Quality Control Results of Pharmaceuticals Analyzed in the Mission for Essential Drugs and  Supplies (MEDS) Laboratory During the Period 2013-2017

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

Kennedy O Abuga Department of Pharmacy, 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 Egerton University, Njoro, P.O. Box 536, Egerton 20115, Kenya

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

Abstract

During the 2013-2017 period, the MEDS laboratory received and processed 6853 samples.
Samples were sourced from Kenya and other sub-Saharan Africa countries. The samples
submitted comprised Kenyan manufactured (31.9%) and internationally manufactured
products (67.9%) while nine samples were of unknown origin. Analysis was carried out
according to compendial and/or in-house specifications. The non-compliance rate was 5.1%
consisting of 1.2 % local and 3.8% imports. The top ten drug classes with high failure rates
were antimyasthenics (50.0%), antiseptics/disinfectants (24.7%), anthelminthics (22.0%),
thyroid/antithyroid drugs (20.0%), nutrient mixtures (18.5%), uricosurics (12.5%), waters
(11.6%), mixed anti-infectives (11.1%), hemostatics (10.0%) and nootropics (10.0%). Full
compliance was however, recorded with laxatives, antidiarrheals, antihemorrhoidals,
prokinetics, antithrombotics, antithrombocytopenia agents, vasopressors, anti-arrhythmic
drugs, anti-anginal drugs, disease modifying antirheumatic drugs, antimigraine drugs,
vertigolytics, muscle relaxants, bisphosphonates, joint lubricants, hormones,
anticholinergics, osmotic diuretics, hypophosphatemics, lubricants, minerals, amino
acids/peptides, immunomodulatory agents, choleretics, antidotes, lozenges, ear drops,
proteins/glycoproteins, herbal products, X-ray contrast media, vaccines, environmental
monitoring, medical devices/equipment and cleaning validation swabs. A total of 23
substandard and falsified medicines devoid of active ingredients were encountered over the
five-year period. The results obtained demonstrate the need to strengthen regulatory
stringency in order to curb incidences of substandard and falsified medicines.