Constructing Pharmacovigilance Guidelines for Medical Institutions Based on Modified Delphi Method
Objective:To construct a local standard of"Pharmacovigilance Guidelines for Medical Insti-tutions"and provide guidance for pharmacovigilance work in medical institutions in Yancheng.Methods:The expert consultation questionnaire was developed by literature analysis and semi-structured interview.Modified Delphi method was used to perform three rounds of consultation for determining the three-level indicators of the guideline.Results:Thirty experts participated in the consultation in the second and third rounds of the consultation questionnaire,the effective recovery rate was 100%,the authority coefficient of experts were 0.89 and 0.92,the Kendall harmony coefficient were 0.309(P<0.001)and 0.404(P<0.001),and the coefficient of variation of each indicator was smaller than 0.25,Cronbach α coefficients were 0.96 and 0.98,respectively.A guideline,including 9 primary indicators,23 secondary indicators and 21 tertiary indicators was determined.Conclusion:The method is scientific and reliable,and it has a good guiding significance for GVP in medical institutions to build pharmacovigilance quality practice.