gms | German Medical Science

26th Annual Meeting of the German Drug Utilisation Research Group (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

21.11. - 22.11.2019, Bonn/Bad Godesberg

Prescribers’ compliance with SmPC recommendations for dabigatran, rivaroxaban, and apixaban – a European comparative drug utilization study

Meeting Abstract

  • corresponding author presenting/speaker Sven Schmiedl - Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany
  • M. Rottenkolber - Diabetes Research Group, Medizinische Klinik und Poliklinik IV, Klinikum der Universitńt MŘnchen, Munich, Germany
  • L. Ibanez - Fundaciˇ Institut CatalÓ de Farmacologia (FICF), Department of Clinical Pharmacology, Hospital Universitari Vall d’Hebron, Department of Pharmacology, Toxicology and Therapeutics, Universitat Aut˛noma de Barcelona, Barcelona, Spain
  • M. Sabate - Fundaciˇ Institut CatalÓ de Farmacologia (FICF), Department of Clinical Pharmacology, Hospital Universitari Vall d’Hebron, Department of Pharmacology, Toxicology and Therapeutics, Universitat Aut˛noma de Barcelona, Barcelona, Spain
  • E. Ballarin - Fundaciˇ Institut CatalÓ de Farmacologia (FICF), Department of Clinical Pharmacology, Hospital Universitari Vall d’Hebron. Department of Pharmacology, Toxicology and Therapeutics, Universitat Aut˛noma de Barcelona, Barcelona, Spain
  • X. Vidal - Fundaciˇ Institut CatalÓ de Farmacologia (FICF), Department of Clinical Pharmacology, Hospital Universitari Vall d’Hebron, Department of Pharmacology, Toxicology and Therapeutics, Universitat Aut˛noma de Barcelona, Barcelona, Spain
  • L. M. Leon-Munoz - Pharmacoepidemiology and Pharmacovigilance Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain
  • C. Huerta - Pharmacoepidemiology and Pharmacovigilance Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain
  • E. Martin Merino - Pharmacoepidemiology and Pharmacovigilance Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain
  • D. Montero - Pharmacoepidemiology and Pharmacovigilance Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain
  • C. Gasse - National Centre for Register-based Research, School of Business and Social Sciences, Aarhus University, Department of Business and Business Economics, Aarhus, Denmark
  • M. Anderson - University of Copenhagen (UC), Pharmacoepidemiology Research Collaboration (PRC), Copenhagen, Denmark
  • M. Asgaer - University of Copenhagen (UC), Pharmacoepidemiology Research Collaboration (PRC), Copenhagen, Denmark
  • M. L. De Bruin - University of Copenhagen (UC), Pharmacoepidemiology Research Collaboration (PRC), Copenhagen, Denmark
  • R. Gerlach - National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany
  • M. Tauscher - National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany
  • P. C. Souverein - Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
  • R. van den Ham - Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
  • O. Klungel - Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
  • H. Gardarsdottir - Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands; Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Utrecht, Netherlands

Gesellschaft fŘr Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 26. Jahrestagung der Gesellschaft fŘr Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn/Bad Godesberg, 21.-22.11.2019. DŘsseldorf: German Medical Science GMS Publishing House; 2019. Doc19gaa23

doi: 10.3205/19gaa23, urn:nbn:de:0183-19gaa237

Published: November 19, 2019

© 2019 Schmiedl et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background: Despite a tremendous increase in prescribing of direct oral anticoagulants (DOACs) in recent years, limited data is available on prescribers’ adherence to registered indications (ICs), contraindications (CIs), special warnings/precautions (SW/PCs), and potential drug-drug interactions (pDDIs). The aim of this study was to assess in six European databases prescribers’ adherence to the Summary of Product Characteristics (SmPC) of three DOAC compounds (dabigatran, rivaroxaban, and apixaban) with a special focus on IC, CI, SW/PC, and pDDI.

Materials and methods: This retrospective cohort study was conducted in databases covering regionally/nationally representative populations in five European countries (Denmark, Germany, Spain, the Netherlands, and United Kingdom). The study cohort consisted of adult patients (≥18 years) initiating dabigatran, rivaroxaban or apixaban between 2008 and 2015. ICs, CIs, SW/Ps and pDDIs as registered in the SmPC of the DOACs were mapped to respective coding systems.

Results: 407,576 patients initiated DOACs during the study period (rivaroxaban: 240,985 [59.1%], dabigatran: 95,303 [23.4%], apixaban: 71,288 [17.5%]). In 2015, non-valvular atrial fibrillation was the most common IC registered, representing more than 60% of incident DOAC users in most databases. For the whole study period, a substantial variety between the databases was found regarding the proportion of patients with at least one CI (interdatabase range [IDR]: 8.2% to 55.7%), with at least one SW/PC (IDR: 35.8%–75.2%), and with at least one pDDI (22.4% to 54.1%). In 2015, the most frequent CI was ‘malignant neoplasm’ (IDR: 0.7%–21.3%) whereas the most frequent SW/Pc were ‘prescribing to the elderly (75 years or older)’ with an IDR from 25.0% to 66.4%. The most common single compound class pDDI was ‘concomitant use of nonsteroidal antinflammatory drugs’ with an IDR between 3.0% to 25.3%.

Conclusion: CIs, SW/Ps, and pDDIs were present in a significant number of new DOAC users. Differences between all databases might be related to ‘true’ differences in prescription behaviour, but could also be partially due to differences in database characteristics.