Evaluation of the appropriateness of dosing, indication and safety of rivaroxaban in a community hospital

WHAT IS KNOWN AND OBJECTIVE: For over 50 years, warfarin was the only oral anticoagulant approved in the United States. In 2011, the Food and Drug Administration (FDA) approved rivaroxaban. Since its introduction, rivaroxaban has served as an alternative to warfarin to minimize drug interactions and avoid drug monitoring. The objective of this study was to evaluate the appropriateness of rivaroxaban dosing, indication and safety in a community hospital and to identify areas for improvement in its use. METHODS: This single-centre, retrospective review evaluated patients who received at least one dose of rivaroxaban between November 2011 and July 2013. The primary outcome included appropriateness of the first day of therapy based on indication and renal function per FDA-approved dosing recommendations for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) and for the treatment or prevention of venous thromboembolism (VTE). The secondary outcome included incidence of major bleeding or non-major clinically relevant bleeding. RESULTS AND DISCUSSION: Of the 445 patients evaluated, 36·9% of patients treated for NVAF and 12·4% treated for VTE were on an inappropriate regimen. Major bleeding within 12 months occurred in 3·5% of patients treated for NVAF, 1·2% for VTE and 0% for off-label indications with a similar trend for non-major clinically relevant bleeding (3·8%, 1·8% and 0%, respectively). WHAT IS NEW AND CONCLUSION: Though offering potential advantages over warfarin, the use of rivaroxaban should be monitored to increase appropriateness of therapy and improve patient safety. Therapeutic interchanges, pharmacist-directed interventions and other initiatives can be implemented to ensure appropriate use.