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

Abstract

2 AbstractPurpose 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: 21 physicians (Dg), 22 pharmacists (Pg) and 20 potential consumers (PCg).Results Almost all (85%) of the PCg participants were educated above the 9 th grade, although the majority of them (95%) referred at least one package insert interpretation issue, mainly related to the comprehension of technical terms. Amongst other differences between groups, the Pg participants obtained a significantly less score regarding the opinion on the layout of the titles. Furthermore, the Pg and Dg 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. Regarding the readability assessment of this package insert, the method proposed in the EMA guideline might not be as effective as expected. Future research is advisable.

Readability assessment of package leaflets of biosimilars

“…The most difficult section to understand was section 1 (‘What X is and what it is used for’), which offers information on the therapeutic indications and is considered the most important by patients 31. Section 4 (‘Possible side effects’) was the second most difficult section and, despite being judged to be very important by patients,46 it usually contains lists of complex medical terms,47 which was the case in the majority of the package leaflets analysed in the present study. This can cause negative attitudes in patients when they are considering using the medicine, which seems to make it clear that this section needs to be written using a language which is less alarming for the patient 48.…”

Evaluation of brand names of medicines: linguistic and format issues

“…It should be nevertheless stressed that further studies on the best linguistic, orthographic and typographic format of brand names are needed, since their use in PLs is considered relevant by patients and health professionals, knowing their inadequate format in PLs or in labels may promote medication errors …”

Using an Automatic Tool to Identify Potential Readability Issues in a Large Sample of Medicinal Package Inserts

“…In the optimized PIs of this study the use of difficult words was reduced in 84%, abbreviations were reduced in 76%, and long words and sentences were reduced in 20% and 76%, respectively. There are reports highlighting that the users of medicines and health professional reject the use of abbreviations in PIs [12,13] and find that reducing their use in health materials favours PI readability and the safe use of medicines [14]. In another study, the use of Latin abbreviations was particularly difficult to understand even for educated people [15].…”