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.
Keywords: Fuera de ficha técnica; Neonatal Intensive Care Unit; Off-label; Sin licencia; Unapproved indications; Unidad de Cuidados Intensivos Neonatales; Unlicensed; Uso no aprobado.
Copyright © 2019. Publicado por Elsevier España, S.L.U.