Assessment of the readability, understandability, informational contents conformity and usefulness of medication package inserts to Sudanese patients

Abstract

The objective of this study was the assessment of the readability, understandability, informational contents’ conformity and the ultimate usefulness of medication package inserts to Sudanese patients. Two equal sets of thirty one (n=31) package inserts, for same generic names, of European and developing countries produce, were compared using seven core indicators which were, the texts’ language, total words count, area (size) to the nearest cm,2 font size, leading in points, frequency of availability of section headings and the presence or absence of nine defined medications’ section headings. Results showed significant differences between the words counts and area size of the two groups of package inserts (P value =0.0000 for both). Majority (67.74%) of studied package inserts, were written in English only with much technical terms. The screening of the nine defined section headings, showed significant differences between five of the nine defined section headings, namely, inactive ingredients, use during pregnancy, over dose and management, use after expiry date and date of last version, (P value<0.05). Package inserts’  information contents’ disparities, texts language and terminology  stand  as  barriers to their readability, understandability and usefulness to patients. To secure package inserts usefulness, official regulators shall standardize their design, typography and informational contents.