Readability assessment of package leaflets of biosimilars

Abstract

ObjectivesTo assess the degree of readability and the length of the package leaflets of biosimilars.SettingThe package leaflets analysed were downloaded from the European Medicines Agency (EMA) website.ParticipantsThe 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).DesignThis 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.ResultsA 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.ConclusionsPackage 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.

Assessing the Readability of Medicine Information Materials: The Case of Tikur Anbessa Specialized Hospital – Mixed Approach

“…One aspect that affects the level of comprehension of written material is, in general, the level of literacy of the community. 1 Literacy is the ability to identify, understand, interpret, create, communicate and compute, using printed and written materials associated with varying contexts. 2 General literacy, acquaintance with the healthcare system, and the method of health information provision influence health literacy and predict an individual's health status.…”

“…These complement and reinforce the information provided by healthcare professionals. 1 The readability of these materials should be grade-appropriate, since understanding them may influence treatment decisions and potentially, patient health outcomes. 7 Readability is defined as "the simplicity with which written materials are read."…”

“…One aspect that affects the level of comprehension of written material is, in general, the level of literacy of the community. 1 Literacy is the ability to identify, understand, interpret, create, communicate and compute, using printed and written materials associated with varying contexts. 2…”

“…The most commonly used medicine information source as consulted by patients is the package leaflet which is defined as “a leaflet containing information for the user which accompanies the medicinal product.” These complement and reinforce the information provided by healthcare professionals. 1 The readability of these materials should be grade-appropriate, since understanding them may influence treatment decisions and potentially, patient health outcomes. 7 …”