美国医疗产品安全主动监测系统概述及启示  

Medical Product Active Surveillance System in America and Its Revelation

作　　者：侯永芳[1] 沈璐[1] 刘巍[1] 宋海波[1] 刘翠丽[1] 王丹[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》2017年第1期32-35,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的为建立我国药品安全主动监测系统提供思路和参考。方法研究美国医疗产品安全主动监测系统,分析其关键技术和实现方式,为我国建立药品安全主动监测系统提出建议。结果与结论美国医疗产品安全主动监测系统借助通用数据模型、分布式数据库等技术将医疗保险、医院电子健康数据、人口登记等有关电子健康数据进行虚拟整合,并通过特定方法对数据综合分析利用,高效、经济地从真实世界获得医疗产品安全性问题方面的证据。我国可结合国情建立药品安全主动监测系统,作为辅助验证药品安全性问题的新手段。Objective To provide reference for establishing active surveillance system of drug safety in China. Methods The active surveillance system of medical product safety in United States was studied by analyzing the key technologies and implementation methods, and the recommendations for establishing similar system in China were provided. Results Conclusion The medical product safety active surveillance system in United States uses common data model（CDM）, distributed database and other technologies to build virtual database consist of health insurance data, hospital health data, population registration data. The system can analyze and utilize the virtual database through specific methods, get evidence about medical product safety issues from the real world efficiently and economically. We can combine with China＇s national conditions to establish active surveillance system for drug safety.

关 键 词：主动监测 药品不良反应 通用数据模型 分布式数据库 

分 类 号：R994.11[医药卫生—毒理学]