建设基于药品不良反应监测的聚集性不良事件预警体系的设想和实践  

Proposal and Practice of Building the Early Warning System on Cluster Adverse Drug Events Based on the Adverse Drug Reaction Monitoring

作　　者：冯红云[1] 杨乐[1] 宋秋洁[1] 侯永芳[1] 郑明节[1] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2015年第11期665-668,共4页Chinese Journal of Pharmacovigilance

摘　　要：药品群体不良事件对社会造成的影响和危害重大,尤其需要药品监管部门关注,要求及时发现、及时处理和及时控制,防止药害事件的扩大和蔓延,避免更多的患者受到伤害。为及时有效的发现、评估、控制药品群体不良事件,国家药品不良反应监测中心着手构建了基于药品不良反应监测的聚集性药品不良事件预警体系。本文从聚集性药品不良事件预警体系建设的意义、工作基础、建设目标等方面详细论述了建设预警体系的设想和实践。The cluster adverse events, which have serious impact concerned by drug regulators. To avoid more damages, the signals and harm on public health and social stability, are of the cluster adverse events need to be discovered, identified and controlled as earlier as possible. In order to discover the drug cluster events and control the risk, an early warning system of the cluster adverse drug events based on the adverse drug events monitoring was built. In this article, the feasibility of building the warning system on cluster adverse drug events was analyzed.

关 键 词：药品不良反应 聚集性药品不良事件 预警体系 

分 类 号：R994.11[医药卫生—毒理学]