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KMID : 1011320190110010001
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Journal of Pharmacoepidemiology and Risk Management
2019 Volume.11 No. 1 p.1 ~ p.8
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Introduction of Current Status of the Adverse Drug Reaction Relief System in Korea, Japan and Taiwan
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Kim Su-Jin
Kim Jong-Yoon
Song Eun-Hae
Choi Moon-Jin
Lee Kwang-Jung
Jung Soo-Youn
Han Soon-Young
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Abstract
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There has been moves to implement a novel system for the relief of injury from adverse drug reaction (ADR) in 2013 in Republic of Korea and the ADR Relief system was finally initiated in December 2014 by MFDS (Ministry of Food and Drug Safety) and KIDS (Korea Institute of Drug Safety and Risk Management). This national system is to protect victims such as the patients, manufacturers and suppliers from serious damages that can occur in spite of properly using licensed medical products. It expanded to include death, disability and serious illness cases sequentially from 2015 to 2017. Work process in KIDS is as follow. Once a claim is received, a pharmacoepidemiologic investigator reviews the case in various ways such as interview of patients and healthcare providers, visit to the hospitals or related institutions, or are also done as needed. The result of causality assessments is then reviewed by the Expert Committee. Then, the written investigation and appraisal is submitted to the ADR Deliberative Committee of MFDS, which finalizes the decision for compensation. Since 2015, the funds for compensation have been collected from pharmaceutical companies. Until December 2017, the total of 211 cases was received and 128 cases were compensated. We would introduce current state of the ADR Relief system, comparing with that of Japan and Taiwan which were operated similarly. From this we will continue to facilitate the ADR review process and actively promote the ADR Relief system in order to protect the public from unintended serious damages from drug use.
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KEYWORD
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Ministry of Food and Drug Safety (MFDS), Korea Institute of Drug Safety and Risk Management (KIDS), Adverse Drug Reaction (ADR) relief system
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