Medical Product Active Surveillance System in America and Its Revelation

Abstract

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

CLC Number:

R994.11

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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