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BRACE, health policy, guidance documents

Session: Poster Session C

(023) Impact of pharmacovigilance interventions targeting fluoroquinolones on systemic antimicrobial drug use and health outcomes in the Netherlands

Wednesday, August 28, 2024
8:00 AM – 1:30 PM CEST
Location: Convention Hall II

    Co-Author(s)

  • TL

    Tomas Lasys, MD

    PhD candidate
    Utrecht University, Netherlands

  • YS

    Yared Santa-Ana-Tellez, PhD

    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands, Netherlands

  • SS

    Satu J. Siiskonen

    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands, Netherlands

  • RG

    Rolf Groenwold, MD, PhD

    Department of Clinical Epidemiology, Leiden University Medical Center, Leiden University, Netherlands

    • Presenting Author(s)

  • Helga Gardarsdottir, PharmD, PhD, FISPE (she/her/hers)

    Professor RWD for decision making on medicines
    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands
    Utrecht, Netherlands

Background: Fluoroquinolones are antibiotics associated with adverse events that prompted the European Medicines Agency to implement risk minimization measures (RMMs) in 2018, 2019 and 2020.

Objectives: To assess the RMMs’ impact on antibiotic prescription rates in primary care during 2014-2023 based on antibiotic use type (incident, add-on or continued).

Methods: We assessed antibiotic prescriptions using CPRD GOLD (the United Kingdom, UK) and PHARMO (the Netherlands, NL) data from 2014 until 2021 (NL) or 2023 (UK). Incident use, add-on use and continued use of antibiotic prescriptions were assessed separately. The impact of RMMs on prescribing was assessed with interrupted time series (ITS) using monthly prescriptions per 10,000 person-years (MPTPY).

Results: Between 2014 and 2023, we identified cohorts of 3.6 million (UK) and 0.9 million (NL) antibiotic users. Fluoroquinolones were used to initiate treatment episodes from 1.5% (UK) to 5.6% (NL) of the patients. An increase in fluoroquinolone prescribing was seen before the RMMs. The 2018/19 RMMs were associated with a steady downward post-RMMs trend (MPTPY -1.5[UK] and -2.7[NL]), and opposite changes after 2020 RMMs (MPTPY 0.8[UK] and 2.4[NL]). In both countries, most alternative antibiotics had stable or increasing trends before RMMs. The 2018/19 RMMs were associated with a shift to a downward trend for several antibiotic groups, including penicillins with extended-spectrum, tetracyclines, macrolides and beta-lactamase sensitive penicillins. The 2020 RMMs were associated with less prominent changes in antibiotic prescribing.

Conclusions: Moderate impact was seen for the 2018/19 risk minimization measures on fluoroquinolone prescribing, while the 2020 RMMs seemed to have no effect in both countries. At the same time, usage patterns of some alternative antibiotics increased immediately after RMMs. However, these were followed by a decreasing trend, indicating negligible unintended effects (overprescribing) of the RMMs.