首页|基于上市许可持有人的药品不良反应主动监测模式的构建与评估研究

基于上市许可持有人的药品不良反应主动监测模式的构建与评估研究

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目的:探讨药品上市许可持有人(Marketing Authorization Holder,MAH)的药品不良反应主动监测创新模式的构建及其效果评估,为落实MAH药物警戒主体责任提供实证参考.方法:首先针对MAH药物警戒的现存挑战,基于中国医院药物警戒系统(Chinese Hospital Pharmacovigilance System,CHPS)设计MAH针对药品不良反应的主动监测模式,包括不良反应的监测、识别、评估及控制;再以注射用卡瑞利珠单抗为例分析主动监测效果.结果 与结论:从MAH视角,构建基于CHPS整合循证证据和真实世界数据开展ADR主动监测的创新模式,包括运行模式、数据挖掘及模型构建.该主动监测模式被成功应用到以卡瑞利珠单抗为例的临床实践中,取到良好的效果.该研究成果不仅能帮助MAH开展药品监测工作,落实药品全生命周期主体责任,还能丰富药物警戒的内涵,为促进药物警戒发展和合理用药提供具有可操作性的实证参考.
Research on the Construction and Evaluation of Active Monitoring Model of Adverse Drug Reactions by Marketing Authorization Holder
Objective:To explore the construction and evaluation of active monitoring innovation model of adverse drug reactions by marketing authorization holder(MAH),to provide empirical reference for implementing the main responsibility of MAH pharmacovigilance.Methods:For the existing challenges of MAH pharmacovigilance,an active monitoring model for MAH adverse drug reactions was designed based on the Chinese Hospital Pharmacovigilance System(CHPS),including the monitoring,identification,evaluation and control of adverse reactions.Camrelizumab was used as an example to analyze the effectiveness of active monitoring.Results and Conclusion:From the perspective of MAH,this study design an innovation model for active monitoring of ADR based on CHPS integrating evidence-based evidence and real-world data,including operation mode,data mining and model design.This active monitoring model has been successfully applied in clinical practice represented by camrelizumab,and achieves good results.The research can not only help MAH to carry out drug monitoring work and implement the main responsibilities of the entire life cycle of drugs,but also enrich the connotation of pharmacovigilance and provide practical empirical reference for promoting the development of pharmacovigilance and rational drug use.

marketing authorisation holderadverse drug reactionactive monitoringmodel constructionChinese Hospital Pharmacovigilance System

陈子桃、赖云锋、陈新林、许星莹、张桂兰、徐梦丹

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广州中医药大学,广州 510006

广东药科大学,广州 510006

上市许可持有人 药品不良反应 主动监测 模式构建 中国医院药物警戒系统

广东省药品监督管理局科技创新项目(2022)广东省中医药局项目广东省哲学社会科学规划项目广东省教育科学规划课题广东省基础与应用基础研究基金广东省基础与应用基础研究基金

2022ZDZ0620204003GD23SQGL012022GXJK0602022A15152201622022A1515220148

2024

10.16153/j.1002-7777.2024.03.004

中国药事
中国食品药品检定研究院（中国药品生物制品检定所）

中国药事

CSTPCD
影响因子：0.844
ISSN：1002-7777
年,卷(期)：2024.38(3)
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