A User‐Centric Comprehension Assessment of Prescription Drug Package Inserts in China: A Cross‐Sectional Study

Background Drug package inserts (DPIs) are crucial to ensure patients use drugs appropriately. Currently, only standard DPIs are available in China. Users' comprehension of standard DPIs and patient‐centered DPIs, and the factors influencing their comprehension, remain poorly understood. Aim Our objective was to evaluate and compare users' comprehension of standard DPIs and patient‐centered DPIs. Additionally, we aimed to explore the association between DPI types and users' comprehension and other influencing factors. Methods We selected two standard DPIs and developed two corresponding patient‐centered DPIs for examination in 258 participants. Participants were divided into four groups (standard DPI A and B groups, patient DPI A and B groups) and interviewed using a structured questionnaire to test their comprehension of DPIs. We scored the participants' responses and recorded the time taken during the interviews. Regression models were employed to analyze the association between DPI types and comprehension. Results Participants in the patient DPI groups scored significantly higher than those in the standard DPI groups [9.47 (±4.56) versus 6 (±4.02) in the DPI A group; 11.94 (±2.99) versus 9.25 (±2.70) in the DPI B group, p < 0.001]. Participants in the patient DPI groups spent less time during the interviews compared to those in the standard DPI groups (543 [±274.74] s versus 776.11 [±264.03] s in the DPI A group and 457.25 [±213.01] s versus 729.55 [±278.14] s in the DPI B group, p < 0.001). Patient‐centered DPIs were positively associated with good comprehension (OR: 80.97; 95% CI: 9.77~670.76; p < 0.001) and negatively associated with time consumption (Coef.: −230.20; 95% CI: −299.13, −161.27; p < 0.001). Education level, age, and income were also identified as potential contributors. Conclusions Comparative analysis showed patient‐centered DPI design significantly improves medication comprehension, supporting its use for effective information delivery.