2016年江苏省药品不良反应报告和监测检查缺陷分析

Analysis of Defects Found in Adverse Drug Reaction Reporting and Monitoring Inspections in Jiangsu within 2016

2016年,江苏省药品不良反应监测中心对辖区内92家药品生产企业开展了药品不良反应报告和监测检查,共发现630项缺陷。对这些缺陷项进行分类统计和分析,得出以下结论:药品生产企业的药品不良反应监测工作尚处于起步阶段,需从理念层次和技术水平等方面全面提升;监管部门应根据实践经验持续改进药品不良反应报告和监测检查的方式方法,以更有效地发挥其作用。

In 2016, the adverse drug reaction（ADR） reporting and monitoring inspections were carried out in Jiangsu on 92 drug manufacturers, and found 630 defects. The classification and statistic analysis of these defects revealed that the ADR monitoring work in drug manufacturers was still in its infancy, which should be improved by comprehensive enhancement in both understanding and technical levels. Meanwhile,the implementation of ADR reporting and monitoring inspections could be more effective by continuous adjustment in practice.