Li V W, Jaffe M P, Li W W, Haynes H A
Department of Medicine, Brigham and Women's Hospital, Boston, Mass., USA.
Arch Dermatol. 1998 Nov;134(11):1449-54. doi: 10.1001/archderm.134.11.1449.
Off-label refers to the prescribing of Food and Drug Administration-approved drugs for a use not indicated on the package insert. The prescribing of off-label drugs may benefit patients with many dermatologic diseases including angiogenesis-related conditions. We surveyed 55 dermatologists from a single large academic program to assess their use of particular drugs for specific skin conditions, their perception of such use as being for Food and Drug Administration-approved or for off-label indications, and their attitudes towards off-label therapies. The practice of prescribing off-label drugs was common among the respondents, many of whom had misperceptions about which conditions are Food and Drug Administration-approved indications and about the legal ramifications of off-label therapies. We suggest that understanding the principles of off-label prescribing in conjunction with the mechanisms of drug action in diseases may help clinicians exercise their judgment in finding innovative therapies for their patients.
超说明书用药是指开具美国食品药品监督管理局（FDA）批准的药物用于药品说明书未标明的用途。开具超说明书用药可能使包括血管生成相关病症在内的许多皮肤病患者受益。我们对来自一个大型学术项目的55名皮肤科医生进行了调查，以评估他们针对特定皮肤病症使用特定药物的情况、他们对这种使用是FDA批准的还是超说明书适应症的认知，以及他们对超说明书治疗的态度。开具超说明书用药的做法在受访者中很常见，其中许多人对哪些病症是FDA批准的适应症以及超说明书治疗的法律后果存在误解。我们建议，结合疾病的药物作用机制理解超说明书用药的原则，可能有助于临床医生在为患者寻找创新疗法时做出判断。
