Introduction of PE (Pharmacoepidemiology)

Introduction of PE

국민의 안전과 건강을 지키는 한국의약품안전관리원

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  1. 1. Pharmacoepidemiologic Investigation

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     Conduct in-depth review of serious ADE reports and important safety signals.

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     Conduct field pharmacoepidemiologic investigations on emerging ADE epidemics.

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     Conduct strategic pharmacoepidemiologic investigations on medicinal products with drug safety issues.

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     Keep up-to-date with pharmacoepidemiologic assessment methodologies and guidelines.


    Introduction of PE

  2. 2. Methods for Causality Assessment


    For individual case reports, we apply causality assessment algorithms which are based on decision criteria including challenge, dechallenge, rechallenge, previous bibliographic descriptions, and other etiologic alternatives. Once the signal of a potential drug safety issue is generated, a signal evaluation is performed. It includes systematic reviews of relevant literature and pharmacoepidemiologic studies either as ad-hoc basis or as database analysis. Pharmacoepidemiologic studies can provide high quality of evidence for clinical decision-making by empirically specifying the nature and magnitude of the risk of having a particular adverse outcome associated with a medication.