Pediatrics. 2014 Mar;133(3):563-7. doi: 10.1542/peds.2013-4060. Epub 2014 Feb 24.
The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in the labeling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Practitioners use their professional judgment to determine these uses. As such, the term "off-label" does not imply an improper, illegal, contraindicated, or investigational use. Therapeutic decision-making must always rely on the best available evidence and the importance of the benefit for the individual patient.
《最佳儿童用药法案》和《儿科研究公平法案》的通过，共同促使儿童合理用药得到改善，包括 500 多项标签变更。然而，药物标签外使用仍然是婴幼儿和青少年的一个重要公共卫生问题，因为绝大多数药物在儿科使用方面的信息仍未纳入标签。药物标签外使用的目的是使个体患者受益。从业者运用其专业判断来确定这些用途。因此，“标签外”一词并不意味着不适当、非法、禁忌或研究性使用。治疗决策必须始终依赖于现有最佳证据，以及对个体患者的重要性。
