Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia
BackgroundMedicine regulation is essential for safeguarding the safety, efficacy, and quality of pharmaceutical products available in medicine retail outlets (MROs). It ensures that medicines, whether sourced locally or internationally, comply with stringent quality standards and regulatory protocol...
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Frontiers Media S.A.
2025-03-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2025.1452875/full |
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| author | Yesuneh Tefera Mekasha Habtamu Getahun Addisu Afrassa Tegegne Gemmechu Hasen Gemmechu Hasen |
| author_facet | Yesuneh Tefera Mekasha Habtamu Getahun Addisu Afrassa Tegegne Gemmechu Hasen Gemmechu Hasen |
| author_sort | Yesuneh Tefera Mekasha |
| collection | DOAJ |
| description | BackgroundMedicine regulation is essential for safeguarding the safety, efficacy, and quality of pharmaceutical products available in medicine retail outlets (MROs). It ensures that medicines, whether sourced locally or internationally, comply with stringent quality standards and regulatory protocols to protect public health. Effective regulation enhances trust in pharmaceutical markets by ensuring the availability of safe and effective medications. However, the regulatory framework within healthcare facilities, particularly in MROs where significant drug-related information is exchanged, is often underperforming. This issue is particularly pronounced in low-and middle-income countries like Ethiopia, where MROs play a critical role as the initial point of healthcare contact. This review aims to assess the level of compliance with pharmaceutical regulatory standards in medicine retail outlets (MROs) in Ethiopia and to evaluate the enforcement of these standards in the country’s pharmaceutical market.MethodsThe review utilized online databases such as PubMed, and Web of Science to collect relevant studies and reports. It focused on issues of regulatory compliance in MROs in Ethiopia, identifying gaps in practice, drug quality, and adherence to national guidelines set by the Ethiopian Food and Drug Authority (EFDA).ResultsThe review revealed significant regulatory compliance issues within Ethiopian MROs, leading to the distribution of poor quality medicines. It was found that drugs obtained from non-compliant outlets failed to meet quality control standards outlined in drug monographs. Many MROs and pharmacy professionals were found to be non-compliant with EFDA guidelines. Additionally, dispensing and storage practices in MROs were not in line with EFDA regulations and required improvements.ConclusionThe review underlines the need for regulatory enforcement in Ethiopia health settings to address issues of non-compliance and the distribution of poor-quality drugs. It suggests that regulatory bodies should enhance inspection measures and provide opportunities for continued professional development for pharmacy staff and regulatory personnel. Collaboration among regulatory authorities, government, professionals, and academic researchers are pivotal to improving compliance and ensuring the availability of safe, effective, and quality medicines within medicine retail outlets and then protecting public health. |
| format | Article |
| id | doaj-art-a0b70f8a955a4a60af4a101f9441c44a |
| institution | DOAJ |
| issn | 2296-858X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj-art-a0b70f8a955a4a60af4a101f9441c44a2025-08-20T03:01:46ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-03-011210.3389/fmed.2025.14528751452875Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in EthiopiaYesuneh Tefera Mekasha0Habtamu Getahun1Addisu Afrassa Tegegne2Gemmechu Hasen3Gemmechu Hasen4Department of Veterinary Pharmacy, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar, Gondar, EthiopiaOromia Regional Health Bureau, Addis Ababa, EthiopiaDepartment of Pharmaceutical Chemistry, School of Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, EthiopiaJimma University Laboratory of Drug Quality (JuLaDQ), Jimma, Oromia, EthiopiaClinical Trials Directorate, Armauer Hansen Research Institute, Addis Ababa, EthiopiaBackgroundMedicine regulation is essential for safeguarding the safety, efficacy, and quality of pharmaceutical products available in medicine retail outlets (MROs). It ensures that medicines, whether sourced locally or internationally, comply with stringent quality standards and regulatory protocols to protect public health. Effective regulation enhances trust in pharmaceutical markets by ensuring the availability of safe and effective medications. However, the regulatory framework within healthcare facilities, particularly in MROs where significant drug-related information is exchanged, is often underperforming. This issue is particularly pronounced in low-and middle-income countries like Ethiopia, where MROs play a critical role as the initial point of healthcare contact. This review aims to assess the level of compliance with pharmaceutical regulatory standards in medicine retail outlets (MROs) in Ethiopia and to evaluate the enforcement of these standards in the country’s pharmaceutical market.MethodsThe review utilized online databases such as PubMed, and Web of Science to collect relevant studies and reports. It focused on issues of regulatory compliance in MROs in Ethiopia, identifying gaps in practice, drug quality, and adherence to national guidelines set by the Ethiopian Food and Drug Authority (EFDA).ResultsThe review revealed significant regulatory compliance issues within Ethiopian MROs, leading to the distribution of poor quality medicines. It was found that drugs obtained from non-compliant outlets failed to meet quality control standards outlined in drug monographs. Many MROs and pharmacy professionals were found to be non-compliant with EFDA guidelines. Additionally, dispensing and storage practices in MROs were not in line with EFDA regulations and required improvements.ConclusionThe review underlines the need for regulatory enforcement in Ethiopia health settings to address issues of non-compliance and the distribution of poor-quality drugs. It suggests that regulatory bodies should enhance inspection measures and provide opportunities for continued professional development for pharmacy staff and regulatory personnel. Collaboration among regulatory authorities, government, professionals, and academic researchers are pivotal to improving compliance and ensuring the availability of safe, effective, and quality medicines within medicine retail outlets and then protecting public health.https://www.frontiersin.org/articles/10.3389/fmed.2025.1452875/fullreviewmedicine retail outletspoor-quality drugscomplianceregulatory standardsEFDA |
| spellingShingle | Yesuneh Tefera Mekasha Habtamu Getahun Addisu Afrassa Tegegne Gemmechu Hasen Gemmechu Hasen Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia Frontiers in Medicine review medicine retail outlets poor-quality drugs compliance regulatory standards EFDA |
| title | Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia |
| title_full | Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia |
| title_fullStr | Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia |
| title_full_unstemmed | Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia |
| title_short | Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia |
| title_sort | situational analysis and future directions for medicine retail outlets compliance with pharmaceutical regulatory standards in ethiopia |
| topic | review medicine retail outlets poor-quality drugs compliance regulatory standards EFDA |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1452875/full |
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