Tanzania Food and Drugs Authority TFDA

Dar es Salaam, Tanzania

Tanzania Food and Drugs Authority TFDA

Dar es Salaam, Tanzania

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'T Hoen E.F.M.,Independent Consultant | Hogerzeil H.V.,University of Groningen | Quick J.D.,Management science for Health | Sillo H.B.,Tanzania Food and Drugs Authority TFDA
Journal of Public Health Policy | Year: 2014

Problems with the quality of medicines abound in countries where regulatory and legal oversight are weak, where medicines are unaffordable to most, and where the official supply often fails to reach patients. Quality is important to ensure effective treatment, to maintain patient and health-care worker confidence in treatment, and to prevent the development of resistance. In 2001, the WHO established the Prequalification of Medicines Programme in response to the need to select good-quality medicines for UN procurement. Member States of the WHO had requested its assistance in assessing the quality of low-cost generic medicines that were becoming increasingly available especially in treatments for HIV/AIDS. From a public health perspective, WHO PQP's greatest achievement is improved quality of life-saving medicines used today by millions of people in developing countries. Prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines. Yet despite its track record and recognized importance to health, funding for the programme remains uncertain. © 2014 Macmillan Publishers Ltd.


Shirima C.P.,University of Leeds | Shirima C.P.,Sokoine University of Agriculture | Kimanya M.E.,Tanzania Food and Drugs Authority TFDA | Kimanya M.E.,The Nelson Mandela African Institute of Science and Technology NM AIST | And 9 more authors.
Environmental Health Perspectives | Year: 2015

Background: Aflatoxin and fumonisin are toxic food contaminants. Knowledge about effects of their exposure and coexposure on child growth is inadequate. oBjective: We investigated the association between child growth and aflatoxin and fumonisin exposure in Tanzania. Methods: A total of 166 children were recruited at 6–14 months of age and studied at recruitment, and at the 6th and 12th month following recruitment. Blood and urine samples were collected and analyzed for plasma aflatoxin–albumin adducts (AF-alb) using ELISA, and urinary fumonisin B1 (UFB1) using liquid chromatography–mass spectrometry, respectively. Anthropometric measure-ments were taken, and growth index z-scores were computed. results: AF-alb geometric mean concentrations (95% CIs) were 4.7 (3.9, 5.6), 12.9 (9.9, 16.7), and 23.5 (19.9, 27.7) pg/mg albumin at recruitment, 6 months, and 12 months from recruitment, respectively. At these respective sampling times, geometric mean UFB1 concentrations (95% CI) were 313.9 (257.4, 382.9), 167.3 (135.4, 206.7), and 569.5 (464.5, 698.2) pg/mL urine, and the prevalence of stunted children was 44%, 55%, and 56%, respectively. UFB1 concentrations at recruitment were negatively associated with length-for-age z-scores (LAZ) at 6 months (p = 0.016) and at 12 months from recruitment (p = 0.014). The mean UFB1 of the three sampling times (at recruitment and at 6 and 12 months from recruitment) in each child was negatively associated with LAZ (p < 0.001) and length velocity (p = 0.004) at 12 months from recruitment. The negative association between AF-alb and child growth did not reach statistical significance. conclusions: Exposure to fumonisin alone or coexposure with aflatoxins may contribute to child growth impairment. © 2015, Public Health Services, US Dept of Health and Human Services. All rights reserved.


Routledge M.N.,University of Leeds | Kimanya M.E.,Tanzania Food and Drugs Authority TFDA | Kimanya M.E.,Nelson Mandela Institute of Science and Technology NM AIST | Shirima C.P.,Tanzania Food and Drugs Authority TFDA | And 3 more authors.
Biomarkers | Year: 2014

The association between aflatoxin intake from maize-based weaning food and aflatoxin albumin adducts (AF-alb) was investigated in 148 Tanzanian children aged between 12 and 22 months, at 2 visits 6 months apart. At the first visit (storage season) there was a significant correlation at the individual level between AF-alb (geometric mean 43.2 pg/mg albumin) and aflatoxin intake (geometric mean 81.7 ng/kg b.w./d) through maize-based weaning food (r = 0.51, p < 0.01). Overall, this correlation was r = 0.43 (p < 0.01). The AF-alb level in weaning-age children in Tanzania closely reflects aflatoxin intake from maize in weaning food. Exposure levels suggest children may be at risk from aflatoxin associated health effects. © 2014 Informa UK Ltd.


Srey C.,Queen's University of Belfast | Srey C.,University of Leeds | Kimanya M.E.,Tanzania Food and Drugs Authority TFDA | Kimanya M.E.,The Nelson Mandela Institute of Science and Technology NM AIST | And 4 more authors.
Molecular Nutrition and Food Research | Year: 2014

Scope: This study assessed deoxynivalenol (DON) exposure in children from three geographic locations within Tanzania, over three time points in 1 year, using a urinary biomarker of exposure. Methods and results: A total of 166 children aged 6-14 months were studied at a maize harvest and followed up twice at 6-month intervals. On two consecutive days, morning urine was collected from each child and urinary DON was measured using an LC-MS method, with and without β-glucuronidase hydrolysis in order to assess free DON (fDON) and glucuronide DON. Overall, urinary DON increased significantly along with the three visits (geometric mean 1.1, 2.3, and 5.7 ng/mL, at visits 1, 2, and 3, respectively, p < 0.01). fDON was 22% of urinary total DON. Urinary DON excretion rate was 74% in village Kikelelwa based on food DON level and food consumption. Assuming 360 mL of urine excreted per day, 10, 19, and 29% of children at visits 1, 2, and 3, respectively, exceeded the provisional maximum tolerable daily intake of 1000 ng/kg b.w./day. Conclusion: Young children in Tanzania are chronically exposed to DON due to eating contaminated maize, although exposure levels varied markedly by region and season. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Shirima C.P.,University of Leeds | Shirima C.P.,Sokoine University of Agriculture | Kimanya M.E.,Tanzania Food and Drugs Authority TFDA | Kimanya M.E.,The Nelson Mandela Institute of Science and Technology NM AIST | And 6 more authors.
Molecular Nutrition and Food Research | Year: 2013

Scope: The study aims to evaluate the status of dietary exposure to aflatoxin and fumonisin in young Tanzanian children, using previously validated biomarkers of exposure. Methods and results: A total of 148 children aged 12-22 months, were recruited from three geographically distant villages in Tanzania; Nyabula, Kigwa, and Kikelelwa. Plasma aflatoxin-albumin adducts (AF-alb) and urinary fumonisin B1 (UFB1) were measured by ELISA and LC-MS, respectively. AF-alb was detectable in 84% of children, was highest in fully weaned children (p < 0.01) with higher levels being associated with higher maize intake (p < 0.05). AF-alb geometric mean (95% CI) was 43.2 (28.7-65.0), 19.9 (13.5-29.2), and 3.6 (2.8-4.7) pg/mg albumin in children from Kigwa, Nyabula, and Kikelelwa, respectively. UFB1 was detectable in 96% of children and the level was highest in children who had been fully weaned (p < 0.01). The geometric UFB1 mean (95% CI) was 327.2 (217.1-493.0), 211.7 (161.1-278.1), and 82.8 (58.3-117.7) pg/mL in Kigwa, Nyabula, and Kikelelwa, respectively. About 82% of all the children were exposed to both mycotoxins. Conclusion: Young children in Tanzania are chronically exposed to both aflatoxin and fumonisin through contaminated diet, although the level of exposure varies markedly between the three villages studied. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Gong Y.Y.,Queen's University of Belfast | Gong Y.Y.,University of Leeds | Shirima C.P.,Tanzania Food and Drugs Authority TFDA | Srey C.,Queen's University of Belfast | And 4 more authors.
World Mycotoxin Journal | Year: 2015

The relationship between child and parent exposure and excretion of deoxynivalenol (DON) and fumonisin B1(FB1), were compared in rural Tanzania. Morning urine samples from matched child-mother-father in 50 families of the Iringa district were collected and analysed for urinary DON and FB1using LC-MS methods. Maize intake was obtained using a seven-day food frequency questionnaire and a duplicate diet method. The urinary DON geometric means were 15.4, 45.0 and 42.0 ng/ml in children, mothers and fathers, respectively, and the urinary FB1were 0.62, 1.25 and 1.38 ng/ml, respectively. Children had significantly lower levels of urinary DON and FB1than their parents (P<0.001 and P=0.009, respectively) but the difference became non-significant when corrected for creatinine concentration. Both DON and FB1were detected in urine samples from all adults and >96% of the children, respectively and were positively correlated between the child and the mother (P=0.007 and 0.02, respectively). DON or FB1biomarkers were not correlated with maize intake. Children who were fully weaned had 3-fold higher urinary DON than those on partial breastfeeding (P=0.002). In adults, maize brew (a local produced beer) showed a strong positive correlation with both urinary DON and FB1levels (P<0.001). The ratio of daily urinary excretion of DON between children and adult, based on assumed urine volume, was 1:2.26, but the excretion of FB1was similar between children and adults. The study showed that DON and FB1exposure are prevalent in rural Tanzania. Further study is required to determine the mechanism for the lower excretion of DON in children compared to adults. There is a good correlation between child and mother's exposure levels to DON and FB1. Increased exposure risk through maize brew in adults is highlighted in this study. © 2015 Wageningen Academic Publishers.

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