Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia

Abdella Aman,1 Gemmechu Hasen,1,2 Hayder Usman,1 Sultan Suleman1,2 1School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia; 2Jimma University Laboratory Drug Quality (JuLaDQ), Jimma, Oromia, EthiopiaCorrespondence: Gemmechu HasenSchool of Pharmacy, Institute of Health, Ji...

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Autores principales:	Aman A, Hasen G, Usman H, Suleman S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	drug retails regulatory compliance quality amoxicillin ethiopia Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/651a2d34151e46d7b51bd96cb4a615e1
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spelling	oai:doaj.org-article:651a2d34151e46d7b51bd96cb4a615e12021-11-30T18:50:37ZRegulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia1179-1365https://doaj.org/article/651a2d34151e46d7b51bd96cb4a615e12021-11-01T00:00:00Zhttps://www.dovepress.com/regulatory-compliance-and-associated-quality-of-amoxicillin-in-drug-re-peer-reviewed-fulltext-article-DHPShttps://doaj.org/toc/1179-1365Abdella Aman,1 Gemmechu Hasen,1,2 Hayder Usman,1 Sultan Suleman1,2 1School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia; 2Jimma University Laboratory Drug Quality (JuLaDQ), Jimma, Oromia, EthiopiaCorrespondence: Gemmechu HasenSchool of Pharmacy, Institute of Health, Jimma University, PO Box 378, Jimma, Oromia, EthiopiaEmail gemmechuhasen2009@gmail.com; gemmechu.godena@ju.edu.etBackground: While the research findings confirm the existence of private drug retail outlets that do not comply with regulatory standards in many low-income countries, there are a lack of reports that evaluate the quality of medicines obtained from these firms. Therefore, the aim of this study was to evaluate the regulatory compliance of the retails and associated quality of amoxicillin in Southwestern Ethiopia.Methodology: Forty-two drug retail outlets in Jimma town were evaluated using an inspection checklist developed by the Ethiopian regulatory authority, and dispensers from these retail outlets were interviewed using the pretested structured questionnaire. The drug outlets were coded and categorized into noncompliant and compliant drug retail outlets. The physicochemical quality of amoxicillin capsules obtained from these retail outlets were evaluated following methods described in the US Pharmacopoeia.Results: The present study revealed that about 54.76% drug retail outlets were compliant with the regulatory standard. Factors like income of retail outlet, experience of dispenser, and training regarding good storage practice were associated with status of regulatory compliance (p-value < 0.05). The identification, dissolution, and assay results indicated that all amoxicillin samples obtained from both noncompliant and compliant drug retail outlets complied with pharmacopoeial specification limit. Besides, the independent unequal variance t-test revealed that there is no significant difference between mean dissolution and assay of API of the amoxicillin samples obtained these drug retail outlets (p-value > 0.05).Conclusion: The regulatory compliance of private drug retail outlets in Jimma town is not satisfactory. Moreover, the laboratory findings revealed that all samples of amoxicillin capsules compiled with pharmacopoeial specifications acceptance for packaging and labeling information, identification, assay, and dissolution. However, despite the fact that assays of the amoxicillin from retail outlets are within the required specification, the assays of amoxicillin obtained from noncompliant retail outlets appears to be slightly degraded, which may potentially demonstrate the impact of noncompliance of the drug retail outlets on the quality of medicines.Keywords: drug retails, regulatory compliance, quality, amoxicillin, EthiopiaAman AHasen GUsman HSuleman SDove Medical Pressarticledrug retailsregulatory compliancequalityamoxicillinethiopiaMedicine (General)R5-920ENDrug, Healthcare and Patient Safety, Vol Volume 13, Pp 241-249 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	drug retails regulatory compliance quality amoxicillin ethiopia Medicine (General) R5-920
spellingShingle	drug retails regulatory compliance quality amoxicillin ethiopia Medicine (General) R5-920 Aman A Hasen G Usman H Suleman S Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia
description	Abdella Aman,1 Gemmechu Hasen,1,2 Hayder Usman,1 Sultan Suleman1,2 1School of Pharmacy, Institute of Health, Jimma University, Jimma, Oromia, Ethiopia; 2Jimma University Laboratory Drug Quality (JuLaDQ), Jimma, Oromia, EthiopiaCorrespondence: Gemmechu HasenSchool of Pharmacy, Institute of Health, Jimma University, PO Box 378, Jimma, Oromia, EthiopiaEmail gemmechuhasen2009@gmail.com; gemmechu.godena@ju.edu.etBackground: While the research findings confirm the existence of private drug retail outlets that do not comply with regulatory standards in many low-income countries, there are a lack of reports that evaluate the quality of medicines obtained from these firms. Therefore, the aim of this study was to evaluate the regulatory compliance of the retails and associated quality of amoxicillin in Southwestern Ethiopia.Methodology: Forty-two drug retail outlets in Jimma town were evaluated using an inspection checklist developed by the Ethiopian regulatory authority, and dispensers from these retail outlets were interviewed using the pretested structured questionnaire. The drug outlets were coded and categorized into noncompliant and compliant drug retail outlets. The physicochemical quality of amoxicillin capsules obtained from these retail outlets were evaluated following methods described in the US Pharmacopoeia.Results: The present study revealed that about 54.76% drug retail outlets were compliant with the regulatory standard. Factors like income of retail outlet, experience of dispenser, and training regarding good storage practice were associated with status of regulatory compliance (p-value < 0.05). The identification, dissolution, and assay results indicated that all amoxicillin samples obtained from both noncompliant and compliant drug retail outlets complied with pharmacopoeial specification limit. Besides, the independent unequal variance t-test revealed that there is no significant difference between mean dissolution and assay of API of the amoxicillin samples obtained these drug retail outlets (p-value > 0.05).Conclusion: The regulatory compliance of private drug retail outlets in Jimma town is not satisfactory. Moreover, the laboratory findings revealed that all samples of amoxicillin capsules compiled with pharmacopoeial specifications acceptance for packaging and labeling information, identification, assay, and dissolution. However, despite the fact that assays of the amoxicillin from retail outlets are within the required specification, the assays of amoxicillin obtained from noncompliant retail outlets appears to be slightly degraded, which may potentially demonstrate the impact of noncompliance of the drug retail outlets on the quality of medicines.Keywords: drug retails, regulatory compliance, quality, amoxicillin, Ethiopia
format	article
author	Aman A Hasen G Usman H Suleman S
author_facet	Aman A Hasen G Usman H Suleman S
author_sort	Aman A
title	Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia
title_short	Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia
title_full	Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia
title_fullStr	Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia
title_full_unstemmed	Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia
title_sort	regulatory compliance and associated quality of amoxicillin in drug retail outlets of southwestern ethiopia
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/651a2d34151e46d7b51bd96cb4a615e1
work_keys_str_mv	AT amana regulatorycomplianceandassociatedqualityofamoxicillinindrugretailoutletsofsouthwesternethiopia AT haseng regulatorycomplianceandassociatedqualityofamoxicillinindrugretailoutletsofsouthwesternethiopia AT usmanh regulatorycomplianceandassociatedqualityofamoxicillinindrugretailoutletsofsouthwesternethiopia AT sulemans regulatorycomplianceandassociatedqualityofamoxicillinindrugretailoutletsofsouthwesternethiopia
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Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia

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