Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics.

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), physi

SUBMITTER: Vromans L 

PROVIDER: S-EPMC3753505 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature