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.     

How to develop a proactive formulary system

To develop a quality formulary system, a proactive approach is necessary. This approach incorporates a prospective product and concurrent product analyses. A prospective product analysis, in turn, involves a review of current formulary agents, those likely to enter the marketplace shortly, and the formation of an expert review panel. This panel's tasks are to examine therapeutic, economic, and humanistic aspects of therapy and to set initial parameters for appropriate and cost-effective use of accepted products. Keys to a successful formulary system are to continuously monitor drug use and compliance with criteria and to work collaboratively with all institutional professionals in the development, implementation, and monitoring of the system.     

Determining the formulary status of quinolone antibiotics: one institution's approach

Streamlining antibiotic therapy--ie, simplifying regimens, route of administration, or both--is necessary in the modern treatment of hospitalized patients with infectious diseases. Due to their pharmacokinetic profiles and comparative efficacy and safety, the quinolone class of antibiotics is an ideal class for which to direct streamlining efforts. Including only one agent of this class on the formulary, however, is inadequate. Having several quinolones available, and thus expanding the local hospital market for them, enables more physicians to be contacted and educated by manufacturers' sales representatives as part of the hospital's antibiotic management program. By assisting in the education efforts, pharmaceutical representative help to conserve hospital resources, both in terms of cost and personnel. In addition, having more than one supplier of quinolones encourages competition, which favors price reductions.     

Computer-based system for maintaining and printing a hospital formulary

Use of a pharmacy department personal computer (PC) with database management and word processing (WP) systems to maintain a hospital formulary is described. Data input and formatting were accomplished with IBM-PC/XT-compatible equipment, the Nutshell (Leading Edge) database management system, and the Wordperfect (WordPerfect Corporation) WP system. Computer-generated pages were photocopied and placed in loose-leaf binders; reduced copies were made for pocket-size binders. The cost of an outside printing service was eliminated, and the loose-leaf format made it possible to replace only the pages with revisions. The large binders were prominently placed and clearly marked to encourage use by physicians; the number of copies needed was reduced because individual copies were no longer provided to each physician. Excluding first-year one-time costs, the annual formulary maintenance cost (for 250 copies) was projected to be approximately one sixth the cost incurred previously, when 1300 bound formularies were printed annually. Maintaining and printing the hospital formulary on a PC facilitated the updating of the formulary and reduced printing costs.     

Evaluating a restrictive formulary system by assessing nonformulary-drug requests

Nonformulary-drug requests were used to evaluate a restrictive formulary system in a large university hospital, and a telephone survey of eight similar hospitals was conducted to assess the restrictiveness of their formulary systems. Nonformulary-drug requests were evaluated by two drug information pharmacists over a 12-month period (January-December 1984) to assess the frequency with which nonformulary items were ordered, the costs associated with the procurement of nonformulary drug products, and the rationales given by physicians when ordering nonformulary products. Of all nonformulary requests, 65% were for drugs previously evaluated by the pharmacy and therapeutics committee and denied admission to the formulary. A cost savings of $1887 would have resulted if formulary alternates had been used instead of nonformulary products. Excluding 22% of nonformulary items that were requested for the continuation of preadmission drug therapy, only 13% of the rationales for the remaining requests were appropriate. Although the eight other hospitals surveyed said they had restrictive formularies, all had frequent requests and procedures for procuring nonformulary items and some formularies included most available drugs. The formulary system at the study hospital was considered restrictive, but procedures for nonformulary-drug requests limited the effectiveness of the system. If any benefit is to result from formulary systems, hospitals must strengthen their enforcement of formulary restrictions.     

AMCP Format dossier requests: manufacturer response and formulary implications for one large health plan

BACKGROUND: The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions, a template for health plans to use in developing formulary submission guidelines, has been widely adopted since its initial release in 2000. Many health plans request a dossier (a standardized set of clinical and economic evidence prepared by pharmaceutical manufacturers) to provide information for consideration during the formulary decision-making process. While dossier quality has reportedly improved over time, there is no recent research examining the response rate to dossier requests and the quality of dossiers received. OBJECTIVE: To perform an evaluation of pharmaceutical manufacturers. response to a request for a product dossier prepared using the AMCP Format, and to determine if dossier receipt was associated with a favorable formulary placement. METHODS: The pharmacy and therapeutics (P&T) committee of a mid-Atlantic health plan with approximately 3 million members reviewed 43 drug products from February 2004 through December 2005. A university-based clinical evaluation subcontractor requested dossiers in the AMCP Format by telephone and e-mail from the manufacturers. drug information center about 8 weeks before the committee meeting. A retrospective evaluation of the materials received from the manufacturers was performed. A logistic regression model was developed to determine if dossier receipt increased the likelihood of second-tier copayment formulary placement for new product reviews. RESULTS: Dossiers were requested for 43 products. We received dossiers for 25 products (58%), other drug information (e.g., journal reprints, product labeling) for 10 products (23%), a formulary kit for 4 products (9%), and no response for the remaining 4 products (9%). Of the 25 dossiers, 21 (84%) generally followed the AMCP Format. Unlocked interactive budget impact models were included in 5 dossiers (20%), and modeling reports (without an unlocked interactive model) were included in 12 dossiers (48%). Dossiers were more likely to be received when the time between U.S. Food and Drug Administration (FDA) approval and dossier request was >/- 4 months (65% vs. 27% when <4 months; P <0.05) and when requested from a large manufacturer (top 25 in sales) compared with smaller manufacturers (75% vs. 43%; P <0.05). Dossier receipt did not improve a product.s likelihood for preferred formulary placement; none of the new products for which dossiers were received were assigned to the second copayment tier compared with 33% of the new products with no supporting dossier. The logistic regression model failed to find any correlation between dossier receipt and preferred formulary placement. CONCLUSIONS: Manufacturers met the request for a dossier nearly three fifths of the time. The dossiers were of high quality and generally followed the AMCP Format; the models included in dossiers varied widely in their design and utility. The product manufacturer.s size and the time between FDA approval and dossier request influenced the likelihood of dossier receipt. Receipt of a dossier did not appear to influence the likelihood of a product attaining preferred formulary status.     

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.     

Managing drug shortages: seven years' experience at one health system.

A health system's experience in monitoring drug shortages since 1996 within the organization and since 2001 on a national level is described. Since January 1996, the Drug Information Service (DIS) at the University of Utah Hospitals and Clinics (UUHSC) has systematically prepared written bulletins to affected practitioners when drug shortages occurred. The DIS began providing information on a national level to the American Society of Health-System Pharmacists in January 2001. A total of 224 drug shortages were tracked from January 1996 to June 2002. All shortages at UUHSC were also national shortages, but only about two thirds of national shortages also affected UUHSC. The most common reasons for shortages were manufacturing problems (28%) and product discontinuation (20%). The most frequently represented pharmacologic-therapeutic categories were central nervous system agents (24%) and serums, toxoids, and vaccines (17%). Of the 119 shortages in 2001, 70 (59%) were still ongoing as of the end of June 2002. The most common potential safety problems were that clinicians might be unfamiliar with the alternative agent (54%) and that the alternative's dosage requirement was different (50%). Over half of the shortages were cost neutral, but the assessment did not include substantial potential indirect costs. Detailed information on drug shortages collected by a health system's drug information service since 1996 indicated a trend toward more frequent shortages.     

Pregnancy and the nephrologist: a review of one year's experience

A study was undertaken to assess the role that a nephrologist can play in modern obstetric practice. During 1981, 699 pregnant women were screened for covert bacteriuria. Thirty (4.3%) had bacteriuria and 24 were treated and followed through pregnancy. Acute pyelonephritis occurred in two. One of 21 intravenous urograms was abnormal. Fifteen women were seen with pregnancy-associated nephrological problems (complicated pre-eclampsia (7), reflux nephropathy (3), glomerulonephritis (3), essential hypertension (2). All women with preeclampsia had a normal intravenous urogram and recovered completely. Pregnancies in women with renal disease or essential hypertension had good outcomes for mother and baby if there was no renal insufficiency and blood pressure control was maintained.     

Therapeutic decision-making: a model for formulary evaluation

A systematic approach of evaluating medications for a hospital formulary is discussed. The hospital formulary is a program of objective evaluation, selection, and use of medicinal agents in the hospital. In light of the ever-increasing numbers of new and/or improved therapeutic agents, formulary decisions must be made with an eye to the future. Therefore, it appears that the best means of choosing a medication for formulary addition, both clinically and economically, is to choose an agent based on its clinical indication(s). Examples of such indications are presented. Selecting formulary agents by indication rather than by simple drug cost or pharmacologic class should ensure the most effective utilization of therapeutic agents and hopefully a diminution of overall costs.