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Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia

BACKGROUND: Medicines of poor quality are currently prevailing problems undermining the quality of health care services in veterinary and human medicine. In this study, physico-chemical quality of veterinary medicines was evaluated. METHODS: A total of 959 veterinary medicines samples were collected...

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Autores principales: Tefera, Belachew, Bacha, Belachew, Belew, Sileshi, Raffaella, Ravinetto, Andualem, Tenaw, Abegaz, Zerihun, Zelelew, Ayalew, Uma, Gudeta, Setegn, Tadese, Hunduma, Abdisa, Jemal, Dinsefa, Daba, Diriba, Belete, Bizuayehu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8892721/
https://www.ncbi.nlm.nih.gov/pubmed/35241169
http://dx.doi.org/10.1186/s40545-022-00410-6
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author Tefera, Belachew
Bacha, Belachew
Belew, Sileshi
Raffaella, Ravinetto
Andualem, Tenaw
Abegaz, Zerihun
Zelelew, Ayalew
Uma, Gudeta
Setegn, Tadese
Hunduma, Abdisa
Jemal, Dinsefa
Daba, Diriba
Belete, Bizuayehu
author_facet Tefera, Belachew
Bacha, Belachew
Belew, Sileshi
Raffaella, Ravinetto
Andualem, Tenaw
Abegaz, Zerihun
Zelelew, Ayalew
Uma, Gudeta
Setegn, Tadese
Hunduma, Abdisa
Jemal, Dinsefa
Daba, Diriba
Belete, Bizuayehu
author_sort Tefera, Belachew
collection PubMed
description BACKGROUND: Medicines of poor quality are currently prevailing problems undermining the quality of health care services in veterinary and human medicine. In this study, physico-chemical quality of veterinary medicines was evaluated. METHODS: A total of 959 veterinary medicines samples were collected during routine regulatory activities, i.e. pre-registration, re-registration, consignment checking and post-marketing surveillance, in Ethiopia. The samples were transported to Animal Products, Veterinary Drug and Feed Quality Assessment Centre (APVD-FQAC), which is the quality control laboratory of the Veterinary Drug and Feed Administration and Control Authority (VDFACA) and stored until analysis. The samples were subjected to visual inspection and chemical analysis following the United States, European or British Pharmacopoeias, or manufacturer’s methods. RESULTS: The findings revealed that 12 (1.3%) of tested products showed defects in physical characteristics, packaging, or labelling information, while a total of 66 (6.9%) samples of the investigated products failed to comply with the Pharmacopoeias and supplier’s specification limit set for assay. Of these, 60 samples did not comply with the minimum assay specification limit. CONCLUSION: Overall, 8.2% of the investigated veterinary medicine samples did not comply with the specification set for the investigated quality attributes and thus were categorized as of poor quality. This indicates the need for continued strengthening of regulatory functions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40545-022-00410-6.
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spelling pubmed-88927212022-03-10 Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia Tefera, Belachew Bacha, Belachew Belew, Sileshi Raffaella, Ravinetto Andualem, Tenaw Abegaz, Zerihun Zelelew, Ayalew Uma, Gudeta Setegn, Tadese Hunduma, Abdisa Jemal, Dinsefa Daba, Diriba Belete, Bizuayehu J Pharm Policy Pract Research BACKGROUND: Medicines of poor quality are currently prevailing problems undermining the quality of health care services in veterinary and human medicine. In this study, physico-chemical quality of veterinary medicines was evaluated. METHODS: A total of 959 veterinary medicines samples were collected during routine regulatory activities, i.e. pre-registration, re-registration, consignment checking and post-marketing surveillance, in Ethiopia. The samples were transported to Animal Products, Veterinary Drug and Feed Quality Assessment Centre (APVD-FQAC), which is the quality control laboratory of the Veterinary Drug and Feed Administration and Control Authority (VDFACA) and stored until analysis. The samples were subjected to visual inspection and chemical analysis following the United States, European or British Pharmacopoeias, or manufacturer’s methods. RESULTS: The findings revealed that 12 (1.3%) of tested products showed defects in physical characteristics, packaging, or labelling information, while a total of 66 (6.9%) samples of the investigated products failed to comply with the Pharmacopoeias and supplier’s specification limit set for assay. Of these, 60 samples did not comply with the minimum assay specification limit. CONCLUSION: Overall, 8.2% of the investigated veterinary medicine samples did not comply with the specification set for the investigated quality attributes and thus were categorized as of poor quality. This indicates the need for continued strengthening of regulatory functions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40545-022-00410-6. BioMed Central 2022-03-03 /pmc/articles/PMC8892721/ /pubmed/35241169 http://dx.doi.org/10.1186/s40545-022-00410-6 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
Tefera, Belachew
Bacha, Belachew
Belew, Sileshi
Raffaella, Ravinetto
Andualem, Tenaw
Abegaz, Zerihun
Zelelew, Ayalew
Uma, Gudeta
Setegn, Tadese
Hunduma, Abdisa
Jemal, Dinsefa
Daba, Diriba
Belete, Bizuayehu
Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia
title Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia
title_full Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia
title_fullStr Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia
title_full_unstemmed Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia
title_short Study on identification, assay and organoleptic quality of veterinary medicines in Ethiopia
title_sort study on identification, assay and organoleptic quality of veterinary medicines in ethiopia
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8892721/
https://www.ncbi.nlm.nih.gov/pubmed/35241169
http://dx.doi.org/10.1186/s40545-022-00410-6
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