Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends

Nelly F. Ly (), Clare Flach, Thom S. Lysen, Emanuil Markov, Hanne Ballegooijen, Peter Rijnbeek, Talita Duarte-Salles, Carlen Reyes, Luis H. John, Leila Karimi, Christian Reich, Sam Salek and Deborah Layton
Additional contact information
Nelly F. Ly: IQVIA Ltd
Clare Flach: IQVIA Ltd
Thom S. Lysen: IQVIA Solutions B.V.
Emanuil Markov: IQVIA
Hanne Ballegooijen: IQVIA Solutions B.V.
Peter Rijnbeek: University Medical Center
Talita Duarte-Salles: Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Carlen Reyes: Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Luis H. John: University Medical Center
Leila Karimi: IQVIA Solutions B.V.
Christian Reich: IQVIA
Sam Salek: University of Hertfordshire
Deborah Layton: PEPI Consultancy Limited

Drug Safety, 2023, vol. 46, issue 4, No 7, 405-416

Abstract: Abstract Introduction Concerns of the persistence and severity of the adverse effects of fluoroquinolones, mainly involving the nervous system, muscles and joints, resulted in the 2018 referral procedure led by the European Medicines Agency (EMA). They advised to stop prescribing fluoroquinolones for infections of mild severity or of a presumed self-limiting course and for prevention of infections, plus to restrict prescriptions in cases of milder infections where other treatment options are available, and restrict in at-risk populations. We aimed to examine whether the impact of EMA regulatory interventions implemented throughout 2018–2019 had an impact on fluoroquinolone prescribing rates. Methods A retrospective population-based cohort study was conducted using electronic health care records from six European countries between 2016 and 2021. We analysed monthly incident fluoroquinolone use rates overall and for each fluoroquinolone active substance through flexible modelling via segmented regression to detect time points of trend changes, in monthly percentage change (MPC). Results The incidence of fluoroquinolone use ranged from 0.7 to 8.0/1000 persons per month over all calendar years. While changes in fluoroquinolone prescriptions were observed over time across countries, these were inconsistent and did not seem to be temporally related to EMA interventions (e.g., Belgium: February/May 2018, MPC − 33.3%, 95% confidence interval [CI] − 35.9 to − 30.7; Germany: February/May 2019, MPC − 12.6%, 95% CI − 13.7 to − 11.6]; UK: January/April 2016, MPC − 4.9%, 95% CI − 6.2 to − 3.6). Conclusion The regulatory action associated with the 2018 referral did not seem to have relevant effects on fluoroquinolone prescribing in primary care.

Date: 2023
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DOI: 10.1007/s40264-023-01286-4

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