Tanzania Food and Drugs Authority

Dar es Salaam, Tanzania

Tanzania Food and Drugs Authority

Dar es Salaam, Tanzania
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Chen G.,Queen's University of Belfast | Gong Y.Y.,Queen's University of Belfast | Gong Y.Y.,University of Leeds | Kimanya M.E.,Nelson Mandela African Institution of Science and Technology | And 2 more authors.
Biomarkers | Year: 2017

Purpose: To determine levels of urinary aflatoxin M1 (AFM1) in children and correlate the concentrations with previously reported aflatoxin albumin adduct (AF-alb) levels in these children. Materials and methods: Matched urine and blood samples were collected from 84 Tanzanian children aged 6–14 months old. From 31 children in one village (Kigwa), samples were collected at three time points six months apart. Samples were collected from 31 and 22 children from two different regions at the second time point only. Urinary AFM1 was measured using a commercial enzyme-linked immunosorbent assay (ELISA) kit with a modified protocol to improve sensitivity. AF-alb was measured using an established ELISA method. Results: The relative ranking of the three villages for exposure to aflatoxin based on either AFM1 or AF-alb biomarker measurements was the same. In Kigwa village, both AFM1 and AF-alb levels were higher at six months post-harvest compared to baseline. However, at the next visit, the AFM1 levels dropped from a GM (interquartile range) of 71.0 (44.7, 112.6) at visit two to 49.3 (31.5, 77.3) pg/ml urine, whereas AF-alb levels increased from 47.3 (29.7, 75.2) to 52.7 (35.4, 78.3) pg/mg albumin between these two visits, reflecting the fact that AFM1 measures short-term exposure, whereas AF-alb measures longer term exposure. There was a correlation between AFB1 intake and AFM1 excretion (r= 0.442, p ≤ 0.001). Conclusions: Urinary AFM1 is a good biomarker for AFB1 exposure in Tanzanian children, reflecting geographical and temporal variations in exposure to this foodborne toxin. © 2017 Informa UK Limited, trading as Taylor & Francis Group

PubMed | Tanzania Food and Drugs Authority, Sokoine University of Agriculture, Ghent University and Nelson Mandela African Institution of Science and Technology
Type: | Journal: BMC pediatrics | Year: 2015

Stunting and micronutrient deficiencies are significant health problems among infants and young children in rural Tanzania. Objective of the study was to assess feeding practices, nutrient content of complementary meals, and their implications for dietary adequacy and nutritional status.A cross-sectional study was conducted in six randomly selected villages in Mpwapwa District, Tanzania during the post-harvest season. Information on feeding practices, dietary consumption and anthropometric measurements of all infants below the age of one year were collected. Forty samples of common meals were collected and analysed for proximate composition, iron, zinc and calcium. Results were expressed per 100 g dry weight.Energy, protein and fat content in porridge ranged from 40.67-63.92 kcal, 0.54-1.74% and 0.30-2.12%, respectively. Iron, zinc and calcium contents (mg/100 g) in porridge were 0.11-2.81, 0.10-3.23, and 25.43-125.55, respectively. Median portion sizes were small (porridge: 150-350 g; legumes and meats: 39-90 g). Very few children (6.67%) consumed animal-source foods. Low meal frequency, low nutrient content, small portion size and limited variety reduced the contribution of meals to daily nutritional needs.Findings of the study highlight inadequate feeding practices, low nutritional quality of meals and high prevalence of stunting. Feasible strategies are needed to address the dietary inadequacies and chronic malnutrition of rural infants.

Kimanya M.E.,Nelson Mandela African Institution of Science and Technology | Shirima C.P.,Tanzania Food and Drugs Authority | Magoha H.,University of Dar es Salaam | Shewiyo D.H.,Tanzania Food and Drugs Authority | And 3 more authors.
Food Control | Year: 2014

Children consuming maize based foods in Tanzania may be exposed to multiple mycotoxins. We estimated co-exposures of aflatoxins with Deoxynivalenol (DON) and fumonisins for children in rural Tanzania. Food consumption by the children was estimated by twice administering a 24h dietary recall questionnaire to mothers of 18-24 months old children in Kikelelwa village. Each mother also, provided a sample of maize based flour used for feeding her child in the previous day. Each child's body weight (bw) was measured by following standard procedures. Aflatoxins, DON and fumonisins were determined in each sample using validated HPLC methods. Exposures for a mycotoxin were estimated by multiplying flour consumption (g/child/kgbw/day) by its contamination (μg/kg). Complete data were obtained for 41 children. Maize flour consumption ranged from 16 to 254g/child/day. Thirteen (32%) of the 41 children consumed flour with detectable aflatoxin levels (range, 0.11-386μg/kg), resulting in exposures from 1 to 786ng/kg bw/day. All these children exceeded the aflatoxins exposure of concern (0.017ng/kg bw/day). Eighteen (44%) of the children consumed flour with detectable DON levels (57-825μg/kg) and 34 (83%), detectable fumonisins levels (63-2284μg/kg), resulting in respective exposure ranges of 0.38-8.87μg/kg bw/day and 0.19-26.37μg/kg bw/day. Twelve (66%) of the DON exposed children and 56% of the fumonisins exposed children exceeded the respective provisional tolerable daily intakes of 1μg/kg bw and 2μg/kg bw. Co-exposures for aflatoxins with both DON and fumonsins were determined in 10% of the 41 children. Co-exposures of aflatoxins with fumonisins alone were found in 29% and of fumonisins with DON alone in 41% of the children. The study showed that children consuming maize based complementary foods in Northern Tanzania are at a risk of exposure to multiple mycotoxins. We recommend adoption of appropriate measures to minimize exposures of multiple mycotoxins in Tanzania. © 2014 Elsevier Ltd.

PubMed | Directorate of Medicines and Complementary Products, Muhimbili University of Health and Allied Sciences, Pharmaceutical Services Unit, Uppsala Monitoring Center and 2 more.
Type: Journal Article | Journal: Clinical drug investigation | Year: 2016

Artemisinin combination therapies such as artemether-lumefantrine (AL) are effective for first-line treatment of uncomplicated acute Plasmodium falciparum malaria. However, the safety profile of AL in large populations has not been fully assessed. The objective of this study was to establish the safety of AL in public health facilities in Tanzania using the Cohort Event Monitoring (CEM) method.Patients who presented to public health facilities in four regions of Tanzania who were prescribed AL were enrolled in a CEM study, a prospective, observational cohort study to establish a profile of adverse events (AEs) for the medicine when used in routine clinical practice. Pre- and post-treatment forms were used to record baseline information and new health events before and 7 days after treatment.A total of 8040 patients were enrolled in the study, of whom 6147 were included in the analysis. Following treatment initiation, a total of 530 AEs were reported in 6% (383) of the patients. The most frequent post-treatment AEs were in alimentary system (42%), including vomiting, nausea, diarrhoea, abdominal pain and anorexia, followed by AEs in the neurological system (25%). Causality assessment of the events showed that 51.9% (275/530) were possibly related to AL. There was a significant difference in the frequency of AEs by age-group with an increase in the number of AEs as age increased (P < 0.001). There was no statistically significant difference in the frequency of the events between males and females (P = 0.504). The AE profile was consistent with the AEs reported in the product information and in other studies; no new adverse drug reactions were identified. The majority of the reported AEs were the same as the symptoms of malaria and therefore indistinguishable from the underlying disease.The safety profile of AL for treatment of malaria continues to be favourable. CEM as a pharmacovigilance tool has proven to provide reliable safety data in a short period.

Kimanya M.E.,Tanzania Food and Drugs Authority | Kimanya M.E.,Ghent University | De Meulenaer B.,Ghent University | Roberfroid D.,Institute of Tropical Medicine | And 3 more authors.
Molecular Nutrition and Food Research | Year: 2010

Infants consuming maize-based foods are at a high risk of exposure to fumonisins. This study explored the association between exposure of fumonisins from maize and growth retardation among infants in Tanzania. Mothers of 215 infants consented for their children to participate in this study. We estimated maize intake for each child by twice conducting a 24 h dietary recall and fumonisins level in the maize, using HPLC. Fumonisins exposure for each child was estimated by combining his/her maize intake and the fumonisins level in the maize. Of the infants, 191 consumed maize. The maize consumed by 131 infants contained fumonisins at levels varying from 21 to 3201 μg/kg. Fumonisins exposure in 26 infants exceeded the provisional maximum tolerable daily intake of 2 μg/kg body weight. At 12 months of age, infants exposed to fumonisins intakes above the provisional maximum tolerable daily intake of 2 μg/kg bodyweight were significantly shorter by 1.3 cm and 328 g lighter. It appears that the exposure to fumonisins is associated with growth retardation. This is the first study to report an association between fumonisins exposures and growth retardation. Copyright © 2010 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Kimanya M.E.,Tanzania Food and Drugs Authority | De Meulenaer B.,Ghent University | Van Camp J.,Ghent University | Baert K.,Ghent University | And 2 more authors.
Maternal and Child Nutrition | Year: 2012

Feeding infants with maize can expose them to fumonisin mycotoxins. We assessed fumonisin exposure from complementary foods in rural Tanzania and determined strategies to reduce the exposure. We conducted a cross-sectional study in four villages of Tarakea division, Northern Tanzania. We used a repeat 24-hour dietary recall to collect data of maize consumption as complementary food for 254 infants aged 6-8 months. Fumonisin concentrations in the maize were also estimated. Fumonisin exposure was assessed using @risk analysis software. With the software, several maximum fumonisin contamination and maize consumption patterns were combined in order to determine effective strategies for minimizing fumonisin exposure. Of the infants, 89% consumed maize at amounts up to 158g/person/day (mean; 43g/person/day±28). The maize was contaminated with fumonisins at levels up to 3201μgkg -1. Risk of fumonisin intake above the provisional maximum tolerable daily limit of 2μgkg -1 body weight was 15% (95% confidence interval; 10-19). The risk was minimized when the maximum contamination was set at 150μgkg -1. The risk was also minimized when the maximum consumption was set at 20g/child/day while keeping the maximum contamination at the European Union (EU) maximum tolerated limit (MTL) of 1000μgkg -1. Considering the economical and technological limitations of adopting good agricultural practices in rural Tanzania, it is practically difficult to reduce contamination in maize to 150μgkg -1. We suggest adoption of the EU MTL of 1000μgkg -1 for fumonisins in maize and reduction, by replacement with another cereal, of the maize component in complementary foods to a maximum intake of 20g/child/day. © 2011 Blackwell Publishing Ltd.

Shewiyo D.H.,Tanzania Food and Drugs Authority | Shewiyo D.H.,Muhimbili University of Health and Allied Sciences | Shewiyo D.H.,Vrije Universiteit Brussel | Kaale E.,Muhimbili University of Health and Allied Sciences | And 5 more authors.
Journal of Chromatography A | Year: 2013

Drug assays in formulations by HPTLC methods.Method validation using accuracy profiles.Accuracy profile is based on total error.Total error integrates several validation parameters. The accuracy profile, based on total error, integrates several validation parameters, such as trueness, precision and linearity, providing one statistic which enables decision on the suitability of a method for its intended purpose. Two assay methods for formulations are validated using accuracy profiles as an alternative approach to classic method validation. It concerns high-performance thin-layer chromatography (HPTLC) methods, which initially were validated using the classic approach. The first method assayed sulfamethoxazole and trimethoprim, and the second lamivudine, stavudine and nevirapine. Both formulations are fixed-dose combination tablets. The resulting accuracy profiles showed that the 95% β-expectation tolerance limits for all compounds fell well within the bias acceptance limits set at ±5%. This means that the two analytical thin-layer chromatographic methods are capable of making accurate results at the studied concentration ranges of each compound. Measurement uncertainties of every compound at each concentration level could also be determined from the accuracy profile data. © 2013 Elsevier B.V.

Kamuhabwa A.A.R.,Muhimbili University of Health and Allied Sciences | Kisoma S.,Tanzania Food and Drugs Authority
Tropical Journal of Pharmaceutical Research | Year: 2015

Purpose: To determine the factors that influence prescribing practices of medical practitioners in public and private health facilities in Dar es Salaam, Tanzania Methods: One hundred and ninety two (192) medical practitioners from 11 public and 3 private health facilities of Dar es Salaam, Tanzania were interviewed for the criteria they consider when making prescribing decisions. Systematic sampling was used to obtain the required number of medical practitioners working in the hospitals, while for those working in the health centers convenience sampling was used. Results: Medical information from textbooks (64 %) and internet (63 %) were the main sources of prescribing information among medical practitioners. In comparison, medical practitioners in private health facilities (97 %) were more concerned with proven effectiveness of drugs than those working in public health facilities (74.2 %, p = 0.001). Cost of drug to patients was considered much more by practitioners in public health facilities (48.4 %) than their counterparts in private health facilities (24.3 %, p = 0.010). Availability of drugs in the health facility influenced prescribing decisions by a majority of prescribers from public health facilities (53.5 %) than those working in private health facilities (18.9 %, p = 0.000). Conclusion: There are substantial differences between prescribers working in public and private health facilities with regard to the factors which influence their prescribing decisions. In order to promote rational use of medicines, these factors should be considered by health planners when formulating policies and allocating resources in health facilities. © Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. All rights reserved.

Shewiyo D.H.,Tanzania Food and Drugs Authority | Shewiyo D.H.,Muhimbili University of Health and Allied Sciences | Shewiyo D.H.,Vrije Universiteit Brussel | Kaale E.,Muhimbili University of Health and Allied Sciences | And 4 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2012

High-performance thin-layer chromatography (HPTLC) is still increasingly finding its way in pharmaceutical analysis in some parts of the world. With the advancements in the stationary phases and the introduction of densitometers as detection equipment, the technique achieves for given applications a precision and trueness comparable to high-performance liquid chromatography (HPLC). In this review, the literature is surveyed for developed and validated HPTLC methods to assay active ingredients in pharmaceutical formulations published in the period 2005-2011. Procedures and approaches for method development, validation and quantitative assays are compared with the standard ways of conducting them. Applications of HPTLC in some other areas are also briefly highlighted. © 2012 Elsevier B.V.

Tanzania is one of the countries that suffer huge burden of malnutrition and food poverty with over two million people living with HIV/AIDS. Despite ongoing nutritional interventions in care and treatment clinics for people living with HIV/AIDS (PLWHA), a high proportion of them still face nutritional problems, with about 29% being underweight. This study therefore aimed assessing social factors and lifestyle attributes associated with nutritional status among adults living with HIV/AIDS and attending care and treatment clinics (CTCs) in an urban district in Tanzania. An interview schedule was administered to 412 randomly selected adult male and female clients attending different CTCs in Ilala district. Their anthropometric measurements i.e. body weights and heights were also taken. Findings revealed that 18.4% of males and females were underweight according to their body mass indices. The risk of being underweight was higher among respondents who were young; who had never married; had no formal education as well as those who reported to be living with their families or friends, although these associations were not statistically significant. On the other hand, factors which had statistically significant association with nutritional status included the type of persons the client was living with and the habit of drinking alcohol. From the findings we conclude that PLWHA attending Care and Treatment Clinics in Ilala district, Dar es Salaam have problems with their nutrition with underweight being common among them. This suggests that the existing care and treatment clinics that provide nutritional support to PLWHA do not appear to address these issues in their totality. There is therefore, need to ensure that more efforts are geared towards providing nutritional counseling, support and encouragement of these clients within social contexts of their lives so in order for the current efforts to give best results.

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