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Readability Assessment of Package Inserts of Biological Medicinal Products from the European Medicines Agency Website

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Abstract

Background

Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability.

Objective

Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010.

Methods

A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones. The package inserts were downloaded from the European Medicines Agency website in 2007 and 2010. Readability was evaluated for the entire text of five of the six sections of the package inserts and for the ‘Annex’ when there was one. Three readability formulas were used: SMOG (Simple Measure of Gobbledygook) grade, Flesh-Kincaid grade level, and Szigriszt’s perspicuity index.

Results

No significant differences were found between the readability results for the 2007 package inserts and those from 2010 according to any of the three readability indices studied (p > 0.05). However, there were significant differences (p < 0.05) between the readability scores of the sections of the package inserts in both 2007 and 2010. The readability of the package inserts was above the recommended sixth grade reading level (ages 11–12) and may lead to difficulties of understanding for people with limited literacy.

Conclusions

All the sections should be easy to read and, therefore, the readability of the medicine package inserts studied should be improved.

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Author contributions

Mª. Angeles Piñero-López acquired, analyzed and interpreted data; and drafted and approved the final submitted manuscript. Pilar Modamio conceived of the study, analyzed and interpreted data, and drafted and approved the final submitted manuscript. Cecilia F. Lastra made suggestions for data interpretation and approved the final submitted manuscript. Eduardo L. Mariño conceived of the study, analyzed and interpreted data, and drafted and approved the final submitted manuscript.

Conflicts of interest

Mª. Ángeles Piñero-López, Pilar Modamio, Cecilia F. Lastra and Eduardo L. Mariño have no conflicts of interest that are directly relevant to the content of this study. The authors certify that no funding has been received for the conduct of this study and/or preparation of this manuscript. The authors have full control of all primary data and they agree to allow the journal to review their data if requested.

The manuscript does not contain clinical studies or patient data.

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Authors and Affiliations

  1. Clinical Pharmacy and Pharmacotherapy Unit, Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028, Barcelona, Spain

    Mª. Ángeles Piñero-López, Pilar Modamio, Cecilia F. Lastra & Eduardo L. Mariño

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  1. Mª. Ángeles Piñero-López
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  2. Pilar Modamio
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Correspondence to Eduardo L. Mariño.

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Piñero-López, M.Á., Modamio, P., Lastra, C.F. et al. Readability Assessment of Package Inserts of Biological Medicinal Products from the European Medicines Agency Website. Drug Saf 37, 543–554 (2014). https://doi.org/10.1007/s40264-014-0188-1

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