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KMID : 0370220140580020112
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Yakhak Hoeji
2014 Volume.58 No. 2 p.112 ~ p.124
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Development of Regulation System for Off-Label Drug Use
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Lee Iyn-Hyang
Seo Mi-Kyeong
Lee Young-Sook
Kye Seung-Hee
Kim Hyun-Ah
Lee Suk-Hyang
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Abstract
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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 regulatory 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 scientific 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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KEYWORD
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off-label drugs, regulation, safety, pharmacovigilance, information
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