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KMID : 1011320080010010008
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Journal of Pharmacoepidemiology and Risk Management
2008 Volume.1 No. 1 p.8 ~ p.12
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Psot-Marketing Surveillance
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Kim Young-Sik
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Abstract
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The objectives of post-marketing study are to detect adverse events not previously observed, improve understanding of safety and efficacy of the new medicine, detect events resulting from drug interactions, evaluate drug effects in particular populations, and assess the potential for causal relationships. The key elements of causality assessment are 1) quality of document, 2) time-relationship, 3) alternative causes, and 4) specific hints for causality such as effects of dechallenge and rechallenge, and pharmacologic plausibility. The adverse events of new drugs approved since 1995 are monitored by the reexamination system during four to six years since approval in Korea. The purposes of reexamination study are 1) to identify unexpected adverse drug reactions (ADRs) or known ADRs whose incidence markedly increased after launch, 2) to survey the safety in special patient categories such as the elderly, pediatric patients, pregnant women, patients with hepatic or renal dysfunction, or long-term use, 3) to detect factors affecting the safety and effectiveness. The reexamination study was well established during the last decade. However, several problems were noticed such as a poor quality of study process and outcome report, a complexity of reexamination system, and a marketing-oriented approach of sponsor. Therefore, the reexamination system should be revised for the better quality and practice.
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KEYWORD
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Post-marketing surveillance, Adverse events, Re-examination study
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