These guidelines outline the recommended processes and techniques for formulary system management and describe the pharmacist’s responsibilities and roles in managing the formulary system in partnership with other health care professionals. These guidelines also provide assistance to pharmacists in the organization and operation of the pharmacy and therapeutics (P&T) committee or equivalent body, evaluation of medications for formularies, and development and implementation of strategies to manage medication use through the formulary system. A glossary of terms is provided in the appendix.
Formulary and Formulary System
A formulary is a continually updated list of medications and related information, representing the clinical judgment of physicians, pharmacists, and other experts in the diagnosis, prophylaxis, or treatment of disease and promotion of health. A formulary includes, but is not limited to, a list of medications and medication-associated products or devices, medication-use policies, important ancillary drug information, decision-support tools, and organizational guidelines. A formulary system is the ongoing process through which a health care organization establishes policies regarding the use of drugs, therapies, and drug-related products and identifies those that are most medically appropriate and cost-effective to best serve the health interests of a given patient population.1 Formulary systems are used in many different settings, including hospitals, acute care facilities, home care settings, and long-term-care facilities, as well as by payers such as Medicare, Medicaid, insurance companies, and managed care organizations. Many organizations have policy statements on the use of formularies.2–8 This document focuses on the use of formulary systems in hospitals and health systems.
Evolution of Formularies
Formulary systems have evolved over time. Modern formularies began as rudimentary drug lists developed by the military in the 1940s and came into more widespread use during the 1950s. Pharmacists, in conjunction with their organizations, developed policies to dispense generic equivalent drugs when a specific brand-name drug was prescribed. Protests from the National Pharmaceutical Council and the American Medical Association (AMA) resulted in state laws prohibiting this activity. Community pharmacies complied, but hospital pharmacies resisted. In the late 1950s, the ASHP minimum standard for pharmacies in hospitals called for the implementation of a formulary system.9
During the 1960s, the concept of a hospital formulary continued to grow. Hospitals developed policies that authorized pharmacists to make generic interchanges in an institutional formulary system based on prior consent from physicians.10 ASHP and the American Hospital Association (AHA) issued joint statements on the legality of formularies.11,12 AMA and the American Pharmaceutical (later Pharmacists) Association subsequently joined with ASHP and AHA to revise the statements.13 In 1965, two significant events occurred: (1) Medicare listed formularies as a reimbursement eligibility requirement14 and (2) the Joint Commission on the Accreditation of Hospitals (now known as the Joint Commission) included an active P&T committee in its accreditation requirements.15 Even with these actions, formularies were typically no more than lists of drugs stocked by the pharmacy.
By the 1980s, literature describing the clinical and economic value of well-designed formularies had emerged. Evidence from the hospital setting was published first, soon followed by evidence from the ambulatory care environment.10 This literature led to more widespread acceptance of formularies. In 1986, the Pharmaceutical Research and Manufacturers Association officially accepted the concept of therapeutic interchange in hospitals and opposed its use in other settings.10 As more evidence emerged, AMA’s views on formularies for inpatient and outpatient settings became more closely aligned with those of ASHP. AMA’s official policy on drug formularies and therapeutic interchange was first published in 199416 and has since been updated several times.5
Today, formulary systems are considered an essential tool for health care organizations. Formularies have grown from simple drug lists to comprehensive systems of medication-use policies intended to ensure safe, appropriate, and cost-effective use of pharmaceuticals in patient care.
The P&T committee is responsible for managing the formulary system. It is composed of actively practicing physicians, other prescribers, pharmacists, nurses, administrators, quality-improvement managers, and other health care professionals and staff who participate in the medication-use process. Customarily, P&T committee member appointments are based on guidance from the medical staff. The P&T committee should serve in an evaluative, educational, and advisory capacity to the medical staff and organizational administration in all matters pertaining to the use of medications (including investigational medications). The P&T committee should be responsible for overseeing policies and procedures related to all aspects of medication use within an institution. The P&T committee is responsible to the medical staff as a whole, and its recommendations are subject to approval by the organized medical staff as well as the administrative approval process. The P&T committee’s organization and authority should be outlined in the organization’s medical staff bylaws, medical staff rules and regulations, and other organizational policies as appropriate.
Other responsibilities of the P&T committee include medication-use evaluation (MUE), adverse-drug-event monitoring and reporting, medication-error prevention, and development of clinical care plans and guidelines. Information about these activities is available in ASHP guidelines on the topics.17–20
Consideration of patient care and unbiased reviews of the biomedical literature are the cornerstone principles of formulary decision-making. A conflict of interest (COI), financial or otherwise, may interfere with professionals’ ability to make evidence-based decisions,22 and even the appearance of a potential COI can undermine a formulary decision. The P&T committee has a responsibility to its patients and its organization to identify and address COI issues in its decision-making processes. Professionals participating in the P&T committee should disclose financial relationships with pharmaceutical manufacturers, medical supply vendors, other health care provider organizations, and other commercial interests. Some health care organizations exclude heath care professionals with COIs from P&T committee membership, whereas others allow participation in committee discussions but prohibit voting on particular items. Practitioners requesting additions or changes to the formulary should disclose financial relationships with pharmaceutical companies and other potential COIs to the P&T committee.
Finally, the role of pharmaceutical company representatives and medical science liaisons in a health care organization should be carefully considered. Organizational guidelines should define appropriate relationships and interactions with such individuals. At a minimum, these guidelines should address the provision of pharmaceutical samples, indirect or direct funding support, and educational programming regarding formulary and nonformulary medications. Applications for formulary additions should be initiated and completed independently by the requesting health care provider and not by an industry representative or vendor. Refer to ASHP’s “Guidelines on Pharmacists’ Relationships with Industry” for more information on appropriate interactions with industry.23
Managing the Formulary System
Health systems should develop, maintain, and implement a formulary management process. Decisions on the management of a formulary system should be founded on the evidence-based clinical, ethical, legal, social, philosophical, quality-of-life, safety, and economic factors that result in optimal patient care.24,25 The process must include the active and direct involvement of physicians, pharmacists, and other appropriate health care professionals. This evidence-based process should not be based solely on economic factors. The formulary system should be standardized among components of integrated health systems when standardization leads to improved patient outcomes and safety.
Management of a formulary system is a significant component of a health care organization’s ongoing medication-use policy development process. A comprehensive, well-maintained formulary that is tailored to the organization’s patient care needs, policy framework, and medication-use systems ensures that the six critical processes identified by the Joint Commission (selection and procurement, storage, ordering and transcribing, preparing and dispensing, administration, and monitoring) work in concert to ensure optimal outcomes.26 A well-managed formulary system ensures a close relationship among the organization’s medication-use policies, the therapies offered by the organization, and the medications routinely stocked in the pharmacy. A formulary also identifies those medications that are most medically appropriate and cost-effective to best serve the health interests of the health system’s patient population. The P&T committee should interpret the term medication broadly in the context of care delivery to include alternative remedies (herbals and supplements), nonprescription drugs, blood derivatives, contrast media, and other diagnostic and treatment agents.26
The formulary system should include review and approval of all policies related to the medication-use process. All medication-use policies, regardless of their origination, should flow through the P&T committee. The organization’s medical staff leadership (i.e., the body to which the P&T committee reports) should complete the final policy approval. Policy review and revision should occur as new information becomes available and at regularly established intervals (e.g., annually). Specific medication-use policies should address
- How medications are requested for addition to or deletion from the formulary,
- How medications are reviewed for addition to or deletion from the formulary, including who performs the reviews,
- The process for developing, implementing, and monitoring medication-use guidelines,
- Methods for ensuring the safe prescribing, distribution, administration, and monitoring of medications,
- Methods for selection of suitable manufacturers for specific medications (a pharmacist shall be responsible for specifications for the quality, quantity, and source of supply of all medications, chemicals, biologicals, and pharmaceutical preparations used in the diagnosis and treatment of patients),27
- The process for using nonformulary agents within the institution,
- The process for managing drug product shortages,
- The process for developing an organization-specific MUE plan,
- Policies regarding specific medication-use processes (e.g., procurement, prescribing, distribution, administration, monitoring), and
- The process for disseminating medication-use policies and how users will be educated regarding the process.
A formal process to review medication-use policies should be in place. This process may include the use of expert panels or subcommittees of the P&T committee. Expert panels should serve in an advisory role to the P&T committee, and their membership should include recognized experts in their areas of practice. Such panels can be helpful in applying clinical study results to specific patient populations, and panel members can help educate groups of physicians, who ultimately drive prescribing behaviors, about significant formulary changes. User groups, representing those primarily affected by the policy, may also be helpful. The P&T committee may also find subcommittees that address specific therapeutic areas to be beneficial (e.g., antimicrobial, cancer chemotherapy, cardiovascular, adverse-drug-reaction, or biotechnology subcommittees).
The P&T committee should have formal interactions (i.e., communication lines) with other committees whose functions may affect the medication-use process. These committees would include those responsible for developing tools to facilitate medication use (e.g., forms or order set review committee, computerized prescriber-order-entry committee), those concerned with safety or performance improvement (e.g., quality-improvement or patient safety committees), those involved in developing patient care policies (e.g., medical and nursing committees), those involved with investigational medications (e.g., investigational review boards), and other committees whose actions may affect medication use (e.g., nutrition, equipment and supply, or finance committees). Recommendations from other committees, subcommittees of P&T, expert panels, and others should be submitted to the P&T committee for review. P&T committee decisions on recommendations should be communicated to the recommending group in a timely fashion.
Evaluating Medications for Inclusion in the Formulary
The P&T committee should use a structured, evidence-based process in the evaluation of medications for formulary consideration. The P&T committee should be provided with information that reflects a thorough, accurate, and unbiased review and analysis of the evidence available in the scientific literature. The evaluation process should encourage objective consideration of clinical and care delivery information, facilitate communication, foster positive patient outcomes, and support safe and effective medication ordering, dispensing, administration, and monitoring. Decisions made by the P&T committee should support improved patient care outcomes across the continuum of care.
Evidence-Based Evaluation. Inclusion of a medication on a health system’s formulary should reflect that an evidence-based evaluation of the relative merits and risks of the medication has been performed and that the institution’s P&T committee, with input from appropriate experts, has determined that the medication is appropriate for routine use in the management of the patient population at that institution.
Evidence-based medicine is a systematic approach to the evaluation of biomedical literature and application to clinical practice and should be applied to formulary decision-making for medication product selection.24 Evidence-based decision-making standardizes and improves the quality of patient care and promotes cost-effective prescribing.24,25 To practice evidence-based medicine, practitioners must be proficient in retrieving, evaluating, and applying the biomedical literature to clinical practice.
Evidence-based decision-making incorporates the systematic approach to reviewing, evaluating, and applying the biomedical literature to guide formulary decisions. Various types and strengths of evidence (e.g., meta-analyses, randomized clinical trials, case reports, association consensus statements) may be useful in the decision-making process. Although different types of evidence are available for application, those with stronger evidence should be used to drive formulary decisions (e.g., meta-analyses, randomized controlled trials). Other types of evidence have a role in the decision-making process, however, and may be appropriate when stronger evidence is not available. Observational studies (i.e., case–control and cohort studies), case reports, and consensus opinions may be valuable even when stronger evidence is available. Some organizations find it useful to grade evidence when evaluating formulary requests; several tools are available for this purpose.28–32
Published evidence and expert opinion are not the only resources available to aid in the formulary decision-making process. Internal data and prescribing and outcomes information may be helpful in formulary decision-making. When published data are not available, it may be appropriate to incorporate expert opinion into the review process. Experts in practice areas sometimes have access to unpublished data or reports that may offer insight into difficult formulary decisions.
The P&T committee should use formulary packets and dossiers prepared by pharmaceutical manufacturers with the utmost caution, since the objectivity of these documents may be challenged. The formulary decision-making process should instead be guided by an independent review of evidence published in the biomedical literature, application of expert opinion, and use of internal data and benchmarking programs.
The information should be provided to the P&T committee in a written document with a standard format (e.g., a drug monograph, drug review, drug-evaluation document). All information provided in the drug-evaluation document should be referenced to the evidence or identified as a conclusion supported by evidence. Any areas of consensus recommendations or opinion should be clearly identified.
Types of Drug Reviews. There are four major types of drug reviews: new drug monographs, reevaluations of previous formulary decisions, therapeutic class reviews, and expedited reviews of newly approved medications. Because of the expertise and training of pharmacists (drug information specialists in particular), pharmacists should play an integral part in the preparation and presentation of the drug review document to the P&T committee.
New drug monographs. When the Food and Drug Administration (FDA) approves a new drug for marketing that is relevant to the health system, a drug monograph should be prepared for formulary consideration by the P&T committee. New chemical entities warrant a thorough evaluation and a written drug monograph. A short (e.g., one-page) summary could be provided along with the full monograph.33 Some organizations use an executive summary format. A new drug that is significantly similar to other available therapeutic alternatives may be presented in a more abbreviated manner (e.g., an abbreviated monograph) provided that the P&T committee or experts agree that the drug is therapeutically equivalent to agents already available on the formulary.
Addenda to original monographs used to reevaluate previous formulary decisions. Formulary decisions may need to be reassessed based on relevant new information or in light of newly marketed drugs or dosage forms. New data on safety, efficacy, stability, methods of administration, cost, or pharmacoeconomics may warrant a reevaluation of the drug or dosage strengths or formulations stocked by the health system. An addendum to the original monograph summarizing the new information should be developed for evaluation by the P&T committee. The P&T committee may want to establish reassessment dates at the time of formulary review so that the committee can reassess the effect of a formulary decision on quality or cost of care.
Therapeutic class reviews. Review of an entire therapeutic class of drugs should be performed at regular intervals, which may be determined by the P&T committee or influenced by regulatory agencies. A therapeutic class review should include all formulary and nonformulary medications within the class and may include institutional utilization or outcomes data and newly published information. Therapeutic class reviews may lead to formulary removal of therapeutically equivalent drugs or a change in restriction or guideline status for a drug.
Expedited reviews. A process should be available for the P&T committee to conduct an expedited review of a new drug, new indication for a drug, or reevaluation of a previous formulary decision. Criteria should be in place to describe when an expedited review is warranted. For example, approval of a new chemical entity for a disease with no therapeutic alternative may warrant an expedited review to ensure availability of the drug for patients who need it. Likewise, a significant new safety concern may warrant an expedited review for addition of restrictions or removal from the formulary.
Elements of a Drug-Evaluation Document. The drug-evaluation document should present the evidence in a manner that is thorough, is consistent from medication to medication, and provides all necessary facts and analysis to the P&T committee to allow for an informed formulary decision. Document structure may vary, depending on the needs of the specific health system and P&T committee, but the following elements are essential to all such documents: