药品不良事件聚集性信号预警系统的建立和运行

摘要

为了及时发现药品不良事件聚集性信号,国家药品不良反应监测系统建立了药品不良事件聚集性信号的预警系统,并已投入正常使用.本文就预警系统的整体工作思路及预警规则的制定、初设预警系统运行后出现主要问题以及相应的调整进行了介绍,并对几次重大历史药害事件进行了人工预警,验证了预警规则的灵敏度和准确性.%To discovery the adverse event cluster signals earlier, a pre- warning system was established and running in national adverse drug reaction monitoring system. Related processes, including background, pre-warning regulations, all problems during pre-warning system running and adjustments were introduced. In order to test the sensitivity and accuracy of pre-warning regulations, the three important historical drug hazards were pre-warned by hand.