知情同意与共同决策：向患者披露药品未标示用途处方的要求。
Informed consent and shared decision-making: a requirement to disclose to patients off-label prescriptions.
作者信息
Wilkes Michael, Johns Margaret
机构信息
School of Medicine, University of California, Davis, California, USA.
出版信息
PLoS Med. 2008 Nov 11;5(11):e223. doi: 10.1371/journal.pmed.0050223.
Abstract
Michael Wilkes and Margaret Johns argue that the doctrine of informed consent should require doctors to disclose to patients when they are prescribing a drug off-label.
摘要
迈克尔·威尔克斯和玛格丽特·约翰斯认为，知情同意原则应要求医生在开具非标签用药处方时向患者披露这一情况。
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本文引用的文献
1
2
The price of sight--ranibizumab, bevacizumab, and the treatment of macular degeneration.视力的代价——雷珠单抗、贝伐单抗与黄斑变性的治疗
N Engl J Med. 2006 Oct 5;355(14):1409-12. doi: 10.1056/NEJMp068185.
3
Designing a strategy to promote safe, innovative off-label use of medications.设计一项促进药物安全、创新的非标签使用的策略。
Am J Med Qual. 2006 Jul-Aug;21(4):255-61. doi: 10.1177/1062860606289020.
4
Off-label prescribing among office-based physicians.门诊医生的非适应症用药情况。
Arch Intern Med. 2006 May 8;166(9):1021-6. doi: 10.1001/archinte.166.9.1021.
5
Dissing disclosure: just what the doctor ordered.
Ariz Law Rev. 2002 Summer;44(2):313-71.
6
Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.未标示用途还是越界行为？开处方者和营销商对FDA批准药物的未批准用途所承担的责任。
Ann Health Law. 2003 Summer;12(2):295-324, table of contents.
7
Off-label use of prescription medication: nursing implications.处方药的非标签使用：护理启示
Nephrol Nurs J. 2003 Feb;30(1):99-100.
8
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Food Drug Law J. 1998;53(1):71-104.
9
Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals.同行评审医学期刊中存在名誉作者和代笔作者文章的比例。
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10
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