我国药品追溯方案和信息化架构研究  

Reseach on Drug Tracing Scheme and Information Architecture in China

作　　者：唐菀晨[1] 王迎利[1] 张熹 宗欣[1] Tang Wanchen;Wang Yingli;Zhang Xi;Zong Xin(Information Center of China Food and Drug Administration,Beijing 100053,China)

机构地区：[1]国家食品药品监督管理总局信息中心,北京100053

出　　处：《中国药事》2018年第7期874-878,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:在企业承担药品追溯体系建设主体责任背景下,研究设计我国药品追溯方案和信息化架构。方法:对比分析欧美追溯体系建设做法和对我国的启发,调研我国药品追溯干系方需求,设计我国药品追溯方案和信息化架构。结果与结论:本研究设计的方案可厘清各追溯干系方职责,落实企业主体责任;实现药品追溯闭环,保障药品供应链安全;强化药品信息验证,促进购药安全;设计药品追溯协同平台,实现各追溯业务系统间的信息交换;充分利用追溯数据,提升监管能力和水平。Objective： To design a drug tracing scheme and information architecture in China under the background that the enterprises undertake the main responsibility of drug tracing scheme. Methods： European and American tracing schemes and their enlightenment were analyzed and the needs of drug tracing scheme in China were investigated. Furthermore, drug tracing scheme and information architecture in China were designed. Results and Conclusion： The scheme designed in this study can clarify the responsibilities of each tracing scheme and implement the main responsibility of enterprises; realize the closed loop of drug tracing and ensure the safety of drug supply chain; strengthen drug information verification and promote the safety of purchasing drugs; design drug tracing coordination platform to realize information exchange among various tracing schemes; and make full use of tracing data to enhance regulatory capabilities and levels.

关 键 词：药品追溯 药品追溯方案 信息化架构 企业主体责任 

分 类 号：R95[医药卫生—药学]