지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
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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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참고문헌 (47)
참고문헌 신청
중앙사회보험의료협의회 / 2010 / 의료보험에 있어서 혁신적인 의료기술의 취급에 관한 방법에 대해 ( 療保における革新的な療技術の取扱いにする考え方について)
Kim, J. M. / 2012 / Off-label use / Korean J. Insur. Med 7:157
Radley, D. C. / 2006 / Off-label prescribing among office-based physicians / Arch. Intern. Med 166:1021
Lindell-Osuagwu, L. / 2009 / Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature / J. Clin. Pharm. Ther 34:277
Turner, S. / 1999 / Unregistered and off-label drug use in paediatric inpatients / Aust. J. Hosp. Pharm 29:265
Kim, J. M. / 2012 / Off-label use / Korean J. Insur. Med 7:157
Radley, D. C. / 2006 / Off-label prescribing among office-based physicians / Arch. Intern. Med 166:1021
Lindell-Osuagwu, L. / 2009 / Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature / J. Clin. Pharm. Ther 34:277
Turner, S. / 1999 / Unregistered and off-label drug use in paediatric inpatients / Aust. J. Hosp. Pharm 29:265
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