药品安全事故危机与对策的研究（一）

目的提出药品安全风险和危机控制体系框架模型的整体设计思路。方法从药品安全风险和危机控制的基本概念及两者之间的关系入手,分析了药品安全风险的4个来源;剖析了近年来我国发生的典型药品安全事件的特征及其处置过程;重点指出了我国在药品安全风险控制和危机处理中的问题和不足。结果与结论目前我国的药品安全事件仍以制造缺陷为主。完整的药品安全风险—危机控制体系框架主要包括结构设计、流程设计和机构设计。该框架整合了常态和危机状态下的药品安全管理的各种资源,为药品安全风险和危机控制提供了理论依据和实践途径。有利于提高政府对风险和危机的处理能力。

Chinese Drug Sefety Risk and Crisis Control, Achievement Problems and Solutions

Objective The framework and mechanism of risk and crisis control on drug safety issue has been provided. Methods The definition and internal relationship between drug safety and rick control were mentioned. The four main sources of drug safety risk were analyzed. The typical drug safety cases and the way that they were solved were also included. The cause of the cases and the characteristics of the cases have also been analyzed. Results anti Conclusions Based on that, a conclusion was drawn that the greatest problem of drug safety lies in the production process. A whole set of drug safety and crisis control system mainly includes structure design, process design and department design. The framework incorporates a variety of resources of management of drug safety under a state of normalcy and crisis, which has provided theoretical basis and practical solutions for drug safety and crisis control, so as to enhance the problem solving ability of the government.