Patient package insert readability and design.

As the popularity of self-medication and direct-to-consumer advertising of prescription drugs increases, the quality, availability, and utility of current patient information strategies become key concerns for pharmacists. It has been suggested that patient package inserts (PPIs) are a high-quality source of information for patients. To determine if this is true, 63 PPIs from three types of sources were assessed for readability and design. Suggested readability level is fifth-to-seventh grade. The PPIs studied had, on average, a 10th-grade reading level. Design characteristics, such as type size and paper quality--which affect patients' likelihood of using the PPI and keeping it for reference--were poorest in PPIs produced by pharmaceutical manufacturers. Overall, associations produce the best PPIs, with commercial vendors and pharmaceutical manufacturers following. However, both readability and design evaluations showed that all PPIs need improvement. Design and testing of new PPI formats and a reassessment of readability are recommended.