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

Anne Laure Sennesael, Anne Sophie Larock, Bérangère Devalet, Valérie Mathieux, Franck Verschuren, Xavier Muschart, Olivia Dalleur, Jean Michel Dogné, Anne Spinewine

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1544-1556
Number of pages13
JournalBritish Journal of Clinical Pharmacology
Volume84
Issue number7
DOIs
Publication statusPublished - 1 Jul 2018

Keywords

  • 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
  • Aged
  • Emergency Service, Hospital/statistics & numerical data
  • Patient Education as Topic
  • Vitamin K/antagonists & inhibitors

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