의약품 점자 표시 국내외 가이드라인의 비교분석 연구

Comparison and Analysis of Domestic and Foreign Guidelines for Braille Labeling of Drugs

This study compares and analyzes domestic and international guidelines for Braille labeling of drugs to promote the safe use of medications by visually impaired individuals. According to the revised Pharmaceutical Affairs Act of July 2021, Braille labeling for medications for visually impaired individuals became mandatory starting in 2024. In preparation for this, relevant laws and guidelines from the European Union, the United States, Germany, Ireland, and Japan were investigated. The study examined various aspects of Braille labeling, including the scope of applicable medicines (mandatory or recommended), the shape and specifications of Braille (dot height, diameter of dots, spacing between dots, letter spacing, and line spacing), and general principles of Braille labeling (pressure, perforation, or sticker). Additionally, the study compared the allowable range of Braille, Braille display items (required, recommended, and omitted exceptions), the location of Braille display, and special items unique to each country. Through examining the practices of these countries, this study aims to propose practical regulations that enhance medication information accessibility for visually impaired individuals while minimizing the burden on the domestic pharmaceutical industry. The study confirmed the effectiveness of utilizing voice information content in addition to Braille labeling for visually impaired individuals and emphasized the need for education and campaigns to support this initiative. Ultimately, continuous improvements in laws and guidelines are required to enhance the practical usability for people with disabilities.