Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review

Abstract

This is a repository copy of Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review.

Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues

“…The initial inclusion criteria was based on the selection of all illustrations and tables related to how to take/use the medicine, because in accordance to previous studies, this theme is relevant for patients, potential users of medicines and health professionals . In a second step, the following illustrations were purposively selected: two figures on the administration of tablets (instructions to not break a tablet or on how to split a pill), because tablets are the most commonly consumed pharmaceutical forms, and two pictograms covering other types of administration instructions: one pictogram on syrup administration of a prescription for paediatric medicines, because the caregivers of children manifest a preference for simple and clear written materials, and one pictogram on the transdermal system application of a OTC medicine, because OTC may be acquired without health professionals' mediation . In addition, the tables with the highest number of columns and rows were selected, because these tables are likely to comprise more information and, thus are likely to be more complex to read and interpret.…”

“…Besides the above mentioned regulatory requirements, there are scientific studies specifically done on the positive and negative aspects of using illustrations or other graphic elements in the MPIs and other written documents (e.g. bullets or headings) . Illustrations increase attention, comprehension and recall of health materials, this being particularly relevant for the low‐literate patients, and especially if pictures are associated with written text or oral instructions .…”

“…found that in the majority of the cases pictures were confusing for the participating patients from a general internal medicine clinic in United States, with around half of them presenting limited literacy. Moreover, the use of bold, bullets and headings are among the common design strategies to facilitate the reading of prose information . Oppositely, the use of underline, italics, hyphenated lists, headings with text boxes and capitalised letters in the body text are not recommended (e.g.…”

“…Oppositely, the use of underline, italics, hyphenated lists, headings with text boxes and capitalised letters in the body text are not recommended (e.g. the use of capitalised sentences in the body text), because these items do not favour text legibility . For instance, boxed headings must not appear in the final printed packaging materials …”

“…Given the current regulatory requirements and the existing body of literature, it was considered relevant to characterise the graphic elements in a representative sample of Portuguese MPIs, as well as to evaluate the level of potential users' comprehension regarding illustrations and tables from the sampled MPIs. In this context, two exploratory studies were developed (Study A and B): Study A aimed to a) characterise (quantitatively and qualitatively) all the following key graphical elements, i.e.…”