Pharmacoepidemiology

Sheila Weiss Smith

Pharmacoepidemiology is the study of the use and effects of medical products (drugs, biological products, and medical devices) in human populations. One of the newer branches of epidemiology, pharmacoepidemiology has emerged as a unique field of study in parallel with the development of large, comprehensive, health care databases. However, it is not the reliance on large databases, but the nature of medical products as exposures that truly differentiates pharmacoepidemiology as a subspecialty of epidemiology. First, medical products are regulated by government entities. They are approved for a particular use or indication with dosing, labeling, and monitoring requirements. Second, exposures to medical products are made consciously for the treatment of a known medical condition or to prevent or delay the occurrence of a disease. The regulatory nature of pharmaceutical products drives the type and timing of studies and often the source of funding and perspective as well. The nonrandom nature of ...

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