Readability of Medication Package Inserts Accompanying Prescription Drugs and Conformity of the Package Inserts Information with Regulatory Requirements

Abstract: Background: Medication package inserts (MPIs) provides patients with appropriate information on the rational use of drugs. This study evaluated level conformity MPIs regulatory drug labelling requirements and determined readability selected prescription MPIs. Methods: One hundred fifty-six commonly used prescribed antilipidemics, anticonvulsants, anti-diabetes, antiarthritis antihypertensives in Nigeria were retrieved from four pharmacies. The availability 20 items for drugs by National Agency Food Drug Administration Control (NAFDAC). 31 randomly was assessed seven measures. Primary outcomes percentage reading grade Secondary sentence characteristics. Results: NAFDAC ranged 82.9% to 89.6%. All included active ingredient(s), adverse reactions, indications. Few MPIs, 46.8% had section product net content 53 (34.0%) omitted overdose. 14.55 ± 1.71 (undergraduate level). Most 25 (80.6%), very difficult read. Conclusion: high though few vital missing some Majority authority may need optimize prior marketing. Keywords: inserts, labelling, Readability assessment, SMOG Reading level, Nigeria.