ArticleEuropean journal of clinical pharmacology2014
The impact of legislation on drug substances used off-label in paediatric wards--a nationwide study.
Article in European journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 17 citations in OpenAlex.
- New Information on Old Medicinal Products: A Cross-Sectional Analysis of Guidance for Paediatric Use for Substances on the European Priority List of Off-Patent Medicinal Products.Paediatric drugs · 2022Article
- Development of one paediatric and one neonatal formulary list in hospital settings.British journal of clinical pharmacology · 2018Article
- Pattern of drug use among preterm neonates: results from an Italian neonatal intensive care unit.Italian journal of pediatrics · 2017Article
- How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians.The Journal of pharmacy and pharmacology · 2017Review
- Off-label prescribing of psychotropic drugs in a Danish child and adolescent psychiatric outpatient clinic.European child & adolescent psychiatry · 2016Article
- Development of a consensus-base list of criteria for prescribing medication in a pediatric population.International journal of clinical pharmacy · 2015Article
- Drug-induced renal damage in preterm neonates: state of the art and methods for early detection.Drug safety · 2015Review
- Use of administrative hospital database to identify adverse drug reactions in a Pediatric University Hospital.European journal of clinical pharmacology · 2014Article
- The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans.Paediatric drugs · 2014Article
- Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center: A Register-Based Study.Journal of research in pharmacy practiceArticle
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis nationwide study is aimed at describing to what extent the European Paediatric Regulation has met therapeutic needs in children.
methodsData for each drug substance in defined daily doses (DDD) were extracted from the national Danish data base. We evaluated if drug substances were used off-label and whether they had a paediatric investigation plan (PIP). This study did not include drug prescriptions for individual paediatric patients; thus, it was not possible to make use of all off-label categories previously used. Additionally, paediatric standard assortments (SA) were compared to the European survey on paediatric medicinal products.
resultsThirteen percent of the 100 most used drug substances were determined as being used off-label, four of which had a PIP and one had a full waiver. Only one of the three drug substances used off-label most often, accounting for 85 % of such use, had a PIP. Neonates were included in one-third of PIPs and adolescents in 15. Nineteen out of 21 PIPs had a waiver and 14 PIPs were deferred. In line with the European survey, carbapenems, corticosteroids and proton pump inhibitors were frequent found in SAs.
conclusionPIPs only cover a small proportion of the drugs found to be used off-label in this study. Despite waivers granted, drug substances were used nonetheless. Unmet regulatory needs are still considerable in some therapeutic areas in neonates as well as in children.
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