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.
Background: Competency-based regulatory sciences education could expand the workforce of regulatory scientists in sub-Saharan Africa. A competency framework is foundational to developing competency-based education. Objective: To identify the entry-level competency requirements of regulatory scientists in sub-Saharan Africa. Method: This research was a systematic review of the literature based on a pre-registered protocol. The research used the "framework synthesis" systematic review model to deductively identify competencies and code them into clusters with NVivo 12 software. Result: Three broad clusters of competencies were identified – enabling behaviours, knowledge, and skills. The knowledge and skills clusters were further subdivided into sub-clusters: the knowledge cluster into administrative, regulatory governance/framework, and scientific knowledge, and the skills cluster into functional and technical skills. Conclusion: The identified competencies will assist in developing an entry-level competency framework required for competency-based regulatory sciences education in sub-Saharan Africa.
This case study presents the results of a data internship and workshop series on data analysis in qualitative biomedical systematic reviews. In a newly developed librarian-led internship program, an intern was trained on data literacy concepts and data analysis tools and, in turn, helped recruit and train other graduate health sciences students. Due to COVID-19 restrictions, a flipped classroom model was applied to develop a completely virtual learning experience for both the intern and workshop attendees. Both the data intern and workshop participants reported improved confidence in data literacy competence at the end of the project. Assessment results suggest that while the workshop series improved participants’ data literacy skills, participants might still benefit from additional data literacy instruction. This case also presents a model for student-led instruction that could be particularly useful for informing professional development opportunities for library interns, fellows, and student assistants.
Quality management systems (QMS) are becoming a global paradigm especially in testing laboratories. A critical component of QMS in testing laboratories is the proper handling of incoming samples to ensure that the integrity of such samples are not compromised in any way before the commencement of testing and assure the validity of the results received from testing units. The sample reception unit in the Central Registry of the Central Drug Control Laboratory (CDCL) of the National Agency of Food and Drug Administration and Control (NAFDAC), Nigeria, did not have a QMS in place. The methodology for instituting QMS involved reorganization of the unit, development of all working documents, training and retraining of all staff/team members, implementation of the new system and then conducting continuous monitoring and evaluation using predefined key performance indicators. The results clearly show that the implementation of a QMS in the Sample Reception unit of the Central Registry of the Central Drug Control Laboratory has greatly improved the overall effectiveness and efficiency of the unit. It has ensured that the integrity of incoming samples is not compromised before testing by the analytical units. This has led to increased trust and reliability of the test results and analytical reports produced by the Central Drug Control Laboratory of the National Agency for Food and Drugs Administration and Control of Nigeria.
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