Drug Risk Communication among Drug Regulatory Agencies in the European Union, the United States and Asia

doi:10.19803/j.1672-8629.2021.09.10

Abstract

Abstract: Objective To provide reference for the establishment of modes of drug risk communication in China by analyzing the current ways of drug risk communication in Asian countries, and by comparing the related contents and forms in China with those of the European Union and the United States. Methods By reviewing domestic and foreign literature, retrieving the guidelines, specifications, laws and regulations related to drug risk communication in Asia, browsing the official websites of drug regulatory authorities and other websites in Asia, information on related institutions, laws and regulations, communication channels, information released, and ways of development was harvested. Results The system of drug risk communication in Europe and the United States was relatively perfect. Some countries in East Asia and Southeast Asia became aware of the importance of drug risk communication and constructed effective modes of drug risk communication. Conclusion The construction of drug risk communication systems Could be strengthened to guarantee safe and rational drug use.

Key words: drug safety, risk communication, Europe and America, Asian countries

CLC Number:

R951

ZHANG Dan, LYU Jintao, SONG Haibo, ZHANG Bing, JIN Yongnan, SA Rina, ZHANG Xiaomeng, LIN Zhijian. Drug Risk Communication among Drug Regulatory Agencies in the European Union, the United States and Asia[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 845-849.

References

[1] Ofrin RH, Buddha N, Htike MM, et al.Strengthening risk commun-ication systems for public health emergencies in the WHO South-East Asia Region[J]. WHO South East Asia J Public Health,2020,9(1):15-20.
[2] Geneva: World Health Organization. International Health Regu-lations (2005), 2nd edition[EB/OL]. (2005-05-23)[2020-08-05]. https://apps.who.int/iris/bitstream/handle/10665/43883/9789241580410_eng.pdf;jsessionid=2235E048F3EA0FDC617685709535EEB0?sequence=.
[3] Geneva: World Health Organization. Communicating risk in public health emergencies: a WHO guideline for emergency risk communication (ERC) policy and practice[EB/OL]. (2018-07-03)[2020-08-05]. https://apps.who.int/iris/bitstream/handle/10665/259807/9789241550208-eng.pdf;jsessionid=378F4B716BCF7DF949752B278187E098?sequence=2.
[4] Gong SW, Zhang L, Huang JM, et al.Drug safety and drug risk management[J]. China Pharmacy(中国药房), 2007(22): 1687-1690.
[5] Li HQ, Gong L, Fan CM.The formation mechanism of the public’s coping behavior in drug safety events[J]. Journal of Public Manag-ement(公共管理学报), 2019, 16(3): 97-107.
[6] Davies NM, Thomas KH.The Food and Drug Administration and varenicline: should risk communication be improved?[J]. Addiction,2017,112(4): 555-558.
[7] Edwards B, Chakraborty S.Risk communication and the pharma-ceutical industry: what is the reality?[J]. Drug Saf, 2012, 35(11): 1027-1040.
[8] Sun WC.Study on the cognition of stakeholders on drug safety risk communication [D]. Beijing University of Chinese Medicine, 2013.
[9] Zhang J, Zhang TF.Research on risk communication in the United States: academic evolution, core proposition and key factors[J].Chinese Journal of Journalism & Communication(国际新闻界), 2009(9): 95-101.
[10] Teasdale A, Elder D, Nims RW .ICH Q9 quality risk management[M]. ICH Quality Guidelines, 2017.
[11] Xu R, Liu Y, Wei XH, et al.Study on the ways of drug risk infor-mation communication based on empirical analysis[J]. Pharma-ceutical Education(药学教育), 2018, 34(1): 62-66.
[12] Lu KR, Hu M, Jiang XH.Consideration on risk communication method in the drug risk management[J]. China Pharmacy(中国药房), 2010(17): 1545-1549.
[13] Wei J, Pan WS, Yang Y.Communication to the public guidance of FDA's drug safety information and the inspiration to our country[J].Chinese Journal of New Drugs(中国新药杂志), 2009, 18(14): 1287-1290.
[14] Food and Drug Administration. Guidance Drug Safety Information-FDA's Communication to the Public. [EB/OL].(2007-03-01) [2020-08-05]. https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications.
[15] Wu SF, Jin Y, Chang H, et al.Drug risk communication in the European Union and United States between regulators and the public[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 17(2): 87-92.
[16] Rollman JE, Heyward J, Olson L, et al. Assessment of the FDA risk evaluation and mitigation strategy for transmucosal immediate-release fentanyl products[J]. JAMA,2019, 19: 321(7): 676-685.
[17] Guideline on good pharmacovigilance practices (GVP)- ModuleXV-Safety communication (Rev 1) [EB/OL]. (2013-01-24)[2020-08-05]. https://www.ema.europa.eu/en/documents/scientificguideline.
[18] European Medicines Agency. Guidelines on good pharmacovigilance practices[EB/OL]. (2020-06-23)[2020-08-05]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345. jsp.
[19] Xie YM, Tian F.Interpretation of guidelines on good pharmaco-vigilance practices for European Union[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2013, 38(18): 2963-2968.
[20] Xu L, Zhao YJ, Li F, et al.Brief introduction and its implication on the drug risk management system in Japan[J]. The Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2010, 26(10): 784-789.
[21] McEwen J. Risk management from an Asian/Pacific Rim regulatory perspective[J]. Drug Saf, 2004, 27(8): 491-497.
[22] Shin JY, Jung SY, Ahn SH, et al.New initiatives for pharma-covigilance in South Korea: introducing the Korea Institute of Drug safety and risk management (KIDS)[J]. Pharmacoepidemiol Drug Saf, 2014, 23(11): 1115-1122.
[23] The Directorate General of Drug Administration,The People’s Republic of Bangladesh. Communication policy. [EB/OL].(2017-09-25) [2020-08-05]. http://www.dgda.gov.bd/index.php/laws-and-policies.
[24] Right to Information Act. Ministry of Hearth and Indigenous Medical Services, Sri Lanka[EB/OL]. (2018-07-01) [2020-08-05]. http://www.health.gov.lk/moh_final/english/others.php?pid=159.
[25] Xinhua News Agency. Law of the PRC Governing the Management of Pharmaceutical Products [EB/OL]. (2019-08-26) [2020-08-05]. http://www.gov.cn/xinwen/2019-08/26/content_5424780.htm.
[26] Jia YX.Research on the visualization system construction of drug safety knowledge towards decision support[D]. Jilin University, 2019.