한국, 일본, 대만에서의 의약품 부작용 피해구제 제도 현황 조사

• Published in: Yaghag-hoi-ji Vol. 63; no. 4; pp. 214 - 220
• Main Authors: 안상완(Sang-Wan An), 노윤하(Yunha Noh), 백연희(Yeon-Hee Baek), 박한희(Han-Heui Park), 박소희(So-Hee Park), 박성민(Sungmin Park), 신주영(Ju-Young Shin)
• Format: Journal Article
• Language: Korean
• Published: The Pharmaceutical Society Of Korea 30.08.2019; 대한약학회
• Subjects: 약학; drug injury; off-label use; adverse drug reaction relief system; non-reimbursement treatment; no-fault compensation
• ISSN: 0377-9556; 2383-9457
• DOI: 10.17480/psk.2019.63.4.214

The adverse drug reaction relief system is no-fault compensation system which provides compensation forsevere injuries that were caused by adverse reaction even after proper use of medicines. The purpose of this study is toevaluate current status of the adverse drug reaction relief system in Japan, Taiwan, and Korea. We investigated the reliefsystem in above three countries through websites, literatures, reports, spot investigation and e-mail questionnaires. Althoughgreat similarities for the relief system were recognized among the three countries, the difference among the countries andthe unique characteristics of each country’s relief system was also identified; for example, the relief for injuries by offlabeluses, details of relief benefits, the relief payment for the adverse drug reactions, and the compensation for medicalexpenses which is classified as non-reimbursement treatment. Therefore, it is possible to establish more valuable no-faultcompensation system in Korea through application of advantage and experience for the relief system in Japan and Taiwan. KCI Citation Count: 1