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Title: Off-label and unlicenced medicine administration to paediatric emergency department patients.
Austin Authors: Taylor, David McD ;Joffe, Paul;Taylor, Simone E ;Jones, Alicia;Cheek, John A;Craig, Simon S;Graudins, Andis ;Dhir, Reetika;Krieser, David;Babl, Franz E
Affiliation: Monash Emergency, Dandenong Hospital, Melbourne, Victoria, Australia
Emergency Department, Sunshine Hospital, Melbourne, Victoria, Australia
Department of Emergency Medicine, Austin Health, Heidelberg, Victoria, Australia
Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
Royal Children's Hospital, Melbourne, Victoria, Australia
Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia
Murdoch Children's Research Institute, Melbourne, Victoria, Australia
School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia
Monash Emergency, Monash Medical Centre, Monash Health, Melbourne, Victoria, Australia
Issue Date: Oct-2015
Date: 2015-06-24
Publication information: Emergency Medicine Australasia : EMA 2015; 27(5): 440-6
Abstract: To 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.
DOI: 10.1111/1742-6723.12431
ORCID: 0000-0002-0592-518X
Journal: Emergency Medicine Australasia : EMA
PubMed URL: 26105103
Type: Journal Article
Subjects: child
emergency department
off label
Appears in Collections:Journal articles

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