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首页> 外文期刊>Journal of pain & palliative care pharmacotherapy >Off-label prescribing of medications for pain: maintaining optimal care at an intersection of law, public policy, and ethics.
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Off-label prescribing of medications for pain: maintaining optimal care at an intersection of law, public policy, and ethics.

机译：标签上的止痛药处方：在法律，公共政策和伦理的交叉点保持最佳护理。

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摘要

For more than 60 years, regulations limited marketing of medications for off-label uses to very low levels. Some key policy changes in the late 1990s ushered in an era of deregulation of off-label marketing. Policy changes included revised United States federal law as well as modifications of Food and Drug Administration (FDA) regulations. Subsequent investigations documented an explosion in scope off-label prescribing. Attempts to limit off-label advertising by manufacturers were vigorously challenged in the courts. Other modalities are needed to maintain a clinical care environment that places the patients' best interests first. In many circumstances, an off-label medication may be in the patient's best interests; however, where there is a lower level of clinical justification, the informed consent of the patient and shared decision making of the patient is essential to optimize outcome.
机译：60多年来，法规将标签外用途的药品销售限制在非常低的水平。在1990年代后期，一些重要的政策变化迎来了标签外行销放松管制的时代。政策变更包括修订后的美国联邦法律以及食品药品管理局（FDA）法规的修改。随后的调查记录了范围外处方的爆炸式增长。法院对制造商限制标签外广告的尝试提出了强烈挑战。需要其他方式来维持将患者的最大利益放在首位的临床护理环境。在许多情况下，贴标签的药物可能符合患者的最大利益。但是，在临床证据水平较低的情况下，患者的知情同意和患者的共同决策对于优化结果至关重要。

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