Construction of Evaluation Indicator System for Pharmacovigilance Work in Medical Institutions of Fujian Province Base on Delphi Method
10.3870/j.issn.1004-0781.2025.04.012
- VernacularTitle: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
- Author:
Shu ZHANG
1
;
Yimin LIN
;
Jin LIU
;
Rongzhen HUANG
Author Information
1. 福建省药品审评与监测评价中心,福州 350003
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
Medical institutions;
Delphi method;
Indicator system
- From:
Herald of Medicine
2025;44(4):569-575
- CountryChina
- Language:Chinese
-
Abstract:
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 in medical institutions.It provides a solid reference for improving the pharmacovigilance capabilities of medical institutions in Fujian province.
