title: [Results from the 2012-2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study)].
abstract: BACKGROUND
  Off-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use.
  
  
  METHODS
  Cross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies.
  
  
  RESULTS
  Out of 673 responses were received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record.
  
  
  CONCLUSIONS
  Most Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC.
authors.affiliation: Servicio de Pediatría, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España; Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), España. Electronic address: roipineiro@telefonica.net.
authors.forename: R
authors.initials: R
authors.lastname: Piñeiro Pérez
authors.affiliation: Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España.
authors.forename: M B
authors.initials: MB
authors.lastname: Ruiz Antorán
authors.affiliation: Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España.
authors.forename: C
authors.initials: C
authors.lastname: Avendaño Solá
authors.affiliation: Servicio de Pediatría, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España.
authors.forename: E
authors.initials: E
authors.lastname: Román Riechmann
authors.affiliation: Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España; Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), España.
authors.forename: L
authors.initials: L
authors.lastname: Cabrera García
authors.affiliation: Servicio de Pediatría, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España.
authors.forename: M J
authors.initials: MJ
authors.lastname: Cilleruelo Ortega
authors.affiliation: Servicio de Pediatría, Hospital Carlos III, Hospital Universitario La Paz, Madrid, España; Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), España.
authors.forename: M J
authors.initials: MJ
authors.lastname: Mellado Peña
mesh_terms: D000328:Adult; D002648:Child; D003430:Cross-Sectional Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010372:Pediatrics; D013030:Spain; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: Children; Community surveys; Drug approval; Drug use; Encuestas comunitarias; Legislación de medicamentos; Niños; Off-label use; Uso de medicamentos; Uso off-label