title: Off-label and unlicensed utilisation of medicines in a French paediatric hospital.
abstract: BACKGROUND
  Off-label or unlicensed medicine use is very common in paediatric practice, ranging from 11 to 80 %, and is one of the predisposing factors for adverse events (23-60 %). Medicine indications are the third leading reason for doctors to perform off-label prescriptions.
  
  
  OBJECTIVE
  The aim of our study was to determine the prevalence and nature of off-label and unlicensed medicine prescriptions in children and propose methods for risk reduction and management.
  
  
  METHODS
  475 bed maternity-paediatric university hospital.
  
  
  METHODS
  Retrospective cross-sectional study lasting 1 day on new prescriptions issued over the previous 24 h by departments using electronic prescribing. Age and indication were compared to those in the French independent formulary Thériaque(®) database.
  
  
  METHODS
  Number of off-label/unlicensed prescriptions, number of patients, proportion of off-label/unlicensed prescriptions by age group, treatment class and International Non proprietary Name (INN), using the established classification.
  
  
  RESULTS
  A total of 315 prescription medicines were analysed for 120 patients, of average age 5.1 years old. For the classification of medicine utilisation, the majority of the medicines were prescribed as licensed (190/60.3 %), followed by off-label (115/36.5 %) and unlicensed (10/3.2 %) medicines. Alimentary tract, metabolic and nervous system medicines constituted the most widely prescribed ATC classes. At least 54 % of patients received an off-label/unlicensed medicine. The indications for these were mainly for off-label prescriptions (80/25.4 %) followed by medicines not evaluated for safety and regarding safety and efficacy in children (14/4.5 %). Pantoprazole was the most widely prescribed off-label INN for stress ulcer prevention (62 %). For risk reduction, we found esomeprazole being prescribed instead of pantoprazole; esomeprazole is indicated for children under a year old.
  
  
  CONCLUSIONS
  This study reflects one given day: 36.5 % of off-label prescriptions and 3.2 % of unlicensed prescriptions in a paediatric setting. Few risk reductions for off-label number prescriptions have been found. This work confirmed the necessity of carrying out further studies in children.
authors.affiliation: Département de Pharmacie, AP-HP, Hôpital Robert-Debré, 48 boulevard Sérurier, 75395, Paris Cedex 19, France.|Pharmacie Clinique, Sorbonne Paris Cité, Université Paris Descartes, Paris Cedex, France.
authors.forename: Perrine
authors.initials: P
authors.lastname: Joret-Descout
authors.affiliation: Département de Pharmacie, AP-HP, Hôpital Robert-Debré, 48 boulevard Sérurier, 75395, Paris Cedex 19, France. sonia.prot-labarthe@rdb.aphp.fr.|INSERM, ECEVE, U1123, Paris Cedex, France. sonia.prot-labarthe@rdb.aphp.fr.
authors.forename: Sonia
authors.initials: S
authors.lastname: Prot-Labarthe
authors.affiliation: Département de Pharmacie, AP-HP, Hôpital Robert-Debré, 48 boulevard Sérurier, 75395, Paris Cedex 19, France.|Pharmacie Clinique, Sorbonne Paris Cité, Université Paris Descartes, Paris Cedex, France.|Laboratoire Educations et Pratiques de Santé, EA 3412, Sorbonne Paris Cité, Université Paris 13, Bobigny, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Brion
authors.affiliation: Département de Pharmacie, AP-HP, Hôpital Robert-Debré, 48 boulevard Sérurier, 75395, Paris Cedex 19, France.|Pharmacie Clinique, Sorbonne Paris Cité, Université Paris Descartes, Paris Cedex, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Bataille
authors.affiliation: Coordonnateur de la gestion des risques associés aux soins- CLIN/CVRiS - Responsable du management de la qualité de la prise en charge médicamenteuse, Hôpital Robert-Debré, AP-HP, Paris Cedex, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Hartmann
authors.affiliation: Département de Pharmacie, AP-HP, Hôpital Robert-Debré, 48 boulevard Sérurier, 75395, Paris Cedex 19, France.|Pharmacie Clinique, Sorbonne Paris Cité, Université Paris Descartes, Paris Cedex, France.|Laboratoire Educations et Pratiques de Santé, EA 3412, Sorbonne Paris Cité, Université Paris 13, Bobigny, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Bourdon
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D055695:Electronic Prescribing / Q000706:statistics & numerical data; D005602:France; D006745:Hospital Bed Capacity, 300 to 499; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data*; D006785:Hospitals, University / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D015995:Prevalence; D012189:Retrospective Studies
keywords: Children; France; Indication; Off-label prescribing; Paediatrics; Risk management; Unlicensed prescribing