Abstract
PURPOSE: E-labeling, which refers to delivering medicine package leaflets electronically, has been introduced in several countries as an alternative to printed leaflets. However, little is known about whether e-labeling improves the readability and usability of medicine information from the patient's perspective. This study aimed to evaluate the readability and usability of e-labeling compared to traditional paper leaflets in South Korea. METHODS: We conducted a mixed-methods user testing involving 77 adult participants recruited via convenience sampling. Participants were assigned to evaluate either a paper leaflet or e-labeling for a prescription antihypertensive or a non-prescription NSAID. Participants evaluated the printed leaflets or the corresponding PDF files by accessing them with their own mobile phones. Quantitative measures included traceability (accuracy in finding information), tracking speed (time taken to find information), and comprehension (whether the content was well understood). Semi-structured interviews were conducted to explore user experiences, perceived barriers, and preferences for e-labeling adoption. RESULTS: Across both drug types, e-labeling showed lower performance compared to paper leaflets. For the antihypertensive, traceability declined by 4.7%, tracking speed by 0.08 points, and comprehension by 3.3%. For the NSAID, these declines were 7.0%, 0.19 points, and 5.7%, respectively. Qualitative findings revealed mixed perceptions to e-labeling, with some valuing search functions and adjustable text size, while others highlighted difficulties navigating content and reduced accessibility. Participants emphasized the need for improved formatting, intuitive structure, and better utilization of digital features. CONCLUSION: The current e-labeling format may not sufficiently meet patients' needs for medicine information. To support successful implementation, e-labeling should be redesigned with a focus on patient-centered principles, ensuring equitable access, and being tested in real-world settings. Education and awareness campaigns on how to use e-labeling would provide practical guidance and encourage acceptance among patients. These findings provide patient-centered evidence to inform improvements in e-labeling policies and design.