Drug usage guidelines, Part 2: Analysis of program outcome

The effect of integrating a Drug Usage Guidelines (DUG) program with a hospital formulary system was analyzed. Significant changes were observed in both the number of requests submitted to the P & T Committee and the number of drugs added to the formulary after implementation of the DUG program. Failure to follow the DUG submission protocol, particularly with respect to the requirement for supportive clinical data from the primary literature, led to delayed consideration and eventual withdrawal of several highly promoted drug products. The initial involvement of physicians in the planning and implementation of the DUG program has been an important factor in the continued success of the program.     

Strengthening the formulary system by implementing a drug usage guidelines program

The development and implementation of a Drug Usage Guidelines (DUG) program in a 1,200-bed, federal teaching hospital are described. The program was designed to promote effective formulary control through established procedures for the review and evaluation of drugs submitted to the Pharmacy and Therapeutics (P & T) Committee for addition to the formulary. The procedures required the submission of the DUG and an oral presentation to the Committee prior to any final vote on the request. Anticipated potential benefits of the DUG program are to: (1) stimulate rational drug therapy, (2) provide reliable drug information to the professional staff in a usable format, (3) promote a thorough evaluation of therapeutic agents before approving for formulary inclusion, and (4) provide physician-generated guidelines for use as criteria in drug utilization review audits.     

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.     

A survey of selective administration procedures in formulary maintenance

The survey attempts to examine various Pharmacy and Therapeutics (P & T) Committees' activities for indications of a rational and objective approach to drugs and the hospital formulary. The objectives were: 1) to gain insight as to how drug products attain formulary listing by examining select P & T Committee's reasons for adding and deleting drugs; 2) to determine whether P & T Committees are attempting to follow generally accepted guidelines for the operation of the formulary system; and 3) to determine how the hospital pharmacist is responding to the rational and/or irrational drug selection by the P & T Committee. The results showed that the hospitals studied appeared to be acting in agreement with the guidelines presented. Definitive statements concerning the activities of the pharmacist and the rational approach of the P & T Committee to the hospital formulary could not be made. The author recommends that P & T Committees begin documenting the methods they utilize to promote and maintain the formulary system in hospitals. This information should be used as an educational tool by the P & T Committee.     

Preparing the P & T committee agenda for new drug requests

Preparing an agenda is an important element in conducting an effective P & T Committee meeting. A key responsibility of P & T Committee members is reviewing the rationale for formulary requests. Therefore, it is generally an agenda item. This article describes a process for planning, preparing, and distributing agenda materials for a committee meeting. A specific format and sequence for reviewing new drugs for formulary admission and criteria for selecting new drugs are discussed.     

Formulary decision making: identifying factors that influence P&T committee drug evaluations.

This study identifies outcomes related to hospital formulary decision making and estimates the importance of 16 specific types of data to five P & T Committees during the formulary decision making process. The two most important outcomes, according to the Committee members involved in this study, were the effects of the potential formulary addition on the quality of drug treatments available in the hospital followed by its impact on hospital costs. Information about the therapeutic advantage of the potential drug addition, the relative adverse effect profile, and cost information were viewed as especially important. On the other hand, promotional literature provided by pharmaceutical companies and letters of evaluation from respected physicians at hospitals other than their own, were not viewed as important. By understanding the factors involved in hospital formulary decision making, strategies encouraging optimal formulary decisions may be developed.     

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.     

Organization and operation of P & T Committees in the state of Florida: a survey

To determine the structure and function of P & T Committees in Florida, a survey was initiated. Questionnaires were mailed to all 289 hospitals in the state. Topics addressed included hospital demographics (type of service provided, institution ownership, hospital size), P & T Committee structure (size of the committee, membership breakdown by specialty, chairman specialty, number of meetings per year), formulary additions (personnel authorized to request drug additions, process for adding drugs to the formulary, monitoring new drug use), and formulary systems (prevalence of therapeutic interchange programs, methods of communicating formulary changes). Overall survey response rate was 71.5%. In general, P & T Committees in Florida appear to be functioning at a relatively high level. Since there is little current information about the composition and operation of P & T Committees in hospitals around the country, it is hoped that this survey will be useful to P & T Committees that wish to upgrade or expand their activities.     

Computer-based support system for formulary decisions

A system is described in which opinions about potential formulary drugs are given numerical values that are compiled into computer-generated reports. The Formulary Decision Support System (FDSS) is a menu-driven database management and statistical package that quantifies pharmacy and therapeutics (P & T) committee drug evaluations. Each P & T committee member inserts numbers on a computer-generated form to rate a given drug for a given indication according to criteria such as effectiveness, cost, and adverse reactions. Each individual rates the drug in relation to the ideal drug for a given indication and rates the relative importance of the criteria in the evaluation (e.g., effectiveness may be twice as important a consideration as cost). Individuals' evaluations are weighted on the basis of level of responsibility and experience or specific practice area. FDSS also compiles individuals' data to indicate overall committee ratings. The system requires P & T committee members to covert subjective opinions to numerical data that permit comparisons among drugs.     

Achieving an effective committee through reorganization: the Ohio State University Hospital's experience

The P & T Committee at Ohio State University (OSU) Hospitals, Columbus, is unique in that it accomplishes the bulk of its tasks through subcommittees. Four subcommittees are currently in place: a formulary subcommittee, a policy and surveillance subcommittee, an antibiotic subcommittee, and a therapeutic drug monitoring subcommittee. An advantage to this method of organization is that it allows for much more medical staff involvement in P & T Committee activities. Other unique aspects of this P & T Committee are that it is responsible for maintaining both an inpatient and outpatient formulary, and it provides decision-making services for a specialty cancer hospital. Expansion of their drug usage evaluation program, further development of their therapeutic monitoring program, and improved communication with the medical staff are future goals of this P & T Committee.     

Challenges of a P & T Committee in a community teaching hospital

Lutheran General Hospital, a 650-bed, tertiary care and trauma center in Park Ridge, Illinois, has had a P & T Committee in place for 11 years. In this exclusive Hospital Formulary interview, David Cooke, MD, and Jackie Kessler, MS, the respective chairman and secretary of that committee, discuss the challenges their committee faces. Somewhat unique to a community hospital, this committee manages a relatively restricted formulary. They attribute their success to dedicated P & T Committee members and a committed pharmacy. Among the more difficult issues still to be resolved at Lutheran General are relationships between pharmaceutical companies and P & T members and the possible institution of a conflict-of-interest disclosure policy, as well as the never-ending battle of evaluating drug use in their institution.     

Operation, formulary decision-making activities of a P & T Committee in a managed care setting

Managing drug benefits in a Health Maintenance Organization (HMO) is perhaps best accomplished through a formulary, as demonstrated by Kaiser Permanente of Colorado. According to Dr. Jim Adams and Ms. Jackie Richardson, the Chairman and Secretary, respectively, of Kaiser Permanente's P & T Committee, since the advent of their formulary only a few years ago, the cost of drugs has been kept well under control, without jeopardizing the quality of care. Both physician and patient education are critical to the success of a formulary in a managed care system--both monumental tasks for Kaiser Permanente of Colorado considering that prescribers exceed 300 and the number of patients they treat approaches 250,000. What is clear in this exclusive Hospital Formulary interview is that HMOs--long recognized for their ability to control costs--can also provide quality health care for patients who use their facilities.     

P & T Committee formulary requests: criteria for admission

The criteria for P & T Committee members to consider when adding or deleting a product to the formulary are discussed. Although each institution will require and develop different standards that reflect the characteristics of the patient population they serve, two general sets of factors should be studied. The anticipated needs of the institution and the therapeutic application of the medication in consideration must be identified. Furthermore, the characteristics of the drug, including pharmacokinetics, biopharmaceutics, and cost must be clearly defined. The P & T Committee formulary decisions are critical in ensuring high-quality, cost-effective health care.     

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.     

P & T Committee role in advocating rational therapeutics.

In this P & T Committee interview with Richard Borreson, MD, issues concerning rational therapeutics in a VA Medical Center setting are identified. Dr. Borreson discusses the frustrations the Houston VA Medical Center P & T Committee encounters in promoting prescribing practices that are therapeutically sound and yet cost-effective. Although their P & T Committee is very active and productive, Dr. Borreson suggests that more effort is needed to educate staff in the cost-effective selection of drugs. The process that the Houston VA has adopted for adding drugs to the formulary and the reporting of adverse reactions as required by the Joint Commission on Accreditation of Hospitals (JCAH) are also discussed.     

The use of pharmacoeconomic evidence to support formulary decision making in Saudi Arabia: Methodological recommendations

In pharmacoeconomics the costs and consequences of alternative medications are compared. Many countries have begun to use pharmacoeconomic evidence to support decisions on licensing, pricing, reimbursement, or addition to the formulary. In Saudi Arabia, it is not mandatory to submit cost effectiveness evidence to support licensing or addition to the formulary decisions however, data will be considered if submitted. Previous evidence suggests that the use of pharmacoeconomic evidence by Saudi Pharmacy and Therapeutic (P&T) committee members in formulary decisions making process is limited mainly because of lack of expertise and lack of resources. This paper intended to provide Saudi P&T decision makers with a clear set of best practice methodological recommendations to help in increasing the utilisation of pharmacoeconomic evidence in the formulary decisions making process.     

Pharmacoeconomic series: Part 3. Applying pharmacoeconomic and quality-of-life measures to the formulary management process

P & T Committees were established as an institution's primary organizational tool for the development and maintenance of the formulary. Traditionally, P & T Committees have focused on the safety, efficacy, and acquisition cost of medications to be considered for formulary approval. Today, the impact of pharmaceuticals on patients' quality-of-life and total health care expenditures are increasingly important considerations to be weighed by P & T Committees. Pharmacoeconomic analyses and quality-of-life outcomes represent valuable contributions to the formulary decision-making and management process.     

Developing guidelines for biotechnology drug use: experience with antithrombin III

Development of institutional guidelines for use of high-cost biotechnology drugs, such as antithrombin III, is a valuable tool in formulary management. This article describes the process by which the University of California Davis Medical Center used an ad hoc committee to the P & T Committee to develop guidelines for antithrombin III use. Performing an objective analysis of available literature to address the appropriate role of a biotechnology agent is necessary to develop consensus guidelines. Approval of use guidelines by the P & T Committee provides the necessary structure for optimal use of biotechnology agents, such as antithrombin III.