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