CAJ | 학술논문

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。
2011년수정적《약품불량반응보고화감측관리판법》제출“약품중점감측”저일신적공작임무。절지목전해판법이실시4년유여，유관약품중점감측공작야적루료일사경험。본문주요종기술감관적각도，중신심시약품중점감측적의의화내함，총결감측적방법급리폐，소리중점감측공작존재적문제，위추동해항공작심입유효지개전제공사로。
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. Experi-ence 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.