摘要
目的:探讨药品生产企业在《药品不良反应报告和监测管理办法》(新《办法》)下顺利开展ADR监测工作的模式。方法:通过对新《办法》解读、现状及制约因素分析,探索生产企业ADR监测工作开展模式。结果与结论:生产企业在短期内一步到位完全按照新《办法》要求开展ADR监测工作与现状跨度较大,可以通过一"平台"四"拓展"的模式,分块逐步突破,开展ADR监测工作,最终完全达到新《办法》的要求,履行主体地位的责任和使命。
Objective： To discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring. Method： Work modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains. Result and Conclusion： As there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2012年第21期3329-3333,共5页
China Journal of Chinese Materia Medica
关键词
药品不良反应
生产企业
工作模式
adverse drug reaction
drug manufacturer
work mode
