Proadi-SUS Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, RS, Brazil.
GGREG-General Management Office for Regulations and Good Regulatory Practices, Brazilian Health Regulatory Agency (ANVISA), Brasília, DF, Brazil.
PLoS One. 2019 Feb 22;14(2):e0212173. doi: 10.1371/journal.pone.0212173. eCollection 2019.
To evaluate the labeling preferences of medication users and characterize their perceptions of the comprehensibility and readability of medication labels.
We conducted a population-based cross-sectional study of medication users aged 18 years or older in 10 Brazilian capital cities. Perceptions of the comprehensibility and readability of medication labels in relation to sociodemographic characteristics were evaluated by Poisson regression models with robust variance. Labeling preferences were assessed through questions addressing possible improvements and through the use of digitally simulated packages.
Of 6,255 medication users interviewed, more than half found it difficult or very difficult to read (50.8%) and/or understand (52.0%) medication labels. Difficulties were more pronounced for participants aged 40 years or older, with lower levels of education, and non-whites. Increasing the font size (93.7%), describing the indications for use (95.9%) and contraindications (95.6%) on the label, and highlighting the expiration date (96.3%) were the most widely accepted improvements. In the evaluation of simulated packages, users preferred factors that improved readability, such as increased font size, use of graphic elements and color to highlight the concentration of the active ingredient, and contrast between the font color and background. The new simulated package design, with increased font size, color to highlight the concentration and contrast between the font color and background, was preferred over the standard design by 77.0% of participants.
Based on users' perceptions, increased font size and use of graphic elements and color to emphasize critical information, such as expiration date and concentration, are factors that contribute to making medication labels clearer to users. Pharmaceutical industries and policy makers should consider these items when developing labels and defining policies on this issue.
评估用药者对药品标签的偏好,并描述他们对药品标签的理解性和易读性的认知。
我们在巴西 10 个首府城市开展了一项基于人群的横断面研究,纳入了 18 岁及以上的用药者。采用稳健方差的 Poisson 回归模型评估了与社会人口学特征相关的对药品标签的理解性和易读性的认知。通过询问可能的改进措施以及使用数字模拟包装的方式评估标签偏好。
在接受采访的 6255 名用药者中,超过一半的人表示阅读(50.8%)和/或理解(52.0%)药品标签有困难或非常困难。40 岁及以上、受教育程度较低和非白人的参与者困难更为明显。增加字体大小(93.7%)、在标签上描述适应证(95.9%)和禁忌证(95.6%)、突出有效期(96.3%)是最广泛接受的改进措施。在模拟包装评估中,用户更喜欢提高可读性的因素,如增加字体大小、使用图形元素和颜色突出活性成分的浓度、以及字体颜色与背景之间的对比度。新的模拟包装设计,增加了字体大小、颜色突出浓度和字体颜色与背景之间的对比度,比标准设计更受 77.0%的参与者的青睐。
根据用户的认知,增加字体大小和使用图形元素和颜色来突出关键信息,如有效期和浓度,是使药品标签更易于用户理解的因素。制药行业和政策制定者在制定标签和制定相关政策时应考虑这些因素。