As vaccine rollout looms, so do big questions around supply chains
As Pfizer and Moderna wait for the U.S. Federal and Drug Administration to issue an emergency use authorization for their respective vaccines, the importance of a seamless – or at least well-connected – supply chain has become increasingly clear.
According to the U.S. Department of Health and Human Services, the first rollout of the vaccine is likely to be very limited, with state governors and public health departments directing allocation of the first available doses.
But if plans to produce tens of millions of doses by the end of 2020 see fruition, professionals say logistics will play an increasingly vital role in getting those doses to people who need them.
"This is a phenomenally critical issue that every health system is going to have to manage and figure out the way forward," said Anne Snowdon, executive director of clinical research at HIMSS (parent company of Healthcare IT News).
Snowdon – who created HIMSS Analytics' Clinically Integrated Supply Outcomes Model, which signifies digital health maturity in a system's supply chain processes – called the question of vaccine rollout the "classic supply chain strategy" in a recent HIMSS TV interview.
"If you are tracking every patient who receives every dose of vaccine, and with the simple scan of a barcode or QR code or RFID tag or however it's labeled, can identify what lot number, what site was it manufactured, when was that manufactured – and now you track that to every individual citizen who receives that dose – you now have an ability to know who had side effects, who had a great response to that vaccine, who didn't, and now you've got a data set to work from," said Snowdon.
Such data, said Snowdon, can be used to ensure every global citizen has access to the vaccine in the order of priority needed.
HIMSS CEO Hal Wolf agreed, saying that such tracking can be used specifically to highlight how different social determinants of health may affect vaccine access and efficacy.
"We could have adverse or different effects based upon the environment in which it's put into," he said, pointing out that some of the vaccines require storage in ultracold conditions (prompting a recent uptick in dry ice demand, for example).
"To be honest, there are going to be times when you're relying on the distribution capabilities of someone who wouldn't normally be in the supply chain. It may be leveraging the delivery capabilities of a local business."
Chris Hale, Kountable
Before vaccines are given to individuals, however, doses have to physically make their way from manufacturers to healthcare providers.
"What we're really talking about is a governance risk and compliance functionality that relies on relative real-time data, coordination and transparency," said Chris Hale, CEO and cofounder of the global procurement company Kountable. "When you put those things together, there's not a lot of solutions that will work that don't involve technology."
Logistically speaking, "what you really have to do is start at the end consumer, in this case the patient, and work backwards," said Hale. "If you start at the supplier, it's a fairly easy journey and a fairly developed journey – until it breaks. You have to finish the job. It's the person in the last position who matters most."
Given the size of the demand and the relatively unconnected nature of some parts of the world – including the rural United States – Hale said unconventional thinking could prove necessary.
"To be honest, there are going to be times when you're relying on the distribution capabilities of someone who wouldn't normally be in the supply chain," he said. "It may be leveraging the delivery capabilities of a local business."
Hale also said that the processes should be nimble, with the potential to shift if circumstances prove necessary.
"There's sort of different degrees of success that need to be tracked independently. Did the vaccines get to the right place at the right time, in the right condition? That's a supply chain problem. Were they distributed to patients and administered effectively? Did they work? What happens after?" he said.
"There's going to be a very real need for continuous improvement in business processes applied to the full chain," he added. "It's a question of vectors: 'Is it working and improving?' rather than 'Did it work?'"
It's important to work the kinks out sooner rather than later, he said, especially as demand grows.
"It's not tomorrow's problem, but it's not next year's either," he said. "The entire thing is going to be driven by availability of supply. … We're still going to be making allocation decisions for years to come."
Hale said he feared that vaccine access in the longer term would follow the trajectory of personal protective equipment, with huge shortages in some jurisdictions.
"I hope it doesn't look and feel like PPE," he said.
"Each state has different communities, different geography, different challenges to address."
Dr. Rhonda Medows, Providence
"I will tell you that I'm disappointed in the federal response" to COVID-19 as a whole, said Dr. Rhonda Medows, president of population health at Providence, one of the largest nonprofit health systems in the United States.
When it came to assessment, surveillance and testing, she said, "we were delayed, we were slow … and now the plan is to distribute vaccines based on state population size. Not population risk for COVID, but state population size. That's not what we were expecting or anticipating."
Given the plan in place, she said she hopes state governors make allocation decisions with public health in mind.
"The volume of vaccines they're getting is really small," she said. "I don't know how else to emphasize it. You need to prioritize within the priority groups. Vaccinate and protect your front line and first responders. One, for their benefit and wellbeing, and two, because we need them. Second is to vaccinate and protect the people who will suffer the highest degree of morbidity and mortality from the agent: nursing homes, elderly [and] those with chronic conditions."
With that prioritization in mind, she said the organization has been planning the best ways to distribute doses efficiently.
"Providence has already done the work of registering with each state health entity" as a distributor, she said. "We've registered each of our hospitals, ERs, individual physicians and clinicians. … We've ordered the special freezers for the Pfizer one, then we have the regular freezers for the other vaccines. We've already stocked the facilities for the ancillary things we need to go along with the vaccine. The supply chain has been accumulating supplies just in case. Our facilities, with that part of the logistics, are fine."
Providence has been relying on advanced analytics as part of its vaccine preparations, she said, including patient population assessments across all care settings, logistics, and personnel planning.
She noted that the initial volume of vaccine to be distributed "will not even be adequate" for the group of clinicians and providers who are most exposed to the virus.
"Even within those groups, we're going to be forced to sub-prioritize," she said. "We've done the logistics of figuring out healthcare professionals at the highest risk from day-to-day work, including doctors, maintenance sanitation employees [and] those doing food delivery to other sites. It's a full health professional suite."
Once more vaccines are available, she said, a challenge will be reaching patients in more rural areas, who might struggle with the freezer requirements or facility access.
"Each state has different communities, different geography [and] different challenges to address," she said. "In those communities where there's already not great physical-access space could we retrofit mobile vans with the deep-freeze requirements?"
"We know that we have some facilities or clinics that could be a [distribution] site, but then there's a whole world of people, so to speak, in the communities" who will be lower on the vaccine-priority list.
Medows noted the importance of centering the needs of groups especially affected by COVID-19, such as Black, Latino, and Native people. A recent Commonwealth Fund study showed that systemic and medical racism is likely to affect vaccination rates, with distrust among many people of color stemming in large part "from institutional experiences with racism and unethical medical experimentation."
Vaccines are also linked to coverage and financial barriers that reflect a legacy of racial inequity, wrote Commonwealth researchers.
Hale, too, said that he feared that uncontrolled or unregulated supply chains would lead to a replication of inequity.
"Unfortunately this kind of complexity also … creates economic distortions," he said.
And given the nature of the disease – which spreads regardless of political borders and disproportionately impacts already underserved people – it's imperative to address these potential gaps from the get-go, said experts.
"When one individual is vulnerable, we are literally all vulnerable," said Wolf.
Taking Stock of Progress and Looking Ahead
This December, we look back at a challenging year – and forward to what we hope is a better, stronger, more connected and resilient healthcare ecosystem.