Abstract
Antibiotics are among the most counterfeited anti-infectious medicines in developing countries. Amoxicillin is one of the commonly prescribed, affordable, and easily accessible antibiotic in Kenya. It is a broad-spectrum antibiotic hence commonly used in chemotherapy. This study sought to determine the quality and identify the various brands of amoxicillin and its combination amoxicillin/clavulanic acid marketed in Nairobi County. Nairobi is the capital city of Kenya, gateway for imports and exports, and the headquarters to most of the pharmaceutical distributors. Ten wards in Nairobi County representing different socioeconomic settings were purposively sampled for the study. A detailed questionnaire was used to collect background data on brands of amoxicillin and amoxicillin/clavulanic acid in the market. A total of 106 different brands were found in the market: 85 were imports while 21 were locally manufactured. Fifty-three samples were analyzed with reference to the United States Pharmacopoeia. Amoxicillin and clavulanic acid contents for oral suspensions were determined immediately after reconstitution and 7 days thereafter to determine their stability during the prescription period. On day seven, 23.1% (3 out of 13) of amoxicillin and 66.7% (8 out of 12) amoxicillin/clavulanic acid oral suspensions presented levels below recommended limits. Uniformity of weight for amoxicillin capsules noted 13.6% (3 out of 22) failure rate, while amoxicillin/clavulanic acid tablets complied. Potency determination for all amoxicillin capsules analyzed were within required limits, but amoxicillin/clavulanic acid tablets showed 33.3% (2 out of 6) noncompliance. For amoxicillin capsule and amoxicillin/clavulanic acid tablet dissolution tests, there was 10.5% (2 out of 19) and 50% (2 out of 4) noncompliance, respectively. Overall, 37.7% of the drugs analyzed failed to comply with the Pharmacopoeia. These results highlight the presence of poor-quality amoxicillin formulations in Nairobi County, affirming the need for regular postmarket surveillance to inform on the situation of antibiotic quality in the Kenyan market.
Highlights
Over the past decade, increased public awareness on drug quality has been assessed in terms of counterfeit and/or substandard products [1]
Innovator brands Amoxil® and Augmentin® were predominantly stocked in Nairobi Central (28.2%), a location that serves all income classes and in the high- and middle-income areas; 14.4% being in Westlands, 10.4% in Karen, 7.7% in South C, and 9.3% in South B
In lower-income populations, 4.5% were stocked in Kibra and 6.2% in Kayole, while in middle–lower-income populations, 6.0% were in Zimmerman and 7.2% in Kasarani
Summary
Over the past decade, increased public awareness on drug quality has been assessed in terms of counterfeit and/or substandard products [1]. According to the United States Food and Drug Administration (FDA), 50% of medicines being sold in Africa are thought to be counterfeit and/or substandard [2, 3]. Studies have reported anti-infectious agents, antibiotics and antiparasitics, being highly predisposed to compromised quality especially in developing countries due to their high demand [4, 5]. Efforts to conduct studies on the quality of drugs in the Kenyan market have been reported since the early 1980s. According to reports by the Kenya National Quality Control Laboratory (NQCL), the failure rate for antibiotics was reported at 24.3% in the year 1996-2001, 9.4% in 20042005, and 17.3% in 2006-2007 [7]
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