The Effectiveness of the Summary of Product Characteristics (SmPC) and Recommendations for Improvement

SmPCs are important documents for both health professionals and patients. Why patients, because the patient leaflet is based on the SmPC. This research arose from the initiative of a pharma company who wanted to improve the SmPCs it produces and contribute to the current EC report on the ‘shortcomings’ of patient leaflets and SmPCs. The two original SmPCs we tested performed as poorly as any document we had previously tested. As is often the case with User Testing, the short qualitative interview which forms the second part of the testing process proved very useful. Doctors did not value SmPCs currently and welcomed a revised version which had a ‘headline section’ and was much easier to find their way round. This paper and a similar paper written at the same time, looking at German doctors, will form a key part of the evidence on SmPCs to the EC report.

The paper can be viewed on this website. If you would like to discuss this research further, please get in touch.