Communicating prescription medication information: A patient-led discussion to simplify Medication Guides

background: Medication Guides (Med Guides) are the only required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines.  Previous research has found Med Guides are written at too high a reading grade level and are too complicated to effectively convey these risks to patients, especially to those with low health literacy.  We sought feedback on proposed one-page Med Guide prototypes from a diverse patient population, to inform the development and field-testing of an improved Med Guide template.

methods:  We conducted six focus groups with 45 adults recruited from two primary care clinics and one basic education center.  Participants were provided a packet containing multiple pairwise comparisons of six Med Guide prototypes (3 FDA, 2 Northwestern, 1 European), and were directed to choose for each pair which they preferred.  We then collected qualitative feedback on each prototype in a group discussion. 

results:  Participants favored a one-page summary highlighting Med Guide contents, rather than the current, multi-page standard. Of the one-page prototypes tested, two were preferred: an FDA prototype resembling an OTC 'drug facts' label and one created by this team (both chosen 54% of times shown).  Qualitative feedback showed these guides were favored due to ample white space, clear headings, and a distinct reading route. 

conclusion:  Through a structured, approach, feedback from a diverse sample was gathered to help refine prototypes of FDA approved Med Guides in an effort to improve their readability and usability for consumers, especially those with limited health literacy.