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东非国家兽医药物警戒情况与前景的叙述性综述。

A narrative review of veterinary pharmacovigilance situations and prospects in East African countries.

作者信息

Mekasha Yesuneh Tefera, Nigussie Sete, Mekonen Abibo Wondie, Berrie Kassahun, Mulaw Asnakew, Feleke Melaku Getahun

机构信息

Pharmaceutical Science, Pharmaceutical Quality Assurance, and Regulatory Affairs, University of Gondar, Gondar, Ethiopia.

Department of Veterinary Pharmacy, College of Veterinary Medicine and Animal Sciences, University of Gondar, Gondar, Ethiopia.

出版信息

Front Vet Sci. 2024 Nov 1;11:1430587. doi: 10.3389/fvets.2024.1430587. eCollection 2024.

DOI:10.3389/fvets.2024.1430587
PMID:39606647
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11600972/
Abstract

BACKGROUND

Veterinary pharmaceuticals must be safe and effective for treating and preventing diseases in animal sectors. Strict adherence to regulations at every stage of production, storage, and administration is necessary as the global sector grows in order to lower the possibility of adverse veterinary drug events. Strong pharmacovigilance regulatory systems are critical in monitoring and managing safety concerns related with veterinary pharmaceuticals.

OBJECTIVE

This review aimed to investigate the implementation of veterinary pharmacovigilance, collaborative initiatives, and reporting practices within the veterinary sector across East African countries.

METHODS

A thorough search was performed using online platforms such as Google Scholar, PubMed, the Web of Sciences, and regulatory Web sites. The search strategies relied heavily on selecting relevant published findings related to veterinary pharmacovigilance status, veterinary adverse drug event reporting practice, and collaborative efforts in veterinary pharmaceutical sectors within the East African landscape. This article search approach confirmed the inclusion state of veterinary pharmacovigilance and associated collaborative initiatives in the region.

RESULTS

In comparison to more developed regions, the review indicated that the veterinary pharmacovigilance system in East African countries was still in its early state. A strong legislative foundation and a large commitment from the veterinary profession are needed to establish a nationwide veterinary pharmacovigilance system. The review reveals a significant lack of consistency in the infrastructure of veterinary pharmacovigilance among the countries of East Africa. Tanzania, Kenya, and Ethiopia have some institutional processes for veterinary pharmaceutical safety, but they lack thorough documentation, which suggests that this systems still require improvement. The analysis emphasizes how inadequate the reporting systems are for adverse veterinary medication events in the majority of East African nations. Given the challenges East Africa faces, customized strategies are required to guarantee the safety and oversight of veterinary medications and improve veterinary pharmacovigilance. For systems to be more effective, veterinary pharmaceutical legal frameworks must be strengthened and stakeholder collaboration must be improved. Stakeholders include legislators, law enforcement, customs officials, regulatory organizations, scientists, pharmaceutical businesses, veterinarians, farmers, and the general public.

CONCLUSION

A multidisciplinary strategy is needed to solve current gaps in veterinary pharmacovigilance and improve overall veterinary drug safety in East Africa. It is feasible to create more reliable methods for tracking and guaranteeing the safety of veterinary medications by combining the efforts of numerous stakeholders, including as legislators, regulatory agencies, veterinary practitioners, and the general public.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e6b/11600972/6829da6ae1aa/fvets-11-1430587-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e6b/11600972/6829da6ae1aa/fvets-11-1430587-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e6b/11600972/6829da6ae1aa/fvets-11-1430587-g001.jpg
摘要

背景

兽用药品必须对动物疾病的治疗和预防安全有效。随着全球兽用药品行业的发展,在生产、储存和使用的每个阶段严格遵守法规,以降低兽药不良事件的可能性至关重要。强大的药物警戒监管系统对于监测和管理与兽用药品相关的安全问题至关重要。

目的

本综述旨在调查东非国家兽用药品行业内兽用药物警戒的实施情况、合作举措及报告做法。

方法

利用谷歌学术、PubMed、科学网等在线平台以及监管网站进行全面搜索。搜索策略主要依赖于选择与东非地区兽用药物警戒现状、兽药不良事件报告做法以及兽用药品行业合作努力相关的已发表研究结果。本文的搜索方法确定了该地区兽用药物警戒及相关合作举措的纳入情况。

结果

与更发达地区相比,该综述表明东非国家的兽用药物警戒系统仍处于早期阶段。建立全国性的兽用药物警戒系统需要坚实的立法基础和兽医行业的大力支持。该综述揭示,东非各国在兽用药物警戒基础设施方面存在显著的不一致性。坦桑尼亚、肯尼亚和埃塞俄比亚有一些兽用药品安全的制度流程,但缺乏详尽的文件记录,这表明该系统仍需改进。分析强调,在大多数东非国家,兽药不良事件的报告系统非常不完善。鉴于东非面临的挑战,需要制定定制化策略,以确保兽用药品的安全与监管,并改善兽用药物警戒。为使系统更有效,必须加强兽用药品法律框架,并改善利益相关者之间的合作。利益相关者包括立法者、执法人员、海关官员、监管机构、科学家、制药企业、兽医、农民和公众。

结论

需要采取多学科策略来解决当前兽用药物警戒方面的差距,并提高东非地区整体兽药安全性。通过整合包括立法者、监管机构、兽医从业者和公众在内的众多利益相关者的努力,创建更可靠的兽药跟踪和安全保障方法是可行的。

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