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PubMed1998

Determining whether managed care formularies meet the needs of pediatric patients.

UNLABELLED: This activity is designed for healthcare providers making formulary decisions for managed care organizations. GOAL: To help clinicians determine whether managed care formularies meet the needs of pediatric patients. OBJECTIVES: 1. List general considerations for establishing a pediatric drug formulary. 2. Understand the importance of growth and development when selecting drug therapy for pediatric patients. 3. Discuss potential difficulties with administering medications during school hours. 4. Identify specific medications within the drug classes of antibiotics, asthma medications, endocrine, and gastrointestinal agents that should be available on a pediatric drug formulary.

Child↗
PubMed1982

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.

Dosage Forms↗
PubMed1999

A novel formulary: collaboration between health care professionals, seniors, private sector and government in Nova Scotia.

A novel formulary has been developed in Nova Scotia with the objective of providing quality treatment with needed medications at affordable cost. Creation of the formulary has involved collaboration among health care professionals, seniors, the Department of Health and pharmaceutical companies. This is the first Canadian formulary to use the Anatomic, Therapeutic, Chemical system. Drug listing is comprehensive rather than exclusive. Colour-coded recommendations on use assist physicians with drug choice. Relative costs are indicated within each therapeutic grouping. Listings indicate drugs approved for reimbursement, interchangeable medications, maximum allowable cost, drug identification number and manufacturer code. Treatment summaries provide brief overviews of therapeutic advice. Updates on new products and new or modified treatment summaries are provided every 6 months. The formulary will be the focus of coordinated educational activities on treatment for seniors and health care professionals.

Aged↗
PubMed2003

Impact of formularies on clinical innovation.

It is important to consider, in light of how innovation has so often occurred, whether today's managed care environment is conducive to continued psychopharmacologic innovation. The initial step in the development of a new area in psychopharmacology has historically relied in large part on individual clinicians who pursued unconventional methods of treatment. When a set of guidelines such as a formulary (a list of drugs eligible for reimbursement compiled by a managed care organization) becomes restrictive, it decreases clinician innovation. In addition to this long-term threat to innovation, studies have found greater restrictiveness in formularies to be associated with higher health care utilization. Thus, restricted formularies that are based on a naive interpretation of "therapeutic equivalence" may slow the advance of medical science without even achieving the only goal that could possibly justify such restrictions-cost control. If innovation is to flourish, formularies must be flexible and advisory, not restrictive. Preserving the climate for innovation in health care requires the management culture to focus on the long-term impact of policies on quality and innovation as well as on the overall health cost in the system.

Antipsychotic Agents↗
PubMed2004

The managed care approach to placing a drug on formulary.

The placement of a drug on a health plan's formulary is important to ensure patient access to the best therapeutic options. Unfortunately, cost is too often a defining attribute that determines whether or not a drug is placed on formulary. Multitiered formularies represent one method for managing costs while still providing access to more expensive medications. Creating a niche for a product is one way that drug companies may be able to obtain formulary acceptance.

Drug Costs↗
PubMed1992

Association between formulary strategies and hospital drug expenditures.

National survey data were analyzed to determine whether an association existed between formulary strategies and hospital drug expenditures. Data on community hospitals were obtained from (1) ASHP's 1987 national survey of pharmaceutical services, (2) the American Hospital Association, and (3) the Health Care Financing Administration. Along with size, case mix, and salary information, data were collected on whether the hospitals used a well-controlled formulary, whether they used therapeutic interchange, and how much money they spent on drugs. A logarithmic cost-function model was used to obtain a straight-line equation that expressed the relationships between drug cost per patient day and the other variables assessed. Summary statistics were calculated with data from 514 hospitals. The adjusted coefficient of multiple determination indicated that the model was able to explain 24.6% of the observed variation in drug cost per patient day. A significant association was found between decreased costs and a well-controlled formulary, therapeutic interchange, or both. Hospitals that used either strategy spent 10.7% less for drugs than those that used neither. Hospitals that used both strategies spent 13.4% less than those that used neither. Analysis of national survey data suggests that use of a well-controlled formulary, therapeutic interchange, or both are associated with lower pharmacy drug expenditures.

Data Collection↗
PubMed1991

FORMREVU: an online formulary adjunct to the HELP System in a community hospital.

The hospital formulary is an important information source on drug availability for staff physicians, nurses and therapists. To facilitate rapid access to formulary data and reduce printing costs, an online formulary review program, FORMREVU, was developed as an adjunct to the HELP System at Rex Hospital. FORMREVU, written in the PTXT Application Language (PAL), is menu-driven, and qualified users can select drug entries from lists matching a specific drug category or subcategory (e.g. cardiovascular drugs, cephalosporins) or keyword (e.g. lasix). Individual drug entries consist of trade and generic names, category and subcategory, comments, and available doses and corresponding manufacturers. A detailed description of the formulary review program, along with a review of implementation objectives and qualitative and quantitative benefits, will be presented.

Clinical Pharmacy Information Systems↗
PubMed1991

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.

Ampicillin↗
PubMed1991

Multiattribute evaluation in formulary decision making as applied to calcium-channel blockers.

The use of multiattribute utility theory (MAUT) to make a formulary decision involving calcium-channel blockers (CCBs) is described. The MAUT method is a procedure for identifying, characterizing, and comparing the many variables that may affect a decision. Although applications in pharmacy have been infrequent, MAUT should be particularly appealing to formulary committees. The steps of the MAUT method are (1) determine the viewpoint of the decision makers, (2) identify the decision alternatives, (3) identify the attributes to be evaluated, (4) identify the factors to be used in evaluating the attributes, (5) establish a utility scale for scoring each factor, (6) transform the values for each factor to its utility scale, (7) determine weights for each attribute and factor, (8) calculate the total utility score for each decision alternative, (9) determine which decision alternative has the greatest total score, and (10) perform a sensitivity analysis. The viewpoint of a formulary committee in a health maintenance organization was simulated to develop a model for using the MAUT method to compare CCBs for single-agent therapy of chronic stable angina in ambulatory patients for one year. The attributes chosen were effectiveness, safety, patient acceptance, and cost and weighted 36%, 29%, 21%, and 14%, respectively, as contributions to the evaluation. The rank order of the decision alternatives was (1) generic verapamil, (2) brand-name verapamil, (3) diltiazem, (4) nicardipine, and (5) nifedipine. The MAUT method provides a standardized yet flexible format for comparing and selecting among formulary alternatives.

Calcium Channel Blockers↗
PubMed1990

Formulary-control procedures in a staff-model health maintenance organization.

Efforts to promote cost-effective drug prescribing in a health maintenance organization (HMO) through (1) revision of the formulary, (2) education, and (3) drug-use evaluations (DUEs) are described. New programs and procedures to promote more cost-effective prescribing were implemented in 1987 at a staff-model HMO with seven health-care centers and 40,000 members. Support to the pharmacy and therapeutics committee in developing formulary recommendations was enhanced, the formulary was revised and the number of listed drugs reduced by half, the focus of pharmacists was changed from purchasing and inventory control to education of physicians about cost-effective prescribing, and the most expensive drug categories were identified and educational efforts instituted. During the next two years substantial changes in the prescribing of oral contraceptives, nonsteroidal anti-inflammatory drugs, antiulcer agents, and anti-infectives, but not antihypertensive drugs, were identified through DUEs. Evaluation of cost savings was limited by the lack of an automated, integrated patient database, and it was difficult to assess the effect of changes in patient population. Revision of the formulary coordinated with enhanced educational efforts and DUEs resulted in more cost-effective prescribing in an HMO without placing severe restrictions on physicians or patients.

Cost-Benefit Analysis↗
PubMed1988

Legal issues associated with formulary product-selection when there are two or more recognized drug therapies.

The legal issues associated with selecting drug products under the formulary system when there are two or more recognized drug therapies are discussed. The primary legal issue involved is whether a decision by a health-care provider to use a particular drug product can be viewed as "reasonable" under the circumstances when there are two or more recognized drug therapies for treating a patient. In the institutional setting, the physician diagnoses and prescribes drug products but authorizes, under the formulary system, the selection of alternative agents. Imposition of civil liability on health-care providers for a patient's drug-related injury based on a formulary decision has not yet occurred. Liability would most likely be based on negligence in such a case. The standard of care a medical provider will be measured against is what a "reasonable provider" would do under like circumstances. An institution's decision whether or not to routinely have available a particular drug product that is among several accepted therapies would probably not be viewed as negligent, so long as that decision was based on the objective clinical judgment of the medical staff operating under the formulary system. It is unlikely that a decision to use one of two (or more) drug products would be "negligent" if that decision was based on a current and objective evaluation of the medical literature and supported by a recognized segment of medical opinion.

Drug Prescriptions↗
PubMed1988

Formulary evaluation of third-generation cephalosporins using decision analysis.

A structured, objective approach to formulary review of third-generation cephalosporins using the decision-analysis model is described. The pharmacy and therapeutics (P&T) committee approved the evaluation criteria for this drug class and assigned priority weights (as percentages of 100) to those drug characteristics deemed most important. Clinical data (spectrum of activity, pharmacokinetics, adverse effects, and stability) and financial data (cost of acquisition and cost of therapy per day) were used to determine ranking scores for each drug. Total scores were determined by multiplying ranking scores by the assigned priority weights for the criteria. The two highest-scoring drugs were selected for inclusion in the formulary. By this decision-analysis process, the P&T committee recommended that all current third-generation cephalosporins (cefotaxime, cefoperazone, and moxalactam) be removed from the institutions's formulary and be replaced with ceftazidime and ceftriaxone. P&T committees at other institutions may structure their criteria differently, and different recommendations may result. Using decision analysis for formulary review may promote rational drug therapy and achieve cost savings.

Cephalosporins↗
PubMed1985

Effect of formulary restriction of cefotaxime usage.

Cefotaxime sodium was assigned to the open formulary for 12 months and then was placed on formulary restriction to evaluate the restriction's effect on rate of use by services and appropriateness of use. Over 18 months, 187 cases (72 before and 115 after restriction) were reviewed. The majority of use (prerestriction and postrestriction) was in the medicine, pediatrics, and surgery services. The postrestriction usage rate for the three services increased significantly. Cefotaxime was used appropriately in 85% of cases during both periods and was not used prophylactically. Appropriateness of use was independent of formulary restriction. During both periods, approximately 76% of patients received cefotaxime for pneumonia, sepsis, meningitis, or immunosuppression. Of 205 infections, gram-negative bacilli accounted for over half of the pathogens isolated. Thus, formulary restriction was ineffective in reducing the rate of cefotaxime usage and had no effect on the appropriateness of usage.

Adolescent↗
PubMed1982

A dental school formulary.

A drug formulary can provide a readily accessible source of drug information that will complement traditional sources and enable students and faculty to make better use of them. This article presents the formal and types of information included in the University of Southern California Dental School formulary. Experiences with this formulary are discussed and recommendations for improvement are made. The formulary can be readily introduced in any dental school and would be beneficial to all dental schools, with or without their own pharmacies.

California↗
PubMedDate not supplied

Drug formulary review process for sargramostim and filgrastim: focus on analysis of adverse drug reactions.

Selection of a drug for formulary inclusion involves evaluation of safety, efficacy, and cost. The colony-stimulating factors (CSFs) sargramostim and filgrastim have a broad range of potential indications and represent a costly formulary addition when acquisition price alone is considered; their comparative safety is unclear. These factors suggest that the CSFs should be closely scrutinized prior to formulary addition. In the absence of direct comparative studies, an assessment of the safety of CSFs involves evaluation of information provided in the product circular, official drug compendia, adverse biologic reports submitted to the United States Food and Drug Administration, and data from key clinical trials. Data in the product circulars report on adverse events in small numbers of patients treated for chemotherapy-induced neutropenia (filgrastim) or neutropenia subsequent to bone marrow transplantation (sargramostim). The official compendia and clinical trials include experience with CSFs produced in a variety of expression systems; these data are not limited to sargramostim and filgrastim. Importantly, there was a similar incidence of adverse events in patients who received sargramostim or filgrastim and in those who took placebo reported in the product circulars and the pivotal trials, suggesting that the underlying disease may have an important role in determining the side-effect profile of these agents. Adverse biologic reports represent experience with sargramostim and filgrastim obtained under actual clinical conditions and suggest that the same types of adverse events are seen with sargramostim as with filgrastim. This analysis suggests that a decision to select filgrastim over sargramostim for formulary inclusion based on the safety profile is not appropriate because currently available data are equivocal and that such decisions would more appropriately be based on efficacy and cost.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Formulary management in a military treatment facility.

In an environment of increased fiscal responsibility and cost constraints, the medical staff must take an active role in deciding how an institution's operating budget is spent. A major expense of a military treatment facility (MTF) is maintaining an adequate and cost-effective formulary. The large number of pharmaceuticals available on the market forces a decision regarding which products to stock. Decision analysis is a technique that helps a medical staff to manage its formulary by listing all of the objective and subjective considerations. The Department of Defense Pharmacoeconomic Center has developed a tri-service formulary to standardize a basic drug list that would be available in each military treatment facility. However, this list cannot be expected to answer all of the factors a medical staff must weigh in developing an MTF-specific formulary. Many considerations must be addressed in these decisions, including the beneficiary population, the potential diagnoses as defined by a database such as the Retrospective Case Mix Analysis System or the Military Health Services System, the institution's mission and defined scope of care, physician interests and specialization, and facility limitations. Military treatment facilities can maintain an appropriate stock of medications that is specific for the scope and practice of a medical staff and work within a budget through careful planning and employment of a decision matrix. This balance of appropriateness and fiscal responsibility allows the maximum range of services within a facility.

Decision Support Techniques↗
PubMed1976

Hospital formularies: organizational aspects and supplementary components.

The organizational aspects and supplementary components of 44 formularies in teaching hospitals of 500 beds or more were compared. The aspects of formularies studied included prescribing regulations and technical aids, economic considerations, information on pharmacy services and procedures, information regarding drug products, hospital regulations, and format and readability. Many inconsistencies were found in the organization of the formularies and in the types of supplementary sections they included. It is suggested that the formulary has not been employed effectively as a document for transmitting drug information and hospital regulations.

Costs and Cost Analysis↗
PubMed1998

Piperacillin/tazobactam versus imipenem: a double-blind, randomized formulary feasibility study at a major teaching hospital.

With the introduction of piperacillin/tazobactam to the North American market, hospitals have been faced with the task of making a decision regarding its formulary role. In view of its broad spectrum of activity, piperacillin/tazobactam could be considered as a formulary alternative to imipenem. To evaluate the formulary feasibility of substituting piperacillin/tazobactam for imipenem, a comparative assessment of these agents in the empiric treatment of serious bacterial infections was undertaken at this tertiary care hospital. This trial was conducted as a randomized, double-blind, single-center study. Consenting adult patients (>16 years of age) who were prescribed imipenem were randomized to receive either 4 g of i.v. piperacillin/tazobactam or imipenem 500 mg of i.v. Q6H with or without concurrent antibiotics. Doses were adjusted according to renal function. There were no restrictions regarding the use of nonstudy antibiotics before and during the study period. Patients with beta-lactam allergies or meningitis or who had received greater than 72 h of previous imipenem therapy were excluded. Patients were evaluated at the end of treatment, at discharge, and at 30 days postdischarge. Endpoints included both clinical and microbiologic efficacy as well as drug toxicity. Over the 433-day study period, 360 imipenem treatment courses were initiated. Of these, 150 treatment courses (75 piperacillin/tazobactam courses and 75 imipenem courses) met study criteria and were subsequently randomized. The distribution of prescriber services for enrolled patients was similar to that for all patients receiving imipenem during the study period (p = 0.15). Also, there were no statistically significant differences in demographic parameters between enrolled and excluded patients. For those patients enrolled in the study, demographic characteristics, treatment course indication(s), and accompanying antibiotics were similar across treatment arms. The mean duration of study drug therapy was 7.7 days (SD, 6.2) for imipenem and 7.5 days (SD, 6.7)for piperacillin/tazobactam (p = 0.84). In the majority of cases, treatment discontinuation occurred as a result of a favorable treatment course outcome, stepdown to a narrower spectrum parenteral agent, or stepdown to an oral agent and did not differ between study drugs (p = 0.73). Clinical and microbiologic treatment course outcomes were also similar across treatment arms. Clinical outcome was deemed successful or improved for 68% of imipenem and 70% of the piperacillin/tazobactam treatment courses (p = 0.54). Fifty-three percent of treatment courses were microbiologically confirmed. Of the 58 courses that were assessed for microbiological outcome, 93% demonstrated successful eradication of the causative pathogens. There was no difference between study drugs (96% imipenem; 90% piperacillin/tazobactam; p = 0.61). The proportion of treatment courses with at least one adverse event was similar between the study drugs (p = 1.0). Nausea and/or vomiting were/was observed more commonly in the imipenem arm (p = 0.03). Discontinuation of therapy due to drug toxicity occurred in 16% of imipenem and 5% of piperacillin/tazobactam treatment courses (p = 0.06). There was no statistically significant difference between the mean treatment course cost for imipenem ($762; range, $55-$3192) versus piperacillin/tazobactam ($696; range, $79-$2967; p = 0.59). In summary, piperacillin/tazobactam seems to represent a suitable alternative to imipenem for several clinical indications including intraabdominal infections, pneumonia, febrile neutropenia, and skin/soft tissue infections in which the causative pathogens are susceptible. However, in view of the prevalence of multiresistant Gram-negative aerobic pathogens at this institution, we do not believe that imipenem can be removed from the drug formulary. In addition, at the currently studied dosing regimen, there seems to be no evidence of a direct cost advantage associated with

Adolescent↗