CHINESE JOURNAL OF MEDICINAL GUIDE >
Analysis of Patient Medication Instructions in the EU, US, and Japan
Received date: 2025-03-14
Revised date: 2025-08-04
Accepted date: 2025-12-03
Online published: 2025-12-17
Drug instructions play a significant role in ensuring the safety of medication. With China's aging population growing steadily, drug instructions "hard-to-read and hard-to-understand" for eldrly has become increasingly prominent. National Medical Products Administration (NMPA) launched the Pilot Work Plan for Elderly-Friendly Drug Instructions Reform in 2023, promoting elderly-friendly adaptations of drug instructions through formats like large-print versions, simplified formats, and digital formats to enhance readability and accessibility. The EU, US, and Japan have established mature systems for elderly-friendly drug instructions, offering valuable references. Based on literature research, this article sorts out the situations of EU, US, and Japan in terms of the management mechanism, content design and practical characteristics of patient medication instructions. These countries have developed distinctive approaches in the management of patient medication instructions, such as establishing patient-involved readability verification procedures, adopting diverse instruction formats with structured digital versions, and implementing elderly-friendly reforms. The elderly-friendly reform for drug instruction in China remain in infancy. Continuous improvements in regulations, technological innovation, and service optimization will enable to develop a tailored reform path, ultimately providing elderly patients with higher-quality, more convenient, and safer medication information services.
Fan Zhang
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Analysis of Patient Medication Instructions in the
EU, US, and Japan
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