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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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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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. |
format | Online Article Text |
id | pubmed-8892721 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
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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