EVALUATION OF CONTENT VALIDITY OF MEDICINE INFORMATION LEAFLETS IN PACKAGES OF ARTEMISININ-BASED COMBINATION THERAPY ANTIMALARIALS USED IN NIGERIA
RACHEL OBONOSE TITUS*, MARGARET OLUBUNMI AFOLABI AND OMONIYI JOSEPH OLA-OLORUN
Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, Obafemi Awolowo University, Ile-Ife, Osun State, Nigeria.
Afr. J Pharm Res Dev; Volume 12(1): 070-078 ; 2020
Artemisinin-based-combination therapies (ACTs) are often used over-the-counter for treatment of malaria which is endemic in Nigeria. Study reports have shown that information contained in their medicine information leaflets (MILs), essential to achieving therapeutic outcomes, is oftentimes incomplete. The study evaluated the content validity of MILs of ACTs used in Nigeria and assessed the ordering of the pieces of information contained in them based on guidelines in the Summary Product Characteristics (SPC) of the Nigeria’s medicine regulatory agency, National Agency for Food and Drugs Administration and Control (NAFDAC). The research was a descriptive cross-sectional study of 32 MILs of ACTs conveniently sampled over four months in pharmacies across four geopolitical zones of Nigeria. The NAFDAC-recommended SPC guidelines were enumerated to yield a 31-item evaluation guide which was employed for the evaluation. There were twenty-three (71.88%) of the thirty-one recommended information items in the thirty-two MILs with a mean content score of 24.17±2.57 which was significantly less (t = -15.99, df = 30, p=.000) than the expected test value of thirty-one. The difference between the mean content scores of the MILs of locally produced ACTs (23.22±2.32) and imported ones (25.11±2.80) was not statistically significant. The information contents were not always ordered as listed in the NAFDAC’s SPC. The content validity of the information in the MILs of ACT antimalarials in Nigeria is suboptimal. Also, ordering of the information was irregular. Therefore, NAFDAC should be firmer in enforcing full compliance with their specifications for information contained in MILs.
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KEYWORDS: Medicine information leaflets, Content validity, Artemisinin-based combination therapies, Antimalarial, Self-medication, Self-care.