title: Drug utilization pattern in children and off-label use of medicines in a pediatric intensive care unit.
abstract: OBJECTIVE
  This study aims to assess the prescription profile and license status of drugs used in a neonatal and pediatric intensive care unit (NPICU).
  
  
  METHODS
  A prospective observational study was conducted on a dynamic cohort of children admitted to an NPICU (N=81) in a tertiary hospital (Granada, Spain). All prescriptions were classified as off-label or unlicensed based on the summary of product characteristics (SPC).
  
  
  RESULTS
  Of a total of 601 prescriptions, the patients received a mean of 7.4 ± 6 drugs each. The most commonly prescribed drugs corresponded to classes J (anti-infectious, systemic use) N (nervous system) and C (cardiovascular). A little over one-half of the prescriptions were off-label (52%), usually due to dosages differing from the SPC recommendations (79%), followed by different indications (13.5%), age (5%) and administration route (2.5%). In this NPICU, unlicensed usage represented only 5% of all prescriptions.
  
  
  CONCLUSIONS
  This study contributes data on prescription of this kind in a Spanish NPICU, revealing at least one off-label prescription in 89% of the children and at least one unlicensed use in 22.3%. These are high figures, but are to be expected given the inclusion of newborn infants and the critical care setting. Even though such usage follows clinical protocols, we underscore the dual need to base treatment on the best available evidence, and to upgrade the SPC accordingly.
authors.affiliation: Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España. Electronic address: eblanco@uma.es.
authors.forename: E
authors.initials: E
authors.lastname: Blanco-Reina
authors.affiliation: UGC de Pediatría, Hospital Axarquía, Vélez-Málaga, Málaga, España.
authors.forename: A F
authors.initials: AF
authors.lastname: Medina-Claros
authors.affiliation: Medicina de Familia, Centro de Salud La Victoria, Distrito Sanitario de Málaga, Málaga, España.
authors.forename: M A
authors.initials: MA
authors.lastname: Vega-Jiménez
authors.affiliation: Departamento de Matemáticas, Escuela Andaluza de Salud Pública, Granada, España.
authors.forename: R
authors.initials: R
authors.lastname: Ocaña-Riola
authors.affiliation: Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España; Dispositivo de Cuidados Críticos y Urgencias, Distrito Sanitario Málaga, Málaga, España.
authors.forename: E I
authors.initials: EI
authors.lastname: Márquez-Romero
authors.affiliation: Departamento de Pediatría, Universidad de Granada, Granada, España; Unidad de Apoyo a la Investigación, Hospital Universitario San Cecilio, CIBERehd, Granada, España.
authors.forename: Á
authors.initials: Á
authors.lastname: Ruiz-Extremera
mesh_terms: D002648:Child; D002675:Child, Preschool; D004363:Drug Utilization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D056687:Off-Label Use; D011446:Prospective Studies; D013030:Spain
keywords: Children; Cuidados intensivos; Fármacos no autorizados; Intensive care; Neonates; Neonatos; Niños; Off-label use; Unlicensed; Usos off-label