Trends in prescriptions of fluoroquinolones in Germany
Description
- Fluoroquinolones are a group of broad-spectrum antibiotics used to treat severe bacterial infections, particularly when other antibiotics are not effective. However, their use is associated with the risk of serious adverse drug reactions, including tendon inflammation and rupture, nerve damage, and cardiovascular events. In addition, inappropriate use of antibiotics can contribute to the development of resistance.
In the European Union, these risks have led to strengthened regulatory measures. In 2017, at the initiative of the German Federal Institute for Drugs and Medical Devices (BfArM), a referral procedure was initiated by the European Medicines Agency (EMA) to reassess the use of fluoroquinolones. In 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded that for certain indications the risks of fluoroquinolones outweigh their benefits. As a result, the approved indications for these antibiotics were substantially restricted.
In Germany, risk minimization measures were implemented, among others, through a Dear Doctor Letter (“Rote-Hand-Brief”) issued in April 2019, which informed healthcare professionals about the risks of fluoroquinolones and listed indications for which these antibiotics should not be prescribed. In June 2023, another Dear Doctor Letter was issued that reiterated these warnings.
So far, it has not been investigated whether the Dear Doctor Letter issued in 2023 has led to changes in prescribing behavior. Moreover, there is still no comprehensive analysis of the specific diseases for which fluoroquinolones are actually prescribed. Differences in prescribing patterns between physicians’ specialties or between different regions have also not yet been systematically investigated.
The aim of this project is therefore to provide a comprehensive description of temporal trends in fluoroquinolone prescribing in Germany between 2010 and 2024 based on data from statutory health insurance providers. Among other aspects, the project will examine for which indications fluoroquinolones are prescribed and whether prescribing patterns differ between physicians’ specialties or across regions.
The project is funded by the BfArM as part of a call for proposals on pharmacovigilance research.
Funding period
- Begin: January 2025
End: December 2026
Sponsor
- Federal Institute for Drugs and Medical Devices