IPPE Final Exam Review

Chapter 2 cont
I. Drug Acquisition
a. Today we are considered essential instead of optional and we move beyond just
acquisition, distribution, and control
II. Patient Safety
a. 1957: drug products were distributed to hospital inpatients using floor stock or patient
prescription systems
i. Rph didn’t get to see the MD’s original prescription order so there were lots of
mistakes made at this time so they moved on to unit dose drug distribution
which have the following key elements:
1. Rph receives MD’s original order or direct copy
2. Rph reviews med order before first dose dispensed
3. Meds are in single-unit packaging
4. Meds are dispensed in as ready to administer form as possible
5. No more than 24hr supply of doses delivered or available in patient care
area at a time
6. Patient med profile is maintained for each patient
b. Centralized drug system: preparation and distribution is more efficient (do more with
less)
c. Decentralized system: Rph come in contact more regularly with doctors, nurses, patients
and can better influence the entire medication use process (consistent with
contemporary views of how the profession should be practiced)
i. 1/4th use decentralized system
d. Hospitals are slowly becoming more technologically sound to improve patient safety
III. Promoting Rational Drug Use
a. 1936: Edward Spease and Robert Porter first introduced the pharmacy and therapeutics
(P&T) committee
b. Formulary system: medical staff works with P&T committee to select drug products
most useful in patient care; it’s the framework in which a hospital’s medication-use
policies are established and implemented.
c. Today the pharmacis in the P&T committee can track adverse events, retrospective drug
use evaluations, monitor high risk therapies
IV. Fostering Optimal Patient Outcomes:
a. In past they said right drug, right patient, right time. Now it’s “to help people make the
best use of the medicines” meaning you want to make sure it’s the right drug prescribed
in the first place.
b. In 1950s, Rph pretty much didn’t have time for anything except compounding, storing,
distributing, etc and had weak knowledge. Now we are moving from this and getting
more clinical.
i. ASHP Hilton Head conference: It was a clinical practice meeting and they
decided that clinical pharmacy shouldn’t be thought of as something separate
from pharmacy practice as a whole but hospital pharmacies should function as
clinical departments with fostering the appropriate use of medicines.
ii. After this ASHP held more regional conferences and more and more people
though this way (ppl changed their mission statements and stuff)
V. Recap of Major Themes:
a. Over the past 50 yrs there were 4 major themes:
 i. Universal recognition by hospitals that pharmacists should do acquisition,
distribution, and control
ii. Hospital pharmacy departments have major role in patient safety
iii. Pharmacy departments have assumed major role in promoting rational druge
therapy
iv. Pharmacy departments have defined their mission in terms of optimal patient
outcomes from medication use
VI. Explaining the Transformation
a. Indirect factors leading to transformation of hospital pharmacy:
i. Shift of national resources into healthcare; Medicare in 1965
ii. Expanded clinical research and drug product development
iii. Greater complexity and cost of drug therapy accompanied by sophisticated
pharmaceutical product marketing
iv. Interest in quality of health care services
b. Internal factors within hospital pharmacy that precipitated:
i. Visionary leadership, professional association, pharmacy education, postgrad
residency training, practice standards
VII. Professional Associations:
a. ASHP: the national organization of hospital pharmacists
b. The Hospital Pharmacy Association of Southern California in 1925: landmark event in
creating an organizational structure for hospital pharmacy
c. APhA: oldest national pharmacist organization in country This made a subset called
ASHP for hospitals
d. Two essential things ASHP has done for advancement of hospital pharmacy:
i. Serve as a vehicle for nurturing, expression, and actualization of the professional
ideals and aspiration of hospital pharmacists
ii. Creations of resources to assist practitioners in fostering development of
hospital pharmacy practice
1. Ie: AHFS Drug Information book, American Journal of Health System
Pharmacy, Midyear Clinical Meeting)
e. Today’s ASHP objectives:
i. Practice standards, advocacy, residency, drug info, practitioner education,
publications/communications
VIII. Practice Standards:
a. The authoritative advisory document issued by an expert body that offers advice on the
minimum requirements or optimal method for addressing an important issue or
problem
i. Doesn’t have the force of law generally
ii. Education and peer pressure are used to foster compliance with practice
standards
iii. This arose back in 1936 when the Minimum Standard for Pharmacies in
Hospitals was made
b. Now ASHP says it needs the following minimum requirements:
i. Organized pharmacy department under direction of pharmacist
ii. Pharmacist authority to develop administrative policies for the department
iii. Development of professional policies with approval of P&T
iv. Ample number of qualified personell
v. Adequate facilities
 vi. Expanded scorpe of pharmacist’s responsibilities: maintain drug info service,
nurse/MD teaching, file progress reports
vii. P&T committee must establish a formulary
Chapter 3: Legal and Regulatory issues
I. Health-system Certification and Accreditation Programs
a. Certifications need to be met for participation in governmental or private
reimbursement programs
i. Ie: Need CMS certification to participate in Medicare program
ii. CMS is a federal agency that administers programs like Medicare which works
with states to make Medicaid and CHIP and HIPPA
iii. CMS maked Conditions of Participation (CoPs) that health care organizations
must meet to participate in Medicare and Medicaid
iv. CMS confers deemed status on a health care org when its compliant with
relevant Medicare requirements and when it has been accredited by a voluntary
organization whose standards and survey process are determined by CMS to be
equivalent to those of the Medicare program
v. Joint Commission, HFAP, and NIAHO are automatically eligible to participate in
Medicare
b. Accreditation acknowledges that a hospital/health care org has met or exceeded
requirements of an accrediting body (Joint Commission, HFAP, NIAHO)
i. Loss of accreditation can affect their prestige, can be unattractive to qualified
staff, its helpful for state licensure and may exempt accredited organizations
from inspections, affects funding
c. The Joint Commission:
i. An independent, not for profit organization dedicated to improving safety and
quality of health care in organized health care settings
ii. Founded in 1951
iii. It is the principal accrediting ody for the operation of hospitals and other health
care organizations
iv. They set continually evolving standards wkhich establish performance
expectations for entities.
1. They aren’t manuals or cookbooks but outline common expectations by
suggesting framework
v. They have developed National Patient Safety Goals (NPSGs) that address specific
patient safety issues
1. Each standard and NPSG includes one or more elements of performance
vi. Accreditation is for three years from Joint commission
d. HFAP (AOA):
i. Not limited to osteopathic hospitals only
ii. HFAP standards are more prescriptive than other accreditation standards and
CMS standards so compliance with CMS isn’t necessarily sufficient to meet HFAP
standards and vice versa
iii. Accreditation is for three years.
e. NIAHO (DNV)
i. Integrates requirements based on the CMS Conditions of Participation with ISO
9001 Standards which promote quality in supplier-customer relationships
ii. Designed to facilitate development and implementation of Quality Management
System for health care organizations
 iii. Requires that hospitals become compliant with ISO 9001 within 3 years of the
first NIAHO accreditation
iv. Accreditation is for three years
f. Surveys:
i. Health care orgs undergo surveys to determine their level of compliance with
accreditation standards and goals.
II. Preparing for an Accreditation Survey Visit
a. TJC publishes its standards in the CAMH book
b. HFAP standards are in Accreditation Requirements for Healthcare Facilities
c. NIAHO standards are in Accreditation Requirements: Interpretive Guidelines and
Surveyor Guidance
III. Federal and State Laws and Regulations
a. Laws: imposed by authority (federal/state)
b. Regulations: Governmental orders having the force of law
c. Rules: address specific limited situations
IV. FDA
a. Protects the public health by assuring safety, efficacy, and security of human and vet
drugs, biologics, medical devices, nation’s food supply, cosmetics, and radiation
products
b. Implements and enforces FDCA (labeling requirements), sets standards for
investigational drug studies and product approval, and oversees
manufacturing/marketing of drugs
V. DEA
a. Enforces federal controlled substances laws and regulations
VI. OSHA:
a. Assures safe and healthful working conditions for working men and women
b. Conducts periodic workplace inspections to ensure safety of workers
VII. NIOSH:
a. Federal agency responsible for conducting research and making recommendations for
the prevention of work-related injury/illness
b. Differs from OSHA which sets and enforces safety standards for workers
c. It originated from the same legislation as OSHA and differences between them are
obscure
VIII. CDC
a. Prevention and control of disease, injury and disability
b. Hand hygiene, universal precautions, infection control
IX. OIG (Office of Inspector General)
a. Protect the integrity of certain governmental programs and health/welfare of these
programs
X. EPA:
a. For environmental issues.
b. Enforces Resource Conservation and Recovery Act (RCRA) which regulates handling and
disposal of hazardous waste from the point of generation to final disposal
XI. Office for Civil Rights (OCR)
a. Enforces Title VI of Civil Rights Act of 1964 and HIPPA
b. Human Relations management: prohibit discrimination
XII. State Boards of Pharmacy:
 a. Licensing requirements, enforce/establish rules and regulation of state’s pharmacy
practice act, disciplines
b. Some State boards enforce their state’s controlled substances act
c. Specific responsibilities differ from state to state
d. May be more or less stringent than accreditation requirements but pick the most
stringent requirement
XIII. Other Agencies:
a. ADA (Americans with Disabilities Act)
b. Key point: government agencies overlap so consider the different agency’s rules like
accommodate disabled people
XIV. Nongovernmental Standards-Setting Entities: enforced by government agencies and other
entities (like by the FDA or TJC)
a. USP:
i. 795: non sterile compounding
ii. 797: Sterile preparations
b. National Fire Protection Association (NFPA):
i. Reduce worldwide burden of fire and other hazards
c. Institute of Medicine of the National Academies (IOM)
i. Ensures scientifically informed analysis and independent guidance
ii. Do not set standards but provide standard setting entities with evidence based
information
iii. Wrote To Err is Human, and Crossing the Quality Chasm
XV. Pharmacy Professional Organizations: Establish standards of practice, guidelines, codes for
their specialty areas
a. ACCP: foundation of clinical pharmacy standards
b. APhA
c. American Society of Consultant Pharmacists (ASCP) :Represents senior care
pharmacists
d. ASHP: Usually have more stringent, explicit statements/guidelines than
TJC/HFAP/HIAHO/CMS so can help an organization meet or exceed accreditation and
certification requirements
i. Accrediting body for practice sites that conduct pharmacy residency programs
and tech training programs
e. Best Practices for Hospital and Health-System Pharmacyhas info on many topics
f. Adaptability of these different organizations to the specific type of hospital is important
but the standard is the same. Just the approach to achieve the standard is different
g. Standards Development:
i. An ASHP member council or commission recommends the development of a
guidance document
ii. A group of experts on a given topic volunteer to develop a preliminary draft
iii. The draft is sent by ASHP to reviewers who have interest and expertise in the
topic. The draft is posted on the ASHP web site for public comment
iv. Based on the comments, a revised draft is submitted to appropriate ASHP policy
recommending body for action. Then it’s sent to ASHP Board of Directors for
approval.
v. *These guidance documents are voluntary and not enforceable by law but
sometimes governing agencies look to this to make framework
XVI. Influence by Internal Bodies:
 a. P&T committee, medical executive committee of each institution, infection control,
quality/performance improvement, safety committess, and institutional review board
XVII. Organization and Department Standards
a. An institutions medical staff bylaws, rules and regulations provide framework for
governing the organization
b. Health care organizations should have programs that determine if individuals are
competent
i. Performance evaluation programs are ongoing processes for providing feedback
on job performance
ii. Most have performance improvement (PI) programs which contain elements of
quality control and quality improvement
1. TJC’s approach to PI includes outcome, process, and structure
iii. Many orgs coordinate their PI program with their risk management activities
**A single department can’t be accredited, it’s the whole institution
Chapter 4: Medication Management
I. Formulary System:
a. Drug formulary: updated list of meds and related info; list of meds routinely stocked by
the health care system; Managed by the PT committee or equivalent group
b. Developed in 1950s as a management tool initially used to assure that MD’s has a
consistent med supply
c. Today it includes medication use policies, PT committee, MUE, and formulary
management; it is continually updated
d. Advantage: provides a systematic method to review scientific evidence on clinical
effectiveness and cost effectiveness in drug selection decidion
e. Disadvantage: overly restrictive formulary system that could limit access to clinically
indicated medications
II. The P&T Committee
a. Usually through the medical executive committee ( a group of hospital med staff in
charge of institution)
b. More recently the PT committee has reported directly to a non-medical staff advisory
committee called a health-system board rather than a local medical executive
committee
c. Meetings should occur at least 4-6x/yr’ monthly meetings usually needed to keep
meeting time to 60-90 minutes
d. There are also subcommittees like medication safety task force which would be
responsible for adverse drug events and errors
e. Important to establish ruls for a quorum to establish a minimum number of members
needed to conduct a meeting or minimum number of member types
f. Should include all healthcare professionals and manager types (nonphysician types)
i. Currently in many hospitals only MD’s can vote in PT committee but this is
changing
g. Responsibilities:
i. Formulary, selects meds (according to efficacy, safety, cost), evaluate med use
and outcomes, prevent/monitor drug reactions/errors, develop guidelines and
policies, educate
h. Barriers to optimal formulary decisions may include MD experience with drug under
consideration, MD preferences, detailing by pharma companies, unpublishes/anecdotal
studies
 i. Medication Use Evaluation:
i. Method for evaluating and improving medication use processes with the goal of
optimal patient outcomes
ii. Meds may be considered for review based on their use, safety, cost, etc
1. Ie: Antibiotics are a high use item and overuse is a problem
j. Medication Safety Evaluation:
i. Evaluated through adverse drug reaction reports and medication error reports
which may be local or global
k. Drug Therapy Guidelines:
i. Listing of the indications, dose regimens, duration, modes of admin, monitoring,
etc for a medication or medication calss
ii. Developed with the oversight of practitioners
iii. Usually put into practice via a pre-printed physician order sheet placed in the
patient chart of computerized order set
iv. Usually a result of a medication use review or medication safety evaluation
l. Policy and Procedure Development:
i. Guidelines on med procurement, selection, distribution and med administration
process; defines formulary management process (guidelines for the PT
committee)
ii. Ie: what is administered in a certain unit or what a nurse can deliver
m. Education:
i. A newsletter is often used
1. Should be visually pleasant, easy to follow, and succinct; 2-4 pages
III. Regulatory Bodies:
a. Some regulatory bodies require a PT committee
i. This includes the State Separtment of Health or Board of Pharmacy (varies)
ii. TJC, AOA, CARF are accrediting bodies that require it
IV. Formulary Management
a. Open formularies: large
b. Closed formularies: limited list of meds; may limit drugs to specific MDs, patient care
areas, or disease states via formulary restrictions
i. Formulary restrictions don’t necessarily translate to optimal med management
and may lead to increased costs and hospitalizations since they can’t get the
drug they want
1. The IOM did a study of the VA and found this not to be the case though
so it depends
c. The FDA defines chemical entities/equivalents in the Orange Book
d. Many health systems have established therapeutic equivalents/therapeutic interchange
programs
i. Therapeutic equivalents: drug products with different chemical structure but of
same pharm class and similar effects and SE
ii. Therapeutic Interchange: authorized exchange of therapeutic alternatives in
accordane with approved guidelines
1. Goes beyond chemical entity and includes strength, frequency, route
e. The PT should establish guidelines for generic substitution and therapeutic interchange
V. New Product Evaluation
a. In preparing a drug monograph see the PT committee’s needs
 i. Some want detailed analysis and some was abbreviated version but all want
efficacy, safety, and cost
ii. Knowing the cost of the agent is meaningless if the cost of comparator agents is
unknown
iii. Rationale should be consise, have rationale, possible formulary deletions that
may occur, guidelines, and consideration for future review
iv. Some health systems add new agents for a limited time or trial of 3 or 6 months
VI. Therapeutic Class Review
a. Objective is to have the optimal agents within a therapeutic class in terms of efficacy,
safety, and cost
VII. Nonformulary Drug Review:
a. Policy for use of nonformulary drugs should be established
b. A new and evolving method of formulary management has resulted from automating
the medication prescribing process
i. CPOE helps compliance with guidelines
VIII. Drug Use Evaluation:
a. A systematic process used to assess appropriateness of drug therapy by evaluation the
data on drug use against predetermined criteria and standards
b. Medication use evaluation: encompasses the goals of DUE in its broadest application
with emphasis on improving patient outcomes
i. Using MUS rather than DUE emphasizes need for more multifaceted approach
to improving med use
c. 1st established in the 1980s; today we also call it outcome assessment
d. It should use a performance improvement model
i. FOCUS-PDCA (or PDSA) is a common one used:
1. Find process to improve, organize team, clarify current knowledge of
the process, understand causes of process variation, select process
improvement, plan, do, check (or Study), Act
e. The Rph should lead design of the DUE program
i. Selection of agents for DUE should be based on whether drug is high use, cost,
or risk
ii. Medication use criteria may be:
1. Diagnosis related DUE: which drugs are good for a disease state
2. Prescriber related DUE: which MD’s can use which drugs
3. Drug-specific DUE: Characteristics of a specific drug like dosage
regimens/frequency
iii. The criteria should be focused and limited; select 3-5 criteria to evaluate that
are meaningful and simple to collect; if possible it should be collected during the
patient visit (concurrent) rather than retrospectively (chart review); it should
include the number of patients to be reviewd and the time period (ie 20
patients a month)
iv. After data is collected it should be complied for review, then a task force may be
beneficial to develop an plan
1. Task force should include all health care professionals and develop an
action plan for ongoing monitoring. Then its presented to PT committee
for consideration
IX. Medication Use Policies should address:
a. Formulary Management
 b. PT Committee
c. Medication Prescribing, Dispensing, Administration:
i. Should talk about following:
ii. writing med orders
iii. verbal orders,
iv. Stop orders: orders that are automatically terminated, how MD is notified, and
method for their reinstatement; usually established for meds that need
additional evaluation (ie: Antibiotics stopped after day 7)
v. Investigational drug orders, Controlled substances, generic and therapeutic
substation, self administration of medications, medication samples, floor stock,
definition of order interpretation (sliding scales, tapering, titrating), medication
administration times, adverse drug reactions, med errors, others
X. Published Formulary
a. Should provide information on the medications approved for use, basic therapeutic info
about each item, info on medication use policies, and special info about meds
b. The Medication List: should include one or more indexes which assist in medication
location
i. One index: trade and generic name; listed alphabetically
ii. Therapeutic index: arranged by therapeutic or pharm class
c. Medication Use Policy and Procedures
i. Includes info on prescribing/dispensing and admin of meds
ii. Info on pharmacy operating procedures (hours, policies, procedures, contact
infor)
d. Medication Use Guidelines:
e. Special Info:
Chapter 5: Clinical Pharmacy
I. Emergence of Clinical Pharmacy
a. As early as the 1950s, health system pharmacy pioneers were advocating that
pharmacists have a clinical role
b. As momentum grew, ASHP held a conference called “Directions for Clinical Practice in
Pharmacy” on Hilton Head that helped this thinking
c. ACCP defines clinical pharmacy as the area of pharmacy concerned with the science and
practice of rational medication use that provides patient care that optimizes medication
therapy and promotes health, wellness, and disease prevention.
i. They also have a detailed definition that focuses on the discipline of clinical
pharmacy, the clinical pharmacist, and the roles of the clinical pharmacist.
d. The Joint Commission of Pharmacy Practitioners (JCPP): a forum for the chief executive
and chief elected officers of the 11 premier national pharmacy organizations
i. Has a vision that Pharmacists will be the health care professionals responsible
for providing patient care that ensures optimal medication therapy outcomes
e. Ultimate goal of clinical pharmacy: every patient who needs the clinical drug knowledge
and skill of the pharmacist does in fact receive the services
f. Some said clinical pharmacy was a “reactive service supplied on the request of
physicians for physicians” rather than for the patient themselves
i. This led to a redefining concept of pharmaceutical care which transformed to
“pharmacy care” which is a rebranding of pharmaceutical care concepts to focus
on pharmacy rather than pharmaceuticals
II. An Evidence Based Process
 a. APhA says that guidelines can promote interprofessional team approaches to patient
care and that clinical guidelines should be developed using interprofessional
approaches and be built on the best scientific data that is evaluated regularly
b. ASHP’s 2015 Initiative: states that by 2015 pharmacists in 90% of hospitals will be
actively involved in providing care to individual patients that is evidence based
III. Therapeutic Problem Solving Processes
a. SOAP and FARM (Findings, Assessment, Recommendations, and Monitoring) are ways to
evaluate/document patient
b. Clinical Pharmacist Recommendation (CPR) Taxonomy): developed for clinical use to
compare clinical pharmacy intervention trials
c. Pharmacists’ Mangagement of Drug-Related Problems (PMDRP): designed to reduce
variation in monitoring forms and focus on identification and mangagement of drug
problems
IV. The Clinical Pharmacist
a. Competencies: In addition to competencies, clinical pharmacist should be dedicated to
life-long learning
b. Education, Training, and Credentials:
i. Pharm D necessary now; residencies becoming more and more important
ii. After graduation you can advance skills through continuing professional
development programs, postgrad training (residencies, fellowships), and grad
school
iii. ACCP and ASHP say that all pharmacy students planning on providing direct
patient care clinical services should be adding PGYI residency training to their
credentials by year 2020
iv. ACCP suggested that most clinical faculty should have a PGY2 as might clinicians
practicing in specialty areas of health0system.
v. Some may pursue graduate degrees or fellowships, especially if interested in an
academic or industry position with research involvement
vi. Some get board certification: these credentials can enhance an individuals
ability to gain clinical privileges to provide patient care services;
1. It also will be increasingly recognized by purchasers of clinical pharmacy
services.
2. AACCP and ASHP have said that most clinical pharmacists providing
direct patient care in specialty areas will be board certified in the future
3. We should look into the Board of Pharmaceutical Specialties
V. Roles of the Clinical Pharmacist
a. Pharmacokinetic consultations can be used as an example of growth and evaluation of a
clinical service over time as well as an indicator of the types of medications for which
pharmacists are providing consultations for a long time.
b. 2006 survey says that more than 60% of institutions provide drug therapy consultations
and therapeutic monitoring for the aminoglycosides and vancomycin
c. 5 key clinical pharmacist services associated with reduced mortality and cost and errors
and length of stay:
i. Drug information, Adverse drug reaction management, drug protocol
management, participating in medical rounds, admission drug histories
VI. Other Clinical Pharmacy Services
a. Medication Reconciliation: transferring from one setting to another; make sure meds
added or deleted are appropriate; TJC established medication reconciliation as an
 important quality service for hospitals and pharmacists increasingly provide these
reviews
b. Education: Institutions associated with educating pharmacy students generally provide
more clinical pharmacy services than institutions that do not
c. Collaborative practice: Enacted in over 40 states in the US; allow pharmacists to control
the medication therapy of specified patients and sometimes specified diseases in
collaboration with one or more prescribers
d. Immunizations: the physical aspect is not a clinical pharmacy service but determining
their need for one is
e. Primary care: Usually done as part of collaborative practice
f. Identifying and resolving drug related problems in population based care
g. Designing systems that prevent drug related problems at the individual and
population level: Many pharmacists are involved as medication safety officers in
hospital settings
VII. Contrasting Clinical and Distributional Activities:
a. Clinical and distributional activities are complementary to ensure safe med use
b. Distribution skills don’t require clinical knowledge of the pharmacist
c. Less than 1/3 of patients are automatically counseled by pharmacists on new meds; it
was unrelated to busyness of the store
d. Payment for clinical services is an important criterion for the advancement of clinical
pharmacy; this can help them move from dispensing to clinical pharmacy services
 Bond and Raehl were unable to find an association between reduced mortality and
pharmacokinetic consults or participation in TPN teams
 Specialty board certification can be achieved by passing a specialty exam after practicing in the
specialty for a specific time period
 Participation on medical rounds is the least likely to be offered by pharmacists in US hospitals
(more common in teaching hospitals and less common in non-teaching hospitals)
o Drug Use evaluation is the most common
Chapter 6: Medication Safety
I. Definitions:
a. Drug Related Problems (DRPs): events associated with drug therapies that can or do
hamper optimal patient health outcomes
i. Include med errors, ADRs, ADEs, SE’s
ii. Also called Medication misadventures
1. Iatrogenic hazards or incidents resulting in patient harm that are
attributable to error, immunologic response, or idiosyncratic response
2. Covers the sum of medication errors and ADEs’ DRPs also do so they are
synonomous
3. Can have negative or no negative outcomes
b. Medication errors:
i. Errors/mistakes in the medication use process (prescribing, dispensing,
administering of drugs) that may result in negative outcomes
ii. Not all DRPs are medication errors because problems in medication use can
occur even when best medication practices are applied
1. Ie: Side effects occur even through no one’s mistake
iii. They may not always have negative clinical effects, they just increase the risk of
adverse consequences
 iv. Can be classified from Category A (no harm) to Category I (death), or by where
they exist in the medication use system
1. Administration error: administered something prescribed for another
patient; wrong dose given, admin time, additional dose, etc
2. Dispensing error: patient gets wrong drug, wrong galenic form (tablet
for NPO), wrong dose
3. Prescribing errors: incorrect selection,
4. Monitoring errors: failure to review for appropriateness
5. Transcription/interpretation errors: illegible hand writing,
misinterpretation
v. Negative outcomes associated with medical errors are called drug-related
morbidity
1. This is the failure of a drug to achieve its intended health outcome due
to unresolved DRPs
c. Adverse Drug Reactions (ADRs):
i. DRPs that are unexpected, unintended, undesired, or excessive responses to
drugs that require a medical response
ii. This may or may not be due to a medication error
iii. Include allergic reactions or idiosyncratic reactions
d. Side Effects:
i. NOT ADR’s
ii. Expected well known reactions that require little or no change in patient
management
e. Adverse Drug Events (ADEs):
i. ADRs that result in injury (small or large, preventable or unpreventable)
ii. Expected, well known reactions to meds that are severe enough to need
medication management is NOT a side effect, it’s an ADE
f. Sentinel Events:
i. Unexpected incidents resulting in death or potential for serious physical or
psychological injury
ii. Called “sentinel” because need immediate investigation and response
g. Most medication errors don’t lead to negative outcomes but they elevate the risk
i. These are also called Latent injuries
h. Potential injuries: mistakes in prescribing, dispensing, med admin that didn’t cause
injury due to luck or interception
i. Errors of commission:
i. Someone did something wrong
ii. Can occur when the patient receives either a correct drug or incorrect drug
1. If got correct drug, it means it was sub-therapeutic, over-dose, ADR,
drug interaction
2. If incorrect drug: improper drug selected, no indication
j. Error of Omission:
i. A patient didn’t receive a drug they should have
ii. Can be if drug is prescribed but not taken
II. Preventing Medication Errors:
a. IOM recommendations to prevent med errors:
i. Involve patient in process, make consumer med resources available, health care
providers should have access to patient info, improve med labeling, use health
 technology, increase congressional funding, health care payers and
organizations should be actively promoting good medication use practices
III. Culture of Safety
a. A reason medication safety problems have remained persistent in health care is there is
no culture of safety
i. This exists where safety is a key element of everyone’s job
ii. People are obligated to take responsibility for protecting the well being of
patients
iii. Inaction is frowned upon; information is saved
b. In a culture of blame (blame/punish when disclosing info): adverse events are rarely
identified because the risk of reprisal discourages reporting
c. A culture of safety avoids blaming and focuses on identifying errors in the system that
lead to errors
IV. Models of Quality Improvement:
a. Many models exist such as total quality management, CQI, six-sigma, LEAN, etc but all
share following principles:
i. Status quo is unacceptable; continuous change necessary
ii. Improve safety by improving core processes of medication use system
iii. Safety efforts must be patient-centered
iv. Quality must be measured (ex: culturing laminar flow hoods)
v. Solutions to safety problems should address the system not the individuals
V. PDSA Cycle of Safety Improvement:
a. Plan-Do-Study-Act
b. First ask: What do we want to accomplish? How will we know when we are successful?
What changes will result in success? Then:
c. Plan:
i. Attempts to clarify the purpose of the quality improvement effort
ii. Bottom up approach is preferred: all involved are consulted in the change first
especially frontline health care workers who are more likely to understand the
problems and ways to fix them
iii. Clear description of problem is developed
iv. Clarify expectations of the actions; details need to be made clear by using flow
charts, root cause analysis, failure mode effects analyses, etc
d. Do:
i. Implementation on a small scale usually to allow adjustments
e. Study (also called Check):
i. Studies the effect of the change
ii. Analyze collected data to see if successful
f. Act:
i. Small scale change is implemented on a larger level and the entire process of
monitoring and assessments starts over again
ii. Changes from the small scale might be warranted requiring further PDSA cycles
VI. Measures of Health Care Quality
a. Most common way is Donabedian: Structure, Process, Outcome
b. Mix of these three can help get a true understanding of quality of healthcare
i. Structure: Measures of the presence of something that is reasonable associated
with quality
 ii. Problem with this is that the relationship with quality and patient safety is not
always clear or established
c. Processes:
i. Actions reasonably associated with quality such as checking of patient med
profiles
ii. Though better than above, still not always associated with positive
consequences (ie: breast screening not always catches it)
d. Outcome:
i. Ultimately the quality of safety systems needs to be assessed by their outcome
ii. Hardest to link to safety efforts but the most important reason for quality
structures and processes
VII. Monitoring, Reporting, and Communicating
a. ADR Monitoring and Reporting Programs:
i. All institutions should have one
ii. It should be concurrent and prospective
1. Concurrent: One form is based on reports of suspected ADRs by health
care professionals, or monitoring for “alerting orders” which are
prescriptions which alert a Rph that an ADR may have occurred and that
investigation is necessary
a. Ie: watchin tracer drugs that are often used to treat an ADR
(steroids, EPI, etc)
b. Ie: abrupt discontinuation or decrease in dosage
c. Ie: stat orders for lab drug levels
2. Prospective:
a. Monitor high risk drugs or patients
iii. When suspected ADR occurs, first notify health care professionals and pharmacy
surveillance program for recording/analysis, attempt to find acues, serious ADRs
should be reported to FDA and or manufacturer
b. Medication Reconciliation:
i. Means to be conducted each time a patient transitions across departments
ii. Steps:
1. Verification
2. Clarification
3. Reconciliation: look at new vs old
4. Transmission: communicate therapy changes, provide patient with final
med list and instructions
VIII. National Quality Organizations
a. IOM
b. IHI (institute for healthcare improvement): 100,000 Lives Campaign
c. NQF (National Quality Forum):
d. Leapfrog Group: Voluntary program who uses employer purchasing power to encourage
leaps in safety/quality
i. Conducts the Hospital Quality and Safety Survey which asks hospitals to rate
themselves on four leaps of quality/safety practices
ii. Hospital Rewards Program
e. TJC, CMS
f. AHRQ: Supports HHS and sponsors NQMC
g. NCQA, ASHP, PQA