As the COVID-19 crisis began to take hold in the U.S. earlier this year, healthcare systems scrambled to treat critically ill patients in an unknown landscape.
Those first few weeks in March and April put unprecedented stresses on the pharmaceutical supply chain that most in the industry had never experienced before. As hospitals and government agencies desperately sought sources for much-needed items that ran the gamut from personal protective equipment to drugs, distributor AmerisourceBergen knew the key to effectively responding to the crisis was communication.
Early on, hospitals—particularly in New York City—were seeing a historic surge in high acuity patients who needed to be put on ventilators that required both highly-trained staff and drugs supporting such drastic treatment.
“It was a scary time when they (the hospitals and healthcare workers) were effectively trying to create a COVID-19 protocol for ICU patients that hadn’t previously existed,” Willis Chandler, President of Health Systems & Specialty Services for AmerisourceBergen, said. “It was unnerving, but early on, we knew communication was going to be key – especially as we worked through addressing health system customers’ immediate needs.”
In a matter of days, AmerisourceBergen went from distributing 4.3 million products daily to nearly 6.5 million – that’s nearly a 50% increase in products shipped. Hospitals in New York City were going through inventory faster than AmerisourceBergen had ever experienced before, so it initiated Sunday deliveries for customers in that area. At the same time, AmerisourceBergen expanded its channels of communication with its customers.
“We knew we had to stay close to the customers in order to understand what was going on and what they needed so we could execute in an agile way and develop all new supply chain solutions,” said Chandler.
Early in the crisis, AmerisourceBergen implemented routine customer town halls and one-on-one calls to stay plugged into health system’s inventory concerns and needs throughout the pandemic. The company, Chandler said, averages about 500 customers per town hall. These touch points will continue as new treatments and an eventual vaccine are approved.
An illustration of that communication and response came soon after the White House recommended the use of hydroxychloroquine and chloroquine—traditionally used to treat malaria and rheumatism—to fight COVID-19. In less than a month, AmerisourceBergen saw demand increase 1,130% for antimalarial drugs. Hydroxychloroquine quickly went on allocation – a supply chain stability mechanism which limits how much sites of care can buy based on their historical purchasing behaviors. In normal times, it ensures that sites of care across the country can get their fair share of a product that’s in short supply. But in the case of hydroxychloroquine, there were larger issues at play.
“Customers immediately started reaching out to tell us not to set their allocation of products based on their previous history,” Chandler said. “We knew right away that we had to come up with an entirely new allocation model.”
A multidisciplinary team at AmerisourceBergen worked with urgency over a weekend to develop a new system based on objective data that displayed existing and developing hot zones, the prevalence of COVID-19 patients and the number of ICU beds at a facility. This system enabled a new allocation methodology that layered in third-party data—such as the John Hopkins Hospital’s COVID-19 database—to identify, at a granular level, the U.S. geographies with the most pressing needs for drugs.
“I think manufacturers and customers appreciated that we were willing to be agile partners. That even in the heat of the crisis we would listen to their concerns and work quickly and thoughtfully to develop creative solutions,” Chandler said.
However, by June, the Federal Drug Administration revoked its emergency use authorization (EUA) for hydroxychloroquine in battling the virus.
Also, in the early days of the pandemic, Gilead’s remdesivir – which now goes by the brand name Veklury – was one in a handful of therapies that showed benefits in combatting the virus. Distribution of Veklury for ICU patients was initially piloted by the U.S. Department of Health and Human Services, but in October Gilead was allowed to directly sell the product to U.S. hospitals with AmerisourceBergen serving as the sole U.S. distributor through the end of the year.
“Having the experience of working with federal and state agencies on EUA products gives us a foundation to bring product to market faster than ever before,” Chandler said. “We act as a bridge between manufacturers and customers, agencies and patients.”
The FDA created a special emergency program for possible coronavirus therapies that is known as the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments to patients as quickly as possible while ensuring efficacy and safety. Within the program, more than 560 drugs are in the development planning stages, over 370 are being reviewed or have been reviewed by the FDA, and 5 therapies have received EUA approval.
With so many new COVID therapies being considered and eagerly awaited, the EUA pathway will continue to be important – at least for the short term. At the same time, the supply chain is becoming more sophisticated as healthcare stakeholders collaborate and innovate to support access to these uniquely approved products.
“With any typical product launch, it takes years of preparation. In the spring, when EUAs were getting provided to potential COVID therapies, we did a year of work in a matter of weeks,” said Chandler. “We learned early on how to leverage the power of listening and communication to execute – and execute efficiently. As a result of supporting these EUA products, we are now working with 99% of the health systems in America. We are more confident; we know what to expect and we can be an effective voice for customers nationwide.”
On November 9, the FDA granted an EUA for Eli Lilly and Company’s investigational neutralizing antibody bamlanivimab and authorized it for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. In Lilly’s announcement, the company shared that AmerisourceBergen will exclusively distribute the product as directed by the U.S. government’s allocation program. And as announced on November 21, AmerisourceBergen is also shipping doses of Regeneron’s EUA-approved casirivimab and imdevimab antibody cocktail, as directed by the federal government.
The Government also recently recognized AmerisourceBergen as indicated in a public contract to bolster the nation’s stockpile of important medications and medical equipment. As part of this, AmerisourceBergen will store, manage, and distribute pharmaceuticals that are important for the treatment of COVID-19 patients.
Ready for vaccine challenges
The role AmerisourceBergen plays as a bridge between stakeholders will become even more important as new COVID-19 vaccines are developed, approved and distributed in the months ahead.
Distributing vaccines to more than 328 million Americans will be an unprecedented feat that will require the entire healthcare industry in conjunction with federal, state and local governments to work together. Initially, the federal government under the auspices of the Centers for Disease Control will be the arbiter of a COVID-19 vaccine with commercial distribution forecasted to launch in mid- to late next year.
It is highly likely the vaccines will require frozen to deep frozen temperatures during transportation and storage to remain viable for patient use. The need for an effective and efficient supply chain strategy that ensures product integrity will be critical, as will transparent communication throughout the process.
“We are already in the process of building out our capabilities and scaling up to meet what will be a historic operation,” Chandler said. “We are in constant communication with our peers, public health channels, manufacturers and customers to establish what their cold-chain capabilities are and if there are any nuances or challenges to face. With our insight and agility, we will be prepared to execute as soon as we get the green light.”