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Post marketing surveillance of selected veterinary medicines in Tanzania mainland

BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of animal diseases. Globally, the veterinary medicine industry is growing. However, there is a significant increase of concern on the quality of veterinary medicines in various developing countries’ legal markets...

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Autores principales: Fimbo, Adam M., Maganda, Betty A., Mwamwitwa, Kissa W., Mwanga, Itikija E., Mbekenga, Engelbert B., Kisenge, Seth, Mziray, Sophia A., Kulwa, Gerald S., Mwalwisi, Yonah H., Shewiyo, Danstan H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178830/
https://www.ncbi.nlm.nih.gov/pubmed/35681204
http://dx.doi.org/10.1186/s12917-022-03329-x
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author Fimbo, Adam M.
Maganda, Betty A.
Mwamwitwa, Kissa W.
Mwanga, Itikija E.
Mbekenga, Engelbert B.
Kisenge, Seth
Mziray, Sophia A.
Kulwa, Gerald S.
Mwalwisi, Yonah H.
Shewiyo, Danstan H.
author_facet Fimbo, Adam M.
Maganda, Betty A.
Mwamwitwa, Kissa W.
Mwanga, Itikija E.
Mbekenga, Engelbert B.
Kisenge, Seth
Mziray, Sophia A.
Kulwa, Gerald S.
Mwalwisi, Yonah H.
Shewiyo, Danstan H.
author_sort Fimbo, Adam M.
collection PubMed
description BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of animal diseases. Globally, the veterinary medicine industry is growing. However, there is a significant increase of concern on the quality of veterinary medicines in various developing countries’ legal markets. Poor-quality medicines are associated with treatment failure, development of drug resistance, increased healthcare cost, and death. These reasons warrant a need for monitoring the quality of the medicines circulating in the Tanzania Mainland. METHODS: This was a survey study and veterinary medicines samples were collected from 9 out of 26 regions of Tanzania mainland between 2014 and 2017. Veterinary medicines were sampled from wholesale pharmacies, retail pharmacies, veterinary clinics and Veterinary Accredited Drug Dispensing Outlets (ADDO-vet). All sampled medicines were subjected to product information review and full quality control testing at the Tanzania Medicines and Medical Devices Authority-World Health Organization prequalified laboratory. RESULTS: A total of 238 samples of veterinary medicines were collected. Out of these, 97.1% (231/238) were subjected to full quality control testing and product information review. All sampled veterinary medicines conformed to visual appearance, clarity, pH, solubility and sterility tests. Also, of the sampled veterinary medicines 97.8% (226/231) and 89.2% (206/231) passed identification and assay tests, respectively. As well as, the majority of the collected samples 92% (219/238) failed to comply with product information requirements. The most observed deficiencies on product information were inadequate information on the package insert 94.1% (224/238), inappropriate storage conditions 55.5% (132/238) and lack of Tanzania registration number 27% (64/238). CONCLUSION: Veterinary medicines with poor quality were found circulating in the legal markets of Tanzania. This can potentiate treatment failure and the development of drug resistance in animals and humans. Post marketing surveillance program will continue to be implemented to ensure that only good quality, safe and efficacious medicines are circulating in the Tanzania Mainland market.
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spelling pubmed-91788302022-06-10 Post marketing surveillance of selected veterinary medicines in Tanzania mainland Fimbo, Adam M. Maganda, Betty A. Mwamwitwa, Kissa W. Mwanga, Itikija E. Mbekenga, Engelbert B. Kisenge, Seth Mziray, Sophia A. Kulwa, Gerald S. Mwalwisi, Yonah H. Shewiyo, Danstan H. BMC Vet Res Research BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of animal diseases. Globally, the veterinary medicine industry is growing. However, there is a significant increase of concern on the quality of veterinary medicines in various developing countries’ legal markets. Poor-quality medicines are associated with treatment failure, development of drug resistance, increased healthcare cost, and death. These reasons warrant a need for monitoring the quality of the medicines circulating in the Tanzania Mainland. METHODS: This was a survey study and veterinary medicines samples were collected from 9 out of 26 regions of Tanzania mainland between 2014 and 2017. Veterinary medicines were sampled from wholesale pharmacies, retail pharmacies, veterinary clinics and Veterinary Accredited Drug Dispensing Outlets (ADDO-vet). All sampled medicines were subjected to product information review and full quality control testing at the Tanzania Medicines and Medical Devices Authority-World Health Organization prequalified laboratory. RESULTS: A total of 238 samples of veterinary medicines were collected. Out of these, 97.1% (231/238) were subjected to full quality control testing and product information review. All sampled veterinary medicines conformed to visual appearance, clarity, pH, solubility and sterility tests. Also, of the sampled veterinary medicines 97.8% (226/231) and 89.2% (206/231) passed identification and assay tests, respectively. As well as, the majority of the collected samples 92% (219/238) failed to comply with product information requirements. The most observed deficiencies on product information were inadequate information on the package insert 94.1% (224/238), inappropriate storage conditions 55.5% (132/238) and lack of Tanzania registration number 27% (64/238). CONCLUSION: Veterinary medicines with poor quality were found circulating in the legal markets of Tanzania. This can potentiate treatment failure and the development of drug resistance in animals and humans. Post marketing surveillance program will continue to be implemented to ensure that only good quality, safe and efficacious medicines are circulating in the Tanzania Mainland market. BioMed Central 2022-06-09 /pmc/articles/PMC9178830/ /pubmed/35681204 http://dx.doi.org/10.1186/s12917-022-03329-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Fimbo, Adam M.
Maganda, Betty A.
Mwamwitwa, Kissa W.
Mwanga, Itikija E.
Mbekenga, Engelbert B.
Kisenge, Seth
Mziray, Sophia A.
Kulwa, Gerald S.
Mwalwisi, Yonah H.
Shewiyo, Danstan H.
Post marketing surveillance of selected veterinary medicines in Tanzania mainland
title Post marketing surveillance of selected veterinary medicines in Tanzania mainland
title_full Post marketing surveillance of selected veterinary medicines in Tanzania mainland
title_fullStr Post marketing surveillance of selected veterinary medicines in Tanzania mainland
title_full_unstemmed Post marketing surveillance of selected veterinary medicines in Tanzania mainland
title_short Post marketing surveillance of selected veterinary medicines in Tanzania mainland
title_sort post marketing surveillance of selected veterinary medicines in tanzania mainland
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178830/
https://www.ncbi.nlm.nih.gov/pubmed/35681204
http://dx.doi.org/10.1186/s12917-022-03329-x
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