RTI Health Solutions, Durham, US.
Bayer AG, Berlin, Germany.
Expert Opin Drug Saf. 2022 Mar;21(3):435-446. doi: 10.1080/14740338.2022.1998451. Epub 2021 Nov 22.
At the request of the European Medicines Agency, a Prescriber Guide and Patient Alert Card were developed to increase awareness and understanding about the initiation of rivaroxaban and potential bleeding risk associated with its use. This study evaluated physician and patient awareness and understanding of key safety messages in these educational materials in three waves.
Three cross-sectional surveys were administered to physicians and one survey was administered to patients (wave 1 only) with recent rivaroxaban experience in France, Germany, Spain, and the United Kingdom.
Patient and physician knowledge of key safety information in the educational materials was generally high. Patients' knowledge was high for questions related to bleeding risk (80% responded correctly), indication (96%), consulting their doctor (86%-91%), and informing other physicians they are taking rivaroxaban (95%). Physicians' knowledge was particularly high for questions related to bleeding risk (92%-94% across waves), populations at increased risk of serious side effects (76%-94%), contraindications (70%-92%), and invasive procedures (76%-82%).
Among patients and physicians, the highest levels of knowledge were on the most important risks, as expected. The Prescriber Guide and Patient Alert Card were found to be useful sources of information.
应欧洲药品管理局的要求,制定了一份《医师指南》和《患者警示卡》,以提高对利伐沙班起始使用及其潜在出血风险的认识和理解。本研究在三个波次中评估了这些教育材料中关键安全信息在医师和患者中的知晓和理解情况。
在法国、德国、西班牙和英国,对有近期利伐沙班使用经验的医师进行了三次横断面调查,仅在第 1 波次对患者进行了一次调查。
患者和医师对教育材料中关键安全信息的了解总体上较高。患者对出血风险(80%回答正确)、适应证(96%)、咨询医生(86%-91%)和告知其他医生正在服用利伐沙班(95%)等问题的了解程度较高。医师对出血风险(各波次均为 92%-94%)、发生严重副作用风险增加的人群(76%-94%)、禁忌证(70%-92%)和有创操作(76%-82%)等问题的了解程度特别高。
在患者和医师中,对最重要风险的了解程度最高,这符合预期。《医师指南》和《患者警示卡》被认为是有用的信息来源。