MSD Oss BV, Oss, The Netherlands.
BMJ Open. 2013 Aug 21;3(8):e003033. doi: 10.1136/bmjopen-2013-003033.
To establish, in the context of the revised European Pharmacovigilance Directive and based on physicians' perspectives, how Summaries of Product Characteristics (SmPCs) could be more user friendly and better support physicians' interactions with patients, thereby improving patients' own understanding of their medicines.
Qualitative focus group discussions (step 1), development of an alternative SmPC (step 2) and an online quantitative survey (step 3) comparing the alternative SmPC to the currently approved version.
Office-based physicians (n=218) from all federal states of Germany.
218 German physicians participated, with an equal representation of office-based general practitioners and specialists. For step 1 (n=18), physicians were recruited who frequently consulted SmPCs.
Planned and performed: Mayring's qualitative content analysis of focus group discussions (step 1), rating on a five-point Likert scale of preference of current versus alternative SmPCs (step 3).
Physicians confirmed the importance of SmPCs as a comprehensive source of medicinal product information, but were moderately satisfied with the current SmPCs, utilised it infrequently and were more likely to engage additional sources of information. The alternative SmPC was consistently preferred. It differed in the way information for particular patient groups was presented, included additional sections (synopsis, checklist for patient information) and used a tabular format. Physicians indicated that SmPCs should be available with search and hyperlink functions, as well as be automatically updated and integrated in available practice software or similar solutions.
This research contributes to the development of an official, reliable medicinal product information system meeting the needs of a modern information society while providing the reliability of an officially authorised source. In the context of health literacy, SmPCs should be established as the primary information source for healthcare professionals to ensure compliant and safe utilisation of medicinal products.
在修订后的欧洲药品监管指令背景下，从医生的角度出发，探讨如何使药品说明书（SmPC）更便于用户使用，更好地支持医生与患者的互动，从而提高患者对自身用药的理解。
定性焦点小组讨论（第 1 步）、开发替代 SmPC（第 2 步）和在线定量调查（第 3 步），比较替代 SmPC 和当前批准的版本。
德国所有联邦州的门诊医生。
共有 218 名德国医生参与，其中包括门诊普通医生和专科医生的平等代表。第 1 步（n=18）招募了经常查阅 SmPC 的医生。
计划和执行：Mayring 的焦点小组讨论定性内容分析（第 1 步），对当前和替代 SmPC 的偏好进行五分制评分（第 3 步）。
医生们确认了 SmPC 作为药物信息综合来源的重要性，但对当前 SmPC 的满意度中等，使用频率较低，更倾向于利用其他信息来源。替代 SmPC 一直受到青睐。它在呈现特定患者群体信息的方式、包括附加章节（概要、患者信息检查表）和使用表格格式方面有所不同。医生们表示，SmPC 应具有搜索和超链接功能，并可自动更新，集成在现有的实践软件或类似解决方案中。
本研究有助于开发满足现代信息社会需求的官方可靠药物信息系统，同时提供官方授权来源的可靠性。在健康素养背景下，SmPC 应作为医疗保健专业人员的主要信息来源，以确保药物的合规和安全使用。
