Klinik für Dermatologie und Allergologie der Ruhr-Universität Bochum, Bochum.
J Dtsch Dermatol Ges. 2009 Nov;7(11):938-45. doi: 10.1111/j.1610-0387.2009.07084.x.
Off-label use is defined as the usage of pharmaceuticals beyond their submitted, tested and approved use. Not only indications but also doses, route of administration, patients' characteristics and concomitant therapies are affected by the approval. In recent years, the impact of off-label use has increased markedly primarily because of the large number of new medications with often limited approval. In dermatology, a multitude of diagnoses exist which are so uncommon that they have no chance of approval studies. Experiences of off-label use often provide important scientific data that can influence or even improve further concepts of therapy. Both professional liability and mode of payment are still controversial for medications in off-label use. There is an urgent need for more legal certainty in use of off-label medication to guarantee maximum safety for patients and medical staff. Both professional societies and funding agencies should work together to resolve this problem.
药品的标签外使用是指超出已提交、测试和批准的用途的使用。不仅是适应证，剂量、给药途径、患者特征和伴随治疗都会受到批准的影响。近年来，标签外使用的影响显著增加，主要是因为大量新的药物通常只获得有限的批准。在皮肤病学中，有许多诊断方法非常罕见，以至于它们没有机会进行批准研究。标签外使用的经验往往提供了重要的科学数据，这些数据可以影响甚至改进进一步的治疗概念。标签外使用的药物在专业责任和支付方式方面仍然存在争议。迫切需要更多的法律确定性来保证标签外用药的使用，以确保患者和医务人员的最大安全。专业学会和资助机构都应该共同努力解决这个问题。
