title: [Off-label and unlicensed drug use: Results from a pilot study in a pediatric intensive care unit].
abstract: OBJECTIVE
  To analyze the prevalence of use of off-label and unlicensed drugs in a pediatric intensive care unit of a University Hospital.
  
  
  METHODS
  An observational, descriptive, prospective six week pilot study in a Pediatric Intensive Care Unit. Hospitalized patients aged between 0 and 18 years were included. Each prescribed drug was evaluated taking into account indication and condition of use, according to the information available on the Summary of Product Characteristics established by the European Medicines Agency. A sequential algorithm was defined allowing drug classification in unlicensed, off-label or approved.
  
  
  RESULTS
  Forty-two patients were included. A total of 696 prescriptions, involving 102 different drugs, were analyzed. All patients had at least one off-label prescription, and a median of 8.9 off-label prescriptions was obtained. Of the total prescriptions, 8.6% were unlicensed and 53.9% corresponded to off-label use. The main reason for off-label use was by indication, followed by age and dose. A lineal tendency between off-label drug use and patient age was observed, where off-label use increased as patient age decreased. The drugs most commonly used off-label were: atropine, etomidate, dipyrone and ranitidine, and unlicensed drugs: spironolactone, sildenafil, acetazolamide and hydrochlorothiazide.
  
  
  CONCLUSIONS
  Pediatric Intensive Care Units are characterized by a high ratio of off-label and unlicensed prescriptions. The scarce number of studies performed in this specific and complex sub-population added inconveniency to the current lack of data on safety and efficacy for drugs in paediatrics. Performing studies with these characteristics allows us to document practice on paediatric drug utilisation are required.
authors.affiliation: Servicio de Farmacia, Hospital Infantil Universitario Niño Jesús, Madrid, España. Electronic address: iglopez@salud.madrid.org.
authors.forename: Isabel
authors.initials: I
authors.lastname: García-López
authors.affiliation: Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Madrid, España.
authors.forename: Javier Ezequiel
authors.initials: JE
authors.lastname: Fuentes-Ríos
authors.affiliation: Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Madrid, España.
authors.forename: Silvia
authors.initials: S
authors.lastname: Manrique-Rodríguez
authors.affiliation: Servicio de Farmacia, Hospital General Universitario Gregorio Marañón, Madrid, España.
authors.forename: Cecilia
authors.initials: C
authors.lastname: M Fernández-Llamazares
mesh_terms: D000293:Adolescent; D000465:Algorithms; D002648:Child; D002675:Child, Preschool; D004363:Drug Utilization / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010865:Pilot Projects; D011446:Prospective Studies
keywords: Drug approval; Drug utilization; Indicación fuera de ficha técnica; Intensive care units pediatric; Off-label prescriptions; Off-label use; Pediatrics; Pediatría; Prescripciones en condiciones off-label; Unidad de cuidados intensivos pediátricos; Unlabeled indication; Uso aprobado de medicamentos; Uso off-label; Utilización de medicamentos