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

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%), ntiseptics/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.