Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (7): 413-418.

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Investigation and Reflection on the Way and Content of Public Reporting of Adverse Drug Reactions in China

WANG Xiao-jun1, LU Chang-fei1, ZHAO Yu-juan1, WU Shi-fu1, WANG Ling2, TIAN Yue-jie1, LI Yu-ji1, LIU Hong-liang2, Ding Chang-ling3, WANG Dong-fang4, WANG Cheng-gang4,*   

  1. 1 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
    2 Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    3 Binzhou Medical University affiliated Hospital, Shandong Binzhou 256603, China;
    4 Shandong university of Traditional Chinese Medicine, Shandong Jinan 250355, China
  • Received:2017-08-16 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

Abstract: Objective To find the proper reporting Methods, reporting contents and feedback ways of public reporting of adverse drug reactions(ADR) in China, so as to provide reference for the establishment of a public reporting model of ADR. Methods Questionnaire survey was carried out in public and the ADR monitoring staff by quota sampling. Results For reporting Methods, the public tended by telephone (74.2%), WeChat official account (68.7%) and Internet site (66.0%); and 54.6% of the monitoring agency chosen the Internet site to report. For reporting contents, 42.6% of the public was willing to provide personal information except the ID number. 47.6% of the monitoring agencies considered that the ID number was not required, and 97.9% of agencies thought that the telephone number of the reporter or contact person was necessary. 80.2% of the public could provide injury performance, but only 34.2% could provide product information such as product name, batch, manufacturer and 24.3% of injury information. 30.5% of the public need information feedback. Conclusion A variety of reporting ways, such as the phone, WeChat public number, and Internet should be provided when public reporting of ADR is working. The contents of the report should be designed to be easy to obtain and necessary parameters for analysis and evaluation according to the characteristics of public. The relevant information should be fed back to the public.

Key words: adverse drug reactions, public reporting, reporting pathway, report content, prevalence study

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