Data from: Shaping medicinal product information – a before and after study exploring physicians’ perspectives on the summary of product characteristics
Data files
Aug 21, 2013 version files 622.59 KB
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Copy of Fachinfo_Completes_2012_08_08_open_ended minus IP.xls
68.10 KB
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Transkript_P12_0018_Facharztinformationen_HD_GD4_FAs_19 00 Uhr.doc
105.47 KB
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Transkript_P12_0018_Facharztinformationen_MUC_GD2_FAs_19 00 Uhr.doc
110.59 KB
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Transkript_P12-0018_Facharztinformationen_HD_GD3_API's_16 30 Uhr.doc
169.47 KB
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Transkript_P12-0018_Facharztinformationen_MUC_GD1_API's_16 30 Uhr.doc
168.96 KB
Aug 21, 2013 version files 1.75 MB
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Copy of Fachinfo_Completes_2012_08_08_open_ended minus IP.xls
68.10 KB
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Copy_of_Fachinfo_Completes_2012_08_08_xls_minus_IP.xls
1.13 MB
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Transkript_P12_0018_Facharztinformationen_HD_GD4_FAs_19 00 Uhr.doc
105.47 KB
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Transkript_P12_0018_Facharztinformationen_MUC_GD2_FAs_19 00 Uhr.doc
110.59 KB
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Transkript_P12-0018_Facharztinformationen_HD_GD3_API's_16 30 Uhr.doc
169.47 KB
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Transkript_P12-0018_Facharztinformationen_MUC_GD1_API's_16 30 Uhr.doc
168.96 KB
Abstract
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.