Sucasas Alonso Andrea, Avila-Alvarez Alejandro, Combarro Eiriz Marina, Martínez Roca Cristina, Yáñez Gómez Pedro, Codias López Alejandra, Fernández Trisac Jose Luis, Pértega Díaz Sonia
Unidad de Neonatología, Servicio de Pediatría, Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, A Coruña, España.
Unidad de Neonatología, Servicio de Pediatría, Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, A Coruña, España.
An Pediatr (Engl Ed). 2019 Oct;91(4):237-243. doi: 10.1016/j.anpedi.2018.12.015. Epub 2019 Feb 13.
To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use.
Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication).
The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P<.001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P<.001).
Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription.
评估新生儿重症监护病房（NICU）中未获批准处方（超说明书用药和未经许可用药）的发生率，并描述与使用此类处方相关的新生儿因素。
在一家三级NICU进行为期6个月的前瞻性观察研究。以药品说明书摘要为参考对每张处方进行分析。采用序贯算法根据当前状态对处方进行分类：批准的、未经许可的、超说明书的（按年龄、给药途径、剂量或适应症）。
该研究纳入了84例患者和564张处方。共有127张（22.5%）处方被视为超说明书用药，45张（8%）被视为未经许可用药。超过一半（59.5%）的患者接受了至少一种此类药物，在极早产儿和手术患者中这一比例增至100%（P<0.001）。发现NICU住院时间与超说明书处方数量之间存在正线性相关（相关系数0.6；P<0.001）。
NICU中经常开具未经许可的药物处方，尤其是在最脆弱的患者中。我们的结果表明，有必要推进临床研究，以使现有关于新生儿药物的数据同质化，从而实现高效、安全的处方开具。
