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

被引：75

作者：

Conroy, S ^{[1
]}

McIntyre, J ^{[1
]}

机构：

[1] Univ Nottingham, Acad Div Child Hlth, Sch Med, Derbyshire Childrens Hosp, Derby DE22 3DT, England

来源：

SEMINARS IN FETAL & NEONATAL MEDICINE | 2005年 / 10卷 / 02期

关键词：

adverse drug reaction; clinical trials; drug; formulation; license; medication error; medicine trials; medicine; neonate; off label; unauthorised; unlicensed;

D O I：

10.1016/j.siny.2004.11.003

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

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. (c) 2004 Elsevier Ltd. All rights reserved.

引用

页码：115 / 122

页数：8

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