Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children

Andrea L Schaffer; Claudia Bruno; Nicholas A Buckley; Rose Cairns; Melisa Litchfield; Simon Paget; Helga Zoega; Natasha Nassar; Sallie-Anne Pearson

doi:10.1111/ppe.12870

Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children

Paediatr Perinat Epidemiol. 2022 Sep;36(5):726-737. doi: 10.1111/ppe.12870. Epub 2022 Feb 16.

Authors

Andrea L Schaffer¹, Claudia Bruno¹, Nicholas A Buckley^{2

3}, Rose Cairns^{3

4}, Melisa Litchfield¹, Simon Paget⁵, Helga Zoega^{1

6}, Natasha Nassar^{5

7}, Sallie-Anne Pearson^{1

7}

Affiliations

¹ Centre for Big Data Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.
² Biomedical Informatics and Digital Health, The University of Sydney, Sydney, New South Wales, Australia.
³ NSW Poisons Information Centre, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
⁴ Faculty of Pharmacy, The University of Sydney, Sydney, New South Wales, Australia.
⁵ The Children's Hospital at Westmead Clinical School, The University of Sydney, Sydney, New South Wales, Australia.
⁶ Centre of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
⁷ Menzies Centre for Health Policy, The University of Sydney, Sydney, New South Wales, Australia.

Abstract

Background: Medicine prescribing for children is impacted by a lack of paediatric-specific dosing, efficacy and safety data for many medicines.

Objectives: To estimate the prevalence of medicine use among children and the rate of 'off-label' prescribing according to age at dispensing.

Methods: We used population-wide primarily outpatient dispensing claims data for 15% of Australian children (0-17 years), 2013-2017 (n = 840,190). We estimated prescribed medicine use and 'off-label' medicine use according to the child's age (<1 year, 1-5 years, 6-11 years, 12-17 years) defined as medicines without age-appropriate dose recommendations in regulator-approved product information. Within off-label medicines, we also identified medicines with and without age-specific dose recommendations in a national prescribing guide, the Australian Medicines Handbook Children's Dosing Companion (AMH CDC).

Results: The overall dispensing rate was 2.0 dispensings per child per year. The medicines with the highest average yearly prevalence were systemic antibiotics (435.3 per 1000 children), greatest in children 1-5 years (546.9 per 1000). Other common medicine classes were systemic corticosteroids (92.7 per 1000), respiratory medicines (91.2 per 1000), acid-suppressing medicines in children <1 year (47.2 per 1000), antidepressants in children 12-17 years (40.3 per 1000) and psychostimulants in children 6-11 years (27.0 per 1000). We identified 12.2% of dispensings as off-label based on age, but 66.3% of these had age-specific dosing recommendations in the AMH CDC. Among children <1 year, off-label dispensings were commonly acid-suppressing medicines (35.5%) and topical hydrocortisone (33.1%); in children 6-11 years, off-label prescribing of clonidine (16.0%) and risperidone (13.1%) was common. Off-label dispensings were more likely to be prescribed by a specialist (21.7%) than on-label dispensings (7.5%).

Conclusions: Prescribed medicine use is common in children, with off-label dispensings for medicines without paediatric-specific dosing guidelines concentrated in classes such as acid-suppressing medicines and psychotropics. Our findings highlight a need for better evidence to support best-practice prescribing.

Keywords: Australia; attention deficit disorder with hyperactivity; gastroesophageal reflux; paediatrics; pharmacoepidemiology.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Anti-Bacterial Agents*
Australia / epidemiology
Child
Humans
Infant
Off-Label Use*
Practice Patterns, Physicians'
Prevalence

Substances

Anti-Bacterial Agents