title: Off-label and unlicenced medicine administration to paediatric emergency department patients.
abstract: OBJECTIVE
  To determine the prevalence and nature of off-label and unlicenced (off-label/unlicenced) medicine administration to paediatric ED patients.
  
  
  METHODS
  We undertook a retrospective, observational study in six EDs (July 2011 to June 2012, inclusive). Patients, aged 0-17 years, who were administered a medicine in the ED were included. At each site, 50 eligible patients were randomly selected each month of the study period. An explicit review of each patient's records was undertaken. Medicines were classified as on or off-label/unlicenced according to categories of use approved by the Therapeutic Goods Administration.
  
  
  RESULTS
  There were 3343 patients enrolled (56.5% men, mean ± SD age 6.7 ± 5.4 years). Of the 6786 medicine doses administered, 2072 (30.5%, 95% CI 29.4-31.7%) were off-label/unlicenced. The off-label/unlicenced doses were administered to 1213 (36.3%, 95% CI 34.7-37.9%) patients. Patients administered an off-label/unlicenced medicine were younger than those who were not (P < 0.01). Salbutamol, ondansetron, ipratropium, fentanyl and oxycodone were the medicines most commonly administered off-label. In 910 (44.0%) cases, the dose/frequency was not approved; in 592 (28.6%), there was an unapproved indication for treatment; in 158 (7.6%), the medicine was administered via an unapproved route; in 154 (7.4%) the medicine was not approved for the weight or age; and in 74 (3.5%) an unlicenced product was administered. The remaining cases had combinations of reasons.
  
  
  CONCLUSIONS
  Off-label/unlicenced medicine administration is common. A registry of commonly used off-label medicines is recommended in which the safety and efficacy of their off-label use have been demonstrated by published evidence.
authors.affiliation: Emergency Department, Austin Hospital, Melbourne, Victoria, Australia.|Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: David
authors.initials: D
authors.lastname: McD Taylor
authors.affiliation: Royal Children's Hospital, Melbourne, Victoria, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Joffe
authors.affiliation: Pharmacy Department, Austin Hospital, Melbourne, Victoria, Australia.
authors.forename: Simone E
authors.initials: SE
authors.lastname: Taylor
authors.affiliation: Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
authors.forename: Alicia
authors.initials: A
authors.lastname: Jones
authors.affiliation: Royal Children's Hospital, Melbourne, Victoria, Australia.|Murdoch Children's Research Institute, Melbourne, Victoria, Australia.|Monash Emergency, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australia.|School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: John A
authors.initials: JA
authors.lastname: Cheek
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
authors.forename: Simon S
authors.initials: SS
authors.lastname: Craig
authors.affiliation: School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.|Monash Emergency, Dandenong Hospital, Melbourne, Victoria, Australia.
authors.forename: Andis
authors.initials: A
authors.lastname: Graudins
authors.affiliation: Emergency Department, Austin Hospital, Melbourne, Victoria, Australia.|Royal Children's Hospital, Melbourne, Victoria, Australia.
authors.forename: Reetika
authors.initials: R
authors.lastname: Dhir
authors.affiliation: Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.|Murdoch Children's Research Institute, Melbourne, Victoria, Australia.|Emergency Department, Sunshine Hospital, Melbourne, Victoria, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Krieser
authors.affiliation: Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia.|Royal Children's Hospital, Melbourne, Victoria, Australia.|Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
authors.forename: Franz E
authors.initials: FE
authors.lastname: Babl
mesh_terms: D000293:Adolescent; D001315:Australia; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D005260:Female; D006784:Hospitals, Teaching / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D056687:Off-Label Use / Q000706:statistics & numerical data*; D012189:Retrospective Studies
keywords: child; emergency department; medicine; off label; paediatric