Research on the Public Reporting Model for Adverse Drug Reactions in China

Abstract

Abstract: Objective To establish a public reporting model for adverse drug reactions in China. Methods Analyze the roles and characteristics of public reporting by retrieve the situation of public reporting of adverse drug reactions in developed countries, and carry out a questionnaire survey to understand the needs of the public and adverse drug reaction monitoring institutions in China. Results Public reporting of adverse drug reactions is an important part of the voluntary reporting system in developed countries, with the effect of reducing the rate of omission, supplementing the report of professionals and enhancing the strength of the risk signal. It's encouraged for the public to report adverse drug reactions in China. Several monitoring agencies had explored and carried out relevant works. The public reporting model with a variety of ways to report and grading audit evaluation was established. Conclusion We should pay attention to the roles of public reporting of adverse drug reactions, and steadily promote the public reporting with strengthening the construction of the relevant laws and regulations, technical specifications, information platform and the talent team.

Key words: adverse drug reactions, public reporting, pharmacovigilance, research

CLC Number:

R994.11

WU Shi-fu, WANG Ling, LI Yu-ji, TIAN Yue-jie, LIU Hong-liang, WANG Xiao-jun, CHANG Hong, WANG Cheng-gang, LU Chang-fei, XU Li-li, ZHAO Yu-juan, ZHAO Hui-rong. Research on the Public Reporting Model for Adverse Drug Reactions in China[J]. Chinese Journal of Pharmacovigilance, 2017, 14(7): 407-412.

References

[1] 国家食品药品监督管理总局.国家药品不良反应监测年度报告（2016年）[EB/OL].（2017-04-28）[2017-06-01]. http://www.cfda.gov.cn/WS01/CL0844/172167.html.
[2] Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries[J]. Drug safety, 2014, 37(6): 409-419.
[3] Banerjee A K, Okun S, Edwards I R,et al. Patient-reported outcome measures in safety event reporting-PROSPER consortium guidance[J]. Drug Saf, 2013,36(12):1129-1149.
[4] 田怡, 杨悦, 田丽娟. 美国FDA药品风险沟通的发展与启示[J]. 中国药物警戒,2016,13(1): 24-27,31.
[5] 王晓燕,杨悦.欧盟新的药物警戒法规简介与启示[J]. 中国药物警戒, 2013, 10(7): 396-399.
[6] 苏畅,邱家学.欧盟药物警戒额外监测制度简介与启示[J].药物评价研究, 2014, 37(1): 7-10.
[7] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) [EB/OL]. (2013-06-06)[2016-05-27]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guid-eline/2013/06/WC500144009.pdf.
[8] 严瑾,邵蓉.中英不良反应监测报告内容对比及启示[J].广东药学院学报, 2015, 31(2): 235-239.
[9] Kalaivani M, Kalaiselvan V, Dabhi K, et al. Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission[J/OL]. Adv Pharmacoepidemiol Drug Saf, 2015,4(3): 184.
[10] Sten Olsson. New WHO handbook on direct patient reporting[J/OL]. UPPSALA REPORTS,2012,(57):11.
[11] H rmark L, van Hunsel F, Grundmark B. ADR reporting by the general public: lessons learnt from the Dutch and Swedish systems[J]. Drug safety, 2015, 38(4): 337-347.
[12] Golomb B A, McGraw J J, Evans M A, et al. Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance[J]. Drug Saf, 2007, 30(8): 669- 675.
[13] Ekins-Daukes S, Irvine D, Wise L, et al. The Yellow Card Scheme: evaluation of patient reporting of suspected adverse drug reactions[J]. Pharmacoepidemiol Drug Saf, 2006,15(S1):S105.
[14] Rolfes L, Hunsel F, Wilkes S, et al. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information[J]. Pharmacoepidemiology & Drug Safety, 2015, 24(2):152.
[15] Medawar C, Herxheimer A. A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine[J]. Int J Risk Saf Med, 2004,16(1):5-19.
[16] Frankenfeld C. "Serious" and "severe" adverse drug reactions need defining[J]. Bmj, 2004, 329(7465):573.
[17] de Langen J, van Hunsel F, Passier A, et al. Adverse drug reaction reporting by patients in the Netherlands: three years of experience[J]. Drug Saf, 2008,31(6):515-524.
[18] Egberts T C G, Smulders M, De Koning F H P, et al. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals[J]. BMJ, 1996, 313(7056): 530-531.
[19] The Netherlands Pharmacovigilance Centre Lareb. Gokverslaving en antiparkinsonmiddelen[J].Geneesmiddelenbulletin,2006,40(8):86-87.
[20] The Medical Products Agency. A Swedish registry based cohort study provides strengthened evidence of an association between vaccination with Pandemrix and narcolepsy in children and adolescents[EB/OL].(2011-03-28)[2017-06-03].https://lakemedelsverket.se/english/All-news/NYHETER-2011/A-Swedish-registry-based-cohort-study-provides-strengthened-evidence-of-an-association-between-vaccination-with-Pandemrix-and-narcolepsy-in-children-and-adolescents-/.
[21] 吴桂芝,王春婷,张力. 药品不良反应自发报告系统信息采集内容和方式的分析[J]. 中国药物警戒, 2011,8(10): 596-599.
[22] 边蕾,赵频,杨悦.药物警戒中患者直接报告情况研究[J].中国药物警戒,2013,10(10):609-613.