ArticleThe Journal of pharmacy and pharmacology2017
Off-label and unlicensed medicines to hospitalised children in Norway.
Article in The Journal of pharmacy and pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed.
- Off-Label Manipulation of Paediatric Medication Remains a Challenge in Clinical Practice: An Observational Study.Acta paediatrica (Oslo, Norway : 1992) · 2026Observational
- A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications.Current pediatric reviews · 2026Article
- Challenges and Considerations in Manipulating Oral Dosage Forms in Paediatric Healthcare Settings: A Narrative Review.Acta paediatrica (Oslo, Norway : 1992) · 2025Review
- Off-label use of psychotropic drugs in youth.BMC psychiatry · 2025Article
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Use of antimicrobials in pediatric wards of five Brazilian hospitals.BMC pediatrics · 2024Observational
- Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data.Healthcare (Basel, Switzerland) · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- Evaluation of off-label medication use and drug safety in a pediatric intensive care unit.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children.Paediatric and perinatal epidemiology · 2022Article
- Gaps in Accessibility of Pediatric Formulations: A Cross-Sectional Observational Study of a Teaching Hospital in Northern Thailand.Children (Basel, Switzerland) · 2022Article
- Manipulations of Oral Medications in Paediatric Neurology and Oncology Care at a Swedish University Hospital: Health Professionals' Attitudes and Sources of Information.Pharmaceutics · 2021Article
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- Adjusting the dose in paediatric care: dispersing four different aspirin tablets and taking a proportion.European journal of hospital pharmacy : science and practice · 2021Article
- Adjusting the dose in paediatric care by dispersing fragments of four different aspirin tablets.Acta paediatrica (Oslo, Norway : 1992) · 2020Article
- Drug Utilisation and Off-Label Use on a German Neonatal Intensive Care Unit: A Retrospective Cohort Study and 10-Year Comparison.Pharmacy (Basel, Switzerland) · 2020Article
- Analysis of Reporting Adverse Drug Reactions in Paediatric Patients in a University Hospital in the Netherlands.Paediatric drugs · 2020Article
- Comparing Two Methods of Tablet Manipulation to Adjust the Warfarin Dose in Paediatric Care.Pharmaceutics · 2020Article
- Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran.BMC pediatrics · 2019Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of this study was to investigate the use of off-label (OL) and unlicensed (UL) medicines to hospitalised children in Norway, to add to the current knowledge on use of medicines in this vulnerable patient group.
methodsThe study was performed as a cross-sectional prospective study. Medication was classified as on- or off-label based on the comparison with the SmPC regarding age, indication, dosage, route of administration and handling of the product. UL products were classified as imported or pharmacy produced. KEY
findingsMore than 90% of children receiving medicines in our study were given OL or UL medicines. More patients received OL (83%) than UL (59%). Route of administration was the most frequently observed OL category. The vast majority of the OL prescriptions were for 'off-patent' products. One-third of products prescribed were UL.
conclusionsThe study confirms that medicines to children in hospital to a significant degree are being used outside or without authorisation, in spite of recent paediatric regulatory initiatives. More data are still needed on efficacy and safety of medicines used in children, data to be incorporated in the SmPC. In addition, suitable formulations are needed to ensure optimal dosing and adherence without risky manipulations.
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