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.