Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (7): 402-406.

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Investigation and Reflection on the Demand of Public Reporting of Adverse Drug Reaction in China

WANG Cheng-gang1, WANG Dong-fang1, XU Li-li2, WANG Xiao-jun2, WU Shi-fu2,*, WANG Ling3, TIAN Yue-jie2, LI Yu-ji2, LIU Hong-liang3, LU Chang-fei2   

  1. 1 Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China;
    2 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
    3 Center for Drug Reevaluation,CFDA, Beijing 100045, China
  • Received:2017-08-16 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

Abstract: Objective To investigate the prevalence of adverse drug reactions (ADR) in public, and to analyze the necessity and feasibility of implementing public reports of adverse reactions in China. Methods By quota sampling, questionnaire survey was used in public and ADR monitoring staff in order to obtain information about the current situation , treatment Methods and public reporting demands of adverse reactions. Statistical Methods such as statistical tables, statistical graphs, chi-square test and rank sum test were used to deal with the data. Results 5 394 public questionnaires and 185 monitoring staff questionnaires were received. 2 032 (37.7%) of the respondents or his family had occurred ADR. If adverse reactions occur, only 17.5% of the respondents directly reporttoinstitutions of ADR monitoring or FDA, and other 16.2%did not know the reporting Methods. In 2015, public reports accounted for only 0.11% of all adverse reactions reported. 78.0% of the monitoring institutions and 87.0% of the public that thought a public reporting system for adverse reactions necessary,with 47.5% of the provincial monitoring institutions indicate they can undertake this work. Conclusion we should pay more attention to the propaganda of the public reports of adverse reactions to improve the public awareness of adverse reactions and self-protection awareness. And at the same time we should perfect the legal system of adverse reaction monitoring, and gradually establish a public reporting mechanism for adverse reactions.

Key words: adverse drug reactions, public reporting, necessity, feasibility, prevalence study

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