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Pharmacy and Therapeutics Committee and the Formulary System

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Pharmacy and Therapeutics Committee and the Formulary System applyparastyle “fig//caption/p[1]” parastyle “FigCapt” ASHP REPORT ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System management within the context of a have policy statements on the use of Am J Health-Syst Pharm. 2021;78:907-918 hospital or health system. Pharmacist formularies.2-8 These guidelines focus Downloaded from https://academic.oup.com/ajhp/article/78/10/907/6224888 by ASHP Member Access, [email protected] on 10 June 2021 Christy Ciccarello, PharmD, MHA, responsibilities and roles in managing on the use of formulary systems in hos- Vice President, Clinical Pharmacy Services, Novant Health, Winston-Salem, the formulary system in partnership pitals and health systems, in both in- NC, USA with other healthcare professionals patient and outpatient settings. Molly Billstein Leber, PharmD, BCPS, are embedded throughout. These FASHP, Associate Director, Drug Use guidelines also provide assistance to Evolution of formularies Policy and Formulary Management, Yale New Haven Health System, New Haven, pharmacists in the organization and Formulary systems have evolved CT, USA operation of the pharmacy and thera- over time. Early formularies began as Mandy C. Leonard, PharmD, BCPS, peutics (P&T) committee or equivalent rudimentary drug lists developed by the System Director, Drug Use Policy and body, evaluation of medications for for- military as early as the Revolutionary Formulary Management, Department of Pharmacy, Cleveland Clinic, Cleveland, mularies and consideration of rational War and came into more widespread OH, USA use of medications, and development use during the 1950s.9 Pharmacists, in Todd Nesbit, PharmD, MBA, FASHP, and implementation of strategies to conjunction with their organizations, Director of Pharmacy Patient Care optimize medication use through the developed policies to dispense gen- Services, The Johns Hopkins Health System, Baltimore, MD, USA formulary system. A glossary of terms is eric equivalent drugs when a specific provided in the Appendix A. brand-name drug was prescribed. In Mary G. Petrovskis, PharmD, BCPS, PGY2 Health-System Pharmacy the late 1950s, the ASHP minimum Administration Resident, University of Formulary and standard for pharmacies in hospitals North Carolina Medical Center, Chapel formulary system Hill, NC, USA called for the implementation of a for- A formulary is a continually up- mulary system.10 Emily Pherson, PharmD, BCPS, Assistant Director, Medication Use Policy dated list of available medications During the 1960s, the concept of a & Clinical Informatics, The Johns Hopkins and related information, representing hospital formulary continued to grow. Health System, Baltimore, MD, USA the clinical judgment, resulting from Hospitals developed policies that au- Heidi A. Pillen, PharmD, FASHP, a review of the clinical evidence, of thorized pharmacists to make generic Director of Pharmacy, Clinical Services & Medication Use Policy, Beaumont Health, physicians, pharmacists, and other interchanges in an institutional for- Southfield, MI, USA clinicians in the diagnosis, prophylaxis, mulary system based on prior con- 11 Celia Proctor, PharmD, MBA, Assistant or treatment of disease and promotion sent from physicians. ASHP and the Director, System Formulary Management of health. A formulary includes, but American Hospital Association (AHA) & Integration, The Johns Hopkins Health System, Baltimore, MD, USA is not limited to, a list of medications issued joint statements on the legality of and medication-associated products formularies.12,13 The American Medical Jennifer Reddan, PharmD, FASHP, Pharmacy Executive Director, Excelerate, or devices, medication-use policies, Association (AMA) and the American Vizient, Irving, TX, USA important ancillary drug information, Pharmaceutical (later Pharmacists) decision-support tools, and organiza- Association (APhA) subsequently Address correspondence to Bruce tional guidelines. A formulary system joined with ASHP and AHA to revise Hawkins ([email protected]) is the ongoing process through which the statements.14 In 1965, two signifi- a healthcare organization establishes cant events occurred: (1) Medicare Keywords: formulary, formulary system, pharmacy and therapeutics committee, policies regarding the use of drugs, listed formularies as a reimbursement medication-use evaluation, quality therapies, and drug-related prod- eligibility requirement15 and (2) the improvement, pharmacoeconomics ucts, including medication delivery Joint Commission on Accreditation devices, and identifies those that are of Hospitals (now known as the Joint © American Society of Health-System most medically appropriate, safe, and Commission) included an active P&T Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals. cost-effective to best serve the health committee in its accreditation require- [email protected]. interests of a given patient population.1 ments.16 Even with these actions, for- DOI 10.1093/ajhp/zxab080 Formulary systems are used in many mularies were typically no more than different settings, including hospitals, lists of drugs stocked by the pharmacy. acute care facilities, home care settings, By the 1980s, literature describing Purpose and long-term care facilities, as well as the clinical and economic value of These guidelines outline im- by payers such as Medicare, Medicaid, well-designed formularies emerged. portant considerations and recom- insurance companies, and managed Evidence from the hospital setting mend processes for formulary system care organizations. Many organizations was published first, soon followed by AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 10 | May 15, 2021 907 ASHP REPORT GUIDELINES ON P&T COMMITTEE AND FORMULARY SYSTEM evidence from the ambulatory care en- healthcare professionals and staff who required to provide COI statements vironment.11 This literature led to more participate in the medication-use pro- to avoid actual or perceived interfer- widespread acceptance of formularies cess, and patient and family engage- ence with evidence-based decisions.23 by providers, payers, and industry.5,17 ment advisors. Some healthcare organizations exclude Today, formulary systems are con- The P&T committee should have healthcare professionals with COIs from sidered an essential tool for healthcare the following administrative compo- P&T committee membership, whereas Downloaded from https://academic.oup.com/ajhp/article/78/10/907/6224888 by ASHP Member Access, [email protected] on 10 June 2021 organizations to foster interprofessional nents in place to maximize meeting others allow participation in committee efforts to promote the rational use of effectiveness: discussions but prohibit voting on par- medications. Formularies have grown ticular items. Practitioners requesting from simple drug lists to comprehen- • Charter additions or changes to the formulary sive systems of medication-use policies • Role of the P&T secretary and/or should also be required to disclose fi- intended to ensure safe, appropriate, formulary manager nancial relationships with pharmaceut- and cost-effective use of pharmaceut- • Committee and subcommittee(s) re- ical companies, payers and insurance icals in patient care.18 sponsibility and scope companies, and other potential COIs • Process to track attendance to the P&T committee. Management P&T committee • Definition of quorum of COI should be specified in organiza- The P&T committee is generally the • Process to allow (or disallow) delega- tional policies and procedures. medical staff committee responsible tion of vote for managing the formulary system. • Process to appeal committee Managing the The P&T committee provides an evalu- decisions formulary system ative, educational, and advisory service • Defined term limits for members Health systems should develop, to the medical staff and organizational • Process for identifying, disclosing, maintain, and implement a formulary administration in all matters pertaining addressing, and reporting conflicts of management process. This evidence- to the use of available medications. The interest (COIs) based process should not be based P&T committee should be responsible • Policy and procedures solely on economic factors. The for- for overseeing policies and procedures • Approach to voting, including roll call mulary system should have aspects related to all aspects of medication use votes to ensure transparency of financial stewardship incorpor- within an institution. • Scope of committee responsibility ated and be standardized within The P&T committee’s organization (eg, specific site or entire system; integrated health systems when stand- and authority should be outlined in inpatient or outpatient sites; drugs, ardization leads to improved patient the organization’s medical staff bylaws, devices, and biologics) outcomes, safety, and cost-effective- medical staff rules and regulations, and • Process for managing minutes, ness. Decisions on the management of other organizational policies, as appro- agendas, record keeping, and com- a formulary system should be founded priate. The description of organization munication of decisions made on the evidence-based clinical, ethical, and authority becomes even more im- legal, social, logistical, philosophical, portant as healthcare facilities merge quality-of-life, safety, and economic into larger health systems. Other responsibilities of the P&T com- factors that result in optimal patient Typically, P&T committee member mittee include medication-use evalu- care.24-26
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