Tong Vivien, Raynor David K, Hamrosi Kim K, Acharya Basoori, Panchal Nisha, Aslani Parisa
1 Faculty of Pharmacy, The University of Sydney, Sydney, Australia.
2 School of Healthcare, University of Leeds, Leeds, United Kingdom.
Ther Innov Regul Sci. 2016 Jul;50(4):427-435. doi: 10.1177/2168479016628301.
With common over-the-counter (OTC) medication use, OTC labels as medicine information sources must be of high quality and usability. Standardized OTC labeling has been proposed in Australia using the Medicine Information Box (MIB), modeled on the US Drug Facts label. However, limited research has explored consumer opinions on existing nonstandardized Australian OTC, US Drug Facts, and proposed MIB labels. Therefore, this study aimed to explore consumer opinions on all 3 groups of OTC labels.
Three focus groups (N = 21 participants) were conducted in Sydney, Australia. Participants were shown existing Australian OTC labels, US Drug Facts labels, and mock MIB formats based on the Australian Therapeutic Goods Administration proposal. Discussions were audio recorded, transcribed verbatim, and thematically analyzed.
Participants expressed varying opinions regarding existing nonstandardized Australian OTC labels' content and design, from acknowledgment of positive aspects (clear headings, relevant content) to decreased perceived readability (suboptimal color use, font size) and content discrepancies. Participants identified key Drug Facts and MIB label characteristics that contributed to perceived usability and format clarity (good headings, black-and-white format). Many preferred the Drug Facts label because of its greater perceived clarity and usability. Missing content (inactive ingredients, further contact details) were identified and consequently became opportunities for MIB improvement.
Most participants seemed to prefer the US Drug Facts label, partly because of its perceived completeness. These findings suggest further improvements for the proposed MIB as a step toward Australian OTC label standardization.
对于常见的非处方(OTC)药物使用,作为药物信息来源的OTC标签必须具备高质量和易用性。澳大利亚已提议采用仿照美国药品说明书标签的药品信息框(MIB)实现OTC标签标准化。然而,针对消费者对现有非标准化澳大利亚OTC标签、美国药品说明书标签以及提议的MIB标签的看法的研究较少。因此,本研究旨在探究消费者对这三组OTC标签的看法。
在澳大利亚悉尼进行了三个焦点小组讨论(N = 21名参与者)。向参与者展示了现有的澳大利亚OTC标签、美国药品说明书标签以及基于澳大利亚治疗用品管理局提议的模拟MIB格式。讨论进行了录音,逐字转录,并进行了主题分析。
参与者对现有非标准化澳大利亚OTC标签的内容和设计表达了不同的看法,从认可其积极方面(清晰的标题、相关内容)到认为可读性下降(颜色使用欠佳、字体大小不合适)以及内容存在差异。参与者确定了有助于提高感知易用性和格式清晰度的关键药品说明书和MIB标签特征(良好的标题、黑白格式)。许多人更喜欢药品说明书标签,因为它的清晰度和易用性更高。发现了缺失的内容(非活性成分、进一步的联系细节),因此这些成为了改进MIB的机会。
大多数参与者似乎更喜欢美国药品说明书标签,部分原因是其完整性。这些发现表明,作为澳大利亚OTC标签标准化的一步,提议的MIB需要进一步改进。