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PubMedDate not supplied

Inter-provincial variation in government drug formularies.

In Canada, coverage for ambulatory prescription drug expenditures is provided to some groups by provincial drug plans through a provincial formulary. Little is known about the drugs provincial formularies give access to. We report the variation in availability of new drug molecules (NDM) across provincial formularies. We identified 108 NDM approved in Canada between 1991 and 1998. From each drug plan bulletin or formulary, we abstracted names of NDM listed as per 15 January 1999. We compared the level of listing across provinces using kappa coefficients. In the Quebec, BC, Manitoba and Saskatchewan formularies, more than 70% of the NDM were listed. In four provinces, this proportion was lower than 50%. In general, the agreement between formularies was poor. There is a wide variation across provinces in terms of NDM listed in the formularies. This variation reflects inter-provincial differences in the way drugs are selected for coverage.

Canada↗
PubMed2003

Weighing the evidence: trends in managed care formulary decision making.

Health plans, pharmacy benefit managers, and other organizations use drug formularies to promote quality care while controlling costs. However, restrictive formularies are often viewed as constraints on physician practice and potential barriers to optimal patient care. Reluctance to add new drugs to an established formulary is rational economic behavior. Innovative compounds may have unknown properties with uncertain outcomes and therefore may impose costs in the form of risk. Products that seemingly duplicate drugs already on formulary may increase transaction costs without additional benefit. In evaluating new products, formulary managers face the task of identifying, assembling, and synthesizing a wide range of complex information. Manufacturers, who may be in the best position to supply that information, have been severely restricted by U.S. Food and Drug Administration (FDA) regulations that limited marketing communications to findings from well-controlled clinical trials. The FDA Modernization Act of 1997 eased these restrictions somewhat by acknowledging that sophisticated purchasers such as organized health plans were capable of weighing the quality and impartiality of manufacturer-supplied evidence. The Academy of Managed Care Pharmacy (AMCP) created a standardized template that formularies can use to request comprehensive information about specific drugs from manufacturers. Widespread adoption of the AMCP format by health plans and manufacturers will greatly increase access to information about new drugs, speeding the process of formulary committee deliberation, and instilling greater confidence in the outcome of those decisions. Wider access to new drugs may result.

Clinical Trials as Topic↗
PubMed2005

Developing a pharmaceutical formulary for joint military medical operations.

This article describes the development of a standardized formulary for medical contingency operations for any theater of operations. The article compares peacetime health care systems within the Department of Defense and the formulary systems developed and used within the fixed facility environment with Department of Defense contingency health care operations systems and the complications encountered while attempting formulary development for the deployed environment. Despite great difficulties, the Joint Readiness Clinical Advisory Board developed, published, and marketed a jointly approved, standardized, modernized formulary to assist forces deploying for Operations Enduring Freedom and Iraqi Freedom. The process used by the Joint Readiness Clinical Advisory Board during formulary development is described in detail, giving readers an understanding of the foundations of the Joint Deployment Formulary. The military departments will experience the benefits of enhanced supply chain predictability and responsiveness, increased clinician satisfaction, and improved patient safety and health care quality by implementing the Joint Deployment Formulary for their forces engaged in contingency operations.

Cooperative Behavior↗
PubMed1984

Cost effectiveness of an enteral products formulary.

The development, implementation, and resultant cost savings of a revised enteral products formulary at a 430-bed, community teaching hospital are described. In 1982, a review of the available enteral nutrition products (ENPs) was performed by the pharmacy and food service departments in conjunction with the pharmacy and therapeutics committee. Three broad categories of products were identified--intact-protein, chemically defined, and modular formulas--with 11 subgroups. Products were then evaluated for inclusion on the restricted formulary on the basis of osmolality; source, quality, and proportions of protein, carbohydrate, and fat; electrolyte, mineral, and vitamin content; and cost. Fourteen products were admitted to the restricted 1983 formulary. Previously, 20 products had been stocked by the pharmacy. Products from two subgroups, blenderized and mild-base diets, were deleted from the formulary because of cost, infrequent use, and availability of suitable alternatives. To decrease inventory carrying costs, products are stocked in vanilla or unflavored form, with flavoring packets available. Educational efforts were undertaken to increase the medical staff's awareness of the revised formulary. Within three months of implementation of the revised formulary, purchase of nonformulary items had ceased. A considerable cost savings was achieved because of the formulary.

Cost-Benefit Analysis↗
PubMed1985

The social drug lag: an examination of pharmaceutical approval delays in Medicaid formularies.

Several states have enacted restrictive drug formularies in order to control the costs of their Medicaid pharmaceutical programs. This study investigates the restrictiveness of these formularies by analyzing the delay in approving new drug products for Medicaid reimbursement. A restrictiveness index is developed which relates the drug product months which are denied to Medicaid patients to the potential product months of availability if all products which were newly approved for general use were simultaneously made available to the Medicaid population. The study then relates the restrictiveness of state formularies to Medicaid drug program costs and to total Medicaid program costs. We find that restrictiveness of formularies is not associated with lower drug costs, but that total Medicaid costs are lower in states with more restrictive formularies. We suggest that restrictive formularies may occur in states with other Medicaid cost-containment measures, so that total Medicaid expenditures are contained in those states, even though there is no reduction in drug expenditures.

Cost Control↗
PubMed1999

Rational pharmacotherapy in The Netherlands: formulary management in Dutch hospitals.

A survey regarding the management of rational pharmacotherapy was conducted among all Dutch general hospitals in 1998. The response was 99% (n = 120). The presence of a drugs and therapeutics committee and antibiotic policies in Dutch general hospitals appears independent of hospital characteristics. However, formulary agreements and treatment guidelines are less likely to be present in hospitals that employ only 1 pharmacist or those served by community pharmacies. More than half of the hospitals claim to have restrictive formulary agreements. Large hospitals, hospitals in the eastern and southern provinces and those served by hospital pharmacies more often tend to have restrictive agreements compared to small hospitals, hospitals in the northern, central, and western provinces, and those served by community pharmacies. Various methods to impose restriction and ensure formulary compliance are mentioned. It must be noted that hospitals tend to operate rather solely regarding the large number of different formularies. Surprisingly just a small majority of pharmacists evaluates formulary agreements positively as a management tool. Many drawbacks appear to be present. The results of this survey indicate that in the future Dutch hospitals will favour disease management (treatment guidelines) over drug management (formulary agreements) in the management of rational pharmacotherapy and that information technology will be used to influence clinicians' prescribing behaviour.

Anti-Bacterial Agents↗
PubMed1996

Formularies in integrated health systems: Sharp HealthCare.

Formulary management implications are described for a California health system consisting of 7 hospitals, 4 skilled-nursing centers, 22 medical clinics, 8 urgent care facilities, and a health maintenance organization. Sharp HealthCare serves nearly 1 million people in the San Diego area. A single institutional care division (ICD) pharmacy service has been created under the guidance of a steering committee consisting of a pharmacy operations coordinator and a staff pharmacist from each site, the system pharmacy director, the system senior pharmacy information systems specialists, and the system senior clinical pharmacy specialist. Operations at each site are overseen by an operations coordinator instead of a pharmacy director. Functional teams reporting to the steering committee are standardizing pharmacy processes, including formulary management; this is particularly important because the ICD has pharmacist and nurse per diem pools. Until 1995, formularies were independently managed at each site. Now, one system formulary is being developed. Standard policies and procedures, a nonformulary drug request form, and a monograph format have been completed. The hospitals' autonomous medical staffs have thus far elected to retain individual pharmacy and therapeutics (P&T) committees but approved a revamped formulary review process and systemwide P&T subcommittees. The computer system is being enhanced so that pharmacists anywhere in one of the hospitals will have access to applicable P&T committee-approved guidelines for drug use. Since vendors were advised that the system is establishing one formulary, Sharp has been able in some cases to achieve better pricing than it previously could through its purchasing group. Drug use is influenced by each site's pharmacy and therapeutics committee. The ideal, however, is to have this responsibility consolidated in a single systemwide committee.

California↗
PubMed1989

How do doctors and patients react to the introduction of a practice formulary?

A formulary covering 10 drug groups and over 50% of prescribing was devised in a general practice and doctors' attitudes to the idea to a formulary were assessed before and after the study. The prescribing of formulary drugs rose from 72% to 81% over two years, and the general practitioners were significantly more positive towards formularies in the practice which devised the formulary but not in three control practices. A group of patients receiving repeat prescriptions was interviewed in three practices in three consecutive years, and there was no difference in satisfaction with drugs between the formulary practice and the two control practices. However, an association between changing a drug and dissatisfaction was noted, and there was a trend of decreasing satisfaction with prescribing and with information given about drugs over the three years in all the practices. Overall 51% of patients felt that they had either too little or no information given to them about their drugs. Improving information given to both doctors and patients about drugs may be important in improving prescribing without causing discontentment.

Attitude of Health Personnel↗
PubMedDate not supplied

United States pharmacopeia development of the Medicare model formulary guidelines.

Prescription drug formularies are a key element in prescription drug benefit management. The use of formularies can both increase the quality of prescribing and reduce the costs of prescription drug therapy. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 specified that an external agency, the United States Pharmacopeial Convention, Inc. (USP) through the Secretary of the United States Department of Health and Human Services develop model formulary guidelines for prescription drug plans. The model formulary guidelines are to assist individual drug plans in developing formularies that would qualify for participation in the Medicare Part D prescription program. The guidelines were developed through a Model Guidelines Expert Committee assisted by USP staff and following input from patient advocate groups, health care organizations, and pharmaceutical organizations over a period of 8 months (April 2004 to December 2004). The USP Model Formulary Guidelines organize prescription medications into 41 therapeutic categories (32 with associated pharmacologic classes and nine with no associated pharmacologic classes), 137 pharmacologic classes, and 146 unique therapeutic categories and pharmacologic classes.

Aged↗
PubMed2005

Does a hospital formulary influence prescribing practice in an acute medical admissions unit?

AIM: To assess the extent to which prescribing of cardiovascular medications in a busy medical unit deviates from the local joint primary and secondary care drug formulary guidelines. METHOD: A retrospective audit of the case notes, prescription charts and discharge summaries of 150 randomly selected emergency medical admissions over a 4 month period. RESULTS: No patient receiving a non-formulary cardiovascular drug on admission had the choice reviewed in line with formulary recommendations. One third of new cardiovascular medications commenced in hospital were not compliant with formulary recommendations. Decisions about drug therapy were rarely justfied in the written hospital record. CONCLUSIONS: Our results demonstrate that in a busy acute medical admissions' unit there is a clear failure to amend or query non-formulary prescribing at the time of admission and a tendency to exacerbate it during the inpatient period. This potentially undermines the purpose of a joint drug formulary as a guideline for safe, evidence-based and cost-effective prescribing.

Acute Disease↗
PubMedDate not supplied

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.

Australia↗
PubMed1994

Expert systems. Assisting formulary decision making in the ambulatory setting.

In this article, the author reviews the application of a computer-assisted decision support system to their formulary decision-making process. Basic information is presented describing expert systems, which are a type of computer-assisted decision support system, and their advantages and disadvantages. A specific example of an expert system, 'RXPERT', is described. 'RXPERT' is a prototype expert system that models the decision-making process for an ambulatory (nonhospital) formulary. This formulary is the underpinning of the prescription drug benefit programme for the nearly 1 million residents of Saskatchewan, Canada. In the current formulary decision process, each drug product is evaluated by 2 separate committees, with the third and final decision resting with the Ministry of Health. The first committee, the Drug Quality Assessment Committee (DQAC), comprises members with expertise in medicine, pharmacology, clinical pharmacy, pharmaceutics, statistics, and regulatory processes. The DQAC evaluates information from the drug manufacturer and other independent sources, and makes an initial assessment with respect to clinical aspects of alternative therapies and generic interchangeability. The committee then makes its recommendation to the Saskatchewan Formulary Committee (SFC). The SFC reviews the recommendation of the DQAC and considers the administrative and economic implications of accepting the product for the patient, the programme, and healthcare professionals' practice. The SFC either reaffirms the recommendation of the DQAC or modifies it based on further review, and forwards its recommendation to the Ministry of Health. Finally, the Ministry of Health reviews the evaluation and determines the drug's formulary status.(ABSTRACT TRUNCATED AT 250 WORDS)

Decision Making, Computer-Assisted↗
PubMed1996

Formularies in integrated health systems: Sharp HealthCare.

Formulary management implications are described for a California health system comprising 7 hospitals, 4 skilled-nursing centers, 22 medical clinics, 8 urgent care facilities, and a health maintenance organization. Sharp HealthCare serves nearly one million people in the San Diego area. A single institutional care division (ICD) pharmacy service has been created under the guidance of a steering committee comprising a pharmacy operations coordinator and a staff pharmacist from each site, the system pharmacy director, the system senior pharmacy information systems specialist, and the system senior clinical pharmacy specialist. Operations at each site are overseen by an operations coordinator instead of a pharmacy director. Functional teams reporting to the steering committee are standardized pharmacy processes, including formulary management; this is particularly important because the ICD has pharmacists and nurse per diem pools. Until 1995, formularies were independently managed at each site. Now, one system formulary is being developed. Standard policies and procedures, a nonformulary drug request form, and a monograph format have been completed. The hospitals' autonomous medical staffs have thus far elected to retain individual pharmacy and therapeutics (P&T) committees but approved a revamped formulary review process and system-wide P&T subcommittees. The computer system is being enhanced so that pharmacists will have access to applicable P&T committee-approved guidelines for drug use. Since vendors were advised that the system is establishing one formulary, Sharp has been able in some cases to achieve better pricing than it previously could through its purchasing group.

California↗
PubMed1999

Assessment of patient satisfaction with a formulary switch from omeprazole to lansoprazole in gastroesophageal reflux disease maintenance therapy.

OBJECTIVE: To determine if patients perceived a difference in the efficacy, side effects, and value of omeprazole versus lansoprazole for gastroesophageal reflux disease (GERD) maintenance therapy after a formulary conversion, and to evaluate the costs of the conversion. STUDY DESIGN: An unblinded questionnaire was mailed to patients who were currently receiving GERD maintenance therapy with lansoprazole from the Veterans Affairs San Diego Healthcare System. PATIENTS AND METHODS: Three hundred patients who had been on omeprazole for a minimum of 2 months prior to the formulary conversion and on lansoprazole for a minimum of 2 months after the formulary conversion were surveyed. Patients were asked to rate the severity and frequency of their symptoms (pain, heartburn, and regurgitation) on a scale from 0 to 9 for each medication. Questions regarding side effects, medication preference, and satisfaction with the formulary conversion process were also addressed. RESULTS: Fifty-two percent of the surveys were returned. There was no statistically significant difference between median total symptom scores for omeprazole and lansoprazole (1.33 vs. 1.34, respectively). More patients reported side effects to lansoprazole (P < 0.001) than to omeprazole. Sixty-four percent of patients preferred omeprazole (P < 0.005). The formulary conversion was estimated to save $29,000 per year. CONCLUSIONS: Omeprazole was the medication preferred by patients for GERD maintenance therapy. Patients were willing to pay an additional fee for their preferred agent. Fewer adverse events were reported with omeprazole. The potential cost savings of the formulary conversion may have been at the expense of patient satisfaction.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

Access to new cardiovascular therapies in Canadian hospitals: a national survey of the formulary process.

BACKGROUND: Access to new therapies in hospitals depends upon both clinical trial evidence and local Pharmacy and Therapeutics (P&T) committee approval. The process of formulary evaluation by P&T committees is not well-understood. OBJECTIVES: To describe the formulary decision-making process in Canadian hospitals for cardiovascular medications recently made available on the Canadian market. METHODS: Postal survey of hospital pharmacy directors in all Canadian hospitals with more than 50 beds. Target drugs included abciximab, enoxaparin, dalteparin, clopidogrel, eptifibatide and tirofiban. RESULTS: Of 428 surveys mailed, responses were received from 164 P&T committees representing 350 hospitals for an effective response rate of 82%. While physicians make up the largest proportion of committee membership, pharmacists play an influential role. Information most commonly cited as influencing formulary decisions included published clinical trials (97%), regional guidelines (90%), pharmacoeconomic data (84%), decisions at peer hospitals (73%) and local opinion leaders (60%). However, this information was often not required on formulary applications. Approval timelines varied widely for target medications but there were no regional, hospital or P&T committee characteristics that were independent predictors of early formulary application or approval. CONCLUSIONS: There is wide variability in the time taken for Canadian institutions to adopt new cardiovascular therapies, which is not explained by regional, hospital or P&T committee characteristics. Standardization of the formulary application and evaluation processes, including sharing of information amongst institutions, would lead to broader understanding of the applicable issues, more objectivity and improved efficiency.

Abciximab↗
PubMed2006

Do drug formulary policies reflect evidence of value?

OBJECTIVE: To investigate the extent to which preferred drug lists and tiered formularies reflect evidence of value, as measured in published cost-utility analyses (CUAs). METHODS: Using 1998-2001 data from a large registry of cost-effectiveness analyses, we examined the 2004 Florida Medicaid preferred drug list and the 2004 Harvard Pilgrim Pharmacy Program 3-tier formulary, and compared cost-utility ratios (standardized to 2002 US dollars) of drugs with preferred and nonpreferred status. RESULTS: Few drugs on the formularies had any cost-utility data available. Of those that did, median cost-utility ratios were somewhat higher (less favorable) for Florida's preferred drugs compared with the nonpreferred drugs (25,465 dollars vs 13,085 dollars; P = .09). Ratios did not differ for drugs on tiers 1 and 2 of the Harvard Pilgrim formulary, although they were higher for tier 3 and for excluded drugs (18,309 dollars, 18,846 dollars, 52,119 dollars, and 22,580 dollars, respectively; P = .01). Among therapies reported to be cost-saving or to have cost-utility ratios below 50,000 dollars, 77% had favored status in Florida Medicaid and 73% in Harvard Pilgrim. Among dominated drug interventions (reported to be more costly and less effective than alternatives), 95% had favored status in Florida Medicaid and 56% in Harvard Pilgrim. CONCLUSIONS: This study underscores the paucity of published cost-utility data available to formulary committees. Some discrepancies prevail between the value of drugs, as reflected in published cost-utility ratios, and the formulary placement policies of 2 large health plans.

Boston↗
PubMed1989

Establishing an enteral product formulary.

An ever-increasing number of enteral nutrition products is being marketed to hospitals for use with nutritionally compromised patients. At the Clinical Center, National Institutes of Health, Bethesda, MD, the nutrition department created a formulary management committee, which developed a system that aligned formulary product selection with the enteral needs of the patients, provided an ongoing system of formulary management, and provided extensive education to dietitians on product formulation. The formulary system involved a stepwise process: determination of categories of products to be considered and criteria for product selection, identification of enteral needs of patients at nutritional risk within the institution, review of current literature on formulation of all major enteral products, and taste evaluation of products to be used orally. Composition of the formulary was then determined, and interdepartmental efforts for implementation were coordinated. The overall department impact included a 37% reduction in variety of products stocked, the creation of an annual update system, and extensive dietitian education on product formulation and usage. The direct impact on patient care was the provision of a formulary specifically targeted to meet the enteral needs of those patients at nutritional risk within the institution.

Enteral Nutrition↗
PubMed1987

Introducing a drug formulary to general practice--effects on practice prescribing costs.

A drug formulary comprising 249 preparations of 132 drugs and drug combinations was prepared by the partners in a three-doctor general practice serving more than 5000 patients. No attempt was made to change to generic prescribing nor were repeat prescription drugs altered. Introduction of the formulary in September 1981 was followed by an increase in the proportion of prescriptions containing drugs from the formulary from about 55% to more than 60% for both repeat and non-repeat prescriptions. The proportion of formulary drugs on non-repeat prescriptions reached a maximum of 78% within the first year with the additional influence of information feedback. Over the first year the level of formulary drugs used for both repeat and nonrepeat prescribing levelled off at about 62%. Even with these modest changes, when compared with the costs of general practice prescribing in Scotland as a whole, the introduction of the formulary resulted in savings of approximately 10% within the practice for the mean ingredient costs both per patient and per prescription.

Costs and Cost Analysis↗