Evidence map›Paper›PMID 39821460›Full record

ArticlePharmacoepidemiology and drug safety2025

Impact of Pharmacovigilance Interventions Targeting Fluoroquinolones on Antibiotic Use in the Netherlands and the United Kingdom.

Tomas Lasys, Yared Santa-Ana-Tellez, Satu J Siiskonen, Rolf H H Groenwold, Helga Gardarsdottir

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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

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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

3 citing papers in PubMed.

  1. HLA-B*44 Alleles and HLA-DQA1*03:01 as Genetic Risk Factors for Drug-Induced Liver Injury due to Fluoroquinolones.Liver international : official journal of the International Association for the Study of the Liver · 2026
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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

5 authors.

Tomas LasysDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0002-8892-9820
Yared Santa-Ana-TellezDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0003-3086-446X
Satu J SiiskonenDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0003-3095-9530
Rolf H H GroenwoldDepartment of Clinical Epidemiology, Leiden University Medical Centre, Leiden, The Netherlands.ORCID 0000-0001-9238-6999
Helga GardarsdottirDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0001-5623-9684

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFluoroquinolones are antibiotics associated with adverse events that prompted the European Medicines Agency to implement risk minimization measures (RMMs) in 2018/19 and 2020. Our aim is to assess the RMMs' impact on antibiotic prescriptions in primary care during 2014-2023.

methodsWe assessed antibiotic prescriptions using CPRD GOLD (the United Kingdom, UK) and PHARMO (the Netherlands, NL). Prescriptions were assessed for fluoroquinolones and alternative antibiotics. The impact of RMMs on prescribing was assessed with interrupted time series (ITS) using monthly prescription rates per 10 000 person-years (MPTPY).

resultsBetween 2014 and 2023, we identified cohorts of 4.0 (UK) and 0.9 million (NL) antibiotic users. Fluoroquinolones were prescribed to initiate 1.5% (UK) to 5.8% (NL) of the treatment episodes. Fluoroquinolone prescribing before the RMMs slowly decreased in the UK and was stable in the NL. The 2018/19 RMMs were associated with a steady downward post-RMMs trend in incident use of fluoroquinolones (MPTPY -0.7 [UK] and -0.8 [NL]) and opposite changes after 2020 RMMs (MPTPY 0.6 [UK] and 1.8 [NL]). The 2018/2019 RMMs were linked with increasing trends for other antibacterials (J01XX) in both countries and other beta-lactam antibacterials in the UK, but most antibiotics had decreasing trends post-RMMs in both countries. After the 2020 RMMs, some antibiotic groups showed upward trends.

conclusionThe risk minimization measures in 2018/2019 were associated with a moderate decrease in fluoroquinolone prescribing, with no further decrease after 2020 RMMs. There was no sustained increase in other antibiotic prescribing, suggesting that overprescribing was negligible as an unintended impact of RMMs.

Indexed as

Anti-Bacterial AgentsFluoroquinolonesPharmacovigilancePractice Patterns, Physicians'Antimicrobial StewardshipDrug PrescriptionsFemaleHumansInterrupted Time Series AnalysisMaleMiddle AgedNetherlandsPrimary Health CareUnited KingdomAnti-Bacterial AgentsFluoroquinolonesantibioticsfluoroquinolonesimpact studiespharmacovigilancerisk minimization measures

Identifiers

PMID39821460
PMCPMC11739677

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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.