Use of off-label drugs in neonatal intensive care

Autor: 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
Jazyk: Spanish; Castilian
Rok vydání: 2019
Předmět:
Zdroj: Anales de Pediatría (English Edition), Vol 91, Iss 4, Pp 237-243 (2019)
Druh dokumentu: article
ISSN: 2341-2879
DOI: 10.1016/j.anpede.2018.12.005
Popis: 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
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