• Emerg Med Australas · Oct 2015

    Observational Study

    Off-label and unlicenced medicine administration to paediatric emergency department patients.

    • McD TaylorDavidDEmergency Department, Austin Hospital, Melbourne, Victoria, Australia.Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia., Paul Joffe, Simone E Taylor, Alicia Jones, John A Cheek, Simon S Craig, Andis Graudins, Reetika Dhir, David Krieser, and Franz E Babl.
    • Emergency Department, Austin Hospital, Melbourne, Victoria, Australia.
    • Emerg Med Australas. 2015 Oct 1; 27 (5): 440-6.

    ObjectiveTo determine the prevalence and nature of off-label and unlicenced (off-label/unlicenced) medicine administration to paediatric ED patients.MethodsWe 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.ResultsThere 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.ConclusionsOff-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.© 2015 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

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