178Formulary ManagementGuidelines

ASHP Guidelines on the Pharmacy and Therapeutics

Committee and the Formulary System
Purpose (AHA) issued joint statements on the legality of formu
laries.11,12 AMA and the American Pharmaceutical (later
These guidelines outline the recommended processes and Pharmacists) Association subsequently joined with ASHP
techniques for formulary system management and describe and AHA to revise the statements.13 In 1965, two signifi-
the pharmacists responsibilities and roles in managing cant events occurred: (1) Medicare listed formularies as a
the formulary system in partnership with other health care reimbursement eligibility requirement14 and (2) the Joint
professionals. These guidelines also provide assistance to Commission on the Accreditation of Hospitals (now known
pharmacists in the organization and operation of the phar- as the Joint Commission) included an active P&T commit-
macy and therapeutics (P&T) committee or equivalent body, tee in its accreditation requirements.15 Even with these ac-
evaluation of medications for formularies, and development tions, formularies were typically no more than lists of drugs
and implementation of strategies to manage medication use stocked by the pharmacy.
through the formulary system. A glossary of terms is pro- By the 1980s, literature describing the clinical and
vided in the appendix. economic value of well-designed formularies had emerged.
Evidence from the hospital setting was published first, soon
followed by evidence from the ambulatory care environ-
Formulary and Formulary System ment.10 This literature led to more widespread acceptance
of formularies. In 1986, the Pharmaceutical Research and
A formulary is a continually updated list of medications and Manufacturers Association officially accepted the concept of
related information, representing the clinical judgment of therapeutic interchange in hospitals and opposed its use in
physicians, pharmacists, and other experts in the diagno- other settings.10 As more evidence emerged, AMAs views on
sis, prophylaxis, or treatment of disease and promotion of formularies for inpatient and outpatient settings became more
health. A formulary includes, but is not limited to, a list of closely aligned with those of ASHP. AMAs official policy on
medications and medication-associated products or devices, drug formularies and therapeutic interchange was first pub-
medication-use policies, important ancillary drug informa- lished in 199416 and has since been updated several times.5
tion, decision-support tools, and organizational guidelines. Today, formulary systems are considered an essential tool
A formulary system is the ongoing process through which a for health care organizations. Formularies have grown from
health care organization establishes policies regarding the use simple drug lists to comprehensive systems of medication-
of drugs, therapies, and drug-related products and identifies use policies intended to ensure safe, appropriate, and cost-
those that are most medically appropriate and cost-effective effective use of pharmaceuticals in patient care.
to best serve the health interests of a given patient popula-
tion.1 Formulary systems are used in many different settings,
including hospitals, acute care facilities, home care settings, P&T Committee
and long-term-care facilities, as well as by payers such as
Medicare, Medicaid, insurance companies, and managed care The P&T committee is responsible for managing the formu-
organizations. Many organizations have policy statements on lary system. It is composed of actively practicing physicians,
other prescribers, pharmacists, nurses, administrators, quality-
the use of formularies.28 This document focuses on the use of
improvement managers, and other health care professionals
formulary systems in hospitals and health systems.
and staff who participate in the medication-use process.
Customarily, P&T committee member appointments are
Evolution of Formularies based on guidance from the medical staff. The P&T commit-
tee should serve in an evaluative, educational, and advisory
Formulary systems have evolved over time. Modern for- capacity to the medical staff and organizational administra-
mularies began as rudimentary drug lists developed by the tion in all matters pertaining to the use of medications (in-
military in the 1940s and came into more widespread use cluding investigational medications). The P&T committee
during the 1950s. Pharmacists, in conjunction with their or- should be responsible for overseeing policies and procedures
ganizations, developed policies to dispense generic equiva- related to all aspects of medication use within an institution.
lent drugs when a specific brand-name drug was prescribed. The P&T committee is responsible to the medical staff as
Protests from the National Pharmaceutical Council and the a whole, and its recommendations are subject to approval
American Medical Association (AMA) resulted in state laws by the organized medical staff as well as the administrative
prohibiting this activity. Community pharmacies complied, approval process. The P&T committees organization and
but hospital pharmacies resisted. In the late 1950s, the ASHP authority should be outlined in the organizations medical
minimum standard for pharmacies in hospitals called for the staff bylaws, medical staff rules and regulations, and other
implementation of a formulary system.9 organizational policies as appropriate.
During the 1960s, the concept of a hospital formu- Other responsibilities of the P&T committee include med-
lary continued to grow. Hospitals developed policies that ication-use evaluation (MUE), adverse-drug-event monitoring
authorized pharmacists to make generic interchanges in an and reporting, medication-error prevention, and development
institutional formulary system based on prior consent from of clinical care plans and guidelines. Information about these
physicians.10 ASHP and the American Hospital Association activities is available in ASHP guidelines on the topics.1720
 Formulary ManagementGuidelines179

P&T committees have been credited with increasing policies, the therapies offered by the organization, and the
practitioners knowledge about drug therapy, improving medications routinely stocked in the pharmacy. A formulary
the safety of drug therapy, and improving therapeutic out- also identifies those medications that are most medically ap-
comes.21 propriate and cost-effective to best serve the health interests
Consideration of patient care and unbiased reviews of of the health systems patient population. The P&T commit
the biomedical literature are the cornerstone principles of tee should interpret the term medication broadly in the con-
formulary decision-making. A conflict of interest (COI), fi- text of care delivery to include alternative remedies (herbals
nancial or otherwise, may interfere with professionals ability and supplements), nonprescription drugs, blood derivatives,
to make evidence-based decisions,22 and even the appearance contrast media, and other diagnostic and treatment agents.26
of a potential COI can undermine a formulary decision. The The formulary system should include review and ap-
P&T committee has a responsibility to its patients and its or- proval of all policies related to the medication-use process.
ganization to identify and address COI issues in its decision- All medication-use policies, regardless of their origination,
making processes. Professionals participating in the P&T should flow through the P&T committee. The organiza-
committee should disclose financial relationships with phar- tions medical staff leadership (i.e., the body to which the
maceutical manufacturers, medical supply vendors, other P&T committee reports) should complete the final policy
health care provider organizations, and other commercial approval. Policy review and revision should occur as new
interests. Some health care organizations exclude heath care information becomes available and at regularly established
professionals with COIs from P&T committee membership, intervals (e.g., annually). Specific medication-use policies
whereas others allow participation in committee discussions should address
but prohibit voting on particular items. Practitioners request-
ing additions or changes to the formulary should disclose How medications are requested for addition to or dele-
financial relationships with pharmaceutical companies and tion from the formulary,
other potential COIs to the P&T committee. How medications are reviewed for addition to or dele-
Finally, the role of pharmaceutical company represen- tion from the formulary, including who performs the
tatives and medical science liaisons in a health care organi- reviews,
zation should be carefully considered. Organizational guide- The process for developing, implementing, and moni-
lines should define appropriate relationships and interactions toring medication-use guidelines,
with such individuals. At a minimum, these guidelines Methods for ensuring the safe prescribing, distribu-
should address the provision of pharmaceutical samples, tion, administration, and monitoring of medications,
indirect or direct funding support, and educational program- Methods for selection of suitable manufacturers for
ming regarding formulary and nonformulary medications. specific medications (a pharmacist shall be respon-
Applications for formulary additions should be initiated and sible for specifications for the quality, quantity, and
completed independently by the requesting health care pro- source of supply of all medications, chemicals, bio-
vider and not by an industry representative or vendor. Refer logicals, and pharmaceutical preparations used in the
diagnosis and treatment of patients),27
to ASHPs Guidelines on Pharmacists Relationships with
Industry for more information on appropriate interactions The process for using nonformulary agents within the
institution,
with industry.23
The process for managing drug product shortages,
The process for developing an organization-specific
Managing the Formulary System MUE plan,
Policies regarding specific medication-use processes
Health systems should develop, maintain, and implement (e.g., procurement, prescribing, distribution, adminis-
a formulary management process. Decisions on the man- tration, monitoring), and
agement of a formulary system should be founded on the The process for disseminating medication-use policies
evidence-based clinical, ethical, legal, social, philosophical, and how users will be educated regarding the process.
quality-of-life, safety, and economic factors that result in op-
timal patient care.24,25 The process must include the active A formal process to review medication-use policies
and direct involvement of physicians, pharmacists, and other should be in place. This process may include the use of ex-
appropriate health care professionals. This evidence-based pert panels or subcommittees of the P&T committee. Expert
process should not be based solely on economic factors. panels should serve in an advisory role to the P&T commit
The formulary system should be standardized among com- tee, and their membership should include recognized experts
ponents of integrated health systems when standardization in their areas of practice. Such panels can be helpful in ap
leads to improved patient outcomes and safety. plying clinical study results to specific patient populations,
Management of a formulary system is a significant com and panel members can help educate groups of physicians,
ponent of a health care organizations ongoing medication- who ultimately drive prescribing behaviors, about signifi
use policy development process. A comprehensive, well- cant formulary changes. User groups, representing those
maintained formulary that is tailored to the organizations primarily affected by the policy, may also be helpful. The
patient care needs, policy framework, and medication-use P&T committee may also find subcommittees that address
systems ensures that the six critical processes identified by specific therapeutic areas to be beneficial (e.g., antimicro
the Joint Commission (selection and procurement, storage, bial, cancer chemotherapy, cardiovascular, adverse-drug-
ordering and transcribing, preparing and dispensing, admin- reaction, or biotechnology subcommittees).
istration, and monitoring) work in concert to ensure optimal The P&T committee should have formal interactions
outcomes.26 A well-managed formulary system ensures a (i.e., communication lines) with other committees whose
close relationship among the organizations medication-use functions may affect the medication-use process. These
180Formulary ManagementGuidelines

committees would include those responsible for develop- grade evidence when evaluating formulary requests; several
ing tools to facilitate medication use (e.g., forms or order tools are available for this purpose.2832
set review committee, computerized prescriber-order-entry Published evidence and expert opinion are not the only
committee), those concerned with safety or performance resources available to aid in the formulary decision-making
improvement (e.g., quality-improvement or patient safety process. Internal data and prescribing and outcomes informa-
committees), those involved in developing patient care poli- tion may be helpful in formulary decision-making. When pub-
cies (e.g., medical and nursing committees), those involved lished data are not available, it may be appropriate to incorpo-
with investigational medications (e.g., investigational re- rate expert opinion into the review process. Experts in practice
view boards), and other committees whose actions may af- areas sometimes have access to unpublished data or reports
fect medication use (e.g., nutrition, equipment and supply, that may offer insight into difficult formulary decisions.
or finance committees). Recommendations from other com- The P&T committee should use formulary packets and
mittees, subcommittees of P&T, expert panels, and others dossiers prepared by pharmaceutical manufacturers with
should be submitted to the P&T committee for review. P&T the utmost caution, since the objectivity of these documents
committee decisions on recommendations should be com- may be challenged. The formulary decision-making process
municated to the recommending group in a timely fashion. should instead be guided by an independent review of evi-
dence published in the biomedical literature, application of
Evaluating Medications for expert opinion, and use of internal data and benchmarking
programs.
Inclusion in the Formulary
The information should be provided to the P&T com-
mittee in a written document with a standard format (e.g., a
The P&T committee should use a structured, evidence-based
drug monograph, drug review, drug-evaluation document).
process in the evaluation of medications for formulary con-
All information provided in the drug-evaluation document
sideration. The P&T committee should be provided with in-
should be referenced to the evidence or identified as a con-
formation that reflects a thorough, accurate, and unbiased re-
clusion supported by evidence. Any areas of consensus rec-
view and analysis of the evidence available in the scientific
ommendations or opinion should be clearly identified.
literature. The evaluation process should encourage objec-
tive consideration of clinical and care delivery information,
facilitate communication, foster positive patient outcomes, Types of Drug Reviews. There are four major types of drug
and support safe and effective medication ordering, dispens- reviews: new drug monographs, reevaluations of previous
ing, administration, and monitoring. Decisions made by the formulary decisions, therapeutic class reviews, and expe-
P&T committee should support improved patient care out- dited reviews of newly approved medications. Because of
comes across the continuum of care. the expertise and training of pharmacists (drug information
specialists in particular), pharmacists should play an integral
Evidence-Based Evaluation. Inclusion of a medication on part in the preparation and presentation of the drug review
a health systems formulary should reflect that an evidence- document to the P&T committee.
based evaluation of the relative merits and risks of the medi- New drug monographs. When the Food and Drug
cation has been performed and that the institutions P&T Administration (FDA) approves a new drug for market-
committee, with input from appropriate experts, has deter- ing that is relevant to the health system, a drug monograph
mined that the medication is appropriate for routine use in should be prepared for formulary consideration by the P&T
the management of the patient population at that institution. committee. New chemical entities warrant a thorough evalu-
Evidence-based medicine is a systematic approach to ation and a written drug monograph. A short (e.g., one-page)
the evaluation of biomedical literature and application to summary could be provided along with the full monograph.33
clinical practice and should be applied to formulary decision- Some organizations use an executive summary format. A
making for medication product selection.24 Evidence-based new drug that is significantly similar to other available ther-
decision-making standardizes and improves the quality of apeutic alternatives may be presented in a more abbreviated
patient care and promotes cost-effective prescribing.24,25 To manner (e.g., an abbreviated monograph) provided that the
practice evidence-based medicine, practitioners must be pro- P&T committee or experts agree that the drug is therapeuti-
ficient in retrieving, evaluating, and applying the biomedical cally equivalent to agents already available on the formulary.
literature to clinical practice. Addenda to original monographs used to reevaluate
Evidence-based decision-making incorporates the sys- previous formulary decisions. Formulary decisions may
tematic approach to reviewing, evaluating, and applying the need to be reassessed based on relevant new information
biomedical literature to guide formulary decisions. Various or in light of newly marketed drugs or dosage forms. New
types and strengths of evidence (e.g., meta-analyses, ran- data on safety, efficacy, stability, methods of administration,
domized clinical trials, case reports, association consensus cost, or pharmacoeconomics may warrant a reevaluation
statements) may be useful in the decision-making process. of the drug or dosage strengths or formulations stocked by
Although different types of evidence are available for ap- the health system. An addendum to the original monograph
plication, those with stronger evidence should be used to summarizing the new information should be developed for
drive formulary decisions (e.g., meta-analyses, randomized evaluation by the P&T committee. The P&T committee may
controlled trials). Other types of evidence have a role in the want to establish reassessment dates at the time of formulary
decision-making process, however, and may be appropri- review so that the committee can reassess the effect of a for-
ate when stronger evidence is not available. Observational mulary decision on quality or cost of care.
studies (i.e., casecontrol and cohort studies), case reports, Therapeutic class reviews. Review of an entire thera-
and consensus opinions may be valuable even when stronger peutic class of drugs should be performed at regular inter-
evidence is available. Some organizations find it useful to vals, which may be determined by the P&T committee or
 Formulary ManagementGuidelines181

influenced by regulatory agencies. A therapeutic class re- Pharmacoeconomic Assessments. Rigorous pharmacoeco-
view should include all formulary and nonformulary medi- nomic evaluations can and should be conducted in some cases
cations within the class and may include institutional utili- when reviewing new medications. These evaluations should
zation or outcomes data and newly published information. explicitly state the perspective of the analysis (e.g., patient,
Therapeutic class reviews may lead to formulary removal of health care provider, payer) and should include consider-
therapeutically equivalent drugs or a change in restriction or ation of all costs and consequences relevant to that perspec-
guideline status for a drug. tive. When new medications being considered are found to
Expedited reviews. A process should be available for the be therapeutically equivalent to existing alternatives (having
P&T committee to conduct an expedited review of a new drug, equivalent efficacy and safety), then the cost-minimization
new indication for a drug, or reevaluation of a previous for- approach is appropriate. In these circumstances, it is im
mulary decision. Criteria should be in place to describe when portant to consider costs associated with the medication
an expedited review is warranted. For example, approval of a and nonmedication-related costs (e.g., costs of administra
new chemical entity for a disease with no therapeutic alterna- tion, monitoring, prolonged hospital stay, and laboratory test
tive may warrant an expedited review to ensure availability of monitoring; costs to patients and providers).
the drug for patients who need it. Likewise, a significant new While cost-effectiveness analysis (evaluating the in-
safety concern may warrant an expedited review for addition cremental difference in investment necessary to produce
of restrictions or removal from the formulary. an incremental difference in clinical outcome) is another
potentially useful analytic approach, it is not often used for
Elements of a Drug-Evaluation Document. The drug- formulary decision-making because of its complexity and
evaluation document should present the evidence in a man- need for strong evidence or data. The academic value of
ner that is thorough, is consistent from medication to medi- this approach lies in its ability to show how little (or how
cation, and provides all necessary facts and analysis to the much) must be spent to achieve a particular margin of clini-
P&T committee to allow for an informed formulary deci- cal advantage when comparing an alternative that is more
sion. Document structure may vary, depending on the needs expensive but safer or more efficacious. No standards cur-
of the specific health system and P&T committee, but the rently exist to determine how much money is reasonable to
following elements are essential to all such documents: spend for any given improvement in out-come; however, it
is unreasonable to recommend alternatives of lower quality
Brand and generic names and synonyms, simply to achieve cost savings. This approach can be used to
FDA approval information, including date and FDA demonstrate how a decrease in clinical outcomes associated
rating, with the use of a less expensive agent can be offset by invest-
Pharmacology and mechanism of action, ing the savings achieved in other interventions that produce
FDA-approved indications, even greater total benefits.
Potential non-FDA-approved (off-label) uses, Cost-utility evaluations (evaluating the incremental
Dosage forms and storage, difference in investment necessary to produce an incremen-
Recommended dosage regimens, tal difference in quality-of-life-adjusted clinical outcome
Pharmacokinetic considerations, [e.g., incremental cost per quality-adjusted life years gained
Use in special populations (e.g., children, elderly, pa- for one medication versus another]) may also be beneficial
tients with renal or liver failure), by serving to reflect patient preference in formulary deci-
Pregnancy category and use during breast-feeding,
sion-making. However, the same concerns related to the use
Comparisons of the drugs efficacy, safety, conve-
of cost-effectiveness evaluations apply to this approach.3436
nience, and costs with those of therapeutic alternatives
Decision analysis models incorporating local data can
(with evidence tables when feasible),
be employed when published pharmacoeconomic data are
If information on comparative efficacy is minimal or
limited or unavailable. Probabilities for each outcome can
lacking, data on absolute efficacy (i.e., efficacy versus
be extracted from the published literature or drawn from lo-
placebo),
cal data sources, which would provide a more relevant local
Clinical trial analysis and critique,
perspective on outcomes. Costs associated with medications
Medication safety assessment and recommendations
and outcomes should reflect those of the health care system.
(adverse drug reactions; drugdrug and drugfood in-
teractions; specific therapy monitoring requirements; Pharmacoeconomic analyses published in the medi-
unusual administration, storage, or stability issues; and cal literature or provided in the manufacturers formulary
potential for medication errors, such as look-alike or dossier should be analyzed carefully before being included
sound-alike issues), and as part of the review process. Particular attention should be
Financial analysis, including pharmacoeconomic as- paid to the assumptions made in these studies. In many situ-
sessments. ations, assumptions made to simplify economic studies are
not valid in particular institutions. Institution-specific costs
Formulary status recommendations (e.g., from drug are often different from the costs used in published studies,
information services or expert groups) may be included in and local data should be used when incorporating their re-
the drug evaluation document. In some organizations, recom- sults into medication reviews.37,38
mendations are not provided in the written document in order Even if a formal pharmacoeconomic evaluation is not
to promote an unbiased discussion by the P&T committee. included in a drug review document, a financial evaluation
Recommendations should consider the formulary status (ad- must be conducted, including consideration of nonmedication-
dition or rejection) of a medication, as well as the need for related costs and financial consequences to the pharmacy
restrictions, educational efforts, or policies and procedures to and to the organization as a whole.
ensure safe and appropriate use within the health system.
182Formulary ManagementGuidelines

Formulary Exceptions. Exclusion of a medication from a The prescriber has the option, at the time of prescrib-
formulary may affect coverage of and access to the medi- ing, to specify the brand or supplier of the drug to be
cation. In a closed formulary system, for example, only dispensed for that particular medication order if con-
medications listed on the formulary are covered under the sidered clinically justified.
patients drug benefit. Regardless of health-system setting, The prescribers decision should be based on pharma-
the formulary system should include an exception process cologic or therapeutic considerations (or both) relative
that provides prescribers and patients with timely access to to that patient.
medications that are not on the formulary but are medically
necessary for the care of the patient. The underlying princi- Therapeutic Interchange. Therapeutic interchange is the
ple for such a process is that unique patient needs may not be authorized exchange of therapeutic alternatives in accor-
satisfied by use of the formulary medications. The formulary dance with previously established and approved written
exception process should generate information on nonfor- guidelines, policies, or protocols within a formulary sys-
mulary medication use that will enable the P&T committee tem.1 Therapeutic interchange provides pharmacists with
to evaluate trends in such use. Criteria for approval of non- the authorization to use a formulary therapeutic alternative
formulary medications should be developed (e.g., allergy to in place of a nonformulary medication or a non-preferred for-
or therapeutic failure of formulary alternative, condition not mulary medication without having to contact the prescriber.
treatable by formulary medications). Drugs appropriate for therapeutic interchange are drug prod-
ucts with different chemical structures that are expected to
Subformularies. Depending on state regulations, subfor- have similar therapeutic effects and safety profiles when
mularies may be developed and maintained, using the same administered to patients in therapeutically equivalent doses.
evidence-based process, to provide lists of appropriate and The authorization of a therapeutic interchange and notifica-
approved medications for furnishing by nonphysician pro- tion of the prescriber should occur according to the organi-
viders or to specific patient subsets, such as Medicare pa- zations policy. In some organizations, prescribers agree to
tients. Health systems must follow specific rules and regula- the therapeutic interchange process as part of their overall
tions provided under the U.S. Medicare Modernization Act agreement to follow the organizations policies when they
of 2003 in their evaluation and inclusion of medications in a are granted prescribing privileges. Other organizations re-
Medicare formulary for those medications to be covered.39 quire that the prescriber be notified each time a medication is
interchanged. A process should be established for when the
prescriber wishes to opt out of the interchange. Adequate ed-
Strategies for Managing Medication Use ucational initiatives should be undertaken to ensure that ev-
eryone affected (prescribers, patients, pharmacists, nurses,
Common strategies for managing medication use via the for- and other health care professionals) is notified of the thera-
mulary include use of generic drugs, therapeutic interchange, peutic interchange. Guidelines on therapeutic interchange
guided-use policies, clinical practice guidelines, and policies are available elsewhere.41
for off-label prescribing and the use of research pharmaceu-
ticals. MUE is also important in managing medication use. Guided-Use Strategies. Medications may be added to the
formulary with additional processes in place to guide the use
Generic Drugs. Optimizing the number of medication enti- of the medications to improve therapeutic outcomes, prevent
ties and products available from the pharmacy can produce adverse events, or reduce costs. Examples of strategies to
substantial patient care and financial benefits. These benefits help guide the use of medications in addition to therapeutic
are greatly increased through the use of generic equivalents interchange may include the following.
(drugs considered bioequivalent by FDA [i.e., AB-rated drug Established-use criteria. Patients must meet the estab-
products40] and therapeutic equivalents (drug products dif- lished criteria before the medication is dispensed. A process
fering in composition or in their basic drug entity that are should be developed to cover situations in which the patient
considered to have very similar pharmacologic and therapeu- does not meet the established criteria, but the medication is
tic activities). The use of high-quality generic equivalents is nevertheless determined to be medically necessary. This strat-
encouraged in order to provide the best possible care at an egy may also be useful when medications are in short supply.
affordable cost. Use of generic drugs that have been deemed Restricting drug use to a service. A specific service
bioequivalent by FDA does not require review or approval must approve the use of the drug before dispensing. This
by the P&T committee, although a review of all new medica- strategy can be used when inappropriate use or severe ad-
tions for key safety issues (e.g., look-alike, sound-alike con- verse effects may occur, and it can also be employed for
cerns) should be conducted to prevent medication errors. For antimicrobial agents when inappropriate use or overuse can
some drug categories, such as those with a narrow therapeu- result in resistant organisms and pose a danger to the general
tic range, a more thorough evaluation of the bioequivalency patient population or the public.
data and approval of experts or the P&T committee should be Limiting use of the drug to specially trained individu-
considered before implementing a generic substitution. als. This strategy may be appropriate when the drug is in-
The P&T committee must establish policies and proce herently dangerous and should only be used by individuals
dures governing the dispensing of generic equivalents. These with specific training (e.g., restricting use of chemotherapy
policies and procedures should include the following points: agents to oncologists).
Designating medications for use in specific areas.
The pharmacist is responsible for selecting from avail- Such policies can be helpful when administration of a medi-
able generic equivalents those drugs to be dispensed cation requires special equipment or staff with particular
pursuant to a prescribers order for a particular medi- skills to use the medication safely (e.g., limiting neuromus-
cation. cular blockers to operating rooms and critical care areas).
 Formulary ManagementGuidelines183

Approval of medical director (or designee) before their awareness of it and may create a sense of investment in
drug use. This strategy is particularly appropriate when the its goals. Process-of-care and outcomes data from the orga-
P&T committee has reviewed a high-cost medication and nizations MUE activities (or, in some organizations, from
determined that the drug has little or no role in the care of such sources as the electronic medical records and com-
patients at that organization but a prescriber would like to puterized prescriber-order-entry systems) can also be used
use the medication on a nonformulary basis. to make informed decisions during the consensus process.
After the consensus process is completed, the guideline
Clinical Practice Guidelines. The implementation of should be reviewed and approved by the P&T committee.
medication-use policy decisions is a complicated process The dissemination and implementation of guidelines
that, when properly conducted, can decrease variability in in the practice environment must also be carefully executed.
practice and improve patient outcomes, including clinical Unlike active intervention tools that directly influence be-
and economic consequences of care. Many tools are used to havior, guidelines change behavior only when they are ac-
reduce practice variability, reduce cost, and improve quality, cessed, read, accepted, and put into practice. Exhaustive
including order sets, clinical pathways, treatment algorithms, communication about the availability of guidelines is neces
and clinical practice guidelines. While active intervention sary. The dissemination of guidelines in hardcopy format
tools, such as order sets, directly influence prescribing for is common, but electronic distribution (often in the form of
individual patients, clinical practice guidelines influence a library of guidelines available via the Internet) is more ef
prescriber behavior in a passive manner, primarily through ficient. Given the dynamic nature of the biomedical evidence
education. Like the medication formulary, clinical practice and the quickening pace of changes in practice, maintaining
guidelines should reflect current biomedical evidence, al- current practice guidelines is an important challenge. Every
though they may also include expert opinion of prescribers guideline should include a time frame for future review and
within a practice seting. Clinical practice guidelines are revision. If resources are not available to properly update
developed and disseminated by national and international and revise an older guideline, the guideline should be retired
organizations, but they can also be developed locally. Not and removed from circulation.
all guidelines are equally valuable, however. Policymakers
should not assume that guidelines, even those endorsed by Off-Label Use. The use of a drug prescribed for an indica-
respected organizations, are necessarily evidence based and tion not specifically approved by FDA is often referred to
should carefully review guidelines to ensure that they are truly as off-label use. Off-label use can include the use of phar-
evidence driven and current. Regardless of the source of the maceuticals outside of specified populations, for different
synthesis of biomedical evidence that forms the framework diseases or stages of diseases, or by different routes of ad-
for an individual guideline, a locally conducted consensus ministration. Other types of off-label use involve changes
development process, incorporating local expertise, must be to dosing or dosing schedules or in chronology or sequence
performed if a guideline is to be accepted and followed. of use.
Whether the medication formulary is a reflection of Before considering off-label use, supporting safety
existing clinical practice guidelines in a particular organiza- and efficacy evidence must be carefully evaluated and a
tion or vice versa, it is critical that the guidelines and formu- risk-benefit determination made, especially when alter
lary are consistent. If a specific medication is recommended natives with FDA-approved labeling are available for the
by a clinical practice guideline, it should in the majority of intended off-label use.42 When considering or reviewing
cases be on the formulary. As formulary changes are made, off-label use, the P&T committee should use an evidence-
agents may need to be removed from or replaced in exist- based process. The approach to evaluating evidence and
ing guidelines. Guidelines should avoid recommending use benefit developed by the U.S. Preventive Services Task
of nonformulary medications, and they can be useful in dis- Force is an example.43,44
couraging nonformulary medication use and guiding the ap- The following principles should guide the off-label use
propriate use of nonformulary products when necessary. of medications:
Guidelines are frequently developed to address com-
plex or particularly expensive medication therapies. However, 1. Off-label pharmaceutical prescribing should be based
complicated specialty therapies that will affect the care of on published evidence, and patient safety should be
very few patients may not justify the time and resources nec- the primary consideration.
essary to develop and maintain a guideline. Guidelines may 2. When the off-label use of an agent is expected to occur
be medication specific or disease oriented and may overlap frequently, the P&T committee should establish proto-
in their scope of coverage. cols guiding that use. The P&T committee should be
The development of a clinical practice guideline considered the arbiter of off-label use and should rely
should begin with the synthesis of all available biomedi- on the scientific evidence to guide its decisions.
cal evidence addressing the guideline topic. In many cases, 3. The ultimate responsibility for the safety and efficacy
guidelines from other organizations, both national and lo- of off-label use resides with the prescriber, who should
cal, can be used as a starting point for development. The be familiar with the evidence before considering off-
national guideline clearinghouse sponsored by the Agency label use, be aware of local protocols for use of the
for Healthcare Research and Quality is a useful source of agent, and, when necessary, consult with an appropri-
previously developed guidelines (www.guideline.gov). The ately knowledgeable pharmacist.
subsequent consensus process, eliciting feedback and input 4. Proper assessment of evidence for off-label use should
from local stakeholders, is critical. Stakeholders may not involve as comprehensive and balanced a review as
reach unanimous agreement about all dimensions of the possible. Selective use of studies to support a position
guideline, but their involvement in its development increases is strongly discouraged and, in the event of a negative
184Formulary ManagementGuidelines

outcome, may not withstand the rigor of a thorough how an individual medication is used or evaluate medica-
peer review. tion management of a given disease state. All steps of the
medication-use process should be evaluated over time. The
Research Pharmaceuticals (Investigational Drugs). An in- P&T committee, or its equivalent, should be involved in the
vestigational drug is defined as a chemical or biological used MUE process.
in a clinical investigation and can include prescription and Concurrent evaluation (collecting data during care de-
nonprescription drugs, nutritional supplements, and herbal livery and sometimes as a component of the care process) is
preparations. Investigational drug study procedures must be usually preferred over retrospective methods because it al-
consistent with all applicable laws and regulations. Efforts lows organizations to select relevant outcomes for collection
should be made to ensure that the prescribing and distribu- rather than rely on out-comes routinely documented in pa-
tion of investigational drugs benefit from the safe medica- tient medical records. For example, quality-of-life measures
tion management systems used for other medications. More remain an infrequently documented measure in medical re-
information on the management of investigational drugs can cords. Only through concurrent evaluation can that outcome
be found in other ASHP guidelines.45,46 measure be reliably captured. Medications recently added to
the formulary should be evaluated, especially if there is the
MUE Process. Although distinctions have historically been potential for inappropriate use or adverse effects of concern.
made among the terms drug-use evaluation, drug-use review, This review should occur 612 months after their addition
and medication-use evaluation, they all refer to the systematic to the formulary. High-cost, high-use, and problemprone
evaluation of medication use employing standard, observa- medications are also good candidates for evaluation.
tional quality-improvement methods (e.g., traditional plan
docheckact approach). MUE is a quality-improvement Incorporating Patient Safety Issues
activity, but it can also be considered a formulary system in the Decision-Making Process
management technique.
MUE methods have traditionally involved establish- P&T committees have always addressed medication safety
ing evidence-based criteria for medication use and apply- issues. However, as medication errors have received in-
ing those criteria retrospectively to determine the degree to creased scrutiny and more is understood about the process
which a particular medication was used in discordance with failures that contribute to such errors, P&T committees have
established criteria. Interventions could then be used to im- more opportunities to address patient safety issues. The P&T
prove prescribing based on those data. As electronic medi- committee should systematically address patient safety as part
cal records have become increasingly important and more of its deliberations. Opportunities for including patient safety
widely available, MUE activities have matured from simple in P&T committee deliberations include the following:
paper-based medical record reviews to sophisticated analy-
ses drawing on multiple sources of data regarding medica- 1. When evaluating a medication for inclusion on the for-
tion use. A more expansive approach to MUE has been de- mulary, the P&T committee should consider adverse
scribed in which not only the use of individual medications effects, issues in preparation, sound-alike or look-
but the entire process of care for disease states is examined.47 alike potential, and dosing or administration issues.
The use of quasiexperimental research methods may provide Assessments should be conducted to identify potential
more meaningful information for quality-improvement pur- safety concerns posed by use of the medication. The
poses (e.g., economic, clinical, and humanistic outcomes of P&T committee should make recommendations for
greater relevance than arbitrarily set appropriateness criteria). managing identified risks.
MUE can be simply informative (collecting data to 2. Organizations, in collaboration with the appropriate
guide decision-making) or be used to measure the effect committees, should undertake projects to proactively
of interventions, such as the addition of a new agent to the assess risk in medication-use processes. The use of
formulary or the implementation of a new medication-use
high-risk medications or major system changes (e.g.,
policy. MUE activities can focus on any dimension of the
a new computer system, new equipment) offer oppor-
medication-use process (from medication acquisition to pa
tunities to perform proactive risk assessments. Failure
tient monitoring) that presents an opportunity for improve
mode and effects analysis (FMEA) can be used to
ment. While MUE often focuses on problem-prone, high-
structure these assessments. The Joint Commission,
risk, or high-cost medications, MUE can be used to examine
Institute for Healthcare Improvement, and National
any aspect of medication use that is problematic to the insti
Center on Patient Safety provide information about
tution conducting the evaluation.
conducting and examples of FMEA projects on their
A systematic plan to monitor, evaluate, and improve
websites (www.jointcommission.org/, www.ihi.org/,
medication use should be established within the organiza-
tion.17 Such a plan is an accreditation requirement for many and www.patientsafety.gov).
organizations (e.g., Joint Commission26). MUE should be 3. The P&T committee should consistently review
a part of the organizations overall quality-improvement medication-event data, including data on near misses,
program. MUE activities should be conducted to examine and make recommendations to prevent future events.
the effect of medication-use policy decisions (particularly 4. The P&T committee should conduct targeted quality-
those made in the absence of convincing evidence from the improvement projects to improve the safety of specific
biomedical literature) but can also be conducted to inform medications or to evaluate the processes involved.
decision-making (again, particularly when making policy 5. When reviewing policies, the P&T committee should
decisions under conditions of uncertainty). Specific proj- ensure that the policies adequately address the poten-
ects to evaluate medication use can either involve assessing tial risk issues.
 Formulary ManagementGuidelines185

6. The P&T committee should champion evidence-based Newsletters,

fail-safe techniques (e.g., bar-coding) to prevent medi- Mailings,
cation events. Prescriber detailing, and
7. The P&T committee should review information avail- Pharmacy or institutional websites.
able on patient safety or events reported by other or-
ganizations to identify ways to prevent medication Pilot or demonstration projects may be beneficial in il-
events and disseminate the information to health care lustrating the value of a new medication-use policy and may
providers and, when appropriate, patients. generate data that could justify a decision or help communi-
cate why a specific policy is necessary.
Resources on medication safety should be routinely
reviewed to identify potential issues an organization could
Conclusion
address. Examples of resources include the Institute for
Safe Medication Practices (www.ismp.org), Medwatch
A formulary system is the multidisciplinary, evidence-based
(www.fda.gov/medwatch), FDA Patient Safety News (www.
process employed by an organization to select and use medi-
accessdata.fda.gov/scripts/cdrh/cfdocs/psn/), and the U.S.
cations that offer the best therapeutic outcomes while mini-
Pharmacopeia Patient Safety Program (www.usp.org/hqi/
mizing potential risks and costs for patients. Organizations
patientSafety/). employ the MUE process to continually improve how medi-
cations are used within the organization at all steps in the
Drug Product Shortages medication-use process. Medication use is an inherently
complex and dangerous process that requires constant evalu-
Health systems frequently need to address drug product short- ation. Organizations need to implement tools and processes
ages. Drug product shortages disrupt patient care and the pro- necessary to meet the goals of using medications effectively
cessing of medication orders, increasing the risks presented and safely. Professionals involved in the medication-use
by all aspects of the medication-use system, including pur- process need to know and understand how the organizations
chasing, storage, pharmacy computer and automation sys- medication-use policies and processes can be incorporated
tems, ordering, preparation, administration, and monitoring. into their daily work so that medications are used appropri-
During a drug product shortage, the P&T committee ately and safely. Technology offers many opportunities to
plays an important role in setting organizational priorities. make those processes more effective. Communicating the
The P&T committee needs to develop strategies to address actions related to medication use is a constant challenge that
shortages in a timely manner, including designating appro- organizations need to address.
priate alternatives, identifying strategies for rationing avail-
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AppendixGlossary of Terms

Formulary: A continually updated list of medications and These guidelines were reviewed in 2012 by the Council on
related information, representing the clinical judgment Pharmacy Practice and by the Board of Directors and were found
of physicians, pharmacists, and other experts in the di- to still be appropriate.
agnosis, prophylaxis, or treatment of disease and pro-
motion of health. Approved by the ASHP Board of Directors on January 28, 2008.
Formulary System: An ongoing process whereby a health These guidelines supersede the ASHP Guidelines on Formulary
care organization, through its physicians, pharma- System Management dated November 20, 1991, the ASHP Technical
cists, and other health care professionals, establishes Assistance Bulletin on Drug Formularies dated November 14, 1990,
policies on the use of drug products and therapies and and the ASHP Technical Assistance Bulletin on the Evaluation of
identifies drug products and therapies that are the most Drugs for Formularies dated November 19, 1987. Developed
medically appropriate and cost-effective to best serve through the ASHP Council on Pharmacy Practice.
the health interests of a given patient population.1
Generic Substitution: The substitution of drug products ASHP gratefully acknowledges the expert panel that developed
that contain the same active ingredient or ingredients these guidelines: Linda S. Tyler, Pharm.D., FASHP; Mirta Millares,
and are chemically identical in strength, concentration, Pharm.D., FCSHP, FASHP; Andrew L. Wilson, Pharm.D., FASHP;
dosage form, and route of administration to the drug Lee C. Vermeulen, Jr., B.S.Pharm., M.S.; J. Russell (Rusty) May,
product prescribed.1 Pharm.D., FASHP; Michael A. Valentino, R.Ph. MHSA; and
Medication: Any prescription medications, herbal remedies, Sabrina W. Cole, Pharm.D.
vitamins, nutraceuticals, nonprescription drugs, vaccines,
or diagnostic and contrast agents used to diagnose, treat, Copyright 2008, American Society of Health-System Pharmacists,
or prevent disease and other abnormal conditions and Inc. All rights reserved.
radioactive medications, respiratory therapy treatments,
parenteral nutrition, blood derivatives, intravenous solu- The bibliographic citation for this document is as follows: American
tions (plain or with electrolytes or drugs), or any product Society of Health-System Pharmacists. ASHP guidelines on the
designated by the Food and Drug Administration as a pharmacy and therapeutics committee and the formulary system.
drug (including investigational drugs).26 Am J Health-Syst Pharm. 2008; 65:127283.