Yang Jinwook, Kwon Kyenghee
Department of Food & Medical Products Regulatory Policy, Dongguk University, Seoul, Republic of Korea.
College of Pharmacy, Dongguk University, Gyeonggi-do, Republic of Korea.
Drug Healthc Patient Saf. 2025 Sep 9;17:181-196. doi: 10.2147/DHPS.S529397. eCollection 2025.
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.
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.
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.
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.
电子标签是指以电子方式提供药品说明书，在一些国家已被引入作为印刷说明书的替代方式。然而，从患者角度来看，电子标签是否能提高药品信息的可读性和可用性，目前知之甚少。本研究旨在评估韩国电子标签与传统纸质说明书相比的可读性和可用性。
我们采用混合方法进行用户测试，通过便利抽样招募了77名成年参与者。参与者被分配去评估一份纸质说明书或一种处方抗高血压药或非处方非甾体抗炎药的电子标签。参与者通过自己的手机访问来评估印刷说明书或相应的PDF文件。定量指标包括可追溯性（查找信息的准确性）、追踪速度（查找信息所需时间）和理解程度（内容是否被很好理解）。进行了半结构化访谈，以探讨用户体验、感知到的障碍以及采用电子标签的偏好。
在两种药物类型中，电子标签的表现均低于纸质说明书。对于抗高血压药，可追溯性下降了4.7%，追踪速度下降了0.08分，理解程度下降了3.3%。对于非甾体抗炎药，这些下降分别为7.0%、0.19分和5.7%。定性研究结果显示，参与者对电子标签的看法不一，一些人重视搜索功能和可调整的文本大小，而另一些人则强调浏览内容困难和可访问性降低。参与者强调需要改进格式、采用直观的结构并更好地利用数字功能。
当前的电子标签格式可能无法充分满足患者对药品信息的需求。为支持成功实施，电子标签应重新设计，重点关注以患者为中心的原则，确保公平获取，并在实际环境中进行测试。关于如何使用电子标签的教育和宣传活动将提供实用指导并鼓励患者接受。这些研究结果提供了以患者为中心的证据，为改进电子标签政策和设计提供参考。
