药品不良事件中风险沟通的影响因素及对策研究

Influence Factors and Countermeasures of Risk Communication in Adverse Drug Event

目的:提出一种在药品不良事件中进行风险沟通的方法,以快速、有效沟通信息,最小化药品不良事件风险。方法:分析风险沟通在风险管理中的重要性,研究人用药品注册技术要求国际协调会议一致性指南文件中的质量风险管理指南(ICHQ9)中有关风险管理的部分,总结以往学者对风险沟通的研究成果,探讨药品不良事件中风险沟通的影响因素,建立在药品不良事件中进行风险沟通的对策。结果与结论:归纳出两大类风险沟通的主要影响因素,以计划行为理论为基础的影响因素包括人的主观方面和外界客观环境2种,以公众理性为基础的影响因素包括信任和专家与公众的认知差异。在此基础上建立了相应的对策模型,即在药品不良事件发生的初始期采用轮式沟通网络的方式进行沟通,然后按照填写信息图谱、迅速透明地发布消息直至成功沟通这4个步骤实施,最终可达到有效沟通,最小化药品不良事件的风险。

OBJECTIVE： To put forward the methods of risk communication in the adverse drug event （ADE） in order to achieve quick and effective information communication and minimize the risk of the ADE. METHODS： The importance of the risk communication was analyzed, and the risk management in ICH Q9 was also studied. The achievements of previous risk communication study were summarized and influence factors of risk communication were investigated to set up the strategy of risk communication in the ADE. RESULTS CONCLUSIONS： This paper has summarized two kinds of influence factors of risk communication. One is on the basis of TPB, containing the subjectivity and objective environment; the other is on the basis of public rationality, containing the trust and cognitive difference between specialists and the public. Corresponding strategy model has been established. It is made up of four steps, i.e. first, carrying out risk communication through wheel type communication network at the beginning of ADE; second, filling in the information spectrum; third, publishing the information quickly and transparently until communication is succeeded; forth, completing successful and effective communication. The risk of the ADE could be minimized by above four steps.