Evidence map›Paper›PMID 37389792›Full record

ArticleTherapeutic innovation & regulatory science2023

Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System.

Ha N Tran, Tien N T Nguyen, Ngan T K Tran, Ly T Nguyen, Hoa D Vu, Anh H Nguyen, Nhung T H Trinh

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In one paragraph

Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 31% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Review
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

7 authors at 2 institutions in 2 countries.

Ha N TranNational Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam.ORCID 0000-0002-1155-9067
Tien N T NguyenNational Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam.ORCID 0000-0002-0638-2172
Ngan T K TranNational Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam.
Ly T NguyenNational Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam.
Hoa D VuNational Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam.ORCID 0000-0002-7976-6716
Anh H NguyenNational Drug Information and Adverse Drug Reaction Monitoring Centre​, Hanoi University of Pharmacy, Hanoi, Vietnam. anh90tkvn@gmail.com.ORCID 0000-0002-9643-1678
Nhung T H TrinhPharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, and, PharmaTox Strategic Research Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.ORCID 0000-0003-2794-5322
Hanoi University of Pharmacy · VNUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntibiotics are commonly used in both outpatient and inpatient settings and are responsible for the majority of adverse drug reaction (ADR) reports. We aimed to characterize spontaneously reported ADRs associated with antibiotics and assessing the preventability of these ADRs in a Vietnamese setting. MATERIALS AND

methodsWe conducted a retrospective descriptive study based on ADRs related to antibiotics spontaneously reported by healthcare workers to the National Pharmacovigilance Database of Vietnam (NPDV) between June 2018 and May 2019. The characteristics of included reports were descriptively analyzed. The preventability of reported ADRs was assessed using a standardized preventability scale. We identified the leading causes and described the characteristics associated with preventable ADRs (pADRs).

resultsWe included 6385 antibiotic-related reports from a total of 12,056 reports submitted to the NPDV during the study period. Beta-lactam antibiotics, mostly broad-spectrum with parenteral route, were suspected in the majority cases. The most commonly reported pADRs were allergic reactions, mostly classified under skin and subcutaneous tissue disorders. Of all included cases, 537 cases (8.4%) were deemed as associated with pADRs. Major causes of pADRs include potentially inappropriate prescribing (352/537, 65.5%) and re-administration of antibiotics causing prior allergy/allergies (99/537, 18.4%). The majority of pADRs involved the use of beta-lactam antibiotics with inappropriate indications.

conclusionADRs related to antibiotic use represent more than half of ADRs spontaneously reported in Vietnam. Approximately one in every ten reported cases is associated with pADRs. The majority pADRs can be prevented through simple improvement in antibiotic prescribing practices.

Indexed as

Anti-Bacterial AgentsDrug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting Systemsbeta-LactamsHumansRetrospective StudiesAnti-Bacterial Agentsbeta-LactamsAdverse drug reactionsAntibioticpADRsPreventabilitySpontaneous reporting system

Identifiers

PMID37389792
OpenAlexW4382630764

What OpenQuestion holds

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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.