Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine.

PURPOSE: To explore and compare the opinions of physicians, pharmacists and potential users on the readability of a package insert of an over-the-counter medicine.
METHODS: Exploratory study based on the administration of a semi-open questionnaire. This instrument was developed according to the readability guideline of the European Medicine Agency (EMA) and used to evaluate participants' accessibility to, and comprehensibility of, the package insert for diclofenac 12.5 mg tablets. Sixty-three participants were recruited from the Lisbon region and enrolled in three groups: physicians (Dg), pharmacists (Pg) and potential consumers (PCg), with a minimum of 20 participants each.
RESULTS: Almost all (85 %) of the 20 PCg participants were educated above the 9th grade, although the majority of them (95 %) referred to, at least, one package insert interpretation issue, mainly related to the comprehension of technical terms. Amongst other differences between the groups, the Pg participants (n = 22) obtained a significantly less favourable opinion regarding the layout of the titles. Furthermore, the Pg and Dg (n = 21) participants proposed technical enhancements, such as the use of a table to explain the posology, precautions in case of renal failure, or the recommendation to take the tablets with meals.
CONCLUSIONS: Differences in the way of using the diclofenac tablets are expected, considering the comprehension dissimilarities between health professionals and potential consumers. The package insert of diclofenac 12.5 mg could be enhanced for safer use. Regarding the readability assessment of this package insert, the method proposed in the EMA guidelines might not be as effective as expected. Future research is advisable.