BACKGROUND: Rivaroxaban is a non-vitamin K oral anticoagulant with several indications including the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation and the treatment and prevention of deep vein thrombosis, both approved in Europe in 2011. As part of a safety risk management plan revision, a prescriber guide (PG) and patient alert card were distributed in Europe to provide education on key safety information.
OBJECTIVES: To measure whether prescribers received the PG and evaluate their knowledge of key safety messages for the indications of interest.
METHODS: This study involved three assessments over 7 years following EMA approval of rivaroxaban in France, Germany, Spain, and the UK. Physicians who had prescribed rivaroxaban in the past 6 months were recruited from a web panel to complete a survey on their knowledge of key safety information for rivaroxaban.
RESULTS: Between 1,224 and 1,297 physicians participated in each assessment with response rates varying from 5% to 9%. Knowledge was remarkably similar across the three assessments, with some improvement over time for several knowledge questions. In the third assessment, knowledge was high on the overall risk of bleeding (93% correct) and on a series of questions about contraindicated populations (74%-92%) and populations at increased risk of serious side effects (68%-93%). A lower percentage of physicians (68%) were aware that rivaroxaban 15mg and 20mg should be taken with food. While almost all physicians (93%) knew that routine coagulation monitoring is not required, knowledge was lower (62% and 75%) for two questions on specific situations that do require INR monitoring. The lowest percentages of correct responses were on questions related to converting to parenteral anticoagulants and converting to/from vitamin K antagonist (35%-75%). More than half of physicians (57%) reported receiving the PG.
Neurologists, cardiologists, and haematologists showed higher levels of knowledge than other specialties. Physicians responsible for initiating or converting treatment had higher knowledge than those responsible only for maintenance treatment. Physicians who reported receiving the PG had higher knowledge than those who did not.
CONCLUSION: Physician knowledge was highest on the most important risks and lower on more complex aspects of safe use that lend themselves to consultation of the PG and/or label rather than reliance on recall. The relatively high knowledge level and consistency over time, despite relatively low levels of reported receipt of the PG, suggest that the key safety information is available to treating physicians.
