摘要
目的分析探讨我国现阶段药品安全的定义和范畴。方法检索1998～2008年国内外相关数据库及网站,采用系统综述的方法对纳入文献进行归纳与分析。结果系统综述共纳入290篇文献报告,其中6篇给出了药品安全的定义。结论药品安全可定义为"通过对药品研发、生产、流通、使用全环节进行监管所表现出来的消除了外在威胁和内在隐患的综合状态,以及为达到这种状态所必要的供应保障和信息反馈",其内涵可以界定为质量符合标准、不良反应在可接受的范围内、临床无用药差错和可及性四个部分。
Objective To analyze the definition and category of drug safety in China. Methods System- atic review of the main documents which were published in 1998-2008. Results 6 pages of 290 doc- uments had the defination of drug safety. Conclusion Drug safety should be defined as a status that the external and internal risk was eliminated by supervising, besides necessary supply and information feedback. The category of these include quality, acceptble risk, none of medical error and accessibility.
出处
《中国药物警戒》
2009年第5期257-260,共4页
Chinese Journal of Pharmacovigilance
基金
SFDA政策法规司委托立项
中国卫生政策支持项目(编号:CS200802-04)
关键词
药品安全
概念
范畴
分析
drug safety
concept
category
analysis
