The effect of risk-minimizing pharmacovigilance measures on the prescription of anti-biotics in Iceland and the Nordic countries

• Main Author: Petra Ósk Guðbjargardóttir 1998-
• Other Authors: Háskóli Íslands
• Format: Master Thesis
• Language: English
• Published: 2024
• Subjects: Lyfjafræði; Iceland
• Online Access: http://hdl.handle.net/1946/46522

Background: Fluoroquinolones are broad-spectrum antibiotics with rare but serious side effects. In October 2018, following a safety referral the EMA recommended restricting fluoroquinolone use due to safety concerns. Objective: To assess the impact of pharmacovigilance actions on fluoroquinolone prescriptions in Iceland and to compare to Nordic countries. Methods: A retrospective nationwide cohort study analysing antibiotic prescriptions in Iceland over the years 2013-2023. Additionally, the prescription rates were compared to the prescription rates in Norway, Sweden and Denmark. Finally, spontaneous reporting rates from Vigibase data was also analysed. Results: Antibiotic prescriptions, including fluoroquinolones, decreased in Iceland during the period after the pharmacovigilance actions were taken (2019-2023) compared to the period before (2013-2018). However, almost all of the most commonly anti-biotics had a decrease, except for broad spectrum penicillin. Iceland's antibiotic use remains higher than in the Nordic countries. Limited number of spontaneous reports were received for fluoroquinolones over the study period, however, a spike in the reports was noted in 2019 following the safety referral. Conclusion: Fluoroquinolone use decreased in Iceland after the pharmacovigilance actions were implemented, but other factors likely also played a role because overall anti-biotic prescription rates decreased during the period.