Howland Robert H
University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
J Psychosoc Nurs Ment Health Serv. 2012 Sep;50(9):11-3. doi: 10.3928/02793695-20120807-05. Epub 2012 Aug 17.
Prescribing medications for off-label uses is not illegal. Off-label prescribing includes using medications for unapproved indications; using a drug outside of the recommended dosage range or duration of use; using a drug in certain unapproved patient populations, such as those defined by age, sex, or particular clinical parameters; or intentionally using a medication in a patient who has a known contraindication. Medications would be considered appropriate for off-label use based on their known clinical pharmacology, evidence from clinical studies, and sometimes from the personal experience of the prescriber. The decision to use a drug off label should be based on a careful assessment of the patient's treatment history and the drug's potential risks and benefits. Patients should be given adequate informed consent about how the drug is being used off label and why, along with appropriate information about known risks and side effects.
开具药物用于未获批准的用途并不违法。未获批准的处方包括将药物用于未获批准的适应症；在推荐剂量范围或使用期限之外使用药物；在某些未获批准的患者群体中使用药物，例如按年龄、性别或特定临床参数界定的群体；或在已知有禁忌证的患者中故意使用药物。基于已知的临床药理学、临床研究证据，有时还基于开处方者的个人经验，药物可被认为适用于未获批准的用途。决定使用未获批准的药物应基于对患者治疗史以及药物潜在风险和益处的仔细评估。应就药物如何及为何用于未获批准的用途给予患者充分的知情同意，以及提供有关已知风险和副作用的适当信息。
