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

Andrea L. Schaffer^*, Claudia Bruno, Nicholas A. Buckley, Rose Cairns, Melisa Litchfield, Simon Paget, Helga Zoega, Natasha Nassar, Sallie Anne Pearson

^*Corresponding author for this work

Faculty of Medicine

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

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.

Original language	English
Pages (from-to)	726-737
Number of pages	12
Journal	Paediatric and Perinatal Epidemiology
Volume	36
Issue number	5
DOIs	https://doi.org/10.1111/ppe.12870
Publication status	Published - 16 Feb 2022

Bibliographical note

Funding Information:
This research is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (ID: 1196900). AS is supported by an NHMRC Early Career Fellowship (ID: 1158763). RC is supported by an NHMRC Emerging Leadership Investigator Grant (ID: 1196516). HZ is supported by a UNSW Scientia Fellowship. NN is supported by the Financial Markets Foundation for Children. CB is supported by an Australian Government Research Training Program Scholarship We thank the Australian Government Services Australia, for providing the data. Open access publishing facilitated by University of New South Wales, as part of the Wiley - University of New South Wales agreement via the Council of Australian University Librarians.

Funding Information:
This research is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (ID: 1196900). AS is supported by an NHMRC Early Career Fellowship (ID: 1158763). RC is supported by an NHMRC Emerging Leadership Investigator Grant (ID: 1196516). HZ is supported by a UNSW Scientia Fellowship. NN is supported by the Financial Markets Foundation for Children. CB is supported by an Australian Government Research Training Program Scholarship

Publisher Copyright:
© 2022 The Authors. Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.

Other keywords

attention deficit disorder with hyperactivity
Australia
gastroesophageal reflux
paediatrics
pharmacoepidemiology
Off-Label Use
Prevalence
Humans
Australia/epidemiology
Infant
Practice Patterns, Physicians'
Anti-Bacterial Agents
Child

Access to Document

10.1111/ppe.12870

Paediatric Perinatal Epid - 2022 - Schaffer - Prescribed medicine use and extent of off‐label use according to age in aFinal published version, 839 KBLicence: CC BY

Cite this

@article{a5ff07159d9745f994e20ae31985bae6,

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

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 = "attention deficit disorder with hyperactivity, Australia, gastroesophageal reflux, paediatrics, pharmacoepidemiology, Off-Label Use, Prevalence, Humans, Australia/epidemiology, Infant, Practice Patterns, Physicians', Anti-Bacterial Agents, Child",

author = "Schaffer, {Andrea L.} and Claudia Bruno and Buckley, {Nicholas A.} and Rose Cairns and Melisa Litchfield and Simon Paget and Helga Zoega and Natasha Nassar and Pearson, {Sallie Anne}",

note = "Funding Information: This research is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (ID: 1196900). AS is supported by an NHMRC Early Career Fellowship (ID: 1158763). RC is supported by an NHMRC Emerging Leadership Investigator Grant (ID: 1196516). HZ is supported by a UNSW Scientia Fellowship. NN is supported by the Financial Markets Foundation for Children. CB is supported by an Australian Government Research Training Program Scholarship We thank the Australian Government Services Australia, for providing the data. Open access publishing facilitated by University of New South Wales, as part of the Wiley - University of New South Wales agreement via the Council of Australian University Librarians. Funding Information: This research is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (ID: 1196900). AS is supported by an NHMRC Early Career Fellowship (ID: 1158763). RC is supported by an NHMRC Emerging Leadership Investigator Grant (ID: 1196516). HZ is supported by a UNSW Scientia Fellowship. NN is supported by the Financial Markets Foundation for Children. CB is supported by an Australian Government Research Training Program Scholarship Publisher Copyright: {\textcopyright} 2022 The Authors. Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.",

year = "2022",

month = feb,

day = "16",

doi = "10.1111/ppe.12870",

language = "English",

volume = "36",

pages = "726--737",

journal = "Paediatric and Perinatal Epidemiology",

issn = "0269-5022",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "5",

}

TY - JOUR

T1 - Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children

AU - Schaffer, Andrea L.

AU - Bruno, Claudia

AU - Buckley, Nicholas A.

AU - Cairns, Rose

AU - Litchfield, Melisa

AU - Paget, Simon

AU - Zoega, Helga

AU - Nassar, Natasha

AU - Pearson, Sallie Anne

N1 - Funding Information: This research is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (ID: 1196900). AS is supported by an NHMRC Early Career Fellowship (ID: 1158763). RC is supported by an NHMRC Emerging Leadership Investigator Grant (ID: 1196516). HZ is supported by a UNSW Scientia Fellowship. NN is supported by the Financial Markets Foundation for Children. CB is supported by an Australian Government Research Training Program Scholarship We thank the Australian Government Services Australia, for providing the data. Open access publishing facilitated by University of New South Wales, as part of the Wiley - University of New South Wales agreement via the Council of Australian University Librarians. Funding Information: This research is supported by the National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Medicines Intelligence (ID: 1196900). AS is supported by an NHMRC Early Career Fellowship (ID: 1158763). RC is supported by an NHMRC Emerging Leadership Investigator Grant (ID: 1196516). HZ is supported by a UNSW Scientia Fellowship. NN is supported by the Financial Markets Foundation for Children. CB is supported by an Australian Government Research Training Program Scholarship Publisher Copyright: © 2022 The Authors. Paediatric and Perinatal Epidemiology published by John Wiley & Sons Ltd.

PY - 2022/2/16

Y1 - 2022/2/16

N2 - 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.

AB - 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.

KW - attention deficit disorder with hyperactivity

KW - Australia

KW - gastroesophageal reflux

KW - paediatrics

KW - pharmacoepidemiology

KW - Off-Label Use

KW - Prevalence

KW - Humans

KW - Australia/epidemiology

KW - Infant

KW - Practice Patterns, Physicians'

KW - Anti-Bacterial Agents

KW - Child

UR - http://www.scopus.com/inward/record.url?scp=85124723330&partnerID=8YFLogxK

U2 - 10.1111/ppe.12870

DO - 10.1111/ppe.12870

M3 - Article

C2 - 35172017

AN - SCOPUS:85124723330

SN - 0269-5022

VL - 36

SP - 726

EP - 737

JO - Paediatric and Perinatal Epidemiology

JF - Paediatric and Perinatal Epidemiology

IS - 5

ER -

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

Abstract

Bibliographical note

Other keywords

Access to Document

Fingerprint

Cite this