影响聚集性药品不良事件预警系统运行的风险因素分析及思考  

Analysis of the Risk Factors Infl uencing the Adverse Drug Cluster Events Early Warning System

作　　者：冯红云[1] 刘佳[1] 董铎[1] 侯永芳[1] 杨乐[1] 宋秋洁[1] 郑明节[1] 李馨龄[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2016年第4期219-222,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的指导预警系统的功能调整和提高预警能力。方法对国家中心2014年收到的3千余条预警信号进行了系统分析,并讨论影响聚集性药品不良事件预警系统运行的风险因素。结果预警规则以及运行参数的设置、药品不良反应/事件报告的质量、基础数据库的建设以及相关工作程序的制定等因素均可对预警系统的运行造成影响。结论聚集性药品不良事件预警系统可以及时有效的发现药品质量风险。针对已经确认的风险因素,提出了相应的调整建议。Objective To provide support for function adjustment of the adverse drug cluster events early warning system and improve the early warning ability. Methods More than 3 thousands early warning information in 2014 was analyzed systematically, and the risk factors infl uencing the early warning system were discussed. Results The risk factors included the early warning rules and algorithms, the quality of adverse drug reaction/event reports, foundation database, and the processing procedure for dealing with the early warning information of cluster adverse drug events. Conclusion The early warning system of the adverse drug cluster events can detect the product quality problem effectively. The function adjustment recommendations for the early warning system were proposed according to the identifi ed risk factors.

关 键 词：聚集性药品不良事件 预警系统 风险因素 

分 类 号：R994.11[医药卫生—毒理学]