title: [Attitudes and experiences of off-label prescribing among paediatricians in a French university teaching hospital].
abstract: OBJECTIVE
  The lack of drugs specifically assessed for paediatric use results in a widespread off-label drug use. The aim of this work is to identify experiences and attitudes towards paediatrics off-label prescribing in a university teaching paediatric hospital.
  
  
  METHODS
  A questionnaire of 24 items was sent by email to 409 paediatricians in February 2013.
  
  
  METHODS
  frequency of off-label prescribing, sources of information, concern about safety and adverse events with off-label drug use, proportion of parents informed and order with "off-label" mention.
  
  
  RESULTS
  Eighty questionnaires were returned. Over 81% of responders were familiar with the concept of off-label drugs prescribing. The most common reason given for off-label prescribing was for a younger age (74%) and for another indication (28%). They (79%) used a colleague's opinion and the most important sources of information used were the literature (72%), international guidelines (62%), the French National Formulary Vidal (56%) and national guidelines (46%). Although 54% of responders expressed concerns about safety about off-label prescription, only 29% had observed adverse event with off-label drug use. Two third of respondents informed the parents but off-label prescribing cannot be always explained to family. Many respondents (81%) did not write "off-label" mention on prescription. However, 52% stated that they would be willing to undertake off-label prescription monitoring with a local observatory.
  
  
  CONCLUSIONS
  Our study describes the perceptions and attitudes of paediatrician's regarding off-label prescribing for children. Patient information and documentation in the patient file remain incomplete. The prospective collection of off-label prescription will locally be performed.
authors.affiliation: Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Joret-Descout
authors.affiliation: Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France.
authors.forename: J
authors.initials: J
authors.lastname: Bataille
authors.affiliation: Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France; Pharmacie clinique, université Paris Descartes, Sorbonne Paris-Cité, 4, avenue de l'Observatoire, 75006 Paris, France; Laboratoire éducations et pratiques de santé, EA 3412, université Paris 13, Sorbonne Paris-Cité, 74, rue Marcel-Cachin, 93017 Bobigny cedex, France.
authors.forename: F
authors.initials: F
authors.lastname: Brion
authors.affiliation: Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France; Pharmacie clinique, université Paris Descartes, Sorbonne Paris-Cité, 4, avenue de l'Observatoire, 75006 Paris, France; Laboratoire éducations et pratiques de santé, EA 3412, université Paris 13, Sorbonne Paris-Cité, 74, rue Marcel-Cachin, 93017 Bobigny cedex, France.
authors.forename: O
authors.initials: O
authors.lastname: Bourdon
authors.affiliation: CLIN/CVRiS (Infection Control Committee/Patient Safety and Risks Management Committee)-Hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France.
authors.forename: J-F
authors.initials: JF
authors.lastname: Hartmann
authors.affiliation: Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France; Inserm, U1123, ECEVE, Paris, France. Electronic address: sonia.prot-labarthe@aphp.fr.
authors.forename: S
authors.initials: S
authors.lastname: Prot-Labarthe
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D002648:Child; D011307:Drug Prescriptions; D005602:France; D006776:Hospitals, Pediatric; D006784:Hospitals, Teaching; D006801:Humans; D056687:Off-Label Use; D000072143:Pediatricians; D011795:Surveys and Questionnaires
keywords: Hors AMM; Indication; Off-label use; Paediatrics; Pédiatrie; Questionnaires; Unlabeled indication