Improving pregnancy drug warnings to promote patient comprehension

Abstract

Objective: We sought to evaluate the effectiveness of a pharmaceutical labeling strategy intended to improve comprehension of a teratogen warning.

Study design: This is a secondary analysis that evaluated women of childbearing age who were assigned prescription containers with the current teratogen warning, a label with simplified text, or a label with simplified text and icons. The association between label type and understanding of label instructions was assessed.

Results: A total of 132 women were interviewed. Comprehension of the icon label (94%) was higher than for the standard and enhanced text-only labels (76% and 79%), respectively (P < .05). Adjustment for age, race/ethnicity, education, literacy, and number of current medications revealed that the label with the enhanced text and icon yielded superior comprehension (risk ratio vs standard, 1.26; 95% confidence interval, 1.04-1.53; risk ratio vs enhanced, 1.22; 95% confidence interval, 1.02-1.46).

Conclusion: In our study, a teratogen warning label that had easy-to-read messages with icons significantly improved comprehension.