Abstract
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.
Highlights
Malaria is a major health problem in sub-Saharan Africa where over 90% of the world’s malaria cases occur
Knowledge about the actual quality of medicines available within a given community is important for formulation of suitable policies, enforcement activities and other practices aimed at improving malaria treatment [7]
All the artemether/ lumefantrine formulations and all of the other Artemisinin-based combination therapy (ACT) medicines complied with identification, assay and dissolution tests as per the pharmacopoeias
Summary
Malaria is a major health problem in sub-Saharan Africa where over 90% of the world’s malaria cases occur. Malaria is a preventable and treatable disease when recommended interventions are properly implemented These include chemoprophylaxis for pregnant women and timely treatment with appropriate anti-malarial medicines [1]. According to the United States Pharmacopoeia (USP) and World Health Organization (WHO) [13, 14], the minimal tests required to evaluate the quality of medicinal products are that a sample must pass one test before moving on to the test. These tests include identity, assay, disintegration, and dissolution. The anti-malarial drugs were tested for identity, assay, dissolution, and microbial load
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