ArticlePaediatrics & child health2016
Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital.
Article in Paediatrics & child health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Improving Medication Safety Through Medication Reconciliation in Pediatric Neurology: Clinical Pharmacist Recommendations and Physician Uptake in a 13-Week Study.Children (Basel, Switzerland) · 2025Article
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval.BMC pediatrics · 2022Observational
- Supporting patients with unlicensed medicine use: Analysing the script schemas for prescribing, pharmaceutical assessment and supply.Exploratory research in clinical and social pharmacy · 2021Article
- Assessing a Mass-Based Method for the Preparation of Low-Dosed Paediatric Capsules with Baclofen and Spironolactone.Pharmacy (Basel, Switzerland) · 2021Article
- The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.Therapeutic innovation & regulatory science · 2020Article
- Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review.Paediatric drugs · 2019Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Medication Safety-A Global Health Priority.The Canadian journal of hospital pharmacyArticle
- Article
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess unlicensed and off-label drug use in a tertiary care paediatric hospital in Canada on a single day.
methodsA cross-sectional study in a tertiary care paediatric hospital was conducted on one randomly selected day. Active prescriptions for children <18 years of age were analyzed. Unlicensed drug use was defined as the use of nonmarketed drugs in Canada or marketed drugs with pharmacy compounding. Off-label drug use was defined as the use of marketed drugs in Canada for an unapproved age group, indication, dosing, frequency and/or route of administration. Off-label drug uses associated with strong scientific support were analyzed using the Pediatric Dosage Handbook, 14th edition and Micromedex(®) Solutions. Number and proportion of unlicensed and off-label drug uses, and off-label drug uses associated with strong scientific support were measured.
resultsA total of 2145 drug prescriptions were extracted on March 5, 2014, for inclusion in the present study. The unlicensed drug use rate was 8.3% (57 unlicensed drug products; 75 nonmarketed drug prescriptions and 103 pharmacy compounding prescriptions) and the off-label drug use rate was 38.2% (161 substances; 819 prescriptions). Reasons for off-label drug use included unapproved age group (n=436 [53.2%]), dosing (n=226 [27.6%]), frequency (n=206 [25.2%]), indication (n=45 [5.5%]) and administration route (n=46 [5.6%]). Of the off-label drug prescriptions, 39.3% (n=322) were associated with strong scientific support.
conclusionsOn a randomly selected day, 8.3% of prescriptions were unlicensed and 38.2% were off-label for children hospitalized at the authors' institution. Of off-label prescriptions, only 39.3% were associated with strong scientific support.
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