Someone designated “supply chain” as a convenient target – if not scapegoat – for just about everything going wrong with the COVID-19 vaccine allocation on a federal, state and even local level.
Of course, much depends on how critics define the concept of “supply chain,” which involves a number of functional components intricately linked to forge a comprehensive process of getting a product or service to one point from another while ricocheting off elements of incompetence, inefficiencies and intricacies in political machinations and maneuvering.
Technically, supply chain comprises ordering, purchasing, contracting and distributing components, among others. Each one of those components is fueled by subcomponents, such as demand forecasting and planning, product/service evaluation and value analysis (clinical or otherwise) and storing. These elements encompass the provider-consumer-buyer side.
On the supplier-producer-manufacturer side, supply chain involves raw material strategic sourcing, research and development, design, molding and mass production and packaging as well as distribution, logistics and transportation.
Either of these intertwined supply chains hinge on what federal regulators like the Food and Drug Administration (FDA) allow. For the pandemic, the FDA fast-tracked approvals and clearances for vaccines with nary a concern about procedural consequences and repercussions – not the safety of the vaccines but the notion that if “desperate times call for desperate measures” that do not generate dire outcomes then maybe the complicated processes during “normal” times can be streamlined effectively.
While the pandemic shook the very core and foundation of the healthcare industry from clinical to financial to operational to supply chain during the initial year that concluded in March, it largely concentrated the pressure on acute-care hospitals for treatment and testing, non-acute care facilities for testing and retail outlets for available supplies. With the emergence of several vaccines during the last few months, the balance has shifted more to non-acute care facilities to administer the vaccines to tens of millions of citizens at physician practices, urgent care centers, long-term care facilities (LTCs), retail pharmacies, supermarkets and a growing number of “mass vaccination centers” (MVCs) managed by state, county and local departments of public health.
Some of these MVCs may reside in gyms and stadia, vacated department store buildings, temporary/tented buildings in parking lots, etc. These MVCs may be staffed by doctors, nurses, military or other professionals with varying degrees of clinical training.
But questions remain about their experience and expertise in such operational components as distribution, inventory management and logistics during the “last mile” of a supply chain, which includes the point of care or point of use.
Uprooting the root cause(s)
The last few months of vaccine administration among non-acute care facilities have yielded varying results that spanned successful completions to frustrations and finger pointing, arguably with plenty of blame to go around.
As the United States lumbers into Year 2 of the pandemic, uncertainties abound among COVID-19 vaccine production, distribution and administration.
The demanding logistical pressures placed on non-acute care facilities administering COVID-19 vaccine doses alone will expose the inherent complexities of supply chain operations that the general public rarely sees, recognizes or minds.
“As this effort scales, we will be stitching together non-specialized staff, siloed systems and technology gaps,” Turner continued. “Then things get thorny. How much do you have that’s available-to-promise? What’s your pipeline inventory? What happens if your next tier of eligibility is bigger or smaller than expected? Sure, we can sit on supply buffers and reschedule appointments when we stock out, and we’ll make it out the other side vaccinated, if not a little shell-shocked. But without expert supply chain orchestration, all those other problems are not only going to surface, they’re going to bubble over.”
Any lack of non-acute supply logistics expertise can be disastrous, according to Turner.
“Often, supply chain is about putting out fires before the flames of disruption are fanned,” he noted, “so, while challenges across the board are to be expected, a lack of supply chain expertise is likely to add fuel to those problems. We’re talking about the largest scale and arguably most complex just-in-time last-mile distribution effort in history, and every link in the supply chain needs to be strong and connected so that vaccines move one way, and data moves the other. Without both those things flowing smoothly, there will be a kink in the chain.”
“Non-acute care facilities have faced several obstacles when it comes to obtaining enough COVID-19 vaccines to meet the demand,” Marani observed. “The two most prevalent constraints are centered on market type and acquisition options. To date, vaccine distribution has been limited to retail pharmacies and long-term care facilities via a single pharmaceutical distributor. This creates issues with product selection, facility staffing and patient access. Logistics remains a challenge for geographically remote facilities, as well as the additional storage space needed for the vaccines.”
Initially, however, the industry faced a seminal problem from a confluence of factors, according to Jamie Chasteen, Director of Corporate Development, Cold Chain Technologies.
“The big challenge for non-acute facilities was the same as for everyone at the regional, state and local level,” Chasteen noted. “All organizations, whether public or private, were left to figure out vaccine supply, storage and distribution on their own. This causes duplicated work and cost and potentially runs the risk that many organizations will implement the wrong products or procedures, which could cause spoilage and waste or, even worse, adverse patient results due to improper handling and storage.” Compounding the challenge? One of two early vaccines required specific temperature limits.
“In pandemic planning, the timely and accurate transmission of data to the federal stakeholder is critical so that stakeholders can monitor progress and identify any opportunities for improvements,” Behlim said. “In the COVID-19 vaccine administration, many non-acute care facilities struggle without the correct infrastructure or technology to communicate regularly in an electronic format with the pertinent required data fields.”
“As vaccine supply increases over the coming weeks and months, distribution and logistics will become the biggest obstacle,” Jordan predicted. “With vaccine allocations and distribution managed by the federal government, providers must work directly with their state/local jurisdictions or the Centers for Disease Control and Prevention (CDC) in order to become a COVID-19 vaccine administrator.
“The storage, handling and data reporting requirements are also challenging for many providers, creating a barrier for many smaller, community healthcare organizations,” Jordan continued. “Vaccine access may differ depending on provider or facility type as well. Retail and long-term care pharmacies have generally been part of the federal partner program for accessing vaccines, while access for other provider types varies by jurisdiction.”
“While there have been a number of roadblocks, demand planning is likely the leading challenge,” Crampton asserted. “Non-acute care facilities rely on federal allocation and state vaccination rollout plans to provide vaccines to their patients and communities. Limited information has been given by governmental entities regarding the expected allocations and distribution timelines. At the same time, healthcare leaders are trying to understand patient refusal rates and no-show frequency. All of this results in incredibly difficult planning that requires a logistics infrastructure with end-to-end agility – something that is difficult for certain types of non-acute facilities to accomplish.”
Cold chain requirements for at least one of the available vaccine products proved a compounding challenge, Crampton acknowledged.
“Product has been shipped and transported in specially designed containers used to maintain temperature state requirements until the time of use,” he said. “Initially, many non-acute facilities were not using the Pfizer vaccine because of the ultra-cold storage and short-shelf life in thawed conditions. The FDA update in late February, which allows the Pfizer vaccine to be stored at more conventional freezer temperatures for a period of up to two weeks, was a positive for non-acute vaccination sites – it meant that they could increase capacity for vaccination with ability to use the Pfizer vaccine.”
Don’t worry, be happy
“The scale of the operation is massive and requires a great deal of coordination from end to end,” Fleming said. “With 50 states employing individual approaches, the lack of a unified system introduces unique variables.”
Fleming urges people to think positive.
“With all of that accounted for, the success of the effort to get vaccines into arms has been rather impressive,” he indicated. “From a distribution and logistics standpoint, manufacturers have implemented new strategies – like shipping directly from manufacturing sites instead of central distribution warehouses – and created custom shipping containers for cold-chain storage requirements. Carriers have prioritized vaccine shipments, ensuring they have capacity and the cold-chain capabilities to rapidly deliver fresh vaccines when and where they’re needed. Vaccination sites have ensured they have the necessary cold storage and the personnel on hand to administer the vaccines in rapid fashion.
“Have there been challenges along the way? Of course, but it’s also been quite successful,” he added.
Fleming highlights the enormous scale and speed of the logistical response as being unprecedented and inspiring at the same time. He outlines the “herculean effort on all fronts” in three ways.
To improve delivery speed: “Manufacturers adjusted distribution networks to ship from new locations like manufacturing sites and added new carriers to their usual mix, while carriers prioritized shipments to ensure space was readily available,” he indicated.
To maintain the required temperatures: “Manufacturers designed custom shippers with insulation and dry ice and equipped shipments with GPS thermal sensors to monitor for potential issues; carriers ensured the availability of cold-chain transport; vaccination sites ensured they were equipped with cold storage solutions to keep vaccines fresh,” he noted.
To ensure the return of the custom shipping containers: “Manufacturers include return shipping labels in each shipment and automatically trigger an email to the recipient after a designated period to remind them to return the container, greatly simplifying the process for them. They simply hand the container to the carrier who transports it back to the pre-determined destination,” he said.
Stacking the deck
Premier’s Jordan contends that while manufacturing capacity and supply availability may be the biggest overall challenge in meeting current demand, distribution/logistics represents a close second.
“In order to receive COVID-19 vaccine, providers must first complete the COVID-19 vaccine provider agreement with either their local jurisdiction or their state,” he indicated. “The CDC allocates doses to the states/jurisdictions, who, in turn, allocate doses to individual providers.
“The vaccine allocation notification process is a ‘just-in-time’ process, and many providers have reported not knowing how many doses they will receive or are able to order until 24 hours before the order needs to be placed,” he continued. “This gives little time for the organization to schedule appointments, set up infrastructure for large-scale clinics, etc.”
Still, Vizient’s Behlim remains sternly sanguine and direct: “I do not believe distribution/logistics are a problem as long there are reputable pharmaceutical distributors handling the product,” she stated.
Product availability and storage challenges have exacerbated one another, according to Medspeed’s Crampton.
“Limited information is being provided to non-acute facilities about product availability and plans for distribution,” he noted. “At the same time, some non-acute facilities could not utilize the Pfizer vaccine in meaningful quantities early on because of the extreme storage requirements and short shelf life.
“From a logistics perspective, distribution of the vaccine includes moving the specially designed containers that maintain temperature state and repositioning extra vaccine doses as needed based on demand,” Crampton said. “The greatest challenge with logistics is that the uncertainty around product availability leads to faster same-day logistics turnaround time requirements. Communication and tracking systems are critical.”
Cardinal Health’s Marani cites competing players, priorities and processes as adding to stress levels.
“With primarily retail pharmacies responsible for distribution of the vaccine, staffing is a dominant issue,” he said. “This also puts a strain on the remaining responsibilities of a pharmacist. It’s important to note the additional duties required for administering the vaccine. The pharmacist must also monitor the patient for 15 minutes after administering the vaccine to ensure no immediate adverse effects. Often, patients choose to leave immediately after vaccination if the pharmacy staff has moved to the next patient.”
Product selection can be challenging, too. “Patients may want a specific version of the vaccine, e.g., Moderna, Pfizer or Johnson & Johnson,” he continued. “Patients register for the vaccine online and do not get preference of what vaccine they will be given. And, unfortunately, pharmacies can’t choose. There is currently little to no control of what vaccine will be given for the first dose at a non-acute facility.
“Many patients struggle with the registration process, including the online registration portals that are required in some states for scheduling a vaccination,” Marani noted. “These patients may have primary care physicians and would rather call their trusted physician and schedule a vaccination instead of navigating multiple websites and online portals.”
LTC facilities rely on retail pharmacies to administer the vaccine, so logistics and scheduling can create challenges, he added. Further, LTC staff often manage who receives the vaccine in coordination with powers of attorney.
Vaccine storage can complicate matters, too, according to Marani. “This is similar to the approach for storing flu vaccines,” he noted. “While current refrigeration storage for most facilities seems adequate to meet the COVID vaccine demand, there may be a need to purchase additional refrigeration units.”
