Enabling Pharmaceutical Traceability in The Nigerian Supply Chain using GS1 Global Standards: Lean Traceability Including In-Country Serialization of COVID-19 Vaccines
Keywords:Traceability, Masterdata, Event data, Serialization, Supply chain, substandard and falsified medicines, COVID-19 vaccines
Traceability of the pharmaceutical products across a supply chain creates an environment that provides visibility of the product status from plant to patient. The supply chain is the trade journey products make to consumers or retail stores (e.g. pharmacy store, patented drug store, medical store etc.,) via a network of producers, manufacturers, distributors, transporters and vendors taking that product from creation to delivery. Some of the key benefits of introducing traceability in the Nigerian pharmaceutical sector besides securing the supply chain includes an increment in the quality of data to support pharmacovigilance, decrease in the presence of substandard and falsified (SF) medications and ultimately ensuring patient safety. The drug distribution system in Nigeria is largely undefined and there have been in-country efforts to sanitize it. One such effort has produced a national policy document referred to as the Nigeria Pharmaceutical Traceability Strategy which stipulates the plan to achieve supply chain visibility, prevent infiltration of the SFs and strengthen existing regulatory and legal frameworks in Nigeria using GS1 global standards. The National Agency for Food and Drug Administration and Control (NAFDAC) and other drug regulatory agencies in Africa jointly signed a Call to Action during the 2nd GS1 African Healthcare Conference held in Lagos, Nigeria on September 16-20, 2019 to demonstrate commitment to pursue pharmaceutical traceability by adopting global supply chain standards. This article focuses on how NAFDAC in collaboration with GS1 Nigeria, National Primary Health Care Development Agency (NPHCDA) and other partners have implemented traceability as a public sector pilot for the COVID-19 vaccines received in Nigeria from March 2021 to December 2021. This included the serialization of COVID-19 vaccines that were received without serial numbers that uniquely identify the secondary packing of the COVID-19 vaccines. The lessons learned from the pilot would be used to support development and dissemination of tracebility regulation, publish guidelines for traceability implementation, and engage stakeholders meaningfully as Nigeria implements full track and trace of pharmaceutical products.
Federal Ministry of Health (FMOH). (2020). Nigeria National Pharmaceutical Traceability Strategy. Retrieved December 15, 2021, from https://www.nafdac.gov.ng/wp-content/uploads/Publications/Others/NIGERIA-NATIONAL-PHARMACEUTICAL-TRACEABILITY-STRATEGY.pdf
Federal Ministry of Health (FMOH). (2017). Second National Strategic Health Development Plan 2018-2022. Retrieved December 14, 2021, from https://www.health.gov.ng/doc/NSHDP%20II%20Final.pdf
GS1. (2021). How GS1 Standards Work. Retrieved 2021, from https://www.gs1.org/standards/how-gs1-standards-work
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). (2021). Identification & Traceability of Medical Products - A tool towards strengthening health systems. Retrieved December 15, 2021, from https://www.ifpma.org/wp-content/uploads/2021/03/IFPMA-PP-Traceability-03_2021.pdf
National Agency for Food and Drug Administration and Control (NAFDAC). (2021). Report of Traceability Implementation for COVID-19 Vaccines Distribution in Nigeria. Retrieved December 18, 2021, from https://www.nafdac.gov.ng/report-of-traceability-implementation-for-covid-19-vaccines-distribution-in-nigeria/
National Agency for Food and Drug Administration and Control (NAFDAC). (2004). NAFDAC Law. Retrieved December 15, 2021, from https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/NAFDAC_Acts/NAFDAC-ACT-Cap-N.-1-LFN-2004.pdf
Parmaksiz, K., Pisani, E., & Kok, M. O. (2020). What makes a National Pharmaceutical Track and Trace System succeed? Lessons from Turkey. Global Health: Science and Practice, 8(3), 431–441. https://doi.org/10.9745/ghsp-d-20-00084
USAID. (2018). Global Standards in Low- and Lower-Middle Income Settings: Policy Design Considerations to Address Domestic Manufacturer Needs. Retrieved December 15, 2021, from https://www.ghsupplychain.org/sites/default/files/2019-03/GS1_Mfg%20In%20LLMICs.pdf
World Health Organization (WHO). (2019). ACCESS TO MEDICINES, VACCINES AND PHARMACEUTICALS: Policy brief on traceability of health products. Retrieved December 15, 2021, from https://www.who.int/medicines/regulation/traceability/7OCT19draft-WHO-policy-brief-on-Traceability-of-Health-Products.pdf
Copyright (c) 2023 Mojisola Adeyeye, John, Kunle, Shade, Walter Udokwelu
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