药品电子说明书及其发展现状  

Electronic drug labeling and its development status

作　　者：于巍 貊润翌 YU Wei;MO Run-yi(Sanofi(China)Investment Co.,Ltd.,Beijing 100022,China)

机构地区：[1]赛诺菲(中国)投资有限公司,北京100022

出　　处：《中国新药杂志》2022年第2期189-192,共4页Chinese Journal of New Drugs

摘　　要：随着数字信息技术的发展,以电子形式提供药品说明书作为纸质说明书的补充或替代,可以为医疗专业人员和患者提供最新的方便阅读的产品信息。电子说明书在有效保障患者安全用药、提升监管效率的同时又能节约自然资源和降低生产成本、减少环境负担。目前,多个国家和地区已开始采取独立的措施以促进药品电子说明书的开发和使用。本文介绍了药品电子说明书的优势及其发展和监管状况,以期为在我国进一步实施药品电子说明书提供有益的参考。With the development of digital information technology,providing drug labeling in electronic form as a supplement or substitute for paper labeling can provide the latest and easy to read product information for medical professionals and patients.Electronic labeling can not only effectively protect patients'safe medication and improve supervision efficiency,but also save natural resources,reduce production costs and environmental burden.At present,many countries and regions have begun to take independent measures to promote the development and use of electronic drug labeling.This article introduced the advantages and development of electronic drug labeling as well as the supervision status by drug regulatory agencies,aiming to provide a reference for exploring the implementation of electronic drug labeling in our country.

关 键 词：数字信息技术 药品说明书 电子说明书 药监机构 安全用药 

分 类 号：R95[医药卫生—药学]