University of Tasmania

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Off-label use of medicines in paediatric inpatients at an Australian teaching Hospital

journal contribution
posted on 2023-05-17, 16:06 authored by Ballard, CDJ, Gregory PetersonGregory Peterson, Angus ThompsonAngus Thompson, Sean BeggsSean Beggs

Aim: The study aims to investigate the prevalence of off-label prescribing in the general paediatric ward at a major teaching hospital in Tasmania, Australia.

Method: The drug charts and medical records from two groups of 150 consecutive paediatric patients, admitted 6 months apart in July 2009 and January 2010, were studied retrospectively. Patients were required to spend at least one night in hospital and be aged less than 12 years. Each prescribed drug was compared with the approved product information to determine if the usage was off-label. Data concerning documented informed consent and adverse drug reactions were also recorded.

Results: Three hundred patients were prescribed a total of 887 medicines. Of these, 31.8% were off-label and 57.3% of children received an off-label medication. There was no significant seasonal variation in patient characteristics or prescriptions. Drugs were most commonly off-label due to their dosage or frequency of administration. Of the 106 different drugs used, the use of 51 was off-label on at least one occasion, and for 30 drugs their use was off-label on more than 75% of occasions. The drugs most commonly used off-label were oxycodone, salbutamol and paracetamol. No informed consent documentationwas identified, and two of five recorded adverse drug reactionswere associated with off-label drug use.

Conclusion: Off-label use of medicines occurred frequently in paediatric inpatients. The available evidence often supported off-label medication use. An improved system for the revision of approved drug information and an Australian guideline for paediatric prescribing are needed.


Publication title

Journal of Paediatrics and Child Health








School of Pharmacy and Pharmacology


Blackwell Publishing Asia

Place of publication

54 University St, P O Box 378, Carlton, Australia, Victoria, 3053

Rights statement

Copyright 2012 The Authors Journal of Paediatrics and Child Health copyright 2012 Paediatrics and Child Health Division (Royal Australasian College of Physicians)

Repository Status

  • Restricted

Socio-economic Objectives

Neonatal and child health

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