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


Ballard, CDJ and Peterson, GM and Thompson, AJ and Beggs, SA, Off-label use of medicines in paediatric inpatients at an Australian teaching Hospital, Journal of Paediatrics and Child Health, 49, (1) pp. 38-42. ISSN 1034-4810 (2013) [Refereed Article]

Copyright Statement

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

DOI: doi:10.1111/jpc.12065


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.

Item Details

Item Type:Refereed Article
Keywords:general paediatrics, pharmacology, quality use of medicine
Research Division:Biomedical and Clinical Sciences
Research Group:Pharmacology and pharmaceutical sciences
Research Field:Clinical pharmacology and therapeutics
Objective Division:Health
Objective Group:Specific population health (excl. Indigenous health)
Objective Field:Neonatal and child health
UTAS Author:Ballard, CDJ (Mr Christopher Ballard)
UTAS Author:Peterson, GM (Professor Gregory Peterson)
UTAS Author:Thompson, AJ (Mr Angus Thompson)
UTAS Author:Beggs, SA (Dr Sean Beggs)
ID Code:82850
Year Published:2013
Web of Science® Times Cited:27
Deposited By:Pharmacy
Deposited On:2013-02-20
Last Modified:2014-05-13

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