BACKGROUND: Rivaroxaban is an oral direct Factor Xa inhibitor approved in Europe in 2011 for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation and treatment of deep vein thrombosis (DVT), and for prevention of recurrent DVT and pulmonary embolism following an acute DVT in adults. As part of a safety risk management plan revision, a prescriber guide (PG) and patient alert card (PAC) were distributed in Europe to provide education on key safety information.
OBJECTIVE: To measure whether prescribers received and used the PG and evaluate their knowledge of the key safety messages.
METHODS: This study was conducted in the United Kingdom, Germany, France, and Spain. 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: A total of 1,224 physicians (9% of the total invited) completed the questionnaire. More than half (56%) of physicians reported that they used the PG as a source of information. Approximately half (47%) reported they received PACs, and 80% of these reported they provide it to most or all of their patients. Physician knowledge was high on the overall risk of bleeding (greater than 90% correct) as well as on the risks for populations with contraindications and populations at increased risk of serious side effects (66%-91%). A lower percentage of physicians (59%) were aware that rivaroxaban should be taken with food. The lowest percentages of correct responses related to converting to and from vitamin K antagonist, monitoring, and dosing. In general, neurologists, cardiologists, and haematologists had higher levels of knowledge. Physicians responsible for initiating or converting treatment had higher knowledge than those who were responsible only for maintenance treatment. Physicians who reported receiving information from the PG consistently had higher knowledge than those who did not.
CONCLUSIONS: Physicians' 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.
