Pharmacoeconomics and formulary decision making

Pharmacoeconomic assessment of formulary actions has become increasingly common in local, national, and international formulary decision making. Tactics for managing medication use include formulary management and drug policies. Pharmacoeconomic data can provide support for these formulary decisions. For example, pharmacoeconomic data can support the inclusion or exclusion of a drug on or from the formulary and support practice guidelines that promote the most cost-effective or appropriate utilisation of pharmaceutical products. Various strategies can be used to incorporate pharmacoeconomics into formulary decision making. These include using published pharmacoeconomic studies and economic modelling techniques, and conducting local pharmacoeconomic research. Criteria for evaluating the pharmacoeconomic literature, suggestions for employing economic models, and suggested guidelines for conducting pharmacoeconomic projects are discussed. Although most formularies are viewed as cost-containment tools, formularies should not be a list of the 'cheapest' alternatives. Today's formulary should contain agents that optimise therapeutic outcomes while controlling cost. Pharmacoeconomic assessments of formulary decisions help to ensure that the agents promoted by our formularies yield the highest outcome per dollar spent. A discussion of the process for formulary action in a US hospital, the influence of pharmacoeconomics on US formularies, and strategies for incorporating pharmacoeconomics into formulary decision making are presented in this paper.     

Content validity of indicators of the appropriateness of long‐term prescribing started during a hospital admission

Fifty‐seven hospital pharmacists and 31 GP practice‐based pharmacists responded to a questionnaire (response rate 43 per cent) to assess 14 indicators The three most important indicators overall were “indication in discharge summary”, “questionable high‐risk therapeutic combination” and “hazardous drug‐drug combination” The three least important indicators were “less suitable for prescribing according to BNF”, “indication upheld in BNF” and “drug in hospital formulary” Assessment of content validity requires a panel of experts rather than a representative sample     

Controversies in antimicrobial therapy: formulary decisions on third-generation cephalosporins

Factors affecting the admission of antimicrobial agents to hospital formularies are discussed, using third-generation cephalosporins as examples. Inappropriate antimicrobial therapy is costly in terms of wasted drugs, ineffective therapy, and drug toxicity. In 1984, 10 of the top 15 drug products (in sales to hospitals) were antimicrobial agents; these accounted for $1 billion in sales. Since third-generation cephalosporins are very similar in terms of spectra, clinical efficacy, and safety, they are useful in illustrating the process a hospital might use in deciding which individual agent to admit to a formulary. Five factors should be considered in formulary evaluations of antimicrobial agents: in vitro activity, pharmacokinetic disposition, adverse effects, clinical efficacy, and total economic impact. As applied to third-generation cephalosporins, this decision analysis leads to the conclusion that these agents should be considered therapeutic alternates. The decision would then rest solely on the institution-specific factors of microbial susceptibility patterns, patient case-mix, and acquisition costs. Antimicrobial agents account for the largest financial expenditure among hospital drug products; a set of these agents should be selected carefully to meet the needs of the individual institution.     

Safety, efficacy, and lipid profile of doxazosin at a VA medical center

The Veterans Administration Lakeside Medical Center (VALMC) is a 500-bed hospital located in downtown Chicago providing a broad scope of inpatient and outpatient medical services for more than 12,000 veterans. The VALMC Pharmacy and Therapeutics Committee requested a study to evaluate doxazosin mesylate (Cardura) to determine if this agent would be an acceptable alternative to other formulary agents. It appears that doxazosin provides several therapeutic advantages, including once-daily dosing, when compared with other more costly antihypertensive agents.     

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.     

Use of ampicillin-sulbactam before and after formulary inclusion

The use of ampicillin-sulbactam before and after the product was formally placed on a hospital formulary is described. In October 1987 the pharmacy and therapeutics committee at an acute-care institution granted ampicillin-sulbactam temporary formulary inclusion on the condition that its use be audited. Formal inclusion was to be based on the results of this preinclusion audit. A second audit was to be performed if formal inclusion was granted. The data were collated after each audit, and for each patient an infectious-disease consultant proposed an alternative antimicrobial regimen representing what would probably have been prescribed had ampicillin-sulbactam not been available. Sixty-four patients received the product during the six-month preinclusion audit period. Ampicillin-sulbactam was given to 37% of the patients for indications listed in FDA-approved labeling. The dosage was considered appropriate in 88% of the patients. Clinical outcome was considered successful in 84% of the patients who received the product for known infections. Therapy with ampicillin-sulbactam was less expensive (by $4125) in 35 patients and more costly (by $1523) in 29 patients; the projected annual savings were $7805. After formal inclusion on the formulary, ampicillin-sulbactam was prescribed for some 700 patients over a 16-month period. A review in 49 patients showed appropriate indication and dosage for 63% and 84% of the patients, respectively, and an 84% rate of therapeutic success. The extrapolated cost savings were $26,429 per year. After formulary inclusion, the use of ampicillin-sulbactam increased, as did the frequency of its use for indications appearing in FDA-approved labeling.     

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.     

医院处方集应用中存在的问题及对策探讨

医院处方集是医院药学信息服务工作的一项重要内容,是提高医院药事管理水平、促进合理用药的重要工具和手段。处方集的编制和管理也成为医院药事管理中非常重要的一项工作内容,但依靠传统模式编制、管理的处方集,在应用中存在的不足或弊端已不能满足医院合理用药及药事管理发展的需要。本文分析了医院处方集目前的应用现状及存在问题,对医院处方集建设的发展思路进行探讨。     

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.     

Building a better online formulary.

The history of and improvements made to the University of Michigan Health System (UMHS) inpatient online formulary are described. The current formulary at UMHS is the third version of the Web-based formulary. The original effort in 1997 consisted of converting word-processing documents to HTML format and exporting this information to the university's intranet. There was no mechanism to search for formulary items, no therapeutic class cross-referencing, and no cost information. Documents and their conversion had to be manually maintained. The second version incorporated a series of automatic daily computer downloads from the inpatient pharmacy computer system. Web pages were built to dynamically display the formulary information from the database based on users' requests. The formulary enabled searching by brand or generic names, provided therapeutic category cross-references, listed the location of products within automated dispensing cabinets, provided accurate cost information, and was always up-to-date. Maintenance efforts drastically decreased. The current version has incorporated additional logic to meet users' needs. If no matches are found, the system expands its search by automatically linking to UMHS's inpatient pharmacy system repository of all drugs, finding matches to what the user entered, and then returning the names of therapeutically similar formulary agents to the user. A cross-index feature allows the system to return all the drugs that fall under the searched therapeutic category. Dramatic improvements have been made to UMHS's inpatient online formulary in the past two years. The current formulary provides a very low-cost, easily maintainable, and effective means to access the formulary and clinically relevant and timely information specific to each medication.     

Institution-specific versus published in vitro antimicrobial susceptibility data in making formulary decisions

The results of susceptibility testing of 549 isolates of gram-negative organisms to 17 antimicrobial agents were compared with published reports of the sensitivity of those organisms to those agents. All gram-negative bacilli isolated from cultures obtained from hospitalized patients during a three-month period were preserved for antimicrobial sensitivity testing. Standard Kirby-Bauer disk diffusion susceptibility tests were performed using 17 broad-spectrum antimicrobial agents that either were included in the hospital formulary or were being considered for inclusion. Organisms were recorded as being sensitive or resistant to each drug, and the results were compared with the published results of in vitro sensitivity studies. When the results of actual antimicrobial sensitivity testing varied from published results, the discordant results were assigned a ranking of 1 to 4 based on the percentage difference. In 34 of 77 drug-organism pairs tested, the results of susceptibility testing differed by more than 10% cumulative susceptibility from published values; 26 of these represented instances in which the results of actual testing were at least 10% less than published values. For seven of the antimicrobial agents that were being considered for inclusion in the hospital formulary, results indicating unexpectedly suboptimal activity against institutional pathogens were a determinant in eliminating the agents from further consideration. In vitro testing of antimicrobial susceptibility of local pathogens can be a better method of predicting the susceptibility of such pathogens to new antimicrobial agents than relying on published susceptibility data. Pharmacy and therapeutics committees should consider testing prevalent institutional pathogens for susceptibility to all antimicrobial agents that are proposed additions to the formulary.     

Rule-based standardised switching of drugs at the interface between primary and tertiary care

Introduction Changes in drug treatment are frequently mandatory with hospital admission and discharge because hospital drug formularies are generally restricted to about 3000 drugs as compared to the many times this number – 62,000 in Germany – that are commercially available. Without computerised support, the process involved with switching drugs to a corresponding generic or a therapeutic equivalent is time-consuming and error-prone. Methods We have developed and tested a standardised interchange algorithm for subsequent implementation into a computerised decision support system that switches drugs to the corresponding generic or a therapeutic equivalent if they are not listed on the hospital drug formulary. Results The algorithm was retrospectively applied to the medication regimens of 120 patients (774 prescribed drugs containing 886 active ingredients) at their time of admission to surgical wards. Of the prescribed drugs, 52.8% (409/774) were part of the hospital drug formulary, thereby rendering a switch unnecessary. The 365 drugs not listed consisted of 392 active ingredients that were successfully switched to a corresponding generic (84.7%) or a therapeutic equivalent (10.2%). No specific switching procedures were defined for only 2.3% (20/886) of the active ingredients. In these cases, the drugs were either discontinued (4/20) or special drug classes, current diseases or co-medication required manual switching (8/20), or the drugs were continued unchanged and ordered from a wholesaler (8/20). Conclusion Using a standardised interchange algorithm, pre-admission drug regimens can successfully be switched to drugs on a hospital drug formulary. These findings suggest that a computerised decision support system will likely be useful to support this important practice.     

Total formulary review--the easy way

In an effort to minimize drug costs, many hospital pharmacy services have limited their drug inventories through the development of a formulary. Evaluation of drug products for addition to the formulary is the responsibility of the Pharmacy and Therapeutics (P & T) Committee. The deletion of rarely used or outdated products is often overlooked. As a means to "clean up" the formulary, Hamot Medical Center (HMC) underwent a total formulary review. Drugs were separated into classes as defined by the American Hospital Formulary Service (AHFS). Approximately three drug classes were evaluated each month by the P & C Committee. Evaluation criteria was based on the following factors: current formulary status, usage statistics, negative comments appearing in six current publications, hospital acquisition cost, and number of formularies containing each product. A final compilation of all deletions and additions were distributed to all medical staff department and division chiefs. Following receipt of all their comments, a final draft of the formulary was made and prepared for publication. This system is a simple, uncomplicated means of either revising or beginning a formulary. It evaluates a drug based on efficacy, individual hospital usage, and cost of the drug while allowing for input of the medical staff. The end result is a formulary tailored to best fit each institution.     

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.     

Reducing costs with formulary limitation of H2-receptor antagonists in a community hospital

Cost containment has become a major issue for all hospital pharmacies. At Carney Hospital, a 366-bed community hospital, where H2-receptor antagonists accounted for 10% of a $1.5 million total drug budget, the search for cost savings led to a move from an open to a limited formulary for the H2-receptor antagonists. Cimetidine and ranitidine, the two most widely used agents of this class, are considered equivalent in terms of safety and efficacy. Prior to formulary limitations, however, most H2-receptor antagonist orders were written for ranitidine, the more expensive agent. Carney Hospital, a member of the Daughters of Charity hospital purchasing group, was able to participate in an advantageous H2-receptor antagonist cost agreement by limiting its formulary to cimetidine. After the first 9 months of the closed formulary program, Carney had realized cost savings of $33,220. At that time, cimetidine accounted for 96% of all parenteral H2-receptor antagonist orders, testifying to physician satisfaction with this agent. Finally, 85% of the parenteral cimetidine orders were written q8h, which was essential to the success of the cost savings program.     

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.     

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.     

医院处方集的基本概念和建立方法

医院处方集是医院药学信息服务工作的一项重要内容，也是提高合理用药水平的重要工具。本丈综述了医院处方集的概念、发展、目的、内容，以及建立医院处方集的基本原则和方法，目的是为编制和管理医院处方集，合理用药服务提供一个参考。     

Results of an antimicrobial control program at a university hospital.

PURPOSE: The results of the first five years of an ongoing antimicrobial control program are reported. METHODS: In 1998, a multidisciplinary antimicrobial subcommittee of the pharmacy and therapeutics committee of a university hospital was formed and charged with making formulary interventions in an effort to reduce rising antimicrobial resistance rates and drug expenditures. In 1999, a number of measures were implemented for controlling antimicrobial use. Selected antimicrobials with the potential for inappropriate use or whose inappropriate use had been documented were placed in the control of physicians in the infectious diseases (ID) division. Prior approval by an ID physician was required before the pharmacy could dispense these agents. Other key interventions included removal of ceftazidime and cefotaxime from the formulary, restriction of vancomycin and carbapenem use, and replacement of ciprofloxacin with levofloxacin as the sole fluoroquinolone on the formulary. Data regarding antimicrobial use and expenditures between 1998 and 2002 were compared and analyzed. RESULTS: Antimicrobial use was reduced by 80% for third-generation cephalosporins and 15% for vancomycin following the implementation of the new antimicrobial policies. Antimicrobial-resistance patterns for many important gram-negative pathogens, including Pseudomonas aeruginosa, demonstrated a reversal of previous increases. In addition, the rate of methicillin-resistant Staphylococcus aureus decreased by an average of 3% each year from 1999 to 2002. Pharmacy expenditures for all antimicrobials, including antiviral, antifungal, and antibacterial agents, decreased 24.7%, with a cumulative cost saving of 1,401,126 US dollars, without inflation assumptions. CONCLUSION: The implementation of an antimicrobial control program decreased the use of selected antimicrobial agents and resulted in substantial reduction of expenditures for antimicrobials.     

Implementing an automatic fluoroquinolone therapeutic interchange program in a community hospital

A community hospital developed an automatic therapeutic interchange program for fluoroquinolone antibiotics. After considering efficacy, available formulations, and cost, this P&T Committee selected ciprofloxacin (Cipro) as the class representative for formulary use. The steps taken to implement this automatic therapeutic interchange policy are presented.