Quality Assessment of Antimicrobial Drug Products Sold by Unlicensed Vendors in Kisumu County, Kenya

Abstract

The quality of antimicrobial drugs is critical for ensuring patient safety and combating
antimicrobial resistance (AMR). The illicit sale of medicines by unlicensed vendors, or
"hawking," exposes these products to uncontrolled environmental conditions that can
compromise their stability, potency, and overall quality. This study was designed to evaluate
the quality of select antimicrobial drug products sold by unlicensed vendors in Kisumu
County, Kenya. A cross-sectional survey was conducted in open air markets of Ahero,
Sondu, Katito, Awasi, and the Kisumu Bus Station, all located within Kisumu County,
Kenya. A total of 25 antimicrobial samples comprising amoxicillin, cotrimoxazole,
doxycycline, ampicillin/cloxacillin, and phenoxymethylpenicillin were purchased using the
convenience sampling approach. The samples were subjected to quality control tests for
identification, weight variation, assay, dissolution and microbial load in accordance to the
United States Pharmacopeia (USP) 2024 specifications. Out of the 25 samples analyzed, 23
(92%) complied with all USP (2024) specifications, while two ampicillin/cloxacillin samples
were found to be substandard. One sample failed in uniformity of weight and the other assay
of ampicillin. Despite the unsanitary sale conditions in the open-air markets, all samples
complied with the microbial load test as they were blister-packed. The presence of
substandard antimicrobial products in the informal market in Kisumu County poses a
significant public health risk, potentially leading to treatment failure and exacerbating the
development of AMR. These findings underscore the urgent need for strengthened
regulatory enforcement to curb the illegal sale of medicines and for public education on the
dangers of procuring medicines from unauthorized sources.