The Partnership for Supply Chain Management (PFSCM) was established to help fight one of the world’s most serious and ongoing epidemics, HIV. When PFSCM set up shop in 2005, it was to develop, implement and manage one of the world’s largest health supply chains to deliver lifesaving HIV diagnostic, treatment and prevention products to low- and middle-income countries (LMICs) around the world.
Since then PFSCM has expanded its expertise to help reduce the impact of other epidemics such as malaria and tuberculosis. Now, 15 years later, PFSCM is responding to yet another pandemic, COVID-19. This time around, equipped with deep experience and better processes and systems. Since May this year, PFSCM has procured $47.2 million worth of COVID-19 diagnostic products and delivered 137 shipments to 56 countries*, maintaining an OTIF of 99%.
Product quality: navigating new COVID-19 products on the market
PFSCM upholds a strict product quality assurance (QA) policy that ensures patient safety, and prevents costly and wasteful product quality issues that may result in destruction or recalls.
PFSCM only procures products that comply with defined quality requirements as prescribed in applicable QA policies. This includes products that are either prequalified by the World Health Organization (WHO), approved by stringent regulatory authorities (SRAs), or the International Medical Device Regulatory Forum (IMDRF); and meet national regulatory requirements.
Further, PFSCM uses a multi-tiered risk-based approach to flag and select products for sampling and quality control testing to ensure that the products continue to meet required specifications.
In light of the rapidly changing landscape for COVID-19 diagnostic and therapeutic products, it is especially important that new products on the market are investigated carefully.
Since March, the U.S. Food & Drug Administration (FDA) alone has granted emergency approval for more than 60 different kinds of molecular in-vitro diagnostic (IVD) products for the detection of SARS-CoV-2.
The WHO has granted emergency use approval for IVDs detecting SARS-CoV-2 Nucleic Acid to 15 products between April and July.
In addition, The IMDRF has also endorsed an extensive list of products approved by country SRAs. Some of these products overlap with what is included in the FDA and WHO’s lists.
PFSCM Strategic Supply Chain Director, Ard van Dongen, says PFSCM started planning its COVID-19 product QA approach and activities long before the diagnostics became available.
“Using our experience from supplying similar diagnostics tests, such as those used for detecting HIV and tuberculosis, we were able to plan for the product quality requirements for the then, potential COVID-19 tests. Factors we took into consideration included temperature stability during shipping, shelf life, labelling and language, in-country registrations, packaging and more.”
Currently, PFSCM procures two types of COVID-19 testing products produced by two reputable manufacturers. The products are particularly suitable for the LMICs PFSCM serves, notes Van Dongen.
“The products we procure for polymerase chain reaction molecular testing are easy to use and compatible with laboratory instruments already used in these countries. The test kits used for COVID-19 testing are based on existing technologies, and laboratory workers are familiar with the product functions,” he explains.
The Africa Centres for Disease Control and Prevention writes in an article in the renowned Nature journal, that “African countries are used to widespread testing for pathogens such as HIV, tuberculosis and malaria, and that this expertise can easily be adapted for SARS-CoV-2 testing.1” The Africa CDC reports that it held training sessions in early February 2020, and by mid-March, 43 countries had gained competence to test for the virus2.
Further, Van Dongen notes that the COVID-19 diagnostics market is very dynamic and rapidly evolving with new products and technologies continuously coming to market. PFSCM is researching this market and has issued an open request for proposal to identify and contract new products and suppliers to ensure the availability of these critical diagnostic products for its clients in LMIC. This process entails:
- Mapping the current products available for COVID-19 testing.
- Understanding production capacity and manufacturing locations as well as raw material supply.
- Grasping suppliers’ priorities in managing supply and demand.
- Understanding the factors that influence product pricing.
- Researching the suitability of products for specific markets.
People, processes and systems: agility in uncertain times
Public health supply chains are complex, fast-changing and sometimes unpredictable. PFSCM is adept at solving unusual problems, and when the coronavirus was declared a pandemic, the organization leveraged its tools and lessons learned to quickly change pace.
PFSCM COVID-19 Coordination Cary Spisak says several emergency actions were taken simultaneously.
Firstly, PFSCM ensured the health and safety of its staff. “Almost instantaneously we changed from office based work to remote working. With all our core operational activities executed electronically, in real-time and in the cloud, our staff could resume work as normal from the safety of their homes. Healthy, happy staff equate to a productive working environment,” stresses Spisak.
Secondly, PFSCM also started recruiting product and emergency response experts to head up its COVID-19 procurement and logistics activities. The COVID-19 specialists established new processes for procuring and moving new diagnostics products under emergency conditions. This entails fast-tracking normal processes to achieve quicker results.
“Through proactive engagement with suppliers, clients and 3PLs, we were able to establish and agree on quick-turnaround processes to help close the COVID-19 testing gap until the crisis has improved enough for procedures to gradually return to normal.”
Through these streamlined processes PFSCM achieved a record fast turnaround time for its first shipment of COVID-19 diagnostics products, which was delivered at the start of May to Uganda. Despite the increased strain on supply chains, the whole transaction — from request to proof of delivery — took just 10 days. This includes issuing the quote, placing the order with the supplier, arranging export documents, collecting the goods, authorizing importation documents, airfreighting the goods, clearing it in-country and trucking it to the warehouse. Normally, a full cycle delivery of diagnostic products could take several weeks, depending on stock availability, and the complexity of the order, explains Spisak.
Thirdly, PFSCM prepared its systems for the procurement and shipment of new types of products.
PFSCM Chief Information Officer Chad Davenport says PFSCM’s new supply chain Control Tower plays an important role in driving COVID-19 service performance through timely and accurate reporting. “We readied our Control Tower for the management of a new product category, and through the detailed and ongoing input of product and shipping data, we have been able to provide our stakeholders with daily updates that help them make informed decisions.” “Every component of the shipping process is meticulously tracked for end-to-end visibility ensuring every stakeholder, at each step of the process, has the correct data to make the best decisions,” concludes Davenport.
Health logistics: bringing products to people
The health logistics sector has been severely impacted by COVID-19. Restrictions and country lockdowns have resulted in disruptions in all modes of transport, making it especially difficult to move COVID-19 diagnostics which require cold chain shipping (including frozen items) to ensure the integrity, and thus, reliability of the products.
PFSCM Logistics Manager Moeen Tahir explains that PFSCM collaborates closely with its 3PL partners to secure air freight as slots become available.
“Recently, we have had to make more use of charter flights, and we have also increased engagement with peer organizations to co-load charters where possible for reduced costs and increased sustainability.” Tahir adds that PFSCM and its 3PL partners have streamlined processes for forecasting, shipping documentation, and lead time estimation. “We had to quickly refine existing processes to manage the changing crisis situation. Identifying potential bottlenecks early has become even more critical, and overall planning from production to delivery has gone into overdrive. ”
Meanwhile, the disruption to logistics has affected PFSCM’s 4PL operations; pushing up prices and lead times, and in some cases, resulting in blank sailings.
“We have leveraged our in-depth understanding of the global health logistics sector, and relied on our longstanding relationships with 3PL partners and their extended networks, to navigate the logistics environment during these challenging times. So far our partners have done the utmost to move our critical health care shipments,” ends Tahir.
Sustainability: Moving from emergency response to streamlined supply chains
Currently, the COVID-19 pandemic is considered a public health crisis and a major threat to existing health programs. Like many organizations, PFSCM has leveraged all its tools, and activated all possible mechanisms to quickly and effectively respond to the emergency, however, when the outbreak is under control, organizations will need to move from crisis mode to a more sustainable mode of operation, stresses Van Dongen.
He adds that there are several best practices which ensure sustainability in supply chains and reduce risk, but for COVID-19 specifically, PFSCM is focused on responsible buying, and sustainable sourcing that integrates social, ethical and environmental performance factors to build lasting supply chains.
This is achieved through:
- Supplier mapping: Extensive mapping of main and sub tier suppliers, significantly increases visibility. Even though in-depth supplier mapping is resource intensive and difficult, it is critical in preparing buyers for potential future emergencies and disruptions. In 2019, PFSCM started mapping diagnostic products suppliers who comply with its QA policy.
- Local sourcing: Local sourcing stimulates developing economies, and uplifts production standards while minimizing upstream supply chain costs, and complexities, and reducing the logistical carbon footprint.
- Coordination: Improved global coordination and engagement increases visibility into supply and demand, and prevents situations where countries and organizations take actions that may negatively impact others, and/or derail health programs. Proper supply chain management systems such as Control Towers can significantly improve coordination provided stakeholders have access to appropriate information.
“It is important that we build the foundation for a sustainable supply chain while we are executing our emergency response to COVID-19. We need to plan for COVID-19 to be part of our supply chains indefinitely. This means planning for demand and supply, engaging with suppliers to understand raw materials, production capacity and pricing, establishing agreements with shippers and ensuring end-to-end visibility among all stakeholders, all while advocating for initiatives to reduce the supply chain’s carbon footprint,” explains van Dongen.
Van Dongen concludes by questioning the sector’s way forward. “By focusing more capital and human resources on COVID-19 responses, we and our peers have been able to achieve above average service levels. But how long will stakeholders be able to uphold these standards? And how can the sector elevate the service levels of HIV, malaria and tuberculosis responses using lessons learned from the pandemic?”
References:
- 1 & 2: https://www.nature.com/articles/d41586-020-01265-0