Adverse drug event monitoring at the Food and Drug Administration - Your report can make a difference
Adverse drug event monitoring at the Food and Drug Administration - Your report can make a difference
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DOI：
10.1046/j.1525-1497.2003.20130.x
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发表时间：
2003-01-01
影响因子：
5.7
通讯作者：
Ahmad, SR
中科院分区：
文献类型：
--
作者：
Ahmad, SR
美国食品和药物管理局（FDA）不仅负责批准药物，还负责在药物进入市场后监测其安全性。由于批准前临床试验的样本量小、持续时间短和普遍性有限，在批准时并不知道药物的完整不良事件特征。本报告描述了FDA的上市后监测系统，许多临床医生向该系统提交了治疗患者时遇到的药物不良事件报告。尽管存在局限性，但自发报告系统是一种非常有价值的机制，通过该机制，可以识别在批准时未观察到或未认识到的药物危害。强烈鼓励医生向FDA提交可疑药物的不良结果报告，他们的报告会产生影响。FDA正在加强其上市后监督，并获得新的数据源，这些数据源有可能进一步改善药物风险的识别、量化和后续管理。
The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk.