SPECIAL FEATURES JCAHO standards

S P E C I A L F E AT U R E S

New JCAHO medication management

standards for 2004
DARRYL S. RICH
Am J Health-Syst Pharm. 2004; 61:1349-58

A
s of January 1, 2004, the Joint
Commission on Accreditation
of Healthcare Organizations
(JCAHO) began surveying health
care organizations using new medi-
cation management standards. These
standards are the culmination of an
effort to revise and consolidate exist-
ing JCAHO standards related to
medication use.
Impetus for change
The major impetus for change in
the medication-use standards was
the release of To Err Is Human: Build-
ing a Safer Health System, in which
the prevalence of medical errors, par-
ticularly medication errors, was
brought to the forefront.1 Many out-
side expert and advisory groups rec-
ommended that JCAHO change its
medication-use standards, which
were the source of numerous ques-
tions and requests for clarification,
suggesting that they were not clear to
organizations. Also, a number of best
practices in medication use were be-
ing published by regulatory and ad-
visory agencies (such as the National
Quality Forum) that were felt to be
relevant but were not addressed in
JCAHO’s medication-use standards.
In 2001, JCAHO decided to revise
the medication-use standards for
2003.
Review and revision process
The process of revising JCAHO’s
medication management standards
was lengthy, lasting over two years,
and involved input from numerous
advisory and focus groups and com-
mittees, including a focus group
from the American Society of
Health-System Pharmacists (ASHP).
New medication management
standards were drafted by JCAHO
and sent to the JCAHO Small and
Rural Hospital Committee, which
evaluated the feasibility of imple-
menting the standards. Cost was
among the many considerations ad-
dressed by this committee. The
JCAHO standards simplification
panel streamlined and clarified the
standards, eliminating nonessential
elements, and the JCAHO Internal
Standards Review Group evaluated
the standards for consistency. The
standards were then sent back to the
advisory and focus groups for further
input before going to a JCAHO pro-
fessional and technical advisory
committee (PTAC), which com-
prised representatives from many
professional associations, including
ASHP. JCAHO has multiple PTACs
(one for each accreditation pro-
gram), which assess the potential
burden of complying and evaluating
compliance with proposed standards
and advise whether the standards
should be approved or modifications
are necessary. The JCAHO Standards
and Survey Procedures (SSP)
Committee, a subcommittee of the
JCAHO Board of Commissioners,
which includes the vice chair of each
PTAC, approved changes in the pro-
posed standards based on the advice
given by the PTACs and sent the
medication management standards
for field review. More than 1000
comments were received from ac-
credited hospitals, physicians, health
care professional associations, and
other individuals. Most field review-
ers considered the proposed stan-
dards appropriate with modification
(84%) and agreed that the standards
would contribute to patient safety
(70%). Most field reviewers (78%)
thought that the new standards
would result in increased costs but
that the increased costs would be jus-
tified by the improvements in patient

DARRYL S. RICH, PHARM.D., M.B.A., FASHP, is Associate Director, Copyright © 2004, American Society of Health-System Pharma-
Accreditation Operations, Joint Commission on Accreditation of cists, Inc. All rights reserved. 1079-2082/04/0701-1349$06.00.
Healthcare Organizations, One Renaissance Boulevard, Oakbrook
Terrace, IL 60181 (drich@jcaho.org).

Am J Health-Syst Pharm—Vol 61 Jul 1, 2004 1349

 SPECIAL FEATURES
Transitions
JCAHO standards
safety. The PTACs reviewed the field
comments and suggested changes to
the standards. The SSP Committee
approved the standards based on this
field review and the advice of the
PTACs. The board of commissioners
reviewed and approved the new stan-
dards, making one change in the
wording of element of performance 1
for standard MM.4.10 in May 2003.
Implementation was delayed until
2004 to coincide with implementa-
tion of the Shared Visions–New
Pathways initiative, and the stan-
dards were rewritten to include ele-
ments of performance.2
What changed
The new JCAHO medication
management standards place a great-
er emphasis on medication safety
than did previous standards. The
new standards are also more pre-
scriptive and have a larger number of
more detailed requirements.
In addition, many standards relat-
ed to medication use are now consol-
idated in a new and separate chapter
on medication management. The
new medication management stan-
dards can be found in the 2004 Com-
prehensive Accreditation Manual for
Hospitals3 as well as the 2004 Com-
prehensive Accreditation Manuals for
Ambulatory Health Care, Behavioral
Health, and Home Care and Long
Term Care. The chapter will be ex-
panded to manuals in other pro-
grams (e.g., critical access hospitals,
networks) in 2005 or 2006. The glos-
sary in each manual was expanded to
include more definitions related to
medication management.
Medication management proc-
ess. The system for how health care
organizations handle medications
was renamed from “medication use”
to “medication management” to bet-
ter reflect the process. In the past, the
medication-use process had four
steps: (1) ordering and prescribing,
(2) preparing and dispensing, (3) ad-
ministration, and (4) monitoring.
Two new steps have been added: (1)
1350 Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
medication selection and procure-
ment (i.e., formulary considerations)
and (2) storage. They have been
placed before the ordering step,
which now includes transcribing
medication orders. The chapter on
medication management was reorgan-
ized around these six steps.
Definition of medication. The
definition of medication was revised
(Table 1) to include more examples,
as the definition of the past was the
source of many questions. The new
definition is found in the glossary
and preamble to the chapter and in-
cludes, but is not limited to, any
product considered a drug by the
Food and Drug Administration
(FDA), with the exception of enteral
nutrient solutions, oxygen, and other
medical gases. The JCAHO defini-
tion of medication does not include
enteral nutrient solutions because
they are considered food products,
nor does it include medical gases
purchased in gaseous form because
they are handled differently from
medications. The definition does in-
clude anesthetic agents that are pur-
chased in liquid form before becoming
a gas. JCAHO has separate standards
for nutritional products and medical
gases.
Changes related to patient-
specific information
JCAHO requires a written policy
on the minimum patient-specific in-
formation that is available to per-
sons involved in the medication
management process because a lack
of information is a major cause of
medication-related sentinel events
and medication errors. This is out-
lined in standard MM.1.10 (formerly
TX.3.5.3) Patient-specific informa-
tion is readily accessible to those
involved in the medication man-
agement system. The minimum
required information is listed in Ta-
ble 2. Access to this information fa-
cilitates continuity of care, creates an
accurate medication history and cur-
rent medication profile, and helps
ensure safety in the medication man-
agement process. Inclusion of rele-
vant laboratory test values in the
minimum required information is
noteworthy because it represents rec-
ognition of the importance of access
to this information by pharmacists
and other health care professionals.
Access to certain patient-specific in-
formation may be necessary, de-
pending on the medication and pa-
tient situation (e.g., weight and
height for medications dosed by
weight or body surface area, preg-
nancy and lactation status for medi-
cations that cross the placenta or are
excreted in breast milk).
The patient-specific information
must be accessible when needed, ex-
cept in emergency situations when
time does not permit. To be accessi-
ble, the information must be present
where the individual is performing
medication management duties (e.g.,
in the pharmacy when the pharma-
cist is reviewing orders). Having the
information in the patient chart on
the floor is not considered accessible
if the pharmacist reviews orders in
the pharmacy. Questions have arisen
about the Standards for Privacy of In-
dividually Identifiable Health Infor-
mation (known simply as the privacy
rule), which was issued by the De-
partment of Health and Human Ser-
vices to protect the privacy of certain
health information in implementing
the Health Insurance Portability and
Accountability Act. The privacy rule
is not intended to restrict the access
of patient-specific information to
persons involved in medication
management and is not acceptable as
a reason for not meeting the intent of
this standard.
Changes related to medication
selection and procurement
JCAHO now requires written cri-
teria for the addition and removal
of items in the list of medications
available for use in the health care
organization (i.e., formulary), as
established by standard MM.2.10
 SPECIAL FEATURES JCAHO standards

Table 1. ing, pharmacy, and medical staff be-

Substances Included in JCAHO Definition of Medicationa fore the drug is officially added to
Prescription medications the formulary.
Sample medications A new JCAHO requirement calls
Herbal remedies for a review at least annually of all
Vitamins
Nutraceuticals medications on the medication list or
Nonprescription medications formulary to determine whether they
Vaccines should continue to be listed on the
Diagnostic and contrast agents
Radioactive medications basis of emerging safety and efficacy
Respiratory therapy treatments (excluding oxygen) information. This review has the po-
Parenteral nutrient solutions tential to be labor intensive but
Blood derivatives
Intravenous solutions (with or without electrolytes and other drugs) should not be if the focus is on
Any product designated a drug by FDA (excluding enteral nutrient solutions, emerging safety and efficacy data.
oxygen, and other medical gases) Health care organizations must
aJCAHO = Joint Commission on Accreditation of Healthcare Organizations, FDA = Food and Drug
have processes to approve and pro-
Administration.
cure medications that do not appear
on the medication list (e.g., nonfor-
Table 2. mulary drugs). The approval process
Patient-Specific Information Required for Persons Involved used to meet this requirement may
in Medication Management be brief and involve the chief of staff
Age or head of the P&T committee. The
Sex requirement is intended to serve as a
Current medications
Diagnosis, comorbidities, concurrent conditions safeguard to prevent the use of ques-
Relevant laboratory test values tionable medications (usually those
Allergies, past sensitivities available only in foreign countries)
Weight and height
Pregnancy and lactation status without careful consideration.
Any other information required by the organization for safe medication management Organizations must have process-
es for handling drug shortages and
outages, including communicating
with prescribers and staff as appro-
(formerly TX.3.1) Medications tions stored in the organization, in- priate, developing approved substi-
available for dispensing or adminis- cluding strengths and dosage forms, tution protocols and educating ap-
tration are selected, listed, and pro- must be maintained and readily propriate staff about these protocols,
cured based on criteria. JCAHO available. This does not mean that and obtaining medications in the
does not use the term formulary be- the pharmacy and therapeutics event of a disaster. These require-
cause its standards apply to organiza- (P&T) committee must approve ev- ments reflect JCAHO’s recognition
tions that do not use that term (e.g., ery strength and dosage form, only of the increasing frequency of drug
long-term-care facilities, home care that these parameters for stock drugs shortages and the potential adverse
organizations, behavioral health care must be included on the list. Drug effect of drug shortages on patient
facilities). Members of the medical samples need not be listed. care.
staff, licensed independent practi- JCAHO requires that processes
tioners, appropriate health care pro- and mechanisms be established to Changes related to medication
fessionals, and staff involved in the monitor patient response to a newly storage
ordering, dispensing, administra- added medication before it is made Standard MM.2.20 Medications
tion, and monitoring of medications available for dispensing and admin- are properly and safely stored
should be involved in development istration. For example, a drug for throughout the organization. This
of the criteria; the effort should not which specific laboratory testing is new standard for medication storage
be a unilateral one by the pharmacy required cannot be used in a health was adopted from standards in other
department. At a minimum, the cri- care organization that does not have programs. JCAHO requires that only
teria should include the medication’s the capability to perform that testing. approved medications are routinely
indications for use, effectiveness, More commonly, this means that the stocked or stored; in this context, ap-
risks (including propensity for medi- organization must disseminate in- proved medications include nonfor-
cation errors, abuse, and sentinel formation regarding adverse effects mulary medications that have been
events), and costs. A list of medica- and monitoring parameters to nurs- briefly reviewed and approved, as

Am J Health-Syst Pharm—Vol 61 Jul 1, 2004 1351

 SPECIAL FEATURES
Transitions
JCAHO standards
well as formulary medications. Med-
ications must be stored under proper
conditions (e.g., temperature, hu-
midity, protection from light) to en-
sure stability.
Medications must also be secured
in accordance with laws, regulations,
and organizational policies so that
unauthorized persons cannot access
them. The Centers for Medicare and
Medicaid Services (CMS) defines
“secured” as stored in a sealed or
locked container (e.g., a drug cart or
box) or a locked room or kept under
constant surveillance (e.g., at or near
a nursing station) (Rich DS, Joint
Commission on the Accreditation of
Healthcare Organizations, personal
communication). JCAHO strives to
be consistent with CMS and is rea-
sonable in its expectations for what
constitutes constant surveillance;
however, JCAHO will accept any in-
terpretation of medication security
from CMS or the state agency re-
sponsible for compliance with Medi-
care’s “Conditions of Participation
for Hospitals.”
Controlled substances must be
properly stored to prevent diversion
and according to state and federal
laws and regulations. Drug Enforce-
ment Administration requirements
apply.
All expired, damaged, or contami-
nated medications must be segregat-
ed until they are removed from the
organization, according to JCAHO.
Medications that are readily con-
fused (i.e., look-alike and sound-
alike medications, reagents and
chemicals that may be mistaken for
medications) must be segregated in
all areas of the health care organiza-
tion. This may require the modifica-
tion of alphabetical medication stor-
age systems.
Stored medications (and chemi-
cals used to prepare medications)
must be accurately labeled with the
contents, expiration date, and appro-
priate warnings. Available concen-
trations of the drug must be stan-
dardized and limited. This means
1352 Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
that the rate of infusion must vary,
rather than the drug concentration,
to achieve a specific dose and that
individualizing the concentration of
medications for all patients is not al-
lowed. Thus, some practices, such as
the use of the “rule of six” (i.e., 6
multiplied by body weight, in kilo-
grams, equals the amount of drug to
be added to 100 mL of solution) in
pediatric patients is no longer ac-
ceptable. Concentrated electrolytes
should be removed from patient care
areas, unless patient safety is at risk if
the concentrated electrolyte is not
immediately available in a specific
area, and specific precautions must
be taken to prevent inadvertent ad-
ministration (e.g., restricting access,
using specialized labeling or separate
storage). Standardizing drug concen-
trations, limiting the number of drug
concentrations available in an organ-
ization, and removing concentrated
electrolytes from patient care areas
are considered National Patient Safe-
ty Goal requirements.4-6 Compliance
with these requirements will be
counted toward compliance with the
National Patient Safety Goals and is
publicly disclosed. Medications
stored in patient care areas must be
maintained in the most ready-to-
administer form available from the
manufacturer (e.g., unit dose, pre-
filled syringes, premixed bags) or, if
feasible, in unit doses that have been
repackaged by the pharmacy or a li-
censed repackager. JCAHO does not
allow the use of bulk containers as
floor stock when unit doses are com-
mercially available or available from
the pharmacy.
All medication storage areas must
be periodically inspected in accor-
dance with the organization’s policy
to ensure that medications are prop-
erly stored. Most organizations con-
duct these inspections at least
monthly; however, JCAHO does not
specify a required frequency.
Standard MM.2.30 (formerly
TX.3.5.5) Emergency medications
and/or supplies, if any, are consis-
tently available, controlled, and se-
cure in the organization’s patient
care areas. This standard applies to
supplies and emergency medications.
Standard MM.2.20 also applies to
emergency medications.
According to JCAHO, the organi-
zation’s leadership, in conjunction
with members of the medical staff
and licensed independent practition-
ers, must decide which emergency
medications and supplies, if any, will
be readily available in patient care ar-
eas. The leadership may decide that
no emergency medications or sup-
plies will be available in certain areas
where staff are not properly trained
to handle emergencies and that pa-
tients will be best cared for by calling
911 or otherwise summoning assis-
tance from an emergency medical
team with its own emergency medi-
cations and supplies.
Emergency medications must be
available in unit dose, age-specific,
and ready-to-administer forms
whenever possible. Emergency medi-
cations must be stored in sealed or
locked containers in a locked room
or under constant supervision; this
requirement is consistent with
CMS’s requirement for security.
Emergency medications must be re-
placed as soon as possible after use in
accordance with the organization’s
policies and procedures. Sending an
emergency medication cart to the
pharmacy for restocking and leaving
the patient care area without an
emergency supply is not acceptable; a
cart exchange procedure, whereby a
new cart would be brought to the pa-
tient care area while the used cart is
taken to the pharmacy for restock-
ing, is acceptable.
Standard MM.2.40 (formerly
TX.3.7) A process is established to
safely manage medications brought
into the organization by patients or
their families. Health care organiza-
tions must have a policy that ad-
dresses when medications brought
into the organization by patients or
family members may be used, if they

may be used at all. JCAHO recogniz-
es several valid reasons for such use,
including avoidance of interruption
in therapy, use of a nonformulary
medication, and a lack of alternatives
to the patient’s personal medication.
Such a policy in itself would not con-
stitute approval as required in stan-
dard MM.2.10.
The policy must specify a process
for identifying the patient’s personal
medication and visually evaluating
product integrity. The inspection
does not need to be scientific or per-
formed by a pharmacist, but it
should preclude the use of unidenti-
fied or obviously deteriorated or
contaminated medications. JCAHO
requires that both the prescriber and
patient be notified if the use of medi-
cations brought into the organiza-
tion is not permitted because of a
policy prohibiting such use or be-
cause of problems establishing prod-
uct identity or integrity.
New standards related to
ordering and transcribing
Standard MM.3.10 Only medica-
tions needed to treat the patient’s
condition are ordered. This new
standard requires a documented di-
agnosis, condition, or indication for
use for each medication ordered. The
documentation need not be part of
the medication order, but it must be
in the patient medical record. This
requirement should not pose a prob-
lem for most medications ordered,
but it will be problematic for pre-
scribers who automatically order cer-
tain medications (e.g., acetamin-
ophen, docusate sodium) for every
patient, regardless of the individual’s
specific needs, or for prescribers who
reorder medications used before ad-
mission without knowing why they
were prescribed.
Standard MM.3.20 Medication or-
ders are written clearly and tran-
scribed accurately. This new standard
was developed to reduce the poten-
tial for error and misinterpretation
when orders are written (or orally
SPECIAL FEATURES JCAHO standards
communicated) and transcribed. high-risk or high-alert medications
This may be the most difficult stan- associated with medication errors,
dard with which to comply because sentinel events, abuse, or toxicity).
of the many detailed requirements The same is true of requiring both
outlined in the elements of perfor- generic and brand names for such
mance and because physician com- products. Policies should outline
pliance is required. JCAHO requires these organizational requirements.
written policies that address the re- Organizational policies must also
quired elements of a complete medi- specify the acceptability and special
cation order (e.g., drug name, dosage required elements of certain types of
form, strength or concentration, orders (Table 3). The organization
dosage, and administration route, must review and update preprinted
frequency, and duration). These order sheets periodically. Organiza-
should be consistent with law and tional policies must define in writing
regulation—both pharmacy and when weight-based dosing is re-
nurse practice acts. Actions to take quired for pediatric patients.
when medication orders are incom- The organization must have poli-
plete, illegible, or unclear should be cies that minimize the use of tele-
outlined in organizational policies. phone and other oral orders as much
Written policies must outline as possible. Finally, JCAHO specifi-
when generic or brand names are ac- cally requires policies prohibiting the
ceptable or required as part of a use of blanket reinstatement of pre-
medication order, and policies vious orders, such as “resume preop
should describe any special precau- medications” or “continue home
tions or procedures for ordering meds.” Each individual medication
drugs with look-alike or sound-alike order must be written.
names. Policies also must specify if
and when the indication for use is Changes related to preparing and
required on a medication order. Al- dispensing medications
though it is possible to comply with Standard MM.4.10 (formerly
standard MM.3.10 by putting the in- TX.3.5.2) All prescriptions or medi-
dication for use somewhere in the cation orders are reviewed for ap-
patient medical record other than in propriateness. A pharmacist must
the medication order, the organiza- review all medication orders before
tion may want prescribers to specify dispensing a medication, removing
the indication for use as part of the it from floor stock, or removing it
order for certain medications (e.g., from an automated storage and dis-
sound-alike and look-alike drugs, tribution device. Exceptions include
Table 3.
Types of Medication Orders for Which JCAHO Expects Organizational
Policies on Acceptability and Requirementsa
“As-needed” (i.e., p.r.n.) orders
Standing orders
Hold orders
Automatic stop orders
Resume orders (blanket reinstatement of previous medication orders is unacceptable)
Orders to adjust the dosage of a medication
Orders to taper a dosage by a particular amount with each dosing interval
Orders for which the dosage or dosing interval varies over a prescribed range
Orders for compounded drugs or drug admixtures not commercially available
Orders for medication-related devices (e.g., nebulizers, catheters)
Orders for investigational medications
Orders for herbal products
Orders for medications at the time of discharge
aJCAHO = Joint Commission on Accreditation of Healthcare Organizations.
Am J Health-Syst Pharm—Vol 61 Jul 1, 2004 1353
 SPECIAL FEATURES
Transitions
JCAHO standards
situations in which a licensed inde-
pendent practitioner controls the or-
dering, preparation, and administra-
tion of the medication and urgent
situations when a delay would harm
the patient (e.g., the new onset of
nausea or pain or a sudden change in
the patient’s clinical status). When
an onsite licensed pharmacy is not
open 24 hours a day, seven days a
week, a health care professional de-
termined to be qualified by the organ-
ization must review the medication
order in the pharmacist’s absence,
and the pharmacist must conduct a
retrospective review of the order as
soon as he or she is available or the
pharmacy opens. The process for re-
view of medication orders includes
the specific elements listed in Table 4,
regardless of who performs the review.
All concerns, issues, and questions
must be clarified with the prescriber
before dispensing the medication. A
number of companies that provide
pharmacist review of orders remotely
when the pharmacy is closed are now
appearing, which provides another
acceptable alternative for meeting
this requirement.
Standard MM.4.20 Medications
are prepared safely. When an onsite,
licensed pharmacy is available, sterile
medications, i.v. admixtures, and
other drugs are compounded or ad-
mixed only in the pharmacy, except
in emergencies or when this practice
is not feasible (e.g., when the dura-
tion of product stability is short).
This requirement does not apply to
simple reconstitution of medica-
tions. JCAHO has defined i.v. admix-
ture as “the preparation of pharma-
ceutical product which requires the
measured addition of a medication
to a 50 mL or greater bag or bottle of
IV fluid.”4 This does not include the
drawing up of medications into a sy-
ringe, adding medication to a Buretrol
or i.v. line, or the assembly and acti-
vation of an i.v. system that does not
involve the measurement of the ad-
ditive (e.g., ADD-Vantage system,
Abbott Laboratories). It should be
1354 Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
Table 4.
Elements of the JCAHO Medication-Order Review Processa
Appropriateness of the drug, dose, frequency, and route of administration
Therapeutic duplication
Real or potential allergies or sensitivities
Real or potential interactions between the ordered medication and other medications,
food, and laboratory test values
Other contraindications
Variation from organizational criteria for use
Other relevant medication-related issues or concerns
aJCAHO = Joint Commission on Accreditation of Healthcare Organizations.
noted that situations in which a li-
censed independent practitioner
controls the ordering, preparation,
and administration of the medica-
tion do not constitute an exception
to the pharmacy preparation of i.v.
admixtures or sterile medications.
JCAHO requires all staff who pre-
pare medications to use techniques
to ensure accuracy (e.g., double-
checking calculations) and avoid
contamination, including using
clean or aseptic technique as appro-
priate; maintaining clean, unclut-
tered, and functionally separate areas
for product preparation to minimize
the possibility of contamination; us-
ing a laminar-airflow hood (or other
class 100 environment as defined by
Federal Standard 209d, General Ser-
vices Administration) while prepar-
ing any i.v. admixture in the pharma-
cy, any sterile product made from
nonsterile ingredients, or any sterile
product that will not be used within
24 hours; and visually inspecting the
integrity of the medications. JCAHO
does not require that sterile products
be prepared only in a cleanroom or
laminar-airflow hood because there
are circumstances when the nursing
staff may need to prepare a dose of a
sterile product for immediate use (or
use within 24 hours) in the patient
care area. However, products should
not be prepared in a cluttered area or
the hallway, where cleanliness may
be compromised. The anesthesiology
department should not prepare ster-
ile products two or three days before
use; the pharmacy should prepare
sterile products that are not to be ad-
ministered within 24 hours after
preparation.
Staff must use safety materials
and equipment while preparing
medications that are hazardous (e.g.,
biological-safety cabinets for cyto-
toxic drugs). This requirement is in-
tended to protect the staff and envi-
ronment from contamination.
Standard MM.4.30 (formerly
TX.3.5.1) Medications are appropri-
ately labeled. Medications must be
labeled in a standardized manner ac-
cording to organizational policy, ap-
plicable laws and regulations, and
standards of practice to minimize er-
rors. This requirement applies to any
medication that is prepared but not
administered immediately (i.e., this
requirement does not apply to a
medication prepared and adminis-
tered immediately in the emergency
department or operating room). At a
minimum, labels must include the
drug name, strength, and amount (if
not apparent from the container);
the expiration date when the medica-
tion is not used within 24 hours after
preparation; the expiration time
when expiration occurs within less
than 24 hours after preparation; and
the date prepared and the diluent for
all compounded i.v. admixtures and
parenteral nutrient solutions. A label
does not need to be affixed to con-
tainers of i.v. solutions that are la-
beled by the manufacturer if nothing
is added to the solution.
When preparing individualized
medications for multiple patients or
when the person preparing the indi-
vidualized medication is not the

person administering the medica-
tion (e.g., when pharmacy prepares
an i.v. admixture for administra-
tion by nursing staff), the label also
should include the patient’s name
and location. Directions for use
and any applicable cautionary
statements (e.g., requires refrigera-
tion, for i.m. use only) also should
be added to the label or attached as
an accessory label.
Standard MM.4.40 (formerly
TX.3.5) Medications are dispensed
safely. JCAHO requires that medica-
tions are dispensed in quantities to
meet patient needs but minimize di-
version (i.e., quantities dispensed are
neither insufficient to meet patient
needs nor excessive to permit diver-
sion), and dispensing must occur in a
timely manner to meet patient needs.
Dispensing must adhere to laws, reg-
ulations, licensure requirements, and
professional standards of practice,
including those legal requirements
for record keeping.
Medications must be dispensed in
the most ready-to-administer forms
available from the manufacturer
(e.g., unit dose) or, if feasible, in unit
doses that have been repackaged by
the pharmacy or a licensed repackag-
er. This requirement is analogous to
the requirements in standard
MM.2.20 for medications stored in
patient care areas and standard
MM.2.30 for emergency medica-
tions. The organization must consis-
tently use the same dose-packaging
system; if a different system is used,
education about the use of the dose-
packaging system should be provided
as appropriate. For example, educa-
tion or instructions should be pro-
vided for staff if a tablet is not pro-
vided in unit-dose form (e.g., it
requires splitting) or if the hospital
uses premixed i.v. minibags as the
dosage system but, because of a drug
shortage, the ADD-Vantage or an-
other system is introduced at the
health care organization. Because such
systems are not routinely used, staff
may not know how to handle them
SPECIAL FEATURES
(e.g., the system may require activa-
tion), resulting in dosage errors.
Standard MM.4.50 (formerly
TX.3.5.4) The organization has a
system for safely providing medica-
tions to meet patient needs when
the pharmacy is closed. The ratio-
nale for this standard is to ensure
that the organization has the ability
to provide medications to meet ur-
gent or emergent needs when the
pharmacy is closed.
JCAHO requires several safe-
guards when nonpharmacist health
care professionals are allowed by law
and regulation to obtain medications
after the pharmacy is closed. Access
must be limited to a set of medica-
tions that have been approved by the
organization. Open access to the en-
tire pharmacy by a nonpharmacist is
not allowed, even when permitted by
law and regulation. These medica-
tions may be stored in a night cabi-
net, automated medication storage
and distribution device, or a limited
section of the pharmacy. Only
trained, designated prescribers and
nurses are permitted to have access
to this limited supply of medications.
Quality-control procedures (e.g., an
independent second check by anoth-
er individual or secondary verifica-
tion built into the system) are in
place to prevent medication retrieval
errors. The organization must pro-
vide for a qualified pharmacist to be
on-call or available at another loca-
tion (e.g., at another organization
that has 24-hour pharmacy services)
to answer questions or provide medi-
cations beyond those accessible to
nonpharmacist staff.
JCAHO requires the process for
providing after-hours medications to
be evaluated on an ongoing basis to
determine what medications are ac-
cessed routinely and why. Changes
must be implemented as appropriate
(e.g., adding certain frequently need-
ed medications to the night cabinet)
to reduce the number of times that
nonpharmacist staff obtain medica-
tion after the pharmacy is closed or
Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
JCAHO standards
require an on-call pharmacist to
come in to the pharmacy.
Standard MM.4.70 (formerly
TX.3.5.6) Medications dispensed by
the organization are retrieved when
recalled or discontinued by the
manufacturer or the Food and Drug
Administration for safety reasons.
Medications must be retrieved and
appropriately handled in accordance
with laws, regulations, and organiza-
tional policies when a medication is
recalled or discontinued (this stan-
dard only discusses recalls for safety
reasons, not all recalls). Although re-
calls are generally made by lot num-
ber, an organization may retrieve all
lots of a recalled medication instead
of recording and identifying medica-
tions by lot number. JCAHO also re-
quires the notification of all persons
ordering, dispensing, or administering
a recalled or discontinued medica-
tion and identification and notifica-
tion of patients who may have re-
ceived the medication.
Standard MM.4.80 Medications
returned to the pharmacy are ap-
propriately managed. JCAHO re-
quires a process that addresses
whether and when unused, expired,
or returned medications will be man-
aged by the pharmacy. The pharmacy
is held responsible for controlling
and accounting for all unused medi-
cations that are returned to the phar-
macy. A process must be in place for
the return of medications to the
pharmacy, including procedures for
preventing diversion of medications.
If outside sources are used for the
destruction of returned medica-
tions, the organization should have
a process for how that activity oc-
curs. Accountability only need be at
a gross level, not at an individual tab-
let level.
Changes related to medication
administration
Standard MM.5.10 (formerly
TX.3.6) Medications are safely and
accurately administered. Policies
and procedures must identify health
1355
 SPECIAL FEATURES
Transitions
JCAHO standards
care staff who may administer medi-
cations with or without supervision,
consistent with organizational poli-
cies, laws, and regulations. Organiza-
tional policies may address qualifica-
tions by medication, medication
class, or route of administration. For
example, the administration of i.v.
medications and cancer chemothera-
py is restricted to staff with certain
qualifications in some organizations.
Organizational policies and proce-
dures also must include guidelines
for prescriber notification in the
event of an adverse drug reaction or
medication error.
Before a medication is adminis-
tered, it must be verified as the cor-
rect medication by reviewing the
product label and medication order.
The medication administration
record may be substituted for the
medication order if there is a mecha-
nism to verify that transcription of
the order to the medication adminis-
tration record is accurate.
JCAHO requires those who ad-
minister medications to verify the
following: the medication is stable
(based on visual examination for
particulates and discoloration), the
medication has not expired, there is
no contraindication to administra-
tion of the medication (e.g., drug al-
lergy), and the medication is being
administered at the proper time in
the prescribed dosage by the correct
route. These verifications must occur
at the time of administration in the
location where the drug is being ad-
ministered, as much as possible.
The patient or, if appropriate, the
patient’s family should be advised
about any potential significant ad-
verse reactions or other concerns
about administering a medication
before it is administered. For example,
a patient receiving vancomycin might
be warned about red man syndrome.
This information allows the patient to
self-monitor for such a reaction.
The nurse or person administer-
ing the drug should discuss any unre-
solved, significant concerns about
1356 Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
the medication with the patient’s
physician, prescriber (if different
from the physician), or relevant staff
involved in the patient’s care. This
discussion should occur before med-
ication administration.
Standard MM.5.20 (formerly
TX.3.7) Self-administered medica-
tions are safely and accurately ad-
ministered. If self-administration of
medications is allowed in a health
care organization, procedures
must be in place to guide the safe
and accurate administration of
those medications and that address
medication administration train-
ing and supervision and documen-
tation of medication administra-
tion. Self-administration involves
the independent use of a medication.
Giving a dose of an oral medication
to a patient who places the dose in
his or her mouth and swallows it
while a nurse watches is not consid-
ered self-administration. Persons
who are not staff members who ad-
minister medications (e.g., a patient
who is self-administering a medica-
tion, a family member who is admin-
istering a medication to a patient)
should be given training and appro-
priate information about the nature
of the medication to be adminis-
tered, the method for administering
the medication (dose or amount, fre-
quency, and route), the expected
actions and adverse effects of the
medication, and the method for
monitoring the effects of the medica-
tion (e.g., self-monitoring of blood
glucose for a patient receiving an an-
tidiabetic medication). Competency
in medication administration must
be determined before allowing per-
sons who are not staff members to
administer medications.
Changes related to monitoring
response to therapy
Standard MM.6.10 (formerly
TX.3.9) The effects of medication(s)
on patients are monitored. The ra-
tionale for this standard is that mon-
itoring helps to ensure that drug
therapy is appropriate and adverse
events are minimized. A patient’s re-
sponse to medication must be moni-
tored according to the clinical needs
of the patient, and actual or potential
medication-related problems must
be addressed. Monitoring includes
consideration of the patient’s per-
ceptions about adverse effects and,
when appropriate, perceived efficacy
(e.g., pain relief after administration
of an analgesic). Information from
the patient’s medical record, labora-
tory test results, clinical response,
and the medication profile should be
considered in monitoring a patient’s
response to medications. The organi-
zation should have a process for
monitoring the response to the first
dose of medications that are new to
the patient while under the direct
care of the organization. This re-
quirement recognizes the higher like-
lihood of an adverse reaction to a
medication that is new to a patient
than to a medication that the patient
has taken successfully in the past. It
will require nursing staff to spend
more time at the bedside after first
doses. This standard does not apply
to drugs given at discharge or drugs
given to patients to be administered
after they leave the facility. It also
does not mean that the first dose of
such drugs must be administered in
the hospital or clinic.
Standard MM.6.20 The organiza-
tion responds appropriately to actu-
al or potential adverse drug events
and medication errors. JCAHO re-
quires health care organizations to
have a plan for responding to an ac-
tual or potential adverse drug event
(e.g., anaphylaxis). Appropriate ac-
tions (and procedures) must be iden-
tified in advance and implemented if
the event occurs. The organization or
responsible individual must comply
with internal and external reporting
requirements for adverse drug events
and medication errors (e.g., send re-
ports to the U.S. Pharmacopeia, FDA,
and Institute for Safe Medication
Practices). This standard is meant to

apply to situations in which an ad-
verse drug event is actually occurring
and does not apply to data about the
trends of adverse drug reactions.
Changes related to high-risk
medications
Standard MM.7.10 The organiza-
tion develops processes for manag-
ing high-risk or high-alert medica-
tions. JCAHO defines high-risk and
high-alert medications as medica-
tions involved in a high percentage of
medication errors or sentinel events
and medications that carry a high
risk for abuse, error, or other adverse
outcomes. Examples include medica-
tions with a low therapeutic index,
controlled substances, medications
not approved or recently approved
by FDA, psychotherapeutic medica-
tions, and look-alike and sound-alike
medications. JCAHO requires organi-
zations to identify high-risk and
high-alert medications used within
the organization. National lists, as
well as organization-specific data, on
drug use should be used for defining
the drugs considered high risk or
high alert by the organization. The
organization also must develop ad-
ditional processes for selecting,
procuring, storing, ordering, tran-
scribing, preparing, dispensing,
administering, and monitoring these
high-risk and high-alert medica-
tions. For example, cancer chemo-
therapeutic agents might be stored
separately from other medications,
ordered using a standardized order
form with an extra step to verify dos-
age calculations, administered only
by certain staff qualified through
specialized training, and monitored
using specialized procedures because
of the high risk of toxicity from these
agents.
Standard MM.7.40 (formerly
TX.3.8) Investigational medications
are safely controlled and adminis-
tered. JCAHO requires organizations
to protect the safety of patients par-
ticipating in clinical studies. The or-
ganization should be sensitive to the
SPECIAL FEATURES
use of particular patient populations
(e.g., children, patients with cogni-
tive impairment) in such studies and
should review all investigational
medications for safety.
Procedures for the use of investi-
gational medications must be imple-
mented and maintained, including a
written process for reviewing, ap-
proving, supervising, and monitor-
ing investigational medication use.
When an investigational medication
protocol is conducted independent
of the organization, the organization
must review and accommodate, as
appropriate, the patient’s continued
participation in the protocol. When
pharmacy services are provided, the
pharmacy (not the researcher) must
control the storage, dispensing, label-
ing, and distribution of all investiga-
tional medications in the organization.
Changes related to evaluating
medication management systems
Health care organizations must
evaluate their medication manage-
ment system on an ongoing basis for
risk points (i.e., steps in the process
that may be at risk for failure and
result in a medication error) and
identify areas to improve safety. This
requirement is detailed in standard
MM.8.10 The organization evalu-
ates its medication management
system. Routine evaluation of the lit-
erature for new technologies and
successful practices that have been
demonstrated to enhance safety in
other organizations and their appli-
cability to the organization is re-
quired. JCAHO also requires a re-
view of internally generated reports
to identify trends and issues that
need to be addressed. In other words,
consistent and constant improve-
ment in the medication management
system is expected.
It should be noted that these are
not the only medication-related
standards in the manual. Pharma-
cists need to look at other chapters.
For example, medication-related pa-
tient education is in the Provision of
Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
JCAHO standards
Care chapter. The requirement for
data collection and analysis of the
medication management system, sig-
nificant adverse drug reactions, and
significant medication errors appears
in the Improving Organizational
Performance chapter. The require-
ments for conducting a proactive risk
assessment of a high-risk process an-
nually and implementing a patient-
safety process are still in the Improv-
ing Organizational Performance and
Leadership chapters, respectively.
Standards related to equipment use
are found in the Environment of
Care chapter, and standards related
to competence assessment and staff-
ing data are found in the Manage-
ment of Human Resources chapter.
Conclusion
The new JCAHO medication
management standards place a great-
er emphasis on medication safety
and are more detailed and prescrip-
tive than previous standards. Com-
pliance with the standards may pose
a challenge to many hospital phar-
macists, particularly where physician
compliance is required. The stan-
dards should increase the role of the
pharmacist in managing appropriate
and safe medication use throughout
the organization. At a minimum,
they should provide pharmacists
with the authority to implement im-
provements in medication safety in
organizations that have been slow or
reluctant to do so.
A list of frequently asked ques-
tions and clarifications have been
issued by JCAHO regarding these
standards and the National Patient
Safety Goals. Organizations are
referred to JCAHO’s Web site
(www.jcaho.org) for this information.
References
1. Kohn LT, Corrigan JM, Donaldson MS,
eds. To err is human: building a safer
health system. Washington, DC: National
Academy Press; 1999.
2. Joint Commission on Accreditation of
Healthcare Organizations. Facts about
Shared Visions–New Pathways. www.
jcaho.org/accredited+organizations/
1357
 SPECIAL FEATURES
Transitions
JCAHO standards
svnp/svnp+facts.htm (accessed 2003
Nov 4).
3. Comprehensive accreditation manual for
hospitals. Oakbrook Terrace, IL: Joint
Commission on Accreditation of Health-
care Organizations; 2004.
4. Joint Commission on Accreditation of
Healthcare Organizations. 2003 National
1358 Am J Health-Syst Pharm—Vol 61 Jul 1, 2004
Patient Safety Goals. www.jcaho.org/
accredited+organizations/patient+safety/
03+npsg/index.htm (accessed 2003 Nov
4).
5. Joint Commission on Accreditation of
Healthcare Organizations. 2004 National
Patient Safety Goals. www.jcaho.org/
accredited+organizations/patient+safety/
04+npsg/04_npsg.htm (accessed 2003
Nov 10).
6. Joint Commission on Accreditation of
Healthcare Organizations. 2004 National
Patient Safety Goals—FAQs. www.
jcaho.org/accredited+organizations/
patient+safety/04+npsg/04_faqs.htm (ac-
cessed 2003 Nov 10).