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《欧洲药品警戒指令》框架下，基于医师视角，探讨如何让药品特性综述（Summaries of Product Characteristics, SmPC）更具易用性，更好地辅助医师与患者开展沟通，从而提升患者对自身所用药物的认知水平。 研究设计：采用三阶段研究方案，第一阶段为定性焦点小组讨论，第二阶段开发替代版SmPC，第三阶段开展在线定量调查，对比替代版SmPC与当前获批版本的使用效果。 研究场景：招募来自德国所有联邦州的门诊医师（样本量n=218）。 研究对象：共218名德国医师参与，门诊全科医师与专科医师占比均衡。其中第一阶段（n=18）招募的为经常查阅SmPC的医师。 研究结局指标：医师认可SmPC作为药品全面信息来源的重要性，但对当前SmPC的满意度处于中等水平，且使用频率较低，更倾向于借助其他信息渠道。替代版SmPC获得了一致的青睐，其在特定患者群体的信息呈现方式上进行了优化，新增了概要板块、患者信息核查清单，并采用了表格化格式。医师还提出，SmPC应具备搜索与超链接功能，支持自动更新，并集成至现有执业软件或同类解决方案中。 研究结论：本研究助力开发符合现代信息社会需求的官方可靠药品信息系统，同时保留官方授权来源的权威性。在健康素养（health literacy）的背景下，应将SmPC确立为医疗保健专业人员的首要信息来源，以确保药品的合规、安全使用。