Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use
Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use
复制标题
根除机构腐败以管理不适当的超说明书用药
DOI：
10.1111/jlme.12075
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
M. Rodwin
中科院分区：
文献类型：
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作者：
M. Rodwin
美国食品和药物管理局（FDA）授权销售的药物仅用于制造商已经证明是安全和有效的，基于至少两个临床试验的证据。然而，FDA并不监管医学实践，因此医生可以以任何方式开药。以偏离FDA批准的药物标签、包装说明书和上市许可中规定的用途的方式开药被称为标签外处方。当医生为治疗目的开药而不是FDA批准的药物时，会发生这种情况;治疗与测试人群不同年龄组或性别的患者;或处方不同的剂量，不同的使用持续时间，或与标签上指示的不同的给药模式。
The Food and Drug Administration (FDA) authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label.
DOI：
10.1001/jama.1990.03440100097014
发表时间：
1990-03
期刊：
JAMA
影响因子：
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作者：
K. Dickersin
通讯作者：
K. Dickersin