Chan Huan-Keat, Hassali Mohamed Azmi
Department of Pharmacy, Sultanah Bahiyah Hospital, KM6, Jalan Langgar, 05460, Alor Setar, Kedah, Malaysia,
Int J Clin Pharm. 2014 Oct;36(5):904-13. doi: 10.1007/s11096-014-0003-1. Epub 2014 Aug 20.
Inability to read instructions on drug labels has been identified among the Malaysian population since 1990's.
To assess the impact of font-enlarged and pictogram-incorporated labels used for long-term medications on patients' adherence, comprehension and preferences.
Outpatient pharmacy in one of the major general hospitals across Northern Malaysia.
This was a three-arm, randomized controlled trial. Outpatients with refill prescriptions of selected oral antihypertensive or antidiabetic medications were screened for eligibility. They were randomly allocated with standard (n = 35), font-enlarged (n = 40) or pictogram-incorporated (n = 35) labels. Assessment of baseline adherence scores using the 8-item Morisky Medication Adherence Scale, comprehension scores using a structured questionnaire and preferences was conducted upon recruitment. Follow-up telephone interviews were conducted after 4 weeks.
The changes of patients' adherence and comprehension scores and their preferences.
Within-group comparisons demonstrated an increase of total adherence scores after 4 weeks in all three groups (mean changes 0.35, 0.58 and 0.67; p = 0.029, 0.013 and 0.011, respectively). The repeatedly measured total comprehension score of pictogram-incorporated label group was significantly higher than baseline (mean change 0.37, p = 0.010). Two intervention groups obtained significantly higher scores for few items in both adherence and comprehension measurements after 4 weeks as compared with baselines. As indicated by F tests, three groups did not significantly differ in the changes of both total adherence and comprehension scores (p = 0.573 and 0.069, respectively) with the subjects' age adjusted. Elderlies and those with a higher number of morbidity preferred pictogram-incorporated label over font-enlarged label.
We did not find a significant change of both adherence and comprehension levels after the introduction of modified medication labels. However, on the basis of within-group comparisons, they may have positive influences on certain aspects of patients' adherence and comprehension. Variations in preferences may reflect the unique need of different subgroups in receiving written medication instructions.
自20世纪90年代以来,马来西亚人群中已发现存在无法读懂药品标签说明的情况。
评估用于长期用药的字体放大且带有象形图的标签对患者依从性、理解能力和偏好的影响。
马来西亚北部一家主要综合医院的门诊药房。
这是一项三臂随机对照试验。对有选定口服抗高血压或抗糖尿病药物续方的门诊患者进行资格筛查。他们被随机分配到使用标准标签(n = 35)、字体放大标签(n = 40)或带有象形图标签(n = 35)的组。招募时使用8项Morisky药物依从性量表评估基线依从性得分,使用结构化问卷评估理解得分,并了解患者偏好。4周后进行随访电话访谈。
患者依从性和理解得分的变化以及他们的偏好。
组内比较显示,所有三组在4周后总依从性得分均有所增加(平均变化分别为0.35、0.58和0.67;p分别为0.029、0.013和0.011)。带有象形图标签组的重复测量总理解得分显著高于基线(平均变化0.37,p = 0.010)。与基线相比,两个干预组在4周后的依从性和理解测量中,有几个项目的得分显著更高。F检验表明,在调整受试者年龄后,三组在总依从性和理解得分的变化上没有显著差异(p分别为0.573和0.069)。老年人和发病率较高的人更喜欢带有象形图的标签而非字体放大的标签。
引入改良后的药品标签后,我们未发现依从性和理解水平有显著变化。然而,基于组内比较,它们可能对患者依从性和理解的某些方面有积极影响。偏好的差异可能反映了不同亚组在接收书面用药说明方面的独特需求。