中国药房2025，Vol.36Issue(9)：1030-1034,5.DOI:10.6039/j.issn.1001-0408.2025.09.02
中美日药品说明书适老化管理的对比研究
Comparative analysis on elderly-friendly management of drug instructions in China,the United States and Japan
摘要
Abstract
OBJECTIVE To compare the measures taken by China,the U.S.and Japan to adapt drug instructions to aging,and provide reference for the reform of elderly-friendly drug instructions in China.METHODS The relevant documents published by the official websites of National Medical Products Administration of China,the U.S.FDA,and Pharmaceuticals and Medical Devices Agency of Japan,were consulted.Additionally,relevant literature from comprehensive databases such as CNKI,Wanfang data,and Web of Science,as well as search engines,was reviewed to understand the measures taken by the above countries in elderly-friendly management process of drug instructions.The comparative analysis was conducted for elderly-friendly adaptations of drug instructions in China,the U.S.and Japan,and the suggestions were put forward for the reform of elderly-friendly drug instructions in China.RESULTS&CONCLUSIONS The measures taken by China,the U.S.,and Japan in the process of elderly-friendly management of drug labels had different emphases:China adopted large fonts and simplified drug instructions to alleviate the problem of the elderly being unable to read and understand drug instructions;the U.S.had set up a special section for the elderly in the drug instructions for special populations and issued the principles for writing information on medications for the elderly.The U.S.and Japan had established a classification management system for patient instructions and professional instructions,promoted structured electronic instructions,and built a unified electronic instructions platform.It is recommended that China incorporate elderly-specific medication information into the writing requirements of drug instructions,improve specific measures to encourage the reform of drug instructions suitable for the elderly,improve the accessibility and readability of electronic drug instructions,and build a drug instruction information disclosure platform to better ensure the safety of medication for the elderly.关键词
药品说明书/适老化/老年人/用药安全/国际比较Key words
drug instructions/elderly-friendly/the elderly/medication safety/international comparison分类
医药卫生引用本文复制引用
王思懿,喻小勇,姜佳缘,田侃..中美日药品说明书适老化管理的对比研究[J].中国药房,2025,36(9):1030-1034,5.基金项目
江苏省社会科学基金项目(No.24CSB003) （No.24CSB003）
