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

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.

SUBMITTER: Ndwigah S

PROVIDER: S-EPMC6138895 | biostudies-other | 2018 Sep

REPOSITORIES: biostudies-other

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

Ndwigah Stanley S Stergachis Andy A Abuga Kennedy K Mugo Hannington H Kibwage Isaac I

Malaria journal 20180915 1

<h4>Background</h4>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.<h4>Methods</h4>A cross-sectional study was conducted in Embu County, Kenya on t ...[more]

PMID: 30219080

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Project description:BackgroundRepositioning of existing drugs has been suggested as a fast track for developing new anti-malarial agents. The compound libraries of GlaxoSmithKline (GSK), Pfizer and AstraZeneca (AZ) comprising drugs that have undergone clinical studies in other therapeutic areas, but not achieved approval, and a set of US Food and Drug Administration (FDA)-approved drugs and other bio-actives were tested against Plasmodium falciparum blood stages.MethodsMolecules were tested initially against erythrocytic co-cultures of P. falciparum to measure proliferation inhibition using one of the following methods: SYBR®I dye DNA staining assay (3D7, K1 or NF54 strains); [(3)H] hypoxanthine radioisotope incorporation assay (3D7 and 3D7A strain); or 4',6-diamidino-2-phenylindole (DAPI) DNA imaging assay (3D7 and Dd2 strains). After review of the available clinical pharmacokinetic and safety data, selected compounds with low ?M activity and a suitable clinical profile were tested in vivo either in a Plasmodium berghei four-day test or in the P. falciparum Pf3D7(0087/N9) huSCID 'humanized' mouse model.ResultsOf the compounds included in the GSK and Pfizer sets, 3.8% (9/238) had relevant in vitro anti-malarial activity while 6/100 compounds from the AZ candidate drug library were active. In comparison, around 0.6% (24/3,800) of the FDA-approved drugs and other bio-actives were active. After evaluation of available clinical data, four investigational drugs, active in vitro were tested in the P. falciparum humanized mouse model: UK-112,214 (PAF-H1 inhibitor), CEP-701 (protein kinase inhibitor), CEP-1347 (protein kinase inhibitor), and PSC-833 (p-glycoprotein inhibitor). Only UK-112,214 showed significant efficacy against P. falciparum in vivo, although at high doses (ED90 131.3 mg/kg [95% CI 112.3, 156.7]), and parasitaemia was still present 96 hours after treatment commencement. Of the six actives from the AZ library, two compounds (AZ-1 and AZ-3) were marginally efficacious in vivo in a P. berghei model.ConclusionsRepositioning of existing therapeutics in malaria is an attractive proposal. Compounds active in vitro at ?M concentrations were identified. However, therapeutic concentrations may not be effectively achieved in mice or humans because of poor bio-availability and/or safety concerns. Stringent safety requirements for anti-malarial drugs, given their widespread use in children, make this a challenging area in which to reposition therapy.

Project description:IntroductionQuality 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.MethodsA 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.ResultsThe 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.ConclusionThis 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.

Project description:BackgroundIt has been established that use and utilization of nutrition services among adolescents are highly linked to availability, access, cost and quality of care. The main objective of this study was to assess the socio-demographic and facility-based factors as proxies to access to perceived quality of nutrition-specific and nutrition-sensitive services among adolescents in Trans-Mara East Sub-County, Narok County.MethodsThe study adopted a cross-sectional approach that employed mixed methods on 291 households. Probability proportionate to size sampling techniques using cluster and simple random methods were used to practically access adolescents who are pregnant or lactating. Data were collected using questionnaires, in-depth interview and Focus Group Discussion. Quantitative data was analyzed descriptively using frequencies and inferentially using odds ratio and Z-test. Framework analysis was employed to analyze qualitative data.ResultsA nutritionist was more likely to increase overall utilization (considered as a proxy index to access quality nutrition-sensitive and -specific services) by 3.18 times (OR = 3.18, 95% CI = 1.50-6.60, P = 0.002) and nurses 2.7 times (OR = 2.70, 95% CI = 1.40-5.30, P = 0.005). Generally, 80.7 and 69.4% attached positive value to environmental and basic personal hygiene, respectively, as being areas of nutrition-sensitive service delivery with a significant number higher than expected frequency of 50% (P < 0.05). An assessment of facility networks isolated only public health center as the key determinant of overall utilization. Public health centers among other health facilities were more likely to increase utilization (OR = 4.52, 95% CI = 1.50-13.50, P = 0.007). Assessment of distance to facility identified both distances as key determinants of overall utilization as those resident < 1 km from the facilities were 2.4 times more likely to utilize the facilities (OR = 2.42, 95% CI = 1.20-4.80, P = 0.012) while those resident 1-5 km were 5.3 times more likely to utilize the services (OR = 5.34, 95% CI = 1.90-15.10, P = 0.002) relative to longer distances. Finally, on methods of conveying messages, those who received messages through Information Education and Communication (IEC) materials were 7.8 times (OR = 7.85, 95% CI = 1.50-40.50, P = 0.014) and through face-to-face were 3.9 times more likely to utilize the services (OR = 3.91, 95% CI = 1.30-11.90, P = 0.016).ConclusionCritical facility-based determinants of utilization of nutrition services include personnel (mainly nutritionist and nurse), distance and IEC materials.

Project description:BACKGROUND:Visceral leishmaniasis (VL) is caused by protozoa of the Leishmania donovani complex. Annually, an estimated 500,000 cases of VL are reported globally posing a public health challenge. The objectives of our study were to confirm and determine the magnitude of VL outbreak, characterize the outbreak clinically and epidemiologically and evaluate the county preparedness and response in Marsabit County, Kenya. METHODS:A retrospective review of laboratory registers and patients' clinical notes was done at Marsabit County Hospital. Cases were persons with confirmed VL diagnosis either by microscopy, serology or molecular technique coming from Marsabit County from May to October 2014. Cases were interviewed using structured questionnaire to collect clinical and epidemiologic information. Blood samples were collected from cases for laboratory confirmation. RESULTS:A total of 136 cases were confirmed of which 77% (105) were male with a median age of 17 (IQR: 22) years and 9.6% (13) case fatality rate. All cases were admitted at Marsabit County Referral Hospital, Kenya. Medical records of 133 cases were retrieved. Of the 133 cases, 102 (77%) presented with fever, 43 (32%) with splenomegaly, 26 (20%) with hepatomegaly and 96 (72%) were managed with Sodium stibogluconate (SSG) monotherapy. Thirty-four cases (26%) received Full haemogram (FHG) test and none had more than one Liver Function Tests (LFTs) in a span of 6 months. Presenting with headache (OR: 4.21, 95% CI: 1.10-16.09) and hepatomegaly (OR: 4.2, 95% CI: 1.30-14.11) were associated with VL death. No VL case management training had been conducted nor VL treatment guidelines distributed among health care workers (HCWs) in the last 1 year. CONCLUSIONS:VL cases were confirmed. Inadequate case monitoring and management was evident. VL case management sensitization training was conducted. The County health department should put in place one health VL surveillance and facilitate periodic case management trainings.

Dataset Information

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

Publications

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

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