RT Journal Article
T1 Off-label and unlicensed drug use in a pediatric intensive care unit of a tertiary care Spanish hospital. A descriptive study
A1 Camacho Arroyo, María T.
A1 Rivas Paterna, Ana Belén
A1 Meneses Monroy, Alfonso
A1 Cabrera García, María Lourdes
A1 Blázquez González, Patricia
A1 Mancebo Salas, Noelia
A1 Rodríguez Leal, Leyre
A1 Vargas Castrillón, Emilio
AB Introduction. In pediatric intensive care units, a large number of drugs are used, many of which are prescribed for condition beyond those established in their summary of product characteristics (off-label and unlicensed drug prescriptions). The objective of this study was to describe drug use and estimate the prevalence of off-label and unlicensed drugs in a pediatric intensive care unit of a tertiary care Spanish hospital. Population and methods. Cross-sectional, observational study with a single cohort of children admitted to a pediatric intensive care unit. The study was conducted in 2017. Each drug prescription, its conditions of use and administration were reviewed. In addition, the summary of product characteristics of drugs used were analyzed in order to identify whether they were used according to their conditions of authorization, or whether they were used in an off-label or unlicensed manner. Results. The sample included 97 patients. At least one off-label or unlicensed drug was administered to 74.2% (n = 72) of patients; 23.8% (n = 243) corresponded to off-label prescriptions and 8.7% (n = 89), unlicensed prescriptions. A sub-analysis by age group showed that the age group that received a higher number of total prescriptions (n = 611) and a higher percentage of off-label and/or unlicensed drug prescriptions (38.4%) was under 2 years of age. Conclusions. Off-label and/or unlicensed drug prescription is a common practice in the pediatric intensive care unit. This study allowed us to document the complexity of therapeutics in children.
PB La Prensa Medical Argentina
SN 0325-0075
YR 2022
FD 2022-10-03
LK https://hdl.handle.net/20.500.14352/124844
UL https://hdl.handle.net/20.500.14352/124844
LA eng
NO «Off-label and unlicensed drug use in a pediatric intensive care unit of a tertiary care Spanish hospital. A descriptive study». Archivos Argentinos de Pediatria, octubre de 2022. DOI.org (Crossref), https://doi.org/10.5546/aap.2021-02550.eng.
DS Docta Complutense
RD 16 dic 2025