Department of Dermatology & Cutaneous Surgery, Institute for Bioethics & Health Policy, University of Miami Miller School of Medicine, Miami, FL, USA.
Int J Dermatol. 2019 Jul;58(7):788-794. doi: 10.1111/ijd.14222. Epub 2018 Aug 31.
The term "off-label drug use" involves the prescription of medications for unapproved indications or in unapproved dosage, dosage form, or route of administration. Off-label medications are common in the management of dermatologic diseases. In the recent years, new indications for botulinum toxin, biologics, spironolactone, topical calcineurin, and topical vitamin D analogues emerged, and these drugs are being used off-label to treat a variety of conditions. The high cost and long time required for the approval discourage pharmaceutical companies from developing studies and pursuing the approval by regulatory agencies. Patients and physicians may have a different perspective regarding the off-label use of medications. The ethical discussion is based on the different opinions concerning the need for informed consent by the patient and how this could be applicable in the clinical practice.
“超说明书用药”一词涉及到为未经批准的适应症或未经批准的剂量、剂型或给药途径开处方。超说明书用药在皮肤病的治疗中很常见。近年来，肉毒毒素、生物制剂、螺内酯、局部钙调神经磷酸酶抑制剂和局部维生素 D 类似物出现了新的适应症，这些药物被超说明书用于治疗各种疾病。由于批准所需的高成本和长时间，制药公司不愿意开展研究并寻求监管机构的批准。患者和医生可能对药物的超说明书使用有不同的看法。伦理讨论基于对患者知情同意的必要性的不同意见，以及这如何适用于临床实践。
