ArticlePloS one2019
Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia.
Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Feasibility of a German High-Frequency Neonatal and Pediatric Intensive Care Dataset (AIx-Neo-Guard Dataset): Secondary Data Cohort Study.JMIR pediatrics and parenting · 2026Article
- Utilization of Child-Appropriate Medicines: Use of Pediatric Use Marketing Authorisation (PUMA) Products in Croatia.Journal of clinical medicine · 2025Article
- Acceptability and Palatability of Novel Orodispersible Minitablets of Enalapril in Children up to the Age of 6 with Heart Failure.Journal of clinical medicine · 2025Article
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study.Pharmacy (Basel, Switzerland) · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Efficacy of administrative intervention for neurosurgical patients with off-label use of alprostadil lipid microsphere.Scientific reports · 2022Article
- Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children.Paediatric and perinatal epidemiology · 2022Article
- Physiologically Based Pharmacokinetic Modeling of Meropenem in Preterm and Term Infants.Clinical pharmacokinetics · 2021Article
- Analysis of the potential inappropriate use of medications in pediatric outpatients in China.BMC health services research · 2021Article
- Application of natural language processing techniques to identify off-label drug usage from various online health communities.Journal of the American Medical Informatics Association : JAMIA · 2021Article
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.-Oct. 2014.PloS one · 2020Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the prevalence of off-label and unlicensed prescribing in inpatients at a major paediatric teaching hospital in Western Australia and to identify which drugs are commonly prescribed off-label or unlicensed, including factors influencing such prescribing.
methodsA retrospective cross-sectional study was conducted in June, 2013. Patient and prescribing data were collected from 190 inpatient medication chart records which had been randomly selected from all admissions during the second week of February 2013. Drugs were categorised as licensed, off-label or unlicensed, according to their approved Australian registration product information (PI). All drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code.
resultsThere were 120 male and 70 female inpatients. The average age was 6.0 years (± 4.7). The study included 1160 prescribed drugs suitable for analysis. The number of drugs prescribed per patient ranged from 1 to 25 with an average of 6.1 (± 4.3). More than half (54%) were prescribed off-label. Oxycodone, clonidine, parecoxib and midazolam were always prescribed off-label. The most common off-label drugs were ondansetron (18.5%), fentanyl (12.9%), oxycodone (8.8%) and paracetamol (6.1%). Many ATC classifications included high off-label proportions especially the genitourinary system and sex hormones, respiratory system drugs, systemic hormonal preparations and alimentary tract and metabolism drugs.
conclusionsThis study highlights that prescribing of paediatric drugs needs to be better supported by existing and new evidence. Incentives should be established to foster the conduct of evidence-based studies in the paediatric population. The current level of off-label prescribing raises issues of unexpected toxicity and adverse drug effects in children that are in some cases severely ill.
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