A critical review of FDA-approved Medication Guides.

OBJECTIVE To investigate whether consumer-directed, FDA-approved Medication Guides issued for potentially harmful medications are likely to be useful to patients with limited literacy. METHODS Lexile analysis and the suitability assessment of materials (SAM) were conducted on the 40 currently issued Medication Guides to evaluate reading difficulty, content, and format. Structured interviews with a literacy assessment were also conducted among 251 primary care patients at a public hospital clinic in Louisiana to determine if patients directed attention to Medication Guides and other accompanying patient information materials. RESULTS The average Lexile score estimated an 11th-12th grade reading level for the guides (M=1223, S.D.=200). None of the 40 Medication Guides met federal recommendations (6th-8th grade level). Most Medication Guides were deemed unsuitable because they did not provide a summary of content (90.0%) or limit the scope of information (77.5%). Only 23.0% of patients reported having looked at Medication Guides or accompanying patient information materials; patients with low literacy were less likely to have looked at them (16.7% versus 32.9%, p=0.03). CONCLUSION Medication Guides in their current form are not likely to be useful to patients with limited literacy skills. PRACTICE IMPLICATIONS Reading level of text in Medication Guides should be reduced, summaries or "highlights" provided, and the scope of information limited to increase the likelihood of use among individuals with limited literacy. Consumers should be involved in their development.