我国药品不良反应监测现状及存在问题

Monitoring Status and Existing Problems of Adverse Drug Reaction in China

目的:探讨我国药品不良反应(ADR)监测工作中存在的问题并提出相应建议。方法:检索近年国内外文献资料,概括我国ADR监测现状,分析存在问题并提出建议。结果与结论:我国ADR监测工作近年来取得了举世瞩目的成绩,但也面临一些问题,主要包括监测机构建设有待加强、报告主体倒置、报告质量和数据可利用度不高等。因此,要通过加强ADR监测法律体系和监测机构体系建设、加强宣传培训、强化报表审核力度、提高报告质量、提高对监测数据的利用程度、细化ADR严重程度分级、拓宽监测范围、强化生产企业ADR监测工作开展等一系列行之有效的措施,不断推进我国ADR监测工作。

Objective： To investigate the existing problems of adverse drug reaction monitoring in our country and put forward the corresponding suggestions. Methods： By retrieving the domestic literatures of the past five years, the status of ADR monitoring was summarized; problems were analyzed and suggestions were put forward. Results and Conclusion： China＇s ADR monitoring in recent years had made remarkable achievements, but was still faced with many problems, for example, monitoring institution-building needed to be strengthened; reporting department was upside down; the quality of reporting and data available were not good enough. Therefore, we need to strengthen ADR monitoring law system and institution-building system, enhance publicity and training, make more efforts to improve the quality of reporting audit report, increase the utilization degree of monitoring data, refine ADR severity grading, expand the scope of monitoring, intensify the ADR monitoring of drug manufacturer and other means, so as to improve the ADR monitoring levels.