ArticleActa paediatrica (Oslo, Norway : 1992)2012
Paediatric drug use with focus on off-label prescriptions at Swedish hospitals - a nationwide study.
Article in Acta paediatrica (Oslo, Norway : 1992), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Guideline for the management of pediatric off-label use of drugs in China (2021).BMC pediatrics · 2022Guideline
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- In situ coating makes it easier for children to swallow and tolerate tablets and capsules.Acta paediatrica (Oslo, Norway : 1992) · 2015Trial
- 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
- The Swedish National Formulary for Children ePed. Comment on Shaniv et al. A Callout for International Collaboration. Reply to Giger, E.V.; Tilen, R. Comment on "Shaniv et al. Neonatal Drug Formularies-A Global Scope.Children (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
- Potential Drug-Related Problems in Pediatric Patients-Describing the Use of a Clinical Decision Support System at Pharmacies in Sweden.Pharmacy (Basel, Switzerland) · 2023Article
- Why children have to wait years for new drugs.Nature · 2022Article
- Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study.Hospital pharmacy · 2021Article
- 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
- Evidence of support used for drug treatments in pediatric cardiology.Health science reports · 2021Article
- "Include me if you can"-reasons for low enrollment of pediatric patients in a psychopharmacological trial.Trials · 2021Article
- Adjusting the dose in paediatric care: dispersing four different aspirin tablets and taking a proportion.European journal of hospital pharmacy : science and practice · 2021Article
- A Focus Group Study about Oral Drug Administration Practices at Hospital Wards-Aspects to Consider in Drug Development of Age-Appropriate Formulations for Children.Pharmaceutics · 2020Article
- New Strategies for the Conduct of Clinical Trials in Pediatric Pulmonary Arterial Hypertension: Outcome of a Multistakeholder Meeting With Patients, Academia, Industry, and Regulators, Held at the European Medicines Agency on Monday, June 12, 2017.Journal of the American Heart Association · 2019Article
- Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.British journal of clinical pharmacology · 2019Article
- Paediatric extrapolation: A necessary paradigm shift.British journal of clinical pharmacology · 2019Review
- Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo perform a nationwide investigation of paediatric drug use at Swedish hospitals, including an analysis of off-label drug use.
methodsAll paediatric hospitals in Sweden were invited to register all prescriptions to children, aged between 0 and 18, during two separate 2-day-periods in 2008. Data were reported and analysed with respect to licence status and proportion of and reasons for off-label drug use.
resultsData on 11,294 prescriptions to 2947 paediatric patients were received. Drugs associated with pain relief, infection, prematurity, nutrition and surgery or anaesthesia were most commonly used. Paracetamol was the most frequently used drug on-label and also among the most commonly used off-label drugs. Nearly half (49%) of all administered prescriptions concerned unlicensed drugs, off-label drugs or extemporaneously prepared drugs. The corresponding rate among neonates was 69%. Lack of paediatric information in the Summary of Product Characteristics was the main reason for off-label classification.
conclusionsPaediatric off-label drug use is common at Swedish hospitals, and nearly half of all prescriptions were not documented for use in children. The findings emphasize a need for paediatric clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in infants and neonates.
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