藥品不良反應通報處理案例剖析：嚴重藥品不良反應通報案件【實務講座】 試閱
Reporting of Adverse Drug Reactions in Taiwan: A Serious Adverse Drug Reaction Report
全國性的藥品不良反應通報系統是國際上藥品安全監視的必備運作模式，也是最常用來收集藥品使用潛在安全性問題的方法之一。我國藥事法第45條之1及「嚴重藥物不良反應通報辦法」明定醫療機構、藥局及藥商對於因藥物引起之嚴重不良反應，應於時限內進行通報。透過國內不良反應通報案件之收集和分析，偵測藥品安全訊號以發掘潛在的安全性風險，並進一步審視藥品於臨床使用之風險效益，必要時採取風險管控措施以避免不良反應的發生或降低其嚴重度，保障國人的用藥安全。本文希望藉由嚴重藥品不良反應通報案件的介紹、分析和評估，讓讀者對於上市後藥品安全監視及嚴重藥品不良反應通報具備基本的概念。
A national adverse drug reaction reporting system is an essential tool for pharmacovigilance operation worldwide. It is the most common method for collecting potential drug related safety issues. According to Article 45-1 of the Pharmaceutical Affairs Act and egulations for Reporting Serious Adverse Reactions of Medicaments?in Taiwan, medical care institutions, pharmacies and marketing authorization holders shall report serious adverse drug reactions within time limits. Collecting, analyzing and evaluating domestic adverse drug reaction reports could help detect drug safety signals and find out potential safety risks. Regulatory authority can further review safety concerns and assess clinical benefits and risks of the drug, and then take risk mitigation measures if necessary to ensure patient safety. In this article, a serious adverse drug reaction report is introduced to let readers get a better understanding of pharmacovigilance and its related regulations.
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