Magalhães Joana, Rodrigues António Teixeira, Roque Fátima, Figueiras Adolfo, Falcão Amílcar, Herdeiro Maria Teresa
Centre for Cell Biology, University of Aveiro (CBC/UA), Aveiro, Portugal.
Eur J Clin Pharmacol. 2015 Jan;71(1):1-13. doi: 10.1007/s00228-014-1768-9. Epub 2014 Oct 16.
The aim of this review is to assess the extent of the use of off-label and/or unlicenced drugs among hospitalised children.
A systematic search was made in MEDLINE-PubMED for papers published from 1994 to 2012, addressing the prescription of off-label and/or unlicenced drugs for the paediatric population in hospital care.
Of the 829 studies retrieved, 34 met the inclusion criteria. Prescriptions ranged from 12.2 to 70.6 % for off-label and from 0.2 to 47.9 % for unlicensed drugs. The percentage of children who received at least one off-label and/or unlicensed drug ranged from 42.0 to 100 %, with newborns being the population that received most of such drugs. Off-label prescriptions were essential for dose modification (7.1-73.1 %) and unlicensed prescriptions for formulation modification purposes (3.6-100 %).
These findings show that: (i) off-label and/or an unlicensed prescribing is widespread among the hospitalised paediatric population worldwide, (ii) there is no consensus on a definition of off-label and/or unlicensed drugs and (iii) preterm newborns receive most off-label and/or unlicensed drugs. By shedding new light on off-label and/or unlicensed drug prescribing, these findings will hopefully contribute to generating new, more effective knowledge about the paediatric population's need for quality drugs that are both safe and efficacious.
本综述旨在评估住院儿童中使用未注册和/或未获许可药物的情况。
在MEDLINE-PubMED中进行系统检索，查找1994年至2012年发表的关于住院治疗中儿科人群使用未注册和/或未获许可药物处方的论文。
在检索到的829项研究中，34项符合纳入标准。未注册药物的处方比例为12.2%至70.6%，未获许可药物的处方比例为0.2%至47.9%。接受至少一种未注册和/或未获许可药物的儿童比例为42.0%至100%，新生儿是接受此类药物最多的人群。未注册处方对于剂量调整至关重要（7.1% - 73.1%），未获许可处方用于剂型调整目的（3.6% - 100%）。
这些研究结果表明：（i）在全球住院儿科人群中，未注册和/或未获许可用药情况普遍存在；（ii）对于未注册和/或未获许可药物的定义尚无共识；（iii）早产新生儿接受的未注册和/或未获许可药物最多。通过揭示未注册和/或未获许可药物处方的新情况，这些研究结果有望有助于产生关于儿科人群对安全有效的优质药物需求的更新、更有效的知识。
