Clinical Pharmacy and Pharmacotherapy Unit, Department of Pharmacy and Pharmaceutical Technology, and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.
BMJ Open. 2019 Jan 17;9(1):e024837. doi: 10.1136/bmjopen-2018-024837.
To assess the degree of readability and the length of the package leaflets of biosimilars.
The package leaflets analysed were downloaded from the European Medicines Agency (EMA) website.
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).
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.
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.
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.
评估生物类似药说明书的可读性和长度。
分析的说明书从欧洲药品管理局（EMA）网站下载。
研究样本包括 2017 年 8 月 31 日 EMA 批准的所有生物类似药的英文说明书，且其内容在该日可通过互联网获取（n=35）。
这是一项横断面分析研究。通过应用 Flesch 和 Flesch-Kincaid 公式来确定 2017 年 8 月 EMA 批准的所有生物类似药说明书的可读性。还分析了以下变量对说明书可读性和长度的影响：说明书章节、生物类似药类型、生物类似药首次批准日期和药物类型。
说明书长度差异较大（3154±803）。考虑到 Flesch-Kincaid 指数，所有说明书的可读性均超过了与健康相关书面材料相关的推荐值，根据 Flesch 指数，没有一个说明书易于理解。在可读性指数和长度方面，说明书各章节之间存在显著差异（p<0.05）。最难理解的章节是与药物治疗指征和可能的副作用相关的章节。
已批准生物类似药的说明书可能无法发挥其设计目的。可向相关主管组织通报这种类型药物使用的潜在负面影响。
