ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Abstract

These guidelines outline important considerations and recommend processes for formulary system management within the context of a hospital or health system. Pharmacist responsibilities and roles in managing the formulary system in partnership with other healthcare professionals are embedded throughout. 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 consideration of rational use of medications, and development and implementation of strategies to optimize medication use through the formulary system. A glossary of terms is provided in the Appendix A. A formulary is a continually updated list of available medications and related information, representing the clinical judgment, resulting from a review of the clinical evidence, of physicians, pharmacists, and other clinicians 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 healthcare organization establishes policies regarding the use of drugs, therapies, and drug-related products, including medication delivery devices, and identifies those that are most medically appropriate, safe, 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 These guidelines focus on the use of formulary systems in hospitals and health systems, in both inpatient and outpatient settings. Formulary systems have evolved over time. Early formularies began as rudimentary drug lists developed by the military as early as the Revolutionary War and came into more widespread use during the 1950s.9 Pharmacists, in conjunction with their organizations, developed policies to dispense generic equivalent drugs when a specific brand-name drug was prescribed. In the late 1950s, the ASHP minimum standard for pharmacies in hospitals called for the implementation of a formulary system.10 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.11 ASHP and the American Hospital Association (AHA) issued joint statements on the legality of formularies.12,13 The American Medical Association (AMA) and the American Pharmaceutical (later Pharmacists) Association (APhA) subsequently joined with ASHP and AHA to revise the statements.14 In 1965, two significant events occurred: (1) Medicare listed formularies as a reimbursement eligibility requirement15 and (2) the Joint Commission on Accreditation of Hospitals (now known as the Joint Commission) included an active P&T committee in its accreditation requirements.16 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 emerged. Evidence from the hospital setting was published first, soon followed by evidence from the ambulatory care environment.11 This literature led to more widespread acceptance of formularies by providers, payers, and industry.5,17 Today, formulary systems are considered an essential tool for healthcare organizations to foster interprofessional efforts to promote the rational use of medications. 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.18 The P&T committee is generally the medical staff committee responsible for managing the formulary system. The P&T committee provides an evaluative, educational, and advisory service to the medical staff and organizational administration in all matters pertaining to the use of available 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’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. The description of organization and authority becomes even more important as healthcare facilities merge into larger health systems. Typically, P&T committee member appointments and voting rights are made based on guidance from the medical staff and other affected stakeholders. Voting members may include facility medical staff, other prescribers, pharmacists, nurses, and administrators, and are a representative sample of the organization. If the scope of the P&T committee includes a health system, site representation needs to be addressed to ensure equitable input and voting authority from each facility. Additional supporting P&T committee members may include quality improvement managers, medication safety leaders, informaticists, other healthcare professionals and staff who participate in the medication-use process, and patient and family engagement advisors. The P&T committee should have the following administrative components in place to maximize meeting effectiveness: Charter Role of the P&T secretary and/or formulary manager Committee and subcommittee(s) responsibility and scope Process to track attendance Definition of quorum Process to allow (or disallow) delegation of vote Process to appeal committee decisions Defined term limits for members Process for identifying, disclosing, addressing, and reporting conflicts of interest (COIs) Policy and procedures Approach to voting, including roll call votes to ensure transparency Scope of committee responsibility (eg, specific site or entire system; inpatient or outpatient sites; drugs, devices, and biologics) Process for managing minutes, agendas, record keeping, and communication of decisions made Other responsibilities of the P&T committee include medication-use evaluation (MUE), adverse drug event monitoring and reporting, medication error prevention, medication safety, and development of clinical care plans and medication management initiatives (eg, delegation and practice protocols, restrictions, guidelines and clinical pathways). Information these is available in ASHP guidelines on the of a formulary system and the to make formulary decisions consideration of patient care and a review of the Voting members should be to provide statements to or with healthcare organizations healthcare professionals with from P&T committee allow in committee but voting on or to the formulary should also be to with companies, payers and insurance companies, and other to the P&T of should be in organizational policies and systems should and a formulary management This process should not be based on economic The formulary system should have aspects of and be within health systems when to patient safety, and on the management of a formulary system should be on the safety, and economic that in patient The process include the active and of physicians, pharmacists, and other healthcare as well with in and of a formulary system is a significant of a healthcare organization’s ongoing medication-use policy development A formulary is to the organization’s patient care policy and medication-use systems with medication management of A formulary system a the organization’s medication-use policies, the by the and the medications stocked in the pharmacy. A formulary also identifies those medications that are most medically and cost-effective to best serve the health interests of the health patient The P&T committee should review all medications Appendix used in the health system. These may include and drugs, and other and treatment policies may to be for P&T committee evaluation of not by the and (eg, The formulary system should review and all policies related to the medication-use all medication-use policies, of their should through the P&T The organization’s medical staff the to which the P&T committee should the policy Policy review and should as becomes available and (eg, The organization should have medication-use policies that the medications are for to or from the formulary medications are for to or from the including who the and when drug are The process for and monitoring medication-use guidelines and policies for the and monitoring of medications for of for specific medications the pharmacy is responsible for for the and of of all medications, and used in the and treatment of The process for within the hospital and health system The process for managing The process for managing drug The process for an organization or health regarding specific medication-use processes (eg, and The process for medication-use policies and be regarding the process Process for over medication delivery (eg, error of medication through prior processes and patient assistance of P&T committee decisions into the health record A process to review medication-use policies should be in This process may include the use of or of the P&T or should serve in an advisory to the P&T and their should include in their of The P&T committee may also that specific to be (eg, adverse drug or and are in clinical to specific patient and strategies for the and use of medications. and members of who significant formulary representing those affected by the may also be The P&T committee should have communication with other may the medication-use These include those responsible for to medication use (eg, or review those with safety or improvement (eg, quality improvement or patient safety those in patient care policies (eg, medical and those with medications (eg, review and other may medication use (eg, and and or patient and family engagement from other of the P&T and should be to the P&T committee for P&T committee decisions on should be to the in a the of and medical in a healthcare organization should be guidelines should and with such a these guidelines should the of or and regarding formulary and medications. for formulary should be and by the healthcare and not by an representative or to on with for more on with The P&T committee should use a process in the evaluation of medications for formulary The P&T committee should be provided with that a and review and of the evidence available in the The evaluation process should consideration of clinical and care delivery information, foster patient and and medication and made by the P&T committee should patient care the of including considerations regarding patient to medications is a to the evaluation of literature and to clinical practice and should be to formulary for medication and the quality of patient care and cost-effective practice be in and the literature to clinical of a medication on a health formulary or the of a medication-use should an the to and the literature to formulary and of evidence (eg, clinical may be in the different of evidence are available for those with evidence should be used to formulary decisions (eg, Other of evidence have a in the process, and may be when evidence is not and and may be even when evidence is organizations to evidence when formulary are available for evidence and are not the available to in the formulary and and may be in formulary published are not may be to into the review in practice have to or that may into formulary The formulary process should be by an review of evidence published in the of and use of and Appendix for a description of the of used in such If a P&T committee medication by a should with the the of these may be Information used in the formulary process should be provided to the P&T committee in a with a standard (eg, a drug drug provided in the should be to the evidence or as a by of or should be Formulary (eg, from drug or may be included in the should the formulary or of a as well as the for restrictions, or policies and procedures to ensure and use within the health system. and should be in when medications. These should the of the (eg, healthcare and should include consideration of all and to that medications considered are to be equivalent to equivalent and the is appropriate. In these is important to with the medication and (eg, of hospital and to and the in to an in clinical is is not used for formulary of its and for evidence or The value of in its to (or be to a of clinical when an that is more but or more to is for a given improvement in is to recommend of quality to This be used to a in clinical with the use of a be by the in other that even is important to the site of care for administration of the the in to an in clinical for medication may also be by to patient in formulary the related to the use of to be when published are limited or for each be from the published literature or from which provide a more on with medications and should those of the healthcare system. published in the medical literature or provided in the formulary should be included as of the review should be to the made in these In many made to economic are not in are different from the used in published and should be used when their into medication Even a evaluation is not included in a drug review a evaluation be including consideration of site of and to the pharmacy and to the organization as a of a medication from a formulary may of and to the In a formulary system, for medications listed on the formulary are the drug of the formulary system should include an process that provides and with to medications that are not on the formulary but are medically for the care of the The for such a process is that patient needs may not be by use of the formulary medications. The formulary process should on medication use that the P&T committee to in such for of medications should be developed (eg, to or of formulary not by formulary and guidelines for use should be considered for medications patient safety have a and are and on regulations, may be developed and the process, to provide lists of and medications for by or to specific patient such as Medicare systems specific rules and provided the Medicare of in their evaluation and of medications in a Medicare formulary for those medications to be strategies for managing medication use the formulary include use of generic drugs, and policies, clinical practice and the of medication and products available from the pharmacy patient care and These are through the use of generic considered by drug The use of generic is in to provide the best care an of generic drugs that have by not review or by the P&T a review of all generic medications for safety (eg, should be to medication when drug such as those with a a more evaluation of the and of or the P&T committee should be considered a generic The P&T committee should policies and procedures the of generic when products are These policies and procedures should include the following The is responsible for from available generic those drugs to be to a for a The the the of to the or of the drug to be for that medication considered The should be based on or considerations (or to that A is a that is to and no from an have as by and of these products on formulary should be considered as a for management of the medication-use system. are not equivalent to the the P&T committee should be in the to include these products on The for also be including and restrictions, and reimbursement of payers, in clinical or the and the and are considerations when are available for the a review of for each of the should as the that each may to each other and the a as even a not have in its should be to treatment with the be to the In in which a to be should be to by the when a with an In in which an may to have both a and a on should be to these are in the to ensure the is is the authorized of in with and policies, or within a formulary for are drug products with different that are to have and safety when to in equivalent provides pharmacists with the to use a formulary in place of a medication or a formulary medication to the interchanges are into the to allow for of formulary A process should be for when the to of the initiatives should be to ensure that affected pharmacists, nurses, and other healthcare is of the may be to the formulary with processes in place to the use of the medications to adverse or guidelines for use for both and should be developed based on the medical of strategies to the use of medications may include the the the medication is A process should be developed to in which the patient not the but the medication is to be medically This may also be when medications are in A specific service the use of the drug This be used when use or adverse may and also be for when use or in and a to the patient or the of a specific medication may be limited to a specific of (eg, use of to policies be when administration of a medication or staff with to use the medication (eg, to and care This is when the P&T committee a medication and that the drug or no in the care of that organization but a to use the medication on a This may also be used as an for medications for use of outlined in the practice guidelines are developed and by and organizations, but also be developed the medication formulary is a of clinical practice guidelines in a organization or is that the guidelines and formulary are If a specific medication is by a clinical practice should in the of be on the formulary are may to be from or in guidelines. should use of medications, and be in medication use and the use of formulary products when are developed to or medication that the care of may not the and to and a may be medication specific or disease and may in their scope of The development of a clinical practice should with the of all available evidence the In many guidelines from other organizations, both and be used as a for The process, and input from is from the organization should be used to make decisions during the the process is the should be and by the P&T The and implementation of guidelines in the practice also be the of guidelines is should be available through If is to the guidelines into the system (eg, through to the care of the should include a for review and If of a medication is guidelines for evidence to safety and should be provided and to the P&T should be in the organization’s to managing medications to ensure the pharmacy the to provide medications in a to patient to medications, and provide of ASHP to in pharmacy including the ASHP This provides guidance on the medication to the site of care for patient administration or to the who to the site of care for administration to in management of pharmaceuticals is is the delivery of a from a health pharmacy to the site of is is a quality improvement but also be considered a formulary system management have to the health with be used to of the medication-use process based on be to or used to the of such as the of a to the formulary or the implementation of a medication-use on or medications, be used to of medication use that is to the the to the formulary should be is the for use or adverse This review should to their to the or medications and of specific disease are also for A to and medication use should be within the a is an accreditation for many organizations (eg, Joint The P&T or its should be in the to on for more an The P&T committee should medication and patient safety as of its The P&T committee should ensure that medication-use policies and safety Hospital or including should be by the P&T with to The P&T committee should also review available on medication or patient safety events by other organizations to to medication events and the to healthcare when appropriate, a medication for on the the P&T committee and its supporting or should adverse or safety, and or administration If a a the of should be to ensure the the formulary decisions for medications that have should be processes in place to ensure both during implementation and on an ongoing should be to safety by use of the and strategies to those should be by the P&T In quality improvement to the safety of specific medications or to the processes should be and by the P&T The P&T committee should (eg, to medication that provide on medication or patient safety events include the for and The Joint for and on provide and of and on their and of the to and decisions made by the P&T committee is should be to drug policy and formulary management The should provide guidance on and the of and A standard process, including for should be developed to and these decisions into the systems and delivery that the and formulary review process should the of implementation efforts should be with and in the and available to implementation into the should with the P&T committee to ensure and of the In with and drug policy and formulary management decisions should with on the and of systems to drug patient care and all aspects of the medication-use system, including systems, the and During a drug the P&T committee an important The P&T committee needs to strategies to in a including strategies for use of available drug and use of these strategies should be developed based on available literature and best be in with drug The P&T committee should with other and such as specific medical and management to management plans for the of drug is not to from P&T committee members prior to implementation of strategies is a for make the P&T committee is of all related to drug organizations should include a drug as a for the P&T with and staff is to of these strategies into the is for implementation of a drug strategies for communication in the including on medications, the of medications on and the of medication or to use of during the of the managing drug be in the ASHP on be used to medication-use The policy should be into the processes that the use of a medication during or into a treatment Other specific of a medication-use policy may include the use of pharmacists and and or institutional may be in the value of a medication-use policy and that P&T committee members are in their of the hospital and health policies and reimbursement strategies related to medications. A to managing a reimbursement and be and reimbursement for medications is hospitals and health systems no focus on and inpatient health systems and systems of medication reimbursement by Medicare, Medicaid, and If policies also be to of drugs, in with the should be a in plans for and The organization should have a process and responsible for reimbursement of and over time. include site of care decisions in a medication be organization should have policies on the use of medications not by the hospital pharmacy. medication and use or patient to medications or during of care care needs to be and systems to be in place to ensure of medication use and to the to of to medications during an inpatient that may be A formulary system is the process by an organization to and use medications that the best and for should the process to continually medications are used within the organization all in the medication-use use is an process that to all and processes to the of and medication in the medication-use process to and the organization’s medication-use policies and processes be into their to ensure medications are used and many to make those processes more and the related to medication use is a that organizations to to ASHP the following organizations and for these guidelines not American Association of A. ASHP also the of of of these A. and The have no conflicts of through the ASHP on and by the ASHP of on These guidelines the ASHP on the and Committee and the Formulary and the ASHP on the and Committee and the Formulary A for the in health to the of different health A of the of different procedures with their in that to a of and are most as quality A of a medical that is by the over and may include all of the administrative clinical to that care a including medications, medical and A continually updated list of medications and related information, representing the clinical of physicians, pharmacists, and other in the diagnosis, prophylaxis, or treatment of disease and promotion of health. ongoing process a healthcare through its physicians, and other healthcare establishes policies on the use of drug products and and identifies drug products and that are the most medically and cost-effective to best serve the health interests of a given patient population.1 The of drug products that the active or and are in and of administration to the drug medications, sample medications, or and used on or to to or disease or other medications, and with and/or and by the and as a This of medication not include are considered and other medical A and improvement with an of patient ongoing evaluation and improvement of medication advisory committee that is responsible for and a formulary system. may to committee by a different products with different but of the or and have and when to in equivalent of in with and guidelines or within a formulary The of a for the drug prior of the This is an the may an of are of drug drug of formulary and of medications. of the and of pharmacists in pharmacists should an in the and of the drug review to the pharmacy and therapeutics (P&T) the and a drug for that is to the health system, a drug should be for formulary consideration by the P&T a evaluation and a drug A (eg, be provided with the organizations use an A drug that is to other available may be in a more (eg, an provided that the P&T committee or that the drug is equivalent to available on the Formulary decisions may to be based on or in of drugs or on safety, of or may a of the drug or or stocked by the health system. to the the should be developed for evaluation by the P&T The P&T committee may to the of formulary review that the committee the of a formulary on quality or of of an entire of drugs should be which may be by the P&T committee or by A review should include all formulary and medications within the and may include institutional or and published may to formulary of equivalent drugs or a in or for a A process should be available for the P&T committee to an review of a for a or of a formulary should be in place to when an review is of a for a disease with no may an review to ensure of the drug for who a significant safety may an review for of or from the

Topics & Concepts