国际药物警戒系统评估指标研究进展

Research progress on evaluation indicators of international pharmacovigilance system

药物警戒是国际通行的对上市后药品安全性进行监管的手段。为评价药物警戒系统的效能,国际上研究并建立了对药物警戒系统能力进行评估的指标。本文系统分析了国际药物警戒系统评估指标研究进展,以及利用相关评估指标开展药物警戒系统评估的实例,以期为我国建立药物警戒系统评估指标体系提供思路。

Pharmacovigilance is an internationally accepted means of regulating the safety of post-marketing drugs.In order to evaluate the effectiveness of pharmacovigilance systems,indicators for evaluating the capacity of pharmacovigilance systems have been studied and established internationally.In this paper,the research progress of international pharmacovigilance system evaluation indicators and the use of relevant evaluation indicators to carry out pharmacovigilance system evaluation were systematically analyzed,in order to provide ideas for the establishment of pharmacovigilance system evaluation indicator system in China.