Quality of Antiretroviral Drugs Analyzed in the Drug Analysis and Research Unit During 2000-2003

During the five-year period January 2001 to December 2005, the Drug Analysis and Research Unit received and analyzed 394 drug samples. Samples were received from regulatory authorities, local industry, non-governmental organizations, hospitals and private practitioners. The samples analyzed constituted 37.8 % locally manufactured and 62.2 % imported products. In contrast to previous years when failure rates of over 20 % were recorded, the overall rate of failure to comply with compendial quality specifications was 6.1 %, comprising of 8.7 % locally manufactured and 4.5 % imported drugs.

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“…This represented 6.2 % of locally manufactured ARVs. Previously reported data for ARVs analyzed in DARU showed a failure rate of 9.1 % [14].…”

Section: Resultsmentioning

confidence: 91%

Drug Quality Control in Kenya: Observation in the Drug Analysis and Research Unit During the Period 2001-2005

Thoithi

Abuga

Nguyo

et al. 2009

East and Central African Journal of Pharmaceutical Sciences

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“…This is encouraging given the high malaria burden in Kenya. Previous reports have reported higher failure rates for anti-malarial drugs in Kenya [ 22 ]. Some products containing chloroquine, amodiaquine and herbal components were found in the market not in accordance with malaria treatment guidelines.…”

Section: Discussionmentioning

confidence: 99%

The quality of anti-malarial medicines in Embu County, Kenya

Ndwigah

Stergachis

Abuga

et al. 2018

Malar J

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BackgroundMalaria is a major health problem in sub-Saharan Africa where over 90% of the world’s malaria cases occur. Artemisinin-based combination therapy (ACT) is recommended by the World Health Organization as first-line and second-line treatments for uncomplicated falciparum malaria. However, there are a growing number of reports of sub-standard and falsified anti-malarial medicines in sub-Saharan Africa.MethodsA cross-sectional study was conducted in Embu County, Kenya on the quality of anti-malarial medicines available in public and private facilities. Sampling of anti-malarial medicines from public and private hospitals, health centers and pharmacies was conducted between May and June 2014. Quality control tests were performed at the Drug Analysis and Research Unit, University of Nairobi, using ultraviolet spectrophotometry and high-performance liquid chromatography. A test for microbial load was also conducted for suspension formulations.ResultsA total of 39 samples were collected from public and private facilities across the Embu County. A visual inspection of the medicines showed no signs of sub-standard or falsification. All ACT passed identification, assay and dissolution tests. Of 11 suspension samples collected, none failed the microbial load test although one sample had 50 colony forming units (cfu). No oral artemisinin monotherapy medicines were encountered during the survey. Amodiaquine and chloroquine monotherapy products accounted for 5% of the collected samples, despite their ban in Kenya. Two herbal anti-malarial formulations were collected during the survey. Sulfadoxine/pyrimethamine (SP) was also found to be available use for malaria treatment, not in accordance with malaria treatment guidelines.ConclusionAll the anti-malarial drugs analysed in this study passed the quality control tests. This is encouraging given the high malaria burden in Kenya. Regulatory actions are required to counter SP and herbal products for malaria treatment.Electronic supplementary materialThe online version of this article (10.1186/s12936-018-2482-3) contains supplementary material, which is available to authorized users.

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“…There has also been a growing global concern on the quality of antibiotics with several studies reporting antibiotics that failed to meet pharmacopeia requirements [ 16 – 19 ]. Fadeyi and Co-workers [ 20 ] reported on quality of antibiotics from Ghana, Nigeria and United Kingdom where 9 out of 15 samples of co-trimoxazole tablets tested failed to meet United States Pharmacopeia limits (USP) while all 20 samples of amoxicillin passed.…”

Section: Introductionmentioning

confidence: 99%

“…Similarly, in Malawi, Khuluza [2014] [ 4 ] reported that 5 out of 11 co-trimoxazole tablets sampled failed to meet British Pharmacopeia content limits. In Kenya, Abuga et al ., [2013] [ 16 ] reported co-trimoxazole as being one of the antibiotics that failed to meet pharmacopeia requirements.…”

Section: Introductionmentioning

confidence: 99%

Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya

et al. 2021

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Introduction Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya. Methods A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out. Results The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements. Conclusion This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.

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Quality of Antiretroviral Drugs Analyzed in the Drug Analysis and Research Unit During 2000-2003

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Drug Quality Control in Kenya: Observation in the Drug Analysis and Research Unit During the Period 2001-2005

Drug Quality Control in Kenya: Observation in the Drug Analysis and Research Unit During the Period 2001-2005

The quality of anti-malarial medicines in Embu County, Kenya

Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya

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