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.     

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.     

Hospital policies regarding herbal medicines.

The prevalence and content of herbal policies and herbal formularies in the hospital setting were studied. Drug information centers affiliated with hospital pharmacies were surveyed by telephone. Hospitals with policies on herbal products were asked to provide detailed information about the policies. Of 70 hospitals included in the analysis, 53 (76%) had policies and procedures on the use of herbal products. Three hospitals (4%) reported having an herbal formulary. A majority of the existing policies required a physician order for an herbal product to be used inhouse. Many of the policies also required pharmacists to verify labeled product ingredients. Product administration, patient consent, and drug interaction screenings were addressed by some hospitals. Most hospitals reported having policies on the use of herbal products, but herbal formularies were rare.     

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.     

Improving patient care and pharmacy management: the effect of hospital formularies

A study of the organizational features and implementation procedures associated with formulary use in major acute-care hospitals throughout Australia was undertaken. Data were collected via a questionnaire mailed to 57 directors of pharmacy. An 86-percent response was obtained. A high proportion of formularies was found to rate poorly in terms of organizational features (e.g., content, compilation methods, format) and process variables (e.g., effectiveness as a communication document, prescribing aid, or management tool). Methods of improving formulary effectiveness are outlined in the context of practical and normative research, including improving the quality of drug therapy, use of formularies in cost control, and improving user acceptance. The results confirm previous research showing that methods of improving organizational features and implementation procedures associated with formulary compilation and use are neither widely applied nor widely known. There is an urgent need to reassess the usefulness of formularies and improve their effectiveness by adopting recommendations resulting from past research.     

Literature review on the structure and operation of Pharmacy and Therapeutics Committees

Aim of the review To review the literature on the structure and operation of hospital Pharmacy and Therapeutics Committees from an international point of view and examine the factors that influence decision-making of these committees. Method We performed a literature search in the Medline and Embase databases from 1997 to January 2009 with the search terms: formulary system decision making, pharmacy and therapeutics committee, formularies hospital, drug formulary, survey, drug selection and outcome assessment health care. Inclusion criteria were the following: studies analyzing Pharmacy and Therapeutics Committees published in English or Spanish from 1997 to January 2009. Exclusion criteria were: publications which were editorials or opinion pieces, studies relating to one hospital, and studies where full text could not be attained. The analysis was divided into structural/organizational data and data on factors affecting the decision-making process. Results Seventeen studies met the inclusion criteria. Pharmacy and Therapeutics Committees and formularies were present in more than 90% of the hospitals in four of the five countries examined. Therapeutic interchange programs existed only in two of these countries. The mean number of committee members ranged between six and eight. More than 89% of the committees included a pharmacist. Standard operating procedures were implemented by 89% of the committees. The most influential factors in the decision-making were clinical trial results or drug costs rather than pharmacoeconomic studies. Other local organization-dependent factors were also important. Conclusions The structure and operating procedures of Hospital Pharmacy and Therapeutics Committees are similar in select Western countries. Information from clinical trials is the most influential factor in the decision-making process.     

Perception of the role of medical-service representatives in hospitals

How sales directors of pharmaceutical manufacturing firms and hospital pharmacy directors perceive the role of medical-service representatives (MSRs) in hospitals was studied. Pharmacy directors at U.S. hospitals and sales directors of Pharmaceutical Manufacturers Association member firms were surveyed by questionnaire in February 1988. Respondents were presented with a list of 13 product-related services and a list of 11 professional and informational services; they were asked to use a five-point scale to indicate how important they believed each service was and how frequently they believed that most MSRs performed the service. A total of 251 (47.0%) usable questionnaires were returned from the hospital pharmacy directors, and 35 (38.5%) were returned from the pharmaceutical sales directors. Hospital pharmacy directors perceived professional and informational services as more important than product-related services. The results suggest that pharmacy directors would like MSRs to place more emphasis on (1) providing drug information to pharmacy before promoting their products to physicians, (2) supporting the role of the clinical pharmacist in promoting appropriate and rational use of a product, and (3) complying with pharmacy and therapeutics committee formulary decisions. Compared with sales directors, pharmacy directors placed less emphasis on information about new dosage forms, assistance in drug recalls, and assistance in obtaining hospital-specific pricing. Differences in perceptions of the role of MSRs exist between hospital pharmacy directors and sales directors of pharmaceutical manufacturing firms.     

Superior hospital formularies: a critical analysis

The drug monograph section of eight superior hospital formularies was examined to (1) determine the type of pharmaceuticals, including dosage forms, listed, (2) delineate patterns of concurrence and divergence in drug acceptance, and (3) ascertain quantitative benchmarks by therapeutic category that may suggest optimum formulary size. The survey also undertook a comparative analysis of marginal drugs and reviewed the role of pharmacy personnel in supporting formulary administration. The critique of pharmaceutical preparations revealed significant patterns of similarity, heterogeneity, perplexity, and redundancy. The investigation also documented problems in dosage form selection and formulary publication. The report concludes that there is a need for more comprehensive studies that incorporate alternative quality assurance methods and focus on the more intangible factors of professional leadership and integrity.     

Drug product management in health maintenance organizations.

A national mail survey of drug product management in health maintenance organizations (HMOs) is described. The survey covered 570 HMOs--502 by questionnaires mailed to pharmacy directors at individual independent and multistate HMOs and 68 represented by six executives of multistate HMOs who agreed to report aggregate data for their HMO operations. Responses for 180 individual HMOs were received (36% response rate); four of the six multistate HMO executives returned aggregate data. Individual HMO respondents reported using the following methods of drug product management: formularies, 66% (of these, 60% reported using a restrictive formulary or a restrictive formulary with exceptions); MACs, 54%; prior authorization, 44%; contracts for co-marketed and single-source drug entities, 46% for each. Almost all HMOs with contracts also had exclusive or preferred status for dispensing or reimbursement of some drug products. Most HMOs received discounts, manufacturer's value-added services, price protection, rebates based on market share, and rebates based on use as contract incentives; discounts and rebates based on use were chosen as the most preferred incentives. Established methods of drug product management, such as formularies and MACs, were most commonly reported by HMOs; however, nearly half reported using new approaches, including contracts with manufacturers, incentives, such as discounts and rebates based on use, and exclusive or preferred status.     

Cephalosporin-use restrictions in teaching hospitals

A survey of pharmacy directors in teaching hospitals was conducted in March 1983 to ascertain policies for management of cephalosporin use. Surveys were sent to 298 institutions in each of the United States except Alaska. Respondents were asked various questions regarding hospital policies on cephalosporin use. Responses were received from 179 hospitals that had formularies; 99 of these had formal restriction policies, more frequently for second- and third-generation agents than for first-generation agents, and 13 planned to institute restriction policies. In 68% of hospitals with restriction policies, restricted drugs were released only after consultation with the infectious disease service. Chart review was the most frequently reported method of monitoring use of restricted cephalosporins. Approximately 40% of respondents had therapeutic equivalence policies, and more than 40% had recently deleted one or more cephalosporins from the formulary. The percentage of hospitals with formal restriction policies (55%) was greater than in a 1979 survey (32%). Many teaching hospitals have initiated policies to curb rising drug costs associated with the use of cephalosporin antibiotics.     

ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing--2004.

PURPOSE: Results of the 2004 ASHP national survey of pharmacy practice in hospital settings that pertain to prescribing and transcribing are presented. METHODS: A stratified random sample of pharmacy directors at 1183 general and children's medical-surgical hospitals in the United States was surveyed by mail. SMG Marketing Group, Inc., supplied data on hospital characteristics; the survey sample was drawn from SMG's hospital database. RESULTS: The response rate was 41.7%. Compared with the results of the 2001 survey, the number of times pharmacy and therapeutics committees met increased, suggesting an increase in efforts to monitor and manage medication use in hospitals. There was an increase in the use of quality-of-life information to make formulary decisions, indicating a shift away from cost-based formularies. There was a decrease in the rates of formulary compliance, but an increase in the use of evidence-based clinical practice guidelines, suggesting the emergence of more comprehensive approaches to improving prescribing. The use of medication-use evaluations increased in smaller hospitals, suggesting greater use of best practices is occurring in these institutions. The use of drug information services continues to decline, as the use of more efficient and easily accessible online sources of drug information increases. Reading back oral orders to improve accuracy dramatically increased since 2001. The adoption of computerized prescriber-order-entry systems continues to be slow, with fewer than 5% of hospitals reporting their use. CONCLUSION: The 2004 ASHP survey results indicate that pharmacists are continuing to improve medication use at the prescribing and transcribing steps of the medication-use system.     

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.     

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.     

Integration of formulary systems with centralized pharmaceutical procurement

The integration of formularies with pharmaceutical group purchasing and supply systems for multiple hospitals and ambulatory health centers in the Indian Health Service of the US Public Health Service is described. Two models by which these systems have been integrated are presented. The approach of one group of facilities for maintaining high-quality therapeutics in a cost-effective manner was to maintain separate P & T Committees and formularies for each facility, with one centralized drug procurement center. The other group developed a central P & T Committee and formulary to serve all area facilities, as well as continued to maintain a separate P & T Committee at each facility that could act between meetings of the central committee. These models of centralized procurement have provided both decreased drug costs and increased information on drug use within the multifacility systems. In both models, staff have reached consensus on drugs that will provide quality therapeutics in a cost-conscious environment.     

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.     

Pharmacy practice in hospital settings in GCC countries: Prescribing and transcribing

PurposeTo outline hospital pharmacy practices across the Gulf Cooperation Councils (GCC) countries’ hospitals.MethodsA modified survey questionnaire was prepared from the original 2019 American Society of Health-System Pharmacist (ASHP) survey questions. Survey details were discussed with some pharmacy directors for clarity and relevance. A list of hospitals were obtained from the Ministry of Health of each of the targeted GCC countries. A secure invitation link containing a survey questionnaire was sent to the participants directly.ResultsSixty four hospitals responded to this survey. The overall response rate was 52%. About 47% of the surveyed hospitals considered their drug formularies as closed, and strict. Additionally, only 44% of hospitals compare the effectiveness of products, when taking formulary decisions for drug inclusion. Forty-four percent of hospitals have computerized prescriber order entry (CPOE / EHR) system functionality for formulary system management. At about 39.1% hospitals, pharmacists have the responsibility for managing medication therapies, majority were engaged in providing anticoagulation therapies. About 61% of hospital pharmacies in GCC countries receive medication orders electronically, through CPOE/EHR. Majority (66%) of the hospitals in GCC countries have an active Antimicrobial Stewardship Program (ASP) while only 40% of pharmacists have a key role in providing clinical support. About 57.8% of hospital pharmacy directors reported that pharmacists do not provide ambulatory care clinical pharmacy services in their hospitals.ConclusionIn GCC countries’ hospitals, there are major areas for improvement to patient care of which pharmacists are uniquely qualified as the medication experts to have the most meaningful outcomes in all of the domains of safe medication use, medication therapy management, antimicrobial stewardship program and participation in outpatient clinics.     

Pharmacy and therapeutics committee review of the parenteral cephalosporins

The process by which a 530-bed university hospital reduced, from three to one, the number of parenteral cephalosporins in its formulary is discussed. In January 1975, cephapirin sodium was added to the formulary which already included cefazolin sodium and cephalothin sodium. Nine months later, the pharmacy and therapeutics committee decided to delete cephapirin and cephalothin from the formulary. The pharmacy department had supplied background information to the committee, and infectious disease specialists advised the committee. The decision was ratified by the executive committee of the medical staff. The rationale for the decision and its implementation, including staff communications, are discussed.