美国应急药品管理与政策系统介绍及其启示

Organization and policy system of American emergency drug and its enlightenment

采用文献研究法和比较研究法，分析了美国应急药品管理的组织机构体系和管理政策内容。由此发现，美国建立了以人类健康与服务部为核心的横向与纵向组织结构体系，覆盖了从应急医药产品研发、采购、存储、紧急使用、临床治疗等一系列的政策法律管理规定。结合美国的应急药品管理经验，针对我国目前应急药品管理在指挥管理、部门协调、资源配置以及法律体系建设等方面所呈现出的问题，建议我国应建立应急药品指挥管理核心组织机构，完善相关的法律体系，并注重提升地方医疗应急救援和信息传递能力，以建立一个协调配合、有条不紊、资源共享的药品应急管理体系。

By means of literature review and comparative study, the paper studied the organization and policy system of emergency drug administration in the U. S. As found by the authors, that the U. S. has established a horizontal and vertical organizational structure system centering on the Department of Health and Human Services. This system covers a series of policy and legal regulations, such as the research and development, procurement, storage, emergency use, and clinical treatment of emergency medical products. In consideration of the experience of emergency drug administration in the U.S. and problems existing in China~ current system in command and management, departmental coordination, resource allocation, and legal system construction of emergency drug, it is suggested that China should establish a core organization for emergency drug command and management, and improve relevant legal system. China also needs to focus on enhancing capabilities of local medical emergency rescue and information transmission, in order to establish a coordinated, well-organized, resource-sharing system of drug emergency administration in the country.