Impact of regulatory interventions to restrict the combined use of renin-angiotensin system-acting agents: A Danish nationwide drug utilisation study

Per Sindahl*, Richard Ofori-Asenso, Christine Erikstrup Hallgreen, Kaare Kemp, Helga Gardarsdottir, Marie Louise De Bruin

*Corresponding author for this work

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Abstract

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) 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 co-dispensed RAS-acting agents. Autoregressive integrated moving average interrupted time series regression was used to evaluate dispensing trends. The prevalence of patients co-dispensed RAS-acting agents decreased from 0.01% to 0.0003%. Pre-intervention trend was declining and further decreased with an additional -0.45 (95% confidence interval -0.66, -0.25) co-dispensing per million population after the intervention. Overall, the intervention had minimal impact on the combined use of RAS-acting agents. However, as the combined use of RAS-acting agents is low, further interventions to restrict the combined use of RAS-acting agents may not be required in Denmark at this point.
Original languageEnglish
JournalBritish Journal of Clinical Pharmacology
Volume88
Issue number3
Pages (from-to)1379-1384
ISSN1365-2125
DOIs
Publication statusPublished - 2022

Keywords

  • ACE inhibitors
  • angiotensin II receptor blockers
  • drug safety
  • drug utilisation
  • pharmacovigilance
  • Renin angiotensin system
  • risk management

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