1Shandong Provincial Center for ADR Monitoring, Jinan Shandong 250014, China; 2The Affiliated Hospital of Shandong University of TCM, Jinan Shandong 250014, China; 3Jining Center for ADR and Drug Abuse Monitoring, Jining Shandong 272025, China
Abstract：Objective To make recommendations for the construction of China's model for drug safety risk communication by analyzing the current drug risk communication in the European Union and United States. Methods By consulting domestic and foreign literature, retrieving relevant regulations on drug safety risk information exchange, browsing the official websites of drug regulatory authorities and other websites, we harvested information on exchange institutions and regulations, contents, timing, methods and effects of such information exchange in the European Union and United States before we made a comparison with China. Results Literature research showed that drug risk communication was an important part of drug risk control. Europe and the United States became aware of the importance of risk communication long ago and built a better risk communication system. In order to achieve a better effect, flexible and diverse communication methods were adopted and improved. This analysis found that strengthening information exchange with the public was the basic means of national drug supervision. The ways of communicating with the public are to be diversified, facilitated, informatized and targeted, and there should be a two-way flow of drug safety information. Conclusion More attention should be paid to the role of risk information exchange in drug risk management. The systems, mechanisms and methods for such communication should be made more accessible, and results of communication should be evaluated.
吴世福, 金毅, 常虹, 田月洁, 徐魁, 许莉莉, 郭凡岭, 张景东. 欧美监管部门与公众药品安全风险信息沟通现状研究及启示[J]. 中国药物警戒, 2020, 17(2): 87-92.
WU Shifu, JIN Yi, CHANG Hong, TIAN Yuejie, XU Kui, XU Lili, GUO Fanling, ZHANG Jingdong. Drug Risk Communication in the European Union and United States between Regulators and the Public. Chinese Journal of Pharmacovigilance, 2020, 17(2): 87-92.
2020, Vol. 17 
