ENHANCING MEDICATION QUALITY CONTROL IN NIGERIA: A COMPREHENSIVE ANALYSIS OF REGULATORY CHALLENGES AND SOLUTIONS

Michael Alurame Eruaga, Esther Oleiye Itua, James Tabat Bature
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Abstract

Medication quality control in Nigeria faces multifaceted challenges rooted in regulatory inefficiencies, infrastructural limitations, and systemic inadequacies. This study undertakes a comprehensive analysis of these challenges while proposing pragmatic solutions to bolster the quality control framework in the Nigerian pharmaceutical sector. Drawing upon extensive literature review and expert insights, the research identifies key regulatory challenges impeding effective medication quality control in Nigeria. These challenges encompass inadequate regulatory capacity, inconsistent enforcement mechanisms, rampant substandard and counterfeit medications, and limited access to essential medicines. Additionally, infrastructural deficiencies such as inadequate laboratory facilities and insufficient human resources further exacerbate the problem, leading to compromised patient safety and public health risks. In response to these challenges, the study proposes a multifaceted approach to enhance medication quality control in Nigeria. This includes strengthening regulatory frameworks through legislative reforms aimed at bolstering enforcement capabilities and harmonizing standards with international best practices. Moreover, improving regulatory capacity through training programs and investment in state-of-the-art laboratory infrastructure is essential to enhance surveillance and detection of substandard medications. Furthermore, fostering collaboration between regulatory agencies, healthcare providers, and pharmaceutical manufacturers is imperative to streamline supply chains and ensure the integrity of medications from production to distribution. Additionally, public awareness campaigns and community engagement initiatives play a pivotal role in empowering consumers to make informed decisions and report instances of substandard medications. By addressing these regulatory challenges and implementing comprehensive solutions, Nigeria can significantly enhance medication quality control, safeguard patient health, and foster a conducive environment for pharmaceutical innovation and growth. Keywords:  Medical, Medication, Drugs, Quality Control, Nigeria, Regulations, Review.
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加强尼日利亚的药品质量控制:对监管挑战和解决方案的全面分析
尼日利亚的药品质量控制面临着多方面的挑战,其根源在于监管效率低下、基础设施有限以及系统性不足。本研究对这些挑战进行了全面分析,同时提出了务实的解决方案,以加强尼日利亚制药行业的质量控制框架。通过广泛的文献综述和专家见解,本研究确定了阻碍尼日利亚有效进行药品质量控制的主要监管挑战。这些挑战包括监管能力不足、执法机制不一致、假冒伪劣药品猖獗以及基本药物获取途径有限。此外,实验室设施不足、人力资源不足等基础设施缺陷也进一步加剧了这一问题,导致患者安全受损,公共卫生风险增加。为应对这些挑战,本研究提出了一种多方面的方法来加强尼日利亚的药品质量控制。这包括通过立法改革加强监管框架,旨在提高执法能力,并使标准与国际最佳实践相一致。此外,通过培训计划和投资最先进的实验室基础设施来提高监管能力,对于加强监督和检测不合格药品至关重要。此外,促进监管机构、医疗服务提供商和制药商之间的合作,对于简化供应链、确保药品从生产到销售的完整性也至关重要。此外,提高公众意识的活动和社区参与倡议在增强消费者做出知情决定和报告不合格药品事件的能力方面发挥着关键作用。通过应对这些监管挑战并实施全面的解决方案,尼日利亚可以大大加强药品质量控制,保障患者健康,并为医药创新和发展营造有利环境。关键词 医疗 药品 质量控制 尼日利亚 法规 综述
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