Data from: Shaping medicinal product information – a before and after study exploring physicians’ perspectives on the summary of product characteristics

Objective: 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. Design: 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. Setting: Office-based physicians (n=218) from all federal states of Germany. Participants: 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. Outcome measures: 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. Conclusions: 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 health care professionals to ensure compliant and safe utilisation of medicinal products.

研究目标：在修订后的欧洲药物警戒指令（European Pharmacovigilance Directive）框架下，基于医师视角，探索如何让药品特性概要（Summaries of Product Characteristics, SmPCs）更具易用性，更好地辅助医师与患者开展沟通，进而提升患者对自身所用药物的认知水平。
研究设计：采用三阶段研究设计，步骤1为定性焦点小组讨论（Qualitative focus group discussions），步骤2为开发替代版SmPC，步骤3为开展在线定量问卷调查，将替代版SmPC与当前获批版本进行对比。
研究场景：招募自德国所有联邦州的私人执业医师（共218名）。
研究对象：共有218名德国医师参与，全科私人执业医师与专科医师的占比均衡。其中步骤1招募了18名经常查阅SmPC的医师。
结局指标：医师们认可SmPC作为药品信息综合来源的重要性，但对当前版本的SmPC仅持中等满意度，且使用频率较低，更倾向于借助其他信息渠道。研究对象始终更青睐替代版SmPC：该版本在特定患者群体信息的呈现方式上进行了优化，新增了概述、患者信息核查清单等板块，并采用了表格化格式。医师们提出，SmPC应具备搜索与超链接功能，同时支持自动更新，并可集成至现有执业软件或同类系统中。
研究结论：本研究助力开发一款官方、可靠的药品信息系统，既契合现代信息社会的需求，又保留官方授权来源的权威性。从健康素养的视角出发，应将SmPC确立为医疗保健专业人员的核心信息来源，以确保药品的合规、安全使用。