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药品安全突发事件应急预案管理创新与发展

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目的 解读2024年版《突发事件应急预案管理办法》(以下简称《办法》)对药品安全应急预案管理的新要求,探讨如何构建完善新形势下我国药品安全应急管理体系,提升应急管理能力.方法 通过对新版《办法》深入分析,提出强化风险评估体系、跨区域协作、预案编制与实施、应急预案管理平台等策略.结果 通过实施这些策略,药品应急预案管理将实现一系列改进.风险评估体系将更加精准化和前瞻性,跨区域协作将打破壁垒实现高效联动,预案编制将实现标准化和动态完善,预案管理更加智能高效等.结论 新版《办法》的实施将有力推动药品安全突发事件应急预案管理的创新与发展,提升药品安全突发事件的应对能力,保障公众用药安全.
Innovation and Development in Emergency Plan Management for Drug Safety Incidents
OBJECTIVE To thoroughly interpret the newly introduced requirements set forth in the 2024 edition of the"Emergen-cy Response Plan Management Measures"for the management of drug safety emergency plans.Furthermore,to delve into the methods for constructing a robust and comprehensive drug safety emergency management system tailored to the current circumstances,ultimately enhancing our emergency management capabilities.METHODS A detailed analysis of the new edition of the"Measures"was conducted.Based on this analysis,several key strategies were proposed.Firstly,the strengthening of the risk assessment system was emphasized,advocating for a more precise and forward-looking approach to identifying potential risks of the drug.Secondly,cross-re-gional collaboration was highlighted as essential for efficient resource allocation were swift response during emergencies.This involved breaking down barriers between regions and fostering seamless cooperation among different stakeholders.Thirdly,the standardization and dynamic refinement of plan formulation and implementation were emphasized.This ensured that emergency plans remained relevant and effective in the face of evolving challenges.Lastly,the development of an intelligent emergency response plan management platform was proposed,leveraging modem information technology to streamline processes,enhance data analysis,and improve overall efficiency.RESULTS The anticipated outcomes of implementing these strategies were multifaceted.The risk assessment system would be significantly enhanced,providing a more accurate picture of potential threats and enabling proactive measures to be taken.Cross-regional collaboration would lead to the establishment of efficient linkages,ensuring that resources could be quickly mobilized where they were needed most.The standardization and dynamic refinement of plans would guarantee that they were not only well-struc-tured but also adaptable to new situations.Moreover,the introduction of an intelligent management platform would revolutionize the way emergency plans were managed,making the entire process more efficient,transparent,and data-driven.CONCLUSION The imple-mentation of the 2024 edition of the"Emergency Response Plan Management Measures"represents a significant step forward in the field of drug safety emergency management.By adopting the proposed strategies,we can expect to witness a paradigm shift in the way these emergencies are handled.The resulting innovations and improvements will undoubtedly bolster our response capabilities,mini-mize the impact of drug safety incidents,and ultimately safeguard the public's well-being.

emergency plandrug safetyemergency managementmanagement measures for emergency plans

陈慧、罗杰

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国家药品监督管理局高级研修学院,北京 100073

应急预案 药品安全 应急管理 突发事件应急预案管理办法

2024

中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子:0.957
ISSN:1001-2494
年,卷(期):2024.59(24)