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Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation
AAPS Open Pub Date : 2019-08-05 , DOI: 10.1186/s41120-019-0032-x
Abigail A. Ekeigwe

It is the right of all humans to have access to safe, quality and effective medicines. This article seeks to expound on the problems of drug manufacturing and challenges of accessing medicines in West Africa, and evaluate the strategies being adopted by international developmental partners and the governments to address them. West Africa is uniquely diverse in culture (having English, French and Portuguese speaking people) but generally affected by the same diseases (e.g., malaria, HIV/AIDS, and Tuberculosis). In this developmentally beleaguered region, drug development and manufacturing are still stuck in their embryonic stages where medicine distribution is chaotic and insufficiently regulated. An enduring question is why investment in research and development in medicines for neglected tropical diseases and manufacturing is still very low in Africa and in particular West Africa. In this article, we look at how these vulnerabilities are exploited by unscrupulous merchants, leading to massive influx of fake and substandard medicines to the supply chain, making it difficult for the rural, voiceless poor to access quality safe medication. Through an examination of current research and published works by the World Health Organization (WHO), the United States Pharmacopeia (USP) and other international development partners in Africa, first hand interactions with manufacturers, medicine regulators, regulatory consultants, and the patients, as well as from personal observations, the article crystallizes the major issues and challenges to drug manufacturing and access to quality, safe, and effective essential medicines in West Africa. This article also examines the strategies and policies being implemented to salvage the situation. It is irrevocably clear that solving the challenges of providing safe medication to West Africa is a collective responsibility - the government (through legislation, strategic regulations and policies), medicines manufacturers (adoption of Good Manufacturing Practices and ethics), regulators (through persuasion and enforcement of rules), regulatory consultants, the patients (empowered, informed about their rights and courage and willingness to report drug reactions and discernible counterfeiting), the international development partners and all other stake holders in the health care sector have roles to play in ensuring that the public has access to quality safe and efficacious medicines.

中文翻译:

药品生产和获得药品:西非的故事。有关挑战和建议补救措施的文献综述

所有人都有获得安全,优质和有效药物的权利。本文旨在阐述西非的药品生产问题和获取药品的挑战,并评估国际发展伙伴和各国政府为解决这些问题而采取的战略。西非的文化独特多元(有讲英语,法语和葡萄牙语的人),但总体上都受到相同疾病(例如疟疾,艾滋病毒/艾滋病和结核病)的影响。在这个受发展困扰的地区,药物的开发和制造仍停留在其药物分配混乱且监管不足的胚胎阶段。一个持久的问题是,为什么在非洲,特别是西非,对被忽视的热带病和制造药物的研发投资仍然很低。在本文中,我们将研究不道德的商人如何利用这些漏洞,导致大量假药和不合格药品涌入供应链,从而使农村无语穷人难以获得优质安全的药物。通过审查世界卫生组织(WHO),美国药典(USP)和非洲其他国际发展伙伴的最新研究成果和已发表的著作,与制造商,药品监管者,监管顾问和患者进行第一手互动,以及个人观察,文章明确了西非药品生产以及获得优质,安全,有效的基本药物的主要问题和挑战。本文还研究了为挽救局势而实施的战略和政策。显而易见,解决向西非提供安全药物的挑战是一项集体责任,即政府(通过立法,战略法规和政策),药品制造商(通过良好生产规范和道德规范),监管机构(通过说服和执行)规则),监管顾问,患者(有权告知患者其权利,勇气和愿意举报药物反应和可辨伪造品的信息),
更新日期:2019-08-05
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