Off-Label Use of Drugs in Children
Off-Label Use of Drugs in Children
复制标题
DOI：
10.1542/peds.2013-4060
复制
发表时间：
2014-03-01
期刊：
影响因子：
8
通讯作者：
Del Monte, Mark
中科院分区：
文献类型：
--
作者：
Frattarelli, Daniel A. C.;Galinkin, Jeffrey L.;Del Monte, Mark
《儿童最佳药品法》和《儿科研究公平法》的通过共同改善了儿童合理处方，包括500多项标签变更。然而，标签外药物使用仍然是婴儿、儿童和青少年的一个重要公共卫生问题，因为绝大多数药物的标签中仍然没有关于儿科使用的信息。标签外使用的目的是使个体患者受益。从业人员使用他们的专业判断来确定这些用途。因此，标签外使用一词并不意味着不当、非法、禁忌或研究性使用。治疗决策必须始终依赖于现有的最佳证据和个体患者获益的重要性。
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.