Impact of regulatory interventions to restrict the combined use of renin–angiotensin system blockers: A Danish nationwide drug utilisation study
Sindahl, Per; Ofori-Asenso, Richard; Hallgreen, Christine Erikstrup; Kemp, Kaare; Gardarsdottir, Helga; De Bruin, Marie Louise
(2022) British Journal of Clinical Pharmacology, volume 88, issue 3, pp. 1379 - 1384
(Article)
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) blocking agents in Denmark. Data from the Danish National Prescription Registry covering all medications dispensed during January 2008–December 2018 was used.
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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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Keywords: angiotensin II receptor blockers, angiotensin-converting enzyme inhibitors, drug safety, drug utilisation, pharmacovigilance, renin–angiotensin system, risk management, Pharmacology, Pharmacology (medical)
ISSN: 0306-5251
Publisher: NLM (Medline)
Note: Funding Information: P.S., M.L.D.B., K.K., R.O.‐A., C.E.H. and H.G. report no conflict of interest. At time of the project, R.O.‐A., C.E.H. and M.L.D.W. were employed by Copenhagen Centre for Regulatory Sciences (CORS). CORS is a cross‐faculty university anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private stakeholders (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) as well as patient organizations (Rare Diseases Denmark). The centre is purely devoted to the scientific aspects of the regulatory field and with a patient‐oriented focus and the research is not company‐specific product or directly company related. In the last 5 years, CORS has received funding from Novo Nordisk, Lundbeck, Ferring Pharmaceuticals and LEO pharma for projects not related to this study. Currently, M.L.D.B. and H.G. are employed by Utrecht University and conduct research under the umbrella of the Utrecht‐WHO Collaborating Centre for Pharmaceutical Policy and Regulation. This Centre receives no direct funding or donations from private parties, including pharma industry. Research funding from public–private partnerships, e.g. IMI, The Escher Project ( http://escher.lygature.org/ ) is accepted under the condition that no company‐specific product or company related study is conducted. The Centre has received unrestricted research funding from public sources, e.g. World Health Organisation (WHO), Netherlands Organisation for Health Research and Development (ZonMW), the Dutch National Health Care Institute (ZIN), EC Horizon 2020, the Dutch Medicines Evaluation Board (MEB) and the Dutch Ministry of Health. R.O.‐A. is currently employed by Roche, UK. Publisher Copyright: © 2021 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.
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