药品监管机构与公众药品风险沟通的研究

Drug Risk Communication between Drug Regulatory Agencies and the Public

目的概述美国食品药品监督管理局(FDA)开展公众药品风险沟通的实践经验,为我国药品风险沟通工作的完善提供参考。方法查阅中外文献,基于风险认知理论归纳公众药品风险认知影响因素,从沟通模式、沟通时机、沟通内容、沟通渠道等方面分析我国与FDA的药品风险沟通实践。结果我国当前药品风险沟通存在着公众参与程度有限、缺乏具备可操作性的风险沟通指南、沟通渠道未区分目标受众及沟通内容不合理等问题。结论建议我国监管部门借鉴国际通行做法,制定风险沟通战略计划或指南,从促使公众理性认识药品安全及促进公众参与、完善沟通内容、丰富沟通渠道等方面着手,优化我国药品监管机构与公众之间的风险沟通工作。

Objective To summarize the practices of the FDA in public drug risk communication, and provide reference for the improvement of drug risk communication in China. Methods Chinese and foreign literature was reviewed in order to summarize the influencing factors of public perceptions of drug risks based on the risk perception theory. The practices regarding drug risk communication adopted by the FDA and its counterpart in China were analyzed in terms of ways of communication, time of communication, contents of communication and channels of communication. Results There are some problems with drug risk communication in China,such as limited public participation, a lack of workable guidelines for risk communication, communication channels that fail to distinguish targeted audiences, and improper contents of communication. Conclusion It is suggested that China’s regulatory authorities should learn from internationally accepted practices and formulate strategic plans or guidelines for risk communication, and optimize risk communication between drug regulatory agencies and the public by advancing public understanding of drug safety, promoting public participation,improving communication contents and diversifying communication channels.