集采常态化背景下药品潜在质量风险及其应急管理研究——基于免疫系统理论

Research on the Potential Quality Risks of Pharmaceuticals and Their Emergency Management in the Context of The Normalization of Collective Purchasing Based on Immune System Theory

目的:探讨完善我国药品潜在质量风险应急管理作用机制的方法和路径。方法:以免疫理论为顶层指导,结合应急管理相关理论,构建集采常态化背景下药品潜在质量风险应急管理的免疫应答机制。结果:药品质量风险存在潜在性和不确定性,通过借鉴免疫识别、免疫反馈、免疫记忆与免疫接种机制为药品质量安全的管理赋予更高层次的智能性和智慧性,完善药品潜在质量风险应急管理的机制建设工作,为我国药品质量安全与应急管理提供新的管理流程和运行逻辑。结论:药品潜在质量风险应急管理是一个涉及多层次、多领域、多主体的复合治理体系,不仅要对药品全生命周期中的潜在质量风险进行有效管控,促进常态化监管与应急管理有效衔接,同时还要落实各相关主体的责任,推进药品质量安全的社会共治。

Objective To explore the methods and paths to improve the mechanism of emergency management of potential quality risks of medicines in China.Methods Taking the immune theory as the top-level guidance,combining with the related theories of emergency management,the immune response mechanism for emergency management of potential quality risks of medi-cines in the context of the normalization of collective purchasing was constructed.Results There has potentiality and uncertainty of drug quality risk.By drawing on the mechanisms of immune recognition,immune feedback,immune memory and immune inocula-tion,a higher level of intelligence and wisdom to the management of drug quality and safety was given,and the construction of the mechanism of the emergency management of potential quality risk of pharmaceuticals was perfected,which had provided a new management process and operation logic for the quality and safety of pharmaceuticals and the management of emergencies in Chi-na.Conclusion Emergency management of potential quality risks of medicines is a complex governance system involving multiple levels,multiple fields and multiple subjects,which not only needs to effectively control potential quality risks in the whole life cy-cle of medicines and promote the effective connection between normalized supervision and emergency management,but also needs to implement the responsibilities of all relevant subjects and promote the social co-governance of drug quality and safety.