About a third of the key antibiotic cotrimoxazole suspension selling in Nairobi pharmacies are of poor quality.
Forty per cent are also not retained with the Pharmacy and Poisons Board, show a recent study by Kenya Medical Research Institute (Kemri).
“Our study provides evidence of poor quality cotrimoxazole medicines in Nairobi that could compromise treatment of infectious diseases in children,” says the study.
The study was published on Wednesday (22nd September 2021) in the journal Plos One.
Cotrimoxazole is an antibiotic used in the treatment against a wide range of bacterial infections including pneumonia, typhoid, bronchitis, ears and infections of the urinary tract.
It is also a critical medicine for preventing opportunistic infection in HIV infected individuals.
The team had collected 106 samples of the antibiotic cotrimoxazole categorized in 15 brands from 17 Sub-counties in Nairobi County.
They had been purchased from 309 retail pharmacies from the different social economic zones of Nairobi County.
Thirteen, about 87 per cent of these brands were manufactured locally while the other two were from India and Egypt.
A third failed pH test
On analysis at Kemri, the report says, 29.2 percent failed to meet pH requirements, which is a pointer to the quality and efficacy of the medicines over time.
Thirty-one samples of local origin had pH values that were above specifications. This, the study says could be attributed to poor quality assurance employed during manufacturing processes.
“It is worrying that 31 out of 106 samples that were of local origin failed this requirement,” say the study by Beatrice Njeri Irungu, Lilian Koech, Joyce Ondicho and Lucia Keter.
Fourteen samples, the report says failed requirements for active pharmaceutical ingredients (API).
Risk of toxicity
Some of the products had insufficient APIs, but cases of excess were also noted. This, the report says may be an indication of poor adherence to good manufacturing practices.
“Excess API poses a risk of toxicity to the patient while insufficient API leads to a sub therapeutic dosage which could promote drug resistance,” say the authors.
Ten of the samples that failed to comply with API requirements were of local origin while four were imports.
Sixteen percent of the samples did not adhere to packaging and labeling requirements, the study shows.
Six out of 15 of the oral suspension brand or 40 per cent, the report says were not registered with the Pharmacy and Poisons Board as required, suggesting they were in the market illegally.
It is required that registration of every product in Kenya be renewed every year but 40 per cent of the product had not been retained in the register at the time of study.
“It was noted that four of the samples whose API limits were non-compliant missed out in the retention register.”
The authors emphasize the need for regular quality assurance tests to ensure only quality medicines are in the market.
By Gatonye Gathura
The report is available here: https://doi.org/10.1371/journal. pone.0257625