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Pharmacoeconomics is the area of health care research that evaluates and compares the costs and outcomes associated with drug therapy.1 Corresponding to recent awareness by the public of rising health care costs has been an increased interest in evaluating drugs’ economic as well as clinical benefits. This interest is readily apparent by the steady growth in the number of pharmacoeconomical studies that have been published in the primary literature since the mid-1990s.2

Pharmacoeconomical research is primarily driven by the basic principle that financial resources are limited and that the organizational needs generally exceed available resources. Most pharmacy managers are constantly faced with doing “more with less,’’ and choices must be made as to how best to allocate available dollars. Consequently, pharmacoeconomical studies help provide data on making critical decisions, such as determining which drugs should be on the organization’s formulary, defining the best organizational strategy for managing a particular disease state, and selecting the most appropriate agent to treat a patient’s medical condition. In addition, pharmacoeconomical research can help administrators and other managers to decide which services to implement within their organization. Consequently, pharmacoeconomical research provides valuable information that is used by a number of health care decision makers.

There are some important differences between pharmacoeconomical research and clinical trial studies. As compared to clinical trial research, pharmacoeconomical outcome research is concerned with evaluating the drug in the “real world.’’ The primary role of clinical trials is to measure the efficacy and safety of a drug2; however, these studies are usually performed in very controlled, “test tube–like’’ environments. Clinical trials typically have strict inclusion criteria that may exclude patients who might otherwise receive the drug in general clinical practice. For instance, children and elderly patients are often not candidates for clinical trials and, for many years, women were excluded from these studies. Also, protocols for patient monitoring in clinical trials are usually more rigorous that what would ordinarily be employed. Given the relatively small sample size of most clinical trials, rare but serious adverse drug reactions may not be detected in these studies. Only after a drug has been used in a much larger patient population do we obtain a more accurate understanding of its safety and effectiveness, which explains why postmarketing surveillance is so important.

In contrast to clinical research, pharmacoeconomical research attempts to measure the efficiency of a drug or its overall value in the health care system.3 It not only evaluates drug therapy outcomes but also compares and contrasts these outcomes in terms of their costs. Most of these studies rely on both retrospective, observational data as well as clinical trial data to obtain a more realistic assessment of a drug’s safety and effectiveness. By including cost in the analysis, pharmacoeconomical studies provide information that helps determine which drugs provide the most clinical benefit for the dollars spent.

Another fundamental difference between pharmacoeconomical research and clinical trial ...

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