Evidence map›Paper›PMID 21453298›Full record

ArticleBritish journal of clinical pharmacology2011

Licensing and labelling of drugs in a paediatric oncology ward.

Henk van den Berg, Nanda Tak

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Off-label and unlicensed medicines to hospitalised children in Norway.The Journal of pharmacy and pharmacology · 2017
    Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Henk van den BergDepartment of Paediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam Medicines Evaluation Board, The Hague, The Netherlands. h.vandenberg@amc.uva.nl
Nanda Tak

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimPaediatric drug prescriptions are known for their high percentages of off-label and unlicensed use. In paediatric oncology data available are scarce. The aim of this paper is an analysis of the licensing and labelling status of all prescribed medication over a 2 week period in a Dutch paediatric oncology centre.

methodsAn analysis of the delivery of medication by the hospital pharmacy to patients admitted to the paediatric oncology centre was carried out.

resultsIn total 268 precriptions were filed for 39 patients. In 87% of children unlicensed medication was used. Fifty-nine per cent of the children received at least two unlicensed drugs. In total 72% of the drugs were used licensed and on-label was found in 57% of the prescriptions. There was a trend that in younger children percentages were lower. International and local guidelines necessitated in many cases unlicensed use, e.g. intrathecal prednisolone, low dose medication such as heparin, ethanol and vancomycin for locking intravenous devices and higher intravenous vancomycin dosages. There were no major differences with respect to type of malignancy.

conclusionOur figures are substantially higher than the figures reported from adult oncology. Comparison with other paediatric reports are cumbersome, due to different percentages of diseases in the reports and other rules to dispense medication in the outpatient setting. Our data are in line with reports mentioning the higher percentages of unlicensed and off-label use. Our data further underpin the need for more research on suitable formulations, dosages, safety and efficacy in these children.

Indexed as

AdolescentAge FactorsAntineoplastic AgentsChildChild, PreschoolDrug ApprovalDrug LabelingDrug PrescriptionsHospitalsHumansInfantLegislation, DrugMedical OncologyNetherlandsOff-Label UsePediatricsAntineoplastic AgentsPharmaceutical Preparations

Identifiers

PMID21453298
PMCPMC3175517

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.