1.Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an 710061, China 2. Center for Drug Safety and Policy Research, Xi'an Jiaotong University, Xi'an 710061, China 3.Shaanxi Food and Drug Administration and Inspection Institute, Xi'an 710065, China
Objective To construct a comprehensive evaluation system for ADR report quality for a more comprehensive analysis and evaluation of the quality status of ADR report forms. Provide reference for relevant management departments to strengthen post-marketing drug management and improve the quality of ADR reports. Methods Combine the questionnaire survey method with the analytic hierarchy process to construct the ADR report quality evaluation system. Results This study constructed a set of quality evaluation index system for adverse drug reaction reports, including the specific scoring criteria and score weights of 65 project indicators in the ADR report, which basically included the main indicators in current “Adverse Drug Reaction/Event Report Form” in China. Conclusion Using the established ADR report scoring system, the report's indicators are evaluated and scored, and the overall system quality status can be reported, so that the report quality can be intuitively and comprehensively understood, and the specific problems that the reporter has in the report process are intuitive. In the case of which project indicators are found to be problematic, and then targeted to intervene in the quality of the report, thereby improving the quality of the report from the root cause.
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