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. 2019 Jan 17;9(1):e024837.
doi: 10.1136/bmjopen-2018-024837.

Readability assessment of package leaflets of biosimilars

María Ángeles Piñero-López  1 , Carlos Figueiredo-Escribá  1 , Pilar Modamio  1 , Cecilia F Lastra  1 , Eduardo L Mariño  1
Affiliations

Readability assessment of package leaflets of biosimilars

María Ángeles Piñero-López et al. BMJ Open. .

Abstract

Objectives: To assess the degree of readability and the length of the package leaflets of biosimilars.

Setting: The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website.

Participants: The study sample included the package leaflets written in English of all the biosimilars that were authorised by the EMA on 31 August 2017, and whose content was available via the internet on that date (n=35).

Design: This was a cross-sectional analytical study. The readability of the package leaflets of all biosimilars authorised by the EMA in August 2017 was determined applying the Flesch and Flesch-Kincaid formulas. The influence of the following variables on the readability and length was also analysed: package leaflet section, type of biosimilar, date of first authorisation of the biosimilar and type of medicine.

Results: A considerable variation of the package leaflets length was found (3154±803). The readability of all the package leaflets overtook the recommended value for health-related written materials taking into account Flesch-Kincaid Index, and none of the package leaflets were easy to understand according to the Flesch Index. Statistically significant differences (p<0.05) were observed between the sections of package leaflets in readability indices and length. The most difficult sections to understand were those related with the therapeutic indication of medicine and the possible side effects.

Conclusions: Package leaflets for authorised biosimilars may not fulfil the function for which they were designed. The competent organisations could be informed about the possible negative effect on the use of this type of medicines.

Keywords: biological medicinal product; biosimilar; package leaflet; patient information; readability.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Example of modifications that were made in the evaluated sections of the package leaflets before calculating quantitative variables.
Figure 2
Figure 2
Box plots of quantitative variables taking into account the package leaflet section and the type of medicine.
Figure 3
Figure 3
Medians of the quantitative variables taking into account the date of first authorisation.
See this image and copyright information in PMC

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References

    1. European Medicines Agency. Biosimilars in the EU. Information guide for healthcare professionals. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC5... (accessed13 Jul 2017).
    1. European Medicines Agency. Guideline on similar biological medicinal products. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin... (accessed 5 Sep 2017).
    1. McCamish M, Pakulski J, Sattler C, et al. . Toward interchangeable biologics. Clin Pharmacol Ther 2015;97:215–7. 10.1002/cpt.39 - DOI - PMC - PubMed
    1. Khraishi M, Stead D, Lukas M, et al. . Biosimilars: A multidisciplinary perspective. Clin Ther 2016;38:1238–49. 10.1016/j.clinthera.2016.02.023 - DOI - PubMed
    1. Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol 2010;28:28–31. 10.1038/nbt0110-28 - DOI - PubMed

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