药品应急检验管理的探索性研究

Innovative Thinking on the Management of Drug Emergency Inspection

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 enhance the level of drug emergency inspection managements, and provide new ideas to deal with the drug incidents. METHODS Firstly, the management courses of our drug emergency inspection were sorted out. Secondly, the solution ideas to the typical drug emergency incidents were analyzed. Thirdly, the relational experiences of developed countries were researched. RESULTS The emergency management of our country had experienced from zero to full, and the responsible institution experienced from the point to surface. Although the emergency network had been basically established, each component was insufficient. We formulated a series of measures to strengthen the management with the analysis results on typical cases and the experiences of developed countries. CONCLUSION A special solution idea and four innovative measures were made by a combination of theory and practice. The firstly, a whole system management plan was drawn up which could form a system cohesion and reverse the individual combat. The secondly, the technical plan was proposed which could provide the reasonable path to find reason. The thirdly, three effective measures were designed which could provide supplementary resources for management plan and technical plan. The fourthly, the government and enterprises strategies were suggested which could prevent from the source. In brief, our emergency management ability would be significantly enhanced by implementing the mentioned measures.