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目的:探索药品安全管理的有效模式。方法:通过对近年来国内外发生的重要药品安全事件的原因分析,结合管理理论研究成果和国际社会最新药品安全管理实践模式,探讨药品安全管理的类型。结果:从风险管理理论、药品安全管理覆盖人群、覆盖区域、药品风险程度、药品治疗疾病类型、安全管理的功能、安全管理设计思想的意识形态7大视角划分药品安全管理的类型,依据国内已发生药品安全事件的特点,找出我国目前药品安全管理中的成功措施、不足之处和管理盲区。结论:要开展有效的药品安全管理,我国目前还需要不断完善药品的生产管理和合理用药政策,建立针对儿童用药品、罕见病患者用药品、妊娠期用药和说明书之外用药的安全监督管理制度,从多主体、多维度的管理思想设计药品安全管理模式,重视药品安全文化和药源性损害者的赔偿救济机制的建设。
Objective: To explore effective modes of drug safety management. Methods: Based on the analysis of the causes of important drug safety incidents occurred in recent years at home and abroad, the types of drug safety management were discussed based on the results of management theory research and the latest practice of drug safety management in the international community. Results: The types of drug safety management were classified according to seven major perspectives: ideology of risk management theory, coverage of drug safety management population, coverage area, drug risk level, drug treatment disease type, safety management function and safety management design concept, Drug safety incidents occurred in the characteristics of China’s current drug safety management to identify the successful measures, deficiencies and management of blind spots. Conclusion: In order to carry out effective drug safety management, our country still need to constantly improve the drug production management and rational drug policy, and establish a safety supervision and management system for children’s medicines, medicines for rare diseases, medication during pregnancy and medication outside the manual , From the multi-agent, multi-dimensional management thinking design drug safety management model, emphasis on drug safety culture and drug-induced damage compensation mechanism.