Quality Control Outcomes of Pharmaceuticals and Allied Products Analyzed in the Mission for Essential Drugs and Supplies (MEDS) Laboratory: 2018-2020

Kennedy O Abuga; Stephen T Kigera; Mildred Wanyama; Wycliffe M Nandama; Isaac O Kibwage

Kennedy O Abuga Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya
Stephen T Kigera Mission for Essential Drugs and Supplies, P.O. Box 78040 – 00507, Viwandani, Nairobi
Mildred Wanyama Mission for Essential Drugs and Supplies, P.O. Box 78040 – 00507, Viwandani, Nairobi
Wycliffe M Nandama Mission for Essential Drugs and Supplies, P.O. Box 78040 – 00507, Viwandani, Nairobi
Isaac O Kibwage Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya and Egerton University, Njoro, P.O. Box 536, Egerton 20115, Kenya.

Keywords: MEDS, drug product, assay, dissolution, substandard and falsified medicine, specification

Abstract

Quality control data was compiled for samples analyzed in the Mission for Essential Drugs and Supplies (MEDS) laboratory in the 2018-2020 period. During this interval, the laboratory received and processed 6,059 samples from Kenya and international sources. These samples comprised domestic (31.9%) and internationallymanufactured (67.0%) products while 1.1% were of undeclared origin. Analysis was performed using compendial and/or in-house specifications. The non-compliance rate was 8.0% consisting of 3.2 % local, 4.5% imports and 0.3% for samples of unknown origin. The top 20 drug classes with high failure rates were: environmental monitoring samples (100.0%), joint lubricants (50.0%), dialysis solutions (50.0%), microscopy stains (50.0%), herbal preparations (43.2%), nootropics (33.3%), solvents (33.3%), waters (32.0%), antiseptics/disinfectants (29.8%), medical devices (28.4%), hormones (23.7%), nutrient mixtures (20.9%), disease modifying antirheumatic drugs (20.0%), anti-incontinence drugs (16.7%), uterotonics (13.8%), vitamins (13.0%), anti-ulcer drugs (12.6%), vasopressor agents (12.5%), anthelmintics (12.2%) and hypolipidemics (10.8%). Full compliance was however, recorded with antiflatulants, digestive enzymes, antidiarrheals, prokinetics, anti-arrhythmics, anti-anginals, choleretics, antimycobacterials, anaesthetics, antimigraine drugs, bisphosphonates, antimyaesthenics thyroid/antithyroid drugs, erectile dysfunction drugs, ovulants, uricosurics, osmotic diuretics, vaginal lubricants, tocolytics, histaminics, lozenges, ear drops, detergents, radiopharmaceuticals, proteins, probiotics, acaricides, sterilization validation swabs and excipients. There was a significant increase in the overall non-compliance rate compared to the previous report for 2013-2017. These results add impetus towards the need for regulatory stringency to curb the occurrence of substandard and falsified products in the market.