应用德尔菲法构建福建省医疗机构药物警戒工作评价指标体系  

Construction of Evaluation Indicator System for Pharmacovigilance Work in Medical Institutions of Fujian Province Base on Delphi Method

作　　者：张纾 林翼旻 刘锦 黄榕珍 ZHANG Shu;LIN Yimin;LIU Jin;HUANG Rongzhen(Fujian Center for Drug Evaluation and Monitoring,Fuzhou 350003,China;School of Pharmacy,Xi’an Jiaotong-Liverpool University,Suzhou 215000,China)

机构地区：[1]福建省药品审评与监测评价中心,福州350003 [2]西交利物浦大学慧湖药学院,苏州215000

出　　处：《医药导报》2025年第4期569-575,共7页Herald of Medicine

基　　金：福建省药品监督管理局科技项目(2022006)。

摘　　要：目的建立福建省医疗机构药物警戒(PV)评价指标体系,为医疗机构的PV工作评估提供参考。方法基于文献和政策法规,结合福建省PV工作实际,采用3轮专家咨询,包括2轮德尔菲法确定指标体系内容,1轮层次分析法确定各指标的权重,构建PV评价指标体系。结果从PV组织机构、人力和设备资源、质量管理体系制度程序文件的制订和记录、监测与报告的绩效考核、风险识别评估和控制、科研能力等方面设置了一级指标9个、二级指标23个、三级指标59个。3轮咨询专家积极系数均为100%。专家平均权威系数为0.878,2轮德尔菲法的专家协调系数分别为0.081、0.343(P<0.001)。层次分析法得到一级指标权向量为0.023~0.263,最大特征值为9.195;二级指标的权向量值为0.096~1.000,最大特征值为3.018~4.061;三级指标的权向量为0.143~1.000,最大特征值为3.000~5.078。各判断矩阵的一致性比率(CR)为0~0.051。结论构建的指标体系结合药品监管职能和医疗机构实际,可用于药品监管部门对医疗机构PV工作的考核评估,对提升福建省医疗机构PV工作水平具有较好的参考意义。Objective To establish an evaluation indicator system for pharmacovigilance(PV)work in medical institutions of Fujian province,and provide a reference for the PV work in healthcare facilities.Methods Based on literature analysis and interpretation of policies and regulations,combined with the practical pharmacovigilance work in Fujian province,a preliminary indicator system was constructed.Following this,three rounds of expert consultation were conducted,including two rounds of the Delphi method to determine the content of the index system,and one round of the Analytic Hierarchy Process(AHP)to determine the weights of each index.Results A total of 9 primary indicators,23 secondary indicators,and 59 tertiary indicators were selected for the evaluation of pharmacovigilance work in health facilities of Fujian province,including pharmacovigilance organizational structure,human resources,equipment resources,development and documentation of the quality management system's procedural documents,Performance indicators for monitoring and reporting,risk identification,assessment,control and research capabilities.The consensus coefficients for three rounds of consultation with experts were 100%,100%,and 100%.The average authority coefficient of the experts was 0.878,and the expert coordination coefficients for the two rounds of Delphi method were 0.081 and 0.343,respectively(P<0.001).In the AHP,the weight vector for primary indicators ranged from 0.023 to 0.263,with a maximum eigenvalue of 9.195.The weight vector values of the secondary indicators were from 0.096 to 1.000,and the maximum eigenvalues were 3.018-4.061;The weight vectors of the tertiary indicators were 0.143 to 1.000,and the maximum eigenvalues were from 3.000 to 5.078.The consistency ratio(CR)of each judgment matrix was between 0 and 0.051.Conclusions The constructed indicator of capability assessment model,integrating regulatory functions and the practical situation of medical institutions,can be used by regulatory authorities to assess pharmacovigilance work

关 键 词：药物警戒 医疗机构 德尔菲法 指标体系 

分 类 号：R77.1[医药卫生—眼科] R969.3[医药卫生—临床医学]