摘要
目的:在新版《药品不良反应(ADR)报告和监测管理办法》要求下探讨药品生产企业开展ADR监测工作存在的问题及解决对策。方法:分析药品生产企业在开展ADR监测工作中存在的问题及原因,有针对性地提出建议。结果与结论:我国应借鉴国外ADR监测经验,通过完善相关法律规定、建立ADR基金救济制度为药品生产企业提供政策保障,采取规范信息收集网络、建立ADR数据库为企业提供技术指导等措施,提高药品生产企业的ADR监测水平。
OBJECTIVE： To explore problems and countermeasures of developing ADR monitoring in pharmaceutical manufac- turers at the request of the new version of Adverse Drug Reactions （ADR） Reporting and Monitoring Management. METHODS： The problems of adverse reaction monitoring of pharmaceutical manufacturers and their reasons were analyzed to put forward sug- gestions. RESULTS＆CONCLUSION： We should learn from foreign experience of ADR monitoring, provide policy support for drug manufacturers through improving relevant laws and regulations, establishing ADR fund relief system, and improve ADR moni- toring of pharmaceutical manufacturers through standardizing information collection network, establishing ADR database and provid- ing technical guidance and other measures.
出处
《中国药房》
CAS
CSCD
2012年第42期3937-3939,共3页
China Pharmacy
关键词
药品不良反应
监测
生产企业
Adverse drug reaction
Monitoring
Manufacturers
