处方事件监测

Prescription Event Monitoring

处方事件监测用非干预性、观察性药品不良反应监测方法, 1981年在英国最早开展。本文简要回顾其发展历史背景,详细描述其操作过程,介绍其开展现状。尽管处方事件监测的开展有相当的难度,但是作为监测药品不良反应的一种方法,它已成为药品上市后安全警戒体系中一种重要的研究方法,可以作为药品不良反应监测自愿报告系统的有益补充。

Prescription Event Monitoring (PEM) is a non-interventional observational method of adverse drug reaction monitoring, which was established first in England in 1981. This review introduces the background of development, the details of procedure and the current situation. It is quite difficult to make PEM studies, but as a method of adverse drug reaction monitoring, it has become an important method of post-marketing surveillance system and can complement spontaneous reporting system of adverse drug reaction.