基于闭环链模型的药品安全事件应急管理能力提升策略研究  

Research on Strategies for Improving Drug Safety Incident Emergency Management Capability Based on Closed-loop Chain Model

作　　者：茅鸯对 丁静 林薇 MAO Yangdui;DING Jing;LIN Wei(Zhejiang Pharmaceutical University,Ningbo 315000,China)

机构地区：[1]浙江药科职业大学,浙江宁波315000

出　　处：《中国现代应用药学》2025年第3期472-480,共9页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省哲学社会科学规划课题项目(23NDJC446YBM,20NDJC221YB);浙江省社科联研究课题项目(2024B077);浙江省药品监督管理局横向课题项目(浙江省药品安全突发事件应急机制建设);宁波市人民政府发展研究中心外联所课题项目(J24-W25-B)。

摘　　要：目的构建药品安全事件应急管理能力评价指标体系,提出能力提升策略。方法利用德尔菲法构建药品安全事件应急管理能力评价指标体系,利用群决策层次分析法确定准则层和方案层权重,利用模糊综合评价法对两大药品安全事件进行应急管理能力评价。结果药品安全事件应急管理能力评价指标体系目标层含1个指标,准则层含8个指标,方案层含31个指标。核黄素磷酸钠注射液安全事件应急管理能力综合得分为4.558(评价等级为优秀),长春长生疫苗安全事件应急管理能力综合得分为2.252(评价等级为较差)。结论药品安全事件应急管理能力评价指标体系能够有效评价基层监管部门应急管理水平,建议实施基于闭环链模型的药品安全事件应急管理能力提升策略。OBJECTIVE To construct the evaluate index system of drug safety incident emergency management ability,and put forward the ability improvement strategy.METHODS Delphi method was used to construct the evaluation index system of drug safety incident emergency management ability,group decision-analytic hierarchy process method was used to determine the weight of criterion level and scheme level,and fuzzy comprehensive evaluation method was used to evaluate the emergency management ability of two major drug safety incidents.RESULTS The evaluation index system of drug safety incident emergency management ability contains 1 index in the target layer,8 indexes in the criterion layer and 31 indexes in the scheme layer.The comprehensive score of riboboin sodium phosphate injection safety incident emergency management ability was 4.558(excellent evaluation grade),and the comprehensive score of Changchun Changsheng vaccine safety incident emergency management ability was 2.252(poor evaluation grade).CONCLUSION The evaluation index system of drug safety incident emergency management ability can effectively evaluate the emergency management level of grassroots regulatory departments,and it is suggested to implement the strategy of improving drug safety incident emergency management ability based on the closed-loop chain model.

关 键 词：药品安全事件 应急管理 能力提升策略 闭环链模型 

分 类 号：R95[医药卫生—药学]