药品说明书和标签现状及电子化探讨

Current Situation and Electronization of Drug Instructions and Labels

药品说明书和标签是指导安全用药的重要信息载体,说明书和标签的规范性和可阅读性有利于减少药物不良反应发生。本文通过查阅国内法规、文献,统计国内说明书修订公告等,对说明书/标签国内法规、发展现状、规范性现状、需求现状以及国内外新路径探讨等进行列析阐述,提出并分析药品说明书和标签规范性和可阅读性的关键控制点,以推动药品说明书电子化进程。

Drug instructions and labels are important information carriers to guide the safe use of drugs,and their standardization and readability can help reduce the occurrence of adverse drug reactions.In this paper,through reviewing domestic regulations,literature,and statistics of domestic manual revision announcements,we analyze the domestic regulations,development status,standardization status,demand status,and the discussion of new pathways at home and abroad,and propose and analyze the key control points for the standardization and readability of drug instructions and labels,in order to promote the process of electronic drug instructions.