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Physicians' behavior and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary.

OBJECTIVE: It is controversial whether physicians' interactions with drug companies affect their behavior. To test the null hypothesis, that such interactions are not associated with physician behavior, we studied one behavior: requesting that a drug be added to a hospital formulary. DESIGN: Nested case-control study. SETTING: University hospital. PARTICIPANTS: Full-time attending physicians. Case physicians were all 40 physicians who requested a formulary addition from January 1989 through October 1990. Control physicians were 80 randomly selected physicians who had not made requests. MAIN EXPOSURE MEASURE: Physician interactions with drug companies, as determined by survey of physicians (response rate, 88% [105/120]). RESULTS: Physicians who had requested that drugs be added to the formulary interacted with drug companies more often than other physicians; for example, they were more likely to have accepted money from companies to attend or speak at educational symposia or to perform research (odds ratio [OR], 5.1; 95% confidence interval [CI], 2.0 to 13.2). Furthermore, physicians were more likely than other physicians to have requested that drugs manufactured by specific companies be added to the formulary if they had met with pharmaceutical representatives from those companies (OR, 13.2; 95% CI, 4.8 to 36.3) or had accepted money from those companies (OR, 19.2; 95% CI, 2.3 to 156.9). These associations were consistent in multivariable analyses controlling for potentially confounding factors. Moreover, physicians were more likely to have requested formulary additions made by the companies whose pharmaceutical representatives they had met (OR, 4.9; 95% CI, 3.2 to 7.4) or from whom they had accepted money (OR, 1.7; 95% CI, 1.0 to 2.7) than they were to have requested drugs made by other companies. CONCLUSION: Requests by physicians that drugs be added to a hospital formulary were strongly and specifically associated with the physicians' interactions with the companies manufacturing the drugs.

Biomedical Research↗

Sharing resources to create a district drug formulary: a countywide controlled trial.

BACKGROUND: Creating a drug formulary takes considerable time, but merely adopting one lacks local perspective and ownership. Sharing resources between several practices treads a middle path between these extremes, but is it effective? AIM: The aim of the study was to audit the influence of a district primary care drug formulary on prescribing by general practitioners. METHOD: A controlled trial was carried out to compare prescribing by 50 general practitioners from 11 urban and semirural practices in south Bedfordshire that participated in creating a district drug formulary with prescribing by all other general practitioners in the county. RESULTS: The proportion of prescription items that were for drugs listed in the formulary rose significantly in three therapeutics groups: cardiovascular (by 7-12% above control practice values); musculoskeletal (by 1-11% above control practice values); and obstetrics and gynaecology (by 6-9% above control practice values). The number of items prescribed per prescribing unit fell significantly in three therapeutic groups: musculoskeletal (by 1-7% below control practice values); nervous (by 7-12% below control practice values); and nutrition and blood (by 15-21% below control practice values). The estimated saving resulting from the creation of the formulary was 150,000 pounds (3000 pounds per doctor) per year. CONCLUSIONS: Sharing resources between practices to create a district-wide primary care drug formulary can lead to changes in prescribing and reduce costs sustained over 3 years.

Cost Savings↗

Impact of 3-tier formularies on drug treatment of attention-deficit/hyperactivity disorder in children.

BACKGROUND: Expenditures for medications used to treat attention-deficit/hyperactivity disorder (ADHD) in children have increased rapidly. Many employers and health plans have adopted 3-tier formularies in an attempt to control costs for these and other drugs. OBJECTIVE: To assess the effect of copayment increases associated with 3-tier formulary adoption on use and spending patterns for ADHD medications for children. DESIGN AND SETTING: Observational study using quasi-experimental design to compare effects on ADHD medication use and spending for children enrolled as dependents in an employer-sponsored plan that made major changes to its pharmacy benefit design and a comparison group of children covered by the same insurer. The plan simultaneously moved from a 1-tier (same copayment required for all drugs) to a 3-tier formulary and implemented an across-the-board copayment increase. The plan later moved 3 drugs from tier 3 to tier 2. PARTICIPANTS: An intervention group of 20 326 and a comparison group of 15 776 children aged 18 years and younger. MAIN OUTCOME MEASURES: Monthly probability of using an ADHD medication; plan, enrollee, and total ADHD medication spending; and medication continuation. RESULTS: A 3-tier formulary implementation resulted in a 17% decrease in the monthly probability of using medication (P<.001), a 20% decrease in expected total medication expenditures, and a substantial shifting of costs from the plan to families (P<.001). Intervention group children using medications in the pre-period were more likely to change to a medication in a different tier after 3-tier adoption, relative to the comparison group (P = .08). The subsequent tier changes resulted in increased plan spending (P<.001) and decreased patient spending (P = .003) for users but no differences in continuation. CONCLUSIONS: The copayment increases associated with 3-tier formulary implementation by 1 employer resulted in lower total ADHD medication spending, sizeable increases in out-of-pocket expenditures for families of children with ADHD, and a significant decrease in the probability of using these medications.

Adolescent↗

Quality control of hospital formularies.

This paper identifies various uses of the formulary concept, outlines factors that underlie the need for such an administrative device, and reviews four barriers to effective formulary control. It then examines selected components of the formulary system and specifies the need for supporting techniques, both internal and external. Twelve guidelines for developing a model drug formulary are presented. While administrative elements associated with implementation of a formulary are stressed, concerns about more intangible behavioural forces are introduced.

Drug Prescriptions↗

Eliminating analgesic meperidine use with a supported formulary restriction.

PURPOSE: Meperidine is a commonly used analgesic despite unique disadvantages compared with other opioid analgesics. The objective of this study was to measure the effects of a meperidine formulary restriction on the prescribing of parenteral opioid analgesics. MATERIALS AND METHODS: The study was performed at a single 750-bed tertiary care teaching hospital in Rochester, NY. The formulary restriction limited meperidine to use exclusively for rigors or procedural sedation and was supported by an educational initiative and a computerized order entry system. Independent computerized pharmacy records were used to capture all doses of parenteral morphine, meperidine, and hydromorphone administered to patients in the emergency department or on a medical or surgical inpatient floor during data-collection periods. Baseline data were collected during two 3-day periods before the formulary restriction; then comparison data were collected during three 3-day periods over 15 months after the formulary restriction. RESULTS: The number of administered doses of meperidine per day decreased from 37.5 (20.8% of parenteral opioid doses before the restriction) to 0.22 (0.1% of parenteral opioid doses, P = .001). The total number of opioid doses and morphine doses given did not change, whereas the number of hydromorphone doses increased significantly postrestriction, from 16.0 doses per day (8.9% of total) to 59.7 doses per day (29.5%) (P = .009). CONCLUSION: Meperidine formulary restriction, supported by an educational program and computerized order entry, effectively eliminated analgesic meperidine use. Hydromorphone use increased proportionately to offset the decreased use of meperidine.

Analgesics, Opioid↗

The effect of incentive-based formularies on prescription-drug utilization and spending.

BACKGROUND: Many employers and health plans have adopted incentive-based formularies in an attempt to control prescription-drug costs. METHODS: We used claims data to compare the utilization of and spending on drugs in two employer-sponsored health plans that implemented changes in formulary administration with those in comparison groups of enrollees covered by the same insurers. One plan simultaneously switched from a one-tier to a three-tier formulary and increased all enrollee copayments for medications. The second switched from a two-tier to a three-tier formulary, changing only the copayments for tier-3 drugs. We examined the utilization of angiotensin-converting-enzyme (ACE) inhibitors, proton-pump inhibitors, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins). RESULTS: Enrollees covered by the employer that implemented more dramatic changes experienced slower growth than the comparison group in the probability of the use of a drug and a major shift in spending from the plan to the enrollee. Among the enrollees who were initially taking tier-3 statins, more enrollees in the intervention group than in the comparison group switched to tier-1 or tier-2 medications (49 percent vs. 17 percent, P<0.001) or stopped taking statins entirely (21 percent vs. 11 percent, P=0.04). Patterns were similar for ACE inhibitors and proton-pump inhibitors. The enrollees covered by the employer that implemented more moderate changes were more likely than the comparison enrollees to switch to tier-1 or tier-2 medications but not to stop taking a given class of medications altogether. CONCLUSIONS: Different changes in formulary administration may have dramatically different effects on utilization and spending and may in some instances lead enrollees to discontinue therapy. The associated changes in copayments can substantially alter out-of-pocket spending by enrollees, the continuation of the use of medications, and possibly the quality of care.

Angiotensin-Converting Enzyme Inhibitors↗

Formularies in integrated health systems: Integris health.

Formulary management implications are described for an Oklahoma integrated health system that consists of 14 acute care facilities, numerous owned medical practices, and a fledgling HMO and has loose alliances with other rural facilities. A systemwide pharmacy director has yet to be appointed; however, the position of pharmacy operations manager for the Oklahoma City area has been created. A physician group has been formed that is expected to address systemwide pharmacy and therapeutics (P&T) committees and formulary strategies. Currently, P&T committee activities take place at the individual hospital level. The hospitals do not have restrictive formularies. An overall formulary system would likely be patterned after the largest hospital's system, which includes a formal approval process in which a P&T subcommittee reviews drug use outside established guidelines and the P&T committee asks the appropriate medical department to address the problem. For ambulatory care, the HMO has contracted with a pharmacy benefit manager (PBM), and there is no coordination of formulary efforts between the PBM and health system entities. Although this and other problems remain to be resolved, some standardization of drug use has begun. Also, all entities in the system use the same purchasing group and plan to use the same information systems. Drug use among hospitalized patients in this integrated health system is influenced by the usage guidelines established at the largest hospital, and drug use among ambulatory managed care patients is influenced by an external PBM.

Cost Savings↗

The evolving use of cost-effectiveness analysis in formulary management within the Department of Veterans Affairs.

The Veterans Health Administration (VHA) runs the largest integrated healthcare system in the nation. Formulary management within VHA primarily involves 3 national groups: the Medical Advisory Panel, the Veterans Integrated Service Network Formulary Leaders, and the Pharmacy Benefits Management Strategic Healthcare Group. Together, these groups manage the VHA national drug formulary with a goal of providing a comprehensive, safe, and cost-effective pharmacy benefit for veterans. Traditionally, VHA has relied on cost-minimization analyses in formulary decisions. More recently, VHA has emphasized the use of cost-effectiveness data, especially for newer, costly drugs. In addition to including this data in drug monographs, the VHA has begun requiring formal cost-effectiveness analysis from manufacturers of selected pharmaceuticals. VHA has also requested that clinically relevant information such as quality of life plus mortality benefit be made available from industry so that internal cost analyses can be performed. It is hoped that by setting the expectation that cost-effectiveness will be formally considered in all VHA formulary decisions, the pharmaceutical industry and others will be stimulated to collect and report data that enables these analyses. We believe that if other organizations also place an emphasis on economic evaluations, industry and the public will be more accepting of decisions that incorporate cost considerations.

Cost-Benefit Analysis↗

The new medicare drug benefit: formularies and their potential effects on access to medications.

During congressional debate over the Medicare Part D prescription drug benefit, much attention was focused on nominal benefit design. Relatively little attention was paid to details about how plans would operate, such as the design of drug formularies. Yet, formularies will be important tools for controlling costs, and may be as important as nominal benefit design in determining enrollees' access to medications and out-of-pocket costs. We describe Part D plan incentives and how they may influence formulary design, and then provide recommendations for Part D formulary implementation. We encourage the Centers for Medicare & Medicaid Services (CMS) to develop standardized tools to provide physicians and patients with up-to-date and easily accessible information about covered drugs on each plan's formulary (perhaps via a central website) and a national set of easy-to-follow procedures for reconsideration and appeals. Such efforts should reduce administrative burden and better allow physicians to help patients obtain needed medications.

Aged↗

Grampian Health Board's joint drug formulary.

OBJECTIVE: To develop a model for creating a joint general practice-hospital formulary, using the example of ulcer healing drugs. DESIGN: A joint formulary development group produced draft guidelines based on an earlier hospital formulary, which were sent to interested local general practitioners for consultation. Revised guidelines were then drawn up and forwarded to the health board's medicines committee for approval and distribution. SETTING: Grampian Health Board. SUBJECTS: Nine members of joint formulary development group plus local general practitioners who were invited to comment on a list of 11 ulcer healing drugs. MAIN OUTCOME MEASURE: Degree of coincidence of drugs selected by hospital doctors and general practitioners. RESULTS: The ulcer healing drugs selected by the panel of general practitioners and by hospital doctors were highly coincident. The cost of one day's treatment with drugs varied considerably between hospital and general practice--for example, one drug cost 46p in hospital and 1 pounds in general practice and another cost 1.26 pounds in hospital and 1.01 pounds in general practice. Overall, six drugs cost more in hospital and five cost more in general practice. CONCLUSIONS: A joint formulary for use in hospitals and general practice in a health board can be devised fairly simply by consultation as virtually the same drugs are used in both types of practice. It should influence the health board's expenditure on drugs and affect the choice of drugs when a patient is discharged from hospital or is referred to any hospital in the region.

Anti-Ulcer Agents↗

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.

Anti-Bacterial Agents↗

Differences in managed care drug formularies: what can consumers learn?

Pharmaceutical coverage has become an especially important issue in health plan design. This article develops an objective measure of drug coverage generosity in managed care drug formularies. Formulary generosity is important because patients respond differently to drugs within a therapeutic class, and so there is benefit in offering a wide variety of products to prescribing physicians. The measure of coverage generosity considers not only the number of products offered to patients through a formulary, but whether plans systematically exclude more expensive products. The correlation between formulary generosity and health plan member satisfaction is analyzed to see if formulary generosity is perceived by subscribes to be related to perceived health plan quality. The findings are that plans vary widely in offering access to pharmaceuticals but that generosity is not highly correlated with health plan satisfaction.

Decision Making↗

An examination of physician use of and attitudes toward closed formulary drug programs.

Efforts to control the rising costs of drug budgets has centered primarily on the use of "closed formularies"--systems in which a set of drug products are pre-approved for dispensing to those eligible for expense coverage. Controversy, however, has surrounded these systems with respect to their effectiveness in controlling costs and their impacts on the quality of care for recipients. This study examined California physician attitudes towards the California Medicaid program's use of a closed formulary and treatment authorizations which must be obtained in order to dispense drugs not on the Medi-Cal pre-approved list. A survey of physicians focused on the extent to which they sought to use non-formulary medications, their experience with formulary products that were not their drugs of choice, and the extent to which the overall system impacted their practices. Results of the survey indicated that the closed formularly discouraged physicians from dispensing drugs of choice. Furthermore, physicians often experienced adverse or sub-therapeutic results with formulary medications that they would not have expected had they dispensed their preferred medications.

Attitude of Health Personnel↗

Managing psychotropic drug costs: will formularies work?

Payers of pharmaceutical benefits are increasingly turning to drug formularies in an attempt to control rising pharmacy costs, including those for psychotropic drugs. In this paper I examine several issues that policymakers should consider when addressing formulary design for psychotropic drugs: heterogeneity within mental health disorders and limited information about treatment effectiveness for individual patients; the potential for plans to try to use formularies to avoid adverse selection and implications for psychotropic coverage; the interaction of Medicaid formulary policy and manufacturers' incentives for psychotropic innovation; and incentives created by mental health institutions that decrease formularies' potential effectiveness in controlling psychotropic drug costs.

Cost Control↗

Physicians' views of formularies: implications for Medicare drug benefit design.

As Congress considers introducing a drug benefit for Medicare, it will more than likely adopt a program that uses a formulary. We examined data from the Community Tracking Study Physicians Survey, a large, nationally representative study of physicians, to learn about physicians' views of formularies. Our results suggest that several aspects of formularies are associated with physicians' positive views about them. Policymakers should consider imposing limits on the number of competing Medicare formularies operating in a particular area, promoting the adoption and use of information technology, and incorporating financial incentives for physicians to adhere to formularies.

Adult↗

Cost-effectiveness analysis and the formulary decision-making process.

BACKGROUND: Faced with high drug expenditures in an environment of cost containment, drug formulary systems, particularly in managed care, have become more dependent on pharmacoeconomic evaluations to assess the value of new products. Within pharmacoeconomics (PE), cost-effectiveness analysis (CEA) is the most commonly used method. However, current methodological concerns about CEA have limited its practical contribution to the formulary process. Advances in analysis are likely to improve the relevance of CEA over time. OBJECTIVE: The purpose of this paper is to review CEA, its limitations, and its applications in formulary decision making in order to promote greater utility of CEA for managed care pharmacists. SUMMARY: Enhancements to CEA, such as the development of modeling software, rank-order stability analysis, cost-consequence analysis (CCA), and budget impact analysis are discussed. A combined method of CCA-CEA and standardized guidelines are suggested to improve the impact of CEA in the drug formulary process. CONCLUSION: Along with advances in its methodology and relevant standardized guidelines, CEA will gain increased importance in formulary decision making, helping to assure the goal of cost containment while ensuring quality of care.

Cost-Benefit Analysis↗

Formulary considerations in selection of beta-blockers.

Selection of beta-adrenergic blockers for formulary addition can be a difficult task, especially with the increasing availability of new beta-blockers, as well as the numerous differences in pharmacodynamic and pharmacokinetic properties of currently available agents. Nevertheless, appropriate evaluation of the important characteristics of beta-blockers should allow selection of the most cost-effective agents for formulary addition. Most importantly, differences in efficacy, product formulation and cost should be carefully considered when making formulary decisions. Notably, evidence from clinical trials indicates differences in efficacy among beta-blockers for post-myocardial infarction prophylaxis, situational anxiety, essential tremor, thyrotoxicosis, migraine prophylaxis and prevention of bleeding associated with oesophageal varices. For many clinical situations, it is also important to select an effective agent that is available in both an oral and intravenous formulation, especially for cardioprotection after acute myocardial infarction and for use in supraventricular arrhythmias. In addition, availability of sustained release products and generic formulations should be considered for their potential to increase compliance and decrease cost, respectively. Comparative drug costs, as well as costs associated with decreased compliance, should also be carefully evaluated. Differences in beta-receptor selectivity, duration of action and presence of intrinsic sympathomimetic activity (ISA) are also important considerations in the selection of beta-blockers for formulary consideration. Although degree of selectivity is relative, beta 1-selective agents may be less likely to induce bronchospasm in patients with chronic obstructive pulmonary disease (COPD) and may be less likely to affect glucose homeostasis in patients with diabetes mellitus. Duration of action of a beta-blocker is an important consideration for evaluation of efficacy throughout the recommended dosage interval. In addition, beta-blockers with a long duration of action can often be administered once or twice daily, potentially leading to increased compliance and thereby improved effectiveness and economic efficiency. The presence of ISA is an important consideration because certain beta-blockers with ISA may be less effective than those without ISA for certain indications. Factors considered to be less important when making formulary decisions of choice of beta-blockers include the route of elimination, lipophilicity and presence of membrane stabilising activity.

Adrenergic beta-Antagonists↗

The formulary decision-making process in a health maintenance organisation setting.

The goal of a health maintenance organisation (HMO) is to provide high quality, cost-effective healthcare services and products which meet the needs of the membership. Providing and managing pharmaceutical products and services within the HMO is a major aspect of accomplishing this goal. Several decisions must be made in developing, implementing and maintaining a formulary system. The numbers of people seeking their healthcare from HMOs in the US has increased 4-fold in 10 years, and several model types of HMOs have developed, including network HMOs, group HMOs, independent practitioner associations and staff models. HMOs utilising formulary systems provided cover to 76% of enrollees in 1992. Formulary system management and decision making entails the use of open vs closed formularies and the role of the pharmacy and therapeutics (P & T) committee. Product selection takes into account efficacy, safety, costs, patient acceptance, ease of use, dosage forms, preparation requirements, stability and storage requirements and the reputation of the manufacturer and the service it provides. We list and describe various policy decisions which HMO pharmaceutical decision makers must address if the formulary system is to become an efficient tool for the HMO.

Consumer Product Safety↗