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

Planned and performed: Mayring's qualitative content analysis of focus group discussions (step 1), rating on a five-point Likert scale of preference of current versus alternative SmPCs (step 3).

RESULTS

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 healthcare professionals to ensure compliant and safe utilisation of medicinal products.