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目的提升我国药品应急检验的管理水平,为药品安全突发事件的处置提供新思路。方法对我国药品应急检验的管理历程进行梳理,对近年来典型药品应急检验事件的应对思路进行分析,对国外发达国家的相关经验进行研究。结果我国药品应急检验经历了管理机制从无到有、应对机构从点到面的过程,应急之网虽已基本建立,但各环节均有不足。课题组依据典型案例分析结果,并结合发达国家的经验,制定了一系列的措施加强管理。结论笔者将理论与实践相结合,形成独特的解决思路图,并提出4条针对措施,具有创新性。第一,提出全系统的管理预案,使药检系统形成合力,扭转单兵作战的现状;第二,提出应急检验技术预案,为检验时查找药害的原因提供合理路径图;第三,提出4条加强技术储备的有效措施,为管理预案与技术预案提供必要的辅助资源;第四,提出政府监管策略和企业防范策略,争取从源头防范。以上措施,将显著增强我国对药品安全突发事件的应急管理能力。
Objective To improve the management level of drug emergency inspection in our country and provide new ideas for the disposal of drug safety emergencies. Methods The management of drug emergency inspection in China was reviewed. The response to the typical drug emergency inspection incident in recent years was analyzed, and the relevant experience in developed countries was studied. Results Our country’s pharmaceutical emergency inspection experienced the management mechanism from scratch, to deal with the organization from point to surface process, although the network of emergency has been basically established, but there are deficiencies in all aspects. Based on the results of typical case analysis and the experience of developed countries, the research team formulated a series of measures to strengthen management. Conclusion The author combines the theory and practice to form a unique way of thinking and put forward four measures aimed at innovation. First, put forward a system-wide management plan to make the drug inspection system work together to reverse the status quo; Second, put forward the emergency inspection technical plan, to provide a reasonable path for finding the cause of injury; Third, put forward 4 Effective measures to strengthen the technical reserve for the management plan and technical plan to provide the necessary auxiliary resources; Fourth, put forward the government regulatory strategy and corporate defense strategy, strive to prevent from the source. The above measures will significantly enhance our emergency management capabilities for drug safety emergencies.