title: [Drug prescriptions study in the outpatient setting: assessment of off-label uses in children].
abstract: OBJECTIVE
  to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric patients.
  
  
  METHODS
  cross-sectional study.
  
  
  METHODS
  pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga).
  
  
  METHODS
  sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC).
  
  
  RESULTS
  A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group. 27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10).
  
  
  CONCLUSIONS
  The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations.
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: Encarnación
authors.initials: E
authors.lastname: Blanco-Reina
authors.affiliation: Centro de Salud «La Victoria», Distrito Sanitario de Málaga, Málaga, España.
authors.forename: M Auxiliadora
authors.initials: MA
authors.lastname: Vega-Jiménez
authors.affiliation: Escuela Andaluza de Salud Pública, Granada, España.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Ocaña-Riola
authors.affiliation: Dispositivo de Cuidados Críticos y Urgencias, Distrito Sanitario de Málaga, Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España.
authors.forename: Elisa Isabel
authors.initials: EI
authors.lastname: Márquez-Romero
authors.affiliation: Departamento de Farmacología y Pediatría, Facultad de Medicina, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Bellido-Estévez
mesh_terms: D000293:Adolescent; D000553:Ambulatory Care; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D011320:Primary Health Care
keywords: Atención primaria; Children; Niños; Off-label; Off-label use; Prescripciones fuera de ficha técnica; Primary care; Unlicensed