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开具“未标明适应证用药”:医生应披露哪些信息?

Prescribing "Off-Label": What Should a Physician Disclose?

作者信息

Furey Katrina, Wilkins Kirsten

机构信息

Second-year resident in the Department of Psychiatry at Yale University School of Medicine in New Haven, Connecticut.

Associate professor of psychiatry and the director of the psychiatry clerkship at Yale University School of Medicine in New Haven, Connecticut.

出版信息

AMA J Ethics. 2016 Jun 1;18(6):587-93. doi: 10.1001/journalofethics.2016.18.6.ecas3-1606.

DOI:10.1001/journalofethics.2016.18.6.ecas3-1606
PMID:27322992
Abstract

This case highlights clinical dilemmas faced by physicians when treating patients with conditions for which there are limited or no FDA-approved treatment options. First, it raises questions about when it is appropriate to prescribe medications for "off-label" indications and what might be the ethical and legal implications of doing so. It also prompts us to consider why pharmaceutical companies might or might not pursue FDA approval for new indications when a drug has already been approved for use in another condition. Finally, this case demonstrates the importance of employing shared decision making when discussing complex clinical decisions and how such techniques might have led to different outcomes and better understanding between Dr. Shannin, Maxine, and Heather.

摘要

该病例凸显了医生在治疗那些FDA批准的治疗方案有限或没有的疾病患者时所面临的临床困境。首先,它引发了关于何时为“未标明的”适应症开药是合适的,以及这样做可能存在的伦理和法律影响的问题。它还促使我们思考为什么当一种药物已被批准用于另一种疾病时,制药公司可能会或可能不会寻求FDA对新适应症的批准。最后,该病例证明了在讨论复杂的临床决策时采用共同决策的重要性,以及这些技巧可能如何导致不同的结果,并增进香宁医生、玛克辛和希瑟之间的理解。

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