美国FDA迷你哨点中公共数据库模型的介绍及对我国的启示  

Introduction of Common Data Model in United States FDA Mini-sentinel and Its Enlightenment to China

作　　者：陈哲[1] 李斌[2] 史录文[1,3] 江滨[1] 

机构地区：[1]北京大学药学院药事管理与临床药学系,北京100191 [2]中国人民解放军军事科学院门诊部,北京100091 [3]北京大学医药管理国际研究中心,北京100191

出　　处：《中国药房》2013年第41期3844-3846,共3页China Pharmacy

摘　　要：目的:为中国药品安全监测中数据利用和数据库建立提供新思路。方法:探索美国FDA迷你哨点药品主动监测系统中公共数据库模型的数据收集、分析及应用,并提出对中国药品安全监测的启示。结果与结论:迷你哨点通过应用公共数据库模型,采用分布式结构,实现了对不同数据伙伴、不同来源数据的复合管理与利用,从而完成了对药品相关信息的收集、转移、查询和分析评估。中国药品安全监测应尽快尝试建立基于公共数据库模型的药品安全监测系统,将已有数据库进行有机地连接和整合,通过对标准化的数据提取,实现药品安全信息的深度挖掘和主动监测,形成主动监测与被动监测互相补充的监测系统。OBJECTIVE ： To provide new idea for data utilization and the establishment of database of pharmacy safety surveil- lance in China. METHODS： The application of common data model in United States FDA Mini-sentinel was explored in fields of data collection, analysis and application. Related suggestions about pharmacy safety surveillance were put forward. RESULTS ＆ CONCLUSIONS： The paper sorts out the distributed structure of common data model. Mini-sentinel achieves multiple management and utilization of different data partners and data from diverse sources through common data model. Thus it accomplishes the collec- tion, transfer, inquiry, analysis and evaluation of relevant information of drugs. The pharmacy safety monitoring system can be es- tablished in China as soon as possible based on common data model. By integrating current databases and extracting the data of stan- dardization, depth exploration and active surveillance of pharmacy safety information can be completed to form surveillance system of active surveillance complementing with passive surveillance.

关 键 词：迷你哨点 公共数据库模型 药品安全 主动监测 

分 类 号：R95[医药卫生—药学]