新生儿中未获许可药物和超说明书用药的使用情况。

The use of unlicensed and off-label medicines in the neonate.

作者信息

Conroy Sharon, McIntyre John

机构信息

Academic Division of Child Health (University of Nottingham), The Medical School, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK.

出版信息

Semin Fetal Neonatal Med. 2005 Apr;10(2):115-22. doi: 10.1016/j.siny.2004.11.003. Epub 2005 Jan 25.

DOI:10.1016/j.siny.2004.11.003

PMID:15701577

Abstract

The use of unlicensed and off-label medicines in neonates in intensive care is common and widespread. Up to 93% of babies receive at least one unlicensed or off-label medicine during their stay in intensive care. Such practice is an essential part of their care and should be done based on the best evidence available. However, problems arise - on an every-day basis - because of the lack of appropriate information and licensed medicine formulations for neonates. These problems include the selection of appropriate medicine and dose, administration and the increased risk of medication errors. Initiatives to improve the situation are underway in the US and are proposed in Europe. However, more urgent action is required to stop these babies continuing to be deprived of their basic human rights to safe, effective and high-quality therapy.

摘要

在重症监护病房中，新生儿使用未经许可和未按说明书用药的情况很常见且普遍存在。高达93%的婴儿在重症监护期间至少接受过一种未经许可或未按说明书使用的药物。这种做法是他们护理的重要组成部分，应该基于现有最佳证据来进行。然而，由于缺乏针对新生儿的适当信息和有许可的药物配方，每天都会出现问题。这些问题包括选择合适的药物和剂量、给药以及用药错误风险增加。美国正在采取措施改善这种情况，欧洲也提出了相关提议。然而，需要采取更紧急的行动，以防止这些婴儿继续被剥夺获得安全、有效和高质量治疗的基本人权。