机构改革下药品监管部门药品不良反应监测工作的探讨  

Exploration of adverse drug reaction monitoring by drug regulatory departments under institutional reform

作　　者：朱瑞红 张丹 ZHU Rui-Hong;ZHANG Dan(Market Supervision and Administration Bureau of Sheqi County,Nanyang 473300,China;Nanyang Product Quality Inspection and Testing Center,Nanyang 473000,China)

机构地区：[1]社旗县市场监督管理局,南阳473300 [2]南阳市产品质量检验检测中心,南阳473000

出　　处：《实验室检测》2024年第8期121-124,共4页Laboratory Testing

摘　　要：随着国家机构改革进程的持续深化,药品监管部门的社会职能愈发突出,迫切需要强化责任落实,完善工作框架体系,提升药品不良反应监测工作实效。基于此,本文首先介绍了加强药品不良反应监测的重要性,分析了药品不良反应监测要素构成。在探讨药品监管部门药品不良反应监测现状及难点问题的基础上,结合相关实践经验,分别从完善监测机构设立与加强上报单位管理等方面,提出了机构改革下药品监管部门药品不良反应监测的方法对策。With the continuous deepening of the national institutional reform process,the social functions of drug regulatory departments have become increasingly prominent,and there is an urgent need to strengthen the implementation of responsibilities,improve the work framework system,and enhance the effectiveness of drug adverse reaction monitoring.Based on this,this article first introduces the importance of strengthening the monitoring of adverse drug reactions and analyzes the composition of the elements of adverse drug reaction monitoring.On the basis of exploring the current situation and difficult issues of adverse drug reaction monitoring by drug regulatory authorities,combined with relevant practical experience,this paper proposes methods and countermeasures for drug adverse reaction monitoring by drug regulatory authorities under institutional reform,including improving the establishment of monitoring institutions and strengthening the management of reporting units.

关 键 词：机构改革 药品监管 药品不良反应监测 方法策略 

分 类 号：R95[医药卫生—药学]