药品说明书阅知障碍的归因与破解  

Attribution and Resolution of Obstacles in Reading Drug Instructions

作　　者：汤啸天[1] TANG Xiao-tian(Shanghai University of Political Science and Law)

机构地区：[1]上海政法学院

出　　处：《中国食品药品监管》2024年第5期64-69,共6页China Food & Drug Administration Magazine

摘　　要：在我国,药品说明书“看不清”“看不懂”的问题尚未完全解决,药品说明书适老化及无障碍改革虽面临挑战但刻不容缓。药品上市许可持有人应依法履行提供语音、大字、盲文、电子等无障碍格式版本的标签、说明书的义务;药品监管部门应履行监督、核准职能,检察机关可通过公益诉讼等方式履行法律监督职能,推动药品安全可及性进一步提升。建议分步骤解决药品说明书“看不清”与“看不懂”的问题,在国家开展药品说明书改革的基础上探索完善药品说明书完整版、简化版与用药提示单并举的制度。In China,the issues of drug instructions being"illegible"or"incomprehensible"have not been fully resolved.It is urgently needed to promote elder-friendly and accessible reform of drug instructions,even though great challenges are faced.Marketing authorization holders of drugs should fulfill their legal obligation to provide labels and instructions in accessible formats,such as voice,large fonts,braille,and electronic versions.Drug regulatory authorities should perform their supervisory and approval duties,and procuratorial organs may exercise their legal supervision functions through public interest litigation and other means,ensuring the public's access to drug safety.It is recommended to address the issues of"illegible"and"incomprehensible"drug instructions in a step-by-step manner.Based on the national reform of drug instructions in China,a system that combines complete and simplified versions of drug instructions with medication reminders can be explored and improved.

关 键 词：药品说明书 阅知障碍 药品安全可及性 公共利益 用药提示单 

分 类 号：R95[医药卫生—药学]