Building capacity for drug development process in Africa‒A workable model
DOI:
https://doi.org/10.46542/pe.2024.241.112Keywords:
Capacity building, Centre of excellence, Drug discovery, Quality medicineAbstract
Background: Africa’s reliance on drug importation translates to disproportionate transfer of foreign exchange and incessant drug shortages, among other vices. Africans, therefore, need to build capacity in drug discovery, development and production. This article showcases a workable model with an innovative approach of teaching together personnel drawn from Nigeria's academia, pharmaceutical industry and medicine regulation agency.
Method: Didactic training via postgraduate programmes was designed with hands-on experience in drug synthesis and production. Training and research objectives formed the core of activities.
Result: The Centre for Drug Discovery, Development and Production (CDDDP), Faculty of Pharmacy, University of Ibadan, was established through grant funding from the MacArthur Foundation. The Centre runs two postgraduate degree programmes, has graduated over forty students, organised four workshops, two international conferences, and translated scientific findings to over eleven finished products. In 2014, the African Medicines Regulatory Harmonisation Programme designated CDDDP a Regional Centre of Regulatory Excellence and since 2019, it has partnered with the United States Pharmacopeia to promote the quality of medicines in low- and middle-income countries (LMIC).
Conclusion: Capacity building in drug development processes in an LMIC has been developed with resultful outcomes and is proposed as a workable template for other LMICs.
References
Abarikwu, S. O., Mgbudom-Okah, C. J., Onuah, C. L., & Ogunlaja, A. (2019). Fluted pumpkin seeds protect against busulfan-induced oxidative stress and testicular injuries in adult mice. Drug and Chemical Toxicology, 45(1), 22‒3. https://doi.org/10.1080/01480545.2019.1657885
Abate, M. A., Stamatakis, M. K., & Haggett, R. R. (2003). Excellence in curriculum development and assessment. American Journal of Pharmaceutical Education, 67(3), 89. https://www.semanticscholar.org/paper/Excellence-in-Curriculum-Development-and-Assessment-Abate-Stamatakis/41f025c2ec126bb7e31d4615adbe7b1e3982de75
Adebisi, Y. A., Nwogu, I. B., Alaran, A. J., Badmos, A. O., Bamgboye, A. O., Rufai, B. O., Okonji, O. C., Malik, M. O., Teibo, J. O., Abdalla, S. F., Lucero-Prisno, D. E., Samai, M., & Akande-Sholabi, W. (2022). Revisiting the issue of access to medicines in Africa: Challenges and recommendations. Public Health Challenges, 1(2), e9. https://doi.org/10.1002/PUH2.9
Agyepong, I. A., Sewankambo, N., Binagwaho, A., Awa, M. C.-S., Corrah, T., Ezeh, A., Fekadu, A., Kilonzo, N., Lamptey, P., Masiye, F., Mayosi, B., Mboup, S., Muyembe, J.-J., Pate, M., Sidibe, M., Simons, B., Tlou, S., Gheorghe, A., Legido-Quigley, H., … & Piot, P. (2017). The path to longer and healthier lives for all Africans by 2030: The Lancet Commission on the future of health in sub-Saharan Africa. The Lancet Commissions, 390, 2803‒2859. https://doi.org/10.1016/S0140-6736(17)31509-X
Andurkar, S., Fjortoft, N., Sincak, C., & Todd, T. (2010). Development of a center for teaching excellence. American Journal of Pharmaceutical Education, 74(7), 123. https://doi.org/10.5688/aj7407123
Anyakora, C., Ekwunife, O., Alozie, F., Esuga, M., Ukwuru, J., Onya, S., & Nwokike, J. (2017). Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer. BMC Health Services Research, 17(1), 1–9. https://doi.org/10.1186/s12913-017-2610-8
AUDA-NEPAD. (2022). Regional Centres of Regulatory Excellence (RCOREs). African Union Development Agency. https://www.nepad.org/publication/regional-centres-of-regulatory-excellence-rcores
Babapour, J., Gholipour, A., & Mehralian, G. (2018). Human resource management challenges to develop pharmaceutical industry: Evidence from developing countries. Iranian Journal of Pharmaceutical Research, 17(Special Issue 2), 224–238. https://doi.org/10.22037/ijpr.2018.2385
Berger, M., Murugi, J., Buch, E., IJsselmuiden C, Moran, M., Guzman, J., Devlin, M., & Kubata, B. (2010). Strengthening pharmaceutical innovation in Africa. Council on Health Research for Development (COHRED) & New Partnership for Africa’s Development (NEPAD). https://www.unido.org/sites/default/files/2016-01/COHRED-NEPAD_Strengthening_Pharmaceutical_Innovation_Africa__Report_May_2010_FINALweb_0.pdf
CDDDP. (2013). Center for Drug Discovery, Development and Production (CDDDP). Center for Drug Discovery, Development and Production. https://pgschool.ui.edu.ng/program.php?department=Centre%20For%20Drug%20Discovery,%20Development%20and%20Production
Diez-Echave, P., Vezza, T., Rodríguez-Nogales, A., Ruiz-Malagón, A. J., Hidalgo-García, L., Garrido-Mesa, J., Molina-Tijeras, J. A., Romero, M., Robles-Vera, I., Pimentel-Moral, S., Borras-Linares, I., Arráez-Román, D., Segura-Carretero, A., Micol, V., García, F., Duarte, J., Rodríguez-Cabezas, M. E., & Gálvez, J. (2020). The prebiotic properties of Hibiscus sabdariffa extract contribute to the beneficial effects in diet-induced obesity in mice. Food Research International, 127, 108772. https://doi.org/10.1016/j.foodres.2019.108722
Ekeigwe, A. A. (2019). Drug manufacturing and access to medicines: The West African story. A literature review of challenges and proposed remediation. AAPS Open, 5(1), 3. https://doi.org/10.1186/s41120-019-0032-x
Hammer, D., Piascik, P., Medina, M., Pittenger, A., Rose, R., Creekmore, F., Soltis, R., Bouldin, A., Schwarz, L., & Scott, S. (2010). Recognition of teaching excellence. American Journal of Pharmaceutical Education, 74(9), 164. https://doi.org/10.5688/aj7409164
Idiegbeyan-Ose, J., Ohaegbulam, H., & Osayande, O. (2015). Conference/workshop attendance by librarians: Benefits, challenges, and prospects. Chinese Librarianship, 39(39), 30–39. https://core.ac.uk/download/pdf/32225491.pdf
International Pharmaceutical Federation (FIP). (2008). A global framework for quality assurance of pharmacy education. The International Pharmaceutical Federation. https://www.fip.org/files/fip/PharmacyEducation/Global Framework Final Draft.pdf
Kabene, S. M., Orchard, C., Howard, J. M., Soriano, M. A., & Leduc, R. (2006). The importance of human resources management in health care: A global context. Human Resources for Health, 4, 20. https://doi.org/10.1186/1478-4491-4-20
Njoku, R. C. C., Abarikwu, S. O., Uwakwe, A. A., Mgbudom-Okah, C. J., & Ezirim, C. Y. (2019). Dietary fluted pumpkin seeds induce reversible oligospermia and androgen insufficiency in adult rats. Systems Biology in Reproductive Medicine, 65(6), 437‒450. https://doi.org/10.1080/19396368.2019.1612482
Odeku, O.A., Adisa, R., Adetunji, O.A., Durowaiye, M.A. and Kotila, O. A., Odeku, O. A., Adisa, R., Adetunji, O. A., Durowaiye, M. A., & O.A, K. (2019). Towards the development of blueprint for health security in Nigeria by 2050: A review of drug development, supply of quality medicines and treatment issues. African Journal of Medicine and Medical Sciences, 48(Supplement), 185–193.
Ogilvie, L., Mill, J. E., Astle, B., Fanning, A., & Opare, M. (2007). The exodus of health professionals from sub-Saharan Africa: Balancing human rights and societal needs in the twenty-first century. Nursing Inquiry, 14(2), 114–124. https://doi.org/10.1111/J.1440-1800.2007.00358.X
Pheage, T. (2017). Dying from lack of medicines: Encouraging local production, right policies the way out. United Nations Africa Renewal. https://www.un.org/africarenewal/magazine/december-2016-march-2017/dying-lack-medicines
Quick, J. D., Boohene, N. A., Rankin, J., & Mbwasi, R. J. (2005). Medicines supply in Africa: Should improve through regional collaborations and accredited drug shops. BMJ: British Medical Journal, 331(7519), 709. https://doi.org/10.1136/BMJ.331.7519.709
Schwartz, A. H., Daugherty, K. K., O, C. K., Professor, F., Smith, L., Poirier, T. I., Professor, B., Scholar, S., Khan Ghilzai, N., Truong, J., Assistant Professor, B., Dey, S., Professor, A., Henriksen, J. A., & Associate Professor, P. (2013). A curriculum committee toolkit for addressing the 2013 CAPE outcomes. https://www.aacp.org/sites/default/files/2017-10/CurriculumSIGCAPEPaperFinalNov2014.pdf
Shukar, S., Zahoor, F., Hayat, K., Saeed, A., Gillani, A. H., Omer, S., Hu, S., Babar, Z. U. D., Fang, Y., & Yang, C. (2021). Drug shortage: Causes, impact, and mitigation strategies. Frontiers in Pharmacology, 12, 1772. https://doi.org/10.3389/fphar.2021.693426
Signé, L. (2021). Strategies for effective health care for Africa in the fourth industrial revolution: Bridging the gap between the promise and delivery. Africa Growth Initiative at Brookings. https://www.brookings.edu/wp-content/uploads/2021/10/Strategies-for-effective-health-care-delivery-in-Africa_FINAL.pdf
Tomei, L., Bernauer, J., & Moretti, A. (2016). Developing a center for teaching excellence: A higher education case study using the integrated readiness matrix. Lanham: Rowman & Littlefield
USP. (2019). Consortium of partners | Promoting the Quality of Medicines Plus. The United States Pharmacopeial Convention. https://www.usp-pqmplus.org/about/consortium-of-partners
WHO. (2012). Human resources management and capacity development. In Management Sciences for Health (pp. 51.1-51.29). http://apps.who.int/medicinedocs/documents/s19628en/s19628en.pdf
WHO. (2014). WHO Prequalification - Building quality-assured manufacturing capacity in Nigeria. WHO Drug Information, 28(4), 425–430. https://www.scribd.com/document/398336553/Building-Quality-Assured-Manufacturing-Capacity-in-Nigeria-WHO-Prequalification
World Health Organization. (2011). Survey of the quality of selected antimalarial medicines circulating in six countries of sub-Saharan Africa. https://www.afro.who.int/sites/default/files/2017-06/WHO_QAMSA_report.pdf
Zhang, B., Yue, R., Wang, Y., Wang, L., Chin, J., Huang, X., & Jiang, Y. (2019). Effect of Hibiscus sabdariffa (Roselle) supplementation in regulating blood lipids among patients with metabolic syndrome and related disorders: A systematic review and meta-analysis. Phytotherapy Research, 34(5), 1083‒1095. https://doi.org/10.1002/ptr.6592