In the US, the Food and Drug Administration regulates written patient information distributed with prescription drugs. This study examined ways to improve the readability of these medication guides. One thousand and three adults assessed three new guide formats, compared to standard guides. The format and layout of content from the Guides were modified several ways to promote information accessibility. Working with patients, the 3 most preferred versions were evaluated. The first used 2 columns to organize content (Column), a second mimicked over-the-counter “Drug Facts” labeling (Drug Facts), and the third followed health literacy best practices using a simple table format (Health Literacy prototype).
All three new formats were associated with greater comprehension compared to usual guides. The simple table format had the highest comprehension scores. Being older than 60 and having lower literacy skills were independently associated with poorer comprehension.
Wolf MS, Bailey SC, Serper M, Smith M, Davis TC, Russell AL, et al. Comparative effectiveness of patient-centered strategies to improve FDA medication guides. Medical Care. 2014 Aug;52(9):781-789.