美国医疗产品安全主动监测系统概述及启示

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (1): 32-35.

美国医疗产品安全主动监测系统概述及启示

侯永芳, 沈璐, 刘巍, 宋海波, 刘翠丽, 王丹, 李馨龄^*

国家食品药品监督管理总局药品评价中心,北京100045

收稿日期:2017-02-16 修回日期:2017-02-16 出版日期:2017-01-20 发布日期:2017-02-16
作者简介:侯永芳,男,硕士,高级工程师,药品不良反应监测。

Medical Product Active Surveillance System in America and Its Revelation

HOU Yong-fang, SHEN Lu, LIU Wei, SONG Hai-bo, LIU Cui-li, WANG Dan, LI Xin-ling^*

Center for Drug Reevaluation, CFDA,Beijing 100045, China

Received:2017-02-16 Revised:2017-02-16 Online:2017-01-20 Published:2017-02-16
Contact: 李馨龄,男,副主任药师,药品不良反应监测。E-mail:lixinling@cdr-adr.org.cn

摘要/Abstract

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。

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

Abstract: ObjectiveTo provide reference for establishing active surveillance system of drug safety in China. MethodsThe 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& ConclusionThe 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.

Key words: active surveillance, adverse drug reaction, common data model, distributed database

中图分类号:

R994.11

侯永芳, 沈璐, 刘巍, 宋海波, 刘翠丽, 王丹, 李馨龄. 美国医疗产品安全主动监测系统概述及启示[J]. 中国药物警戒, 2017, 14(1): 32-35.

HOU Yong-fang, SHEN Lu, LIU Wei, SONG Hai-bo, LIU Cui-li, WANG Dan, LI Xin-ling. Medical Product Active Surveillance System in America and Its Revelation[J]. Chinese Journal of Pharmacovigilance, 2017, 14(1): 32-35.

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