Impact of European Union Label Changes for Fluoroquinolone-Containing Medicinal Products for Systemic and Inhalation Use: Post-Referral Prescribing Trends.
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
accepted:
01
03
2023
medline:
20
4
2023
pubmed:
29
3
2023
entrez:
28
3
2023
Statut:
ppublish
Résumé
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. 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). 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). The regulatory action associated with the 2018 referral did not seem to have relevant effects on fluoroquinolone prescribing in primary care.
Identifiants
pubmed: 36976448
doi: 10.1007/s40264-023-01286-4
pii: 10.1007/s40264-023-01286-4
pmc: PMC10044099
doi:
Substances chimiques
Fluoroquinolones
0
Anti-Bacterial Agents
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
405-416Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
Hooper DC. Mechanisms of action of antimicrobials: focus on fluoroquinolones. Clin Infect Dis. 2001;32:S9-15. https://doi.org/10.1086/319370 .
doi: 10.1086/319370
pubmed: 11249823
PRAC. Referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data—quinolone and fluoroquinolone medicinal products for systemic and inhalation use. In: PRAC Assessment Report; 2018. https://www.ema.europa.eu/en/documents/referral/quinolone-fluoroquinolone-article-31-referral-assessment-report_en.pdf . Accessed 19 Nov 2022.
Morales DR, Slattery J, Pacurariu A, Pinheiro L, McGettigan P, Kurz X. Relative and absolute risk of tendon rupture with fluoroquinolone and concomitant fluoroquinolone/corticosteroid therapy: population-based nested case–control study. Clin Drug Investig. 2019;39:205–13. https://doi.org/10.1007/s40261-018-0729-y .
doi: 10.1007/s40261-018-0729-y
pubmed: 30465300
Etminan M, Brophy JM, Samii A. Oral fluoroquinolone use and risk of peripheral neuropathy: a pharmacoepidemiologic study. Neurology. 2014;83(14):1261–3. https://doi.org/10.1212/WNL.0000000000000846 .
doi: 10.1212/WNL.0000000000000846
pubmed: 25150290
Lee C-C, Lee MG, Chen Y-S, Lee S-H, Chen Y-S, Chen S-C, et al. Risk of aortic dissection and aortic aneurysm in patients taking oral fluoroquinolone. JAMA Intern Med. 2015;175:1839–47. https://doi.org/10.1001/jamainternmed.2015.5389 .
doi: 10.1001/jamainternmed.2015.5389
pubmed: 26436523
Kim GK. The risk of fluoroquinolone-induced tendinopathy and tendon rupture. J Clin Aesthet Dermatol. 2010;3:49–54.
pubmed: 20725547
pmcid: 2921747
European Medicines Agency. Quinolone- and fluoroquinolone-containing medicinal products; 2019. https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products . Accessed 14 Feb 2022.
Pasternak B, Inghammar M, Svanström H. Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study. Br Med J. 2018;360: k678. https://doi.org/10.1136/bmj.k678 .
doi: 10.1136/bmj.k678
NICE. Antimicrobial prescribing guidance—managing common infections; 2021. https://www.bnf.org/wp-content/uploads/2021/07/summary-antimicrobial-prescribing-guidance_july-21-for-BNF.pdf . Accessed 19 Nov 2022.
SWAB. Antimicrobial Stewardship—Algemene informatie; 2016. https://swab.nl/nl/antimicrobial-stewardship . Accessed 3 Aug 2020.
European Commission Eurostat. Revision of the European Standard Population: report of Eurostat’s task force; 2013. https://data.europa.eu/doi/10.2785/11470 . Accessed 21 Apr 2021.
Lin K, Zahlanie Y, Ortwine JK, Mang NS, Wei W, Brown LS, et al. Decreased outpatient fluoroquinolone prescribing using a multimodal antimicrobial stewardship initiative. Open Forum Infect Dis. 2020;7: ofaa182. https://doi.org/10.1093/ofid/ofaa182 .
doi: 10.1093/ofid/ofaa182
pubmed: 32548204
pmcid: 7284006
Yarrington ME, Anderson DJ, Dodds Ashley E, Jones T, Davis A, Johnson M, et al. Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals. Infect Control Hosp Epidemiol. 2019;40:1297–300. https://doi.org/10.1017/ice.2019.247 .
doi: 10.1017/ice.2019.247
pubmed: 31474240
Bratsman A, Mathias K, Laubscher R, Grigoryan L, Rose S. Outpatient fluoroquinolone prescribing patterns before and after US FDA boxed warning. Pharmacoepidemiol Drug Saf. 2020;29:701–7. https://doi.org/10.1002/pds.5018 .
doi: 10.1002/pds.5018
pubmed: 32390266
Weatherburn CJ, Guthrie B, Dreischulte T, Morales DR. Impact of medicines regulatory risk communications in the UK on prescribing and clinical outcomes: systematic review, time series analysis and meta-analysis. Br J Clin Pharmacol. 2020;86:698–710. https://doi.org/10.1111/bcp.14104 .
doi: 10.1111/bcp.14104
pubmed: 31465123
Morales DR, Slattery J, Pinheiro L, Kurz X, Hedenmalm K. Indications for systemic fluoroquinolone therapy in Europe and prevalence of primary-care prescribing in France, Germany and the UK: descriptive population-based study. Clin Drug Investig. 2018;38:927–33. https://doi.org/10.1007/s40261-018-0684-7 .
doi: 10.1007/s40261-018-0684-7
pubmed: 30143952
Adriaenssens N, Coenen S, Versporten A, Muller A, Minalu G, Faes C, et al. European Surveillance of Antimicrobial Consumption (ESAC): outpatient antibiotic use in Europe (1997–2009). J Antimicrob Chemother. 2011;66(Suppl 6):vi3–12. https://doi.org/10.1093/jac/dkr453 .
doi: 10.1093/jac/dkr453
pubmed: 22096064
Kabbani S, Hersh AL, Shapiro DJ, Fleming-Dutra KE, Pavia AT, Hicks LA. Opportunities to improve fluoroquinolone prescribing in the United States for adult ambulatory care visits. Clin Infect Dis. 2018;67:134–6. https://doi.org/10.1093/cid/ciy035 .
doi: 10.1093/cid/ciy035
pubmed: 29373664
pmcid: 6005119
FAMHP. Public hearing on quinolones and fluoroquinolones at EMA; 2018. https://www.famhp.be/en/news/public_hearing_on_quinolones_and_fluoroquinolones_at_ema . Accessed 14 Feb 2022.
Gradl G, Werning J, Enners S, Kieble M, Schulz M. Quality appraisal of ambulatory oral cephalosporin and fluoroquinolone use in the 16 German federal states from 2014–2019. Antibiotics. 2021;10:831. https://doi.org/10.3390/antibiotics10070831 .
doi: 10.3390/antibiotics10070831
pubmed: 34356753
pmcid: 8300794
Vermeulen H, Coenen S, Hens N, Bruyndonckx R. Impact of changing reimbursement criteria on the use of fluoroquinolones in Belgium. J Antimicrob Chemother. 2021;76:2725–32. https://doi.org/10.1093/jac/dkab255 .
doi: 10.1093/jac/dkab255
pubmed: 34374778
pmcid: 8446932