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Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants:a prospective study

Title: Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants:a prospective study
Authors: Sennesael, Anne Laure; Larock, Anne Sophie; Devalet, Bérangère; Mathieux, Valérie; Verschuren, Franck; Muschart, Xavier; Dalleur, Olivia; Dogné, Jean-Michel; Spinewine, Anne
Source: Sennesael, A L, Larock, A S, Devalet, B, Mathieux, V, Verschuren, F, Muschart, X, Dalleur, O, Dogné, J-M & Spinewine, A 2018, 'Preventability of serious thromboembolic and bleeding events related to the use of oral anticoagulants : a prospective study', British Journal of Clinical Pharmacology, vol. 84, no. 7, pp. 1544-1556. https://doi.org/10.1111/bcp.13580
Publication Year: 2018
Collection: Research Portal - University of Namur / Portail de la recherche de l'Université de Namur
Subject Terms: adverse drug reactions; medication errors; oral anticoagulants; patient safety; qualitative research; Atrial Fibrillation/prevention & control; Prospective Studies; Administration; Oral; Humans; Continuity of Patient Care; Male; Intracranial Hemorrhages/chemically induced; Anticoagulants/administration & dosage; Stroke/prevention & control; Aged; 80 and over; Gastrointestinal Hemorrhage/chemically induced; Female; Hospitalization/statistics & numerical data; Thromboembolism/chemically induced; Emergency Service; Hospital/statistics & numerical data; Patient Education as Topic; Vitamin K/antagonists & inhibitors
Description: 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.
Document Type: article in journal/newspaper
Language: English
ISSN: 0306-5251; 1365-2125
Relation: info:eu-repo/semantics/altIdentifier/pmid/29522647; info:eu-repo/semantics/altIdentifier/pissn/0306-5251; info:eu-repo/semantics/altIdentifier/eissn/1365-2125
DOI: 10.1111/bcp.13580
Availability: https://researchportal.unamur.be/en/publications/75ca1768-d920-49f1-9ff3-ac2178e950c9; https://doi.org/10.1111/bcp.13580; https://www.scopus.com/pages/publications/85048674067
Rights: info:eu-repo/semantics/openAccess
Accession Number: edsbas.4FAF7242
Database: BASE