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약물 이상반응

Adverse drug reactions

대한의사협회지 2019년 62권 9호 p.472 ~ 479
조민경 ( Cho Min-Kyung ) - 서울대학교병원 약물안전센터

강동윤 ( Kang Dong-Yoon ) - 서울대학교병원 약물안전센터
강혜련 ( Kang Hye-Ryun ) - 서울대학교병원 알레르기내과

Abstract


There are no drugs without the risk of potential adverse reactions. All pharmacologically active substances can cause adverse drug reactions (ADRs). This paper aims at introducing recent trends in pharmacosurveillance systems for ADRs, which can be broadly classified into type A and B reactions. Since type A reactions are associated with drug pharmacology, they are usually dose-dependent and predictable. Whereas, type B reactions occur in some susceptible individuals, regardless of the pharmacological action of drug. Drug hypersensitivity reactions are typical examples of type B reactions and are subclassified according to the underlying pathomechanism. Recent advancements in pharmacogenomics have enlightened the understanding of individual differences in drug efficacy and susceptibility to ADRs. Therefore, expectations for safe personalized medicines are higher than ever before. However, premarketing clinical trials are too small and too short to uncover rare but serious ADRs and detect long-standing ADRs. In the past, post-marketing surveillance systems mainly focused on passive ADR monitoring systems, based on spontaneous reports. Recently, the importance of active pharmacovigilance systems, which use big data, is growing with recent advancements in medical informatics. Thus, regarding ADRs, suspecting and detecting the causative drug using causality assessment based on data science may contribute to decrease suffering induced by ADRs.

키워드

약물이상반응; 약물감시; 약물이상반응 보고체계; 약물유전체; 빅데이터
Drug-related side effects and adverse reactions; Pharmacovigilance; Adverse drug reaction reporting systems; Pharmacogenetics; Big data
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