사용자 중심 의약품 정보 전자적 제공을 통한 의약품 안전사용 제고방안

초록

This study analyzes and compares e-Label systems in South Korea, the United States, Europe, and Singapore following the amendment of Article 58 of the Korean Pharmaceutical Affairs Act and proposes a user-centered e-Label design. Methods: A comparative analysis was conducted on e-Label regulations in the selected regions. Key proposals include Quick Response (QR) codes for real-time regulatory information, integration into pharmacy dispensing bags, standardized visual indicators for labeling changes, an official regulatory platform for accuracy, and a QR code-based adverse event reporting system. Results: Findings indicate that QR code integration enhances information accessibility, standardized labeling improves clarity, and a centralized regulatory platform ensures accuracy. The QR code-based adverse event reporting system streamlines post-market safety monitoring. Conclusion: This study provides a comprehensive e-Label strategy to enhance information delivery and safety monitoring, fostering a patient-centered medication environment and regulatory innovation.

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