Shimizu Yuri, Tsuchiya Masami, Asano Masaki, Imai Shungo, Kizaki Hayato, Ito Yukiko, Tsuchiya Makoto, Kuriyama Ryoko, Yoshida Nao, Shimada Masanori, Sando Takanori, Ishijima Tomo, Hori Satoko
Division of Drug Informatics, Keio University Faculty of Pharmacy, 1-5-30 Shibakoen, Minato-ku, Tokyo, 105-8512, Japan.
harmo Co., Ltd, 1-1-1 Shibaura Minato-ku, Tokyo, 105-0023, Japan.
Sci Rep. 2025 Jul 24;15(1):26867. doi: 10.1038/s41598-025-12249-3.
Tablets and capsules are widely used forms of oral medication, but some patients experience difficulty handling them, which can reduce medication adherence and affect health outcomes. This study aimed to identify factors contributing to perceived handling difficulty, using data from harmo, a nationwide electronic medication notebook system. A questionnaire was distributed to adult users who had been prescribed oral medications, and the responses were linked with personal health records to analyze medication characteristics and patient backgrounds. Among the 1,230 respondents, 24% reported difficulty with small tablets or capsules. A size threshold was identified: a combined long and short diameter of 13.3 mm or less was most associated with handling problems (ROC-AUC = 0.834). Binomial logistic regression analysis revealed that difficulty in applying force with the hands (OR = 2.64), prescription of small tablets or capsules (OR = 2.52), and medical histories of hypertension (OR = 1.69) and osteoporosis (OR = 4.99) were significantly associated with reported difficulty. These results suggest that both the physical characteristics of formulations and individual patient factors influence medication usability. Our results provide evidence to inform more patient-centered approaches to oral formulation design and prescribing practices, ultimately supporting better adherence and medication safety.
片剂和胶囊是广泛使用的口服药物剂型，但一些患者在服用时遇到困难，这可能会降低用药依从性并影响健康结果。本研究旨在利用全国性电子药物笔记本系统harmo的数据，确定导致感知服用困难的因素。向已开具口服药物处方的成年用户发放了一份问卷，并将回复与个人健康记录相关联，以分析药物特征和患者背景。在1230名受访者中，24%的人报告在服用小片剂或胶囊时存在困难。确定了一个尺寸阈值：长短径之和为13.3毫米或更小与服用问题最相关（ROC-AUC = 0.834）。二项式逻辑回归分析显示，手部用力困难（OR = 2.64）、小片剂或胶囊的处方（OR = 2.52）以及高血压病史（OR = 1.69）和骨质疏松症病史（OR = 4.99）与报告的困难显著相关。这些结果表明，制剂的物理特性和个体患者因素都会影响药物的可用性。我们的结果为以患者为中心的口服制剂设计和处方实践方法提供了依据，最终有助于提高依从性和用药安全性。
