Uso de medicamentos en condiciones no aprobadas en cuidados intensivos neonatales
- Andrea Sucasas Alonso
- Alejandro Avila-Alvarez
- Marina Combarro Eiriz
- Cristina Martínez Roca
- Pedro Yáñez Gómez
- Alejandra Codias López
- Jose Luis Fernández Trisac
- Sonia Pértega Díaz
ISSN: 1695-4033, 1696-4608
Year of publication: 2019
Volume: 91
Issue: 4
Pages: 237-243
Type: Article
More publications in: Anales de Pediatría: Publicación Oficial de la Asociación Española de Pediatría ( AEP )
Sustainable development goals
Abstract
Objective 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. Materials and methods 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). Results 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). Conclusions 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.