Evidence map›Paper›PMID 29661234›Full record

ArticleBMC pharmacology & toxicology2018

Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study.

Niccolò Lombardi, Giada Crescioli, Alessandra Bettiol, Ettore Marconi, Antonio Vitiello, Roberto Bonaiuti, Anna Maria Calvani, Stefano Masi, Ersilia Lucenteforte, Alessandro Mugelli and 2 more

Abstract read
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In one paragraph

Article in BMC pharmacology & toxicology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing 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

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

  1. The epidemiology of drug-related hospital admissions in paediatrics - a systematic review.Archives of public health = Archives belges de sante publique · 2024
    Pooled it
  2. Estimating cost savings from reducing antibiotic overprescription in european general practices.The European journal of health economics : HEPAC : health economics in prevention and care · 2026
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  9. The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022
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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

12 authors.

Niccolò LombardiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy. niccolo.lombardi@unifi.it.
Giada CrescioliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Alessandra BettiolDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Ettore MarconiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Antonio VitielloDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Roberto BonaiutiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Anna Maria CalvaniDepartment of Pharmacy, Anna Meyer Children's University Hospital, viale G. Pieraccini, 24, 50139, Florence, Italy.
Stefano MasiDepartment of Emergency Medicine, Anna Meyer Children's University Hospital, viale G. Pieraccini, 24, 50139, Florence, Italy.
Ersilia LucenteforteDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Alessandro MugelliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Lisa GiovannelliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.
Alfredo VannacciDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, viale G. Pieraccini, 6, 50139, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo describe frequency, preventability and seriousness of adverse drug reactions (ADRs) in children as cause of emergency department (ED) admission and to evaluate the association between specific factors and the reporting of ADRs.

methodsA retrospective analysis based on reports of suspected ADRs collected between January 1st, 2012 and December 31st, 2016 in the ED of Meyer Children's Hospital (Italy). Demographics, clinical status, suspected drugs, ADR description, and its degree of seriousness were collected. Logistic regression was used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of potential predictors of ADR seriousness.

resultsWithin 5 years, we observed 834 ADRs (1100 drug-ADR pairs), of whom 239 were serious; of them, 224 led to hospitalization. Patients were mostly treated with one drug. Among patients treated with more than one drug, 78 ADRs presented a potential interaction. The most frequently reported ADRs involved gastrointestinal system. The most frequently reported medication class was antinfectives. Risk of serious ADR was significantly lower in children and infants compared to adolescents (ROR 0.41 [95% CI: 0.27-0.61] and 0.47 [0.32-0.71], respectively), and it was significantly increased in subjects exposed to more than one drug (ROR 1.87 [1.33-2.62] and 3.01 [2.07-4.37] for subjects exposed to 2 and 3 or more drugs, respectively). Gender, interactions and off-label drug use did not influence the risk of serious ADRs.

conclusionActive surveillance in pharmacovigilance might represent the best strategy to estimate and characterize the clinical burden of ADRs in children.

Indexed as

AdolescentChildChild, PreschoolDrug-Related Side Effects and Adverse ReactionsEmergency Service, HospitalFemaleHumansInfantInfant, NewbornItalyMalePharmacovigilanceRetrospective StudiesAdverse eventsDrug interactionsObservational studyPediatricsPreventabilitySafety

Identifiers

PMID29661234
PMCPMC5902928

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Registered trials

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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.