Using an Automatic Tool to Identify Potential Readability Issues in a Large Sampleâof MedicinalâPackage Inserts

Methods Inf Med 2015; 54: 379–381 http://dx.doi.org/10.3414/ME15-04-0003 received: March 6, 2015 accepted: May 29, 2015 epub ahead of print: June 25, 2015 * Supplementary online material published on our website www.methods-online.com Dear Editor, The main aim of this brief communication was to highlight how automatic methodologies are useful in the process of optimization of medicinal package inserts (PIs). In this context, the objectives of the present work were to quantify the average number of words and the most frequent abbreviations, i.e. the abbreviations with twenty or more occurrences in a large sample of medicinal PIs using an electronic tool that enables to apply an automatic procedure to this end. PIs of medicinal products are very important in transmitting information on the effective and safe use of medicines [1– 4]. Currently, there is a wide range of regulations worldwide concerning the adequate development and approval of PIs by marketing authorization holders and medicine agencies [5–7]. Aiming to ensure proper intelligibility and usability of PIs, it is recommended the use of: • A limited number of words (e.g. approximately 1500 words) [4, 8–10]. • A restricted use of abbreviations, with the exception of the abbreviations to express units of measure that are allowed, such as ml, but not cc (cubic centimetres) that may be mistaken as ‘u’ (units) [5–7, 11].