Key result
EMA measures linked to a ~0.45 per million further decline in combined RAS blocker codispensing.
Why the study?
To evaluate the impact of 2014 European Medicines Agency risk minimisation measures restricting the combined use of renin-angiotensin system blocking agents in Denmark.
Did the 2014 EMA risk minimisation measures reduce the combined use of RAS blockers in Denmark?
Observational
Did the 2014 EMA risk minimisation measures reduce the combined use of RAS blockers in Denmark?
Effect estimate: additional -0.45 codispensing per million population (95% CI -0.66, -0.25)
The 2014 EMA regulatory intervention had minimal additional impact on the already declining and low combined use of RAS blockers in Denmark.
This study aimed to evaluate the impact of the risk minimisation measures issued by the European Medicines Agency in 2014 to restrict the combined use of renin-angiotensin system (RAS) blocking agents in Denmark. Data from the Danish National Prescription Registry covering all medications dispensed during January 2008-December 2018 was used. The outcome was monthly prevalence of patients codispensed RAS blockers. Autoregressive integrated moving average interrupted time series regression was used to evaluate dispensing trends. The prevalence of patients codispensed RAS blockers decreased from 0.01 to 0.0003%. Preintervention trend was declining and further decreased with an additional -0.45 (95% confidence interval -0.66, -0.25) codispensing per million population after the intervention. Overall, the intervention had minimal impact on the combined use of RAS blockers. However, as the combined use of RAS blockers is low, further interventions to restrict the combined use of RAS blockers may not be required in Denmark at this point.
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Sindahl et al. (2021) conducted an observational in Combined use of renin-angiotensin system (RAS) blocking agents. Risk minimisation measures issued by the European Medicines Agency in 2014 vs. Preintervention trend was evaluated on Monthly prevalence of patients codispensed RAS blockers (additional -0.45 codispensing per million population, 95% CI -0.66, -0.25). The 2014 EMA risk minimisation measures further decreased the declining trend of combined RAS blocker codispensing by an additional -0.45 per million population (95% CI -0.66 to -0.25).
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