의약품 허가외사용 관리 체계 발전 방안

• 영문명: Development of Regulation System for Off-Label Drug Use
• 발행기관: 대한약학회
• 저자명: 이인향 서미경 이영숙 계승희 김현아 이숙향
• 간행물 정보: 『약학회지』제58권 제2호 (2014년), 112~124쪽, 전체 13쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2014.04.30

영문 초록

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a reg-ulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers’ self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with sci-entific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official ‘Off-Label Drug Use Report’ to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

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키워드

off-label drugs regulation, safety pharmacovigilance information