浅议药物警戒制度中药物有害反应的控制

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...

Prevention of Harmful Drug Reactions in Pharmacovigilance System

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.