摘要
目的:了解贵州省药品上市许可持有人(MAH)药物警戒工作现状,为MAH开展药物警戒工作提供参考意见。方法:对贵州省内30家MAH的机构人员与资源,质量管理,文件、记录与数据管理,监测与报告,风险识别与评估,风险控制情况等药物警戒工作情况进行统计分析。结果:30家MAH基本建立了药物警戒体系,但存在药物警戒相关培训不到位、制度和程序文件内容不完善、主动收集药品不良反应能力不够、风险管理能力不足等问题。结论:MAH应持续加强药物警戒相关培训、完善制度和程序文件、强化自主收集报告意识、提升风险管理能力,还建议监管部门进一步加强药物警戒检查的组织与实施。
Objective:To master the current situation of pharmacovigilance work carried out by marketing authorization holders in the administrative region,and provide reference for inspection and holders to carry out pharmacovigilance work.Methods:Statistical analysis was conducted using Excel on the personnel and resources,quality management and document records,monitoring and reporting,risk identification and assessment,risk control of 30 holders in the administrative region from pharmacovigilance inspections.Results:Although the holder has basically established a pharmacovigilance system,there are still some problems such as insufficient ability to actively collect adverse drug reactions,inadequate pharmacovigilance related training,incomplete content of system and procedural documents,and insufficient risk management capabilities.Conclusions:Holders should strengthen their awareness of self-collection,strengthen pharmacovigilance-related training,complete systems and procedural documents,and enhance risk management capabilities.The supervision department should further strengthen the organization and implementation of pharmacovigilance inspection.
作者
周黎
任鹏宇
游正琴
周明皓
牟茂
ZHOU Li;REN Peng-yu;YOU Zheng-qin;ZHOU Ming-hao;MOU Mao(Guizhou Drug Administration and Inspection Center)
出处
《中国食品药品监管》
2024年第8期100-107,共8页
China Food & Drug Administration Magazine
关键词
药品上市许可持有人
药物警戒
药品不良反应
风险管理
marketing authorization holder
pharmacovigilance
adverse drug reactions
risk managemen
