Evidence map›Paper›PMID 24862557›Full record

ArticleBritish journal of clinical pharmacology2015

Adverse drug reactions in neonates and infants: a population-tailored approach is needed.

Karel Allegaert, Johannes N van den Anker

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
7.1field-weighted citation impact, top 4% 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.

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

26 citing papers in PubMed, 57 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Observational
  9. Comparison of Dosing Accuracy Between the ENFit LDT and a Neonatal-Specific ISO-Compliant Enteral Syringe.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  10. Article
  11. Perioperative Care Structures and Non-Routine Events: Network Analysis.Studies in health technology and informatics · 2022
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Observational
  17. Observational
  18. Paediatric extrapolation: A necessary paradigm shift.British journal of clinical pharmacology · 2019
    Review
  19. Review
  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

2 authors at 2 institutions in 4 countries.

Karel AllegaertNeonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.
Johannes N van den AnkerDivision of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA.
Children's National · USKU Leuven · BE

Funding

Preclinical dosing optimization: Dosing schedule, tissueU54HD071601 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI JOSE, PEDRO A. · 2011 to 2015
$4.0M
Optimizing the Use of Morphine in Preterm InfantsR01HD048689 · NICHD · CHILDREN'S NATIONAL MEDICAL CENTER · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2005 to 2009
$1.5M
Optimizing the Use of Methadone in Newborn InfantsK24DA027992 · NIDA · CHILDREN'S RESEARCH INSTITUTE · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2010 to 2014
$878k
NICHD NIH HHS R01HD048689NICHD NIH HHS U54HD071601NIDA NIH HHS K24DA027992
6 · The paper itself

Abstract

Drug therapy is a powerful tool to improve outcome, but there is an urgent need to improve pharmacotherapy in neonates through tailored prevention and management of adverse drug reactions (ADRs). At present, infants commonly receive off-label drugs, at dosages extrapolated from those in children or adults. Besides the lack of labelling, inappropriate formulations, (poly)pharmacy, immature organ function and multiple illnesses further raise the risk for ADRs in neonates and infants. Pharmacovigilance to improve the prevention and management of ADRs needs to be tailored to neonates and infants. We illustrate this using prevention strategies for drug prescription and administration errors (e.g. formulation, bedside manipulation, access), detection through laboratory signalling or clinical outlier data (e.g. reference laboratory values, overall high morbidity), assessment through algorithm scoring (e.g. Naranjo or population specific), as well as understanding of the developmental toxicology (e.g. covariates, developmental pharmacology) to avoid re-occurrence and for development of guidelines. Such tailored strategies need collaborative initiatives to combine the knowledge and expertise of different disciplines, but hold promise to become a very effective tool to improve pharmacotherapy and reduce ADRs in infants.

Indexed as

AlgorithmsPharmacovigilanceDrug-Related Side Effects and Adverse ReactionsHumansInfantInfant, NewbornRisk Factorsadverse drug reactiondevelopmental pharmacologyinfantnewbornpharmacovigilance

Identifiers

PMID24862557
PMCPMC4594721
OpenAlexW1576549357

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.