大数据应用于药物警戒的内涵现状与思考

The Connotation Status and Thinking of Big Data Application in Pharma⁃covigilance

我国在2019年修订发布的《中华人民共和国药品管理法》从立法层面提出国家建立药物警戒制度,也意味着对药物警戒提出了更高的要求。近年来随着医疗行业信息化的深入发展、物联网智能设备的普及,大数据已经在医药卫生领域得到了较多应用与发展。本文以药物警戒作为医药卫生领域的重要代表,首先阐述从药物警戒的内涵与大数据在医药卫生领域的发展以及二者之间的需求关系,进而研究大数据应用于药物警戒的研究与实践,进一步探讨将大数据应用于药物警戒所面临的挑战以及可行路径探索的思考,以期为我国建设从智慧监管层面更加完善的药物警戒制度提供一定理论参考。

The"Drug Administration Law of the People's Republic of my country"revised and issued in 2019 pro⁃posed that the country establish a pharmacovigilance system from the legislative level,which also means that higher requirements are put forward for pharmacovigilance.In recent years,with the in-depth development of medical indus⁃try informatization and the popularization of Internet of Things smart devices,big data has been widely used and devel⁃oped in the field of medicine and health.Taking pharmacovigilance as an important representative in the field of medi⁃cine and health,this paper first expounds the connotation of pharmacovigilance,the development of big data in the field of medicine and health,and the demand relationship between the two,and then studies the research and practice of big data in pharmacovigilance,further discuss the challenges of applying big data to pharmacovigilance and the ex⁃ploration of feasible paths,in order to provide some theoretical reference for my country to build a more perfect phar⁃macovigilance system from the level of smart supervision.