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

One of the roles of the Summary of Product Characteristics (SmPC) is to provide information for health professionals. The objective of this work was to understand the effectiveness of the SmPC document in communicating essential information to prescribers. The process of user testing, widely used to test information for patients, was applied. First, 30 general practitioners were involved in the testing of the SmPC for Lariam, an antimalarial drug. As user testing is an iterative process, 15 points of information in the original SmPC were tested in 3 rounds of 10 participants. The document was revised between rounds according to the results; good practice in information writing and design was used. Next, the SmPC for CellCept, an immunosuppressant, was tested in 20 senior hospital doctors. Again, the document was revised between rounds, according to the results, with revisions also taking account of findings from the Lariam testing related to the general structure of SmPCs. Of the 15 points of information tested, for the original Lariam SmPC, 6 points of information met the target of 90% to find, and 90% of those to understand, whereas for the final version of the CellCept SmPC, 11 points of information met this target. Qualitative comments showed that in their current format, SmPCs are of low perceived value to prescribers and are not central to the clinicians' prescribing behavior. Current content and presentation of SmPCs, while meeting regulatory approval standards, contribute little to the safe and effective use of medication in practice. Key recommendations include revising and simplifying the heading structure and making the headings more visible, adding a "Key Information" summary at the start, using simpler language, and adding bullet points for listings.