The Pharmacy and Therapeutics Committee Part 1: overview

The Pharmacy and Therapeutics (P & T) Committee is an important medical staff advisory group. As the primary, formal communication link between the pharmacy and medical staff, the P & T Committee is of particular importance to the department of pharmacy services. All matters pertaining to the use of medications within the institution, including pharmacy programs, must be reviewed and approved through the committee. In addition, medication formulary data is reviewed through the committee and recommendations are offered to the medical staff. Such a wide diversification of involvement and activity necessitates the effective communication between all committee members. An active involvement in the committee by the department of pharmacy services is vital in order to develop a contemporary and progressive institutional pharmacy program. This series of four articles will address several important aspects of the committee's operation, including committee formation, mechanics, operation, and problem solving.     

Activities, functions, and structure of pharmacy and therapeutics committees in large teaching hospitals.

The results of a survey on the activities and functions of hospital-based pharmacy and therapeutics (P&T) committees are presented. Questionnaires were mailed to the pharmacy director or the person responsible for the pharmacy's drug information service at 267 teaching hospitals throughout the United States in 1994 and 1995. The survey questions covered P&T committee composition, functions, roles of members, policies and procedures, and formulary-maintenance activities. The overall response rate was 70%. The mean number of members on the P&T committees was 19.3, of whom 91% were allowed to vote. There was an average of 12.3 physicians on the committees. Each P&T committee had at least one pharmacist member, with an average of 3.2 pharmacist members; 69.5% of the institutions reported having a committee secretary, who was almost always a pharmacist. On almost all committees, pharmacists wrote the minutes, prepared the formulary review documents, and were responsible for monitoring formulary activities outside the meeting. The P&T committee functioned in a very formal manner. Most (87.7%) of the respondents reported that their institutions had a closed formulary. At all hospitals, the attending medical staff could request additions to the formulary, but at only 62.4% of the hospitals could pharmacy staff make a similar request. The committees were active in changing the formulary. P&T committees in large teaching hospitals are active in formulary management, are large and diverse, and consist mainly of physicians, although pharmacists play an important role in the meetings.     

Drug usage review and inventory analysis in promoting rational parenteral cephalosporin therapy.

Drug usage review and inventory analysis data on the cephalosporin antibotics were presented by the pharmacy to a hospital pharmacy and therapeutics committee in an effort to promote rational use of these drugs and decrease drug costs. The committee recommended that cefazolin be the parenteral cephalosporin of choice. Cephalothin was placed on a limited formulary status for ophthamology patients and patients with renal impairment. Efforts by the committee to promote physician compliance with its recommendations are discussed.     

The formulary decision-making process in a health maintenance organisation setting

The goal of a health maintenance organisation (HMO) is to provide high quality, cost-effective healthcare services and products which meet the needs of the membership. Providing and managing pharmaceutical products and services within the HMO is a major aspect of accomplishing this goal. Several decisions must be made in developing, implementing and maintaining a formulary system. The numbers of people seeking their healthcare from HMOs in the US has increased 4-fold in 10 years, and several model types of HMOs have developed, including network HMOs, group HMOs, independent practitioner associations and staff models. HMOs utilising formulary systems provided cover to 76% of enrollees in 1992. Formulary system management and decision making entails the use of open vs closed formularies and the role of the pharmacy and therapeutics (P & T) committee. Product selection takes into account efficacy, safety, costs, patient acceptance, ease of use, dosage forms, preparation requirements, stability and storage requirements and the reputation of the manufacturer and the service it provides. We list and describe various policy decisions which HMO pharmaceutical decision makers must address if the formulary system is to become an efficient tool for the HMO.     

Controlling financial variables--changing prescribing patterns

Techniques of formulary management, pharmacy and therapeutics committee intervention, and the use of clinical pharmacy services to change prescribing patterns and contain costs in hospital pharmacy departments are reviewed. Methods of using the formulary to contain costs include deletion of generic and therapeutic equivalents, inclusion of therapeutic categories and cost codes, and regular reviews and updates of its contents. Drug monographs for formulary evaluation prepared for the P & T committee should include a comparative review of other drugs in the therapeutic category and a cost impact statement. The P & T committee can help contain costs by developing policies for automatic stop orders and restricted drug use. Clinical pharmacy activities that can result in cost savings include physician education (focused on prescribing), target drug programs, target disease programs, pharmacist participation on TPN and i.v. therapy teams, and patient training programs for home care. A matrix for evaluating cost-containment activities is presented. By tailoring the described methods to departmental personnel resources and hospital needs, the pharmacy can be effective in controlling costs.     

The formulary decision-making process in a US academic medical centre

This article reviews and describes the formulary decision-making process in an academic medical centre. The pharmacy and therapeutics (P & T) committee is the organisational nucleus of the drug use control process in the institutional environment. Thomas Jefferson University Hospital (TJUH), a 720-bed academic medical centre in an urban locality in the US, is used as a model representative of how most of these committees function. Survey responses collected from 29 peer academic medical centres are presented to compare and contrast the structure and function of the P & T committee at TJUH with corresponding procedures in other university hospitals in the US. TJUH is typical of the institutions which comprise the University Hospital Consortium (UHC). The P & T committee of TJUH is composed of 29 members, meets once per month for 10 months of the year, and has a network of 13 subcommittees. TJUH has an intermediately controlled (mixed) formulary, and uses both restricted drugs and treatment guidelines. Of the 29 UHC member institutions responding to the survey, the average P & T membership is 18, the average meeting frequency is 11 times per year, and 83% of these committees have a network of subcommittees. None describe their formulary system as open, 86% have a closed formulary and 14% have a mixed formulary system. There is a restricted drug programme in 76% of the institutions, 79% utilise treatment guidelines, 76% practice therapeutic interchange and all employ generic substitution. Specific areas addressed in this review include the history of the formulary system, the structure and function of the P & T committee, types of formularies, cost containment and the formulary decision-making process, the impact of organisational culture on physician decision making, the role of the pharmacy department, the role of pharmaceutical sales representatives and their impact on prescribing habits, the impact of the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) Agenda for Change on the formulary process, and future challenges.     

Justifying additional pharmacist staff in an era of cost reductions

A proposal is described that justified adding one full-time equivalent (FTE) pharmacist in a 125-bed community hospital that already employed in its pharmacy department 2.5 FTE pharmacists and 5.2 FTE other personnel. The administrative steps taken included identifying the need for an additional staff member and documenting the cost effectiveness of various clinical activities. Literature references were used to justify the proposed ratio of pharmacists to technicians; to show the results of deficiencies in supervision, motivation, and scheduling; and to demonstrate the cost effectiveness of serum concentration monitoring, formulary review, and patient discharge-medication consultations. Results of formulary review, drug-use audits, dosing guidelines, and serum concentration monitoring performed by the pharmacy department were included in the proposal. Prospective drug-use reviews, computerized pharmacokinetic dose determinations, additional educational programs, and tighter purchasing policies were identified as other cost-saving activities that could be performed with an additional pharmacist. A 12-page proposal was submitted in July 1983 to the hospital administrator and the budget review committee, and the additional staff position was approved. The key to maintaining the new pharmacist position will be the continual documentation of cost-saving activities within the department.     

Application of economic analyses in U.S. managed care formulary decisions: a private payer's experience

BACKGROUND: Promoting use of pharmaco-economic models by formulary reviewers is a goal of the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions, but relatively few decision makers use such models, and many doubt that they provide meaningful input. OBJECTIVE: To demonstrate how sophisticated disease-based pharmaco-economic models can aid formulary decision makers when long-term outcomes data are lacking. METHODS: The Center for Outcomes Research (CORE) Diabetes Model (CDM), a published, validated Markov pharmaco-economic model that projects clinical and economic endpoints, was used to model the cost-effectiveness of exenatide, a new injectable antidiabetic agent that enhances glucose-dependent insulin secretion, in a standard cohort of type 2 diabetes patients (mean body mass index [BMI] = 27.5 3 kg/m2), compared with a modified obese cohort (mean BMI = 35 3 kg/m2) that was otherwise demographically identical at baseline to the standard cohort. The standard cohort was assumed to maintain baseline weight during treatment, and the modified obese cohort was assumed to experience weight loss of approximately 9% (mean = 3 kg/m2), with corresponding improvements in blood pressure, low density lipoprotein cholesterol, and triglycerides. We selected a 30-year time horizon because it was the time interval during which the CDM predicted most of the subjects would have died, and the costs obtained thus reasonably projected lifetime total direct medical costs for these cohorts. While treatment options certainly will change over a 30-year period, our goal was to estimate the incremental effect of exenatide over other available therapies. RESULTS: The model predicted reduced long-term treatment costs in obese patients, driven by an 11% decrease in cardiovascular disease burden and derived from the presumed weight loss. The incremental cost-effectiveness ratio (ICER) for adding exenatide over 3 years was 35,000 dollars/quality-adjusted life-year (QALY). Using a 30-year horizon, ICER values were 13,000 dollars/QALY versus insulin, 32,000 dollars versus generic glyburide, and 16,000 dollars versus no additional treatment. Exenatide dominated pioglitazone. By comparison, the 30-year ICER for exenatide versus insulin in the nonobese cohort was 33,000 dollars. These results were presented to the pharmacy and therapeutics (P&T) committee and influenced its decision to add exenatide to the drug formulary. While our modeling assumed certain patient characteristics (e.g., obesity, need of further A1c reduction at baseline, motivation to lose weight), the P&T committee imposed only a step-therapy requirement to try either metformin or a sulfonylurea before trying exenatide and did adopt a nonspecific requirement for physician reauthorization of refills before the fourth pharmacy claim for exenatide. CONCLUSIONS: Disease-based pharmaco-economic models may help third party payers project costs and be particularly useful when only data from short-term clinical trials are available. In the present case, the pharmacy staff of a health plan used a pharmaco-economic model for drug treatment of type 2 diabetes provided by the manufacturer as part of the AMCP Format dossier process to project cost outcomes for exenatide, adjunct injectable therapy for patients taking metformin and/or sulfonylurea. The P&T committee approved the drug for inclusion in the drug formulary based in part on the results of the pharmaco-economic model produced from the cost inputs entered into the model by the health plan pharmacists.     

Formulary evaluation of third-generation cephalosporins using decision analysis

A structured, objective approach to formulary review of third-generation cephalosporins using the decision-analysis model is described. The pharmacy and therapeutics (P&T) committee approved the evaluation criteria for this drug class and assigned priority weights (as percentages of 100) to those drug characteristics deemed most important. Clinical data (spectrum of activity, pharmacokinetics, adverse effects, and stability) and financial data (cost of acquisition and cost of therapy per day) were used to determine ranking scores for each drug. Total scores were determined by multiplying ranking scores by the assigned priority weights for the criteria. The two highest-scoring drugs were selected for inclusion in the formulary. By this decision-analysis process, the P&T committee recommended that all current third-generation cephalosporins (cefotaxime, cefoperazone, and moxalactam) be removed from the institutions's formulary and be replaced with ceftazidime and ceftriaxone. P&T committees at other institutions may structure their criteria differently, and different recommendations may result. Using decision analysis for formulary review may promote rational drug therapy and achieve cost savings.     

Experience with intrainstitutional clinical evaluations of newly marketed preparations as a basis for drug-product selection to hospital formularies

The decision to admit a new drug-product formulation (NDPF) to a hospital pharmacy formulary is a difficult task, particularly when minimal pharmacokinetic or clinical efficacy data are available. To provide objective information to the Pharmacy and Therapeutics (P&T) Committee, we implemented a procedure to evaluate these NDPFs at our institution. This procedure, termed clinical evaluation, was initiated at our institution in 1981. The clinical evaluations of two NDPFs were performed. The two NDPFs studied were a transdermal nitroglycerin preparation and a sustained-release procainamide preparation. The clinical assessment of the therapeutic and the pharmacokinetic performance of each preparation was made by clinical pharmacists. Following completion of the clinical evaluation, the data were presented at a regular meeting of the P&T committee. The presentation of clinical data derived from our patient population facilitated objective assessment by the P&T committee regarding formulary status. We conclude that the clinical evaluation represents a novel approach to acquire data necessary for objective decisions on NDPFs by the P&T committee.     

Cephalosporins: use review and cost analysis

The prescribing patterns for the cephalosporins and the cost-savings following restriction of cephalothin sodium and approval of cefazolin sodium were studied over a three-year period at a university hospital. The prescribing patterns for cefazolin relative to dose, frequency, duration of therapy and clinical indications were studied for 64 patients during a one-month period. Parenteral cephalosporin use for three years was analyzed to determine comparative use rates and costs. For the most part, cefazolin was used properly during the one-month study. The greatest misuse was as prophylactic therapy in postsurgical patients. The switch from cephalothin to cefazolin resulted in a projected annual savings of $5,500, equal to more than 10% of the hospital's expenditures for parenteral cephalosporins. The prescribed daily dose of cephalosporin dropped by one-third following the formulary change. The decision to use cefazolin as the major parenteral cephalosporin resulted in substantial cost savings.     

Experience with a two-tiered therapeutic interchange policy

A university hospital's formulary policy for therapeutic interchange is described in which pharmacists can routinely interchange some drugs but must contact the prescribers before interchanging other drugs. For drugs that are not automatically interchanged by the pharmacy, the formulary contains a "class representative," which pharmacy may change as relative prices of drug products change. When a non-formulary drug for which there is a designated class representative is prescribed, pharmacy contacts the prescriber. When a class representative for injectable histamine H2-receptor antagonists was being selected, previous positive and negative experiences with establishing therapeutic equivalence for antimicrobial agents were considered. The implementation of H2 antagonist therapeutic equivalence included the following steps: determining potential cost savings, reviewing the literature, consulting with specialty practitioners, presenting the information to the pharmacy and therapeutics committee, distributing formal bids, and educating hospital staff. Before cimetidine was designated the class representative, 84% of orders for injectable H2 antagonists were for ranitidine; one year later, 90% were for cimetidine. Orders for oral H2 antagonists also changed from predominantly ranitidine to predominantly cimetidine. The hospital's total costs for H2 antagonists decreased 8.4% in one year. The two-tiered approach to therapeutic interchange can reduce drug costs and increase the scope of agents deemed therapeutic equivalents in a manner that is acceptable to physicians and pharmacists.     

Survey of formulary system policies and procedures.

A telephone survey was conducted to determine the policies and procedures of hospital formulary systems. Directors of pharmacy at a random sample of 150 community hospitals were interviewed, and letters were sent to each respondent requesting copies of the formulary and drug evaluation form. One hundred thirty hospitals completed the interview (gross response rate of 87%), and 35 evaluation forms and 49 printed formularies were received. Almost all hospitals had a formulary system and a printed formulary; the most frequently stated purposes were to decrease costs and to ensure appropriate therapy. Most formularies received were simple drug lists with no supporting information. The typical pharmacy and therapeutics committee consisted of 11 members, met every month, and reported to the executive committee. About 80% of the responding institutions had formal procedures for considering formulary additions. Less than half had standardized drug evaluation forms. Most hospitals have a formulary system and a printed version of the formulary; however, the formulary often serves primarily as a drug list, with no supporting information.     

P & T Committee perspectives: maintaining a successful formulary system in a private community hospital

Institution of an effective formulary and P & T Committee is a difficult but critical task for many private hospitals. In this exclusive Hospital Formulary interview, Drs. Benner, Mykita, and Brown, members of Sutter Memorial Hospital's Pharmacy, Formulary, and Therapeutic Review Committee (their name for the P & T Committee) emphasize the need for a sound formulary system in order to survive the current changes in health care. Sutter Memorial is sophisticated in its delivery of healthcare services, which include advanced neonatology and state-of-the-art heart transplantation. Although good patient care remains the foremost concern, these committee members acknowledge that care must be affordable as well as therapeutically sound. Key to their committee's success is the cooperative effort among the pharmacy, nursing, and medical staff. They foresee the issue of rational therapeutics as a major challenge in the 1990s.     

Multiattribute evaluation in formulary decision making as applied to calcium-channel blockers

The use of multiattribute utility theory (MAUT) to make a formulary decision involving calcium-channel blockers (CCBs) is described. The MAUT method is a procedure for identifying, characterizing, and comparing the many variables that may affect a decision. Although applications in pharmacy have been infrequent, MAUT should be particularly appealing to formulary committees. The steps of the MAUT method are (1) determine the viewpoint of the decision makers, (2) identify the decision alternatives, (3) identify the attributes to be evaluated, (4) identify the factors to be used in evaluating the attributes, (5) establish a utility scale for scoring each factor, (6) transform the values for each factor to its utility scale, (7) determine weights for each attribute and factor, (8) calculate the total utility score for each decision alternative, (9) determine which decision alternative has the greatest total score, and (10) perform a sensitivity analysis. The viewpoint of a formulary committee in a health maintenance organization was simulated to develop a model for using the MAUT method to compare CCBs for single-agent therapy of chronic stable angina in ambulatory patients for one year. The attributes chosen were effectiveness, safety, patient acceptance, and cost and weighted 36%, 29%, 21%, and 14%, respectively, as contributions to the evaluation. The rank order of the decision alternatives was (1) generic verapamil, (2) brand-name verapamil, (3) diltiazem, (4) nicardipine, and (5) nifedipine. The MAUT method provides a standardized yet flexible format for comparing and selecting among formulary alternatives.     

Pharmacokinetics of five cephalosporins in healthy male volunteers

This paper deals with data on the pharmacokinetics of cephazolin, cephalothin, cephapirin, cephaloridine and cephradine after i.m. injection of a single dose of 0.5 g in healthy male volunteers. Peak serum concentrations occurred 45 min after the administration and were 31.52 microgram/ml for cephazolin, 17.32 microgram/ml for cephaloridine, 13.98 microgram/ml for cephapirin, 9.51 microgram/ml for cephradine and 8.60 microgram/ml for cephalothin. The average half-lives were found to be 2.07, 1.80, 0.98, 1.24 and 0.97 h, respectively. The percentage of protein binding was found to be 82 for cephazolin, 59 for cephalothin, 51 for cephapirin, 31 for cephaloridine and only 10 for cephradine, half an hour after drug administration. The total urine recovery of the above cephalosporins, within 24 h, was 91.9% for cephradine, 81.9% for cephaloridine, 73.3% for cephazolin, 69.5% for cephapirin and 51.2% for cephalothin.