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ASHP Statement on the Pharmacy and Therapeutics Committee and the Formulary System
American Society of Health-System Pharmacists (ASHP) believes that health systems should develop, organize, and administer a formulary system that follows the principles below in order to optimize patient care by ensuring access to clinically appropriate, safe, and cost-effective medications.
Background
A formulary is a continually updated list of medications and related information, representing the clinical judgment of pharmacists, physicians, and other experts in the diagnosis and treatment of disease and promotion of health.1 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. The multiplicity of medications available, the complexities surrounding their safe and effective use, and differences in their relative value make it necessary for health systems to have medication-use policies that promote rational, evidence-based, clinically appropriate, safe, and cost-effective medication therapy. The formulary system is the ongoing process through which a health care organization establishes policies on 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.
Pharmacy and Therapeutics Committee
To be effective, medication-use policies must have the concurrence of individuals involved in the medication-use process. Such consensus is achieved by developing medication-use policies through a properly organized and representative pharmacy and therapeutics (P&T) committee or equivalent body and ensuring that those policies are approved by the organized medical staff.
The P&T committee is composed of actively participating 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 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 that pertain to the use of medications (including investigational medications). The P&T committee is a policy-recommending body to the medical staff and the administration of the organization on matters related to the safe and therapeutic use of medications. 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 basic policies and procedures that govern the P&T committee’s administration of the formulary system should be incorporated, as appropriate, in the health system’s medical staff bylaws, medical staff rules and regulations, and other organizational policies.
The overarching purposes of the P&T committee are policy development, communication and education, and formulary management.
Policy Development
The P&T committee formulates policies regarding evaluation, selection, diagnostic and therapeutic use, and monitoring of medications and medication-associated products and devices. The P&T committee should establish and assist in programs and procedures that ensure safe and effective medication therapy (e.g., clinical care plans, treatment guidelines, critical pathways, disease management protocols). Members of the P&T committee, or their representatives from appropriate specialties (including pharmacists), should participate in or direct the development and review of such programs or procedures, which should be kept current.
The P&T committee should participate in performance improvement activities related to procurement, prescribing, dispensing, administering, monitoring, and overall use of medications. The P&T committee should advise the institution, including the pharmacy department, in the implementation of effective medication distribution and control procedures, incorporating technological advances when appropriate. The P&T committee should initiate, direct, and review the results of medication-use evaluation programs to optimize medication use and routinely monitor outcomes (economic, clinical, and humanistic) of formulary decisions. Medication-use evaluation should result in performance-improvement initiatives to improve the medication-use process.
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