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Omweri LG, Okaru AO, Abuga KO, Ndwigah SN. "Quality of povidone-iodine and chlorhexidine-based oral care products in Nairobi, Kenya." F1000Research. 2022;11:343. Abstract

Background: The oral cavity harbors many microbes that may cause diseases, including dental caries and periodontal diseases. Progressive inflammation from periodontal diseases may lead to gum detachment from the teeth. Povidone-iodine and chlorhexidine mouth rinses and gargles are broad-spectrum antimicrobial products that effectively manage dental caries and periodontal diseases and eliminate plaques. This study was conducted in Nairobi County, Kenya to establish the quality of povidone-iodine and chlorhexidine oral care products by determining the content of the active pharmaceutical ingredient and compliance with labeling requirements.
Methods: A total of 34 samples (from 15 brands) of povidone-iodine and 15 samples (from nine brands) of chlorhexidine were collected from retail pharmacies using convenience sampling. All samples were subjected to labeling analysis, identity, and assay tests. Potentiometric titration was used to assay povidone-iodine in the samples, while chlorhexidine was assayed using high-performance liquid chromatography (HPLC) according to British Pharmacopeia 2017 specifications.
Results: All samples complied with identification tests. Moreover, 47.1% of povidone-iodine and 66.7% of chlorhexidine products complied with pharmacopoeial assay specifications. Five povidone-iodine (14.7%) and four chlorhexidine (26.7%) samples had missing label information on the storage conditions and the address of the manufacturer.
Conclusions: Strict adherence to current Good Manufacturing Practices (cGMP) by manufacturers of povidone-iodine and chlorhexidine mouthwashes/gargles is necessary to guarantee quality assured products in the market. Regular post-market surveillance and regulatory enforcement of standards are instrumental in minimizing the circulation of poor-quality products.

Abuga KO, Kigera ST, Wanyama M, Nandama WM, Kibwage IO. "Quality Control Results of Pharmaceuticals Analyzed in the Mission for Essential Drugs and Supplies (MEDS) Laboratory During the Period 2013-2017." East Cent. Afr. J. Pharm. Sci.. 2021;24(2):57-66. Abstract

During the 2013-2017 period, the MEDS laboratory received and processed 6853 samples. Samples were sourced from Kenya and other sub-Saharan Africa countries. The samples submitted comprised Kenyan manufactured (31.9%) and internationally manufactured products (67.9%) while nine samples were of unknown origin. Analysis was carried out according to compendial and/or in-house specifications. The non-compliance rate was 5.1% consisting of 1.2 % local and 3.8% imports. The top ten drug classes with high failure rates were antimyasthenics (50.0%), antiseptics/disinfectants (24.7%), anthelminthics (22.0%), thyroid/antithyroid drugs (20.0%), nutrient mixtures (18.5%), uricosurics (12.5%), waters (11.6%), mixed anti-infectives (11.1%), hemostatics (10.0%) and nootropics (10.0%). Full compliance was however, recorded with laxatives, antidiarrheals, antihemorrhoidals, prokinetics, antithrombotics, antithrombocytopenia agents, vasopressors, anti-arrhythmic drugs, anti-anginal drugs, disease modifying antirheumatic drugs, antimigraine drugs, vertigolytics, muscle relaxants, bisphosphonates, joint lubricants, hormones, anticholinergics, osmotic diuretics, hypophosphatemics, lubricants, minerals, amino acids/peptides, immunomodulatory agents, choleretics, antidotes, lozenges, ear drops, proteins/glycoproteins, herbal products, X-ray contrast media, vaccines, environmental monitoring, medical devices/equipment and cleaning validation swabs. A total of 23 substandard and falsified medicines devoid of active ingredients were encountered over the five-year period. The results obtained demonstrate the need to strengthen regulatory stringency in order to curb incidences of substandard and falsified medicines.

Abuga K, Nyamweya N, King’ondu O. "Quality of alcohol-based hand sanitizers marketed in the Nairobi metropolitan area." East Cent. Afr. J. Pharm. Sci.. 2021;24(1):29-37. Abstract

The emergence of the COVID-19 pandemic has propelled the use of alcohol-based hand sanitizers to the fore as a SARS-CoV-2 control measure. To be effective these products must comply with relevant quality parameters such as alcohol concentration, methanol limits and purity. The current study was designed to determine the quality of alcohol-based hand sanitizer products in the Nairobi metropolitan area. For this purpose, 74 commercially marketed samples were collected and subjected to analysis by gas chromatography. Only three samples (4.1%) complied with the regulatory specifications for alcohol content, methanol limits and pH. Five samples (6.8%) complied with the specification for alcohol content but did not meet methanol or pH limits. A total of 44 (59.5%) samples had methanol levels that exceeded threshold limits. Eleven samples (14.9%) were found with methanol substitution (i.e., methanol, instead of ethanol or isopropanol, was the main alcohol component). The results show that users of alcohol-based hand sanitizers are being exposed to substandard and falsified products which in addition to being non-efficacious pose harm due to unacceptable levels of toxic impurities. Regular, routine post-market surveillance is needed to prevent such products from reaching the market.

Odoyo AO, Abuga KO, Mugo HN, Mang’oi JS. "Quality of metronidazole benzoate suspension products marketed in Nairobi County, Kenya." East Cent. Afr. J. Pharm. Sci.. 2021;24(3):131-135. Abstract

Metronidazole benzoate is an ester derivative of metronidazole utilized in the formulation of oral suspensions owing to its palatability. The drug is liable to hydrolytic degradation during shelf life which could lower assay values and increase free metronidazole content. A medicine quality survey study was carried out in Nairobi County whereby 32 metronidazole benzoate samples representing 13 brands were collected from retail pharmacies. The samples were subjected to British Pharmacopoeia specifications for pH, free metronidazole content and assay. From the results obtained, only nine samples (28.1%) passed all the quality tests performed while five (15.6%), seven (21.9%) and 18 (56.3%) did not comply with pH, metronidazole content and assay specifications respectively. The results obtained demonstrate the existence of substandard metronidazole benzoate products in the market. This underscores the need for regular post market surveillance surveys and execution of appropriate regulatory actions.

Abuga KO, Ndwigah SN, Amugune BK, Ongarora DB, Njogu PM, Okaru AO, Kibwage IO. "Quality Control Report of Drugs Analyzed in the Drug Analysis and Research Unit during the Period 2011-2015." East Cent. Afr. J. Pharm. Sci.. 2020;23(3):79-86. Abstract

During the period 2011-2015, the Drug Analysis and Research Unit (DARU) analyzed 1972 drug samples. The samples consisted of 21.5% locally manufactured and 78.2% imported products while the origin of 0.3% of products was indeterminate. Samples were subjected to compendial and/or in-house analytical specifications. The overall non-compliance rate was 4.5% comprising 2.5% local products and 2.0% imports. High failure rates were recorded for uterotonics (37.5%), hemostatics (33%), anthelmintics (17%) and anticancers (10.5%) while ophthalmic, immunomodulatory, musculoskeletal and endocrine drugs all complied with the quality acceptance criteria. Erectile dysfunction drugs, received by the laboratory for the first time, all complied with specifications. The results obtained demonstrate an improvement in the quality of samples submitted to DARU when compared to previous performance.

Ndwigah S, Stergachis A, Abuga K, Mugo H, Kibwage I. "The quality of anti-malarial medicines in Embu County, Kenya." Malaria Journal. 2018;17:330. Abstract

Malaria 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.

A 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.

A 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.

All 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.

Abuga KO, Amugune BK, Ndwigah SN, Kamau FN, Thoithi GN, Ogeto JO, Okaru AO, Nguyo JM, King'ondu OK, Mugo HM, Kibwage IO. "Quality Performance of Drugs Analyzed in the Drug Analysis and Research Unit (DARU) during the Period 2006-2010." East Cent. Afr. J. Pharm. Sci.. 2013;16(2):33-43. Abstract

During the period 2006-2010, the Drug Analysis and Research Unit analyzed 583 samples. The samples comprised 50.6% local and 49.4% imported products. Samples were subjected to compendial or in-house specifications. The failure rate was 12.2% for local products and 14.2% for imports. Antibacterial products recorded the highest failure rate (21.6%) while anticancers and drugs acting on the gastrointestinal, respiratory and reproductive systems all passed in the tests performed. The failure rate for antiprotozoals, antimalarials, antifungals, anthelminthics and analgesics was 14.3%, 12.5%, 11.8%, 8.9% and 11.5%, respectively.

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