Usability of Medicine Package Inserts for Chronic Diseases: A Survey of the Pharmaceutical Market in Jos, Nigeria

Abstract

Background: The burden of illness is increasingly tending towards chronic diseases while medication adherence is often unsatisfactory. The patient information leaflet is one model that has the prospect to improve medication adherence. Improving the readability and content based validity of medication information has great educational potential to influence adherence to medicines. Objectives: This study assessed the readability and content based validity of patient information leaflets. It compared the readability and the content based validity of foreign and indigenous based patient medicine inserts. Methods: The study was conducted in two tertiary hospitals in Jos, Plateau State, Nigeria. The study was a cross-sectional design. Sixty six leaflets for chronic diseases were randomly selected. Results: The mean Flesch readability ease was 23.17, the Flesch-kincaid grade level was 13.7 and mean word count was 1219.89. The average font size and line spacing were 1.13 and 1.15 respectively. Only 3% of the leaflets had pictogram. All the leaflets had information on generic name of the drug and indication for use. Nigeria indigenous leaflets recorded an average Flesch readability ease of 18.39 compared to foreign leaflets which had 25.43 (p-value = 0.070). Flesch Kincaid grade level for indigenous and foreign leaflets were 14.46 and 13.30 respectively (p-value = 0.075). The Nigeria pharmaceutical leaflets had a mean font size of 1.12 while the foreign leaflets had 1.13. The line spacing for Nigeria leaflets was 1.11 compared to the foreign leaflets which recorded 1.17. The foreign pharmaceutical companies were more likely to indicate information on pregnancy/lactation (p-value = 0.002), paediatric/geriatric (p-value = 0-007), shelf-life (p-value = 0.033) and handling of machine while on medication (p-value = 0.038).    Conclusion: These findings exposed the inadequacy and failure of the Nigeria’s drug policies to coordinate and ensure best practices in the pharmaceutical sector. Our findings demonstrated that the readability and content validity of the indigenous patient information leaflets were poor. However, the foreign leaflets compared statistically better in terms of content validity.