Written Medicine Information from English-Speaking Countries--How Does It Compare?

Background: There has been an increasing drive from consumers for more information to be available about their medicines. However, the layout and presentation of such written information is variable, and the poor format and design discourages people from reading the documents. Objective: To identify, collate, and evaluate different formats of written medicine information (WMI). Methods: Three researchers evaluated 157 samples of WMI for 10 prescription and 3 over-the-counter medicines from 6 English-speaking countries compared with the United States Keystone Consensus Criterion 8 (USKCC8) and the Ten Key Principles (TKP) of Consumer Medicine Information. Readability was measured using Flesch-Kincaid Grade Level (FKGL) and Fog tests. Compliance (%) with the criteria was computed and examined using the median test. Results: Overall median compliance with USKCC8 was 70%, and 74% to TKP. New Zealand leaflets achieved the highest compliance with USKCC8 (83%, Interquartile range (IQR) 70–89%), with US leaflets the lowest (55%. IQR 45–70%). Australian and New Zealand leaflets showed the highest compliance with TKP (90%, IQR 80–100% and 87–97%, respectively), while UK leaflets demonstrated the lowest (60%, IQR 52–71%). Overall median reading grades for the leaflets were 10 (Flesch-Kincaid Grade Level) and 11 (Fog). Conclusions: Compliance with USKCC8 and TKP varied greatly between countries, with readability grades exceeding the recommended range. International examples of WMI show wide variation in compliance with guidelines on recommended format and presentation. These examples of WMI require high literacy to read. Future WMI development should use more recommended formats and increase comprehensibility.