摘要
2011年修订的《药品不良反应报告和监测管理办法》提出"药品重点监测"这一新的工作任务。截至目前该办法已实施4年有余,有关药品重点监测工作也积累了一些经验。本文主要从技术监管的角度,重新审视药品重点监测的意义和内涵,总结监测的方法及利弊,梳理重点监测工作存在的问题,为推动该项工作深入有效地开展提供思路。
The key drug monitoring is a new task introduced by the approach of adverse drug reaction reporting and monitoring revised in 2011. As of now, the approach has been implemented for more than four years. Experience in the key drug monitoring has been accumulated. The article, in the point of technical supervision view, tries to re-examine the meaning and content of the key drug monitoring, summarizes the methods as well as its advantages and disadvantages, combings the existing problems, and provides ideas in order to promote the work to carry out in deep and effective way.
出处
《中国药物警戒》
2015年第9期534-537,共4页
Chinese Journal of Pharmacovigilance
关键词
药品不良反应监测
主动监测
药品重点监测
adverse drug reaction monitoring
active monitoring
key drug monitoring
