related to medication
order processing.
MOTION: Christopher Barry moved that the board approve the proposal from MultiCare Acute Care
Facilities to use remote order entry/medication order verification to support pharmacy services to its
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inpatient facilities. They are to report back six months after the official start date and the approval is to
be used only by facilities mentioned in the proposal. Rebecca Hille seconded. MOTION CARRIED:
5-0.
Medication Reconciliation of Discharged Patients

The board was asked to consider a proposal by Group Health Cooperative to use a Pharmacist/
Pharmacy Technician medication reconciliation process for patients hospital discharge orders. Tim
Fuller introduced Meg Kilcup and Diane Schultz from Group Health. They provided the board with a
back ground and are asking to extend the program they are already providing in some facilities.
Medication reconciliation is a Joint Commission Patient Safety Goal. NPSG.03.06.01:
Obtain and/or update information on medications the patient is taking currently.

After discharge, obtain discharge medication list and compare to outpatient list for
reconciliation.
The focus of the Group Health pharmacy technician taking a medication list will be the
patient's discharge summary and compare it to the outpatient medication list in the patient's
electronic medical record. The pharmacy technician identifies potential medication issues
such as therapeutic duplication, discontinued medications, and new prescriptions.
The pharmacy technician provides the medication list to the pharmacist for review. The
pharmacist reviews the discharge summary, the medication list, and the recommendations.
If
there are safety concerns, the pharmacist call the patient.

Selected pharmacy technicians will receive both didactic and practical training from the
pharmacist on how to interview a patient and obtain a medication list. The pharmacy
technicians must pass a competency examination and then shadow the pharmacist for a
minimum of three hours or until the pharmacy technician demonstrates competency. The
hospital pharmacy quality assurance program will routinely audit the performance of the
pharmacy technicians.
MOTION: Donna Feild moved that the board approve the proposal from Group Health Cooperative to
use a Pharmacist/ Pharmacy Technician medication reconciliation process for patients hospital
discharge orders. Rebecca Hille seconded. MOTION CARRIED: 5-0.
2012 Draft Legislation
Pharmacist Patrick Gallaher discussed proposed legislation to amend the definition of the practice of
pharmacy RCW 18.64.011(23) to include a pharmacists independent authority to initiate, modify, or
terminate drug therapy as defined by the board in rule .
MOTION: Donna Feild moved that the board endorse Patrick Gallaher and Washington State
Pharmacist Association to work together on this direction . Elizabeth Jensen seconded. MOTION
CARRIED: 5-0.
Prescription Monitoring Program (PMP)
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Chris Baumgartner, PMP Program Director updated the board on the Prescription Monitoring Program
(PMP) since it has been implemented. The board was asked to discuss and provide feedback on
possible legislation to collect an annual surcharge from pharmacists and prescribers for ongoing
funding of the prescription monitoring program . The board provided Christopher Baumgartner some
concerns and some ideas. The board also acknowledged his great work and their appreciation.
DISCUSSION
Safe Handling of Hazardous Drugs Rulemaking
Susan Teil Boyer led the discussion with the board on the rule proposed by the Department of Labor
and Industries in implementing 2011 Legislation - ESSB5594. The rule applies to all health care
settings where employees with occupational exposure to hazardous drugs. It includes both pharmacy
technicians and pharmacists and all health care settings. Hazardous waste is seen as equivalent to
dangerous waste which is designated by the State Department of Ecology as all drugs. The board is
being asked to provide feedback on this rule.
Donna Feild suggested that board staff write a communication to Labor and Industries regarding this
rule. Susan Teil Boyer asked what the board would like to have in this communication. Al Linggi
suggested the board think about it and email Susan with anything they would like in this
communication.
Drug Repackaging/Reuse Balancing Cost with Safety

Grant Chester provided the board with a little background and asked them to revisit the topic discussed
at the August meeting and consider future rule making on the subject.
The pharmacist investigators are reporting growing concern with repackaged modified unit dose
(bubble pack) medications being returned, reprocessed, and reused multiple times after being initially
dispensed to community long term care facilities. These facilities have grown in numbers throughout
the state and include assisted living facilities, boarding homes, residential treatment facilities and adult
family homes, in addition to nursing homes. The facilities listed vary in staffing, oversight, security,
control and storage of medications. Al Linggi asked Doreen Beebe to email all the board members this
WAC so they could make suggestions.
MOTION: Donna Feild moved that the board begin work on a guideline checklist to be used for
repackaging/reuse of medication. After all board members have looked over the WAC and made
suggestions for this checklist. Christopher Barry seconded. MOTION CARRIED: 5-0.
Prescription Guarantees
Susan Teil Boyer summarized information that National Association of Boards of Pharmacy has
regarding this issue. The board discussed prescription turnaround guarantees offered by some
pharmacies. After discussion and concerns regarding this issue the board suggested that staff provide
some publication of information in the next NABP Newsletter.

Doreen Beebe, Program Manager updated the board on what has been done on its 2011- 2012
initiatives, goals, and Strategies identified at the August 2011 planning session .
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The core group met on September 8, 2011on scanning the rules. This is the first step on
updating the Rules/Laws.
There is a worksheet that is broken into tables and buckets.
The board will be updated as we go along.
A bit of a struggle trying to narrow things downs. There has been a lot of input from all
members on the workgroup.
2012 Meeting Dates

Doreen Beebe asked the board to re-evaluate its proposed 2012 meeting calendar to consider changing the
business meeting rotation from eight to six weeks.
MOTION: Gary Harris moved that the board approve the amended six week interval schedule as
amended due to availability of conference rooms when this is finalized it will be emailed to all the
board members. Elizabeth Jensen seconded. Rebecca Hille abstained. MOTION CARRIED: 4-0.
Rulemaking Update
Kitty Slater-Einert led the discussion with the board asking them to consider approving draft rule
language to implement 2011 Legislation HB1353 Continuing Education for Pharmacy Technician
and review rule priorities. After some discussion Kitty was given some suggestions and direction from
board and staff for some changes.
Kitty was asked to take the language back for some clean up and the board will hold a special meeting
for more input or approval.
MOTION: Donna Feild moved that the board will have a special meeting to approve or give more
input to the draft rule. Rebecca Hille seconded. MOTION CARRIED: 5-0.
Correspondence
The board discussed correspondence received
Agency Proposed Leg 69 50ElectronicPrescrip_Z-draft

Board of Pharmacy feedback regarding Medical Assistant Sunrise
BudgetReductionOptions2011
Comment by Reid Nelsen re - Reuse_Repackaging
CPE Monitor You
DEA - CII Changes - CarmenCatizone Aug242011
King County Superior Court Petition for Judicial Review - John Worthington
Letter from ISMP-NABP Response
Memo_CPE Monitor Update 8-2011
Protecting Yourself from Identity Theft
Review of Pharmacy Speed Racer programs
StakeholdersPartnersBudgetLetter2011
USP Webinars Announcement
Walgreens Prescription Refill Text Alerts Deliver Important Reminders for Mobile
Users and Make Ordering as Simple as a Reply
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OPEN FORUM
Christopher Barry asked if there is work being done with the Governors Office to find a replacement
for former board member Kim Ekker and for R ebecca Hille. Doreen Beebe shared that the Governors
Office has asked that the board staff do interviews for board members.
Rebecca Hille shared that she gave all the kids in her neighborhood the Washyourhandsington post
cards that were handed out at the NABP/AACP District Meeting. She also shared that she finally
received her first flu shot.
Lis Houchen mentioned that someone was told that Collaborative Agreements were being handled by
credentialing. This is not true. Tim Fuller and Leann George in Pharmacy are still the ones handling
these agreements.
The board adjourned for Closed Session at 4:35 p.m.
CLOSED SESSION
_______________________________
_______________________________
Al Linggi, Chair
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STATE OF WASHINGTON
Regular Scheduled
Amended Business Meeting Minutes
CONVENE
Chair Christopher Barry called the meeting to order October 23, 2014.
Commission Members:
Guest / Presenters:

Gary Harris, RPh,
William Rhodes, WRAPP Program Manager

Dana Doyle Johnson, owner and Pharmacist in Charge

Steve Anderson, RPh
Nancy Hecox, PharmD
Tim Lynch, PharmD
Al Linggi, RPh, MBA
of Doyles Pharmacy
Jason Priest, Pharmacy Technician from MedCerts
Nabile Hayek,PharmD
Glenn Adams, Corporate Director of Pharmacy,
Confluence Health
Tracy Clark, Director of Pharmacy for Lourdes Health
Network
Sandra Dahl, RPh, KPNW Pharmacy Area Director
Andy Brigant, VP of Pharmacy Services
Shawn Brockman, Director for Clinical Product
Management for PointClickCare
Staff Members:
Joyce Roper, AAG
Call to Order:
MOTION: Tim Lynch moved that the commission approve 1.1. Steve Anderson second. MOTION
CARRIED: 11-0.
MOTION: Gary Harris moved that the commission approve 1.2 with suggested amendments. Steve
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MOTION: Dan Rubin moved that the commission approve the amendments to the May 29, 2014
minutes. The motion for the presentation by Lady Lourdes Hospital was amended . Al Linggi second.
CONSENT AGENDA - Items listed under the consent agenda are considered routine commission
matters and will be approved by a single motion of the commission without separate discussion. If
separate discussion is desired, that item will be removed from the consent agenda and placed on the
September 2014
a. Albertsons
a. Capital Medical Center Pharmacy Tech Taking Med Lists
b. Mason General Hospital Tech Taking Med Lists
c. PeaceHealth Tech Taking Med Lists
Newport Hospital & Health Services
2.9 Ancillary Utilization Plans
Franciscan Technician Utilization Plan barcode verification for automated drug

distributions devices (follow-up September 2014)
Elizabeth Jensen requested to remove 2.4 (a) from the consent agenda for further discussion . Items 2.6,
2.7, and 2.8 were deleted from the consent agenda.
MOTION: Al Linggi moved that the commission approve items 2.1, 2.2, 2.3, 2.4 (b) & (c) 2.5.
Kristina Logsdon second. MOTION CARRIED: 11-0.
MOTION: Al Linggi moved that the commission approve items 2.9. Kristina Logsdon second. Tim
Lynch and Maureen Sparks recused themselves from item 2.9.MOTION CARRIED: 9-0.
CONSENT AGENDA
a. Capital Medical Center Pharmacy Tech Taking Med Lists
Elizabeth Jensen had a concern regarding the Techs taking the list and the list going straight to the
physician without a pharmacist seeing it first. Lisa Roberts clarified that is not the case and had the
procedure rewritten to clearly state that. The pharmacist looks at the list before the physician receives the
list.
MOTION: Elizabeth Jensen moved to approve Consent Agenda Item 2.4 (a). Nancy Hecox second.
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REPORTS
Commission Members
Dan Rubin reported:
Dan Rubin continues to work with staff towards analysis of survey of pharmacists, interns, and
techs.
He was an observer to represent the commission at the Accreditation site visit for WSU School of
Pharmacy. He personally enjoyed the opportunity to see and understand what life is like in a
School of Pharmacy.
th
September 16 Steve was part of the pharmacy 500 professional identity panel at the University
of Washington. A great experience 100 students. We were able to share about our careers and
how we got where we were.
Steve took the MPJE for Mississippi and Kentucky and passed both of them.
Nancy sat for the Opioids use and abuse webinar.

She is still helping with reviewing CDTAs and finds this to be a new passion for her.
Nancy is applying for a Masters in Pharmacy Regulation.
Tim Lynch reported:
He facilitated a WSPA Hospital Pharmacy Leadership Meeting. Chris Humberson attended and
spoke to the group.
Tim participated in Washington Patient Safety Collation Medication Reconciliation Committee.

Attended an ASHP pharmacy SAG meeting on pharmacy business management.
Participated in a CDC Grand Rounds presentation titled How pharmacists can improve the
nations health.
He was a guest surveyor at an ASHP PGY1 residency program in Sturgis, South Dakota
He will be attending the home coming event for the University of Washington Pharmacy Alumni
Association and as the new president, he will be giving a two minute hello and welcome to the
students.
Al Linggi reported:
He attended the District 6, 7 & 8 Annual NABP Meeting in Montanta. This was an excellent
opportunity to gain insight from other boards regarding the new regulations and the FDA.
Executive Director
Chris attended the NABP District 6, 7, & 8 Meeting in Whitefish, Montana. This meeting covered
issues relating to district business and learned additional information about compounding security
act and drug quality security act. 3PLs and pedigrees for products.
He then participated in the NABP Executive Forum. This forum was to discuss issues relative to
regulatory functions among issues, compounding, PICs, intern hours, business accountability,
and more.
Chris spoke about Compounding rules draft, and Health Care entities relative to pharmacy at the
WSPA Hospital Meeting in Yakima.
He met with Oregon BOP staff for a meeting regarding Writing rules on auto-refill programs;
compounding update on our rules, and how to collate data from both workplace survey questions.
Met with the DEA to discuss CFR 21 and exempt narcotics.
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Worked with the business rules committee to discuss the progress of the survey data analysis and
work plan.
The Lean Progress is coming along and now formalizing the central inbox and logistics for
tracking requests and applications.
DOH shared the agency legislative agendas with association representatives.

Held high-level meeting to discuss how to review facility-licensing issues/concerns within DOH
and path forward.

th
The Stormans Case argument is still scheduled for November 20, 2014 in the 9 Circuit at the
Portland Federal Court House.
Since the last meeting she has been on two site visits. She and Brad Dykstra visited ProPac.
Gordon MacDonald, Chris Humberson and Lisa visited ZoomCare in Portland.
Lisa also attended a two day rule class. It was an amazing course.

He and Eleanor Carbett gave a law presentation to a group of technicians in Spokane.

In the last month, Gordon accompanied 4 investigators on 4 field inspections just to observe.
This helps him get a meaningful understanding of the reports that come in from the investigators.
Greg Lang attended the NABP Inspector workshop. This was designed to help inspectors with
797 inspections.
Brad Dykstra and Pam Sanders participated in the RSS Drill that was in early October.

Implementation of Chapter 276, Laws of 2013
Peggy Crain led the presentation on proposed rule changes to implement SSB 5416 Act relating to
prescription information. Peggy asked the commission to approve the language to move forward with
filing the CR-102.
SSB 5416 redefined electronic communication of prescription information. To be consistent with

the law, we are proposing to amend chapter 246-870 WAC to align rules with statutes. Also as a
result of SSB 5416, we are proposing to amend WAC 246-887-020 and -030 to clarify
prescription dispensing requirements for Schedule II through Schedule V controlled substances.
Because we are only implementing legislation, we are using the CR-102 exception process. This
process does not require a CR-101 to be filed. It also does not require a small business economic
impact statement or a significant rule analysis to be prepared. Additionally, because of the
exception process being used, additional language changes or clarifications cannot be made.
MOTION: Gary Harris moved that the commission accept the proposed rules changes to implement
SSB5416. Steve Anderson second. MOTION CARRIED: 11-0.
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Before Chris Humberson began his presentation on Compounding rules, he asked Joyce to speak on issue
regarding the schedule V that keeps being brought forward. Joyce Roper stated, The proposed rule that
was just discussed will be subject to a rules hearing brings the commission rules into conformance with
legislation addressing Schedule Vs by prescription only. The commission had requested a memo on this
and it has been distributed to all the commission members. The rule cant override the statute. If there is
some community need this may be a great opportunity for a collaborative drug therapy agreement.
Pharmaceutical Compounding Rules:
Chris Humberson thanked everyone who has put in a large amount of time and effort into this draft rule.
There has been a lot of research put into this draft language. Critical Points Compounding looked over the
draft language, they made some suggested changes and we accepted those. Comments will be taken from
the public until the end of December. There has been great feedback from those that have looked at the
draft language.
Doreen Beebe was contacted by a representative from Washington State Patrol Crime lab regarding
updates needed to the Uniformed Controlled Substances Act Chapter 69.50 RCW. The WSP crime lab
has offered their assistance in updating rules (Chapter 246-887 WAC) to mirror recent federal changes
placing additional substances synthetic cannabinoids into schedule 1 of the Code of Federal Regulations.
Updates will include scheduling of tramadol and rescheduling of hydrocodone combination products.
Committee Updates:
Al Linggi updated the commission on the Technology rules committee work. There hasnt been much
done because staff has been working on the compounding rule. Al had an opportunity to sit and talk with
10 board members from 10 different states regarding their technology rules. He and the committee are
hoping to finish gathering information from other states that seem to have contemporary technology
WACs in November/December. The goal will be to start stakeholder meetings in January.

Dan Rubin updated the commission on the Business Practices committee work. He and the rest of the
committee are unable to meet formally as a group until the CR-101 has cleared. We have begun to try to
pre plan meetings so we will be ready when we are able to meet. Really hoping to get this started as soon
as possible.
Survey of Washington Pharmacist, Interns and Technicians

Chris Humberson updated the commission on the Survey that was sent out. The commission has been
given the report and the report is on our website as well. The survey report is about a 95 page report. 30
pages are on the questions and remaining 65 were comments. Neal Travon who works for the PMP
Program has graciously worked with us on this project. About 2,800 people had substantially completed
the survey the others had answered some of the questions. About 28% of all Washington State
pharmacists and 8% of pharmacy technicians. The other respondents were broken out as well. We are
sorting through the comments now, looking to put comments into spreadsheet broken down into
topics/issues. We hope to have this to you by the December meeting.
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DISCUSSION
Washington Recover Assistance Program for Pharmacy (WRAPP)
William Rhodes, Program Manager for WRAPP led the discussion regarding the requirement for urine
analysis for program participants not currently working in pharmacy. He first gave the commission an
update on what has been going on with the program.
WRAPP Update:
In June WRAPP presented its online app it is called WRAPPRx.com it is a site available to the
public for information regarding the program.
July WRAPP completed the required survey of WRAPP participants over 66% of our program
responded to that. There were very positive comments regarding the advocacy that WRAPP has
for its participants.
August thru now we are working with Kathy Schmitt, Office Deputy from DOH to update the
contract language and our statement of work.
We continue to have annual meeting with our participants.

October we have 4 new WRAPP participants
Last 5 months 3 relapsing participants
Outreach - WRAPP presented on the western side of the state at the WSPA October 11 at
technician day then presented again in Spokane at the Spokane Community College again to
technicians.
WRAPP is asking to work on changes to a memo that was crafted in 1993. It is very specific and accurate
but over 21 years WRAPP feels some things need to be updated. WRAPP would like to come before the
commission to get approval for changes and then create a new document for final approval. Currently we
test participants upon return to work. Participants will be tested 4 times a month for 6 months, 3 times for
6 months, and then 2 times for remainder of their contract. WRAPP is asking the commission for
approval to change the document to be able to include random testing to all part in program once they
complete treatment and even if they are not working.
Few other changes they would like make to the language from the old document states fluid testing we
would like to change this to all testing and to make changes that state observed UAs to monitored
if there is a gender specific situation. Some of these will need to be done with rule change.
The commission gave WRAPP permission to move forward with updating their documents and then
come back with a draft for final approval.
Initiate Joint Commission Workgroup

Chris Humberson led the discussion about concerns of nursing students accessing automated drug
distribution machine. Chris Humberson introduced two representatives of the nursing commission AAG
Gail Yu amd Mindy Schaffner that were available to answer questions. .Chris, Joyce Roper, Gale Yu and
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Paula Meyer, Executive Director of the Nursing Commission met internally about this concern. The
solution we came up with was to come and ask that a workgroup be formed to come up with some joint
policies. There were several documents that were given at the meeting but Chris felt there needs to be a
workgroup before anything is done. Our law does not allow this.
If there is diversion someone will be responsible but who will depend on the situation. It is in their statute
that nursing students dont need to be licensed. Background checks are to be done annually.
MOTION: Elizabeth Jensen moved that there is a subcommittee put together to work on this issue. Tim
Lynch and Sepi Soleimanpour volunteered to be on the subcommittee. Sepi Soleimanpour second.
Prescription Monitoring Rules Review

Chris Humberson led the discussion on PMP Rules review pharmacist delegation. Should pharmacist be
able to delegate to pharm tech to query PMP. When this was originally implemented the biggest concern
was HIPPA. There are very strict rules on who can access this information. Even when law enforcement
uses PMP it is closely monitored. And random audits are being done to make sure this is appropriately
used.
MOTION: Dan Rubin moved that the commission support and recommend that PMP add delegations of
a technician by pharmacist to use the PMP Program. Tim Lynch second. MOTION CARRIED: 11-0.
Healthcare Entity Registration

Joyce Roper led this discussion on Healthcare Entity Licensing and who needs to be licensed. She is still
working on the memo regarding this HCE Licensing issue. This issue has arisen with respect to clinics,
particularly those owned by health care systems rather than being owned by physicians or other health
care practitioner. In her research she has focused on the question What is their authority to possess
legend drugs RCW 69.41.030 if they are not licensed as HCEs? If the individual practitioners own the
clinic, then, assuming they are among the professions identified in RCW 69.41.010 (16), then presumably
they possess the legend drugs under the authority of their licenses. RCW 69.41.010(16) defines
practitioner as:
(a) A physician under chapter 18.71 RCW, an osteopathic physician or an osteopathic physician and
surgeon under chapter 18.57 RCW, a dentist under chapter 18.32 RCW, a podiatric physician
and surgeon under chapter 18.22 RCW, a veterinarian under chapter 18.92 RCW, a registered
nurse, advanced registered nurse practitioner, or licensed practical nurse under chapter 18.79
RCW, an optometrist under chapter 18.53 RCW who is certified by the optometry board under
RCW 18.53.010, an osteopathic physician assistant under chapter 18.57A RCW, a physician
assistant under chapter 18.71A RCW, a naturopath licensed under chapter 18.36A RCW, a
pharmacist under chapter 18.64 RCW, or, when acting under the required supervision of a
dentist licensed under chapter 18.32 RCW, a dental hygienist licensed under chapter 18.29
RCW;
(b) A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to
distribute, dispense, conduct research with respect to, or to administer a legend drug in the
course of professional practice or research in this state;
(c) A physician (M.D. or D.O.) licensed to practice surgery in any state, or province of Canada,
which shares a common border with the state of Washington.
In some instances, the health care systems owning these clinics have said that the legend drugs are at the
clinics under the authority of a hospital license. However, the hospital licensing statute, RCW
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70.41.020(4) defines a hospital as a place which provides accommodations, facilities, and services over
a continuous period of twenty-four hours or more, for observation, diagnosis or care. RCW
70.41.020(4) specifically excludes clinics, or physicians officers where patients are not regularly kept as
bed patients for twenty-four hours or more. So this seems to exclude clinics from the scope of the
hospital license.
Some have also suggested that the hospital pharmacys license extends or includes these clinics.
However, pharmacy licenses issued under RCW 18.64.043(1) are location specific: The owner of each
pharmacy shall pay an original license fee . . . for which he or she shall receive a license of location,
which shall entitle the owner to operate such pharmacy at the location specified, or such other temporary
location as the secretary may approve. So this would seem to preclude the notion of extending the
hospital pharmacy license off premises.
Some clinics are licensed as ambulatory surgery centers and that license may satisfy RCW
69.41.010(16)(b).
Tim Lynch asked Joyce for some clarity on two parts of this issue. He believes some hospitals do have
ambulatory surgery centers licensed under their organization and are not separately licensed. Joyce will
look closer at this and provide some clarity. The other need for clarity on this issue is the question of
Medical Assistants and their scope of practice. Joyce shared selecting drugs is not in their scope of
practice. Tim asked that something be put in writing so people can reference it. Chris Humberson did say
that this document is being worked on within DOH and the M.A. program. It is not ready to be sent out to
the public. The M.A.s do have the ability to choose vaccines and administer them to people.
Critical Point Boot Camp

Chief Investigator Gordon MacDonald requested that the commission approve funding to send remaining
investigative staff to Critical Point Boot Camp. Course designed to provide practical experience and
resources to critically evaluate existing sterile compounding practice and make modifications necessary to
ensure compliance with USP.
MOTION: Dan Rubin moved that the commission approve funding for Critical Point Boot Camp or
similar intensive onsite training for all investigators, recognizing that it will possibly take longer than
2015 to complete this. Maureen Sparks second. MOTION CARRIED: 11-0.
DISCUSSION Contd.
Non-Resident Doyles Pharmacy Exemption Request:
Doreen Beebe introduced Dana Doyle who was on teleconference to answer questions regarding her
requests for Doyles Pharmacy exemption from licensure. A panel of commission was chosen to consider
this request.
Background:
Doyle's Pharmacy is a 70 year old family-owned Pharmacy in Houston, Texas licensed by the Texas State
Board of Pharmacy. Our TSBP license number is 1341. We compounded Rapamycin topical cream for
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the University of Texas Health Science Center in Houston for a 2 year study funded by the U.S.
Department of Defense. Rapamycin topical cream is used to treat Facial Angiofibromas in Tuberous
Sclerosis Complex (a rare disease). The results of the study have been positive and we are receiving
requests for the cream from physicians and patients. Rapamycin cream is dispensed by prescription only.
We do not expect to dispense more than10 prescriptions a MONTH to Washington State patients.
Doyles Pharmacy will NOT deliver any other medication to Washington State patients.
Doyle's Pharmacy does NOT promote its services in Washington State.
Doyle's Pharmacy does NOT have a contract to provide pharmacy services to any employee, or to
any other beneficiary in Washington State.
Rapamycin topical cream is a medical necessity for a limited group of patients, and very few
pharmacies in the US compound it.
The majority of patients are children, and patients/parents/physicians are extremely happy with
the results.
MOTION: Nancy Hecox denied the request presented by Doyles Pharmacy for exemption for licensure.
Doyles Pharmacy needs to be licensed to provide this service in Washington State. Gary Harris second.
Shiraz Pharmacy Technician Training Program application:

Cathy Williams led the discussion regarding Shiraz Pharmacy Technician Training Program. In July 10,
2014 the application was pulled because of a previously failed inspection. The commission moved to
table the application and discussion for further information.
The updated application now meets all needs and the pharmacy passed a follow up inspection 2 weeks
after the failed inspection. The responsible pharmacy manager, Laura Fletcher, has made changes to the
ancillary utilization plans that are required for submission of a technician training program. The ancillary
plans are now completed.
MOTION: Steve Anderson moved that the commission approve Shiraz Pharmacy Technician Training
Program. Gary Harris second. MOTION CARRIED: 11-0.
Federal Drug Administration draft guidance on Drug Supply Chain Security Act:
Chris Humberson provided the draft guidance to the commission for discussion. This has been discussed
already but Chris wanted to bring it up because there will be a closing window for opportunity for
commission to comment December 7, 2014.
Background:
FDA issues draft guidance on identifying suspect drug products in the supply chain
FDA today, issued its first guidance under the Drug Supply Chain Security Act seeking public comment
on its proposal for how prescription drug supply chain stakeholders should identify suspect drug products
in the supply chain and notify the agency when illegitimate drug products are found.
Suspect or illegitimate drug products may pose risks to consumers because they may be counterfeit,
diverted, stolen, the subject of a fraudulent transaction or otherwise unsafe. The guidance, Draft
Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect
Product and Notification, describes potential signs of suspect drug products, including:
Product labeling that contains misspelled words or looks different from the standard labeling;
The finished product is a different shape or color from the standard product or has an unusual
odor;
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The packaging is missing identifying information such as the lot number or expiration date;
The original packaging seals have been opened, damaged, repaired or altered.
FDA also advises supply chain stakeholders to be vigilant in certain situations that could increase the risk
of receiving potentially dangerous drugs, including:
Purchasing drugs from a new source;

Responding to an unsolicited offer, usually with a significantly lower price, that comes through
an advertisement, email, fax or telephone call;
Purchasing a product on the Internet from an unknown source; and
Purchasing a product that is in high demand or one that is on the drug shortage list.
This draft guidance also provides information for supply chain stakeholders about how to quickly notify
FDA when they determine that they have an illegitimate product, and it sets forth a process for
stakeholders to follow when terminating previously made notifications.
The Drug Supply Chain Security Act further enhances the safety of the U.S. supply chain and protects
consumers from potentially unsafe drugs. The Drug Supply Chain Security Act outlines critical steps to
build an electronic, interoperable system over the next 10 years capable of identifying and tracing the path
of certain prescription drugs as they travel through the U.S. distribution chain. This draft guidance is one
of the first steps to implement this new law.
Correspondence, notices, or articles received or distributed by or on behalf of the commission
HCP-DEA Fact Sheet

PARE Standard Setting invitation
Federal Drug Enforcement Administration

Chris Humberson shared the updated information from the DEA regarding the Disposal of Controlled
Substances. There was some brief discussion on this within the commission members. It was agreed that
this would be brought back to the commission in December/January for further review and discussion to
work on some guidelines to help provide some guidance for those that want to provide this Take Back
service.
MedCerts LLC:
Cathy Williams gave the commission some background and introduced Jason Priest. Jason Priest,
pharmacy technician from MedCerts was asking the commission to consider the request for approval of
their online pharmacy technician training program.
Background:
The MedCerts pharmacy technician training program is an online proprietary training program that
prepares students to specifically take the PTCB examination. (The Pharmacy Technician Certification
Board is one of the 2 board-approved national standardized pharmacy technician certification
examination[s] that are recognized nationally, namely, the PTCB or the NHA/ExCPT examinations.
In June 2014, DOH Credentialing referred a pharmacy technician application as an exception application
because the indicated technician training program was not an approved one. The program is MedCerts, an
online accreditation school in Livonia, Michigan. To date MedCerts has enrolled over 1400 students in
our Pharmacy Technician program, most of which are spouses of Active-Duty Military personnel, funded
through the Department of Defenses MyCAA grant program. Of these 1400 students, over 900 have
completed their training and the remainder technicians are actively working towards completion. When
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MedCerts became aware of the situation, they asked how they could become an approved program. At
this point there are still unresolved issues.
MOTION: Dan Rubin moved that the commission deny MedCerts request to approve of their online
pharmacy technician training program. Nancy Hecox second. MOTION CARRIED: 11-0.
PRESENTATIONS
Internship Hours:
Doreen Beebe introduced Nabil Hayek, a foreign pharmacy graduate. Mr. Hayek asked the commission to
waive all 300 intern hours required prior to license. A panel was chosen to hear is request.
MOTION: Nancy Hecox moved to deny Nabil Hayeks request to waive all 300 intern hours prior to
getting licensed. Steve Anderson. MOTION CARRIED: 6-0.
Renton Technical College:

Cathy Williams provided background to the commission this was a non-routine review/approval of
academic technician training program.
MOTION: Nancy Hecox moved to approve Renton Technical Colleges academic technician training
program. Steve Anderson. MOTION CARRIED: 11-0.
PointClickCare :
Lisa Roberts presented this situation with PointClickCare to the commission. She is asking that the
commission reconsider their approval for PointClickCares electronic prescription transmission system.
She introduced Andy Brigant, Vice President of Pharmacy Services and Shawn Brockman, Director for
Clinical Product Management for PointClickCare.
PointClickCare is an electronic prescribing transmission sending system specifically targeted for longterm care facilities. In July 2014, it was brought to the pharmacy commissions attention that
PointClickCares electronic system allows for agents of the physician to enter prescription orders and
submit prescriptions electronically to retail pharmacies with no physician reviewing, sending or
electronically signing the prescription. Pharmacy Commission is being asked to reconsider prior approval
of this electronic prescribing system due to non-compliance with:
WAC 246-870-020 Electronic Transmission of Prescription Information Electronic

Transmission of Prescription Information which by definition means the communication of an
authorized prescriber to a pharmacy.
WAC 246-870-030 - Electronic prescription must require a prescribers electronic, digital or

manual signature.
RCW 69.41.055 - Electronic Communication of Prescription Information which states,

Information concerning an original prescription or information concerning a prescription refill
for a legend drug may be electronically communicated between an authorized practitioner and a
pharmacy
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Background:
PointClickCare is based out of Ontario, Canada. Their electronic prescription transmission system was
Washington State approved in 2012. This system is used exclusively in conjunction with long-term care
facilities. Upon review of PointClickCares submitted materials from 2012, it was apparent that there was
no documentation supporting the requirement for physicians to review, sign or submit electronic orders to
pharmacies. PointClickCares system allows an agent of the physician to enter a telephone order and
submit such an order with no physician review or physician electronic signature. This is not an authorized
process in WA State per WAC 246-870- 020 and RCW 69.41.055.
PointClickCares opinion is that nurses are authorized practitioners and therefore it falls within their
scope to prepare a verbal order electronically and submit electronic prescriptions to pharmacies without
the physician reviewing, signing or submitting the prescription him or herself
MOTION: Dan Rubin moved that this be tabled until December or January when more information can
be gathered. Tim Lynch second. MOTION CARRIED: 11-0.
Confluence:
Lisa Roberts led the September 2014 presentation and had introduced Glenn Adams, Director of
Pharmacy, from Confluence Health Systems. Initially Glenn Adams was asking the commission to
approve the technician specialized function training and competency program for implementation of pilot
project.
Background:
Glenn Adams, Director of Pharmacy Services, from Confluence Health Systems presented a proposal at
the September 11, 2014, commission meeting. The request was for Central Washington Infusion Center
(but was changed during presentation to Wenatchee Valley Hospital) to provide remote medication order
processing and remote supervision of pharmacy technicians compounding parenteral products, including
chemotherapy, for Omak remote infusion center. Although this type of operation violates multiple WACs,
this operation was approved under WAC 246-901-100 as a pilot project. Confluence was required to
license the infusion clinic as a pharmacy and submit a technician specialized function training and
competency program and now operational controls and bounds of this pilot project must be defined by the
commission.
Julie Faun, Pharmacy investigator was in the area not long after the September 11, 2014 meeting. She
stopped by the Infusion Center to introduce herself. She met a pharmacist that has been contracted with
Confluence since July and her contract ends October 31, 2014. She provided Julie an overview of what
she does in the pharmacy. The investigators findings brought concern to the pharmacy commission. The
prior approval of the pilot project was partly based upon the inability to find a pharmacist for this area.
The commission members were not aware at the September 2014 commission meeting that Omak
Infusion Center already had a contract pharmacist compounding chemotherapy.
There was a very in depth conversation regarding this recent discovery. Pharmacy commission members
discussed options of hiring a pharmacist instead of going forward with a pharmacy technician and the
pilot project.Elizabeth Jensen mentioned having a pharmacist at the Omak site and remoting into
Wenatchee for other work as a possible solution.
Glenn Adams answered commission questions and provided additional information.
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MOTION: Elizabeth Jensen moved that the commission rescind the motion made September 11, 2014
Gary Harris second. MOTION CARRIED: 11-0.
Per Al Linggis suggestion, the decision after further discussion was to assign a task force of commission
staff and members to address the issues.. The task force will be Al Linggi, Nancy Hecox, Joyce Roper,
Gordon MacDonald, and Lisa Roberts.
Some items identified for the task force to consider:
.
Facilities and Staffing

Hours of service
Minimum standards
What should be tracked in a pilot project
Until this is resolved Confluence will hold off on the licensing of Moses Lake.
Lourdes Health Network:

Chris Humberson introduced Tracy Clark, Pharmacy Director for Lourdes Health Network. Tracy Clark
asked the commission to consider for approval to implement use of remote pharmacy services through
Medication Review, and specialized technician functions (unit-dose checking).
In their May 29, 2014 presentation to the Commission, the Lourdes Health Network did not include in
their request for approval the Richland Facility. When discovered by the pharmacy investigator that they
were utilizing Remote Order processing and workload balancing, they were contacted to present this
facility for approval from the commission as well. During her presentation Tracy brought up other
requests that the commission wasnt given any information to consider.
MOTION: Elizabeth Jensen moved that the commission table this presentation for more information and
extend the interim approval until January so Lourdes can continue providing their service. Tracy Clark
must work with the consultant to prepare her proposal with all the information needed for the commission
to make educated decisions on exactly what Lourdes Health Network is requesting. Steve Anderson
Kaiser Remodel:
Chris Humberson introduced Sandra Dahl, RPh, KPNW Pharmacy Area Director who asked the
commission to consider their proposal to amend the workload balancing proposed in July to
accommodate the closure/remodel of the NW Salmon Creek Pharmacy.
Overview
Kaiser Permanente Northwest (KPNW) is implementing the PDX-EPS pharmacy

dispensing system and is requesting the Washington State Pharmacy Quality Assurance
Commission (PQAC) approval of a Workload Balancing prescription process for KPNW
Washington licensed Pharmacies utilizing Washington licensed staff.
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Similar to other Workload Balancing programs, this would allow Washington licensed
pharmacists and technicians at multiple Washington licensed pharmacy locations to
remotely assist one another in processing prescription orders.
The purpose is to maximize staff resources, create efficiencies, and maintain patient safety.
KPNW Pharmacy Services
Sizes of the outpatient pharmacy locations range from small ( 75 Rx/8 hr day) to large
(1000+/14 hr day).
Pharmacy staff mix ranges from 1 technician & 1 pharmacist teams (1:1) to14 technicians
teams & 10 pharmacists (1.4:1)
The clinical pharmacy services includes Drug Information, Formulary and Therapeutics
Management, Benefits management, MTM, Anticoagulation Clinic, Transition Pharmacy,
International Travel Clinic, Pain Management, Cardiovascular Risk Management,
Pharmacy Residency Program, Infectious Disease, Diabetes management, and Refill
Protocol.
ePIMS (Enterprise Pharmacy Information Management System)ABOUT THE SYSTEM
PDX-EPS Retail Pharmacy Management System platform, known as the Kaiser

Permanente enterprise Pharmacy Information Management System (ePIMS), includes a
few program enhancements to accommodate the interface with KP HealthConnect our
electronic medical record system, Central Fill and Mail Order Pharmacy systems
ePIMS retains all the regulatory compliant functions of the PDX-EPS Retail Pharmacy
Management System
The basic prescription dispensing work flow of ePIMS is the same as the PDX-EPS system
ePIMS uses a common patient data base.
work flow
Prescription Work Load Balancing
What it is:
o
Distributing the work across all appropriate pharmacy locations (depending

on location licensure and staff licensure) at the appropriate times while not
exceeding the 3:1 technician to pharmacist ratio.
This is work that does not require direct contact with the patient or physical
handling of the medication.
Staff at a low volume or slow pharmacy location can remotely access orders
at a busier location to assist in processing those orders.
What it is not:
o
It is not counseling
It is not the physical manipulation of medication products or the act of

filling the prescription (preparing medication for dispensing or labeling)
It is not doing the final verification of the filled prescription (checking for
right drug with right label on the bottle)
The purpose for implementing Workload Balancing
Improves efficient use of pharmacy staff resources by preparing (includes Order Entry,
Data Entry, Data Verification, and DUR)the prescription order for fill at a location
pharmacy.
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Leverages the use of the common patient database which keeps the patient profiles whole.
The pharmacy systems automated prioritization function allows a high volume pharmacy
environment to better manage their incoming prescription orders with the assistance of
Workload Balancing and the Central Fill Pharmacy.
Reduces stress in the work environment due to high incoming prescription order volume.
Assists to maintain a high level of patient safety by allowing staff more time to better focus
on the needs of those patients present at the pharmacy.
What does success look like?
Getting Todays work done Today
Improved People Pulse Work Index Survey results (indicator of staff satisfaction)
Maintaining a high level of patient safety and quality
Building collaborative relationships between staff at different work locations
Expansion of patient counseling opportunities (medication adherence, medication

reconciliation, prescription synchronization) due to more efficient use of pharmacist staff
resource.
Quality Indicators
Expected decrease in Drug Furnishing Irregularities
Sentinel events are explored through Root Cause Analysis (extremely rare)by a multidisciplinary team
Pharmacy is closely partnered with Regional Quality Resource Management, Risk

Management, Regional Compliance, and National Compliance and regularly reviews
patient safety issues
MOTION: Tim Lynch moved that the commission approve the proposal to amend the workload
balancing proposed in July to accommodate the closure/remodel of the NW Salmon Creek Pharmacy.
Steve Anderson second. MOTION CARRIED: 11-0.
OPEN FORUM:
Grant Chester passed out copies of the Exempt Narcotic Rules. What he came to talk to the commission
about at this meeting was precedence. Every time you have a board meeting you set precedence. When
you have someone come and present something to you odds are it has been seen before. When you make a
decision you should be provided the precedence from what has been done before. These decisions have
been made before. Your prerogative to change a precedence but if you do you should realize that it may
only apply just to the one firm or topic. He provided a few examples. What I recommend you do prior
to making a decision is have staff provide you with precedence with what has been decided in the past.
When you do make a decision post it on PQAC website to allow those interested in a presentation they
may be able to see what has been needed for going before the commission. It may save the commission
some time. When you are setting precedence be very cautious.
Christopher Barry shared a concern that when we talk about live feeds of pharmacy technicians working
remotely. What happens when no one is watching? As a commission we really need to pay attention to
this portion of a proposal.
15
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by:

Christopher Barry,
Chair
Washington State Pharmacy
Quality Assurance Commission
16
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MEETING
October 27, 2006
Washington State University
Academic Center, Room 147
600 North Riverpoint Blvd
Spokane WA 99210-1495
CONVENE
Chair Asaad Awan convened the meeting at 9:06 a.m. on October 27, 2006.
Donna Dockter, RPh
Gary Harris, RPh
Rosemarie Duffy, RN
George Roe, RPh
Bill Kristin, Pharmacist Investigator
October 27, 2006
Open Meeting
CONSENT AGENDA
1.1
Joshua Nutting Nuclear Pharmacist
New and Closed Firms 08/03/2006 through 09/13/2006

Yokes Pharmacy
Dan Kent Vytorin
1.2
1.4
1.5
Scott Craig Nuclear Pharmacist

Propac Pharmacy
Hanie Castro Philippine Womens University
Kristy Green The Bryman School of Tempe
Hefeng Huang Fujian College of Public Health
Dan Kent Diabetes
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1.6
Klickitat Valley Hospital

August 31, 2006
1.8
Items 1.3 Pharmacy Technician Application Approval; 1.7 Sample Distribution Requests were
deleted from the consent agenda. MOTION: Rebecca Hill moved to approve 1.1, 1.2, 1.4, 1.5, 1.6
and 1.8. George Roe second. MOTION CARRIED 6-0.
REPORTS
The Department of Health held the Annual Board, Commission and Committee (BBC)
conference on August 28, 29 and was attended by Rebecca Hille and Gary Harris.
Initiative 900 mandates that the State Auditor review and analyze the economy,
effectiveness and efficiency of state agencies operations . The Department of Health,
Health Professions Quality Assurance will be the first program to under go the audit. The
Auditors office contracted with Clifton Gunderson, a firm from Austin, Texas. The audit
is expected to be completed May 2007. The audit will focus on the Departments
compliance with existing performance measures .
The Department has submitted decision packages to the Office of Financial Management
for the 07-09 budget. The Department is asking for additional spending authority to
reduce the 574 disciplinary case backlog, Attorney General Services, and completion of
the new licensing system (ILRS).
The legislature directed the Department to conduct a criminal background feasibility

study. The study is due in December and will examine whether the Department should
query additional sources upon receipt of applications and if background checks should be
conducted on credential renewals. Currently, the Department queries the Washington
State Patrol, National Practitioner Database, and the Health Integrity Protection Database.
The Board has received one application for the Central Washington Investigator position.
Staff will be working with the Human Resources Office to expand recruitment efforts.
George Roe, Grace Cheung and Lisa Salmi attended the National Association of Boards
of Pharmacy (NABP) District VII and VIII (Washington, Arizona, California, Idaho,
Montana, Nevada, New Mexico, Oregon, Utah and Wyoming) meeting in Anaheim,
California. Program presentations included creating an ethics program for pharmacists,
pharmacy practice in long-term care facilities, Medicare prescription drug benefits
program, internship/externship experience, Food & Drug Administration update on
Prescription Drug Marketing Act, Drug Enforcement Agency update and
disaster/emergency preparedness.
District VII and VIII voted to send a resolution to NABP asking the association to work
with DEA and FDA to develop a public education campaign to education consumers
about the dangers of ordering drugs through the Internet.
Staff has devoted a considerable amount of time to prepare rule making documents for
the Pharmacists Professional Responsibilities issue.
Board Members
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Rebecca Hille reported on a presentation on Ethics in Government at the BCC conference, which
provided an overview of the ethic laws and an opportunity for discussions and exercises on how
the ethic laws apply to a variety of scenarios.
In addition, there was a discussion on the Uniformed Disciplinary Act, responsibilities of Boards
and Commissions, and the lawsuit that initiated changes in the disciplinary process.
The conference included a viewing of the July 12, 2006, Departments Government Management
Accountability & Performance (GMAP) presentation to Governor Gregoire on Health
Professions Oversight and Discipline.
Gary Harris reported that the BCC conference provided an opportunity to discuss differences in
authorizing investigations, decision processes and the diversity in the number of disciplinary
cases handled by Boards and Commissions represented at the conference.
George Roe reported that he participated in the task force charged with reviewing disciplinary
and investigative processes.
Donna Dockter reported that she was chosen to participate in a pilot project on Continual
Professional Development. The University of Washington and the University of Wisconsin have
received money for a pilot tasked with looking at improving/enhancing professional practice
th
verse continuing education requirement . The first meeting is scheduled for November 5 .
Susan Teil-Boyer reported on an emergency preparedness drill that will be taking place on
th
November 14 from 3 to 8 p.m. in Pierce County Operation Tremor (large magnitude
earthquake drill). The drill will involve hospitals and Emergency Medical Systems (EMS) in the
county.
Pharmacist Consultants/Investigators
Summarized activities related to recent survey conducted to gather input on the Pharmacists
Professional Responsibilities proposed rule.
Briefed the Board on discussion on the potential for approving electronic transmission of
Schedule II prescriptions with the use and verification of digital certificates.
Updated the Board on emergency response activities resulting from federal and state funds.
The funds will provide an opportunity for state and local health districts to purchase antiviral
drugs and storage challenges.
Presented to attendees of the BCC conference on illegible prescriptions . The presentation

focused on several of the recommendations resulting from the Department of Health 2000
Medication Error Report. The reports primary recommendation was to eliminate all
handwritten prescription by 2005.
Participated with representatives from the Department of Labor and Industries, Department
of Social and Health Services and the Health Care Authority at a public meeting on October
rd
23 discussing Opioid dosing guidelines developed by the Agency Medical Directors Group.
3
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Training changes are being implemented for Nuclear Pharmacist to comply with didactic and
experiential training requirements developed by the State Radiation Control Agency.
Mr. Mecca briefed the Board on the DEAs new program Control Substance Ordering
System (CSOS) will allows pharmacists to order C2s electronically.
Chief Investigator
Investigation and Inspection statistics for August and September.
Rebecca Hille will attend the next quarterly Investigators Meeting scheduled for December.
August 2006
Investigator Jim Lewis provided an overview of Pharmacy Law Relevant to the Role
of Pharmacy Technicians in the Pharmacy Inspection Process to the Clark College
Pharmacy Technician class.
Investigator Richard Morrison provided a presentation to the staff at Jefferson
General Hospital on Drug Diversion Detection and Responsibilities .
September
Board member Rosemarie Duffy attended the quarterly Investigators meeting.
Investigator Morrison participated in the MPJE Review Committee Meeting where
they reviewed and revised law questions for appropriateness in preparation of the
state specific MPJE review in January 2007.
Investigator Cheung attended a DEA presentation entitled The Changing Landscape
of Prescription Drug Abuse . Several panels provided updates on current trend and
challenges in controlled substance diversions .
Investigator Cheung attended the Pacific Rim Meth Summit. Updates on
methamphetamine action teams from across the country and presentations on other
meth related topics.
October
Investigator Cheung attended the National Association of State Controlled Substances
Authorities (NASCSA) meeting. Updates on topics relating to controlled substances,
Prescription Monitoring Programs, Buprenorphine, drug disposal and others.
DISCUSSION
Update on Methamphetamine Workgroup
nd
th
The Methamphetamine workgroup held its 2 meeting October 18 . Board Investigator Jim
Doll will lead the Workgroup following Randy Fletts retirement. The Board is represented by
Donna Dockter.
Highlights:
Representatives from the Snohomish County Meth taskforce and Pierce County
taskforce presented information on their respective activities to combat methamphetamine in
their respective communities .
Snohomish County has personnel dedicated to review logs and entering the
information into a database. They feel the logs appear to be working as a deterrent to purchases
made for illegal purposes. The Pierce County taskforce reports that the log has not deterred these
activities.
Presentation by two vendors of electronic transaction logs both offering real-time
point of sale technology. Concerns regarding mandating use of electronic logs include ease of
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integration within pharmacy computer systems and potential financial impacts to small
shopkeepers.
Discussed pros & cons of making pseudoephedrine products prescription only.
The next meeting of the Workforce is scheduled for January 17, 2007. Representatives from
Oregon will discuss their experiences and outcomes in making pseudoephedrine a legend drug.
Pharmacists Professional Responsibilities WAC 246-863-095
Chair Awan restated the decision made at the August meeting regarding Pharmacists
Professional Responsibilities proposed rule amendments and asked to open the proposal for
further discussion.
st
MOTION: Gary Harris moved that the Board reconsider the motion from the August 31
nd
meeting in order to discuss new information. Rebecca Hille 2 . MOTION CARRIED. 6-0
Susan Teil-Boyer offered alternative languague developed by representatives of the Washington
State Pharmacy Association, Northwest Womens Law Center and Planned Parenthood and
supported by Governor Gregoire. The alternative language addresses concerns raised regarding
pharmacist versus pharmacys duty to dispense. MOTION: Susan Teil-Boyer moved to
nd
approve the new language and proceed with filing a CR102. George Roe 2 . MOTION
CARRIED 5-0, Donna Dockter abstained.
Discussion:
The Board discussed the differences between deliver verses dispense and reviewed the
definitions in statute.
RCW 18.64. Deliver defined as the actual contructive or attempt to transfer from one person
to another of a drug or device whether or not there is an agency relationship.
RCW 18.64. Dispense defined as the interpretation of a prescription or order for a drug and
pursuant to that prescription or order the proper selection, measuring, compounding, labeling or
packaging necessary to prepare that prescription for delivery.
Donna Dockter expressed concerns that the use of the word deliver is unclear and that the
assumption is that dispense includes counseling and giving the medication to the patient . Ms.
Dockter felt that the word deliver is not consistent with the way the Board has written rules in
the past. In additon, she stated the practice detailed in 3(c) of the draft establishes a level of
service that is unfunded and unreasonable.
Gary Harris felt that 3(c) meets the intent of the rule by minimizing barriers for patient access.
The Board discussed at length the need to hold additional stakeholder meetings or solicit written
public comments on the draft language regarding pharmacies. Donna Dockter supported
additional stakeholder meetings. Other members felt that the previous stakeholder meetings and
large number of written comments had contributed to these changes. There will be additional
opportunities to comment after filing the CR102. Additional stakeholder meetings would delay
the rules process well into the 2007 Legislative Session.
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Joyce Roper clarified that the Administrative Procedures Act (APA) does not require the Board
to go back to interested parties and hold additional stateholder meetings or solicit written
comments once the Board has developed language as a result of stakeholder work.
MOTION: Rosemarie Duffy moved to proceed and file a CR101 (Preproposal Statement of
Inquiry) regarding WAC 246-869 Pharmacies Responsibilities with a witten comment
submission process. Gary Harris second. MOTION CARRIED. Vote 5-1. Donna Dockter
opposed.
Next Steps:
File CR101 (Public Notice) to open draft WAC 246-869 (Pharmacies) language for written
pubic comments.
Discuss comments Board decides whether to proceed with CR102.

CR102, Small Economic Business Impact Statement and Significant Analysis prepared/filed.
Public Comment Period.
Rules Hearing (projected hearing date March 2007).
PRESENTATIONS
Wal-Mart/Sams Club - request for approval of Will-Call Kiosk.
Tim Fuller provided a brief introduction to the request by Wal-Mart/Sams Club for approval to
utilize automated will-call bin technology. The will-call bin/kiosk is designed to allow for
controlled storage management, purchase and will-call pick-up of prescriptions during or after
pharmacy hours. Mr. Fuller summarized concerns regarding compliance with patient counseling
rules and pharmacy standards in the absence of a pharmacist, which does not permit
prescriptions to be removed from the pharmacy without a pharmacist present.
Mr. Jason Reiser of Wal-Mart was accompanied by William Holmes, the vendor president . Mr.
Reiser described the automated will-call bin as another deliver device; such as, mail order,
courier, etc. Currently, the will-call bins are utilized in 15 states . Most recently, Nevada passed
final rules on will-call/retail delivery devices.
Automated Will-Call Bin - Specifications
7.5 feet tall and 600 800 lbs.
If more than one Rx available, customer may select which Rx they purchase at that time.
Floor bolts and door locks.

Holds up to 1000 prescriptions .
Barcode verification during loading & delivery.
Integrated with pharmacy computer system.
Front & rear access.
Full inventory.
Electronic signature pad.
Manual override for power outage.
Telephone for contacting pharmacist after pharmacy hours.
Customer has a user name and a personal identification issued the PIN is only known to
the person registering on the machine.
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Machine asks for customer to verify medications with on-screen reference.

Digital photograph and signature.
52 languages
Options to customize configurations of screens
nd
rd
Use of the kiosk is optional for patients. The pharmacist will designate which 2 or 3 time refill
prescription will be available for access through the kiosk. The selection will be done on a case
by case basis and will include only refills where no counseling is deemed necessary. It is
estimated that one-third of all refills processed at the pharmacy would be accessed by using the
kiosk and only 5% of those prescriptions would be accessed after pharmacy hours .
Mr. Rieser demonstrated the operation of the will-call bin/kiosk and explained options that can
be tailored based on the Boards requirements.
MOTION: Rosemarie Duffy moved that Wal-Mart/Sams Club is directed to work with Board
staff Tim Fuller and Grace Cheung in drafting a written proposal for review and approval by the
Board prior to the initiation of a six-month pilot . The proposal shall include the following
conditions:
1.
Refills only, pass through front of kiosk.
nd
2.
The kiosk intructions provides the patient a 2 oppportunity to speak to pharmacist after
the drug is delivered.
3.
Will-call bin/Kiosk is physically attached to the pharmacy.
4.
The kiosk has a telephone to allow patient to speak with a Washington licensed
pharmacist.
5.
The kiosk is operational only when the pharmacy is open.
6.
Board Investigators will negotiate with Wal-Mart on placement of will-call bins/kiosks
Susan Teil-Boyer second. VOTE: 3 -3. Donna Dockter, Rosemarie Duffy and Susan Teil-Boyer
voted in favor George Roe, Gary Harris and Rebecca Hille voted in opposition. Chair Asaad
Awan breaks tie in favor of motion. MOTION CARRIED.
EXECUTIVE SESSION CLOSED SESSION

pending litigation.
Chair Awan announces that the Central Fill proposal by Rx.com has been postponed to a future
meeting (Agenda Item 4.2). In addition, the Government Management Accountability &
Performance video of the Health Professions Oversight and Discipline presentation to Governor
Gregoire was removed from the agenda (Item 4.3).
DISCUSSION Contd
Open Forum with WSU College of Pharmacy Students
rd
The open forum provided an opportunity to inform WSU College of Pharmacy 3 year students
on the role of the Board on the practice of pharmacy in Washington and its current activities.
Issues and exchanges of information included intern/externship programs; pharmacists licensing
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requirements, jurisprudence examination, and NAPLEX; access to care (Pharmacists

Professional Responsibilities Rule), pharmacists staffing issues; medication errors/safety;
patient counseling; FDA Plan B over-the-counter; Provider Look-up Website; statutes
(RCWs) and administrative rules (WACs); Uniformed Disciplinary Act and Washington
Recovery Assistance Program for Pharmacy (WRAPP); household pharmaceutical return pilot
(PH:ARM); and Collaborative Agreements.
The Board extends its thanks to the WSU College of Pharmacy faculty and students for their
participation.
Delegation to Initiate Investigations.
Lisa Salmi lead the discussion regarding the August of 2005 Yoshinaka A & B decision and an
opinion issued by the Washington State Court of Appeals that investigations could not proceed
until the Board or Commission reviewed the complaint and determined that there was reasonable
grounds to believe that unprofessional conduct had occurred.
However, the Court of Appeals acknowledged that Boards and Commissions did have the
authority to adopt rules to allow delegation to staff to initiate an investigation. The Board was
asked to consider rule making to delegate to staff the authority to investigate allegations of
unprofessional conduct and applicants or credential holders who may be unable to practice with
reasonable skill and safety by reason of mental or physical condition.
Proposal 1 Delegates authority to a Case Management Team (CMT) which will include the
Executive Director or designee, a pharmacist investigator, and staff attorney.
Proposal 2 Delegate authority to a CMT which will include a Board member, the Executive
Director or designee, a pharmacist investigator, and staff attorney.
The Board expressed interest in considering proposed draft 1 with amended language where
established categories of unprofessional conduct may be delegated to CMT for initiation of
investigations. Conduct not included in the established categories must be considered for
investigation by CMT and a Board member. The Board did not enter a motion on this issue.
ACTION: Staff will developed a list of categories for the Boards review at a later date.
Suspicious Transaction Rule.
The Board discussed proposed rule language regarding reporting requirements for wholesale and
retail suspicious sales or transfers of ephedrine, pseudoephedrine and phenylpropanolamine in
excess of legitimate consumer needs.
MOTION: Rebecca Hille moved that the Board file a proposed rule language with the Office of
the Code Reviser (CR102) with correction to subsection 4 removing the s to over-the-counter
drugs. George Roe second. MOTION CARRIED 6-0.
Rule Prioritization.
The Board was asked to priorities rule making activities using the guidelines provided by the
Department of Health and to name a Board member sponsor for each rule. The Departments
guidance established priority criteria as 1) Legislative mandates 2) High priority and patient
safety rules; 3) Petitions for rule making; and 4) Discretionary rules.
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Pharmacists Professional Responsibilities All members

Sexual Misconduct Donna Dockter
Precursor Suspicious Transaction
Pharmacy Technicians National Standardized Examination
Extended Care Facilities Destruction of Controlled Substances Asaad Awan
Add Soma to CSA Gary Harris
Update Wholesaler Rules Asaad Awan
Update Animal Control Agency and Humane Society Rules* Rosemarie Duffy
Stop Renumbering Refill Rx if No Changes are Made to the Original Prescription
Rebecca Hille
Extend Expiration of Non-Controlled Substance Prescription to 2 years Rebecca Hille
Update Controlled Substance Act George Roe
Update Hospital Rules Susan Teil-Boyer, Asaad Awan
Law Book Asaad Awan
*Correction noted for petitioner - Update Animal Control Agency and Humane Society Rules
corrected to Adam Karp.
Multiple Prescriptions for Schedule II Drugs.
The Board reviewed the Drug Enforcement Agencys proposed regulations allowing authorized
practitioners to issue multiple Schedule II prescription on the same day with instruction to fill on
different dates allowing patient to receive up to a 90 day supply of controlled substances so long
as specific conditions are met.
Andy Mecca summarized that the proposed rule would:
1.
Allow an authorized practitioner to issue up to but not to exceed 90 days of multiple
prescriptions example- three prescriptions for 30 day supply.
2.
Restrict pharmacists from filling the prescription prior to the date specified on the
prescription.
Mr. Mecca reiterated that pharmacists may not change or add the patients name, drug or
physicians signature to a CII prescription. The dose, strength, and directions may be changes or
added upon the permission of the prescriber.
ACTION:The Board has asked staff to write a letter to the DEA in support of the proposed rule
regarding multiple prescriptions for CIIs.
Correspondence
st
The Board was provided copies of the Governors 1 Annual Government Accountability
Report, and information regarding a performance audit of the Department of Health, Health
Professions Quality Assurance office.
Gary Harris asked about the implications of the consolidation/realignment of the Health Systems
Quality Assurance Division (HSQA) reference in the audit summary and how it may impact the
personnel of Health Section 4. (In August 2006, Laurie Jinkins, Assistant Secretary of HSQA
briefed the Board on the divisions realignment strategies.)
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Lisa Salmi offered that the realignment is still in the planning stages. Recently, Departments
staff were briefed on the process used to design the restructure of the Assistant Secretarys office
to include new staff focused on human resources and media. The realignment of HSQA will
impact the division as a whole; therefore, plans are to move forward with all offices
simultaneously.
ACTION: George Roe, Rebecca Hille, and Asaad Awan will work with Lisa Salmi and Grace
Cheung to write a letter to the Assistant Secretary expressing the effectiveness and efficiencies in
preserving the education and experiential expertise of pharmacists when conducting
investigations and inspections of pharmacy practice sites and disciplinary cases.
Consumer Waste Pharmaceutical Collection Pilot Program.
In August the Board approved the model guidelines to be used by pharmacies in developing their
policies and procedures for participation in the Pharmaceuticals from Households: A Return
Mechanism (PH:ARM) pilot. The Board was asked will consider delegating approval of these
operating policies and procedures to staff.
Doug Beeman, representing Group Health Cooperative provided an update of the GHC
participating pilot locations and indicated that all sites will be operational on Monday, October
30, 2006. Pilot locations include:
Seattle Eastside Primary Care

Olympia
Silverdale
Everett
Renton
Burien
Spokane Riverfront
ACTION: Department staff is requested to coordinate with Department of Ecology to draft a

media release announcing the PH:ARM pilot.
MOTION: Susan Teil-Boyer moved to delegate to staff the review and approval of policies and
procedures submitted for participation in the Household Pharmaceutical Waste Pilot Project.
Rebecca Hille second. MOTION CARRIED 6-0.
OPEN FORUM
Doug Beeman, Group Health Cooperative shared new OTC packaging for Plan B.
Mr. Beeman also inquired to the status of the Executive Director appointment . Lisa Salmi
explained that the position was offered to a candidate but he elected not to accept. The
Department will begin recruitment in the near future. The Board acknowledged Lisa Salmi for
her work as Acting Executive Director.
Adjournment
There being no further business, the Board adjourned at 4:05 p.m. They will meet again on
December 14, 2006 in Kent, Washington.
10
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__________________________________________
_________________________________________
Board of Pharmacy
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State of Washington

October 29, 2015
Renton, WA 98057
CONVENE
Commission Members:
Al Linggi, RPh, MBA
Guest / Presenters:
Call Center Manager
Steve Anderson, RPh

Nancy Hecox, PharmD
Gary Harris, RPh,
Pharmacy


Tim Lynch, PharmD
Staff Members:
Joyce Roper, AAG
CALL TO ORDER
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CARRIED: 12-0.
CONSENT AGENDA
September 2015
Old Business
Bartell Drugs
2014.
Goals

service offerings
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Principal Functions
Workflow Issues
Drug not covered

Q.A. Assessment

Challenges



Dispensing - 80%
Paperwork 70%
Returns 55%
Counseling -83%
Immunization 60%
MTM 23%
Future

rd
3 Party
Specialty Pharmacy
pharmacist
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the commission.

New Business
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business
January 2016
2016
2016
Current System:
discovery.
deliveries.
New System:
authorities.
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Today
Demonstration
Ongoing
Citrix User Guide
HSQA Call Center
Recorded Webinar
Expectations
In 7 days Log-In
o Survey
New Business

Plans.
approval.
approving body.
when
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CARRIED: 11-0.

first
Open Forum
Jeff Rochon WSPA
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New Business Contd

CARRIED: 12-0.
2.4
Pharmacy Technician
2.5



A statement of
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Correspondence:
Requests
system.
Shopko
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Committee Reports
moving forward.
th

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Olgy Diaz reported:


Dan Rubin reported:
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pharmacy.
October 9 and 22
incoming class.
th
nd
LTCFs
rd

Al Linggi reported:

Staff Reports
Executive Director
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Consultants

them at this point.
Kyle Wu reported:
looked at USP 800.
pharmacists do.

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the field.
Open Forum


being overwhelmed.
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Al Linggi, Chair
Commission
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State of Washington
Special Meeting
October 30, 2015
Kent Commons
Crystal Mountain Hall
th
525 4 Ave N
Kent, WA 98032
CONVENE
Chair Al Linggi called the special meeting to order at 12:00 p. m.
Commission Members:
Tim Lynch, PharmD
Nancy Hecox, PharmD
Al Linggi, ChairRPh, MBA
Tim Lynch, PharmD (via phone)
Guest/ Presenters:
Marie Sullivan
Staff Members:
Stakeholders:
Jeff Rochon, Chief Executive Officer, Washington State Pharmacy Association
Claudia Sanders, Senior Vice President Policy Development, Washington State Hospital
Association (phone)
Lis Houchen, Regional Director, Government Affairs, National Association of Chain Drug
Stores (phone)
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Lauri St. Ours, Director of Governmental and Legislative Affairs, Washington Health Care
Association.
This meeting was put together to discuss the communication plan put together by Marie Sullivan
along with an action plan put together by Department of Health. The goal of this meeting was to
have stakeholders, commission members and staff to discuss their concerns and suggestion ways
for the commission to better serve, communicate and meet the needs of stakeholders and patients
while staying on the same page.
The meeting began by allowing the stakeholders share their views, concerns and suggestions.
Jeff Rochon, Chief Executive Officer, Washington State Pharmacy Association

Claudia Sanders, Senior Vice President Policy Development, Washington State Hospital
Association (phone)
Lis Houchen, Regional Director, Government Affairs, National Association of Chain

Drug Stores (phone)
Lauri St. Ours, Director of Governmental and Legislative Affairs, Washington Health
Care Association.
The commission members followed responding to stakeholders and also sharing their concern
and suggestions on ways to bring together the commission and stakeholders.
Maria Sullivan discussed her communication plan that she brought before the commission first in
July and back again in September. She opened the floor to allow for more questions and or
suggestions from both stakeholders and commission members.
The staff and Executive Director, and Lisa Hodgson also had an opportunity to share their input
and answer questions. The Commission and staff discussed where to focus priority work and
moving forward while providing better communication and transparency with stakeholders and
the public.
Comments:
1) The inspection process - having more communication on changes, what type of system to
use and changing / updating the process.
2) Communication
internally (staff, commission members and inspectors,
(externally
(stakeholders and public). The goal is to have as much transparency as possible.

3) Rules process- many concerns how this process has been done in past year or so.
Stakeholders shared that the way it was done in the past was/ is preferred and they felt
much more efficient. Allowed transparency and the stakeholders to play a bigger role in
the final outcome.
4)
Providing commission members and the
stakeholders commission meeting material.
In a timely manner
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How to get it the information out to the stakeholders and public to provide more
transparency.
5) It was noted the action plan is very aggressive.
There being no further business, the commission adjourned at 3:45 pm


Al Linggi, Chair
Commission
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STATE OF WASHINGTON
MEETING MINUTES
November 4, 2010
Lacey Community Center
Banquet Rm. A & B
6729 Pacific Avenue SE
Lacey WA 98509-3400
CONVENE
Chair Gary Harris called the meeting to order at 8:40 a.m., November 4, 2010.
Dan Connolly, RPh

Heather Carter, AAG
Joyce Roper, AAG
Guest / Presenters:
Jo Schnotala, RPh
Andre Rossi, Pharm.D., RPh, Dept. of Corrections
K. Douglas Crafton, RPh, Medication Review
President/CEO
Lateef Olaniyan, RPh, Southgate Pharmacy
Tim Lynch, Pharm D., MS, Regional Director of
Pharmaceutical Services Franciscan Health System
Hatam Shafeean, Pharm.D
Eric Werttemberger, Pharmacy Director for
Providence Everett Medical Center
Jerry Berndt, General Manager for
Roger Melching, Omnicare IT Product Manager
Daniel Y. Kim, Clinical Pharmacy Manager for
Northwest Hospital and Medical Center
CONSENT AGENDA
1.1
New Pharmaceutical Firms - Aug 27-Oct 21, 2010
1.3
Closed Pharmaceutical Firms Aug 27- Oct 21, 2010

1.5
Providence ADDD service to St Joseph Care Center

Board Minute Approval. (September 16, 2010)
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agenda. Item 1.2 and 1.4 has been deleted from the agenda.
MOTION: Dan Connolly moved that the board approve items 1. 1, 1.3 and 1.5. Vandana Slatter
REPORTS
Board Member
She attended the Spokane Pharmacy Association banquet October 12, 2010. This was
very informative and a great turn out. The numbers of members are up this year.
Al Linggi reported:
Al attended the Annual National Association Boards of Pharmacy (NABP) District
Meeting 6, 7 & 8 held September 28-30, 2010.
NABP launched a community pharmacy accreditation program that includes
Continuous Quality Improvement and is a voluntary program and will begin
2011.
American Association of Colleges of Pharmacy (AACP) shared that over
17,000 applied to schools of pharmacy last year 86 schools participated in
pharm-cast program. There are 119 schools accredited by Accreditation
Council for Pharmacy Education (ACPE) 6 schools are pending.
In Nevada Prescription Monitoring Program (PMP) investigators are
policemen. They provided recommendations and information for this
program. Nevada has had this program for five years.
There was a lot of discussion regarding electronic generated prescriptions.
October 29, 2010 attended the University of Washington Practice Advisory Group.
October 4, 2010 Gary participated in the Boards/Commission Leadership meeting in
Kent.
Each Board/Commission had 3 minutes to discuss what their board has been
working on.
Gary shared with other boards that the board has been working on:
The funding for Prescription Monitoring Program
His involvement in the Chronic Non-Cancer Opioid Task Force
The boards involvement in the Access to Medication Rule
September 22-23, 2010 Gary was a guest at NABP in Chicago.
NABP is a great resource we should be using them more for model rules, information we
could utilize.
September 17 & 29, 2010 Access to Medication Stake holder Meetings.
Executive Director
Pain Management Workgroup: Five prescribing boards and commissions are developing
rules for safe and effective pain management therapy for chronic non cancer pain
patients. The workgroup is setting a dose threshold (MED) for a required pain consult.
The board of pharmacy has been an active participant and has submitted rule language
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content to require communication with the pharmacist when prescribing high dose opiate
therapy. Gary, Tim and I presented recommendations to the Workgroup to include the
medication indication on the prescription when prescribing high dose opiate therapy.
The workgroup added a requirement for patient identification when picking up a high
dose opiate prescription.
Board and Commission Leadership Meeting: October 4, 2010 Gary, Al and I attended
the B/C leader meeting by videoconference. The meeting topics included Health Systems
Quality Assurance Updates, Reshaping Governmental Public Health in Washington State
Public Health in a Time of Change, update from Secretary Mary Selecky and board
updates.
Researching synthetic cannabis (spice, k2): We have had multiple inquiries as to the
boards position on the legal status of this substance(s). We are meeting internally to
determine next steps including meeting with law enforcement and prosecutors.
Hospital Pharmacy Directors Stakeholder Meeting: Tim and I met with the statewide
hospital pharmacy directors at the rules stakeholder meeting September 24, 2010 in
Yakima.
Jail medication draft policy: Jim Doll and I reviewed and provided specific feedback to
WASPC regarding their jail medication policy. The feedback has been sent out to their
members.
The 2010 Legislature passed a bill to require implementation of board of
pharmacy rules and statewide electronic tracking of retail sales of
pseudoephedrine, ephedrine and phenylpropanolamine (PSE) products. These
efforts will support law enforcement as it increases its interventions with
smurfing, the term for multiple purchases of these products at pharmacies

and retail stores. A stakeholder workshop was held August 26, 2010 at the
department of health with excellent feedback from the public and interested
parties.
NABP District 6,7,8 2011 Seattle: We are beginning the planning for the NABP/AACP
Meeting to be held October 4,5,6, 2011 at the Edgewater Hotel, Seattle. Mark your
calendars!
Tim attended the DOH Chronic Pain Treatment Workgroup s final meeting October 18,
2010 at the Black River Conference Center in Renton. The Workgroup achieved
agreement on a mandatory consultation at 120 mg Morphine Equivalent Dose (MED),
and additional considerations, such as CE and experience with a multidisciplinary chronic
pain treatment center, under which a practitioner may exceed the threshold without
consultation. The agreement specifies in the treatment plan the indications for
medication use on the prescription and requires photo identification in or der to fill the
prescription. Health information exchange is listed as part of the patient evaluation . The
Final Working Document now goes to the Boards and Commissions for the rules process.
October 25-26, 2010 Tim attended a pharmacist investigator meeting. A good many
issues were discussed with the group. Topics include RTFs and LTCs, Group Health
computer system, DEA Interim Final Rule for electronic transmission of scheduled
prescriptions, drug disposal and take-back, Agent of the Practitioner and the startup of the
Prescription Monitoring System.
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September 28, 2010 Cathy participated in the Delfini Evidence-Based Washington State
Training Program funded by Dr. Steve Hammond, Medical Director for the Department
of Corrections.
October 20, 2010 she also participated in the Washington State Pharmacy & Therapeutics
Committee.
Chief Investigator
Starting in September and going through December 15
th
participating in a pilot Customer Satisfaction Survey.
the pharmacist investigators are

This survey is sponsored by the
Office of Customer Service.

September 17, 2010 Greg Langand Dick Morrison gave a presentation on Drug Diversion
at Stevens Hospital.
Tyler Varnum gave a Pharmacy Law presentation at the Spokane Community College
October 9, 2010.
There was a Pharmacy Investigator Meeting held in Tumwater October 25-26, 2010.
DISCUSSION
Access to Medication Rules Process
Gary Harris, Board Chair, provided a summary of the rule activities to date, acknowledged that
the board has received over 5000 comments, and identified the possible next steps in the rule
process. Mr. Harris acknowledged that because this is an open public process, this is the first
opportunity the board members have had to discuss this topic as a group. He added that the board
would not take comments from the public during this discussion.
Melissa Burke-Cain, Assistant Attorney General, joining the meeting by telephone, briefly
discussed the Administrative Procedures Act and rule making. Following the AAGs brief,
Chair asked each member to share their thoughts.
the
Vandana Slatter acknowledged the existing rules adopted in 2007 and expressed recognition of
the publics involvement in this process. She stated that new knowledge or information has not
been received to provide a compelling direction for the board to re-open the rule.
Dan Connolly commented that the board is here to protect citizens and this has to do with every
class of drugs not just one drug. His goal is pharmacy to serve and provide medication to
everyone.
Christopher Barry stated the goal is to improve access not make it more difficult. If this rule
can be improved than it should be re-opened.
Al Linggi commented that the political environment had been directed towards one drug. This is
a much bigger issue than one drug. There are 200 time sensitive medications that need
consideration. Mr. Linggi illustrated a number of scenarios that speak to access, challenges such
as rural communities, specialty pharmacies, Medicaid/reimbursements, etc. He stated that the
current rule is myopic and under serves a larger patient population within the state of
Washington. Rebecca Hille, as one of the original board members who worked on the existing
rule said she has read the publics comments several times. Ms. Hille agreed with the other
members that pharmacies could not be expected to stock every drug and feels that the current
rule should not be re-opened. She expressed concerns that this process has been driven by a
court case.
Gary Harris shared that he did not hear once that changing the rule to facilitated referral would
increase access to medication and still allow a pharmacist to have a right of conscience. Mr.
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Harris stated that facilitated referral is already a standard practice, but he expressed concerns
about defining facilitated referral too broadly in this scenario and not to cause additional barriers
to care and services.
MOTION: Christopher Barry moved that the board make a decision at the next board meeting.
Al Linggi seconded the motion with a friendly amendment that the board has an opportunity to
discuss with the Department of Health and the Governor to articulate and reach a better
understanding of the views that have developed since the adoption of the current rules.
Amended MOTION FAILS: 2-3.Original MOTION Restated: Christopher Barry moved that
the board make a decision at the next board meeting with more information provided by board
staff and AG s office. Al Linggi second. Dan Connolly, Rebecca Hille and Vandana Slatter
opposed. MOTION FAILS: 2-3.
Melissa Burke-Cain assured the board that the lawsuit will move forward regardless of the
boards decision. The board needs to make a decision based on the fundamentals of the boards
regulatory responsibility to protect the public.
Ms. Cain reiterated that the litigation should not drive this process. She directed the board to
remember that it is not limited to amending the current rules. The board must ask, in the interest
of public protection and patient safety, what minimum standard for pharmacists and pharmacies
can the board craft that will improve access beyond what is reached by its current rules.
Susan Teil Boyer reminded the board of their mission. Their decision needs to be based on their
mission.
MOTION: Dan Connolly moved the board continue with the option to change the rule. Al
Linggi second. Chris Barry voted in favor; Vandana Slatter and Rebecca Hille opposed.
The board is asking that staff provide information on the 200 time sensitive medications, AGs
review of the stocking rule and more background on specialty pharmacies.
Rule Making Petition Closing A Pharmacy
The board was asked to consider a petition for rule making filed by pharmacist Jo Schnotala to
amend WAC 246-869-250 to require a closing pharmacy to provide two-week notice to patients
prior to closure.
Doreen Beebe provided the board with some background regarding the current rule. WAC 246869-250 does not require patient notification when a pharmacy closes. Doreen Beebe introduced
pharmacist Jo Schnotala. Jo Schnotala was able to share her experience and concerns about
patient notification of pharmacy closures. The board discussed some of their concerns they
would have amending the rule.
MOTION: Rebecca Hille moved to deny the petition to amend WAC 246-869-250 to require a
closing pharmacy to provide two-week notice to patients prior to closure. The board will leave
WAC 246-869-250 as is and board staff will draft a procedure to be reviewed by the board at the
next meeting. Vandana Slatter second. Dan Connolly opposed. MOTION CARRIED: 4-1.
Department of Corrections
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The board discussed Department of Corrections (DOC) request to revisit the draft Correctional
Pharmacies rules Chapter 246-874 WAC to allow the correctional pharmacy to provide floor
stock or emergency kit services to its facilities off-site. Andre Rossi provided the board some
information to support his request for the rule to be revisited.
Background:
WAC 246-874 correctional pharmacies draft rule
The scope of this rule addresses pharmaceutical distribution within correctional
facilities with pharmacies
The rule does not address other DOC facilities that do not have pharmacies
Health Care Entity License (HCEL)
In September 2010, BOP granted authority to 3 DOC facilities
The HCE license
Allows the facility to order and stock medications for use by the facility at the
direction of a prescriber when the prescriber is present.
Does not consider rules to allow for Emergency medications in DOC facilities
without pharmacy.
Applicable WAC / RCW:
RCW 18.64.510 - Limitation on authority to regulate or establish standards
regarding a jail.
Nothing in this chapter or in any provision of law shall be interpreted to invest the
board with the authority to regulate or establish standards regarding a jail as
defined in RCW 70.48.020 that does not operate, in whole or in part, a pharmacy
or a correctional pharmacy.
This section does not identify the board's authority to regulate a pharmacist that
has entered into an agreement with a jail for the provision of pharmaceutical
services.
Impact on Patient Care:
Draft rules Chapter 246-874 WAC Correctional Pharmacy law only applies to DOC and
the King County Jail since they are the only correctional facilities that operate
pharmacies.
In 2009 DOC served over 23,500 patients (seen by prescribers) mostly had
multiple visits within a year.
We provide over 500,000 prescriptions annually.
We have established and have been maintaining a system to ensure patient
safety and medication security would be intact through our policy & procedure
and internal auditing.
Conclusion:
Resume stakeholder work on Chapter 246-874 WAC Correctional Pharmacies, to allow
amendment to regulate the pharmacist and pharmacy that provide pharmaceutical services to
facility with no pharmacy.
Availability of emergent medications at facilities without a pharmacy onsite
Inspection and expectation for facilities with no Pharmacy onsite
Licensing process for facilities with no Pharmacy onsite
Responsibility of establishing procedures for medication shipments
Considerations for Safety and security of medications in such facilities
MOTION: Vandana Slatter moved that board staff will check with the Attor ney Generals office
to see if Chapter 246-874 covers the Department of Corrections request to stock E-Kits . Dan
PRESENTATIONS
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Medication Review, Inc

Doug Crafton presented a PowerPoint to update the board for a one-year follow up on his
approved telepharmacy services. Tim Fuller briefly provided the board with some background
and introduced Mr. Crafton.
Review of Authorization:
Small and rural hospitals
Coverage 24 hour phone/video/messaging/digital image
Time Range: After-hours to 24 hrs
Facility dependent
Remote supervision of pharmacy technicians
Facility dependent
Pharmacist on site minimum one time per week
Census dependent
Metrics of Telepharmacy Services:

Time period August 2009 July 2010
Total Orders Entered =15,193
Total Order Deficiencies =721
Deficiencies by type
Clarification of directions: 242
Inappropriate dose, frequency, rate: 43
Patient info requested: 102
Non-Formulary or unavailable: 61
POM verification required: 47
Formulary interchange per protocol: N/a
Drug allergy/intolerance: 37
Lab data requested: 10
Renal/Hepatic dose adjustment: 26
Drug interaction: 8
ADR or drug induced: 3
Contraindication to prescribed Rx: 6
Therapeutic duplication: 29
Other: 107
Impact to Facilities:
Hospital CBH Pharmacy Mgmt & Telepharmacy
Ave Daily Acute Census ~ 6
Hospital EAR Pharmacy Mgmt & Telepharmacy
Ave Daily Acute Census <1
Southgate Pharmacy
The board heard a proposal from Southgate Pharmacy to provide telepharmacy services to
Mattawa Clinic.
Background:
Mattawa is a remote Eastern Washington community of over 3,000 people without a
pharmacy and patients must drive long distances for prescriptions.
Many of the residents are impoverished and a majority of the residents are foreign born.
There is an active Community Medical Clinic that worked with the previous
telepharmacy service and is Southgate is committed to re-establish a telepharmacy
service.
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Southgate Pharmacy has used the previous policies and procedures as a template to
define their telepharmacy services.
There will be no controlled substances as part of the telepharmacy.
The policies and procedures satisfy the b oards
Requirements.
Telepharmacy Guidelines and
Grant County Public Hospital Formed 26 years ago

Operates MCMC to provide primary medical care to all in the District.
The clinic has three full-time providers and one part-time provider
The facility is open Monday- Friday from 9:00am-6:00pm . and Saturdays
10:00am-2:00p.m.
Services Offered
Child and Adult exams
OB care through 32 weeks
Walk-in services
Urgent Care
Labor and Industry service
Support Services
WIC
Maternity Support Services
Outreach
State Certified Medical Interpreters
CEDEMS Diabetic/Asthma Registry
Sliding Fee Program
Other services provided inside the clinic by outside providers include:
Dental Services, Ophthalmology and Massage Therapy, DSHS out
station worker.
MOTION: Dan Connolly moved the board approve the proposal from Southgate Pharmacy to
provide telepharmacy services to Mattawa Clinic. With a one year update to the board.
Christopher Barry second. MOTION CARRIED: 5-0.
Franciscan Health System - Automated Drug Distribution Devise (ADDD) Used for Anesthesia
Trays in Operating Room (OR)
The board was asked to consider a proposal by Franciscan Health System to allow certified
anesthesia techs to access ADDD in the OR to obtain clean anesthesia trays and deposit used
trays after a procedure. Tim Lynch provided the board with more information per their request at
the September meeting regarding this proposal.
Job Description
Draft Policy and Procedure
The person/persons responsible to be licensed.
MOTION: Christopher Barry moved that the board approve the proposal from Franciscan
Health System to allow certified anesthesia techs licensed as HCAs to access ADDD in the OR
to obtain clean anesthesia trays and deposit used trays after a procedure. Rebecca Hille second.
EXECUTIVE SESSION
CASE PRESENTATION
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PRESENTATIONS contd
Shiraz Pharmacy
The board was asked to consider a proposal by Shiraz Pharmacy to provide telepharmacy
services. Mr.Shafeean revised his previous proposal for a specialized telepharmacy service for
mental health patients. He continues to believe the location of a pharmacy technician in a mental
health facility supervised remotely by a pharmacist can provide the kind of coordinated care that
is needed by many mental health patients.
Overview:
He closely monitored hundreds of schizophrenia patients with their medications. He saw
that many mental health patients do not take their prescriptions to the pharmacy or they
forget to pick up their medications.
The operation proposed uses the electronic and video technology standard for
telepharmacies. The pharmacy technician will fax the orders to Shiraz Pharmacy and,
after the prescription is checked and initialed by the pharmacist at the Support (or Main)
Pharmacy, the prescription will be delivered to the Remote (telepharmacy) Pharmacy.
When the patient picks up their prescription, the pharmacist counsels the patient using a
webcam. To assist with patient compliance, Mr. Shafeean expects to offer various
medication packaging for patients who can only manage a small supply of medication.
Telepharmacies require a comprehensive pharmacy proposal to assure all of the patient
safety requirements are met.
Mr. Shafeean also plans to have a pharmacist perform quality assurance of the
telepharmacy. The pharmacist will visit the Remote Site 3-4 times a week and check all
pharmacy technician procedures, status of the room, status of the robot, and contents of
the robot.
MOTION: Christopher Barry moved that the board recognize this as a unique situation and
accept the proposal by Shiraz Pharmacy for a specialized telepharmacy service for mental health
patients. Shiraz Pharmacy must come back to the board in one year for an update. Al Linggi
proposed a friendly amendment that this approval is limited to the use of the SP X50 Robotic
Prescription Dispensing System. If there are any changes they must come before the board.
Vandana Slatter second. Dan Connolly opposed. MOTION CARRIED: 4-1.
Providence Regional Medical Center-Everett
The board heard a proposal from Eric Werttemberger, Pharmacy Director for Providence
Regional Medical Center-Everett to provide discharge medications using telepharmacy services
from a remote dispensing device.
Background:
Provides over $120,000 in charity retail prescription to our community annually
New building
New retail pharmacy.
Largest and busiest emergency department in the state

Limited 24/7 retail pharmacy services in community
Opportunity to increase retail access to our patients
Limited space in the hospital and would like to maximize public space
Would like to provide a 24 hour service kiosk
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Similar to remote drive through

Interior pneumatic tube access point
Conferencing center - Back of the pharmacy
Patient conferencing center - Public front area
Conclusion:
Purpose
Increase access to retail pharmacy services in community
Rational
Creative way to meet need with finite resources
Each component of the model is in current practice in our state today
Use of tube access points (same as drive through)
Use of telepharmacy
Many of the proposed processes are superior
HIPAA compliance
Proposal complies with all applicable pharmacy laws
MOTION: Al Linggi moved that the board approve the proposal by Providence Regional
Medical Center-Everett to provide discharge medications using telepharmacy services from a
remote dispensing device. This approval is limited to the campus at Everett and a one year
follow up to the board. Christopher Barry second. Vandana Slatter and Rebecca Hille opposed.
Dan Connolly abstained. Gary Harris approved to break the tie. Motion passes. MOTION
CARRIED: 3-2.
Electronic Prescription Storage System by Omnicare
The board was asked to consider a proposal for the use of the Omnicare electronic storage
system for prescriptions received through traditional facsimile transmissions . Tim Fuller
provided some brief background before introducing Jerry Berndt, General Manager for
Bridgeport Pharmacy Services. Mr. Berndt provided a power point to the board. Roger
Melching, Omnicare IT Product Manager was available for questions regarding the Omnicare
electronic storage system.
Workflow-Electronic Image Prescription:

Omnicare customers send a traditional facsimile transmission to the Omnicare pharmacy
fax number.
The facsimile document is received by Omnicare Fax Server and delivers faxes to the
an image.
pharmacy s document imaging system as
The electronic image is presented to a pharmacy technician for order entry.

Pharmacist accesses the electronic image and verifies the order was entered correctly,
performs the clinical review and approves the order for label print.
Images are stored in Omnicare electronic storage.
Benefits of Electronic Image Storage:
Upon successful receipt of the facsimile transmission, the electronic image cannot be lost,
as a piece of paper has the potential to be lost .
The integri ty of the original facsimile transmission is
and cannot be modified.
maintained in its original form
Workflow tracking provides for user accountability, every user activity is logged.
Document access is secured by a series of user permissions approved by pharmacy
management
Documents, their associated annotations, and data elements are stored separately in
electronic storage.
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Documents that would remain on paper:

Images are identified with facility, patient, prescription details, Rx# and date information.
Images are identified with facility, patient, prescription details, Rx# and date information.
Documents containing the following types of orders would continue to be filed as paper
documents.
Scheduled medication prescription orders, including C-II and C-III through C-V
Prescription orders for IV compounded medications
Prescription orders for other compounded medications
MOTION: Al Linggi moved that the board accept the proposal for the use of the Omnicare
electronic storage system for prescriptions received through traditional facsimile transmissions
and they must come back and provide the board with a one year follow. When the rule becomes
updated they must comply with the rule. Rebecca Hille second. MOTION CARRIED: 5-0.
Northwest Hospital & Medical Center

The board heard a proposal by Northwest Hospital & Medical Center to allow trained pharmacy
technicians to interview patients to obtain a medication list . Daniel Kim provided the board with
a brief overview of their proposal.
Overview:
Nurses were audited and the discovery was there was a 30% discrepancies in medication
lists taken by the nurses
We feel that specialized trained pharmacy technicians should be the ones to take a
medication list
Pharmacy technicians must take at least 8 hour didactic training
Pharmacy technician shadows pharmacist
Pharmacy technician is then followed by a pharmacist
Pharmacist audits lists
If there is a discrepancy the pharmacist will contact the prescriber
Pharmacist is always responsible for lists taken by pharmacist technicians
Data that is collected from an audit will be used to improve this procedure
MOTION: Christopher Barry moved that the board approve the proposal by Northwest Hospital
& Medical Center to allow trained pharmacy technicians to interview patients to obtain a
medication list and Northwest Hospital & Medical Center must report back to the board in one
year. Dan Connolly second. MOTION CARRIED: 5-0.
DISCUSSION
Contd
Guidelines for Pharmacy Technicians Taking Medication Lists

The board was provided draft guidelines for pharmacy technicians taking patients
medications by Tim Fuller. They were asked to consider and approve the draft.
list of
MOTION: Christopher Barry moved that the board approve the draft guidelines for pharmacy
technician taking patients list of medication and that this function be delegated to the pharmacist
consultants. Dan Connolly second. MOTION CARRIED: 5-0.
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Rules Update
The board reviewed and discussed the proposed rulemaking workload. Board staff shared
updates to the board with the status of their assigned rules.
Correspondence
Senator Parlette
ISMP Medication Safety Alert September 2010
ISMP Medication Safety Alert October 2010
Staffing Levels Anonymous Letter
Representative Tami Green Letter
NABP October 2010 State News Roundup
ACLU comments re Combat Meth Act requirements
NABP eNews
OPEN FORUM
Joyce Roper shared that the Supreme Court issued a decision today, with a 5 to 4 vote, which
reverses the Court of Appeals dismissal of Mr. Jones tort lawsuit. The Board of Pharmacy
summarily suspended Mr. Jones pharmacy and pharmacist licenses. Mr. Jones signed a
stipulation and agreed order, agreeing to the revocation of his pharmacy license and a 5 year
suspension of his pharmacist license, but did not admit that he had engaged in unprofessional
conduct. He then filed a civil rights tort lawsuit . The Court of Appeals dismissed his lawsuit,
granting the states summary judgment motion on the basis that the Board of Pharmacy
Executive Director and Pharmacy Investigators are immune from a lawsuit in this situation. The
State Supreme Court reviewed the case, assuming that the facts alleged by Mr. Jones are true,
since the case was dismissed on summary judgment. The Supreme Court reversed the Court of
Appeals and remanded the case to the Superior Court for a trial.
Colin Conway asked the board if they were aware of what and when the Prescription Monitoring
Program process would begin. Susan Teil Boyer shared that the Department of Health (DOH) is
in the hiring process for a Manager. This is a 2011 initiative. Department of Health has received
the grant that is time limited. This program is to be managed by DOH not by the Board of
Pharmacy.
CLOSED SESSION
Case presentations
Disciplinary Hearings___________________
Point Plaza East Room 139
310 Israel Rd
Tumwater, WA 98501
_____ November 5, 2010_9:30 a.m.

9:30 a.m. -- Hollie Stevens (Assistant)
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_______________________________
_______________________________
Gary Harris, Chair
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STATE OF WASHINGTON

November 8, 2012
CONVENE
Chair Christopher Barry called the meeting to order at 9:06 a.m., November 8, 2012
Board Members:
Guest / Presenters:
Gary Harris, RPh,
Dr. Al Carter, Corporate Manager for Pharmacy Affairs
with Walgreens Company
Glenn Adams, PharmD, Wenatchee Valley Medical Ctr
Terry Clark, PharmD, BCPS, Pharmacy Manager for
Wenatchee Valley Hospital
Becky Casewell, for PeaceHealth Southwest
Mike Jozwiakowski, PhD Vice President, Scientific
Affairs for Ther-Rx
Staff Member:
Joyce Roper, AAG
Heidi Welbourne, Pharmacy Investigator
Kitty Einert-Slater, Rules Coordinator
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CONSENT AGENDA
1.1
1.2
1.3

Approval of the September 27, 2012 Business Meeting Minutes
MOTION: Dan Rubin moved that the board does not support NASCSAs 2012
resolution #1. A RESOLUTION RECOMMENDING DETAILED REPORTING BY
LAW ENFORCEMENT OF CRIMINAL OFFENSES INVOLVING CONTROLLED
SUBSTANCE as written. The board recommends more support for the Prescription
Monitoring Program versus criminal justice. Elizabeth Jensen second. MOTION
CARRIED: 7-0.
MOTION: Dan Rubin moves that the board approves minutes with the correction as stated in the
previous motion. Elizabeth Jensen second. MOTION CARRIED: 7-0.
MOTION: Dan Rubin moves that the board approves 1.1, 1.2, and 1.3. Donna Feild second.
2.1
2.2
2.5
2.7

Continuing Education Program Approval
Electronic Prescription Transmission System Approval
2.8, 2.9 and 2.10 were deleted from the agenda.
MOTION: Dan Rubin moved that the board approve items 2.1, 2.2, 2.5 and 2.7. Donna Feild
REPORTS
Board Member
2
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He attended The Washington State Pharmacy Association (WSPA) Annual Convention. Mr.
Harris made contact with several old board members. There were a lot of great continuing
education opportunities which he took advantage of. All together it was a great meeting.
Elizabeth felt there was a lot of progress on the R2P2 project made at the November 7, 2012
Strategic Planning Session.
She also felt the planning session was productive.
Chris attends Spokane Pharmacy Association as a liaison for the board when he is not working.
He will be attending their annual awards banquet November 13, 2012.
At the planning session there were workgroups formed for the R2P2 project there will be more
people assigned to these workgroups for extra input. This will be an interesting process.
Mrs. Feild attended the WSPA Hospital Directors meeting. She submitted three questions
which should be addressed later today.
Donna works at Peace Health Southwest and they won the ASHP best practice award. She is
real excited about it.
Dan Rubin reported:
Dan looks forward to the prolonged process of working on rules.

He arranged a learning visit to a compound pharmacy with Jim Doll. He wanted a visual
understanding on some of the processes in a compound pharmacy.
Emma enjoyed the planning session and is looking forward to the R2P2 project.
Executive Director
Attended Tri-Regulator Conference: Washington DC 10/16-17

This was a joint meeting of medical, nursing and pharmacy boards to discuss joint issues
affecting all three professions. The issues discussed were medication misuse and abuse of
prescription medications and the status of national drug policies affecting medical community.
NABP District Meeting: Little Rock, Ar. 10/21-24

Most of this meeting revolved around the NECC compounding issue and how to respond to the
growing problem.
Group Health Opioid Conference: Seattle, Wa. 10/31-11/01

3
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There were multiple presentations on epidemic of opioid use, and alternatives for treatment for
pain management patients. Primary care providers formatted draft principles for discussion on
chronic non-malignant pain control.
NABP Executive Forum:

Chicago, Il 11/12-14
Gathering consisted of mostly growing NECC compounding problem and ideas for supporting
states in regulating compounding practice.
Extern Rotation: 6 week rotation from WSU. Intern traveled with all WA state investigators in
the field . Extern project was evaluation of State boards concerns and potential remedies of
prescription transfers for non-professional reasons. Looked at Alabama/New York/Oregon.
North Carolina.
WSPA Meeting: Invited to sit in on BOD meeting on Friday Nov 2

meet with Board of Directors.
Attended WSPA dinner where Richard Morrison, retired state board of pharmacy inspector,
was recognized with Rodney Shafer Award for his pioneering and sustaining contributions to
the pharmacy profession. Stanley Jeppesen, retired state board of pharmacy inspector, was
recognized with the Generations Rx Award for his work in community based prescription drug
nd
meeting to network and
abuse prevention. Representing the board of Pharmacy, I accepted Stans award on his behalf.
Sixteen pharmacists were presented with 50 years of service to the profession of pharmacy in
Washington State.

November 5, 2012 the judge in the Stormans case issued the order for attorneys fees,
expenses, and costs awarded to the plaintiffs. The judge reduced their requested amount by
$475,047.19. The final award to the plaintiff was $2,250,140.27. This amount will accrue
interest after 30 days while the matter is appealed.
She was happy with the way the strategic planning session went.

Washington State has a little over 1,400 pharmacies that may compound. There are about 90
pharmacies that specialize in compounding and/or preparing parenteral products and all have
been inspected within the last two years.
Washington State has licensed 524 non-resident pharmacies with the majority (495) being
classified as mail order and community/retail.
Every year we receive several calls from pharmacies wanting to know what they have to do if
they want to sell a poison. RCW 69.38.010 defines a poison as: arsenic, cyanide, strychnine, or
any other substance designated by the state board of pharmacy which, when introduced into the
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human body in quantities of sixty grains or less causes violent sickness or death . A pharmacy
in Washington State is required to identify the purchaser (photo identification with signature)
and maintain a poison register. The poison register must contain the following information
which must be maintained for 2 years.
1. Date and hour of sale;
2. Name and home address of the purchaser;
3. Kind and quantity of poison sold;
4. Purpose for which the poison is being purchased;
5. Signature of the seller; and
6. Signature of the purchaser.
Heidi Welbourne reported:
On behalf of the all the investigators Heidi thanked the board for the great opportunity to be a
part of the strategic planning session November 7, 2012.
Patient safety in and compound pharmacy manufacturing

Investigators inspect many compound pharmacies and the majority of them are doing
everything right from cleanliness to documentation. There are some that are not and are sitting
in the gray area. We encourage the board to take this in to consideration when working on the
rules update.
Safety workload
Safety workload issues are becoming a bigger problem even more so in retail pharmacies. The
investigators are being confronted by pharmacists saying they are asked to do more with less.
There are no answers the investigators have and realize not much can be done at this point . The
investigators just want the board to be aware of how big this problem is.
PRESENTATIONS
Well Experience by Walgreens

Dr. Al Carter, Corporate Manager for Pharmacy Affairs with Walgreen Company demonstrated a new
approach and pharmacy design to improve patient care. He was just sharing this new concept and will
soon bring a proposal back to the board for approval.
Background:
Walgreen executives have spent the last 4 or 5 years to look at the pharmacy profession in a
community setting and realized that something was missing. After 2 years of surveying/reviewing
along with in depth conversations with patients and not just Walgreens patients. Two main issues came
up.
Patients were intimidated because pharmacists always seem to have phone to their head or
doing some typing and they felt the pharmacy looked like a mad house.
Patients were unaware pharmacist had the knowledge base to provide consultation and services
that they go to their doctor for. Also, the patients felt a disconnect with pharmacists and
community setting based just off the scene at the pharmacy.
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Goal is to bridge gap between pharmacists and patients and to allow pharmacist be pharmacists again.
Project Bridge has been approved in 21 states. Mr. Carter played an 8 minute video to explain this new
up and coming pharmacy.
Some key features of this new pharmacy include:
A highly accessible pharmacist who is located outside the production area of the pharmacy.
Centralized support for many administrative tasks such as data entry, phones and third party
adjudication.
A state of the art video system that allows direct and constant supervision of technicians.
A private consultation and medication administration room adjacent to the pharmacist desk.
A high definition digital imaging filling process that allows final product verification by the
pharmacist from any workstation.
WVMC Telepharmacy Services

Tim Fuller introduced Glenn Adams who asked the board to consider a proposal by Wenatchee Valley
Medical Center to open another telepharmacy in Waterville identical to the services provided to Royal
City. Glenn Adams provided brief background and history of the services that is provided to Royal
City.
Overview:
Pharmacy services being requested by the community

Goal: No physician dispensing
Wenatchee Valley Medical Center takes over operation November 1, 2012
CWH Professional Pharmacy to provide telepharmacy support using the same model that is
approved in Royal City
MOTION: Donna Feild moved that the board accept the proposal from Wenatchee Valley Medical
Center to open another telepharmacy in Waterville . Gary Harris second. MOTION CARRIED: 7 -0.
WVMC Telepharmacy Services to Infusion Center

Glenn Adams provided some brief background to the board. He then introduced Terry Clark who
proceeded to ask the board to consider the proposal by Wenatchee Valley Medical Center (WVMC) to
use telepharmacy technology to manage an offsite infusion center providing oncology services.
Overview:
Infusion Therapy at WVMC
Wenatchee Infusion
Outpatient hospital based dept
o
o
Pharmacy staff (2 Technicians, 2 Pharmacists)
Omak Infusion
o
Rural Health Clinic
Mixing performed by nursing staff
Moses Lake Infusion

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o
o
Rural Health Clinic
Hospital pharmacy standards

Standard mixing procedures developed
Gold Standard of IV compounding
Patient care team (Patient-MD-RN-RPh)

Remote Infusion Proposal
Moses Lake Infusion (Remote Technician)
Wenatchee Valley Hospital (pharmacy staff)
Utilize all of our current pharmacy policy and procedures (Hospital Standards)
Electronic Medical Record (physician order entry)
Video/Audio Technology to remotely supervise technician
Lync Software
The Hood Camera
High resolution camera

Zoom capability
Real time video streaming
Still image capture

Operated by the pharmacist remotely
Electronic Medical Record
Epic/OncoEMR
Physician order entry
Pharmacist verification/approval
Generate medication labels

Gold Standard of IV Compounding
Purchase premixed medications
Housekeeping:
Clean up and organize
o
Tall man lettering in all computer systems
o
Kit medications/supplies (by patient)
Proactive patient review by pharmacist prior to compounding

Verbal read back
Confirmation of current order
Quality Assurance
Adverse medication events
o
Medication errors
Adverse drug reactions
o
Medication storage audits
o
Stocking errors
o
Scanned or not at restock
o
Controlled substance
Evaluate all interruption of services
Future Opportunities
Expand remote medication supervision and order entry to Omak Infusion

Monitor workload statistics
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Develop criteria to determine when a remote site should be staffed with a

pharmacist and technician
MOTION: Elizabeth Jensen moved that the board accept the proposal from Wenatchee Valley
Medical Center (WVMC) to use telepharmacy technology to manage an offsite infusion center
providing oncology services with a mandatory report back 6 months after the initial start date. Dan
Rubin second. MOTION CARRIED: 7 -0.
Pharmacy Services from Remote Locations

Cathy Williams led the presentation asking the board to consider a proposal by PeaceHealth Southwest
Medical Center (PHSW) to allow staff pharmacists to provide limited patient care services from home.
Home Medication Order Processing Overview:

Increases patient satisfaction more timely availability of meds, especially after computer
downtimes
Increases patient safety Decreases frequency of override medication requests, profiled
medications are administered via Bedside Barcode Scanning, allows staff with specialty
knowledge to help co-workers (ex: NICU, Oncology)
Increases staff satisfaction allows staff who live far from work to help in times of high
workload
Helps hospital to better serve our patients
Voluntary for staff who wish to do this
Secure computer access via Citrix thin client
Assurance of reasonable privacy at home
Shredding of any printed materials
Only fully trained pharmacists on staff at PHSW eligible
Full access to medical record same as on site
Review of policy prior to starting work from home
MOTION: Dan Rubin moved that the board deny the proposal from PeaceHealth Southwest Medical
Center (PHSW) to allow staff pharmacists to provide limited patient care services from home with.
The board asks that PHSW come back with suggested changes to the proposal for board approval.
Elizabeth Jensen second. Donna Feild recused herself. MOTION CARRIED: 6 -0.
DISCUSSION
Pharmacy Compounding Practice
Chris Humberson provided the board some background regarding the scope of pharmacy practice in
compounding pharmaceutical products . Mr. Humberson introduced Mike Jozwiakowski, PhD Vice
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President, Scientific Affairs for Ther-Rx Corporation. Mr. Jozwiakowski asked the board to consider a
response to the Ther-Rx Corporation letter reviewed at the September meeting and to notify
pharmacist s registers in Washington State of the update.
Compounding pharmacies filled an im portant void by providing 17P prior to the availability of
an FDA-approved form ulation. We recognize that Ther-Rx made mistakes in the original pricing
for Makena, but we have responded to the criticisms raised by concerned stakeholders:
Pricing to State Medicaid programs is less than $300 per injection
A pharmacoeconomic model demonstrates that programs can save

approximately $1.50 in preterm birth costs for every $1 spent on Makena acquisition
costs
Average co-pay assigned by insurers is $8 per Makena injection
Comprehensive patient assistance programs are also available for both
insured and uninsured patients

More than 20% of shipped Makena vials across the U.S. have been provided by
Ther-Rx at no cost
Despite the availability of FDA-approved Makena and our efforts to ensure access, a substantial
proportion of pregnant women at risk for preterm delivery continue to receive unapproved
compounded products that do not meet federal standards required for Makena. The return
to
normal enforcement policy by FDA is an im portant step forward for high-risk pregnant patients.
Chris Humberson agreed to compose a general statement specifying the job duties/ roles of a pharmacy
technician and a specialized pharmacy technician in a compound pharmacy along with a general
review of compounding rules and regulations.
Chris Humberson shared with the board that there hasnt been any changes regarding drug shortages.
He opened the floor up for any comments or questions no one had any concerns at this point .
Evaluating Military Training or Experience Equivalency
Doreen Beebe provided a bit of background and asked the board to evaluate whether pharmacy
technician training and experience received through the Department of the Defense is substantially
equivalent to Washington State standards (ESSB5307).
MOTION: Donna Feild moved that the board recognize the pharmacy technician training education
offered by the Department of the Defense is substantially equivalent to Washington State standards
(ESSB5307) and will be routinely approved by Washington State Board of Pharmacy as long as they
have met all requirements. Dan Rubin second. MOTION CARRIED: 7 -0.
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MOTION: Gary Harris moved that policy #4 be changed to have election of officers at the last
meeting of each year by the board members. Donna Feild second. MOTION CARRIED: 7-0.
MOTION: Donna Feild nominated Christopher Barry as Chair and Christopher Barry nominated
Donna Feild as Vice-Chair for 2013. Gary Harris second. MOTION CARRIED: 7-0
Rules Update
Chris Humberson updated the public on what happened in the strategic planning session November 7,
2012. The planning session was focused on the rules re write project R2P2.
The board was given an overview of the rules process. This was significant since there are
many new board members who have not been through the entire rule making process.
A Department of Health Legislation liaison provided a presentation to the board an overview of

the legislative process and some of the hurdles involved.
The board then broke up into 5 workgroups

1. Pharmacist and Interns
2. Pharmacy technician and ancillary pharmacy personnel
3. Compounding
4. Technology
5. Business practices within pharmacies in hospital and retail dealing with workflows
matrix
Two board members and a staff members was assigned to each workgroup
The next step will be setting up conference/meetings with the assigned staff, board members
and open to the public. These meeting will be focused on working towards a CR101 for each
category. This will get the rules process started for the beginning of the year.
Correspondence
The board may discuss any correspondence received or distributed.
DEAs Fifth National Prescription Drug Take-Back Day results in another big haul
CDC Health Advisory Update: Multistate Outbreak of meningitis and Stroke Associated with
Potentially Contaminated Steroid Medication
OPEN FORUM
Kelly McCormick with Bartell Drug acknowledged the fact that there is a lot of pressure being put on
pharmacists regarding quotas and pharmacists being asked to do more with less. This is unsafe practice
for patients. Many pharmacists in the trenches are hoping to see something be done about this issue.
Jeff Rochon Washington State Pharmacy Association we met this weekend as a board the public is
welcome anytime to our board meetings. The compounding issue was discussed.
Brian Oftebro believes it is incredibly important that Washington State continues to have high
standards regarding pharmacies.
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CLOSED SESSION
Case presentations
Next scheduled business meetings: January 10, 2013

310 Israel Rd SE
Tumwater WA 98501
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STATE OF WASHINGTON

MEETING MINUTES
November 12, 2009
Special Meeting
Teleconference
CONVENE
Albert Linggi, RPh
Dan Connolly, RPh
Rosemarie Duffy, RN, MA, MSN, Public Member, Vice-Chair
Joyce Roper, AAG
Susan Teil Boyer, RPh, Executive Director
A special meeting of the Washington State Board of Pharmacy is scheduled to begin at 11:15 am on
Thursday November 12th. The meeting is being held to allow the board to review education/training
requirements submitted by applicants for pharmacy technician certification. To expedite the
credentialing process, the board - represented by a quorum - will review and consider training and
education qualifications for the following programs/applicants .
Consent Agenda -- Items listed under the consent agenda are considered to be routine agency matters
and will be approved by a single motion of the Board without separate discussion. If separate
discussion is desired, that item will be removed from the consent agenda for separate discussion.
1.1 Foreign Graduate - Islamic Azad University
1.2 Idaho State University, School of Applied Technology
1.3 Remington College, AK
1.4 Apollo College, Phoenix AZ
1.5 Milan Institute, TX
1.6 American College, CA
1.7 Apollo College, Tucson AZ
1.8 Tennessee Technology Center
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again on December 10, 2009 for its regularly scheduled business meeting in Auburn, Washington
_______________________________
Leann George, Program Manager
_______________________________
Gary Harris, Chair
Kingsbury1038
STATE OF WASHINGTON
November 12, 2009
Special Meeting - Teleconference
CONVENE
Albert Linggi, RPh
Dan Connolly, RPh
Rosemarie Duffy, RN, MA, MSN, Public Member,

Vice-Chair

Joyce Roper, AAG
Susan Teil Boyer, RPh, Executive Director

A special meeting of the Washington State Board of Pharmacy is scheduled to begin at 11:15 am on Thursday
November 12th. The meeting is being held to allow the board to review education/training requirements
submitted by applicants for pharmacy technician certification. To expedite the credentialing process, the board represented by a quorum - will review and consider training and education qualifications for the following
programs/applicants .
Consent Agenda -- Items listed under the consent agenda are considered to be routine agency matters and will
be approved by a single motion of the Board without separate discussion. If separate discussion is desired, that
item will be removed from the consent agenda for separate discussion.
1.1 Foreign Graduate - Islamic Azad University
1.2 Idaho State University, School of Applied
Technology
1.3 Remington College, AK
1.4 Apollo College, Phoenix AZ
1.5
1.6
1.7
1.8
Milan Institute, TX
American College, CA
Apollo College, Tucson AZ
Tennessee Technology Center
MOTION: Dan Connolly moved that the board approve items 1.1 thru 1.8. Rosemarie Duffy second.
There being no further business, the board adjourned at 11:32 p.m. The Board of Pharmacy will meet again on
December 10, 2009 for its regularly scheduled business meeting in Auburn, Washington.
_______________________________
Leann George, Program Manager
_______________________________
Gary Harris, Chair
December 10, 2009
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STATE OF WASHINGTON

Special Meeting Minutes
Teleconference
Tumwater WA 98501
November 22, 2011
10:00 a.m.
Board Chair Al Linggi called the meeting to order at 10:04 a.m. on November 22, 2011. Board members present
by telephone.
Board members:
Gary Harris, R.Ph.
Donna Feild, R.Ph., MBA
Rebecca Hille, Public Member
Open Session Business Meeting
Staff members present:

Grant Chester, R.Ph. Chief Investigator
_________________
OPEN SESSION
List and Label Request. The board considered a request by Russo CME for recognition as an educational
organization permitting it to receive contact lists of credential holders to provide continuing education
opportunities. An education organization is an accredited or approved institution or entity, which either prepares
professional for initial licensure or provided continuing education.
ACTION: Donna Feild moved to approve Russo CME as a recognized educational organization for provided
continuing education for two years after which, Russo CME must seek accreditation by the American Council
for Pharmacy Education (ACPE) . Rebecca Hille seconded the motion. MOTION CARRIED. 4-0.
*****
There being no further business, the board adjourned at 10:30 a.m. The Board of Pharmacy will meet again on
December 15, 2011 for its regularly scheduled business meeting in Renton, Washington,
___________________
___________________________________
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STATE OF WASHINGTON

Regular Scheduled
Business Meeting Minutes Amended
December 5, 2013
Mt. Constance
2400 South St.
CONVENE
Chair Christopher Barry called the meeting to order December 5, 2013
Commission Members:
Gary Harris, RPh,
Dan Rubin, MMP, Public Member
Steve Anderson, RPh
Nancy Hecox, PharmD
AL Linggi, RPh, MBA
Tim Lynch, PharmD

Guest / Presenters:
Will Rhodes, Program Director for WRAPP
Micki Kedzierski, Volunteer with WRAPP
Chris Baumgartner, PMP Program Manager
Thomas Schilling, Pharmacy Clinical Director
for Yakima Valley Farm Workers Clinic
Douglas Crafton, RPh, President& CEO
of Medication Review
Christopher Terriff, RPh, VP Clinical Operations
of Medication Review
Andrew J Burton PharmD for Summit Pacific Med Ctr
Lisa Roberts, R.Ph, Pharmacy Director for
Willipa Harbor Hospital
Robert Brower, Director of Operations
at RxRemote Solutions
Beata Przebinda, Regional VP for Comprehensive
Pharmacy Services
Staff Members:
Joyce Roper, AAG
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1.3 Approval of July 18, 2013 Meeting Minutes.
MOTION: Elizabeth Jensen moved that the commission approves 1.2 and 1.3. Al Linggi second.
New Member Introduction
Kristina Logsdon is a second generation Japanese American. Since moving to Seattle in 2001, she
has worked for and served on the board of a number of nonprofits engaging in issues such as
environmental health, sustainable agriculture, and civic engagement of underrepresented
communities. Her most recent adventure has taken her outside of the nonprofit world to local
government. She currently serves as Senior Legislative Aide to King County Council member Rod
Dembowski
Maura Little is the Life Science Sector Lead for the Washington State Department of Commerce.
As the state lead, she supports the development and expansion of the Life Sciences industry, with a
goal to recruit, retain and expand the industry. Previous to her current role, she was the
Washington State Director of Government Relations for the American Cancer Society Cancer
Action Network. After graduating from the University of Washington, Maura spent 5 years
supporting then Congressman Jay Inslee's legislative agenda as a Legislative Assistant and
Community Liaison.
Maura is a life-long resident of Washington State. She currently resides in Seattle with her
husband and son.
Steve Anderson is a 1980 graduate of the University of Wyoming School of Pharmacy. He has
been a licensed pharmacist in the state of Washington since 1980, and was employed as a pharmacy
manager with the Bartell Drug Company for 30 years. Steve has been a Clinical/Affiliate Faculty
member of the University of Washington School of Pharmacy and preceptor since 1989, and is an
APhA Immunization Instructor, and an AHA CPR/First Aid Instructor. He is currently the
Assistant Pharmacy Manager at Costco Wholesale's RX E-Commerce division in Everett,
Washington.
Dr. Nancy Hecox is the Clinical supervisor for Tieton Village Drugs in Yakima Washington. She
received her BSPharm in 1978 from Massachusetts College of Pharmacy, returning to school in
1994 to obtain her PharmD from Idaho State University. She has worked in retail pharmacy,
independent and chain drugstores and has taught pharmacology at Pacific Northwest University
College of Medicine. She also helped start the WRAPP program and worked as the chemical
dependency counselor for that organization for 6 years.
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Dr. Hecox has published articles in various journals and has presented topics concerning
pharmacists participation public health services at several conferences. In addition, Dr Hecox may
be found running marathons, hunting, fishing and hiking all over the world. She lives in Selah,
WA with her husband Ray and two Weimeraners, Gus and Cooper.
Al Linggi is a Consultant/Contractor for McKesson Corporation. Prior to June 2013 he served as

Vice President, Corporate Business development for McKesson Corporation located in San
Francisco, CA. His was responsibilities for the Corporation included business development,
strategic planning, investment alliances and acquisitions. Al actively participated or managed over
17 investment/acquisitions for McKesson Corporation. Throughout his tenure with McKesson, Mr.
Linggi has held numerous positions: 1) President, Medication Management, 2) President and
General Manager McKesson Specialty Services, 3) Vice President Product Development, Mr.
Linggi has 40 years of experience in the pharmaceutical industry. A registered pharmacist, Al spent
twenty-three years with the Franciscan Health System serving St. Joseph Hospital and Health Care
Center in Tacoma, Washington prior to joining McKesson.
Mr. Linggi is well published and served on numerous boards of directors for national and regional
organizations as well as advisory boards for Creighton University, University of Tennessee and
University of Washington Schools of Pharmacy. Mr. Linggi served as an active member of the
Washington State Board of Pharmacy from 2008 to 2012. Al graduated from the University of
Washington School of Pharmacy and has an Exec. He has a MBA from Fuqua School of Business
at Duke University. Al is happily married to Sheila (42 years), lives in Tacoma, Washington and
has five children (two of which are pharmacists) and 8 grandchildren.
Tim Lynch is the Associate Vice President, Pharmacy Services for Franciscan Health System of
Tacoma Washington. Franciscan Health System is comprised of 7 hospitals, over 100 physician
clinics and a community hospice program that includes an inpatient hospice facility. Tim has
responsibility for all hospital pharmacy departments, 7 retail pharmacy locations, 5 pharmacy
managed pharmacotherapy clinics, a durable medical equipment program and a pharmacy managed
research center. In addition, Tim is the residency program director for an ASHP accredited PGY1
residency program with 6 residents. Tim received both his BS in pharmacy and his Doctor of
Pharmacy degree from the University of Washington. Tim also received a Masters in Healthcare
Management from Troy University, completed a fellowship from the Advisory Board Company,
completed a PGY1 residency at St. Joseph Medical Center in Tacoma Washington and is an affiliate
assistant professor at the University of Washington. Tim is the past president of the Washington
State Pharmacy Association as well as the Chair of ASHP Pharmacy Business Management Section
Advisory Group. Tim also supports ASHP as a guest surveyor for residency program
accreditation. Tim is a recipient of the Washington State Pharmacist of the Year and the
Washington State Health System Pharmacist of the Year awards. Tim continues to organize a state3
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wide health system pharmacy leadership meeting twice a year to share best practices across
Washington State.
Maureen Sparks graduated from the program I now teach over 20 years ago. In 1995 a part time
position came open at Clover Park Technical College for a clinical pharmacy technician instructor.
Maureen found teaching to be a blast, and has been at CPTC ever since.
It is an ASHP accredited program, and believes that pharmacy technicians need education to
perform the increasingly responsible tasks technicians are now taking on. She has been a member
of the Pharmacy Technicians Educators Council, and served on the board as Secretary for four years
2007 2011. This organization has been instrumental in changes to the Pharmacy Technician
Certification, and promotion of a standard education for pharmacy technicians.
During Maureens career at Clover Park Technical College she served on many committees,
including Curriculum, Tenure, College Assembly and Labor/Management. She is currently the
Faculty Union President. Since 1999 she has been a per-diem technician for St. Clare Hospital, part
of the Franciscan Health System . Every day she feels she learns new things about the practice of
pharmacy.
Maureen and her husband enjoy traveling in their motor home, 4 wheeling in the mountains, and
drag race at Bremerton raceway. Maureen like to garden and she likes to build race cars. She has 4
children and 6 grandchildren and enjoys spending time with her families .
CONSENT AGENDA
July - October
July - October
a) Providence Tech check Tech- Renewal
b) Peacehealth St. Joseph Medical Center
c) Legacy Salmon Creek
a) Pharmerica
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2.10
a) Weno Exchange LLC New

b) Prodigy Data Systems, Inc./PROscript 2000- Renewal
c) Surescripts Renewal
d) Toptec Software_ MD ToolBox Rx New
e) SuiteRx LLC IPS (Intelligent Pharmacy Software New
f) Health Business Systems Inc RxAxis Renewal
g) PDX, Inc EPS (Enterprise Pharmacy System) - Renewal
a) Kaye-Smith Enterprises, Inc.
be removed from the consent agenda and placed on the regular business agenda. Items 2.3, 2.4, 2.8 and
MOTION: Gary Harris moved that the Commission approve items 2.1, 2.2, 2.7 and 2.10. Items 2.5
(a) and (b) and 2.6 were pulled for further discussion. Elizabeth Jensen second. MOTION
CARRIED: 11-0.
REPORTS
Commission Members
Attended retirement party for Keith Campbell
Dan was on a recreational trip with his family at paint a plate place he made a ceramic PQAC
plate to represent the Pharmacy Quality Assurance Commission.
Gary has been invited to continue to give his lecture on pharmacy law and Ethics to the
Washington State University students of Pharmacy. Now that Keith Campbell is no longer there
and the school has moved to Spokane Gary will give this lecture for one more year and would
like to pass that opportunity on to a commission member in that area.
Dan Rubin reported:
At the end of October he attended a national nonprofit organizations conference called the
Citizen Advocacy Center. Department of Health has played an active role in supporting that
organization. There were a number of members from various boards and commissions at this
meeting.
She attended the ACPE re-accreditation of University of Washington College of Pharmacy. It was a
great conference and felt it was well put together. They provided the attendees with such great packets
and information.
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Sacred heart went thru a computer change over been 3 months of learning and a lot left to be
learned.
Al Linggi reported:
He also attended the NABP District 6, 7, 8 Meeting in Boulder, Colorado.
Tuesday attended the University of Washington School of Pharmacy practice board. Dean
Bailey is leaving he is taking a year sabbatical and will return as a faculty member at University
of Washington.
Monday listened in to FDA conference on drug quality security act Obama passed. Very
interesting.
Al was appointed to UW School of Pharmacy curriculum committee. We help design

curriculum that is commensurate to current pharmacy practices today.
He was recently at University of Washington on a preceptor committee we help ACPE

committee recertify members of Washingtons preceptor program. There were some tough
questions but really turned out well for the University of Washington.
He also listened in on FDA conference on drug quality security act Obama passed.
Other than providing thousands of vaccinations she also has Collaborative Drug Therapy
Agreement with the providers of Merk.
Nancy has free vaccine from them. If someone doesnt have the vaccine or doesnt know how to
do it she would be glad to assist . So there is no reason not to get your Pertussis vaccine.
Tym Lynch reported:
September Tym conducted hospital leadership meeting for Washington State there were many
great presentations.
He gave a presentation to his organization regarding transition care in pharmacy practice what
the pharmacy profession can do to improve that.
He is coordinating a medication reconciliation effort to come up with best practices for

transitioning care between long term care and acute care and other environments in the
community and how we do hand offs to improve that
Executive Director
In September he attended the NABP District 6, 7, 8 meeting in Boulder, Colorado. Covered

Prescription Drug Abuse Issues, Inter-professional Precepting of Professionals, Issues related to
Marijuana and pharmacology, patient considerations, DEA proposed rule for disposal of
Controlled Substances, and an update on Federal Compounding legislation . Mark Johnson
discussed proposed by-laws for the District 7, by executive committee member Mark Johnson,
ED of Idaho Board of Pharmacy. During business meeting sessions, the district introduced a
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resolution regarding pharmacy and veterinary colleges work together on cross educational
opportunities for both professions by facilitating rotations and elective coursework at the
respective colleges. This was met with unanimous approval to send to the executive committee
for consideration.
At the end of September Chris attended the Executive Director Meeting in Chicago
Topics of discussion were:
Compounding Blueprints and plans by states of Virginia, New Jersey, Nevada, and
Minnesota.
Expanding Uniformity and Simplifying License Transfer between states.
Synchronization of Medication Scheduling
Update on PMP Interconnect and Integrations
Training Compliance Officers; other states solutions on training.( Texas, AR,
Practitioner Dispensing (Oregon presentation based upon ATTNY General Opinion)
and regulation of Drug Outlets.
Discipline and Fines (S.C.)
In October Chris spoke to Washington Veterinary Association Annual Meeting about

Pharmacist-veterinarian collaboration and the Pharmacy Commission efforts to promote proper
counseling and accurate prescription services from Washington State pharmacists.
November he met with Exec Director and Chief Compliance Officer at Oregon board to
continue facilitation of cooperation. This was an opportunity to introduce Gordon MacDonald to
them both.
Also in November he was able to attend the Thursday Board meeting of Washington State
Pharmacy Association with Don Painter for an open forum and to answer questions from WSPA
board members. He did attend WSPA awards luncheon to recognize those Washington State
pharmacists who have been licensed to practice for 50 years.
He visited the University of Washington Rx School and attended the UWSOP Law class to
discuss and review their projects.
Chris and Chris Barry attended Department of Health Board and Commission Leadership
meeting comprised of various boards and commission leadership and DOH Leadership.
He received National Association of Boards of Pharmacy appointment to Committee on Law

Enforcement/Legislation to represent WAPC and NABP District 6, 7, 8. Meeting scheduled for
January 21-22 in Chicago, Il.

Introduced Jack Bucknell, who recently joined the attorney generals office. He is now an
assistant attorney general instead of staff attorney and Joyce asked him to assist by serving as
back up legal advisor for the Pharmacy Commission. This seemed a natural fit, since he also
worked with the Commission as a staff attorney and is familiar with the Commissions laws.
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The Commission previously heard a petition for rulemaking submitted by an attorney

representing organizations opposed to fluoridation. The Commission declined to open
rulemaking to amend its rules on legend drugs. The attorney representing the organization filed
an appeal of the Commissions decision to not open rulemaking as requested by the petition.
On behalf of the Commission, a motion to dismiss the appeal was filed. The Thurston County
Superior Court granted the Commissions motion to dismiss. We are now waiting to see if an
appeal to the Court of Appeals is filed in the next 30 days. If no appeal is filed, then the case is
resolved.
The Stormans case was scheduled to be argued in 9 Circuit Court of Appeals in October. The
day before arguments were to be presented, one of the 3 judges recused himself. The argument
was then rescheduled to be heard on Monday December 1, 2013 in San Francisco. A week
th
before the December 1 date, the 9 Circuit issued an order on its own motion delaying
arguments until the US Supreme Court decides a case that is now pending, Conestoga Woods
vs. Sibelius, which challenges the Affordable Care Acts requirement for employers to include
contraceptive coverage in health insurance for their employees . The question of whether a forprofit corporation has the First Amendment protections for the free exercise of religion is a
central question in that case.
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Cathy introduced herself to the new commission members and provided a brief bio of her
background.
Tim also shared a brief bio of himself to the new commission members .
Pharmacy Supervisor Investigator/Field Investigator

The Investigators hold the distinct dual role of conducting both investigations and inspections.
The State is divided into ten regions with each Investigator assigned to a region. Those regions
and assigned Investigators can be found at the end of this memorandum. All nine current
Investigators (our E. Washington region is currently vacant due to a recent retirement) come
from varied practice backgrounds and collectively hold more than thirty-two years of experience
with the Commission. On average, each investigator has been a licensed pharmacist for more
than 20 years. Consider them your eyes and ears in those regions. They are a resource to
contact when you are reviewing investigation reports and they welcome your contact and
feedback. I encourage you to contact them directly with questions when considering novel
requests by licensees. Undoubtedly theyve been to the facility and may provide you some
additional perspective.
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Currently the Pharmacist Investigator acts as a resource for and provides pharmacy expertise to
other law enforcement agencies in conducting drug related criminal investigations. The
Pharmacist Investigators conduct investigations of alleged drug law and pharmacy practice
violations using their current education, training and experience. All Investigators have been
trained in interviewing technique and have completed Departmental and State required
investigative training.
Investigators have also completed up to thirty hours of online training regarding sterile product
preparation due to the importance placed on compounding by the Commission. One
Investigator has recently received in-depth training at the Critical Point Sterile Compounding
Boot Camp and another will receive the same training in the spring of 2014 to serve as
resources for the other Investigators. As inspectors, the Pharmacist Investigators conduct
routine and complex inspections of firms licensed by the Department. Those firms include;
Pharmacies (retail, hospital, long-term-care, parenteral, nuclear, mail-order, internet etc.), drug
manufacturers, drug wholesalers, K9 drug dog handlers, humane societies, researchers, state
institutions, shopkeeper outlets, jails/correctional facilities, health care entities and all other sites
where legend drugs, controlled substances, precursor substances, and over-the-counter drugs are
sold, stored, dispensed or administered. These firms total over 2,100 in number and include
1,425 pharmacies for an average of over 200 firms per Investigator.
In addition to firm inspections, Investigators conduct investigations authorized by the

Commission on any of the 6939 Pharmacists, 895 Pharmacy Interns, 9146 Pharmacy
Technicians and 9473 Pharmacy Assistants licensed in Washington in addition to the 2100 firms
previously mentioned.
In the period from November 1, 2012 to October 31, 2013 Investigators performed 1,513
inspections and completed 181 investigations .
Investigations and inspections consume approximately 80% of the Investigators duties. The
remainder of their time is spent providing technical assistance to both internal and external
stakeholders regarding pharmacy practice, providing consultation regarding drug law and
coordinating with other State and Federal agencies. As a participating member of the NABP
(National Association of Boards of Pharmacy) and having opted to use the MPJE (Multi-state
Pharmacy Jurisprudence Exam) as the licensure examination, the Commission is obligated to
maintain the pool of questions in that exam. The Investigators have been assigned to fulfill this
duty on behalf of the Commission because of their position as a pharmacy law expert. One of
our Investigators is a member of the MPJE Review Committee (MRC) which works to ensure
that questions submitted by all states across the country are reviewed and meet the current
standards. They also assist state question writers in drafting defendable questions .
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Investigator William Bill Kristin (E. Washington) retired November 30
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after serving the
State Board of Pharmacy and Pharmacy Quality Assurance Commission for over thirty years.
His dedication, depth of experience, knowledge and leadership will be missed.
Tyler Varnum reported:
In 2012 it was identified that there was a need for more robust compounding rules and a need
for the investigators to be trained more in depth.
Tyler completed training 30 plus hours of online training all relating to 797 compliance
provided by Critical Point.
In September he received another 19 hours of live training at the Critical Point Compounding
Boot Camp in Denver, CO.
Eric Kastango (elected member of USP Expert Committee for Sterile Compounding, cGMP
manager, Baxter, Coram, extensively published).Kate Douglass (a USP <797> Study CoDirector, extensively published, Coram, Solumet). James T Wagner (USP Expert Committee
member, lead Controlled Environmental Testing Association (CETA) efforts for USP guidance
documents, USP Hazardous drug compounding expert committee, steering committee member
for NSF/ANSI)
There were attendees from all corners of the country; NY, IL, LA, NC and CO. He was the
only inspector from WA but there were others, 2 from LA and 2 from NC.
Most of the attendees were pharmacy managers, pharmacists and technicians from hospitals,
large industry like Cardinal, Pharmacy One Source and even some independent retail pharmacy
practices.
Objectives of the training ranged from the broad scope and objectives of 797 all the way to the
practical experience in environmental testing, end product testing, facility design and the
performance of aseptic manipulations .
Tyler felt that Critical Point provided exceptional training for anyone involved in either the
regulation of or the practice at a compounding pharmacy.
The main points of the Critical Point training and elements in 797 were:
Maintaining a clean state of control in your environment.

Operator competencies/training.
CSP checks and tests.
Most facilities that produce CSPs need assistance in one or more of these areas.
Safe harbor helping to maintain the sovereignty of pharmacy compounding by demonstrating
reproducible quality.
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CONSENT AGENDA Item 2.5(a)
Providence Tech check Tech- Renewal was pulled from the Consent Agenda for further discussion.
MOTION: Dan Rubin moved that the commission conditionally approve Providence Pharmacy
Technician Specialized Functions renewal subject to their follow up by the January meeting in the
specific areas of change that was recommended by staff. Also, the commission would like the wording
in their APUP be changed from a Level A pharmacy assistant (which is inconsistent) to pharmacy
technician. Sepi Soleimanpour second. MOTION CARRIED: 11-0.
CONSENT AGENDA Item 2.5(b)
PeaceHealth St. Joseph Medical Center Pharmacy Technician Specialized Functions was pulled from
the Consent Agenda for further discussion.
MOTION: Dan Rubin moved that the commission conditionally approve PeaceHealth St. Joseph
Medical Center Pharmacy Technician Specialized Functions subject to their follow up by the January
meeting in the specific areas of change that was recommended by staff. Sepi Soleimanpour second.
CONSENT AGENDA Item 2.6
Pharmericas Automated Drug Distribution Device was pulled from the Consent Agenda for further
discussion.
MOTION: Dan Rubin moved that the commission conditionally approve Pharmericas Automated
Drug Distribution Device now subject to they will not go live until the commission has approved an
initial list. Emma Zavala-Suarez second. MOTION CARRIED: 11-0.
PRESENTATIONS
Washington Recover Assistance Program for Pharmacy
The commission heard a brief overview of Washington Recover Assistance Program for Pharmacy
(WRAPP). Will Rhodes, Program Director, and Micki Kedzierski also provided an update and
clarification on contract/statement of work and audit findings.
Micki discussed the recent audit of the programs and how they have been addressing the issues
identified in the report. WRAPP asked the commission to consider guidance on making some changes
to the Contract and Statement of Work Modifications related to the audit.
1. Re-designation of categories of participation from three categories: "Voluntary", "Voluntary-inLieu (Case-in Progress)" and "Board-Ordered" to two categories: "Voluntary" and "Mandatory".
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MOTION: Nancy Hecox moved that the commission make motion to support the request to Redesignate categories of participation from three categories: "Voluntary", "Voluntary-in-Lie" and
"Board-Ordered" to two categories: "Voluntary" and "Mandatory". Gary Harris second. MOTION
CARRIED: 11-0.
2. Designation of phases to "Intake/Assessment", "Treatment", and "Monitoring". WRAPP

considers these phase designations to more accurately define phases in the WRAPP monitoring
program than the UAs/month phases used by other practitioner groups.
MOTION: Gary moved that the commission accepts the language changes for the phases of treatment
as purposed by WRAPP. Sepi Soleimanpour second. MOTION CARRIED: 11-0.
3. Provision of WRAPP services to unlicensed and/or non-practicing clients
MOTION: Nancy Hecox moved that the commission support changing provisions of WRAPP services
to unlicensed and/or non-practicing clients . Gary Harris second. MOTION CARRIED: 11-0.
Prescription Monitoring Program Overview and Update

Program Director Chris Baumgartner provided an overview and update of the prescriptions monitoring
program to the commission.
Overview/History
A PMP is a program designed to improve patient safety and protect public health with the goal
of reducing overdose deaths, hospitalizations, and other related prescription drug abuse issues.
Records for dispensing of controlled substances are submitted to a central database by

pharmacies and other dispensers.
Health providers and other authorized users are able to register for access, and once approved,
can view information through a secure web portal .
PMP information can help providers avoid duplicative prescribing and dangerous drug
interactions; and help identify substance abuse or pain management issues.
Legislation was passed in 2007 (RCW 70.225)
Federal funding was obtained in October 2010 to start implementing the program
Rules were adopted in July 2011 (WAC 246-470)
DOH contracted with an application service provider for data collection and reporting in July
2011
An additional federal award was obtained in October 2011 to finalize implementation
2011
Begin Data Collection October 1
Begin Mandatory Reporting October 7
Begin DOH/PMP Staff/Licensing Board Access October 26
Begin Oversight Agencies Access November 15

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Begin Pilot Data Requestor Access December 1
2012
Begin Data Requestor Access January 4
Begin Law Enforcement/Prosecutorial Agencies Access February
Begin Medical Examiners/Coroners Access May
Operations, Maintenance, Enhancements ongoing

PMP Operational Funding
HB 1565 provides ongoing funding through the Medicaid
Signed by Governor on 4/23
The signed operating budget (6/30) includes funding for the PMP from this account and from
HCA.
The operating budget also includes a proviso requiring the PMP to integrate with EDIE.
Goals for Washingtons PMP
To give practitioners an added tool in patient care
To allow practitioners to have more information at their disposal for making decisions

Data Submission Compliance
At the end of October 2013 we had:
1,444 licensed resident pharmacies
600 licensed non-resident pharmacies
We average 98% compliance each month
Pharmacies who do not dispense controlled substances file a no dispensing of CS form with the
program
2 complaints filed to date for non-compliance

Who isnt required to submit data
Practitioners who directly administer a drug
A licensed wholesale distributor or manufacturer
Prescriptions provided to patients receiving inpatient care at hospitals
Pharmacies operated by the Department of Corrections (unless an offender is released with a

dispensing)
Veterans Affairs, Department of Defense or other federally operated pharmacies (Indian Health
Services is now reporting voluntarily & Veterans Affairs should be soon)
Who Has Access
Prescribers & dispensers - in regards to their patients
Licensing boards in regards to investigations
Individuals in regards to any prescription dispensed to them
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DOH/Vendor in regards to program operation

Law Enforcement/Prosecutor for bona fide specific investigations
Medical Examiner/Coroner cause of death determination
HCA (Medicaid), L&I (Workers Comp), DOC (Offenders)
De-identified information may be provided for research and education
Future enhancements / Version 4.2
As part of our grant enhancements we are required to upgrade our data collection format to the
most recent version
A new implementation guide was sent out in April so dispensers could begin work
Data submission in the new format began in October 2013

Interstate Data Sharing
The technical components are now in place
The next step will be putting into place data sharing agreements with state PMPs
Once in place WA providers will be able to select additional states to request data from when
using our system
Health Information Exchange
We have built the connection to our state HIE (OneHealthPort) this summer.
In phase II starting this fall:
Connection through the HIE to UW Medicine
Connection through the HIE to EDIE
If you know of other organizations who would be interested in connecting this way please have
them contact DOH
Yakima Valley Farm Workers Clinic

Cathy Williams gave a brief overview before introducing Dr. Thomas Schilling, Pharmacy Clinical
Director for Yakima Valley Farm Workers Clinic (YVFWC). Dr. Thomas Schilling asked the
commission to consider approving services to clinics using workload balancing via remote order
processing and use of collaborative drug therapy agreements . He would like to expand the functions of
the YVFWC Call Center.
Overview:
2012 YVFWC Served 119,614 patients
66.5%....Hispanic
27.7%....White, Non-Hispanic
28.4%....Best served in a language other than English
34. 6%....Migrant/seasonal farm workers or their dependents
76.6%.....Income below 100% FPL
43.9%.....Medicaid
8.5%.....Medicare
2012 Patient Encounters Totaled 540, 735
Medical.406, 661
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Dental.72, 989
Mental Health.32, 181
Other Professionals (RD).10, 160
Enabling Services.17, 081
Six YVFWC Pharmacies located in our Washington Clinics. All participate in the Federal 340b drug program
and provide care to all eligible YVFWC clinic patients:
Yakima
Toppenish
Grandview
Walla Walla
Spokane (2)
Definition of Workload Balancing: Assisting our local pharmacies with their prescription workload using
the shared Pharmacy Software, EnterpriseRx.
The remote pharmacist will be authorized to perform the following functions:
Process Prescription Reception and Inbound Communications
Prescription Data Entry
Process Adjudication Exceptions
Prescription Renewal Requests
Authorized functions would NOT include:
Product Dispensing
Verification
Patient Counseling
Processing prescriptions through the pharmacy Enterprise Rx system:
The Pharmacist or the Pharmacy Technician under the direct Supervision of a Pharmacist may process
prescriptions in the Enterprise Rx system.
Renewal of prescriptions requested by the patient:
Only a Pharmacist approved by the Pharmacy Commission under our CDTA protocol may process
prescription renewal requests.
Workflow Steps for Processing a Medication Order
1. Receipt of the prescription order (New Rx or Refill Rx) in Reception or Inbound Communications
Queues
2. Data Entry
3. Adjudication resolution*
4. Product Dispensing
5. Verification/DUR resolution
6. Patient Counseling
*Only steps 1 3 will be done by a remotely as workload balancing
Where are the Remote Functions Going to be Performed
Remote processing of existing prescription orders will be done at another pharmacy or from the call center, or a
remote location.
Remote processing of prescription renewals using the CDTA will be performed only by a pharmacist at another
pharmacy, from the call center, or a remote location.
Responsible Pharmacist
The individual who takes responsibility for the final medication dispensed to the patient.
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In our remote process, the local pharmacist* is the Responsible Pharmacist
*She/he needs to have performed or directly supervised all of the workflow steps for product handling,
dispensing, prescription verification, and patient counseling during the preparation of the prescription order for
the patient.
Pharmacy Call Center
Location:
YVFWC Yakima Clinic where our Yakima Pharmacy is located.

Oversight:
Currently by the Yakima Pharmacy Manager

Call Center Agents:
Are Registered Pharmacy Assistants.

Function:
Receive prescription refill and renewal requests from patients and enter them into the Pharmacy
Software System
Call Center Procedures
1. The patient tells the call center agent the prescription number they would like to refill.
2. The call center agent locates the prescription number in the patients medication profile
3. If the exact prescription number is not found in the profile, the call is transferred to the pharmacist in the
local pharmacy.
Prescription Renewal Process
1. Patient requests prescription renewal by contacting the Pharmacy Call Center.
2. Call center agent saves this request in the reception queue of the local pharmacy.
3. If there are no refills remaining, when the local pharmacy staff opens the prescription in the reception,
EnterpriseRx will allow them to initiate a renewal request that goes to the pharmacists work list in the
Electronic Medical Record system, (IC-Chart).
4. Pharmacist approves the prescription renewal if allowed by the CDTA or forwards it to the provider for
approval.
5. Approved prescriptions sent to the pharmacy by the pharmacist or the provider.
Benefits for Our Pharmacy
Workload
Workload balancing spreads the workload over the entire pharmacy system helping local pharmacy to:
Reduce Patient Wait time
Improve overall efficiency
Allow the pharmacist more time with the patient

Quality Improvement
More time spent on workflow steps our data shows result in the highest percentage of medication errors
Improved Safety
Reducing medication errors to improve patient safety
Benefits for Pharmacy Call Center
Current Yakima Pharmacy Responsible Manager may devote all of her time to the Yakima Pharmacy instead of
both the pharmacy and call center
More efficient for the local pharmacy: Fewer calls forwarded to local pharmacy and are handled by the Call
Center Pharmacist
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MOTION: Tym Lynch moved that the commission approve Yakima Valley Farm Workers Clinic
workload balancing proposal as presented. Al Linggi and Elizabeth Jensen recused themselves, and
Gary Harris opposed. Sepi Soleimanpour second. MOTION CARRIED: 8-1.
MOTION: Nancy Hecox moved that the commission approve Yakima Valley Farm Workers Clinics
proposal to add a pharmacist in the call center as Responsible Manager to expand call center with the
requirement that it MUST be licensed as a pharmacy. Elizabeth Jensen recused herself, Tym Lynch
abstained. Dan Rubin second. MOTION CARRIED: 9-0.
Medication Review
Chris Terriff, VP Clinical Operations and Doug Crafton, President and CEO provided an updated
overview of Medication Review and the remote medication order processing services it provides.
Company Background
2005 Pharmacy management services rural hospitals
Clinically trained RPhs hospital experience
2009 began remote order entry services

Today remotely enter/verify in excess of 9,000 Rxs per week
Licensed in 10 states
Two regional offices Spokane, WA & Minden, NV
Serve 18 of 39 critical access hospitals in WA
Pharmacy management services

Our Culture
Incentivize our pharmacists for BCPS, CDE, etc.
Centralized order processing
Strict hiring guidelines
Faculty & Adjunct Faculty at WSU College of Pharmacy
Rotation site for WSU College of Pharmacy
WSU preceptor of the year awards

All of these provide a clinical setting that encourages learning, competency, high practice standards,
and forward thinking.
Policy & Procedure Overview
Medication Review P & P when providing order entry

Ancillary Personnel Utilization Plan at Med Review
Secure transmission of medication order/notice
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Electronic Health Record (EHR) at remote site
Remotely supervise the daily activities of the Pharmacy Technician by digital interactive video,
audio, data transmission and/or still image capture.
Medication Review Pharmacists are responsible for verifying accuracy of filled orders prior to
release of medications (ADDD fills, direct to staff, repackaging bulk to unit dose)
Technician to Pharmacist Ratio 3:1
Automated Drug Dispensing Device required

Order transmission/disaster recovery downtime
On-site Pharmacist-In-Charge
Ancillary Personnel Utilization Plan Remote Facility
CQI & Reporting

Electronic Supervision of Technicians
Permanent digital records archived and readily retrievable for minimum 2 years
Continuous Quality Improvement
Measure current and improve future work!
Productivity
Order volumes per facility
Clinical Consultations/Interventions
Order Variance/Error incorrect entry & harm vs. no harm
Adverse Drug Events
State/Federal Regulations Update
Implementation/Strategies for improvement

Hospital Pharmacy CQI Reporting
Order deficiencies aka Pharmacist Interventions
QI data back to the facility
Track medication errors
Summit Pacific Medical Center

Tim Fuller introduced Dr. Andrew Burton, PharmD. Dr. Burton provided an overview of Summit
Pacific Medical Centers (SP-MC) use of Medication Review for remote medication order processing
services. The commission was asked to consider for approval SP-MCs policies and procedures.
Background
Opened February, 2013

10-bed Medical Unit + Emergency Department
Critical Access Hospital
Located in Elma, WA: Population 3,052
Nearest hospital is 24 miles away
Pharmacy Department open approximately 20 hours/week
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Uses Pyxis Automated Drug Distribution Device for medication distribution control
Remote Order Entry
Provided by Medication Review

1206 orders entered for SPMC in November
Provides 24-hour pharmacy services in accordance with WAC 246-873-050 including
Order entry
DUR checks
Drug information
Dosage calculation
Procedure Overview
Nursing staff reviews and scans written medication order and indicates if order is urgent
(STAT)
Remote order entry pharmacist receives order and checks order against patient profile for
accuracy, completeness, and contraindications
Pharmacist enters order into Pyxis system
Every order is reviewed by a pharmacist for accuracy, allergies, interactions, etc prior to
administration by nursing staff
Orders are entered promptly, 24/7
Accessed via private VPN tunnel
10-Bed Medical Facility
Excessive delay in medication delivery
Acquire and maintain all appropriate Washington State licenses and approval for Pharmacy and
all employees
Ensure that all pharmacists providing remote order entry have been trained on Summit Pacific
Medical Centers policies and procedures regarding medication order processing
Nurse can then access medication from the Pyxis Medstation for administration
Advantages
Nursing staff has immediate access pharmacist via phone and instant messaging
Security
SHA1 AES 256 Bit Encryption
Allows only specific computers within the Medication Review network access to Pyxis Console
24-hour Hospital Pharmacy
Only 40 med orders processed per day
Not reasonable or cost effective

On-Call Hospital Pharmacist
Nurse overrides in Pyxis system to access medications omits pharmacist order verification
Safety concern
SPMC Requirements of Medication Review
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All MR employees with access to SPMC electronic files containing patient health information
must be appropriately trained in HIPPA protocol
Continuous quality improvement program in place
MOTION: Dan Rubin moved that the commission approve Summit Pacific Medical Centers remote
order entry as proposed. Elizabeth Jensen second. MOTION CARRIED: 11-0.
Willapa Harbor Hospital Pharmacy

Lisa Roberts, Director of Pharmacy will provide an overview of Willapa Harbor Hospital Pharmacys
use of Medication Review or another Washington State Board of Pharmacy approved Remote Order
Processing Company for remote medication order processing services.
Policy:
Provide medical and nursing staff with twenty-four hour pharmacist services for electronic
medication order verification and clinical pharmacist consultation.
Procedure:
The hospital will provide continued pharmacist services after hours when the hospital inpatient
pharmacy is closed.
Willapa Harbor Hospital inpatient pharmacy is staffed with a full-time pharmacist covering at least
forty hours of pharmacy services weekly. Hours may be subject to change depending on the needs
of the facility.
In order to provide continued pharmacist services after hours and on weekends, the hospital will
enter into a written contract or agreement Medication Review Washington State Board of Pharmacy
approved Remote Order Processing Company. The written contract will be reviewed annually and
may term inate by either party without cause. Medication Review o r Washington State Board of
Pharmacy approved Remote Order Processing Company must provide Washington State licensed
pharmacists for remote electronic medication order verification and clinical consultation. The
remote pharmacists must provide their current pharmacist license for Willapa Harbor Hospital
Pharmacy Department to maintain on file. All remote pharmacists must comply with federal and
s ta te laws and regulations. Any out-of-state pharmacy providing remote order processing services
must be licensed as a non-resident pharmacy.
Medication Review Washington State Board of Pharmacy approved Remote Order Processing
Company will not be responsible for the dispensing of a prescription drug; however, they will be
responsible for the following:
1.
Receiving, interpreting, clarifying and remote processing of medication orders
2.
3.
4.
5.
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6.
Providing drug information/clinical consultation to nursing or medical staff
Willapa Harbor Hospital and the Medication Review or Washington State Board of Pharmacy
approved Remote Order Processing Company must share common electronic files or have
appropriate technology to allow secure access to the pharmacy's information system and likewise,
to provide the Medication Review with access to the information necessary or required to process a
medication order. Willapa Harbor Hospital utilizes Computerized Physician Order Entry (CPOE).
Willapa Harbor Hospital is responsible for maintaining records of all orders entered into their
information system including orders entered from a rem ote location. Medication Review o r
Washington State Board of Pharmacy approved Remote Order Processing Company must provide
Willapa Harbor Hospital with the ability to audit the activities of the individuals remotely
processing m edication orders.
The Remote Processing Order Entry facility must conform to Willapa Harbor Hospital's drug
formulary, therapeutic interchange program, IV concentrations, standard adm inistration times,
and collaborative dosing agreem ents. Willapa Harbor Hospital will provide the Remote Order
Entry facility with this inform ation.
Medication Review or Washington State Board of Pharmacy approved Remote Order Processing
Company must follow Willapa Harbor Hospital's policy and procedure manual relating to the
pharm acy's operations. This manual shall include the following:
1.
Outline the responsibilities of the pharmacy and Medication Review
2.
A list of the name, address, telephone numbers, and all license/registration
numbers of th e pharm acy/pharm acists involved in rem ote order processing.
3.
Maintenance of appropriate records to identify the name(s), initials, or
identification code(s)and specific activities of each pharmacist who performed
any processing
4.
Compliance with federal and s ta te laws and regulations
5.
A continuous quality improvement program for pharmacy services designed to
objectively and system atically monitor and evaluate the quality and
appropriateness of patient care, pursue opportunities to improve patient care, and
resolve identified problems. Such Quality Assurance will be conducted routine
and will include:
i. Adverse Drug Event tracking
ii. Volumes and timeliness of order verification
iii. Performance feedback from Willapa Harbor Hospital nursing and medical
staff
This policy and procedure m anual will be reviewed annually and documented upon completion
of review.
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MOTION: Tym Lynch moved the commission approve Willipa Harbor Hospitals proposal to provide
services with Medication Review or another Washington State Board of Pharmacy approved Remote
Order Processing Company and the use of Automated Drug Dispensing Device (ADDD). Steven
CAPSA Solutions
Tim Fuller led the discussion for CAPSA since Andrew Sherrill, VP Long Term Care, Capsa Solutions
Inc. did not attend. Tim began to provide information on CAPSAs new product Electronic Emergency
Kits for nursing homes.
The commission tabled this presentation for the January meeting so someone from CAPSA can answer
the commissions question and concerns.
RxRemote Solutions
Tim Fuller introduced Beata Przebinda, Regional VP for Comprehensive Pharmacy Services asked the
commission to approve RxRemote Solutions remote order processing service. The commission asked a
few questions regarding some concerns.
All pharmacists that will be practicing for this facility are Washington State licensed.
The entire system is encrypted.
Each hospital and nursing station is given is assigned specific fax line.
This does not affect the pharmacist to pharmacy technician ratio because there are no pharmacy
technicians practicing
MOTION: Gary Harris moved that the commission accept RxRemote Solutions Remote Medication
Order Processing Services to provide services for FairFax. Elizabeth Jensen second. MOTION
CARRIED: 11-0.
FairFax Hospital Everett and Kirkland

Beata Przebinda, Regional VP for Comprehensive Pharmacy Services requested approval for FairFax
Hospital Everett and Kirkland to use RxRemote Solutions Services.
Overview
Fairfax Hospital is a psychiatric hospital located in Kirkland, WA.
157 licensed beds.
We offer:
1. Inpatient Hospitalization
2. Partial Hospitalization
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3. Treatment for co-occurring Disorders and Medical Detoxification.

On 10/22/13, Fairfax Hospital received a Certificate of Need to operate a 30 bed acute
psychiatric hospital.
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Fairfax Behavioral Health Everett (Fairfax Everett) will be located on the 7 floor in the South
Building at the Pacific Campus of Providence Regional Medical Center.
Fairfax will be leasing 21,000 square feet for the unit.
Pharmacy
Clean, secure, separate room.
Medications will be stored on shelves; controlled substances will be locked in a separate, locked
cabinet.
The pharmacy will contain a sink, work space, an area to prepare medications, refrigerator, and
climate controls.
Day to Day Operations
Fairfax Hospitals Medication Management Policies and Procedures will serve as the template
for operations at Fairfax Everett Pharmacy.
A Pharmacist in Charge will work 4-5 hours a day Monday through Friday and will report to the
Director of Pharmacy.
Pharmacy staff members at Fairfax Hospital will be cross trained to work at both facilities.
AmerisourceBergen (ABC) will supply medications Monday through Friday.
A pharmacist will be present to accept all deliveries from ABC.
Control substances movement will be tracked and documented.
Medication orders sent up to 5pm, will be processed by the Fairfax Pharmacy, Kirkland
location.
After hour medication orders will be processed by Remote Order Entry Fairfax Everett
Pharmacy will utilize the same formulary as Fairfax Hospital, Kirkland.
Pyxis Automated Drug Distribution Devices
Profile Driven Pyxis ADDDs (2) will be located in the medication room.
These ADDDs will interface with the pharmacy patient profiles.
The pharmacist will be responsible for filling the ADDDs daily as required and for maintaining
them.
See Medication Management P&Ps for further information.
After some discussion the board felt there needs to be a clarification in the P&P regarding verbal
orders. This was the biggest concern the commission had regarding this proposal. The P&P needs to
be amended.
MOTION: Elizabeth Jensen moved that the commission table this proposal until January requesting
that Policy & Procedures for FairFax Hospital Everett and Kirkland be updated. Kristina Logsdon
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OTHER
White Bagging
Chris Humberson led this discussion. The practice of having patient-specific medications or supplies
delivered directly to the practice setting (hospital outpatient infusion center or physician office) or a
secondary in-state pharmacy that then supplies product(s) sent by specialty pharmacies for use by a
specific patient.
Background
Specialty drugs are a subgroup of medications that are often biotech/gene based products that
are usually high cost and require complex care and monitoring. They are most often injectable
drugs with many being infusion based. White bagging is the practice of having patient specific
medications dispensed directly to the practice setting (outpatient infusion center, physician
rd
office or hospital). Usually this distribution is done by a 3 party specialty drug pharmacy per
mandate of the insurance company.
Specialty drug expense is increasing at an alarming rate and as purely a cost reduction effort, the
insurers have mandated specialty drugs to come from dedicated facilities at locations across the
US. The drug is dispensed as a prescription from one of these facilities based on an order
generated by the patients managing healthcare provider. Because the drug is billed at the time it
is filled by the specialty pharmacy, the institution delivering the care is not allowed to bill for
any pharmacy related services (drug ordering, acquisition, order maintenance, storage
preparation and mixing, patient monitoring, care coordination and documentation). In this
regard, the delivery system is doing the work, assuming the liability for infusion but without
reimbursement.
Assessment
There is an increasing trend to carve out specialty drug distribution using specialty pharmacies
that are not part of the delivery system. Often this prescription dispensing is being done
contrary to state regulations but enforcement with either the distributer (specialty pharmacy) or
the receiving organization (Care Delivery Organization) has been variable. The mostly out of
state specialty pharmacies have often taken a passive not my problem approach that they are
just filling the prescription, billing the insurer and shipping the drug and its up to the
organization to figure out how to comply with regulations .
The commission would like staff to do more research and discussion to determine what the needs are
for the safety of patients in Washington State.
Collaborative Drug Therapy Agreements

The commission discussed the communication that was distributed in August 2013 regarding the
standards for acceptance of CDTAs.
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Background
Relevant to this discussion is how the path, once decided at that time, the process was not
followed as decided by the board at that time. There have been no subsequent decisions by the
board to divert from this original 2003 decision referenced in any subsequent meetings of the
Board of Pharmacy to date.
The WSPA at the time supported the board decision as noted in the minutes by Rod Shafer,
Executive Director of the WSPA.
This information should be considered given the board discussion of CDTAs at the May 30,
2013 meeting and the subsequent August communication of a return to the board approved
process from 2003, recognizing CDTAs as agreements between pharmacists and prescribers
and not as agreements between prescribers and business entities in which a pharmacist may be
employed.
Communication
When it is time to renew your Collaborative Drug Therapy Agreement (CDTA), please ensure
that your agreement clearly establishes a relationship between the medical prescriber and the
pharmacist. Under RCW 18.64.011(25), CDTAs cannot establish a delegation of prescriptive
authority between a business entity and a medical provider. Please see WAC 246-863-100 for
more information.
The Pharmacy Quality Assurance Commission (Commission) plans to provide more detailed
information regarding CDTAs in October. The practice of submitting a cover memo listing all
pharmacists as party to a single CDTA does not meet the legislative intent of the Practice of
Pharmacy, RCW 18.64.011(25), and will no longer be accepted nor considered as a valid or
active CDTA submission. Additionally, all pharmacists engaging in CDTAs, and care
documentation will be required to maintain a copy of their agreements at their practice site for
inspection upon request .
Any pharmacists employed through a pharmacy relief service must operate under the
pharmacists own CDTA. No other accommodation is acceptable.
Furthermore, a pharmacy intern can perform under an approved CDTA if an intern's preceptor
has an agreement is in active status by the Commission.
The commission allowed the public to speak on this matter regarding their concerns. Each concern was
heard and addressed by the commission and Joyce Roper, AGG.
OPEN FORUM
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CLOSED SESSION
Next scheduled business meetings: Business Meeting Agenda
Date:
December 6, 2013
Time:
9:00 a.m.
Location:

Mt. Constance
2400 South 240 St.

Approved on January 23, 2014

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STATE OF WASHINGTON

Special
Business Meeting Minutes Amended
December 6, 2013
Mt. Constance
2400 South St.
CONVENE
Chair Christopher Barry called the meeting to order December 6, 2013
Commission Members:
Dan Rubin, MMP, Public Member
Steve Anderson, RPh
Nancy Hecox, PharmD
Al Linggi, RPh, MBA
Tim Lynch, PharmD
Guest / Presenters:
Glenn Adams, PharmD for Confluence Health
Terry Clark, PharmD for Confluence Health
Sandra Locklear
Officer Josh Bolender from Liquor Control Board
Shannon Potts, RPh for ReliantRx LTC

Zavala-Suarez, J. D., Public Member
Gary Harris, RPh,
Staff Members:
Joyce Roper, AAG
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MOTION: Dan Rubin moved that the commission approves 1.2. Steve Anderson second. MOTION
CARRIED: 10-0.
PRESENTATIONS
Confluence Health Updates
Tim Fuller introduced Glenn Adams and Terry Clark from Confluence Health. Glenn Adams provided
a brief update to the commission on their approved retail telepharmacys.
Confluence asked for approval to update their P&P to have the ability to deliver medication to the
Telepharmcy sites that are not in the equipment so patients can pick them up instead of having them
mailed to their homes.
Overview:
Primary pharmacy in Wenatchee that provides Retail Telepharmacy services to two remote
pharmacies in Royal City and Waterville.
Dispensing close to 200 prescriptions a month total for both pharmacies

There was one near miss in Royal City Telepharmacy it was never dispensed to the patient .
There have been no errors dispensed to patients
There has been a substantial growth in prescriptions that we dont have in telepharmacy
equipment. We end up having to mail a lot of medications out. sending a lot of medications out
Process Improvements
Implement Telepharmacy room surveillance camera

Royal City (9/2013)
Waterville (9/2013)
Wireless Headsets
Confluence would like to update their policy. They would like to have ability to have them
delivered to telepharmacy site and require that all the medications get dispensed just like the
medications in the telepharmacy equipment. This will require the patients signature and face to
face consult with pharmacist prior to dispensing.
Redundancy
Update to P&P
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Patients prefer the idea of picking them up at the site than having them mailed to them.
MOTION: Al Linggi moved that the commission require Confluence Health to license the
Telepharmacy sites as a pharmacy if there will be medications that are not stored in a robotic device .
Dan Rubin second. MOTION CARRIED: 10-0.
Glenn Adams and Terry Clark from Confluence Health provided a brief update regarding their
approved Remote Infusion Supervision and Order Entry to the commission.
Current Infusion Therapy at Confluence Health

Wenatchee Infusion
Outpatient hospital based dept
Pharmacy staff (2 Technicians, 2 Pharmacists)
Omak Infusion
Rural Health Clinic
Moses Lake Infusion
Rural Health Clinic
Mixing performed Technician remotely monitored by a pharmacist
Remote Infusion
Moses Lake Infusion (Remote Technician)
Wenatchee Valley Hospital (pharmacy staff)
Maintains a 3 to 1 ratio of Technicians to Pharmacist
Utilize all of our current pharmacy policy and procedures (Hospital Standards)
Electronic Medical Record (physician order entry)
Video/Audio Technology to remotely supervise technician
Planning for Patient Safety
Mixing room upgrade
June 2013 a glove box was installed in the Moses Lake Mixing room to meet 797
guidelines. This could cause disruption in the telepharmacy over view. To be proactive a
pharmacist was on site during the project in case the telepharmacy link was not
available.
Success and Challenges
Interventions
Over view by pharmacist on the day of treatment
ADR prevention: Lab data reviewed on day of therapy allows dosage
adjustments.
Optimizing therapy based on lab data review.
The most current order wasnt always available in the clinic.
Pharmacist over view of all orders prior to administration.
Statistics
938 separate patient visits (Feb 2013 July 2013)
3216 images captured for documentation and stored
One near miss wrong dose was in EMR when the original paper order was reviewed by the
pharmacist. The pharmacist was able to intervene before the medication was mixed.
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Confluence IV Robot
Glenn Adams, PharmD introduced the new technology used in sterile compounding the IV Robot
technology.
Why Automate Sterile Compounding

Patient safety
Regulatory compliance
Centralized compounding center
Dirtiest item in the hood = the people
Automation Selection Process
FDA approved device
USP 797 Compliant
Batch IV production
Patient specific IV production
Manual IV production
ROI vs. Patient Safety
IV Robot
Non-Hazardous IVs
Batch IVs
Patient Specific IVs
Self contained sterile compounding room (ISO Class 5)
IV bags and syringes
Dilution capabilities
Hood certification
Sterility testing
Achievements
Quality Controls
Barcode verification
Video/camera monitoring (image storage)
Double gravimetric control
Electronic audit trail of compounding
Standard work forced compliance
Redundancy if robot or manual IV automation fails
Compliments infusion telepharmacy practice
Patient Safety
Implementation Timeline
Robot Install
Aug 19 Kickoff
Sep 9 15 Go-live
Conservative implementation (batch)
Anesthesia products
Lidocaine syringes
Oxytocin bags
Patient specific production in the future (interface)
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Manual IV Automation Install

Aug 21-22 Sterile IV Compounding Kaizen
Sept 16 Kickoff
Sept 30 Go-live
WVH
CWH
Infusion centers - TBD
Synthetic/Designer Drugs
Chris Humberson led the discussion regarding emerging information regarding new dangerous
substance being sold as legal alternatives to marijuana and amphetamines. Chris introduced Sandra
Locklear who attended to share a personal story regarding synthetic drug use and Officer Josh Bolender
from Liquor Control Board.
Sandra Locklear shared her son Milos story about his battle with Synthetic Drugs and loss of his life.
She is very passionate about banning these Synthetic drugs and how available they are. Sandra ended
her story with a plea to the commission to ban all synthetic drugs from Washington State and to provide
better oversight and funding for routine testing for synthetic drugs and cannabis when listed on court
orders.
Josh introduced himself to the commission before sharing with the commission what the officers from
the Liquor Board are seeing out in the field. They are in and out of smoke shops on a daily basis. It is
easier to find a smoke shop that doesnt sell synthetic drugs. The labeling says not for human
consumption and there are tons of labeling geared toward kids as well. The labeling used to have what
the package does not contain, which are the illegal ingredients. Now most packages dont have any
ingredient information on the labels . There are so many various ways of packaging, labeling. The
availability of this has spiked.
Al Linggi volunteered to do some investigation on the science aspect of synthetic drugs with the
University of Washington. He will bring some more information to the commission in January.
ReliantRx LTC Pharmacy
Shannon Potts, RPh presented a proposal by REliantRx Long Term Care Pharmacy to use remote
medication order processing from home to service long-term care facilities.
Procedure Overview:
General
Remote staff access for patient care purposes will comply with all relevant
state and federal laws.
An audit trail will be maintained allowing identification of staff that have
performed remote activities and the actions they performed while
performing remote work.
Remote patient care will only be performed by pharmacists
Employed by ReliantRx who are fully trained and experienced in
performing on site the work they would be performing remotely.
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Pharmacists performing work functions from home are required to

maintain an environment free from distractions and home
responsibilities for the time they are performing these work functions.
Participation in remote order entry and other remote clinical functions

will be voluntary for staff and not a requirement for
employment. Pharmacists will be provided the opportunity to volunteer.
Communication via phone or notes attached to order
Director of Pharmacy or CEO will determ ine need for on-call remote
pharmacy services
Technical support will also be available for any issues that arise.
Remote Pharmacy Services

Supplemental order entry
Cycle/MAR (medication administration record) reconciliation
MAR correction review
Initial Verification of Orders
Clarification of Orders
MTM (medication therapy management)
Medication review
Returning facility phone calls
DOES NOT INCLUDE: Final verification of medication
Patient Confidentiality
Patient confidentiality will be maintained
Remote patient care activities will be performed in a private area to
prevent a confidentiality breach.
Inspection of the proposed order entry area at a home will occur by the
Director of Pharmacy before approval is given to check for compliance
with all security measures.
No patient information shall be maintained on private
computers.
Anything printed during patient care activities will be
shredded when work is completed.
Designated "shred" bins will be routinely cleaned out and picked
up to be properly destroyed
Remote access shall be via secure virtual private network connection.
The application will not reside on a private computer.
The remote access session will automatically log the user off
using the FrameworkLTC/DocuTrack system timeout intervals for
inactivity.
This policy will be reviewed annually
Policy Review
The commission requested that RelientRx make some amendments to their P&P then come back to the
board for approval. Staff will work with RelientRx to meet the concerns of the commission.
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NAPLEX Study Plan

A commission panel was asked to consider a request by Pharmacist Applicant David Larson for
authorization to re-take the North American Pharmacist License Examination. The applicant presented
a study plan for consideration by a panel of the commission
MOTION: Nancy Hecox moved that the panel accept the plan as submitted in addition he is required
to complete an additional 300 intern hours and wait 12 months before taking the NAPLEX. Elizabeth

Meet Me Call
The commission named Elizabeth Jensen as the representative and Tym Lynch as the alternate
to participation on legislative meet me call to discuss legislative bills that may potentially impact
multiple professions.
Rules and Legislation Implementation Update
Rules Process Overview

Peggy Crane provided the commission with a rules overview for the new commission members was
able to answer questions from the commission.
Compounding Rules there have been 3 stakeholder meetings and still working on draft language in the
CR102.
SSB5416 Electronic Communication of Prescription
MOTION: Dan Rubin moved commission allows staff to proceed with the CR102 for Electronic
Communication of Prescription. Elizabeth Jensen second. MOTION CARRIED: 10-0.
HB1609 Renaming the Board of Pharmacy
MOTION: Elizabeth Jensen moved commission allows staff to proceed with the CR105 expedited
process for Renaming the Board of Pharmacy. Steven Anderson second. MOTION CARRIED: 10-0.
Correspondence
a) Washington Recovery Program for Pharmacy WRAPP Reports
b) Letter to Care Health Solutions Technician Training Program
c) Ltr: regarding pharmacy dispensing practices
d) DEA Press Release: Three More Synthetic Drugs Become Illegal for at Least Two
Years
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OTHER
Eligibility for Pharmacy Intern Registration
The commission was asked for clarification on when a WSU or UW student eligible could be issued a
pharmacy intern registration. In the past authorization was based on notice from the school showing
acceptance into the pharmacy program. Recently, the department of health received a notice from
WSU advising the commission of the students that will be admitted beginning the fall semester 2014.
After some discussion there was no motion made on this. Chris Humberson will work with
credentialing and report back to the commission.
Policy Review and Revisions
a) Continuing Education Approved by Another Board Review of Draft Policy
MOTION: Tym Lynch moved staff accept Continuing Education approved by Washington State or
ACPE certified classes for pharmacist and pharmacy technicians. Steve Anderson second. MOTION
CARRIED: 10-0.
b) Policy/Procedure #40 Qualification for Re-exam NAPLEX
Policy/Procedure #40 Qualification for Re-exam NAPLEX was tabled until the meeting in January
because there was no material.
Recognition of 50 Years of Services

The Chair read the names of the pharmacists that have been licensed in Washington State for 50 years.
2014 Meeting Dates and Travel Calendar

The commission was asked to finalize and discuss the 2014 meeting and travel calendar.
MOTION: Dan Rubin moved that the commission accept the 2014 meeting calendar with a change to
the October meeting date to be October 23-24, 2014. Tym Lynch second. MOTION CARRIED: 10-0.
Review of Performance Measures

Chris Humberson just provided information in the commission meeting packet regarding Department of
Health Credentialing, Investigations, and Case Dispositions and the performance measures. There were
no questions from the commission.
Model Bylaws
Chris Humberson led the initial discussion on model bylaws to provide a framework from commission
operations and management not covered in law or rule. He shared a template with the commission so
they had an understanding of bylaws . Bylaws are not due from the commission until 2014.
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Election of Commission Officers

The commission was asked to consider suspending election of officers until December 2014 to ensure
consistency in the parliamentary function of the commission.
MOTION: Tym Lynch moved that the commission keep the existing leadership until December 2014
as suggested by commission staff. MOTION CARRIED: 10-0.
OPEN FORUM

CLOSED SESSION
Next scheduled business meetings: Business Meeting Agenda

Date:
January 23, 2014
Time:
9:00 a.m.
Location:
PPE Room 152/153
310 Israel Rd SE
Tumwater WA 98501


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STATE OF WASHINGTON
Regular Scheduled
December 11, 2014
Building Two
2400 South 240 St.
CONVENE
Chair Christopher Barry called the meeting to order December 11, 2014.
Commission Members:
Guest / Presenters:

Gary Harris, RPh,
Dave Galvin, King County

Chris Baumgartner, PMP Program Director

Steve Anderson, RPh
Nancy Hecox, PharmD
Al Linggi, RPh, MBA
Gary Garrety, PMP Operations Manager

Neal Traven, PMP Epidemiologist
Bryan Foster, Director of Forks Community
Hospital Pharmacy
Chris Terriff, Medication Review

Tim Lynch, PharmD
Staff Members:
Joyce Roper, AAG
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CALL TO ORDER
1.2 Approval of October 23, 2014 Meeting Minutes .
MOTION: Dan Rubin moved that the commission approve 1.1. Maureen Sparks second. MOTION
CARRIED: 10-0.
MOTION: Gary Harris moved that the commission approve 1.2 as amended. Steve Anderson second.
CONSENT AGENDA
approved by a single motion of the commission without separate discussion. If separate
November 2014

CVS Pharmacy Technician Training Program

CarePoint receiving system

Custom Prescription Shoppe City of Bellingham Program
Items 2.3, 2.6 & 2.9 were pulled for from the consent agenda for further discussion. Items 2.4, 2.5, 2.7,
and 2.8 were deleted from the consent agenda.
MOTION: Kristina Logsdon moved that the commission approve items 2.1, & 2.2. Steve Anderson
CONSENT AGENDA
CVS Pharmacy Technician Training Program
There was a concern on the length of this program and are there employed pharmacy technicians. Cathy
Williams shared that the entire program has been revised and there is a specific section to meet
Washington States requirements. They do employee pharmacy technicians. The commission asked for
other clarifications questions. Are there two different programs for technician and specialized technicians,
what does 35 hours of drive thru training entail and is there a didactic training portion included in this
program?
After further discussion the commission felt this program meets the criteria to be approved. Joyce Roper
shared that there is nothing in statue or rules that specify what needs to be taught in a training program. If
the commission feels there needs to be specific subjects taught in a program then the commission will
need to come up with specific standards they would like to see in a Technician Training Program and
make it a standard for all programs.
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MOTION: Steve Anderson moved to approve Consent Agenda Item 2.3. Gary Harris second. MOTION
CARRIED: 10-0.
CONSENT AGENDA
CarePoint receiving system
Al Linggi shared with the commission some information he had heard while at a conference about
encrypting and electronic shredding coming out. His comment regarding this was that this will start
coming up in the future. His opinion is this could very well put safety patient at risk if there are changes
in a patients prescription and or other changes and also a risk for fraud. He feels in the future the
technology committee should look into this and consider the adoption of further safety measures above
encryption for electronic of health data concerning pharmacy and healthcare.
MOTION: Dan Rubin moved to approve Consent Agenda Item 2.6. Sepi Soleimanpour second.
CONSENT AGENDA
There were some questions raised in the S-Bar that some commission members felt was concerning about
policies and procedures. Joyce explained to newer commission members that the commission doesnt
have legal authority to move, motion or approve. The commission however agreed regardless of authority
they wanted to be aware of these programs and the policies and procedures. With the success of these
programs there may be some changes.
MOTION: Dan Rubin moved to approve Consent Agenda Item 2.9 narrowly this specific take back
pharmacy. Dan rescinded his motion.
This was postponed until later.
REPORTS
Commission Members
Dan Rubin reported:
He has been doing a bunch of work on business practices.
Mr. Rubin attended the argument of the Stormans case before the 9
th
Circuit as an interested
commission member.
He attended a meet the Dean evening which is a chance to meet new dean for the University Of
Gary participated on the Business Practice Committee conference call in November.
He went to WSPA event in Cle Ellum as President of University of Washington Alumni
Washington School Of Pharmacy.
Association. Part of his job is to push the University of Washington Graduates to be involved.
Steve also participated in the Business Practice Committee Meeting conference call.
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Took and passed the Louisiana and Marilyn MPJEs.
Kristina Logsdon reported:
Kristina shared that this is her last commission meeting. Her term was one year term. She thanked
everyone for a wonderful eye opening experience and for mentoring and guiding her along the
way.
She continues to help pharmacy staff in the reviewing of CDTAs.
Had the privilege of going to Sun Cadia with Chris Humberson and give the Pharmacy Law
Lecture.
Nancy rode along with Tyler Varnum to Confluence Health for a site visit.
Took the Opioid Overdose Reversal Training webinar with WSPA.
Sepi attended University of Washington mentorship program with Doug Black. We work with 3
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& 4 year student help them get ready for rotation and selecting their profession.
AL Linggi reported:
He participated in the Business Practice conference call.
Al attended the Compounding meeting for new rules at the Tumwater office.
He attended the last University of Washington curricula meeting.
Attended University of Washington School of Pharmacy practice board. There was discussion
regarding new involvement of different types of pharmacy practice. They are thinking about
revamping the current attendees and invitees of the practice board.
Al went to the ASHP conference in Anaheim, CA. This was a 3 hour meeting. The first hour was
with state associations and board of pharmacy members, the last 2 hours was just board of
pharmacy members that are members of ASHP.
Al is on the Confluence task force that was formed to review the proposal from Confluence Health
for their Omak facility. The task force gathered information from 5 states that are contemporary in
telepharmacy and shared pharmacy services. The task force is now waiting to hear from Glenn
Adams to provide more granular information, and waiting to hear Joyce Ropers review of our
current standards with regards to what Confluence is proposing.
She had opportunity to review comments from the survey of pharmacist and pharmacy
technicians. Good job on all those pharmacists and technicians who participated.
He had the opportunity to attend the NABP Interactive Forum in Chicago December 2-3. There
are a lot of great ideas that come from these meetings. There was a lot of discussion on training
new board/commission members. He feels there could be some more mentoring to help new
commission members.
Chris stated that he is happy that there has finally getting input on the compounding rules.
Executive Director
In October Chris and Doreen Beebe met with Governors staff to talk about where we are and how
we can help facilitate filling the remaining seats of the commission. They are constrained by the
way the legislation was put in they have now developed a process to work through that.
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He met with Governors office policy staff regarding the Medical Assistants and the drug
dispensing issues and the concerns about the scope of practice. There will be a workgroup put
together with Blake Maresh and Brett Cain along with practitioners and get their input as well as
stake holders to come together and define what is the scope of practice for an M.A. this should
start sometime in January.
Had a quarterly meeting with unintentional poisoning work group on opioid overdoses and heroin
working closely on getting the association and Steve Singer involved in getting g naloxone out and
available through collaborative drug therapy agreements.
Attended an NABP Meeting on the PARE Exam similar with what they do with MPJE
November Chris and Nancy went to talk about new rules and new laws. Nancy provided some
suggestions that may help make the presentation more meaningful
Chris spoke with the Seattle Pain Physicians Group to discuss the DEA reclassification of
Hydrocodone and Tramadol.
Had compounding stakeholder meeting
Legislatively Chris met with folks with legislator last week about our request legislation
Participated in a two day workshop with DOH
Spent a lot of time over the next six weeks on getting the comments from the survey together.
Chris thanked Dan Rubin for all of his help on getting this out in a timely manner.

th
The Stormans vs. Wiesman argument before the 9 Circuit Court of Appeals actually happened
on November 20 in Portlands federal courthouse. Alan Copsey presented the Commissions
arguments. It was an active 3 judge panel, who asked many questions. The argument can be
th
viewed on you tube . We cannot predict when the decision will be issued by the 9 Circuit.
Lisa attended meeting with king county waste management folks. Gordon and I will be
collaborating with them to create some guidelines for take back programs.

As a result of the commissions motion to allow more investigators to attend the critical point boot
camp. Brad Dykstra and Julie Faun will be attending the next session in March. That will be a total
of 5 investigators that have gone through this boot camp.
Greg Lang reported:
Greg participated in the MPJE item review.
He also went to the NABP investigator training for compounding this was geared specifically for
investigators.

Al Linggi updated the commission regarding the work that has been done from the Technology
Committee. We have filed the CR101. There will soon be some stakeholder meeting dates. Al personally
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thanked Lisa Roberts and Peggy Crain for the work they have done. The committee has gathered a bunch
of information from other contemporary states regarding their technology rules. It will be exciting to start
moving forward and getting input from the stakeholders.

Dan Rubin provided the commission an update regarding the work that has been done by the Business
Practice Committee. The Business Practices Committee met telephonically at 7:30 am on November 20.
The CR-101 for Pharmacy Business Practices was file on October 30, 2014, allowing the Committee to
begin substantive discussions on rule topics. The Committee agreed on meeting dates through the end of
February (with some details pending). A preliminary report on comments submitted through the 2014
Pharmacy Survey will be discussed today (December 11) following the Commission Business Meeting.
Further meetings in December, January and February are expected to discuss results from structured
(multiple choice) questions on the survey, information from pharmacy investigators and information,
discussion with a representative of the Department of Labor and Industries addressing labor laws as
related to pharmacy personnel and other topics. The mid-January meeting will be the first one devoted to
a longer forum-style opportunity for participatory discussion. More information is available on the
Pharmacy Commission Websites page on Pharmacy Business Practices (under Rules in Progress).
Survey of Washington Pharmacist, Interns and Technicians

Chris Humberson led the update regarding the Survey that went out. Everyone received a redacted
comment portion of the survey. It is very lengthy. It was such a great opportunity because these were
people we dont usually get to hear from because they are busy working when we have our meetings. As a
pharmacist for 32 years he was not surprised but he found the comments particularly troubling regarding
the profession.
Pharmacy Compounding Rules

Chris Humberson provided an update to the commission for Peggy Crain. There was a stake holder
meeting on compounding rules discussing the draft that went out October 1, 2014. We hoped to get
suggestions and comments earlier in the process. We are now getting much more input. We have enough
comments and we feel meeting was productive. Comment period was extended to February 15, 2015.
Hoping we can get more suggestions and possibly some critic on what we have drafted now. The goal is
to use these comments and continue work on the working draft.
Department of Health Legislative Meet Me Calls

Chris Humberson briefed the commission on what a Meet ME call is. Every Tuesday at 8:00 a.m.
during the legislation session DOH has a weekly call that includes all different boards and commissions
to discuss legislation updates. The Pharmacy Commission needs to designate a representative and
alternate member to participate in these weekly discussions on bills with potential impact to multiple
programs/professions
Agency Request Legislation Update

Chris Humberson updated the commission members with the 3 proposals from DOH.
A request to increase the fees for a researchers credential has gone forward as part of an overall package.
Its a fee request for legislature to approval.
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The request to charge a fee for pharmacy assistant license has been approved by the Governor and is
moving forward as well.
Another agency request via the pharmacy Commission was to provide for expanded discipline authority
including fining authority of the commission. When presented to key legislators, they felt that this
concept needed some expansion outside of just pharmacy entities and that it be more inclusive of other
facilities. This has been tabled for further review and work for the 2016 session.
DISCUSSION
Al Linggi led the discussion to the commission asking them to consider adopting a process for
delegation of authority and criteria to approve or deny applicants based on standards identified in
the policy.
About 6 months Al had suggested that the commission needed a more standardized and
consistent matrix to approve or deny applicants. Information was gathered from a number of
other board and commissions and then a matrix and a policy was created based on what our
legislation allows us to do. This entire matrix has been sent to all commission members for
review. Kyle Kernin an attorney for DOH who works with the commission went through the
matrix with the commission and to answer any questions. This matrix is to help make consistent
decisions. Joyce clarified that this tool has to be very clear that this is not an authorization for
staff to take this matrix and go ahead and issue the sanctions and the commission must be clear
that this is not an automatic decision when making a final decision for an application. There
really should be some more work on some of this language for more clarification.
After further discussion Kyle will take this and make some changes in the language to provide more
clarification on the purpose of the matrix and bring it back before the commission for further
discussion and approval.
Drug Enforcement Administrations final rule on Disposal of Controlled Substances

Chris Humberson briefed the commission on the final rule passed by the DEA regarding Disposal of
Controlled Substances. He asked the commission for some discussion on what path the commission
should take moving forward.
On September 9, 2014, the Disposal of Controlled Substances final rule was published in the Federal
Register. The final rule will become effective on October 9, 2014.
The Disposal Act was passed in an effort to curtail prescription drug abuse by authorizing regulations
that outline methods for ultimate users to dispose of their unused or unwanted pharmaceutical
controlled substances. The final rule authorizes ultimate users to transfer unwanted and unused
pharmaceutical controlled substances in their lawful possession to an authorized collector for safe,
secure, and responsible disposal. In addition to ultimate users, long-term care facilities and persons
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lawfully entitled to dispose of a decedent's property may also transfer pharmaceutical controlled
substances to an authorized collector for the purpose of disposal.
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The new rule also establishes regulations related to each element of the disposal process, including
the transfer, delivery, collection, destruction, return, and recall of pharmaceutical controlled
substances, by both registrants and non-registrants. These regulations are incorporated into a new 21
C.F.R. part 1317 on disposal. The final rule and supporting documents describe in detail the new
collection programs and the various changes to the existing regulations. Several important
requirements are summarized below. This letter is not a complete list of all changes, nor does it detail
the nuances of the various requirements. Please consult the final rule, the Code of Federal
Regulations, or your local DEA field office for detailed information.
Joyce shared that the new regulations lends some authority for the commission to put some
requirement in place for these types of programs. There will need to be rules so the commission
has the ability to enforce the requirements.
Steve Anderson provided some of his experiences that he had while participating in a Take Back
Program. He feels this is not for a busy pharmacy. This is a ton of extra work. To change out the
box both key holders need to be present and that can be a problem. Preparing a box to be shipped
takes a significant amount of time two or three times a day. At times there would be bags filled
with drugs including CS and hazardous drugs sitting outside pharmacy that was dropped off
while pharmacy closed. Dealing with the public became very difficult at times as well. This is a
much bigger program than what is seen. Steve feels this is much better to be done through a
county not through a pharmacy there is just a lot of additional work added to those in the
pharmacy.
Dave Galvin works for a King County Regional program that deals with hazardous waste. King
County Board of Health passed a regulation to require drug manufacturers to set run and fund a
Take Back System in King County. One of significant wrinkles they dont typically deal with is
the difference between OTC and CSs. This is a serious issue and we are working on this step by
step on this matter and appreciate the commissions help on this. We have informal voluntary take
back programs at a few Bartell outlets and few police stations. Typical residential person is
unable to distinguish what is difference between controlled and uncontrolled drugs . Having
separate boxes we have learned doesnt work. Most people dont really stop by their local police
department unless they have to but they will stop by a pharmacy so it really is a must to have
pharmacies part of these take back programs. We will work with you all to set up real strict
protocols to make sure they meet your needs and work on the impact of inspections.
There was a general consensus of the commission to with current process of asking people if
they want to have a take program to submit that to us as we work with King County. Some
commission members would like to see the way the drugs are being handled after a box is full
and the workload added to the pharmacists be addressed.
CONSENT AGENDA
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MOTION: Dan Rubin moved to approve Consent Agenda Item 2.9 City of Bellingham Take-back
Program. Gary Harris second. Elizabeth Jensen and Steve Anderson abstained . MOTION CARRIED: 80.

Doreen Beebe led the discussion asking the chosen panel to recognize The University Learning Systems
as an educational organization . Per request, the University Learning System is requesting a list of
pharmacist and pharmacy technicians.
MOTION: Nancy Hecox moved to recognize The University Learning Systems as an educational
DISCUSSION Contd
Review of Past Commission Policies and Procedures
Doreen Beebe led this discussion she asked the commission to take a comprehensive look at these policies
and procedures to see if there needed to be some changes and or updates.
Dan Rubin suggested Policy #35 be amended to add pharmacy technicians to this. He felt that Policies #
31, 33 and 41 all internship issues should be combined . Mr. Rubin suggested that maybe Policy #1
conflict of interest be re written so it doesnt seem so broad.
MOTION: Dan Rubin Dan Rubin moved that the commission table Policy #1, and #2, rescind
#13, re affirm Policies #3, #34, #38, # 39, and #40 and bring back the rest after some
amendments have been made to them. Nancy Hecox second . MOTION CARRIED: 10-0.
Elizabeth Jensen nominated Al Linggi as Chair and Steve Anderson nominated Dan Rubin as
Vice Chair, Maureen Sparks nominated Nancy Hecox as Vice Chair. The commission took a
vote on who will be Vice Chair. Dan Rubin was voted in as Vice Chair. Al Linggi was
elected and voted in as Chair.
Meet Me Call Volunteers

Chris Barry and Chris Humberson will discuss this and have it decided before the calls start.
Discuss Alternative Processes/Structure for Commission Business Meetings

The commission was asked to read the draft of an alternative process and structure for the
Commission Meetings to discuss at a future commission meeting.
PRESENTATIONS
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Prescription Monitoring Program Update

Chris Baumgartner, PMP Program Director and Gary Garrety, PMP Operations Manager shared
a power point to update the commission members on how the PMP is doing.
Update Overview:
There are about 30% DEA registrations now have an active account.
Pharmacy community just over 4,000 pharmacists.

DOH Rule Exploration Areas
Frequency of data collection (daily?)
RCW 70.225.020 The program shall be designed to improve health care quality and
effectiveness by reducing abuse of controlled substances, reducing duplicative prescribing and
overprescribing of controlled substances, and improving controlled substance prescribing
practices with the intent of eventually establishing an electronic database available in real time to
dispensers and prescribers of controlled substances.
Clarification on zero reporting (guidance needed?)
Better patient identification (more uniform data)
Adding data fields (ex: NPI)
Parent/Guardian access (clarification)
Delegates for Pharmacists (techs, interns, assistants?)
Top 10 Drugs by Rx Count (2012 to 2013)
Hydrocodone/Acetaminophen
Oxycodone HCL
Oxycodone HCL/Acetaminophen
Zolpin
Alprazon
Lorazepam
Clonazepam
Amphetamine
Methlyphenidate
Morphine Sulfate
DOHs Goals for Washingtons PMP
To give practitioners an added tool in patient care
To allow practitioners to have more information at their disposal for making decisions
Continual Process Improvement

The PMP is working with the Alcohol and Drug Abuse Institute (ADAI) and School of Pharmacy at the
University of Washington to evaluate the program and identify areas for improvement.
Better Data for a Better PMP
PMP data is received from many different sources. Each has their own protocols/procedures for
creating and maintaining records.
PMP submission standards (ASAP 4.2) designate how fields are recognized on the system, not
what is in the fields
Pharmacy Data Dual Purposes

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It is critical that all pharmacy staff understand that the data being stored and transmitted to the PDMP as
prescription records must be able to be combined with data from other pharmacies in order to truly make
the PDMP a viable healthcare solution .
Pharmacy support staff typically work to create and maintain fill records.
Records on the system need to be similar enough to be linked/clustered
Key Practices to Consider

Educate Support Staff
What is being entered is important beyond the walls of the pharmacy, chain/corporation, and
beyond the dispensing end of the care spectrum.
Evaluate your fill system
Do you need better support from your vendor
Does your system need improvements?
An extra eye on detail

Cleaning up legacy records
Is it possible to develop and integrate steps to review and clean up records at the pharmacy level?
Review record Update, Void and Delete process for the PMP
Key Errors to Try and Avoid
Invalid DEA #s cannot identify the prescriber of the medication
Invalid day supply trouble identifying overlapping Rx
Invalid quantity difficult to discern patients supply
Variations in patient info (name, DOB, address) challenging to match records across pharmacy
systems
Reporting updates to records as new records instead of updates creates duplicate records
Health Information Exchange
We have built the connection to our state HIE (OneHealthPort).
In phase II:
Connection through the HIE to EHRs
Connection through the HIE to EDIE
If you know of other organizations who would be interested in connecting this way please have
them contact DOH
Interstate Data Sharing
The technical components are now in place
The next step will be putting into place data sharing agreements with state PMPs
Once in place WA providers will be able to select additional states to request data from when
using our system on the RxSentry system.
Next step national inter-hub exchange
UW PMP Evaluation Study
Contract started 8/1/13 and runs to 6/30/15
A de-identified data set has been provided to UW
Analysis is underway
Community Health Profiles
DOH used part of a 2012 BJA grant to hire a 1 year project position for an Epidemiologist
This position is working to create state, county, and local level profiles from de-identified PMP
A LHJ workgroup has begun meeting to assist DOH with developing the profile measures
data to assist DOH and our partners with seeing controlled substance use at various levels
New Provider Interface

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Provide current users with information on new interface
Provide current users with link to new videos
The new interface went live August 25, 2014
New features have been added like the ability to search multiple patients at once (up to 20 at
once).
New videos are available for training at www.doh.wa.gov/pmp
We are continuing to improve all aspects of this program and plan to work with the commission and
others moving forward.
Forks Hospital Pharmacy

Lisa Roberts provided a brief background to this presentation. Forks Community Hospital
Pharmacy is reporting back on its use remote medication order processing services approved as a
demonstration project in March 2014 with provisions . Since this demonstration project was
granted there is a new Pharmacy Director, Bryan Foster . He didnt provide a full presentation
since he is new but was open to answer all questions the commission has regarding the granted
demonstration project.
There was a time when the network went down. Being in Forks that tends to happen since it is
such an isolated location. The network was down for three weeks and before it went down there
were some camera situations. Bryan assured the commission that this has been fixed he did look
at the stills that there were. Bryan does take the time to look at the videos daily. There is no
audio so they use phones to communicate while on video. It seems that this is not needed since
Bryan Foster is at the pharmacy while the technician is there. If video feed is not working do you
know that? Of the two of you if video isnt operable who is responsible for this? The commission
should have been notified when the system went down. If the system was to ever go down the
technician should not be in the pharmacy without the pharmacist.
MOTION Dan Rubin moved that commission allow Forks Hospital Pharmacy to continue the
demonstration project with regard to remote order entry and terminate with regard to remote supervision.
They must report back to the commission in 6 months and report back immediately with any departures of
the present policy and procedures. In the report back please include the status of the project and include
any changes, issues or challenges. Steve Anderson second. MOTION CARRIED: 10-0.
OPEN FORUM.
Jeff Rochon Washington State Pharmacy Association thanked the commission for the extension on the
compounding rules. We do feel that since USP 797 is over going major overhaul that finalizing the
compounding rule before then would be quite redundant. Jeff asked the commission to just consider that.
We are restructuring the WRAPP that contract based on the new guidelines. We are working on this and
will bring that to you as soon as we can. Drug Take Back biggest issues are liability, robberies and the
cost. We are heading into an interesting legislation he asked the commission to keep abreast of what is
going on this year. Please reconsider the structure for open comments during the meetings.
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by:

Al Linggi, Chair Washington

State Pharmacy Quality
Assurance Commission
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STATE OF WASHINGTON

MEETING MINUTES
December 13-14, 2007
nd
20435 72 Avenue Ste 200
Board Office: (360) 236-4825
CONVENE
Chair Rebecca Hille called the meeting to order at 9:03 a.m. on December 13, 2007.
Dan Connolly, RPh
George Roe, RPh
Rosemarie Duffy, RN Public Member

Steven Saxe, Executive Director (Acting)
Lisa Salmi, Executive Manager
Guests/Presenters:
John Prete, NW Health Systems
David Rose, Kent Community Health Svcs
John Worthington
Steve Sarich
Andre Rossi, Department of Corrections

Grace Cheung, Pharmacist Investigator
Susan Perrini, AAG Prosecutor
Mission Statement
The mission of the Board of Pharmacy is to achieve the highest standards in the practice of pharmacy,
to promote public health and safety and to effectively communicate with the Governor, Legislature, the
Department of Health, the public and profession.
Vision Statement
The Washington State Board of Pharmacy leads in creating a climate for the patient-focused practice
of pharmacy.
Pharmacists inform, educate, consult, manage drug therapy and provide products as an integral part of
an accessible, quality based health care system.
As an outcome, the citizens of Washington State:
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Special Announcements:
Grant Chester presented Pharmacist Investigator Joseph Honda with a plaque in recognition and
appreciation for his dedicated service to the Board and the people of Washington State. Mr. Honda
will retire on December 13, 2007 after 23 years of service as a Board Member and Investigator.
Gary Harris presented Executive Manager Lisa Salmi with a proclamation from Governor Gregiore
declaring December 13, 2007 Lisa Salmi Day for her contributions to the Board of Pharmacy and
service with distinction.
CONSENT AGENDA
1.2
New and Closed Firms 10/1/2007 11/26/2007
1.4
1. Julia Nguyen Oregon State University
2. Kriss Bradley Technology Development Center - Ventura CA
3. Gale Erie CBS Pharmacy - Chicago IL
4. Kathryn Martinez National Institute of Technology San Antonio TX
5. Marcia Stevens Northwest Medical Center Tucson AZ
6. Benjamin Callo School of Continuing Education Anaheim CA
7. Saulla Goldshmid Opportunities for a Better Tomorrow Brooklyn NY
8. Western State Hospital
1.5
1. Community Health Care Pharmacy, Lakewood Refill Various Pharmacists
2. Jims Pharmacy , Port Angles Hepatitis B Joe Cammack
1.8
Board Minute Approval - October 25, 2007
by a single motion of the Board without separate discussion. Items 1.1, 1.3, 1.6 and 1.7 have been
deleted from the agenda. ACTION: George Roe moved that the Board approve items 1. 2, 1.4, 1.5 and
1.8 from the consent agenda. Susan Teil-Boyer second. MOTION CARRIED. 6-0.
RULES HEARING WAC 246-856-030 - Delegation of Authority to Initiate Investigations

The Board will hear and consider public testimony in its deliberations regarding proposed rules that
would allow the Board to delegate to a Department of Health Case Management Team the authority to
initiate investigations of specific category of complaints.
Doreen Beebe presented background and a summary of proposed rules - WAC 246-856-030.
In 2003, the Board of Pharmacy adopted a policy to delegate its authority to review complaints for
closure or referral to investigations to a department case management team (CMT). The delegation to
CMT was limited to specific categories of complaints named in policy. The process eliminated a
significant workload for board members and decreased the time needed to move complaints from
assessment to the investigative phase. The process assisted the board to further its mission to protect
the health, safety and welfare of the people of Washington.
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In August 2005, the Washington State Division One of the Court of Appeals issued its decision in the
matter of Clients A&B v. Yoshinaka. The decision arose out of a Psychology Board investigation
where the complaint was referred to investigations by Department of Health staff.
The court concluded that the Boards authority to investigate could not be delegated to department
staff through oral delegation or policy, only through the adoption of rules.
The proposed rule provides that the Board of Pharmacy will delegate to a DOH case management team
the authority to decide whether to begin an investigation for specific types of complaints. Complaint
types not listed in the rule must be considered by a panel of the board for investigation. The proposed
rule states that the CMT must, at a minimum, include the executive director or his or her designee, a
pharmacist investigator and a staff attorney.
The Rules Hearing was divided into two parts: Questions and answer session and public comments.
Board members discussed comments and questions raise during the written public comment period.
Does the Board have authority to delegate its powers?
Did the court limit the boards ability to delegate only when a complaint warranted an
immediate investigation?
The language is too broad and unclear.

The court stated a rule that delegates the boards authority, must balance the substantial privacy
and confidentiality interest of health professionals and their patients with the states interest in
protecting the public. Health professionals and patients must be provided the ability to
challenge specific document requests made by the state.
The nature of the delegation and the composition of the case management team seem to be of greatest
concern. Joyce Roper shared that the Medical Quality Assurance Commission has adopted similar
delegation rules; however, they have included a commission member as part of their CMT. In
addition, Joyce Roper clarified that the court did not state that delegation could only occur with regards
to complaints involving real danger.
Susan Teil-Boyer shared that the process followed under the old board policy was effective and she
acknowledged the difficulty presented in facilitating weekly complaint review panels.
Lisa Salmi clarified that under the proposed rule the CMT would not be able to make a decision on a
complaint without the presence of a pharmacist staff member (Executive Director and Pharmacist
Investigator). Gary Harris suggested that involvement of a board member would be beneficial to the
process.
The Chair opened the hearing to public testimony
none was given.
Summary of Written Comments/Response

Public comment: The rule language is too general and unclear. Do all complaints initiate an
investigation?
Boards response: To clarify the intent of the rule, the board amended the proposed rule language
by stating the board delegates the decision whether to initiate an investigation
Public comment: Complaints and investigations should be address by pharmacists.

Boards response: The Board feels it is imperative that a pharmacist be involved in the process of
assessing complaints for possible investigation. The proposed rule ensured professional oversight
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by including the Executive Director, who by statute must be a pharmacist and a pharmacist
investigator. The Board also amended the proposed rule by adding a Board member to the case
management team.
Public comment: Delegating this authority to a case management team within the department of
health will result in reduced transparency and less public accountability.
Boards response: Acknowledging the importance of the boards role in the complaint and
disciplinary process, the board amended the proposed rule adding a board member to the case
management team.
Public comment: The board does not have the statutory authority to delegate its functions.
Boards response: RCW 18.130.050(1) of the Uniform Disciplinary Act, states that the
disciplining authority has the authority to adopt, amend, and rescind such rules as are deemed
necessary to carry out this chapter.
Public comment: The rule does not address an educational component not all complaints
warrant a disciplinary action.
Boards response: The proposed rule only speaks to the process on who may decide to move a
complaint from assessment to investigation. The rule does not address the investigative or
disciplinary process. No changes were made to the proposed rule as a result of this comment.
Public comment: The proposed rule is not in compliance with courts opinion unless delegation is
limited to cases where on the face of the complaint, immediate investigation is necessary to protect
the public.
Boards response: The court decision did not limit delegation by rule to complaint where
immediate investigation is deemed necessary for the protection of the public.
Public comment: The court stated a rule that delegates the boards authority, must balance the
substantial privacy and confidentiality interest of health professionals and their patients with the
states interest in protecting the public. Health professionals and patients must be provided the
ability to challenge specific document requests made by the state.
Boards response: The Board did not address this concern in it deliberation of the proposed rule
citing that this issue can be addressed at a later time.
ACTION: Rosemarie Duffy moved that the proposed rules be amended to clarify that the delegation
pertains specifically to the decision to investigate and the CMT must include a board member. George
Roe second. MOTION CARRIED. 5 1. Dan Connolly opposed.
The adopted rule varies from the content of the proposed rule. The general subject matter of the
adopted rules remains the same as the proposed rule. The changes will be described and the principal
reasons for adopting the changes will be filed with the code reviser. Within sixty days of publication of
the adopted rule, any interested person may petition the board to amend any portion of the adopted rule
that is substantially different from the proposed rule.
REPORTS
Executive Manager
Ms. Salmi welcomed Grant Chester, who was recently appointed Chief Investigator. Mr.
Chester previously worked with the board from August 1989 to October 2003 as an
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investigator assigned to Southwest region and Deputy Executive Director/Operations

Manager.
Grant Chester, Stan Jeppesen, Steven Saxe and Ms. Salmi met with representatives of the
Pharmaceutical Household: A Return Mechanism (PH:ARM) coalition to discuss
legislation being proposed for household pharmaceutical take-back programs.
Ms. Salmi represented Health Systems Quality Assurance at the departments Emergency
Operations Center.
Grant Chester obtained a waiver for the Centralia/Chehalis area pharmacies to refill
maintenance schedule III-V controlled substances prescriptions for patients displaced by
flood waters.
Staff has trained on the departments single complaint process. The new procedure provides
for coordination among programs and divisions when multiple practitioners or facilities are
involved in a single complaint allegation. At this time, the processing is being coordinated
by one individual within the department.
Pharmacy program participating in ILRS end-to-end testing. The new licensing/disciplinary

computer system is scheduled to go live mid-February.
The departments Injury Prevention program is applying for grants through the Attorney
Generals Purdue Frederick settlement. The grant will be used to provide pharmacies with
educational materials for patients on the proper disposal of narcotics. The brochures will be
used by those pharmacies not participating in the Substance Abuse and Mental Health
Services Administration (SAMHSA) pilot project or for those pharmacies after the pilot has
concluded. The SAMHSA project is a twenty-six week pilot that began in Washington on
st
November 1 targeting patients with prescriptions with Hydrocodone, Oxycontin,
Benzodiazepines and sleep aids . Forty percent of retail pharmacies in Washington are
estimated to be participating in the project.
Acknowledged Grant Chester, Tim Fuller, Cathy Williams and Lisa Salmi in their efforts
during the recent flood emergency.
2007 legislation formed the Health Care Associated Infections Advisory Committee that
will provide recommendations to the Department of Health on carrying out its
responsibilities under the new law related to data collection and reporting of hospital
acquired infections. The committee s first meeting is scheduled for later this month.
Mr. Saxe presented at the Citizens Advocacy C enter (CAC) conference in October on
patient safety and adverse events.
Board Member
Vandana Slatter reported :
Acknowledge the presentations made by department of health staff and the diversity of the
participants and their organizations at the CAC conference. Topics included how we
communicate with the public; and how we work in collaboration with other boards.
Dr. Slatter was unable to attend the recent Investigators

asked to attend the next quarterly meeting.
Rosemarie Duffy reported:
meeting due to illness and has
Attended the emergency preparedness exercise in Spokane. The exercise simulated an

emergency situation where salmonella was found to be in the water. The coordination of
participants [(Federal Bureau of Investigations (FBI), Centers for Disease Control (CDC),
and the Department of Health (DOH)] was impressive.
Dan Connolly reported:
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Attended two PH:ARM meetings. The program is operating in twenty-six Group Health
Cooperative facilities collecting approximately 1,100 pounds of take-back medications per
month. Bartell s retail program is projected to begin in January.
Attended the CAC great opportunity to discuss issues facing boards of other states.
Attended the American Society of Health- Systems Pharmacists mid-year clinical meeting.
Ms Boyer acknowledged the past eight years on the board and urged the board to
appointment a new pharmacist member with hospital practice.
Participating on the Uniform Disciplinary Act Task Force

via conference call.
will be attend the next meeting
Shared letter from the Secretary of Health, Mary Selecky thanking the board for continued
roll in protecting patient safety and adoption of sexual misconduct rules and sanction
guidelines.
Attorney General
Draft bill proposing that executive sessions, under the Open Public Meetings Act, be
recorded. Taped will be available for the judge to review if persons file a legal challenge
questioning the appropriateness of the executive session under the Open Public Meetings
Act.
Filed appeal of preliminary injunction in the Stormans lawsuit on Monday. A motion will
be filed to stay the preliminary injunction and underlying proceeding while the court
decision is pending.
Chief Investigators
Stan Jeppesen and Dick Morrison have been working with federal Drug Enforcement
Agency, Department of Health and Human Services and the FBI on investigations.
Tyler Varnum attended the Reid Basic Interview Course as preparation for performing
investigations.
Quarterly Investigators meeting held on December 4 and 5 th.
Acknowledged Rosemarie Duffys performance during the Washington State Bioterrorism
Recruiting for a full-time and a part-time investigator.
Dick Morrison presenting at University of Washington, School of Pharmacy

law review.
pharmacy
Exercise (WASABE) drill in Spokane.

Attended a methadone summit at the Evergreen Treatment Center addressing patient care in
an emergency situation.
Involved with the Washington Patient Safety Coalition

to promote patients keeping track of their medications
Program Manager
Statewide promotional campaign
Board member appointments 13 applications received for professional member, and 3 for
public member appointments. A review of the qualifications for appointment confirmed
that since the Chair has not served two 4-year terms, Rebecca Hille is eligible for
reappointment and has submitted an application.
Will conduct interviews for board support position in January.

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DISCUSSION
Dispensing Error Committee Goal/Mission . Investigator Grace Cheung provided the board with an
update on the group meeting to discuss development of appropriate sanction guidelines for dispensing
errors. The group has expanded its original goal, as she understood it, to include continuing quality
improvement programs. Although both issues are important and need to be explored, Ms. Cheung
requested that the board split the projects into two groups allowing her to focus on developing sanction
guidelines for the boards consideration. Kristi Weeks and Ms. Cheung will review the last two or
three years of dispensing error cases to examine the data for assistance in developing the guidelines.
MOTION: Susan Teil-Boyer moved that the board appoint Kristi Weeks, Grace Cheung and Grant
Chester to gather data and develop guidelines for disciplinary sanctions in dispensing error cases.
Rosemarie Duffy second. MOTION CARRIED. 6-0
MOTION: Susan Teil-Boyer moved that the board form a group lead by Dan Connolly with
participation from the Washington State Pharmacy Association and other stakeholders to develop
continuing quality improvement standards. The group will present to the board in 3 months. Vandana
Slatter second. MOTION CARRIED. 6-0
Review of Health Professions Quality Assurance Procedure 212 Imminent Harm. The Board reviewed
the revised procedure that is used to identify and evaluate those complaints that pose a serious threat to
public health and safety and to ensure that the complaints are handled in a timely manner. The board
made no changes to the criteria listed in the procedure . MOTION: Rosemarie Duffy moved that the
board approve the procedure as presented and require that a Reviewing Board Member be involved at
the initiation of the Expedited Case Management Team . Susan Teil-Boyer second. MOTION
CARRIED. 60
Northwest Health System Pharmacy Request to Increase the Pharmacist to Pharmacy Technician
Ratio. At the October meeting the board requested staff to gather information on how other states
establish pharmacist to pharmacy technician ratios. Cathy Williams distributed articles highlighting the
key issues pharmacies face today including the shortage of pharmacists. She referred to data from the
National Association of Boards of Pharmacy showing that eighteen states have no ratio; many have a 1
to 4 ratio. The national trend seems to lean toward eliminating ratio standards or establishing less
restrictive standards.
John Prete presented an overview of the pharmacy services provided by Northwest Health Systems to
residential/institutional care facilities assisted living facilities, boarding homes, supported living
facilities for developmentally disabled adults, etc. Mr. Prete explained that these facilities differ from
nursing homes in that most do not have clinical staff on-site. All institutional care facilities serviced by
Northwest Health Systems have 24-hour care giver. Clinical questions are most often direct to the
pharmacist. There are approximately 320 residential care facilities in Spokane representing up to 800
patients.
Mr. Prete stated that an increase in technical support staff will not cause pharmacists to do anything
differently; it would only provide more opportunity to do what we are mandated to do.
MOTION: Rosemarie Duffy moved that the board grant conditional approval for a pilot project once
Northwest Health System submits a proposal for review and approval to Pharmacist Consultant Tim
Fuller. The proposal must include how the facility plans to measure the effectiveness of the increased
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ratio on improving patient care. The standard ratio is increase to one pharmacist to four pharmacy
technicians. The pilot will begin at the time of implementation hiring of additional pharmacy
technicians. Northwest Health Systems will report back in 6 months from implementation. Vandana
Slatter second. MOTION CARRIED. 5-1 George Roe opposed.
King County Community Healthcare Center Requests to Expand Telepharmacy Services . Tim Fuller
reminded the board that King County Community Healthcare Center (KCCHC) presented its proposal
for telepharmacy services earlier this year. The board approved services at the SeaTac location
supported by the pharmacy in Kent. David Rose presented KCCHCs proposal to provide the same
services to clinics in Renton, Eastside, Bothell/Kenmore and Federal Way.
Mr. Rose explained the telepharmacy service provides KCCHC access to their patients and patients
access to their program. Fifty percent of the patients pay on a sliding scale based on income. The
clinics are federally funded and qualify as 340B clinics.
No scheduled drugs are dispensed from the telepharmacy locations.

The Kent pharmacy staffs three pharmacist and eight technicians.
Medications are verified through webcam technology.
MOTION: Dan Connolly moved that the board approve the expanded protocol for King County
Community Healthcare Centers telepharmacy services. Rosemarie Duffy second. MOTION
CARRIED. 5-1 George Roe opposed.
Proposed Legislation (Information only). Suellen Mele of the Washington Citizens for Resource
Conservation and Cheri Grasso of Local Hazardous Waste Management Program (King County)
updated the board on the Pharmaceutical Household A Return Mechanism (PH:ARM) pilot project and
discussed the 2008 proposed legislation that addresses the issue of proper disposal of unwanted
household medications.
Current Washington pilot is funded exclusively by grants. The PH:ARM program looked at the
program in British Columbia which has been operational for over 10 years over 850 pharmacies
provide collection sites. Program funding is mandated and paid by the pharmaceutical industry.
Representative Dawn Morrell is the prime sponsor of a bill to establish a free, convenient and safe
return program for expired and unwanted medications from households . The program will be available
to residents, hospice services, nursing and boarding homes, schools and kennels. By January 1, 2010
drug companies/brand owners will establish and pay for a product stewardship program for the
collection transportation and disposal of the medications. The Board of Pharmacy will review program
policies, oversight and enforcement of the program.
EXECUTIVE SESSION
The Board adjourned at 12:30 p.m . for Executive Session to discuss personnel issues and pending
litigation. The Board reconvened at 1:08 p.m.
DISCUSSION Contd
Petition for Rulemaking . With assistance from Steve Sarich, John Worthington clarified his intent to
file a petition to amend administrative rules to reschedule medical and industrial marijuana with the
Board of Pharmacy and the petition for declaratory order to the Department of Health. Joyce Roper
explained the procedures and timelines involved with each process.
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Highlights of presentation given by Mr. Worthington and Mr. Sarich
Current schedule for marijuana is inconsistent with Washington medical marijuana laws.
Medicinal value of marijuana.
States have legal authority for rescheduling.
Prevent the practice of law enforcement to act against medical marijuana patients. State law
enforcement agencies enforce federal drug laws by arresting and confiscating patients
marijuana to ensure access to federal grant moneys.
variation due often to patients ability to care for
Usable medication varies from plant to plant

the plant.
States have rescheduled marijuana

others do not.
Rescheduling marijuana will not change how physicians order medical marijuana. The federal
Drug Enforcement Administration prohibits the issuance of a prescription.
some of these states
have medical marijuana laws and
Ms. Roper briefed the board on the departments rule activities to define what constitutes a sixty-day
supply of medical marijuana and prepare a report to the legislature on the options for an authorized
medical marijuana patient to obtain medical marijuana. She went on to read the boards authority to
change schedules of controlled substances and in making a determination, what the board must
consider under the Uniformed Controlled Substance Act (RCW 64.50.210). MOTION: Vandana
Slatter moved that the Board initiate rulemaking to examine the scheduling of medical marijuana.
Susan Teil-Boyer second. MOTION FAILED. 2-4 Vandana Slatter and Susan Teil-Boyer supported
George Roe, Gary Harris, Rosemarie Duff and Dan Connolly opposed.
The board summarized that it finds sufficient questions exist about the safety of medical marijuana,
given its variability in strength, lack of standardization, and uncertainty about dosing, that it lacks
accepted safety for use in treatment under medical supervision, particularly in its current method of
distribution or acquisition. The board determines marijuana is appropriately substance for Schedule 1
Department of Corrections Central-Fill Pharmacy. Andre Rossi, of the Department of Corrections
presented a proposal to establish a central location for dispensing prescriptions. The central dispensing
pharmacy will be setup similar to a mail-order pharmacy utilizing United Parcel Services for delivery
to onsite pharmacy. Other DOC pharmacy sites will act as satellite locations with pharmacist focusing
on clinical care for patients/inmates reviewing patient charts/profiles, contacting prescribers and
dispensing stat medications.
All time sensitive medications will be dispensed from the satellite pharmacy.
Every pharmacy within the system will access the same database regardless of the location of
the patient.
The location of the central-fill pharmacy has not been determined, but will likely be in the I-5
corridor.
Central-fill staffing model includes 3 to 4 pharmacists, 8 to 9 pharmacy technicians and 2

pharmacy assistants.
Currently process 500,000 prescriptions per year (16 prisons).
Counseling is done by the prescriber and written pharmaceutical instructions are provided at
the time the medication is administered/distributed.
Delivery system has not been finalized must have defined procedure for security.
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MOTION: Rosemarie Duffy moved that the board approve the Department of Corrections proposal
to establish a centralized pharmacy filling system with a secure delivery system. George Roe second.
MOTION CARRIED. 6-0.
Imposition of fines as a sanction in disciplinary proceedings . The Board was seeking legal advice
regarding its legislative authority to issued fines as a sanction in disciplinary proceedings against
business entities (e.g. pharmacies, wholesalers, etc.).
Joyce Roper explained that the board does not have the authority to impose a fine; however, as part of
the settlement negotiations, if agreed, a fine can be issued. The statutes that address penalties for nonresident pharmacies and shopkeepers allow the board to impose fines as sanctions in disciplinary
proceedings.
Gary Harris stated that a broader scope of sanctions, similar to those in the Uniform Disciplinary Act,
would provide a mechanism to impose sanctions other than suspension or revocation of a business
entitys pharmaceutical license. MOTION: Gary Harris moved that the board submit a request to the
department of health for agency request legislation for 2009 proposing broader range of sanctions for
business entities credential by the Board of Pharmacy. Rosemarie Duffy second. MOTION
CARRIED. 6-0
Delegation of Authority to Health Law Judge. A deficiency noted in the performance audit reported
concerns in the time delay from the entry of a Notice of Default (failure to respond) and the Final
Order of Default. Supervising Staff Attorney Kristi Weeks presented a proposal to the board to
consider delegating the authority to sign Final Orders to a Health Law Judge. She explained this will
expedite the process keeping it within 10 days. This delegation does not affect the boards decision
making on the sanctions imposed in the order. The Reviewing Board Member will continue to make
the recommendations. MOTION: Rosemarie Duffy moved that the board delegate the authority to
sign Final Order of Default in writing to a Health Law Judge. Gary Harris second. MOTION
CARRIED. 6-0
Election of Officers. MOTION: George Roe moved to re-elect Rebecca Hille as Board Chair and
Gary Harris as Vice-Chair. Vandana Slatter second. MOTION CARRIED. 6-0
Correspondence. The Board review correspondence received, drafted, or articles of interest regarding
pharmacy practice. Information only.
Department of Health and Human Services

information.
Study re: Patients receiving new medication
Letter to President Bush re: electronic prescribing of controlled substances.

Federal Drug Enforcement Agency allows multiple C-II prescriptions.
Rules Workshop. Doreen Beebe and Tim Fuller updated the board on current rule activities and status
of rule priorities.
OPEN FORUM.
Doug Beeman, Board Liaison for Group Health Cooperative Administration will be retiring at the end
of next week after 34+ years. Jim Ramsey, Mr. Beemans successor, will attend the next meeting.
Questions:
During a power outage, is it legal to handwrite a prescription label? Yes, in ink.

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Impaired patient contacts the pharmacist is it OK not to dispense? Contact prescriber. You
must be careful that you are not drawing judgments about the individual. There person may
only appear to be impaired and other issues may be present. Pharmacist must use professional
judgment based on individual circumstances.
Is a Pharmacist s license at risk ifworking in a licensed medical clinic preparing medication

for administration (not dispensing)? Is there a requirement for a pharmacy license? A
pharmacy license is not required. Pharmacists retain their professional responsibilities and
ability to practice regardless of where they work.
Board Chair Rebecca Hille acknowledged Doug Beeman for his valued input and loyal attendance.

again on January 24, 2008 in Kent, Washington.
_______________________________
_______________________________
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STATE OF WASHINGTON
December 14, 2006
CenterPoint Corporate Park Conference Center
nd
20809 72 Ave South
Kent, WA 98032
Board Office: (360) 236-4825

CONVENE
Chair Asaad Awan convened the meeting at 9:16 a.m. on December 14, 2006.
Donna Dockter, RPh
Gary Harris, RPh
Rosemarie Duffy, RN
George Roe, RPh
Tim Fuller, Pharmacist Investigator/Consultant
Andy Mecca, Pharmacist Investigator/Consultant
Stan Jeppesen, Pharmacist Investigator
Dick Morrison, Pharmacist Investigator
December 14, 2006
Open Meeting
RULES HEARING -WAC 246-860 Standards for Professional Conduct Sexual

Misconduct- No public testimony was given. Written public comment received from Jennifer
Shaw, Legislative Director of the Washington American Civil Liberties Union was read into
record.
MOTION: Rebecca Hille moved to amend subsection WAC 246-860-100(3) to read: A health
care provider shall not engage, or attempt to engage, in the activities listed in subsection (1) of
this section with a former patient, client, or key party and to amend subsection (4) to read: When
evaluating whether a health care provider engaged or attempted to engage, in sexual misconduct,
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the Board will consider factors, including but not limited to: (the rest remains unchanged).
CONSENT AGENDA
1.1
Nuclear Pharmacists Brian Osterberg & Dave Osterberg

New and Closed Pharmaceutical Firms 09/03/200 11/02/2006

Cavallinis Pharmacy
Glenn Adams Warfarin therapy
Nicole Klosterman Anticoagulation
Auburn Regional Medical Center
1.2
1.4
1.5
1.6
1.8
Out of State Program for Ann Hubacher Career Skills Institute of Vacaville CA
Out of State Program for Catherine DeGeorge CVS Pharmacy of Norwood MA
Out of State Program for Daniel Silhan Pioneer Pacific College of Wilsonville OR
Quynh Trana Hepatitis B & C
Richard Molitor Nipple Ointment
Virginia Mason Medical Center TPN Total Parenteral Nutrition
Jami Beemer Anti- Malarial Prophylaxis, Epi-Pen, Altitude Sickness, Motion Sickness,
and Travelers Diarrhea Agreements
St John Medical Center Anticoagulation therapy
Stacy Eria Aminoglycoside
Automated Drug Distribution Device Acceptance
ExcelleRx, Inc Evergreen Hospice
Olympic Medical Center
Board Minute Approval October 27, 2006
Item 1.3 Pharmacy Technician Application Approval; 1.7 Sample Distribution Requests were
deleted for the consent agenda and items 1.6 and 1.8 were pulled for further discussion.
MOTION: George Roe moved that the Board accept consent agenda items 1.1, 1.2, 1.4.and 1.5.
Susan Teil-Boyer second. MOTION CARRIED 6-0.
1.6 Automated Drug Distribution Device Acceptance
ExcelleRx, Inc
Tim Fuller briefed the Board on ExcelleRx, Inc.s proposal for the use of automated drug
distribution devices (ADDDs) in a hospice setting where pharmacists managing the order
review are out-of-state (Pennsylvania). Ms. Catherine Woods, Esq. representing ExcelleRx .Inc
participated via telephone.
Ms. Woods explained that ExcelleRx, Inc. operating as Hospice Pharmacia currently provides
mail order and clinical review services for Evergreen Hospice homecare and is requesting to
provide remote order processing for Evergreen Hospice inpatient unit (IPU) using automated
drug distribution devices .
Discussion:
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Responsible pharmacist manager licensed in WA and PA
Board has disciplinary authority over WA pharmacist and WA pharmacy license and
referral of complaint to resident licensing authority.
Remote pharmacy systems manager (system specialist) a pharmacy technician reports to

pharmacist.
Stocking ADDDs is restricted to pharmacists, pharmacy interns, and pharmacy

technicians.
Hospice IPU site visit to answer how discrepancies are resolved

tracking/accountability.
ExcelleRx.Inc WA licensed non-resident pharmacy

Does the Board have legal authority to charge the responsible pharmacist manager if a
staff pharmacist commits an error? Does the responsible pharmacist manager accept
responsibility?
MOTION: Susan Teil-Boyer moved that the Board defer ExcelleRx. Inc.s request until a future
meeting and asks that the Responsible Pharmacist Manager of the Pennsylvania pharmacy be
available in person to address the Boards questions about the process. Gary Harris second.
MOTION CARRIED 6-0
Auburn Regional Medical Center & Olympic Medical Center
MOTION: Donna Dockter moved to approve the automated drug distribution devices requests
from Auburn Regional Medical Center, and Olympic Medical Center. Susan Teil-Boyer second.
MOTION CARRIED 6-0.
1.8 Board Minutes Approval October 27, 2006

Final MOTION: Rosemarie Duffy moved that the Board accept the October 27, 2006 meeting
notes with amendments to the Wal-Mart/Sams Club Will-Call Kiosk proposal to show that the
written policies and procedures must be presented to the Board for approval prior to initiation of
the six-month pilot, and by adding Asaad Awan, as Board member sponsor, to the law book rules
under the Rule Prioritization item . George Roe second. MOTION CARRIED 6-0.
DISCUSSION
Pharmacies Responsibilities
The Board reviewed and discussed public comments received during the written stakeholder
th
comment period collected via the Department of Healths webpage ending December 11 .
During this time the Board Members had access to all comments posted to the web and received
copies of all other written comments submitted. In total, web responses tabulated 1,119
comments in concurrence with the Pharmacies Responsibilities draft rule language and 219 in
opposition. The draft rule language was written through collaborative efforts by the Northwest
Womens Law Center, Planned Parenthood and the Washington State Pharmacy Association.
Discussion:
Donna Dockter suggested that the Board take a positive approach by simply stating that it is the
pharmacys duty to deliver prescriptions and not try to list exceptions. Ms. Dockter states the
patient needs to be provided care and that might include an appropriate referral. Ms. Dockter
indicated that she felt the draft rule is impractical in todays market where in most situations
there is only one pharmacist on staff at a given time.
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Rosemarie Duffy offered that the statement except for the following or substantially similar
circumstances provides for similar situations that are not explicitly stated in the rule.
Action: Donna Dockter requests that the Board be provided with the results of the survey
conducted as part of the rules analysis.
Subsection (1) Does not allow a pharmacy to not participate in the delivering of
drugs/devises such as: Schedule V drugs, syringes etc.
Subsection (1)(a) - Lethal dose verses Inappropriate dose

Subsection (1)(c) - Compounding not requiring specialized equipment or expertise
Subsection (3) - Consistent with customary pharmacy practice Reasonable/Valid attempt
Final MOTION: Rosemarie Duffy accepts a friendly amendment by Ms. Dockter and moves
that the Board accepts the draft rule Pharmacies Responsibilities with changes to subsection (1)
(a) removing such as an obviously lethal dosage; in subsection (1) (b) adding the word usage
to read National or state emergencies or guidelines affecting availability, usage, or supplies of
drugs or devices and in subsection (3) (a) removing the quotes around the words therapeutically
equivalent. George Roe second. MOTION CARRIED. 4 2. Rosemarie Duffy, George Roe,
Rebecca Hille and Gary Harris voted in favor Donna Dockter and Susan Teil-Boyer voted to
oppose.
Ms. Dockter presented the Board with a letter expressing her thoughts on this rule.
Steven Saxe informed the Board and the audience on the next steps in the rule making process.
He stated that the decision today does not adopt the rules but directs staff to proceed with
preparing the Proposed Rule Making filing ( CR102), Significant Legislative Analysis and Small
Business Economic Impact Statement on the amendments to the Pharmacists Professional
Responsibilities and new proposed rule regarding Pharmacies Responsibilities .
Once filed with the Code Revisers Office the documents will be distributed to interested parties
and a public hearing would be held. Written and verbal public input will be considered and
deliberated by the Board before a decision would be made on these rules. Mr. Saxe stated that
we anticipate that the public hearing may be held in March 2007.
REPORTS
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The 2007 Legislative Session convenes on January 8 . The Department will be holding
Meet Me calls again this year. Rebecca Hille has volunteered to represent the Board of
Pharmacy on these conference calls. The Meet Me calls are used to update Boards,
Commissions, and Committees on bills that are of interest to all health care practitioners.
As Ms. Salmi reported in October, the Health Professions Quality Assurance Division is
participating in a performance audit. The audit is in response to Initiative 900 that
requires the audit of state agencies to review and analyze the economy, efficiency and
effectiveness of state and local government operations. The audit report will be
completed in May 2007.
Additional recruitment for the Central Washington Investigator position is being

conducted. The position announcement was originally sent to all pharmacies in Yakima,
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Benton and Franklin counties. The recruitment has been expanded by mailing notices to
all pharmacists in these counties. To date, we have received two applications.
Under a law passed last legislative session, the Washington State Patrol reports certain
felony convictions to the Department each quarter. As a result of a comparison with
names in the Departments licensee database, the first report showed 32 practitioners who
were convicted of crimes during the first six-months of 2006. The convictions include
crimes such as homicide, assault, kidnapping or sex offenses.
Staff is recommending that the Board move up on its list of rule priorities rule making to
address pharmacy practice in correctional facilities. The rules currently on the books do
not adequately this practice setting. (Future Agenda Item)
Ms. Salmi distributed to the Board a copy of the Seattle Times article. The article is a
follow-up to an article last-Fall titled Licensed to Harm.
Board Member
George Roe will present a draft letter written to Laurie Jinkins, Health Systems Quality
Assurance Assistant Secretary, expressing the Boards concerns regarding proposed HSQA restructure.
th
Rebecca Hille attended the December quarterly Investigators Meeting on December 7 . She
briefed the Board on topics discussed.
o Pharmacy inspection issues, prescription safety caps and update on the pharmaceutical
house hold waste project .
On December 14, the Supreme Court issued its decision in Ongom v. Dept. of Health case which
focused on the level of proof necessary to take disciplinary action against a registered nursing
assistant's license. The Supreme Court decided, in a 5 to 4 decision, that the level of proof
necessary is clear and convincing evidence, rather than proof by a preponderance of the
evidence, which is the level of proof in most civil cases. The clear and convincing level of proof
is less than the criminal burden of proof of beyond a reasonable doubt, but more than
preponderance of the evidence (commonly referred to as the "more likely than not" level of
proof). The court extended its decision in Nguyen v. Medical Quality Assurance Commission ,
which applied the higher level of proof to physician's licenses, to all licensed health care
professions in the Ongom decision. The AGO is evaluating next steps, which could include a
request that the U.S. Supreme Court accept review of the Ongom decision. Because the Supreme
Court bases its decision on an interpretation of the U.S. Constitution's due process clause, the
U.S. Supreme Court would have jurisdiction to accept review of this case. This basis also limits
the ability of the legislature to revise the level of proof to the preponderance of the evidence,
which had been the standard used for all health professions cases until the Nguyen and now the
Ongom decisions. The preponderance of the evidence standard is more protective of the public,
which the legislature declared as the primary purpose for licensing and disciplining of the health
care professions.
Investigators/ Consultant Pharmacists
The following were topics of discussion at the December Investigators' Meeting.

o Inspection of public health facilities licensed for emergency response drug storage.
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o
o
o
o
Development of inspection criteria for drug storage by local health districts.

Review of new Automated Drug Distribution Device rule with an emphasis on
expectations during site inspections.
Will-call bin/kiosk technology and recently approved pilot program.
Medication Therapy Management services.

o During the month of December a University of Washington, School of Pharmacy
student served one of his clerkships working with Board staff. A majority of his time
was spent in the field with Board Investigators visiting many different pharmacy
practice settings to gain information and experience on how pharmacy
laws/regulations are applied.
th
o On December 11 Mr. Mecca conducted a presentation on the proper technique for
prescribing, storing, and dispensing controlled substances to the Washington State
Veterinarian Board of Governors. Discussions included focusing on what veterinary
technicians and clerks could do.
o The Agency Medical Directors Group issued their final Opioid Guideline. They are
planning to implement an educational pilot as well as a mechanism to evaluate it.
Pharmacist Investigator
Stan Jeppesen provided an update on the Group Health Cooperatives (GHC) Take Back
Medication Program, a project designed for pharmacies to take back patients unwanted
medications for destruction. Investigator Jeppesen distributed to Board members GHCs
protocol.
In November GHC started six collection sites in Western Washington and one in Spokane. To
date, the project has collected 19 five-gallon buckets of drug waste materials. Advertising of the
program has been delay until January or February to ensure that all processes/procedures are
working appropriately. All has been going well. In January, an additional 17 to 18 sites
throughout the state will be added to the program.
At this time, the program has not partnered with a disposer for the destruction of the waste
materials; however, the Department of Ecology (DOE) has been working with four disposal
vendors.
The program was successful in gaining approval by Spokane Airborne for incineration of
pharmaceutical waste material in this state. This was is a significant accomplishment since it
would allow other disposers to use this site.
Bartell Drugs will join the program once the project has adequate collection vessels for their
facilities.
Phil Schoeneman, of P.S. Industries Inc. (a Washington licensed reverse distributor), presented
the Board with a letter requesting to participate in the Consumer Waste Pharmaceutical
Collection Pilot Project.
Program Manager
Doreen Beebe advised the Board that the January business meeting has been re-scheduled for
Friday, January 26 in Tumwater.
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Delegation to Initiate Investigations

The Board discussed a proposed draft rule to delegate the authority to initiate investigations to
the Case Management Team (CMT). MOTION: George Roe moved that the Board request that
staff initiate the rule making process to delegate the authority to the CMT to initiate
investigations for the allegations/conditions listed in the proposed draft . Rebecca Hille second.
MOTION CARRIED 6-0.
EXECUTIVE SESSION
pending litigation.
The Board reconvened at 1:00 p.m. Susan Teil-Boyer was excused.
PRESENTATION
Wal-Mart Remote Review of Prescriptions
Dr. Susan Hiland, presented Wal-Marts proposal for remote medication order review, using
Connexus, to help balance workloads between Wal-Mart pharmacies. The process begins with
the receiving pharmacy scanning the original prescription and transmitting the image
electronically to an off-site location for data entry and pharmacists verification (4-point checklabel verification Patient name, drug, strength, and directions) and drug utilization review
(DUR). The prescription would then appear in the originating pharmacys filling queue where
the pharmacist will verify, fix or override the DUR and conduct final visual verification before
dispensing the prescription.
MOTION: Rosemarie Duffy moved that the Board approve Wal-Mart proposal to utilize a
remote order processing/review only in licensed pharmacies located in Washington State. The
Board requires Wal-Mart to post signs informing patients that they have the option not to
participate in remote order review. Rebecca Hille second. MOTION CARRIED 5-1. George
Roe opposed.
MOTION: Rosemarie Duffy moves that the Board amends its Remote Processing of Medication
Orders guidelines to require pharmacies post signs informing patients that they have the option
not to participate in the remote order processing. Rebecca Hille second. MOTION CARRIED
50.
Skagit Valley Hospital After-Hours Remote Order Processing for United General Hospital
Andy Mecca provided a brief introduction to a request proposed by Skagit Valley (SVH) and
United General (UGH) Hospitals for after hours processing of medication orders.
Rick Thurman, Pharmacy Director of Skagit Valley Hospital detailed the proposed process and
accepted questions by the Board. Mr. Thurman explained that a pharmacists review is required
in order for the (UGH) nurses to remove medications for the Omnicell automated distribution
devices without an override. SVH pharmacy proposes to provide remote order review after
UGHs pharmacys operating hours. The SVH pharmacist will receive the order via facsimile or
electronic transmission. The SVH pharmacist will enter the prescriptions directly into the UGHs
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computer system providing the pharmacist with access to the patients allergies/care plan
information.
Mr. Mecca clarified that remote order processing is permitted by Board guidelines by pharmacies
that do not have the same owner so long as the pharmacies have entered into a written contract or
agreement which outlines the services to be provided and the responsibilities and accountabilities
of each pharmacy in compliance with federal and state regulations.
MOTION: Donna Dockter moved that the Board approve the remote medication order
processing request by Skagit Valley Hospital for United General Hospital. Rebecca Hille second.
MOTION CARRIED 5-0.
Providence Everett Medical Center Requests Approval for Emergency Department Pharmacy
Booth.
Tim Fuller provided a brief introduction to the request proposed by Providence Everett Medical
Center (PEMC) for an Emergency Department (ED) pharmacy booth to process prescription for
discharged ED patients.
Eric Werttemberger, Director of Pharmacy for PEMC detailed the proposed process and
accepted questions by the Board. Mr. Werttemberger explained that the hospital is in the process
of planning a major redesign of its campus which spans over approximately four city blocks. The
location of the pharmacy has yet to be determined but the reconstruction may result in the
pharmacy being located a distance away from the Emergency Department (ED). The reconstruction project is scheduled for completion in 2011.
The proposed pharmacy booth will provide an opportunity for the hospital pharmacy to continue
to service discharges prescriptions to ED patients (approximately 97,000 ED patients per year).
The booth (kiosk) will provide patients with audio/video access for remote interaction with a
pharmacist and the dispensing of prescriptions through a pneumatic tube system similar to those
used by retail pharmacies with drive-up windows . Drug utilization review/evaluation and
counseling are conducted before the medication is dispensed to the patient .
Discussion:
Telepharmacy reserved for 340B clinics . (PEMC 340B hospital)

No established regulations/guidelines for these types of proposals.
Similarities/differences to other pneumatic tube systems .
MOTION: Donna Dockter moved that the Board defer the decision on this until the Board has
developed guidelines on the use of systems such as proposed by Providence Everett Medical
Center. George Roe second. MOTION CARRIED. 4-1. Rosemarie Duffy opposed.
Action: Donna Dockter asked for a report from Investigators on what kind of similar systems are
currently being used and which ones may be problematic.
Lisa Salmi explained that the development of guidelines will require stakeholder input and that
the Board will advise Mr. Werttemberger at the earliest regarding PEMCs proposal.
Yakima Valley Farm Workers Clinics Call Center 6-month Board review
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Investigator Jim Doll summarized his observations while conducting an inspection on November
15, 2006, of the Yakima Valley Farm Workers Clinic call-center. Mr. Doll stated that callcenters bi-lingual staff, English and Spanish, handled callers with ease. The YVFWC callcenter, approved by the Board at its April 2006 meeting, services pharmacies located in Yakima,
Grandview, Toppenish, Walla Walla and Spokane.
Concerns:
No documentation of call monitoring or evaluation of call-center staff.
Call-center staff using discretionary judgment to identify medication requested for refill
th
when the prescription number was not available. (noted in May 14 bi-monthly meeting
minutes)
Call-center staff process prescription refills for Yakima pharmacy and use pharmacists
password to override DUR .
Lack of documentation of bi-monthly meetings (the minutes were provided to the Board
prior to this meeting)
YVFWC was represented by Patrick Bucknum, Director of Operations, Jade East, Pharmacy
Director, Laine Dowling, Regional Operations Manager and Brandy Voight, Yakima Pharmacy
Manager.
Mr. Dowling and Ms. Voight summarized the objectives of the Call-Center and some of the
challenges that they have encountered. They increased the number of call-center staff to improve
call wait times and to handle the high volumes of calls. The call-center has successfully reduced
the number of telephone interruptions in the pharmacies.
Action: The Board advised YVFWC to contact Board staff for assistance with any concerns or
issues that may arise and asks that YVFWC provide the Board with the following:
1) Written acknowledgment that the issue of pharmacist(s) failing to have inadequate
control over their personal passwords has been resolved.
2) Updated policies and procedures/quality Assurance to include:
a. Personal passwords must be under the users control.
b. No processing of prescriptions by call center staff.
3) Copies of satisfaction surveys and mystery shopper information.
The Board will re-inspect the YVFWCs call center operation in 3-months .
Peninsula Community Health Services Requests Approval of Telepharmacy
Tim Fuller introduced Douglas Phelps, M.D., the Medical Director at Peninsula Community
Health Services, who briefly described PCHS organization and its objective to use telepharmacy
services to improve patient safety and staff productivity at the Poulsbo clinic.
Dr. Jennifer Kreidler-Moss, Pharmacy Services Manager detailed the telepharmacy function.
Pharmacist located at Central Pharmacy in Bremerton will to processing for telepharmacy.

Pharmacist video-link to patient in Poulsbo
Telepharmacy cabinet to stock formulary (automated distribution device)
PDX software program
Intergraded medical records system
Poulsbo currently averages 12 prescriptions per day
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Extensive sample formulary
MOTION: Rosemarie Duffy moved that the Board approve Peninsula Community Health
Services policies and procedures for a telepharmacy in Poulsbo supported by the central
pharmacy in Bremerton. Gary Harris second. MOTION CARRIED 5-0.
Operating Agreement
Chair Awan introduced Bonnie King, Director of Health Professions Quality Assurance.
Ms. King began her discussion by updating the Board on the hiring process for the Executive
Director position with the Board of Pharmacy. Asaad Awan, George Roe, Rebecca Hille, Lisa
Salmi, Steve Saxe, and Bonnie King participated in interviews held this fall. The position was
offered but later declined by the candidate. The Department of Personnel and Department of
Health is reviewing the Washington Management System positions to assess the salary level with
comparable positions in state service to justify a higher salary level . More information should be
available at the end of January.
Ms. King asked to discuss with the Board the history and purpose behind the operating
agreement between Boards/Commissions and the Department of Health. She explained the
Secretary of Health, Mary Selecky, worked with all 16 Boards/Commissions to get consensus on
the agreement language. Fourteen of the 16 Boards/Commissions have signed the agreement.
However, the Department has abided by the agreement in spirit of cooperation and collaboration
with all Boards and Commissions.
Ms. King also explained that the Board of Pharmacy and the Nursing Care Quality Assurance
Commissions agreement required addendums to capture specific statutory requirements .
Signing the agreement would memorialize the way we work together. Pharmacy Board requires
an addendum because - where there is a specific statutory requirements an addendum is attached
to the agreement to spell out those requirements the Nursing Commission is the only other
Boards and Commissions with statutory requirements .
Discussion:
Concerns that the agreement does not provide assurances that the Board has control over
funding the priorities that it identifies. Example End of last biennium spending freeze
prevented staff/board members from attending the Utah School of Alcoholism and Drug
Abuse. This training is a high priority for the Board of Pharmacy with the number of drug
diversion cases that are handled by this Board.
Budget development/credentialing fees Proposal for increase in credentialing fees to

subsidize impaired provider program (WRAPP) must be presented to the Secretary of Health.
Ms. King acknowledged that the Board has faced many challenges in 2006 and stated that she
appreciated their dedication and looks forward to being invited back for further discussion on the
operating agreement.
Joyce Roper reminded the Board that she cannot serve as their counsel when addressing issues
regarding the Operating Agreement, since she serves as counsel to the Secretary of Health. She
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asked that the Board notify her in advance when they plan to discuss this in the future so she may
arrange for another AAG to serve as the Boards counsel.
Correspondence
The Board was given correspondence, articles and other relevant information for review. No
discussion.
Generic-drug Machines Grow ATM devices dispense samples. By Kathleen Kerr

U.S. to Allow Canadian Drug Imports by Lisa Girlon LA Times
CDC Portfolio Assessment Washington 2006
Planning for Board Performance Measures by Lucy C. Gee, M.S. Florida State Medical
Quality Assurance Division Director (PowerPoint)
Election of Board Officers for 2007

MOTION: George Roe moved that the Board reappoint Asaad Awan and Rebecca Hille as Chair
and Vice-Chair respectively. Gary Harris second. MOTION CARRIED 5-0.
OPEN FORUM.
Doug Beeman, Group Health Cooperative Requests that the Board consider placing the
prescription transfer process on the rule review list.
PRESENTATION OF AGREED ORDERS Orders presented to the Board for consideration.
ADJOURNMENT
meet again on January 26, 2007 in Tumwater, Washington.
It is with sincere appreciation that the Washington State Department of Health wishes to
recognize Donna Dockter for her commitment and service as a member of the Washington State
Board of Pharmacy from June 1999 to January 2007.
December 15, 2006 Disciplinary Hearing Cancelled due to power outage.
Respectfully Submitted by: Doreen E. Beebe, Program Manager

_________________________________________
Board of Pharmacy
11
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STATE OF WASHINGTON

MEETING MINUTES
December 15, 2011
Renton WA 98057
CONVENE
Chair Al Linggi called the meeting to order at 9:04 a.m., December 15, 2011
Board Members:
Gary Harris, RPh,
Guest / Presenters:
Tim Lynch, PharmD., MS Regional Director
for Franciscan Health System
Chris Simard, Pharmacy District Manager
for Bartell Drugs
Darren Shimanuki, Pharmacist Intern

Abbey Horner, PharmD
Absent Board Member:

Staff Member:
Heather Carter, AAG
Steven Saxe, Director of Health Professions and
Facilities
Heidi Welborn, Pharmacist Investigator
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CONSENT AGENDA
1.1
Business Meeting Agenda Approval December 15, 2011
1.2
1.4
Closed Firms Oct 7 - Dec 6, 2011

Opened Firms Oct 7 - Dec 6,2011
Automated Drug Dispensing Device Acceptance (ADDD)
Kindred Hospital Seattle
First Hill
PeaceHealth Southwest Medical Center - Vancouver
Swedish Edmonds Inpatient Pharmacy

Specialized Function Pharmacy Technicians Take Med Lists Approval
1.6
PeaceHealth St Josephs Medical Center - Bellingham

Board Minute Approval. October 20, 2011; November 22, 2011
1.7
agenda. Items 1.3, and 1.5 were deleted from the agenda.
MOTION: Gary Harris asked to remove both Items under Item 1.4 from the consent agenda for
further discussion.
MOTION: Christopher Barry moved that the board approve items 1. 1, 1.2, 1.6 and 1.7. Gary
Harris seconded. MOTION CARRIED: 5-0. Donna Feild recused.
Item 1.4 MOTION: Donna Feild moved that the board approve Kindred Hospital Seattle First
Hills ADDD for after hour use pending a revised medication list with no controlled drugs .
Medication list will be reviewed by Tim Fuller and Grace Cheung. Elizabeth Jensen second.
Item 1.4 MOTION: Donna Feild moved that the board approve Swedish Edmonds Inpatient
Pharmacys ADDD with removal of patient information after twelve hours. Gary Harris second.
REPORTS
Board Member
Former Dean Sid Nelson of University of Washington School of Pharmacy passed away
this past weekend. He was a very kind and unpretentious person. He was awarded Dean
of the year, several years ago, for all the Schools of Pharmacy in the U.S .
She attended the ASHP Midyear Meeting with Al Linggi representing WA State Board of
Pharmacy. This is a joint Board of Pharmacy meeting with other boards to go over hot
pharmacy topics going on at the state level and how they are being handled across the
United States.
Al Linggi reported:
He also attended the ASHP Midyear Meeting State Boards of Pharmacy meeting. Some
of the topics covered at this meeting were repackaging, telepharmacy along with a
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number of other issues that our board is currently dealing with. This was a great exchange
and great opportunity to see how other states are wrestling with these issues.
Mr. Linggi also attended a Weekly Meet Me Call representing the board to discuss
legislative issues.
Mr. Linggi was asked

yet.
to testify for the state on the Stormans case and hasnt been called
Executive Director
WSPA Annual Meeting October 21 and 22: Susan felt honored to represent the board and to
recognize Dick Morrison and Stan Jeppesen at the WSPA Awards banquet for their service to
the profession and the board. She also gave a board update to the membership at the general
membership meeting October 22.
UW Pharmacy Practice Advisory Board: October 26, both Al and Susan attended the UW
pharmacy practice advisory board meeting. The advisory board reviewed the budget
challenges facing the School of Pharmacy. The advisory board reviewed the mentor program
and medication therapy management training for students.
Hazardous Drug Handling Rules: This topic is addressed separately on the agenda. Susan
attended the L and I rules hearing November 28.
Stormans Trial: The trial continues next week with the defendants
testified for two days last week as did Steve Saxe and Tim Fuller.
Medical Assistants (MA); HSQA and DOH drafted a sunrise review and recommend
credentialing MAs and combining current HCA credentials to ensure public safety and assure
professional ability:
Blend the existing HCA categories with a medical assistant certification in the
following way:
Replace the current HCA categories C and E with Certified Medical
Assistant.
Replace the current HCA categories A and B with Certified
Phlebotomist.
Replace the current HCA category G with Certified Hemodialysis
Technician.
Remove the requirement that new certifications be issued each time a
credential holder leaves a facility, and replacing it with the portable
credential that exists for every other health care profession.
Grandfather the 17,600 HCAs
Categories C and E into the new medical assistant certification when
they renew their credentials, with a requirement to submit a practice
arrangement plan. This would impact 7,150 currently certified HCAs.
Currently certified health care assistants as follows:
Categories A and B into the new Phlebotomist credential. This would
impact approximately 9,600 currently certified HCAs.
Category G into the new Hemodialysis Technician credential. This
would impact approximately 730 currently certified HCAs.
Governor Gregoire files petition with DEA to move marijuana to Schedule II: On November
30, the governor filed a petition with DEA to change the scheduling of marijuana to schedule
II. The governor of Rhode Island signed on to the petition in support.
Lawsuit filed against the Board of Pharmacy: On September 27, a lawsuit was filed in King
County Superior court against the Board of Pharmacy. The lawsuit is based on the boards
side of the case. Susan
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decision to deny a petition to remove marijuana from the states Schedule I controlled
substance list.
Spice (synthetic marijuana) and Bath Salts (amphetamine-like chemicals) The Board of
Pharmacy has promulgated permanent rules to place these dangerous chemicals in Schedule I
of the Controlled Substances Act effective December 2, 2011.
He attended the private-public partnerships meeting among the Public Health Emergency
Preparedness and Response (PHEPR)part of Department Of Health (DOH) and Group
Health for repackaging bulk medications from the Strategic National Stockpile and
Safeway for use of their Distribution Center for Receipt, Storage, and Staging (RSS) for
distribution of these emergent medications.
Tim participated in the Spokane Pharmacy Associations Rewards banquet.
It was held
in the gorgeous Davenport Hotel. He was the invited Board of Pharmacy representative.
An award was given to board member Rebecca Hille for her contributions to the
Association.

Our investigator recruitment was successful we have hired 3 new pharmacist investigators who
started work November 16, 2011.
Julie Faun (East King, Kittitas, Chelan, Douglas, and Okanogan Counties)
Patient Medication Record Systems (WAC 246-875- 020&040)
Drug Product Substitution (WAC 246-899 / RCW 69.41)
Heidi Welborn (South Seattle and SW King County)
Stan Moore (Clark, Cowlitz, Lewis, Skamania, and Thurston Counties)

Most common of 37 violations cited during 821 pharmacy inspections.
Child Resistant Container Rules (WAC 246-869-230
Physical Standards for Pharmacies Adequate Stock (WAC 246-869-150)
Uniform Controlled Substances Act (WAC 246-887-020)
Prescription Record Requirements (WAC 246-869-100)
Prescription Labeling (WAC 246-869-210)
Physical Standards for Pharmacies-Adequate Facilities (WAC 246-869 (Cleanliness,
sink, hot and cold running water, refrigeration)
Violations of state or federal laws (RCW 18.64.160 & RCW 18.64.165)
License Display (RCW 18.64.150)
11.
Patient Counseling Required (WAC 246-869-220)
12.
Pharmacists Professional Responsibilities
Pharmacy Inspections and Investigations
Month and Year
Inspections
Completed
January
2011
113
February
2011
133
March
2011
167
April
2011
150
May
2011
140
June
2011
90
(WAC 246-863-095)
Investigations
New Open Completed
17
36
23
6
30
13
16
23
10
20
29
15
16
34
10
6
40
4
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July
August
September
October
November
December
2011
2011
2011
2011
2011
2011
130
121
131
94
113
11
26
21
18
11
42
38
42
37
43
45
15
22
26
10
9
December 1-2, 2011 Tyler Varnum attended the NABP Compliance Officer Meeting.
Grace passed out a memo written by William Kristin, Pharmacy Investigator to share
with the board. This memo relates to the inspection process . Bill expressed that there has
not been a review and update of the inspection process for quite some time. All the
investigators agreed that the format and the process should be reviewed and updated.
December 5, 2011 a Pharmacy Investigator meeting via videoconference was held.
December 7-8, 2011 Julie Faun and Stan Moore attended an Investigator Core Training.
MOTION: Donna Feild moved that the board review the inspection process for all practice
settings. Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
MOTION: Donna Field moved that she and Elizabeth Jensen would chair and lead an ad hoc
committee. Gary Harris second. MOTION CARRIED: 6-0.
PRESENTATIONS
Office of Health Professions and Facilities
Steve Saxe, Director Office of Health Professions and Facilities thanked the board for setting
aside time for him to update the them on the NASCSA Annual Meeting and the process to recruit
for the Executive Director Position as well as a Lean project on pharmacy credentialing.
He mentioned that Governor Gregoire has asked all agencies to work on Lean performance
Implementation. One of the Department of Health (DOH) groups that will be getting trained in
this program will be the credentialing team. Mr. Saxe is working with Shannon Beigert,
Customer Service Office Director to use pharmacy credentialing as a project for the Lean
Performance Improvement.
National Association of State Controlled Substance Authorities (NASCSA) brings together
controlled substance authorities from all states. Mr. Saxe attended this meeting to update
NASCSA on the Washington Prescription Monitoring Program (PMP) from the grant we
received. He also represented the board of pharmacy at the NASCSA business meeting.
Mr. Saxe then updated the board on the resolutions that were passed.
THEREFORE, BE IT RESOLVED, that the National Association of State Controlled Substances
Authorities (NASCSA) hereby recommends states, commonwealths, districts and territories
encourage and support the implementation of electronic prescribing of controlled substances; and
BE IT FURTHER RESOLVED, that NASCSA recommends states, commonwealths, districts and
territories promulgate laws and/or regulations authorizing the electronic prescribing of controlled
substances consistent with regulations as authorized by the US Drug Enforcement Administration .
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THEREFORE, BE IT RESOLVED that the National Association of State Controlled

Substances Authorities (NASCSA) supports the placement of Carisoprodol into Schedule IV of
the Federal Controlled Substances Act;
BE IT FURTHER RESOLVED that NASCSA encourages State Controlled Substances
Authorities and State legislatures to place Carisoprodol under regulation as soon as possible.
THEREFORE, BE IT RESOLVED, that the National Association of State Controlled
Substance Authorities encourages the federal government and state controlled substance
authorities to make Salvia divinorum and salvinorin a controlled substances.
THEREFORE, BE IT RESOLVED, that the National Association of State Controlled
Substances Authorities hereby supports the passage of federal legislation authorizing the U.S .
Department of Defense and U.S. Department of Veterans Affairs to submit dispensing data on
controlled substances to state prescription monitoring programs and to authorize prescribers and
dispensers within their systems to utilize such programs in making treatment and dispensing
decisions.
Mr. Saxe described the status of the recruitment for Executive Director in high gear. He will
work with the board chair on pharmacy board representation. He reviewed with the board the
other professions that Susan currently supports. The department would like to get this job posted
in the beginning of the year 2012.
Pharmacy Technicians Taking Patient Medication Lists

Tim Lynch from Franciscan Health Systems presented a follow-up report on the process
implemented for using specially trained pharmacy technicians to interview patients to obtain a
medication list.
Program Review
Program Initiation: December 2010
Training and Orientation
4 weeks (December 2010)
Cerner Power Chart
Cerner PharmNet
FHS Drug Information Resources
ED Workflow Design
Brand/Generic Comprehension
Patient Interview Techniques
Theradoc
Program Structure
2 Pharmacy Technicians
10hr shifts covering high patient volume periods
7 days/week coverage
Medication List Collection Process
Interview patient or caregiver
Record medication information from bottles brought by patient/caregiver
Contact patients pharmacy

Contact patients provider(s)
Clarify with patient/caregiver any discrepancies
Enter medications into Power Chart and print medication list
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Deliver printed medication list to ED pharmacist for review and approval

Pharmacist provides admission medication list to provider for reconciliation
Pre-Implementation Analysis
Accuracy
Verified with outpatient pharmacy:
58 patients, 4 correct, 53 incorrect
6.9% correct, 91.3% incorrect
Reviewed but not verified with outpatient pharmacy:
83 patients, 36 appear correct, 47 incorrect
43.3% appear correct, 56.63% incorrect*
*obvious errors (missing dose, frequency, wrong dose, strength,
etc.)
Combined Averages:
28.3% correct, 70.9% incorrect
Timeliness of Medication Reconciliation Completion
Study period: December 2009 to October 2010
50 charts each month
Reviewed % Admission Med Rec completed within 12hrs of admission
Results:
41% completed after 12hrs of admission
59% completed within 12 hrs of admission
Staff Survey (pharmacy, nursing, providers)
533 responses
Results:
>90% confidence in accuracy of medication list
17.4%
Medication list available at time of admission >80% of time
44.7%
Biggest barriers to accuracy
Time to Complete: 16.5%
Information availability/quality: 63.2%
ACIS (complexity of process): 20.3%
Frequency errors/discrepancies are corrected in ACIS
21.2% corrected for each patient
Post-implementation Results
Study period: January 2011 March 2011
776 patient medication lists collected
Average of 19 patients/hr interviewed
Average of 14.35 medications/patient
Average time to complete medication list
25 minutes for technician
45 minutes for nurse
Labor cost savings $11,906 for study period
582 additional nursing hours
Post-Implementation Analysis
Clinical Intervention
Technicians used our standard intervention definitions to record potential ADE
situations
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Pharmacists validated clinical intervention and ADE potential and determined

severity level (minor versus major)
17 major ADEs identified, 257 minor ADEs identified
Clinical intervention cost savings
ADE Prevention: $93,940
Medication List Completion: $58,200
Timeliness of medication list completion
86.6% of patients medication lists completed and Med Rec completed by provider
within 12hrs
Compares to 58.9% of patients pre-implementation
63% of admission medication reconciliation completed prior to admission
Accuracy
Triple validation by technician (patient/caregiver, outpatient pharmacy, patients
provider(s))
Assumed 100% accuracy compared to 6.9% with nurse medication list
completion
Conclusions
Technician medication list collection resulted in:
Improved Accuracy
Timeliness of medication list completion
Re-deployment of nursing time to direct patient care activities
Capturing of potential ADE information and savings
Improved continuity of care; accuracy at front end improved accuracy at transfer
and discharge
Partner with Group Health to gain access to EPIC
Utilization of Elysium to access information for patients seen by
Franciscan Medical Group
Next Steps
Expansion of program
20hrs/day coverage approved for St. Joseph Medical Center
10hr/day coverage approved for St. Francis Hospital
Potential placement of medication reconciliation technicians at St. Clare Hospital
Workload Balancing
Susan Boyer introduced Chris Simard, Pharmacy District Manager for Bartell Drugs to give the
board a one year follow-up report on its use of remote order prescription processing for workload
balancing.
Overview
March 2010 the board approved Bartell Drugs for a six month remote data entry test
between two locations and created a new workflow. This test was successful and at the
November 2010 Board of Pharmacy meeting the program was rolled out to all locations.
At that time the board asked for a follow up in one year.
Workflow Steps
The process of filling a prescription is broken down into steps with a single person
performing the same step for multiple prescriptions.
As the program expanded, there were no issues that developed with individual steps.
Each step and the person performing the task were recorded correctly and local
ownership of the prescription was maintained.
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The workflow steps are not currently being load balanced to the full potential and the
explanation is below.
Safety
The biggest change to workflow was the creation of pre-verification.
The results were a reduction in errors by 25% due to the pharmacist performing the
cognitive check to be able to perform the task at different locations where distractions
might be minimized.
The last step is the verification where that pharmacist can focus on making sure the
correct product is in the bottle and making it to the correct patient.
This moved the cognitive portion of the final verification to after data entry and
adjudication but before dispensing, thus allowing any DUR or typo issues to be handled
before a label is created.
Communications between the three areas are done via an internal note system.
Data Entry
Due to physical hard copy requirements most stores have found it easier to perform the
data entry portion locally.
If done remotely, the remote location will place a note telling the local location to create
a hard copy.
A system update requesting auto-printing of hard copies or board approval for stickerless
hard copies are being weighed as a way of by passing this issue.
Verification
The biggest issue that has come up is the definition of the responsible pharmacist if a
quality event occurs.
As described above, the verification process has been split into three steps where three
different pharmacists may verify different components of a single prescription.
Current board rulings state the final pharmacist to dispense the prescription is responsible
for all components of the prescription.
Bartell Drugs is requesting that if a quality assurance event occurs, the pharmacist
responsible for that component of the prescription should be held responsible. For
example:
Pharmacist A performs the DUR and patient profile check. If an event occurs
in one of these areas, pharmacist A should be held responsible.
Pharmacist B performs the hard copy check. This step focusing on the data
entry portion to make sure the correct patient, drug, strength, sig, etc have been
entered.
Pharmacist C (local) performs the physical check focusing that the correct drug
is in the correct bottle.
MOTION: Gary Harris moved that the board postpone discussion on which pharmacist is
responsible if an event occurs in the of remote order prescription process for workload balancing.
Either the final check pharmacist or the pharmacist responsible for the specific step performed in
the process. Elizabeth Jensen seconded. MOTION CARRIED: 6-0.
Patient Counseling
Grace Cheung led the discussion with the board by first providing them with some background
related to patient counseling.
Overview
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Pharmacist Investigators have reported observations during on-site inspections of

community/retail pharmacies relating to the Patient Counseling Requirement. Many chain
pharmacies are employing a Point-Of-Sale (POS) signature capture system at the cash
register. Investigators have witnessed Ancillary Personnel (Pharmacy Assistants or
Technicians) prompting the patient to select the decline counseling check box.
Investigators have observed poor adherence to the counseling rule in general. This
appears to be partially due to the fact that the rule has not been followed in its entirety.
In reference to refills, most licensees have the misconception that all refills may be
automatically released with no pharmacist intervention.
The board clarified that all new prescriptions (to include all prescriptions that have been
issued a new Rx number) must be counseled by the pharmacist and that any refusal of
counseling must be directly communicated by the patient/agent to the pharmacist .
The historical separation between refills and new prescriptions has caused confusion on
what the rule actually requires. In addition to witnessing new prescriptions being
dispensed without pharmacist counseling; it is also routine to hear licensees indicate that
a refill may be processed without an assessment by the pharmacist relating to counseling
simply because it is a refill.
Counseling is no longer a new concept. Pharmacists and interns are the only learned
individuals in the pharmacy who have authority and the knowledge/skill & ability to
provide meaningful counseling, but Investigators are not been observing adherence to the
rule in pharmacies.
After discussion the board agreed to re educate pharmacists in a newsletter article. The article
will be written by staff then sent to the board members for their review. This article will run in
the January 2012 newsletter.
MPJE Study Plan

Panel for the study plan presentation chosen included Christopher Barry, Gary Harris, and
Elizabeth Jensen.
Darren Shimanuki, Pharmacist Intern presented a study plan for consideration by a panel of the
board. The Intern requested authorization to re-take the Multistate Pharmacy Jurisprudence
Examination.
MOTION: Christopher Barry moved that the panel approve the study plan presented by Darren
Shimanuki. He may re-take the Multistate Pharmacy Jurisprudence Examination on or after
February 1, 2012. The panel suggested he study for an hour everyday and Darren is required to
review both sets of questions with Bill Fassett and review his recorded law lectures. Elizabeth
DISCUSSION Contd
Boards Strategic Plan.
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Susan Teil Boyer provided an update to the board on the where staff and board champions are
with the boards 2011- 2012 initiatives, goals, and strategies.
Strategies identified at the August 2011 planning session.
a) Quality Assurance Program Guidelines. Susan shared with the board the research
and background Cathy Williams has come up with for this
Objective. The board members believe this should be looked at in
the rules scan.
b) Update on Rule Scan. Staff workgroup has been meeting fairly regularly. The
workgroup has reviewed 13 chapters and put into bucket categories..
Karen Jensen has made it clear that she is in support of this project but has
asked staff to file for exemption before the board is included in the review
of the rules to move forward.
Cancer Drug Repository/Drug Return Proposal

The board was asked to consider a proposal by Abbey Horner, Pharm. D., Pharmacy Practice
Resident, at Southwest Washington Medical Center in Vancouver to create a cancer drug
repository/return program. Abbey shared some background on other repository/return programs
started by other states.
Program Overview
Create a statewide cancer drug repository program that would allow, under specific
criteria, the donation and redistribution of unused prescription medications used for the
direct treatment of cancer or for side effects associated with various anti-cancer agents
Multi-phase project with goal of completing first phase during residency year
Program Goals
Ensure safe and effective practices while assessing risk/benefit ratio
Provide necessary care to a population who would otherwise be unable to obtain them
Decrease wastage of cancer drugs that are often expensive and are increasingly of limited
supply
Pilot Program Objectives
Cancer Drug Repository Pilot Program
Demonstrate the feasibility and potential impact of this program
Identify rules or processes which need to be amended to support this program
Offer a clear path for statewide implementation of the Washington State Cancer
Drug Repository Program
Phase I
Development of ground rules of WA State Cancer Drug Repository Program
By 11/30/11
Development of Cancer Drug Repository pilot program proposal
On 12/15/11
Review of program by Washington Board of Pharmacy
By 1/15/12
Finalize pilot program implementation plan and timeline
By 2/1/12
Implementation of Cancer Drug Repository Pilot Program
Phase II
Continuation of pilot implementation
Analysis of pilot program results
Presentation of pilot program results to Washington Board of Pharmacy
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Revision of rules/processes of Cancer Drug Repository Program

Summarization of results and preparation for introduction to WA state legislature
Phase III
Introduction and passage of the Washington State Cancer Drug Repository to WA state
legislature
Notification and education of potential participants
Advertisement seeking donations & identifying participating sites
Program implementation
Retrospective analysis of implementation
Limitations of Other State Programs
Most programs adopted Nebraskas CDR rules which were written in 2003
Many standard chemotherapy drugs FDA-approved after 2003
Monoclonal antibodies
Oral chemotherapies
Newer therapies are effective but expensive
Only allowed drugs stable at room temperature
All monoclonal antibodies refrigerated
All monoclonal antibodies IV, thus stored & administered at health-care facilities
Only allowed drugs in unit-dose packaging
Prevents inclusion of oral chemotherapies
Example:
Patient with GIST tumor
Switched from Gleevec (imatinib) to Sutent (sunitinib), but had just
picked up a 1-month supply of Gleevec and had >20 capsules remaining at

home
Patient was RN and stored drug as recommended
Wasted drug represented >$4235
Expiration dating
Current CDR programs allow 3 6 months
Patients could benefit during this time
Key Desired Changes in Pilot Program

Key desired changes
Allow refrigerated drugs if donated by health care facility [1]
Allow donation of oral chemotherapy drugs from general public if storage and
[2]
handling can be reasonably determined by pharmacist
Allow drugs up until the manufacturers listed expiration date[3]

Pharmacist may only dispense complete course of therapy if it can be
completed prior to expiration date
Washington Senate Draft Bill

Senate bill being investigated by Senator Jim Kastama
Suggested changes[5]
Remove 6 month expiration cut-off
[4]
Change participant to participating facility

Add contact person to participant facility registry
Revised draft bill includes all changes as recommended
[6]
Target Population
Uninsured is better than underinsured
Catch the patients who fall through the cracks
Bridge during Medicaid/patient assistance application period
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Example:
Woman felt lump in breast 4 years prior
No treatment sought due to financial hardship
Recently presented to ED with neurological symptoms
Stage IV metastatic breast cancer
Conclusion
Inherent risks of program
Sub-optimal drug potency
Benefits of program
Patients choose treatment vs. no treatment
Greater access to care
Pilot program would demonstrate benefit and highlight needed modifications
MOTION: Gary Harris moved that the board support the concept of the pilot program presented
by Southwest Washington Medical Center in Vancouver to create a cancer drug repository/return
program and the board will act as a resource. Christopher Barry seconded. MOTION
CARRIED: 5-0. Donna Feild recused.

Susan Boyer updated the board on the legislative session.
HB 2343 The Electronic communication of prescription information for controlled substances.
Agency requested legislation. The bill allows prescribers to send prescriptions for controlled
substances by electronic transmission to a pharmacy. The bill amends chapter 69.50 RCW to
align with federal standards and allow electronically communicated prescriptions for controlled
substances.
Concern with a draft model bill prohibiting pharmacists from substituting opioid analgesic drugs
for a specific brand of opioid analgesic drug incorporating a tamper resistance technology
without verifying equivalence or obtaining the written, signed consent of the prescribing
physician.
HB 2142 If federal or private grants or other funds are not sufficient for the operation of the
prescription monitoring program the department of health may charge a fee ($15) for the
operation of the program. There was a public hearing held December 8.
SSB 5969 This establishes procedures for the professional licensing of military spouses after
relocation to Washington. Licensing authority is required to develop a method to authorize a
March 14, 2012.
Jeff Rochon spoke on a few bills.
SB 6096 & HB 2303 Protection Against Unfair Prescription Drug Practices By Pharmacy
Benefit Managers. This establishes consumer protection from unfair prescription drug practice
by pharmacy benefit managers that contract with covered entities.
Cleanup bill to correct the RCW, the Legend Drug Act, that identifies all prescribers, but omits
pharmacists.
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Safe Handling of Hazardous Drugs Rules Hearing

Susan Boyer shared an update on the public rules hearing held by the Department of Labor and
Industries (L and I) for rules to implementing 2011 Legislation - ESSB5594.
The board and Office of Health Professions and Facilities staff met with John Furman, PhD, RN
and Michael Silverstein, MD, L and I, November 7, 2011 to review the draft rule. We provided
them feedback including substitute language to encourage a tiered approach for low risk drugs.
The rules hearing held November 28, 2011 regarding Hazardous Drugs incorporated the
following principles:
Oral solids listed on the NIOSH 2010 drug list are minimal risk drugs and if not
manipulated, crushed, compounded require no special consideration when dispensing. If
tablets are cut, gloves should be worn.
L NI is incorporating a tiered approach for employees handling hazardous drugs.
L and I has extended the dates for implementation of the rule to January 2013 for the
Hazardous Drug Control Program and June 2013 for the Training Program and ventilated
cabinet installation, where required, by January 2014.
L and I has incorporated a more limited approach to medical surveillance requirements
The rules require a hazard assessment initially and then annually to identify occupational
exposure to employees. A hazardous drug control program would be implemented including
policies and procedures and a performance based assessment. A tiered approach may be used.
Personal Protective Equipment (PPE) use will be based on the hazard assessment and will ensure
appropriate use and disposal of PPE.
Hazardous drug waste will be managed according to Department of Ecology requirements for
dangerous waste.
Medical surveillance will be made available to employees.
No requirement for a retail pharmacy if dispensing, for example, 6 of the oral solids on the
hazardous drugs list.
Drug Repackaging/Reuse
Susan Boyer and Tina Lacey asked the board to consider adopting procedures for the
application of WAC 246-865-060 and WAC 246-869-130 return, repackaging, and reuse of
drugs. Tina Lacey provided some brief background to the board regarding this issue. Tina Lacey
researched the topic extensively, and together Susan and Tina were able to put together some
guidelines for the board to consider .
MOTION: Al Linggi moved that the board write an interpretive statement regarding the chain of
custody of a drug. Christopher Barry added that the board/staff allow for interested parties input .
MOTION: Christopher Barry nominated Al Linggi as Chair and Donna Feild nominated
Christopher Barry as Vice-Chair. Elizabeth Jensen second. MOTION CARRIED: 6-0.
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Rulemaking Update
Doreen Beebe discussed the proposal rulemaking workload as it applies to the extended rules
moratorium.
MOTION: Christopher Barry moved Patient Counseling be added to the rules priority list and
Elizabeth Jensen will be the board champion. Donna Feild second. MOTION CARRIED: 6-0.
Kitty Slater asked the board for approval on the draft rules implementing HB1353 Pharmacy
Technician Continuing Education. She shared the board the changes that were made to this rule
recommended by the board during the October 2011 board meeting.
MOTION: Donna Feild moved to approve the draft language with an amendment to include a
pre approved Continuing Education program by the Board of Pharmacy to be submitted and
approved for Continuing Education for Pharmacy Technician Continuing Education . Christopher
Doreen Beebe asked the board to approve the changes to the rule language for Animal Control
Agencies Chapter 246-886 WAC.
MOTION: Christopher Barry moved that the board approve changes to the rule language for
Animal Control Agencies Chapter 246-886 WAC. Donna Feild second. MOTION
CARRIED: 6-0.
Correspondence
Hazardous Drug Proposed Rules Comments to L and I December 7, 2011
OPEN FORUM
Colin Conway from Group Health asked that the board be more clear and concise on the agenda
items. So there could be more involvement from the community.
Julie Akers from the Everett Clinic asked the board about the placement of the Tamper Resistant
Prescription Pad (TRPP) seal of approval. She stated that pharmacies have been penalized
during an Insurance Audit for accepting T RPP with the seal of approval printed in the wrong
corner. The board responded that the placement of the seal of approval is not in law (RCW) or
rule (WAC). It is recommended for printers in Washington TRPP .

CLOSED SESSION
The business meeting adjourned at 4:14 pm.

January 26, 2012

310 Israel Road SE
Room 152/153
Tumwater WA 98501
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_______________________________
Al Linggi, Chair
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2. Collect stakeholder feedback on 3
options and their implications.

3. Collect additional ideas for options
the department might consider.

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Agenda
Handouts
Guidelines

Governors Directive

Stakeholder Input
Wrap Up, Next Steps
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welcome.

public record.

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1970 - 2015
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Federal Law
possessing:

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caregivers.

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level, however federal guidance has been given to states who

have chosen to move forward with legalization.
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Remove from Schedule I of our states Controlled
Substances Act any medical marijuana product that
identifies in rule as:
appropriate for sale to qualifying patients and
designated providers in a retail outlet that holds a
medical marijuana endorsement.
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Instructions to the
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or rules.



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violations.
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Verbal Comments


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or rules.



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violations.
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Other Options?
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Wrap Up, Next Steps

What happens next?
Thank you
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Contact Information
Website
Email
ListServ
Phone
360-236-4819
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2. Collect stakeholder feedback on 3
options and their implications.

3. Collect additional ideas for options
the department might consider.

Kingsbury1187
Agenda
Handouts
Guidelines

Governors Directive

Stakeholder Input
Wrap Up, Next Steps
Kingsbury1188

welcome.

public record.
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1970 - 2015
Kingsbury1190
Federal Law

possessing:

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caregivers.

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level, however federal guidance has been given to states who

have chosen to move forward with legalization.
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Remove from Schedule I of our Washingtons
Controlled Substances Act (WCSA) any medical
marijuana product that identifies in rule as:
appropriate for sale to qualifying patients and
designated providers in a retail outlet that holds a
medical marijuana endorsement.
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Instructions to the
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Does not require any changes to WA state laws or rules.
Keeps the WCSA aligned with federal law.
Marijuana use would still be illegal under federal law. Marijuana
authorization by healthcare practitioners continues without putting

controlled substance prescriptive authority at risk.
The Schedule I penalties apply to any misuse of marijuana outside
the legal market established under WA laws.

The WCSA continues to list marijuana as a substance that has no
currently accepted medical use; conflicts with chapter 69.51A RCW.

Though not in compliance with federal law, Washington States
tightly regulated system focuses on meeting the federal

governments enforcement priorities.
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Option 3: De-Schedule When Used

Within Parameters of Current Law
Does require changes to Washington state laws or rules.
Marijuana would be legal and not a Schedule I drug for people
following all rules under current WA law.

Schedule I penalties would still apply to any misuse of marijuana
outside the legal market established under current WA law.

authorization by healthcare practitioners could continue without

putting controlled substance prescriptive authority at risk.
The WCSA will align with current Washington law.
Though not in compliance with federal law, WA States tightly
regulated system would continue to focus on meeting the

federal governments enforcement priorities.
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Verbal Comments


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Does not require any changes to WA state laws or rules.
Keeps the WCSA aligned with federal law.
authorization by healthcare practitioners continues without putting

controlled substance prescriptive authority at risk.
The Schedule I penalties apply to any misuse of marijuana outside
the legal market established under WA laws.

The WCSA continues to list marijuana as a substance that has no
currently accepted medical use; conflicts with chapter 69.51A RCW.

Though not in compliance with federal law, Washington States
tightly regulated system focuses on meeting the federal

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Option 3: De-Schedule When Used

Within Parameters of Current Law
Does require changes to Washington state laws or rules.
Marijuana would be legal and not a Schedule I drug for people
following all rules under current WA law.

Schedule I penalties would still apply to any misuse of marijuana
outside the legal market established under current WA law.

authorization by healthcare practitioners could continue without

putting controlled substance prescriptive authority at risk.
The WCSA will align with current Washington law.
Though not in compliance with federal law, WA States tightly
regulated system would continue to focus on meeting the federal

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Other Options?
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Wrap Up, Next Steps

What happens next?
Thank you
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Contact Information
Website
Email
ListServ
Phone
360-236-4819
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Options
January 2016


P.O. Box 47850
360-236-4612
Secretary of Health
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Contents
Page
1
Executive Summary
Recommendation
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Executive Summary

The department developed three marijuana scheduling options to propose for stakeholder input .
listed in Washington s Controlled Substances Act . The commission proposed a fifth option .

symbolic.

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under federal law.


69.51A RCW.

that has no currently accepted medical use, which conflicts with chapter 69. 51A RCW.
Though not in
compliance with federal law, Washington States tightly regulated system


Conflicts with I-502s
recognition and legalization of recreational use of marijuana.

allowed.
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Conflicts with federal law, so h ealthcare practitioners
wouldnt be able to legally
systems created under I-502, SB 5052 and chapter 69.51A RCW .


69.51A RCW.
RCW.

69.51A RCW.

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by pharmacies.
quality medication.

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allowed.
marijuana and pharmacies that dispense marijuana .


Recommendation
comports well with chapter 69.51A RCW s acknowledgement of marijuana as having medical
marijuana to Schedule II but take no affirmative steps to treat it as such . This creates a legal
Kingsbury1218
recreational marijuana, medical marijuana or both are now reconsidering their positions .
Kingsbury1219


Federal Law, 1970

1
other substance under medical supervision. Healthcare practitioners cannot legally prescribe or
add substances or delete or re-schedule controlled substances. Petitions to the commission to reschedule marijuana in rule have been unsuccessful .

2
primary caregivers. The patient was required to have a recommendation from a healthcare
21 U.S.C. 812(b)(1).
Kingsbury1220
market.
3
to note, however, that the medical use of marijuana is not yet legal at either the state or federal
4
applicable state laws.
marijuana.
5
federal law for healthcare practitioners to prescribe or dispense marijuana.
Department of Justice may be used, with respect to the States of Alabama, Alaska, Arizona, Califor nia Washington, and

5
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7
Pharmacy to classify marijuana as a controlled substance in Schedule II, III, IV or V. On June
8
Conant v. Walters
9
government which was later upheld by the Ninth Circuit Court of Appeals. The United States

7
8
th
Conant v. Walters, 309 F.3d 629, United States Court of Appeals, 9 Circuit, 2002
9
Washington.
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10
the patient acquire marijuana, and intend to help the patient acquire marijuana.
11
significant risk of administrative action and criminal prosecution under federal law.
Liability Issues
states and Washington D. C. that have some sort of medical marijuana laws, as well as the 17
12
states that currently allow high CBD/low THC products for medical use. Most often, the
administration.
10
Conant at 636.
pract itioners from prescribing Schedule II controlled substances in compliance with Oregons Death with Dignity
11
12

10
Kingsbury1223

provide all services according to federal and state laws and rules WAC 182 -502-0016(1)(b).
1320a-7(b)(5).
Supply
13
into the authorization database will be able to legally grow plants and participate in small,
system.
13
11
Kingsbury1224

14
articles related to the efficacy of medical marijuana.
One article found the use of medical
15
indications.
A second article found only low-quality evidence that marijuana was associated
16
events.
17
marijuana used for medical purposes.
18
sufficiently tested.
14
15
16
17
18
12
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13
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Options
January 2016


P.O. Box 47850
360-236-4819
Secretary of Health
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Contents
Page
1
Executive Summary
Recommendation
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Executive Summary
The department developed three marijuana scheduling options to propose for stakeholder input.
listed in Washingtons Controlled Substances Act. The commission proposed a fifth option.

symbolic.

Kingsbury1231
under federal law.


69.51A RCW.

that has no currently accepted medical use, which conflicts with chapter 69.51A RCW.

Conflicts with I-502s recognition and legalization of recreational use of marijuana.
allowed.
Kingsbury1232
Conflicts with federal law, so healthcare practitioners wouldnt be able to legally

systems created under I-502, SB 5052 and chapter 69.51A RCW.

excluded from participating in Medicare/Medicaid.

69.51A RCW.
RCW.

69.51A RCW.
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by pharmacies.
quality medication.

Kingsbury1234
allowed.
marijuana and pharmacies that dispense marijuana.

excluded from participating in Medicare/Medicaid.
Recommendation
comports well with chapter 69.51A RCWs acknowledgement of marijuana as having medical
marijuana to Schedule II but take no affirmative steps to treat it as such. This creates a legal
Kingsbury1235
recreational marijuana, medical marijuana or both are now reconsidering their positions.
Kingsbury1236

Federal Law, 1970
other substance under medical supervision. 1 Healthcare practitioners cannot legally prescribe or
add substances or delete or re-schedule controlled substances. Petitions to the commission to reschedule marijuana in rule have been unsuccessful.
primary caregivers.2 The patient was required to have a recommendation from a healthcare
1
2
21 U.S.C. 812(b)(1).
Kingsbury1237
market.
to note, however, that the medical use of marijuana is not yet legal at either the state3 or federal
applicable state laws. 4
marijuana.
federal law for healthcare practitioners to prescribe or dispense marijuana. 5

Department of Justice may be used, with respect to the States of Alabama, Alaska, Arizona, CaliforniaWashington, and
5
4
Kingsbury1238
Pharmacy7 to classify marijuana as a controlled substance in Schedule II, III, IV or V. On June
8
Conant v. Walters
government which was later upheld by the Ninth Circuit Court of Appeals. 9 The United States

7
8
Conant v. Walters, 309 F.3d 629, United States Court of Appeals, 9th Circuit, 2002
9
Washington.
Kingsbury1239
the patient acquire marijuana, and intend to help the patient acquire marijuana.10
significant risk of administrative action and criminal prosecution under federal law. 11
Liability Issues
states and Washington D.C. that have some sort of medical marijuana laws, as well as the 17
states that currently allow high CBD/low THC12 products for medical use. Most often, the
administration.
10
Conant at 636.
practitioners from prescribing Schedule II controlled substances in compliance with Oregons Death with Dignity
12
11
10
Kingsbury1240

provide all services according to federal and state laws and rules WAC 182-502-0016(1)(b).
1320a-7(b)(5).
Supply
into the authorization database will be able to legally grow plants 13 and participate in small,
system.
13
11
Kingsbury1241
articles related to the efficacy of medical marijuana. 14 One article found the use of medical
indications.15 A second article found only low-quality evidence that marijuana was associated
events.16
marijuana used for medical purposes. 17
sufficiently tested. 18
14
16
17
18
15
12
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13
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STATE OF WASHINGTON
December 11, 2015
Regular Scheduled
Business Meeting Agenda- AMENDED
Time:
Location:
Contact:
9:00 a.m.
Mt. Constance
2400 S. 240 St.
Phone: (360) 236-4834
In accordance with the Open Public Meetings Act, notices were mailed electronically to individuals who
requested notification of meetings of the Pharmacy Quality Assurance Commission.
Times and Order: The meeting will begin at 9:00 a.m. and will continue until all agenda items are
complete. This agenda is subject to change. Items might not be taken in order of the agenda. Please call
(360) 236-4834 before the meeting date to confirm the meeting agenda.
9:00 a.m.
Call to Order
1.1
1.2
1.3
9:10 a.m.
Approval of Business Meeting Agenda.

Approval of October 29, 2015 Regular Business Meeting Agenda
Approval of October 30, 2015 Special Meeting Minutes .
Action
Action
Action
Consent Agenda
Items listed under the consent agenda are considered routine commission
matters and will be approved by a single motion of the Commission without
separate discussion. If separate discussion is desired, that item will be
Action
2.1
2.2
October 2015
2.3
2.4
Al Linggi, Chair

Pharmacy Technician Training Program Approval no items
a. Seattle Childrens Hospital Tech check Tech
b. MultiCare Medical Center (Tacoma Ge neral) Tech check Tech
c. Providence Holy Family Medication Reconciliation
d. Providence Sacred Heart
i.
Tech check Tech
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2.5
ii.
Medication Reconciliation
2.6
2.7
2.8
2.9
St. John Medical Center St. John Medical Broadway

Dialysis
Follow-up Report on Routine Remote Medication Order Processing
9:25 a.m.
4.1
Forks Hospital
Legislation
Paula Meyer, Executive Director Nursing Care Quality Assurance
Commission Discuss Commission request legislation for 2016
Information/Action
regarding notification of changes in applicant or licensees criminal

history.
4.2
The Commission is asked to provide feedback on legislation

proposed by the East Asian Medicine Practitioner Association to
amend RCW 69.41.030 to grant authority to purchase, possess, and
administer sterile water, herbs, minerals, vitamins in liquid form, and
nutritional supplements.
10:20 a.m.
5.1
Requests/Proposals
The Commission will consider a proposal by Evergreen Health
Monroe Pharmacy to provide remote medication order processing
services for the detox unit at Evergreen Health Recovery Center, a
licensed health care entity in Monroe.
10:40 a.m.
Break
10:50 a.m.
7.1
Rulemaking, and Committee Reports

County Citizens Against Fluoridation and Washington Ac tion for
Safe Water to amend WAC 246-883-020 to clarify the designation of
legend drugs.
7.2

County Citizens Against Fluoridation and Washington Action for
Safe Water to adopt a new rule to clarify that fluoridation chemical
additives and fluoridated drinking waters are drugs pursuant to RCW
18.64.011(12), 69.04.009, and 69.41.010(9) when the intended use is
to aid in the prevention, mitigation and/or pro phylactic treatment of
dental caries disease.
Information/Action
Action
Action
Action
11:45 a.m.

2
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Speakers will be called forward by the Commission Chair in the order on the sig n-in sheet.
12:00 p.m.

This time may also be used by the Commission to me et in Executive Session to discuss
1:00 p.m.
Legislation Contd
4.3
The Commission will be briefed on activities associated with Senate

Bill 5052 the Cannabis Patient Protection Act. The Comm ission is
asked to weigh in on options regarding recommendations to the
Governor and Legislature on the rescheduling or de-scheduling of
marijuana.
Information/Action
4.4
Chris Baumgartner, Program Director will provide an update on

Prescription Monitoring Program.
Information/Action
4.5
The Commission will designate a representative and alternate
Action
member to participate on the weekly Department of Health Meet

Me Call to discuss legislative bills with potential impact to multiple
programs/professions.
2:10 p.m.
Requests/Proposals contd
5.2
2:50 p.m.
The commission will consider the policies and procedures of the

King Call2recycle Pharmaceutical Waste takeback program for
potential collection sites in pharmacies.
Action
Break
3:00 p.m.
6.1
6.2
New Business
Consent Agenda items placed on the regular business agenda.
Discussion related to correspondence received or distributed on
behalf of the commission.
3:30 p.m.
Action
Information/Action
Characteristics of Complaints - report by Dr. Hecox
Rulemaking, and Committee Reports contd

7.3
Committee Reports
a. Technology Rules Committee
i. Designation of new Committee Chair
b. Pharmacy Business Practice Rules Committee
c. Inspection Process Rules Committee
Information/Action
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d. Pharmacy Compounding Rules Committee
3:50 p.m.

8.1
8.2
8.3
8.4
4:40 p.m.
5:00 p.m.
The Commission will hold election for 2016 Commission leadership.

Designate Member to represent the Commission on University of
Washingtons School of Pharmacy Curriculum Committee
Commissioners open discussion related to items or issues relevant
to commission business/pharmacy practice.
i. Pharmacy Action Plan
ii. Survey members for special meeting date before 2016 to
discuss priority recommendations for statutory updates.
Staff Reports
9.1
9.2
9.3
9.4
Information/Action
Information/Action
Program/Department

The purpose of the open forum is to provide the public an opportunity to add ress the
Speakers will be called forward by the Commission Chair in the order on the sign -in sheet.
5:15 p.m.

Mission Statement
The mission of the Pharmacy Quality Assurance Commission is to promote public health and safety by
establishing the highest standards in the practice of pharmacy and to advocate for patient safety through
effective communication with the public, profession, Department of Health, Governor, and the
Legislature.
Vision Statement
The Washington State Pharmacy Quality Assurance Commission leads in creating a climate for the
patient-focused practice of pharmacy as an integral part of an accessible, quality based health care
system.

4
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Time:
Location:
January 21, 2016

9:00 a.m.
Red Lion Hotel - Seattle Airport
18220 International Blvd
Seattle, WA 98188
Accessibility: This meeting is accessible to persons with disabilities. Special aids and services can be
made available upon advance request. Requests must be made no later than ten (10) days prior to the
meeting. If you would like general information about this mee ting, please call (360) 236-4834. If you
need assistance with special services, you may leave a message with that request at 1 -800-525-0127 or if
calling outside Washington State call (360) 236-4052. TDD may be accessed by calling the TDD relay
service at 1-800-833-6388. If you need assistance due to a speech disability, Speech -to-Speech provides
human voices for people with difficulty being understood. The Washington State Speech to Speech toll
free access number is 1-877-833-6341. Smoking is prohibited at this meeting.
Kingsbury1248
State of Washington

October 29, 2015
Renton, WA 98057
CONVENE
Commission Members:
Al Linggi, RPh, MBA
Guest / Presenters:
Call Center Manager
Steve Anderson, RPh

Nancy Hecox, PharmD
Gary Harris, RPh,
Pharmacy

Tim Lynch, PharmD
Staff Members:
Joyce Roper, AAG
CALL TO ORDER
MOTION: Elizabeth Jensen moved that the commission approve 1.1. Gary Harris second.
Kingsbury1249
CONSENT AGENDA
Items listed under the consent agenda are considered routine commission matters and will
be approved by a single motion of the commission without separate discussion. If separate
September 2015

The commission requested that Items 2.3, 2.4, 2.5 (a) be pulled from the Consent
Agenda for further discussion. Items 2.6, 2.7 2.8, & 2.9 were deleted from the consent
agenda.
MOTION: Maureen Sparks moved that the commission approve items 2.1, 2.2, & 2.5
(b & c) on the consent agenda. Dan Rubin second. MOTION CARRIED: 12-0.
Old Business
Bartell Drugs
Cathy Williams introduced Billy Chow and Amy Pashinski from Bartell Drugs. Amy led
the power point providing the required status report for their Call Center that was approved
July 2014.
Goals

Increased time for local staff to perform clinical services as we continue to diversify our
clinical service offerings

Principal Functions

Q.A. Assessment
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Screen replication of call center tech work terminal on display at the call center pharmacist
terminal

Challenges
Workflow Issues
Drug not covered



Dispensing - 80%
Paperwork 70%
Returns 55%

Counseling -83%
Immunization 60%
MTM 23%
Future

rd
3 Party
Specialty Pharmacy

pharmacist
Billy Chow said what he learned is he would spend more time in helping employees
understand they didnt need to focus on data entry. Getting them to shift their core focus
(mindset) of data entry, as trivial as it sounds it was significant and took a few months and
will help for the future. There was minimal discussion regarding promise time and having
pre-verification turned off didnt affect anything. Bartell Drugs runs patient surveys all the
time.
MOTION: Christopher Barry moved that the commission approve the report and allow the
program to continue and report back in one year. Sepi Soleimanpour second. Steve Anderson
recused himself. MOTION CARRIED: 11-0.

Commission Policy #36 permitting intern registration for postgraduate participation in
residency or specialized internship programs . She explained the amendments that were
made.
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Commission and staff discussed some pieces of the language in the Policy that will need
more review and work. Staff will go back make some amendments after listening to the
concerns from the commission.
MOTION: Christopher Barry moved that staff will work with Joyce Roper and make revisions to
Policy #36 and bring back to the December business meeting for commission approval. Elizabeth

discuss the logistics for extending the business meetings in 2016 to one and one half day
with the intent to dedicating Friday to rule development and other strategic planning. These
Fridays are promised to the ad judiciary courts office for hearings. Each commission
member provided Mr. Humberson their concerns, opinion and whether or not it would
work for them.
MOTION: Dan Rubin moved that staff plan for additional meeting time on the Friday after the
business meetings preferably in the morning and preferably in the same location as the business
meeting. Steve Anderson second. MOTION CARRIED: 12-0.
New Business
Joyce Roper discussed the implementation of Engrossed Second Substitute Bill 5052 as it
relates to the Governors veto message directing the department/commission to review and
prepare a report on the rescheduling of marijuana. The Governor vetoed two sections in
Second Substitute Bill 5052, which proposed to remove medical marijuana from Schedule
1 in the states Uniform Controlled Substances Act, chapter 69.50 RCW. The Department
of Health has been instructed by the Governor to prepare a report in consultation with
stakeholders prior to the 2016 legislative session. The Department has a number of
responsibilities under E2SSB 5052 and has staff working on those responsibilities. That
group has offered to undertake the stakeholdering responsibilities to prepare the requested
report. Statutorily, PQAC has the authority to reschedule controlled substances .
Joyce asked the commission what level of involvement they would like in this process.
Nancy Hecox volunteered to represent PQAC during the stakeholdering process, working
with the DOH staff implementing E2SSB 5052. Tim Lynch was not at the meeting but
asked it to be shown that he does support this, Elizabeth Jensen, Gary Harris, and Steve
Anderson said they wanted to go on record opposing the rescheduling of marijuana until
the federal controlled substances act is changed.
MOTION: Maureen Sparks moved that Nancy Hecox represent and update the commission during
the implementation of this part of Engrossed E2SSB 5052. Judy Guenther second. MOTION
CARRIED: 9-0.

Taylor Linke, HSQA Business Practice & Productivity Manager presented information on
Health System Quality Assurance Divisions move to electronic information systems for
Boards and Commissions. We are moving to an electronic information system for all of
your official board business
July 2015- December 2015
January 2016
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2016
2016
Current System:
discovery.
Mail documents to home or office. There have been some cases of lost and
mishandled deliveries .
New System:
We will provide an account (Citrix) to reach those files from home or work
computer.
Your program manager, executive director, investigative staff members and legal
staff members will post documents you need to do your work to your personal
folder on the departments network. You will work on and save documents to
your folder on the departments network rather than to your personal or work
computer.
You will be able to use any brand of computer, any operating system and any
browser. You will continue to be responsible for your own personal and/or work
equipment.
Court Ruling: Declared that government officials have no reasonable expectation of
privacy when using private devices. Information stored on private devices and in private
accounts is subject to public disclosure. The agency desires to establish a method that
maintains a record of all communications with members.
Risk Mitigation: In an effort to mitigate the risks and concerns associated with the
transference of sensitive and sometimes confidential information, Health Systems Quality
Assurance (HSQA) is implementing a secure electronic process to provide a secure method
to accomplish the critical regulatory work statutorily outlined for health professional board,
commission, and committees.
authorities.
Process optimization and efficiency to increase capacity for ongoing regulatory
work.
Today
Citrix User Guide
Demonstration
Ongoing
HSQA Call Center
Recorded Webinar
Expectations
In 7 days Log-In
o Survey
Kingsbury1253

The commission members were given a chance to ask Taylor questions and discuss
concerns. Taylor encouraged the commission members to contact herself or Doreen Beebe
with any questions, suggestions of methods that would make things better for future and
any other input.
New Business

Plans.
With many internal transitions and staff retiring some information during training may not
have been passed on clearly. We rely on what is written in rule. She provided the
commission the laws that apply to AUP and specialized functions . IV admixtures are
specialized functions under the law and should have been placed on the consent agenda for
Commission approval .
reason, this practice did not continue. Credentialing staff and PQAC staff agreed they
should be sending approval letters and will work together to reinstitute the process of
sending letters of approval.
Joyce reminded the Commission and staff that under the Yoshinaka and Seymour cases, if
the statute requires the Commissions approval, the Commission cannot delegate that
decision to staff. Staff can review and prepare for the final approval but the commission
must be the approving body.
Some of the issues discussed: Why would Transcribing orders be in the template AUP
when this doesnt happen much, if at all, anymore. It was noted that the sample AUP was
approved by a past board and the current Commission could change the sample to update it
to current practices. There was discussion on how to handle the issue of past AUPs,
particularly specialized functions, which did not come before the Commission for
approval. It was agreed that some form of communication should be sent out. In addition,
the requirement for Commission approval could delay the opening of new pharmacies if
they have to wait for Commission approval of their AUPs, since our meetings are 6 weeks
apart. The question arose about being able to use a panel of Commissioners to approve the
AUPs. Gordon MacDonald asked the commission and staff to provide written direction on
how to handle these during inspections. The investigators will be given written direction
once the commission choses how to move forward.
MOTION: Cheryl Adams moved that Maureen Sparks, Chris Humberson, Irina Tiginyanu
and Doreen Beebe will look into the scope and size of the issue and bring back preliminary
recommendations on how to move forward at the December meeting. They will consult
with Joyce. Secondly, they will develop updated template/guidelines and provide
inspectors an updated guideline on how to handle AUPs while in the field. The commission
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will have a panel to review and approve AUPs. Steve Anderson second, Dan Rubin
abstained . MOTION CARRIED: 11-0.

Doreen Beebe put the document up for the commission members to discuss and share their
input and led the discussion on the implementation of Bill 5460. The law adds a new
section to chapter 70.41 RCW regarding hospital licensing and regulation. It allows a
practitioner in a hospital to prescribe and distribute a limited supply of pre-packaged
emergency medication to patients discharged from the emergency department (ED) when
access to community or hospital pharmacy services are not available within 15 miles by
road or if consistent with hospital policy the patient has no reasonable ability to access a
community or outpatient pharmacy. In collaboration with applicable hospital staff, the
director of the hospital pharmacy must develop policies and procedures to implement this
practice.
The commission discussed and agreed with most of the document and asked for an
amendment to add outpatient before hospital pharmacy in a sentence at the beginning
of the first paragraph in the document.
MOTION: Dan Rubin moved that the commission authorize staff to proceed with rule
making with the CR 101 process on rules to implement SB 5460, section 1. Nancy Hecox
Open Forum
Jeff Rochon WSPA
Many members are inquiring about the Compounding rules status and what the next steps
are.
New Business Contd

function and asked for this to be clarified. Irina Tiginyanu explained that it means return to
a shelf in its existing bottle.
CARRIED: 12-0.
2.4

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Chris Barry asked about certified technicians arent all technicians supposed to be certified.
Do they have IV Add mixture as a specialized function? Maureen explained they do now.
MOTION: Cheryl Adams moved that the commission approve Allenmore Hospital
specialized function for Tech check Tech 2.4 (a). Elizabeth Jensen second. MOTION
CARRIED: 12-0.
2.5

Nancy Hecox had a concern that the ADDD override guidelines are 2 and half years old.
Cathy Williams shared that per her request for this information this was given to her. This
is the current policy there will be an update but there wont be any changes.
MOTION: Nancy Hecox moved that the commission approve 2.5 (a). Judy Guenther
second. Cheryl Adams recused herself. MOTION CARRIED: 11-0.

Chris Humberson shared the developed guidelines with the commission and asked if they
had any input and guidance from the commission. He gave a brief background and Medical
Services program for the implementation of Substitute House Bill 1625.
One suggestion from the commission was to amend the guidelines to say, A statement of
responsibility that should read Pharmacy designee shall ensure the pharmacy practices
and complies with all federal and state laws and regulations. Maybe to place this in the first
MOTION: Chris Barry moved the commission move this document forward with
suggested amendment. Steve Anderson second. MOTION CARRIED: 12-0.
Correspondence:
concern by a couple US representatives regarding compounding for pet use. FDA has come
up with guidelines that they should be held to US 797. No further discussion.
Requests
Cambia Health Solutions asked the commission to recognize them as a professional association to
receive a list for commercial purposes to assist their credentialing department with updating data in
their internal system.
MOTION: Chris Barry moved that panel A deny the request from Cambia Health
Solutions as a professional association. This denial is because they are not a professional or
educational organization. Steve Anderson second. MOTION CARRIED: 4-0.
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Shopko
Cathy Williams introduced Keith Koscielski, RPh from Shopko Pharmacy. The
commission had already viewed and reviewed the power point presentation provided to
them in the meeting materials. Keith Koscielski did brief the commission on some of his
presentation. Than allowed for the commission to make comments or ask questions
regarding any concerns .
optional capability to balance and share work between Shopko pharmacies . This system
has the capability to control what tasks are being shared with a sister pharmacy and what
tasks need to be done at the home pharmacy. The goal of the system is to balance and
share tasked between Shopko Pharmacies . The sharing and balancing of task reduces
pharmacist workload and increases patient safety.
As a part of a workload balancing group, pharmacies are currently allowed to share
between them only the Data Entry and Data Verification steps in the process.
Shopko allows only pharmacies licensed within that same state to workload balance with
one another. Within the application Shopko has set up different publishing scopes and
retrieval stores that determine what stores share with what stores. Each state will have their
own unique publishing scope that directs the system to only share pharmacys tasks with
other pharmacies with that same publishing scope.
hardcopy. How often does the original prescription show up for the verification process?
There is an option within the system that can be turned on to allow the pharmacist doing
the first refill the hard copy will be displayed. Is there a setting that can display the
prescription for every refill? Keith wasnt sure but will look into it and turn it on.
MOTION: Elizabeth Jensen moved that the commission approve Shopko requests to
implement workload balancing in its Washington pharmacies, with the contingency that if
the system allows the prescription to be displayed for every refill that it be turned on, if the
system only has the ability to display the prescription on the first refill than that must be
turned on immediately. With a one year follow up. Nancy Hecox second. MOTION
CARRIED: 12-0.

pharmacy is open daily from 0900 to 1730 and employs one full-time pharmacist and three per
diem pharmacists. Currently no pharmacy technicians are employed. The pharmacy would be
utilizing their remote medication order processing vendor during closed hours of pharmacy
operations (approximately 16 hours/day). Lisa introduced Doug Beck RPH, from Schick Shadel
Hospital.
Since the commission has already viewed the power point for his request to use of remote
medication order processing services Doug Beck offered to answer any questions. He was
asked about the average of orders done after hours. The average number of orders is two. The
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average range can be zero to six orders after hours. However, there are times at 2 am intoxicated
patients show up. There are about 20 medications on this list. The intent will be to pair that down
with Medication Review being able to evaluate the orders to prevent any drug interactions. The full
list is in the ADDDs request that was submitted in the Consent Agenda.
request to use of remote medication order processing services, this motion was amended
with a requirement to report back a written follow-up in one year to include: error reporting by
type; specific outcomes of the quality assurance program; number of any security breaches (if any);
number of users in the system; number of daily transactions including those currently reported; and,
feedback from hospital, medical and pharmacy staff. Nancy Hecox second. MOTION
CARRIED: 12-0.

Cathy Williams introduced Steve Wanaka, RPh, and Director of Pharmacy for Seattle Childrens
Hospital (SCH). Steve asked the commission to approve his requests to use remote medication
order processing for locations specified in its proposal. The current request is to expand this
program to allow all SCH pharmacists at all SCH pharmacy sites (Seattle main campus, Bellevue,
and the Seattle Childrens South Clinic) to perform remote medication order processing for hospital
and clinic administered medications.
A question from the commission regarding Narcotics for Patient Specific in the SCH ADDD and
how is it decided when to put a narcotic into the ADDD. Steve shared that this will most likely not
come up but sometime there is a baby who is weening off a narcotic so the hospital will draw these
for patient specific. This is not something that happens in a clinical setting. Steve was asked to
explain why 100% of medications are on override list. It is a contingency that will enable the
provider to still provide medication in a situation where communication between systems may have
broken down. This is not to be used routinely. A comment made from the commission that this is
excellent.
MOTION: Chris Barry moved that the commission approve the request for SCH to
expand the use of remote medication order processing for locations specified in its proposal with a
written follow up one year to report back on: outcomes data from the quality assurance program
looking at any changes in error rates; allocation of workload to support clinical activities; and,
assessment of staff. Steve Anderson second. MOTION CARRIED: 12-0.
Committee Reports
Al Linggi provided an update on the status of the Technology Committee . There have been
three meetings for about two hours each. We have received excellent input from the
different market places on how they currently use these devices and how they would like to
use it. Theres been a lot of work put in from the committee and especially Lisa Roberts.
The committee plans to start the putting this work out there for some stakeholders input.
The work is not done but they are moving forward.
th
The Pharmacy Business Practices Committee met on October 6 to continue discussion concerning
Draft PIC and Shared Accountability Rules. The committee reviewed and engaged in open
discussion with the stakeholders regarding their comment/concerns.
No definitive action was taken by committee members at this meetingit was purely carried out as
a way to discuss the rule proposals and comments with stakeholders and among committee
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members. The discussion was very productive and brought forth insights and new ideas into the
difficult process of composing these rules. I would like to thank all the stakeholders for their
positive input and support as well as the committee members who were all physically present at this
meeting.
There is a meeting scheduled for October 30, 2015. Well continue open discussion and comment
review, with the focus being WAC 246-869-062 Responsibilities of the PIC. The goal is to wrap
up our preliminary review of the rules proposals and comments without coming to any conclusions
as to what the final draft will actually contain, and begin to transition into the next category of BP
rules, Quality Assurance. QA and inspection are both addressed in the Accountability rules being
discussed, so it will only be possible to compose a final draft when QA is completed by the BPC
and the committee writing the inspection rules nears completion of its work.

Inspection process rules committee. At the last PQAC Business meeting, the commission
agreed to combine the two work groups (inspection priorities/ inspection process rule
writing). We have requested and received the reports from the Investigations department.
We are in the process of scheduling our next inspection meeting. The two chairs feel like
the committee is too big. There was a small discussion on the committee size and who
should be on this committee. Chris Barry made it clear he wants to continue to participate
in the committee.

Chris Humberson updated the commission on where the compounding work is . A second
draft was released by DOH before Brittany Mahung left for maternity leave. The comments
are being collated right now. However, in October USP released a draft revision which is a
substantial change. Chris reached out to the committee members asking them their input on
the newly released draft from USP and the next steps for them. The new draft certainly
contains significant changes but the concern is that it could be a year before the new draft
is released by USP.


Cheryl attended the tour provided by Laurie St. Ours at a long term care facility and
pharmacy
Cheryl also attended a WSPA Health Systems leadership meeting and tried to update the
laws and rules at this meeting. Thanks to Jeff Rochon who helped her.

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Olgy Diaz reported:


Dan Rubin reported:

pharmacy.
interview with the board to complete my pharmacist license requirements for their state.
Their board members and executive director asked him to convey greetings to the
commission and an open invitation to tour their new building and attend one of their
meetings if any of us are ever in the vicinity. He set in on a significant portion of their
meeting, including the open disciplinary hearings they conduct as part of their agenda.
They face exactly the same issues concerning patient safety as we do.
October 9 and 22 he attended the webinars for the draft letter to the legislature
concerning LTCFs
October 23 Mr. Anderson taught the Intro to Pharmacy Law class to the first year
pharmacy students at the UW SOP. In that lecture he emphasized notification requirements
for interns, so hopefully we will have at least one class that correctly reports change of
address, practice site, and any brushes with the law.
Steve was a panelist on the Pharmacy 500 Professional Identity Panel at the UW SOP for
the incoming class.
th
nd
rd
Gary held a UW Pharmacy Alumni Association retreat planning session at his home
a nice potluck and social time.
She has participated in the technology committee, assisted with the LTC document,
and attended the pharmacy business practice meetings
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Nancy did some research at DOH regarding inspections and complaints. She did
put together a document on her research and contains UDA information.
She did a presentation on Drug Addiction Medicine for the federal courts here in
the state of Washington. Attendees were Federal Officers, Federal AGs, DOC,
probation officers, and drug court staff.
Al Linggi reported:

Staff Reports
Executive Director
He attended a Take Back Summit Day in Lynwood for the morning session. This
was a joint summit including the state as well as Snohomish and King County with
many different interested parties and stakeholders.


She has been busy with Medical Marijuana integration into the recreational marijuana
market. DOH staff has been conducting rules hearings and stakeholder meetings in three
primary areas.
Consultants
Joyce and the AAGs for the Veterinary Board of Governors and the Department of Fish
and Wildlife are in consultation on the question of the authority for wildlife rehabilitators
who work in partnership with veterinarians and who are regulated by the Department of
Fish and Wildlife to possess, store and administer drugs for their work as wildlife
rehabilitators.
She attended the Drug Take back Summit in Lynwood for the entire day sponsored
by DEA and Governors Office. This was a very interesting meetings and great
ideas.
meeting in Yakima. She has been working through dozens of programs around 50
of them at this point.
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She thanked Lisa Roberts and Chris Humberson for all the support and work they
have done with the Intern Kyle Wu.
Kyle Wu reported:
He has worked on drafting policy brief on USP Compounding draft that came out
and he looked at USP 800.
pharmacists do.


Met with Jeff Rochon with Mr . Humberson on a monthly basis
Met with Cheryl Adams regarding the inspection process and some of the
challenges the inspectors are facing.
She was assigned investigations only for the past year and half and is happy to be
back in the field.
The main challenge the inspectors face in the field continues to be the gap with
unclear rules or previous decisions that were made in the past compared to the
present.
The inspectors really appreciate and need written clarification communication from
the commission so we can all be on the same page. This will allow for clarity for all
from the pharmacies, pharmacist and investigators.
Open Forum
The purpose of the open forum is to provide the public an opportunity to address the Commission
on issues of significance to or affecting the practice of pharmacy and that are not related to topics
for which a hearing has or will be scheduled.

This is an opportunity for the commission members to openly discuss related to items or issues
Cheryl Adams commented about how she really liked the process of asking the stakeholders/public
for comment after each motion.
She asked if there is a way to shorten the process of reviewing ADDDs? Als response is that the
technology committee is working these things out and there really are different uses of these
systems. Most of this is process and we just need to get down to good credible safe process that
ensures patient safety and redundancy when the system doesnt work.
Elizabeth Jensen was thinking that even if something is on the consent agenda she does feel an
obligation to look through all of them. The idea of all the AUPs that will need to be reviewed
causes her a feeling of being overwhelmed.
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Dan Rubin mentioned he would like to hear more from public when asked if there were any
comments from the stakeholders/public. He also mentioned a concern about electing new Chair
and Vice-Chair and felt it was a vague process. Chris Humberson and Christopher Barry both
suggested that commission members that are interested in being Chair or Vice-Chair submit their
names by Thanksgiving. When the December Commission Packet goes out the names will appear
for the other commission members to decide on how to vote.
Christopher Barry wanted to discuss the budget the issue was there was no detail in the spread
sheet provided to them and there was a significant difference to the before and after total. Doreen
Beebe explained that the information provided to her is usually detailed. This time due to a system
update this wasnt provided or available. If she is provided the proper report in the interim she
would be happy to share that with the commission. There will be a much more detailed report
provided in December.


Al Linggi, Chair
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Commission SBAR Communication

Agenda Item/Title: Report to Governor on R escheduling/De-Scheduling M arijana
Date SBAR Communication Prepared: November 17, 2015
Reviewer: Chris Baumgartner
Link to Action Plan: N/A
Action
Information
Follow-up
Report only
Situation: (Briefly describe the current situation. Give a clear, succinct overview of pertinent issues)
The department was directed to create a recommendation regarding the current scheduling of marijuana in
light of recent legislative moves to legalize use (I-502 in 2012 and 2SSB 5052 in 2015) which do not
align with the drugs scheduling in our controlled substances act.
Background: (Briefly state the pertinent history):

During the 2015 legislative session, Second Substitute Senate Bill 5052 (SB 5052) was passed by the
legislature. It was signed by Governor Inslee on April 24, 2015. The Governor vetoed Sections 42 and
43, which would remove from Schedule I of Washington S tates Controlled Substances Act any medical
marijuana product that the department identifies in rule as appropriate for sale to qualifying patients and
designated providers in a retail outlet that holds a medical marijuana endorsement.
In his veto message, the Governor noted that rescheduling just medical marijuana may cause serious
problems such as having the unintended effect of limiting the types of marijuana that are considered
medicine. Therefore, he directed the Department of Health to thoroughly consider this idea in
consultation with medical professionals and stakeholders, and bring an appropriate resolution to me and

On November 20, 2015 the department held a stakeholder meeting to gather input and feedback around
this issue.
Assessment: (Summarize the facts and give your best assessment. What is going on? Use your best
judgment)
There are three potential options to consider based on our work with the commissions Assistant Attorney
General:
1. Leave marijuana as a schedule I drug and do not make any changes.
2. Re-schedule marijuana to Schedule II - V or to a legend (prescription) drug.
3. De-schedule marijuana from Washington States Controlled Substances Act when used within the
parameters of I-502 and SB 5052; all other use would still be illegal.
Please see the attached report for implications associated with each option and for comments we received
at the 11/20 meeting.
Recommendation: (What actions are you asking the commission to take? What do you want to happen
next?
Before the department prepares a final recommendation for the Governor we would like the commission
to weigh in based on our report and the stakeholder comments we received at our 11/20 meeting. We feel
this is vitally important as the commission is an important partner and is the authority responsible for our
state level controlled substances act.
DOH XXX-XXX
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Commission SBAR Communication

Follow-up Action: (Next Steps After the meeting Document the commissions
additional steps or follow-up requested; such as, report back in 6- months, etc.)
decision and/or any
We need a document outlining the commissions recommendation for the report. The department will
review this recommendation along with the other comments we have received to assist us in developing a
final report. We will provide the commission with a copy of the final report.
DOH XXX-XXX
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STATE OF WASHINGTON
October 29- 30, 2015
nd
October 29, 2015
Time:
Location:
Contact:
Amended Regular Scheduled

9:00 a.m.
Renton, WA 98057
Phone: (360) 236-4834
In accordance with the Open Public Meetings Act, notices were mailed electronically to individuals who requested
notification of meetings of the Pharmacy Quality Assurance Commission.
Times and Order: The meeting will begin at 9:00 a.m. and will continue until all agenda items are complete. This
agenda is subject to change. Items might not be taken in order of the agenda. Please call (360) 236-4947 before the
meeting date to confirm the meeting agenda .
9:00 a.m.
9:10 a.m.
Call to Order
Al Linggi, Chair

Action
Consent Agenda
Items listed under the consent agenda are considered
routine commission matters and will be approved by a
single motion of the Commission without separate
discussion. If separate discussion is desired, that item
will be removed from the consent agenda and placed on
the regular business agenda.
Action
Action
September 2015
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2.6
2.7
2.8
2.9
9:30 a.m.
10:00 a.m.

Follow-up Report on Routine Remote Medication Order
Processing -no items
Old Business
Review of items or issues relevant to past or ongoing commission
business.
3.1 Bartell Drugs - Call Center status report
3.2 Review suggested changes to Commission Policy #36 permitting
intern registration for postgraduate par ticipation in residency or
specialized internship programs. The proposed adds reporting
criteria into the policy.
3.3 Commission will discuss the logistics for extending the business
meetings in 2016 to one and one half day with the intent to
dedicating Friday to rule development and other strategic
planning.
New Business
4.0 Discuss the implementation of Engrossed Second Substitute Bill
5052 as it relates to the Governors veto message directing the
department/commission to review the rescheduling of marijuana.
4.1 DOH Network via Citrix - Information on Health System Quality
Information/action
Information/action
Information/action
Information/Action
Information/Action
Assurance Divisions move to electronic information systems for

Boards and Commissions.
10:59 a.m.
Break
11:10 a.m.
New Business Contd

4.2 Pharmacy Technician Specialized Functions and Ancillary
Utilization Plans.
4.3 Discuss the implementation of Engrossed Substitute Senate Bill
5460 Section 1- Emergency Medications Prescription and
Distribution
11:45 a.m.
Action
Action

to address the Commission on issues of significance to or affecting th e
Commission Chair in the order o n the sign-in sheet. If time permits, all
2
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12:00 p.m.

This time may also be used by the Commis sion to meet in Executive Session to discuss
1:00 p.m.
New Business
Contd
4.4 Discuss Consent Agenda items placed on the regular business

agenda.
4.5 Review guidelines developed by the Emergency Medical Services
4.6 Discuss any correspondence received or distributed on behalf of
the commission.
2:00 p.m.
Requests
5.1 List and Label Request Cambia Health Solutions is seeking
recognition as professional association to receive a list for
commercial purposes to assist their credentialing department with
updating data in their internal system.
5.2 Shopko requests approval to implement workload balancing in its
Washington pharmacies.
2:40 p.m.
Break
2:50 p.m.
Requests Contd
5.3 Schick Shadel Hospital requests approval for use of remote
medication order processing services.
5.4 Seattle Childrens Hospital Pharmacy requests to use remote
medication order processing for locations specified in its
proposal.
3:15 p.m.
3:40 p.m.
Action
Information/Action
Action
Action
Action
Action
Information/Action
Committee Reports
6.1
6.2
6.3
6.4
Action
Technology Rules Committee

Pharmacy Business Practice Rules Committee
Commission Members
Open Discussion and Reports
Information/Action
7.1 Commission Member Reports

7.2 Commissioners open discussion related to items or issues
4:30 p.m.
Staff Reports
Information/Action
8.1 Executive Director

8.2 Assistant Attorney General
3
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8.3 Pharmacist Consultants

8.4 Pharmacist Supervising Investigator
4:45 p.m.

to address the Commission on issues of significance to or affecting the
Commission Chair in the order on the sign -in sheet. If time permits, all
5:00 p.m.

Mission Statement
The mission of the Pharmacy Quality Assurance Commission is to promote public health and safety by establishing
the highest standards in the practice of pharmacy and to advocate for patient safety through effective
communication with the public, profession, Department of Health, Governor, and the Legislature.
Vision Statement
The Washington State Pharmacy Quality Assurance Commission leads in creating a climate for the patient-focused
practice of pharmacy as an integral part of an accessible, quality based health care system.

Special
October 30, 2015
12:00 p.m.
Time:
12:00 p.m.
Location:
Kent Commons
220 Fourth Avenue South Room: Crystal Mountain
Kent WA 98032
Contact:

Phone: (360) 236-4834
Call to Order
Communication Plan the Commission will discuss Communication
Plan for the Pharmacy Quality Assurance Commission prepared by
Al Linggi, Chair
Informaton/Action
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Marie Sullivan on behalf of the Health Systems Quality Assurance

Division of the Department of Health. Strategic Planning
December 11, 2015
Time:
9:00 a.m.
Location:

Mt. Constance
2400 S. 240 St.
Accessibility: This meeting is accessible to persons with disabilities. Special aids and services can be made
available upon advance request. Requests must be made no later than ten (10) days prior to the meeting. If you
would like general information about this meeting, please call (360) 236-4947. If you need assistance with special
services, you may leave a message with that request at 1-800-525-0127 or if calling outside Washington State call
(360) 236-4052. TDD may be accessed by calling the TDD relay service at 1-800-833-6388. If you need assistance
due to a speech disability, Speech -to-Speech provides human voices for people with difficulty being understood.
The Washington State Speech to Speech toll free access number is 1-877-833-6341. Smoking is prohibited at this
meeting.
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STATE OF WASHINGTON

Pharmacy Quality Assurance Commission

Approval of Business Meeting Agenda.

NPLEx Monthly Report Acceptance

New and Closed Pharmaceutical Firms Report

St. John Medical Center St. John Medical Broadway

regarding notification of changes in applicant or licensees criminal

The Commission is asked to provide feedback on legislation

Rulemaking, and Committee Reports

The Commission will consider a request for rulemaking by the King

Open Forum Morning Session

Executive Session/Lunch & Case Presentations Closed Session

The Commission will be briefed on activities associated with Senate

Chris Baumgartner, Program Director will provide an update on

The Commission will designate a representative and alternate

member to participate on the weekly Department of Health Meet

The commission will consider the policies and procedures of the

Characteristics of Complaints - report by Dr. Hecox

Rulemaking, and Committee Reports contd

d. Pharmacy Compounding Rules Committee

Commission Members Open Discussion and Reports

The Commission will hold election for 2016 Commission leadership.

Open Forum Afternoon Session

Business Meeting Adjourned.

Pharmacy Quality Assurance Commission

Are well informed about medications;

Take responsibility for their health;

Next scheduled business meeting:

January 21, 2016

Business Meeting Minutes

Steve Anderson, RPh

Keith Koscielski, RPh from Shopko

Sepi Soleimanpour, RPh, MBA-HA

for Seattle Childrens Hospital

Absent Commission Member:

1.2 Approval of September 17, 2015 Meeting Minutes.

Targeted workflow balancing throughout our network of stores

Perform and support targeted clinical services

Maintain and/or improve specific store level metrics

Transfers less than 10% of store transfers

Direct technician supervision and spot check

Staffing at both call center and store level

New Prescription Data Entry less than 5% of store data entry

Final verification always conducted by store pharmacist

Notification of completed Rx Transfers

Store Level Adoption

Technician Workflow Data- Entry Benefits

More complex patient case management

Review Commission Policy #36

Extending 2016 Business Meeting

shown that he also does not support reclassification.

DOH Network via Citrix

Pharmacy Technician Specialized Functions and Ancillary Utilization Plans

Why would Transcribing orders be in the template AUP

this doesnt happen much, if at all, anymore.

It was noted that the sample AUP was approved by

Implementation of Engrossed Substitute Senate Bill 5460

to add outpatient before hospital pharmacy in a sentence at the beginning of the

New Business Contd

Specialized Functions Approval

a) Allenmore Hospital Tech check Tech

Automated Drug Distribution Device Approval

policy there will be an update but there wont be any changes.