Pharmacovigilance & Clinical Trials

Biography

Biography: M Ángeles Piñero-López

Abstract

According to European Directives, the package leaflet is the leaflet containing information for the user which accompanies the medicinal product, and it must be written and designed to be understandable and clearly legible. The aim of this study was to evaluate and compare the readability levels of package leaflets of biopharmaceuticals available on line. Two samples of package leaflets of the same authorized biopharmaceuticals available on line in two years (2007 and 2010) were selected and downloaded from the European Medicines Agency (EMA). Biopharmaceuticals were sorted into 5 product categories according to their source, and into 2 groups according the year of authorization. Five out of the six entire sections of the package leaflets were studied: “1. What X is and what it is used for”, “2.What you need to know before you take (or use) X”, “3. How to take (or use) X”, “4. Possible side effects” and “5. How to store X”. Three formulas (SMOG grade, Flesh-Kincaid grade level, and Szigriszt’s perspicuity index) were used to obtain readability levels. No significant differences between readability results for the two years studied were observed (p>0.05). However, significant differences between readability package leaflet sections in both 2007 and 2010 were found (p <0.05). The most difficult section was “4”, and the less difficult was “5”. Besides, all evaluated package leaflets had a very low degree of readability. Efforts to improve readability of package leaflets of biopharmaceuticals, available from EMA website, must be done to promote patient safety.