Pharmacoepidemiology

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Pharmacoepidemiology
Huang, Boji
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Pharmacoepidemiology is the study of the use of
the effects of drugs in large numbers of people.
The term pharmacoepidemiology contains two
components "pharmaco" and "epidemiology."
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The joining of the fields of clinical
pharmacology and epidemiology has resulted in the
development of a new field pharmacoepidemiology,
the study of the use of and the effects of drugs
in large numbers of people.
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Pharmacoepidemiology applies the methods of
epidemiology to the content area of clinical
pharmacology.
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Pharmacoepidemiology encompasses elements of both
of these fields, exploring the effects achieved
by administering a drug regimen. It does not
normally involve or require the measurement of
drug levels.
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Pharmacoepidemiology has become the science
underlying postmarketing drug surveillance,
studies of drug effects which are performed after
a drug has been marketed.
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In attempting to optimize the use of drugs, one
central principle of clinical pharmacology is
that therapy should be individualized, or
tailored to the needs of the specific patient at
hand.
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Clinical pharmacology is traditionally divided
into two basic areas, pharmacokinetics and
pharmacodynamics.
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Together, these two fields allow one to predict
the effect one might observe in a patient from
administering a certain drug regimen.
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Specifically, the field of pharmacoepidemiology
has primarily concerned itself with the study of
adverse drug effects including Type A and Type B
reactions.
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The usual approach to studying adverse drug
reactions has been the collection of spontaneous
reports of drug-related morbidity or mortality.
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However, determining causation in case reports of
adverse reactions can be problematic, as can
attempts to compare the effects of drugs in the
same class.
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This has led academic investigators, industry,
FDA, and the legal community to turn to the field
of epidemiology.
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Specifically, studies of adverse effects have
been supplemented with studies of adverse events.
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This marriage of the fields of clinical
pharmacology and epidemiology has resulted in the
development of a new field pharmacoepidemiology.
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Since pharmacoepidemiology is the study of the
use of and effects of drugs in large numbers of
people, it falls within epidemiology, as well.
Epidemiology is also traditionally subdivided
into two basic areas.
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The pharmacoepidemiology field uses the
techniques of chronic disease epidemiology to
study the use of and the effects of drugs.
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Although pharmacoepidemiology method application
can be useful in performing the clinical trials
of drugs which are performed prior to marketing,
the major application of these principles is
after drug marketing.
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This has primarily been in the context of
post-marketing drug surveillance, although in
recent years the interests of pharmacoepidemiologi
sts have broadened.
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Thus, pharmacoepidemiology is a relatively new
applied field, bridging between clinical
pharmacology and epidemiology.
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From clinical pharmacology, pharmacoepidemiology
borrows its focus of inquiry. From epidemiology,
pharmacoepidemiology borrows its methods of
inquiry.
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In other words, it applies the methods of
epidemiology to the content area of clinical
pharmacology.
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In the process, multiple special logistical
approaches have been developed and multiple
special methodological issues have arisen.