Please use this identifier to cite or link to this item:
Full metadata record
DC FieldValueLanguage
dc.contributor.authorTaylor, David McD-
dc.contributor.authorJoffe, Paul-
dc.contributor.authorTaylor, Simone E-
dc.contributor.authorJones, Alicia-
dc.contributor.authorCheek, John A-
dc.contributor.authorCraig, Simon S-
dc.contributor.authorGraudins, Andis-
dc.contributor.authorDhir, Reetika-
dc.contributor.authorKrieser, David-
dc.contributor.authorBabl, Franz E-
dc.identifier.citationEmergency medicine Australasia : EMA 2015; 27(5): 440-6-
dc.description.abstractTo determine the prevalence and nature of off-label and unlicenced (off-label/unlicenced) medicine administration to paediatric ED patients. 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. 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. 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.-
dc.subjectemergency department-
dc.subjectoff label-
dc.titleOff-label and unlicenced medicine administration to paediatric emergency department patients.-
dc.typeJournal Article-
dc.typeObservational Study-
dc.identifier.journaltitleEmergency medicine Australasia : EMA-
dc.identifier.affiliationMonash Emergency, Dandenong Hospital, Melbourne, Victoria, Australiaen
dc.identifier.affiliationEmergency Department, Sunshine Hospital, Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Emergency Medicine, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationDepartment of Medicine, The University of Melbourne, Melbourne, Victoria, Australiaen
dc.identifier.affiliationRoyal Children's Hospital, Melbourne, Victoria, Australiaen
dc.identifier.affiliationPharmacy Department, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationMurdoch Children's Research Institute, Melbourne, Victoria, Australiaen
dc.identifier.affiliationSchool of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australiaen
dc.identifier.affiliationMonash Emergency, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australiaen
Appears in Collections:Journal articles

Files in This Item:
There are no files associated with this item.

Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.