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한국, 일본 대만에서의 의약품 부작용 피해구제 제도 현황 조사

Current Status of Adverse Drug Reaction Relief System in Korea, Japan and Taiwan

약학회지 2019년 63권 4호 p.214 ~ 220
안상완 ( An Sang-Wan ) - 성균관대학교 약학대학

노윤하 ( Noh Yun-Ha ) - 성균관대학교 약학대학
백연희 ( Baek LYeon-Hee ) - 성균관대학교 약학대학
박한희 ( Park Han-Heui ) - 성균관대학교 약학대학
박소희 ( Park So-Hee ) - 성균관대학교 약학대학
박성민 ( Park Sung-Min ) - 성균관대학교 약학대학
신주영 ( Shin Ju-Young ) - 성균관대학교 약학대학


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.


adverse drug reaction relief system; no-fault compensation; drug injury; non-reimbursement treatment; off-label use
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