The overall objective of Use Case 3 is the preparation of a good practice example for safety analyses of real-world data (RWD) for the post-authorisation stage and the improvement of methods for risk estimation in observational data. Use Case 3 will also evaluate the impact of regulatory warnings on the use of broad-spectrum antibiotics.
The target population of this study will be adults who initiate oral antibiotics in community-dwelling settings. Fluoroquinolones (FQs) are broad-spectrum antibiotics with a high potential for serious adverse drug reactions (ADRs). In the last years, regulatory agencies have warned increasingly about FQs’ risk for serious ADRs. In 2019, restrictions and changes were established after a risk assessment report on FQs conducted by the European Medicines Agency.
Two studies will be performed:
- A descriptive drug utilization study will illustrate the changes in prescription retrievals of fluoroquinolone and other broad-spectrum antibiotics and user characteristics during the study period. Furthermore, the change in the distribution of demographic characteristics and prevalence of comorbidities in fluoroquinolone users over time will be ascertained.
- A cohort study with multiple entries per person using an active comparator, new user design will assess the risk of ADRs associated with fluoroquinolone use compared with other broad-spectrum antibiotics. The incidence of ADRs among the exposure groups and the relative risk using hazard ratios will be calculated. The absolute risk difference and number needed to harm will also be calculated.