浅议药物警戒制度中药物有害反应的控制  

Prevention of Harmful Drug Reactions in Pharmacovigilance System

作　　者：宋英杰 王海燕 李雨嘉 SONG Yingjie;WANG Haiyan;LI Yujia(Institute of Regulatory Science for Medical Products,Cheloo College of Medicine,Shandong University,Jinan Shandong 250014,China;School of Medicine,Shandong Modern University,Jinan Shandong 250104,China)

机构地区：[1]山东大学齐鲁医学院药品监管科学研究院,山东济南250014 [2]山东现代学院医学院,山东济南250104

出　　处：《中国药物警戒》2021年第1期52-55,63,共5页Chinese Journal of Pharmacovigilance

摘　　要：药物警戒制度贯穿于药品全生命周期,是对药品安全风险进行管理的最基本制度,它包含对药物有害反应的监测、识别、评估与控制,其中“控制”与其他三个过程一脉相承、相互交叉,是药物警戒制度相对药品不良反应监测制度最为先进性的体现,应当加强研究。本文通过梳理我国药物警戒制度的概念、分析我国对药物有害反应“控制”的实践以及国外药物有害反应“控制”的先进经验,建议从提高设计阶段的风险防控意识、把好注册审评审批关口、重视个案不良反应监测、制定药害救济制度、做好安全用药宣传、鼓励探索性研究等六个方面加强对药物有害反应的控制。The pharmacovigilance system is the most basic system for drug safety risk management throughout the life cycle of drugs,involving the detection,identification,assessment and prevention of harmful drug reactions.Among the four tasks,prevention,which is the most advanced element of the pharmacovigilance system compared with the adverse drug reaction monitoring system,is overlapping with the other three,which is why the research on prevention should be strengthened.By interpreting the concept of pharmacovigilance systems in China,analyzing China’s practices and summarizing foreign experience on prevention of harmful drug reactions,this paper proposes that we can strengthen the prevention of harmful drug reactions by enhancing the awareness of risk prevention in the early stage of drug research and development,making registration review and approval rigorous,attaching importance to the monitoring of adverse reactions in individual cases,formulating relief systems for drug misadventures,promoting the safety of medicine use,and encouraging exploratory research.

关 键 词：药物警戒制度 药物有害反应 药品不良反应 控制 

分 类 号：R951[医药卫生—药学]