Off-label use of pharmaceuticals involves a wide array of aspects ranging from legal and regulatory ones to clinical to safety considerations. Access to off-label therapies is particularly relevant question for patients in areas of unmet medical need. Simultaneously, off-label use also triggers wider considerations relating to social and economic sustainability of health care systems and access to health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) “regulatory silence”; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.

药品的超说明书使用涉及广泛的方面，从法律和监管到临床和安全考虑。对于医疗需求未得到满足的地区的患者来说，获得标签外治疗是一个特别相关的问题。同时，超说明书使用也引发了对卫生保健系统的社会和经济可持续性以及获得健康的更广泛考虑。国家当局对药品的超说明书使用采取了不同的监管方法，包括（1）“监管沉默”； (2) 根据治疗医生的判断允许超说明书使用； (3) 更严格的方法，其中超说明书使用须经第三方批准。本文从直升机角度简要概述了这些不同的监管方法，并讨论了这些方法的优点和缺点。最后，它提出了可持续和负责任地超说明书使用药品的先决条件的想法，以确保患者安全，同时确保他们及时获得健康。