省级药品不良反应聚集性信号监测与处置工作机制探讨

The Mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level

目的从省级层面探讨药品不良反应聚集性信号监测与处置工作机制。方法基于山东省监测工作实践,归纳总结聚集性信号内在逻辑和特点,明确聚集性信号监测与处置具体要求,提出完善药品不良反应聚集性信号监测的建议。结果与结论药品不良反应聚集性信号监测和处置要强调落实药品上市许可持有人主体责任,注重风险控制为先、多方专业合作、闭环处置等原则。

Objective To explore the working mechanism of monitoring of adverse drug reaction cluster signals and disposal at the provincial level. Methods Based on ways of monitoring in Shandong Province, the patterns and characteristics of adverse drug reaction cluster signals were summarized, specific requirements were clarified and advice on improving the monitoring of ADR cluster signals was given. Results and Conclusion The monitoring and disposal of adverse drug reaction cluster signals requires that the main responsibilities of drug marketing authorization holders are fulfilled, risk control be given the top priority, multi-sided collaboration and closed-loop disposal be ensured.