Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (11): 674-679.

Previous Articles     Next Articles

Conception of Establishing Computerized Quality Assessment System of Adverse Drug Reaction/Event Report in China

CHEN Jia-yin, YUAN Li, YANG Yue*   

  1. School of Business Administration, Shenyang Pharmaceutical University, International Food and Drug Policy and Law Research Center,Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2017-12-26 Revised:2017-12-26 Online:2017-11-20 Published:2017-12-26

Abstract: Objective To put forward a conception of computerized identification for quality assessment system of adverse drug reaction/event report in China. Methods By introducing the World Health Organization drug monitoring center's vigiGrade and VigiBase management Methods, ADR/ADE report quality assessment standards and algorithms were described in detail. Results The vigiGrade inputs data in structured format. For each information dimension, a penalty is detracted which varies with causality assessment. The vigiGrade completeness score ranges from 0.07 to 1. We classified reports with C>0.8 as well-documented. Conclusion It is suggested that computerized identification for quality assessment system of adverse drug reaction/event report should be established by using structured report format, each information dimension should be evaluated according to its importance, and the method of addition and subtraction should be replaced by multiplication.

Key words: pharmacovigilance, vigiGrade, quality assessment, computerized

CLC Number: