Evidence map›Paper›PMID 21667125›Full record

ArticleEuropean journal of clinical pharmacology2011

Drug utilisation pattern and off-label use of medicines in Estonian neonatal units.

Jana Lass, Ruth Käär, Kaarin Jõgi, Heili Varendi, Tuuli Metsvaht, Irja Lutsar

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in European journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02545712 (Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
10.5field-weighted citation impact, top 2% of its field
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.

NCT02545712 unknown statusnot on this mapstarted 2016, after this paper: background citation

Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients

TypeobservationalSponsorBispebjerg HospitalRan2016Enrolled630ConditionsExcipient Exposure, Neonatal, PediatricArmsExposure to ethanol, Exposure to propylene glycol, Exposure to benzyl alcohol, Exposure to acesulfam potassium, Exposure to aspartame
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Article
  6. Review
  7. Article
  8. Review of Drug Utilization Studies in Neonatal Units: A Global Perspective.International journal of environmental research and public health · 2020
    Review
  9. Cross-sectional study of drug utilisation in a Chinese neonatal unit.The Journal of international medical research · 2020
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Magistral drugs in hospitalized newborns and children.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2016
    Article
  18. Article
  19. Article
  20. 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

6 authors at 3 institutions in 1 country.

Jana LassInstitute of Microbiology, Tartu University, Estonia. jana.lass@kliinikum.ee
Ruth Käär
Kaarin Jõgi
Heili Varendi
Tuuli Metsvaht
Irja Lutsar
University of Tartu · EETartu University Hospital · EETallinn Health Care College · EE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo characterise neonatal hospital drug use and to compare the availability of drug information between Estonian Summaries of Product Characteristics (SPCs) and other sources. STUDY

designThis was a prospective cohort study in which pharmacotherapy information on neonates admitted to Tartu University Clinics between 1 February and 1 August 2008 and to Tallinn Children's Hospital between 1 February and 1 August 2009 was collected. Drug labelling status was determined according to Estonian SPCs, and neonatal information was compared with the British National Formulary for Children (BNFC) and the Thomson Micromedex database.

resultsOf 490 hospitalised neonates, 71% received pharmacotherapy. Within the entire study period, there were 1981 prescriptions for 115 products, with a median of four (interquartile range 2-7) products per child. Antibacterial, cardiovascular and central nervous system drugs were the most commonly prescribed. All treated preterm neonates received at least one unlicensed or age-related off-label prescription. All prescriptions for alimentary, genitourinary, musculoskeletal and sensory system drugs were off-label. There were large differences in the neonatal information provided by the different sources, with the largest differences found for term neonates, for whom the information was available for 67, 38 and 24% of prescriptions according to the BNFC, Micromedex and Estonian SPC, respectively.

conclusionsThe high rate of age-related off-label prescribing for neonates calls for urgent action from medical professionals and others to reinforce effective and safe pharmacotherapy for this age group. The existing SPCs should be regularly updated and more closely harmonised to each other.

Indexed as

Drug LabelingDrug UtilizationEstoniaFemaleHospitals, PediatricHospitals, UniversityHumansInfant, NewbornIntensive Care Units, NeonatalMaleOff-Label Use

Identifiers

PMID21667125
OpenAlexW2019050521

What OpenQuestion holds

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Registered trials

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.