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PubMed1982

Evaluation of a limited drug formulary in an adult internal medicine clinic.

The utility of a 30-drug, limited formulary in an adult internal medicine, ambulatory-care clinic was investigated. The formulary was developed using a mail survey of a random sample of members of the ASHP Ambulatory Care Pharmacy Practice Special Interest Group. The consensus formulary comprised the 30 most frequently recommended drugs; the utility of the formulary was then tested by chart review in a primary-care internal medicine clinic. Over a two-month period, the charts of alternating patients were reviewed daily; patient data collected included demographic information and prescribed drug therapy. A panel of two physicians and one pharmacist reviewed each patient's data and determined the appropriateness of drug treatment. If an agent was prescribed that was not on the consensus formulary, the panel determined whether an appropriate formulary agent could have been prescribed. Of the prescribed drug orders, 57.8% were for agents in the consensus formulary; by including patients who could have received formulary drugs appropriately, 73.7% of all prescription orders were or could have been for formulary drugs. Age, race, and sex of patients had no significant effect on utility of formulary agents. Had the 30 drugs most commonly prescribed in this clinic been in the formulary, 82.6% of all prescription orders would have been covered. This approach to establishing a new formulary and selecting drugs for inclusion is potentially useful.

Adult↗
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↗
PubMed2000

Formulary management.

The hospital formulary is not only a list of drugs, but also a policy that involves several complex processes and activities. Formularies are developed based on cost-effectiveness evaluation, but maintaining cost-effectiveness requires educational strategies. The clinical pharmacist plays an active role in formulary processes. These processes are discussed in this paper. There is a need for studies on the cost-effectiveness of clinical pharmacy services in support of the hospital formulary.

Clinical Trials as Topic↗
PubMedDate not supplied

Group processes of decision making for hospital-based technology assessment committees.

There are a variety of group-judgment methods to resolve controversial issues in health care. Meta-analysis and group judgment methods such as consensus conferences are attempts to bring diverse elements of information together for synthesis. Leape notes that a significant body of literature exists regarding the techniques used to elicit opinions from groups. Organizational structures and functions of groups vary in terms of the natures of interactions among group members and the manners in which final conclusions are reached and expressed. The introduction of the process of technology assessment into the hospital setting introduces a problem inherent in the introduction of somewhat academic processes into the operational real world of interpersonal relations, administrative and medical staff interactions, staff costs, and institutional priorities. Hospital administrative processes are based on the committee approach. Medical staff credentialing, drug formularies, and administrative policies are all developed, approved, and implemented through committees. It would seem logical that if technology assessment is to be effective in the hospital setting, then those same group decision processes inherent in committees should be used in technology assessment. Relatedly, if technology assessment is to be successful in the hospital setting, then how can the limited resources of hospital-based staff be best utilized to carry through the assessment of elected technologies? This paper discusses group decision processes, particularly as they relate to technology assessment. The processes of particular interest are those that focus on group interactions rather than theory-based decision processes. The purpose for the paper is to provide to clinical engineering management and senior hospital management background information to use in the formulation of the operating parameters of a hospital-based technology assessment committee.

Biomedical Engineering↗
PubMed1991

Impact of clinical trials on the adoption of new drugs within a university hospital.

To assess the influence that clinical trials may have on the introduction of new drugs into prescribing routines, the adoption of drugs has been studied in a university hospital in the Netherlands. A significant relation was found between the testing of semi-innovative drugs in clinical trials in the hospital and the introduction of these drugs into general use in the same hospital. No such relationship was found for innovative drugs. Employment in clinical trials only affected the frequency of adoption of semi-innovative drugs. It did not influence the quantity of their use once they had been adopted. The idea that the stimulating effect of clinical trials on the adoption of semi-innovative drugs is only due to acceleration of the adoption process was not confirmed. These findings support the idea that clinical trials can lower the barriers for adoption of semi-innovative drugs.

Clinical Trials as Topic↗
PubMed1992

Institutional formularies: the relevance of pharmacoeconomic analysis to formulary decisions.

Formularies, in one form or another, have been in existence for nearly 100 years. Beginning simply as a list of available agents, the formulary has evolved into a complex system which acts as a guide to prescribing practices. As the importance of the formulary has increased, so has the need for formulary managers to make an appropriate decision about each drug's formulary status. Several systematic approaches to drug evaluations have been developed to aid in the decision process. However, while some reviews of drug utilisation contain fairly rigorous analyses of their clinical efficacy, very few include an economic evaluation that goes beyond the cost of drug acquisition, preparation, distribution and administration. This is surprising, since formulary managers rank economic data second only to clinical data when making formulary decisions. In the past this apparent oversight has been due, in part, to the absence of a sophisticated model which can both approximate a drug's true economic impact and express cost and quality in similar terms. The explosion of new and very expensive biotechnology drugs into the market has the potential to improve patient care significantly. Such drugs also have the potential to increase institutional pharmacy budgets significantly; with some analysts predicting a spending of $US60 million yearly for these drugs by the year 2000, critical evaluation will be mandatory. Fortunately, advances in the relatively new science of pharmacoeconomics have made it possible to conduct appropriate estimates of the true economic impact of new drug therapies. Pharmacoeconomic studies can be very useful in evaluating drugs for formulary inclusion and in assessing the effects of formulary changes on institutional budgets. Cost-effectiveness and cost-benefit analyses, utilising decision analysis models and/or data gathered from clinical studies, are used most frequently. Relatively simple models can be used to evaluate drugs within the same class if sufficient published data on their clinical efficacy and safety are available. More complex analyses are necessary when comparing dissimilar agents or when comparing agents with non-drug therapy. Pharmacoeconomic studies have frequently been used to demonstrate that very substantial direct costs of drug therapy are often offset by equal or greater reductions in other institutional direct and indirect patient care costs. Pharmacoeconomic studies have also been used to calculate the relative cost-effectiveness of drug therapies for different disease states, although such evaluations are more useful to governmental and regulatory agencies than to individual institutions.(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Trials as Topic↗
PubMed1986

Experience with intrainstitutional clinical evaluations of newly marketed preparations as a basis for drug-product selection to hospital formularies.

The decision to admit a new drug-product formulation (NDPF) to a hospital pharmacy formulary is a difficult task, particularly when minimal pharmacokinetic or clinical efficacy data are available. To provide objective information to the Pharmacy and Therapeutics (P&T) Committee, we implemented a procedure to evaluate these NDPFs at our institution. This procedure, termed clinical evaluation, was initiated at our institution in 1981. The clinical evaluations of two NDPFs were performed. The two NDPFs studied were a transdermal nitroglycerin preparation and a sustained-release procainamide preparation. The clinical assessment of the therapeutic and the pharmacokinetic performance of each preparation was made by clinical pharmacists. Following completion of the clinical evaluation, the data were presented at a regular meeting of the P&T committee. The presentation of clinical data derived from our patient population facilitated objective assessment by the P&T committee regarding formulary status. We conclude that the clinical evaluation represents a novel approach to acquire data necessary for objective decisions on NDPFs by the P&T committee.

Administration, Topical↗
PubMed2001

Integrating fluoroquinolones into the hospital formulary.

With the increasing availability of new agents, selection of fluoroquinolones for formulary inclusion can be difficult. Appropriate evaluation of the important characteristics (pharmacokinetic and pharmacodynamic properties, antimicrobial activity, efficacy, tolerability, cost) of these agents should allow selection of the most cost-effective ones. Evidence from in vitro studies and clinical trials indicates differences exist among fluoroquinolones, especially in terms of activity against gram-positive, aerobic organisms. For selected clinical situations, it may be important to choose an agent that is available in both intravenous and oral formulations. Comparative drug costs, as well as costs associated with potential clinical failure and adverse events, should be evaluated carefully. Dosage regimens should be considered, as shorter durations of therapy and less frequent dose administration may lead to reduced labor costs and increased patient compliance, thereby improving effectiveness and economic efficiency.

Anti-Infective Agents↗