의약품 허가외사용 관리 체계 발전 방안

Title
의약품 허가외사용 관리 체계 발전 방안
Other Titles
Development of Regulation System for Off-Label Drug Use
Author(s)
이인향서미경[서미경]이영숙[이영숙]계승희[계승희]김현아[김현아]이숙향[이숙향]
Keywords
off-label drugs; regulation; safety; pharmacovigilance; information
Issue Date
201404
Publisher
대한약학회
Citation
약 학 회 지, v.58, no.2, pp.112 - 124
Abstract
This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketeddrugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a bodyof academic literature to explore current regulating trends. We included European Union, United Kingdom, United Statesof America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatorystructure, safety control before and after off-label use, and information management. The findings of the presentinvestigation called for several measures in off-label drug uses: enhancing prescribers’ self-regulation, providing up-to-dateinformation to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientificrigor, building an official registering process for off-label use in good quality and extending the role of pharmaceuticalindustry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses bothat national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicantswould submit. We newly introduced an official ‘Off-Label Drug Use Report’ to evaluate the safety and clinical efficacy of agiven off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institutionto help set up the culture of evidence-based practices in off-label drug uses
URI
http://hdl.handle.net/YU.REPOSITORY/32391
ISSN
0377-9556
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약학대학 > 약학부 > Articles
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