药品不良反应监测机构建设探讨

药品不良反应监测是对上市后药品进行安全性监管的重要手段,是保证药品安全的重要环节。本文通过对我国药品不良反应监测机构现状的分析,从ADR监测机构的法律地位确立存在偏差致监测机构建设不健全、ADR监测机构不健全致监测人员业务水平不高和信息反馈不畅等方面探讨省以下ADR监测机构建设存在的问题,并对完善我国药品不良反应监测机构的建设提出相应的建议。

Discussion on Adverse Drug Reaction Monitoring Organization

Adverse Drug Reaction Monitoring is an important means of post-marketing drug surveillance,which is the important link to ensure drug safety.Through analysis of the below the province level adverse drug reaction monitoring of institutional construction present situation,From the three aspects discuss institution-building below the provincial ADR monitoring problems:inadequate monitoring institution-building is caused by ADR monitoring institutions to establish the legal status of deviations,Monitoring personnel business level is not high and Feedback is not smooth are caused by ADR monitoring institutions which is not sound on perfecting the construction of the below the province level adverse drug reaction monitoring organization to make recommendations accordingly.