Anne-Laure Sennesael1,2, Anne-Sophie Larock3, Bérangère Devalet4, Valérie Mathieux4, Franck Verschuren5, Xavier Muschart6, Olivia Dalleur1,7, Jean-Michel Dogné2, Anne Spinewine1,3. 1. Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université catholique de Louvain, Brussels, Belgium. 2. Namur Research Institute for Life Sciences, Namur Thrombosis and Hemostasis Center, Department of Pharmacy, University of Namur, Namur, Belgium. 3. CHU UCL Namur, Namur Thrombosis and Hemostasis Center, Department of Pharmacy, Université catholique de Louvain, Yvoir, Belgium. 4. CHU UCL Namur, Namur Thrombosis and Hemostasis Center, Department of Hematology, Université catholique de Louvain, Yvoir, Belgium. 5. Institute of Experimental and Clinical Research, Cliniques Universitaires Saint-Luc, Department of Emergency Medicine, Université catholique de Louvain, Brussels, Belgium. 6. CHU UCL Namur, Department of Emergency Medicine, Université catholique de Louvain, Yvoir, Belgium. 7. Cliniques Universitaires Saint-Luc, Department of Pharmacy, Université catholique de Louvain, Brussels, Belgium.
Abstract
AIMS: To determine the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs), and to explore contributing factors to preventable ADRs. Results were compared with vitamin K antagonists (VKAs). METHODS: We conducted a prospective observational study in the emergency departments of two teaching hospitals from July 2015 to January 2016. Patients admitted with a thrombotic or bleeding event while under DOAC or VKA were included. Four independent reviewers assessed causality, seriousness and preventability of ADRs using pilot-tested scales. For cases of serious and potentially preventable ADRs, we performed semi-structured interviews with general practitioners to identify contributing factors to ADRs. The primary outcome was the proportion of serious ADRs that were potentially preventable. RESULTS: The analysis included 46 DOAC and 43 VKA patients (median age 79 years). Gastrointestinal (n = 34) and intracranial (n = 16) bleedings were the most frequent ADRs. Results were that 53% of DOAC- and 61% of VKA-related serious ADRs were deemed potentially preventable. Prescribing issues and inadequate monitoring were frequent for DOAC and VKA respectively. We identified many causes of preventable ADRs that applied to all oral anticoagulants, such as pharmacodynamic drug interactions and lack of communication. CONCLUSIONS: More than half of serious ADRs were potentially preventable for both DOACs and VKAs. Interventions focusing on prescribing, patient education and continuity of care should help improve the use of DOACs in practice.
AIMS: To determine the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs), and to explore contributing factors to preventable ADRs. Results were compared with vitamin K antagonists (VKAs). METHODS: We conducted a prospective observational study in the emergency departments of two teaching hospitals from July 2015 to January 2016. Patients admitted with a thrombotic or bleeding event while under DOAC or VKA were included. Four independent reviewers assessed causality, seriousness and preventability of ADRs using pilot-tested scales. For cases of serious and potentially preventable ADRs, we performed semi-structured interviews with general practitioners to identify contributing factors to ADRs. The primary outcome was the proportion of serious ADRs that were potentially preventable. RESULTS: The analysis included 46 DOAC and 43 VKA patients (median age 79 years). Gastrointestinal (n = 34) and intracranial (n = 16) bleedings were the most frequent ADRs. Results were that 53% of DOAC- and 61% of VKA-related serious ADRs were deemed potentially preventable. Prescribing issues and inadequate monitoring were frequent for DOAC and VKA respectively. We identified many causes of preventable ADRs that applied to all oral anticoagulants, such as pharmacodynamic drug interactions and lack of communication. CONCLUSIONS: More than half of serious ADRs were potentially preventable for both DOACs and VKAs. Interventions focusing on prescribing, patient education and continuity of care should help improve the use of DOACs in practice.
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