DOI: 10.5061/dryad.jh667
title: Data from: Shaping medicinal product information – a before and after study exploring physicians’ perspectives on the summary of product characteristics

description: 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.
description: Transcript focus group
 discussion (step 1) part 1 Word transcript of
 qualitative focus group discussions with German office-based physicians
 part 1 (n=5) Transkript_P12-0018_Facharztinformationen_MUC_GD1_API's_16 30 Uhr.doc Transcript focus group discussion (step 1) part 2 Word transcript of qualitative focus group discussions with German office-based physicians part 2 (n=4) Transkript_P12_0018_Facharztinformationen_MUC_GD2_FAs_19 00 Uhr.doc Transcript focus group discussion (step 1) part 3 Word transcript of qualitative focus group discussions with German office-based physicians part 3 (n=4) Transkript_P12-0018_Facharztinformationen_HD_GD3_API's_16 30 Uhr.doc Transcript focus group discussion (step 1) part 4 Word transcript of qualitative focus group discussions with German office-based physicians (part 4) n=5 Transkript_P12_0018_Facharztinformationen_HD_GD4_FAs_19 00 Uhr.doc Fachinfo on-line survey data part 1 Top-line general information on time and duration on-line survey Copy of Fachinfo_Completes_2012_08_08_open_ended minus IP.xls Fachinfo online survey charts and responses to questions Excel file with individual responses to the questions in the on-line survey and summary data and charts of the validated data sets. Questions have been detailed in Appendix III to the publication. Code book is included in file. Copy of Fachinfo_Completes_2012_08_08_xls minus IP.xls