Distributors, manufacturers and supply chain teams across the country were hard at work preparing for the upcoming respiratory season.
In 2020, there will be no rest for the weary. At least not in the healthcare supply chain. As summer turned to fall, the nation’s med/surg community was hard at work making preparations for known demand and the unknown possibility of COVID-19 surges. Repertoire spoke to several stakeholders about the preparations and expectations of what promises to be an unprecedented fall season.
Industry Prepared for COVID-19 Vaccine
Alarms were raised this spring and summer about potential shortages of vaccine-related products. Despite the uncertainty, industry experts expressed confidence the country would avoid situations such as the PPE shortages experienced earlier in the year.
The race to develop a COVID-19 vaccine has been in the public eye since spring. The race to provide enough needles, syringes and glass vials to administer it has been somewhat lower key. Still, it hasn’t been without nervous moments.
For example, in early May, Rick Bright, former deputy assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority (BARDA), warned that the nation’s stockpile of needles and syringes was only 2% of the required amount. (In addition to anticipating a two-shot vaccine, Bright’s calculations included about 180 million more syringes for an increase in requests for flu shot, reported USA Today.)
Questions about the vaccine remain. For example, when will it be available? How quickly will it be rolled out? Will it be injected, or taken orally or nasally? Will it be delivered in pre-filled syringes? Will one injection be enough to achieve immunization, or will two injections be needed? How many Americans will actually get vaccinated?
Feds take action
The federal government has taken an active role, contracting for 820 million syringes, including 420 million by the end of 2020 and the rest in 2021, reported USA Today.
- In May, BARDA – part of the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response – awarded contracts for needles and syringes for approximately $110 million to Retractable Technologies (Little Elm, Texas) and Marathon Medical (Aurora, Colorado) for 320 million needles and syringes, and to Franklin Lakes, New Jersey-based Becton Dickinson for approximately $11 million for 50 million units of needles and syringes.
- Also in May, the Department of Defense and HHS announced a $138 million contract with ApiJect Systems America for U.S.-based manufacturing capacity that could produce approximately 100 million pre-filled syringes using the company’s “blow-fill-seal” technology in 2020, and more than 500 million through 2021.
- In mid-July, Smiths Medical announced a partnership with BARDA and the Department of Defense to expand capacity at its facility in Keene, New Hampshire, for production of integrated hypodermic needle and syringe products to support COVID-19 vaccination. The federal government will have priority access to this expanded capacity for vaccination efforts dedicated to COVID-19, flu vaccines, and future pandemics.
- In July, BD announced a partnership with BARDA to develop new manufacturing lines for injection devices that would provide priority access to the U.S. government for hundreds of millions of syringes and needles to support current and future pandemic vaccination efforts. BARDA agreed to invest an estimated $42 million into a $70 million capital project to further expand BD’s operations and manufacturing capacity in Nebraska. The new capacity was expected to be online within 12 months. Later that month, BD signed an agreement with BARDA for 140 million injection devices for the U.S. market.
“We’ve been very clear that these large pandemic orders will not affect BD’s ability to fulfill existing customer requirements for needles and syringes, including the annual flu vaccination and childhood immunization campaigns,” BD spokesperson Troy Kirkpatrick told Repertoire in mid-July. “We have capacity to manufacture hundreds of millions of syringes between now and January, but if governments wait too long, there will not be enough manufacturing capacity across the global industry to make billions of devices in a month or two.
“A vaccination campaign the size and scope of an entire country/world isn’t something that happens in a month,” he added. “It will be the better part of a year to get everyone inoculated, so even if the new lines don’t come online for 12 months, there could still be a significant need for devices at that time.”
Avoiding panic buying
Terry Altshuler, portfolio executive for Vizient Inc., told Repertoire that needle-and-syringe suppliers indicate they have a surplus of product due to the decline of non-essential procedures that accompanied COVID-19. “In addition, suppliers are factoring in the possibility of a vaccine being available and making the necessary preparations,” she said. “While they are allocating product to an extent, the intent is to avoid ‘panic buying’ and ensure that facilities throughout the country are able to obtain product.”
Mittal Sutaria, Vizient’s vice president, contracting and program services for pharmacy, said that as of mid-July, Vizient was not aware of any members attempting to stockpile needles and syringes. “After the government began placing orders for needles and syringes in May in anticipation of a vaccine for COVID-19, most manufacturers and distributors put their products on protective allocation to prevent anticipatory purchasing by providers and to help ensure that available product is distributed as evenly as possible across all healthcare settings,” she said.
“From a vaccine perspective, there are still too many unknowns when it comes to considerations for creating a stockpile. The allocation of vaccine will involve many stakeholders, including manufacturers, distributors, hospitals, government and public health entities.”
Right measures and steps
Chaun Powell, group vice president of strategic supplier engagement at Premier Inc., said that Premier members anticipate having enough needles and syringes to get through flu season and COVID-19 vaccines. “Lead indicators show that providers and supply chain stakeholders are taking the right measures and steps to be prepared,” he said.
“Over the next 18 months, we, as a nation, will have contracted to create more than 870 million syringes above normal production, which exceeds 5 billion syringes for the acute domestic healthcare industry alone. In addition, the private sector is also ramping up its production output. Assuming there are no unforeseen external variables, we anticipate having enough syringes.”
The situation with needles and syringes differs from that faced with N95s earlier in the year, he added. “With N95s, we, as a country, went from a national consumption rate (specific to acute healthcare) of approximately 25 million masks annually to over 300 million. The twelve-fold increase was unsustainable. With syringes, our baseline is 5 billion consumed annually in the acute space. Adding another 800+ million syringes indicates an approximate 20% increase, but it is no comparison to the twelve-fold impact we saw with masks.” What’s more, the U.S. healthcare supply chain has had the time and foresight to increase production and inventories of needles and syringes, he said.
Premier members express confidence that their physician practices will have enough needles and syringes to meet upcoming demand, added Powell. “In our June survey of acute care members, we asked our members how adequate they felt their inventory of vaccines was in physician offices. Eighty-three percent said they had an adequate supply, and in fact, a small number (2%) noted they were overstocked due to the decrease in other procedures.”
Sekisui: ‘Robust’ respiratory season ahead
Editor’s note: Jonathan Overbey, corporate alliances and channel management, Sekisui Diagnostics, provided Repertoire with insights into how the company is preparing for the upcoming respiratory season.
Repertoire: How are you preparing for the upcoming flu season amid COVID-19?
Overbey: We are ramping up production of all of our flu testing options in preparation for a robust respiratory season as we continue to monitor the COVID-19 pandemic. We are also prepping our reps with proper PPE, supplies and guidance so they are protected when they get back out in the field.
Repertoire: What kinds of challenges does this upcoming season present?
Overbey: The pandemic is causing many issues but one in particular is the overall stress on the healthcare supply chain. The current situation could cause more testing for all respiratory tests including flu, strep, and RSV which could be very taxing on manufacturers trying to keep up with demand. On the other hand if there is a second wave which triggers another round of shelter-in-place orders, we could see a very mild to limited season which will add to the complexity of predicting and planning for this Flu Season.
Repertoire: What are you hearing from providers in their preparations?
Overbey: PPE as well as infection control is top of mind and rightly so. With regards to testing it is all about availability of products to test patients. All manufacturers are working diligently to increase production to meet the overwhelming demand. It’s going to take time to ramp up sufficiently to meet the global need.
Repertoire: Besides PPE, what product categories, or even raw materials, will the supply chain need to monitor for any possible disruptions?
Overbey: Swabs are one of the key raw materials for diagnostic tests, and the demand for testing is outstripping the supply. The lack of swabs will continue to limit the amount of tests available.
BD: ‘Dramatically’ scaled up production
Editor’s note: Jim Berdela, channel development and marketing vice president sales distribution for Becton Dickinson, shared his thoughts on BD’s preparation and expectations for the upcoming respiratory season.
Repertoire: How are you preparing for the upcoming flu season amid COVID-19?
Jim Berdela: We have dramatically scaled our production for test kits for our BD Veritor™ Plus Analyzers and test kits. By September, we will be able to produce 8,000 analyzers per month and 2 million test kits for influenza A/B and COVID-19 per week, roughly four times our production capacity during the 2019-2020 flu season.
Repertoire: What are you hearing from providers (e.g. HCPs) in their preparations?
Berdela: HCPs want to be prepared to meet the testing needs of their patients. They find it compelling to be able to offer their patients answers while the patient is still on-site, without having to wait several days for a test to be sent to a reference lab for processing.
Repertoire: What kinds of challenges does this upcoming season present?
Berdela: We anticipate unprecedented demand for the BD Veritor™ product line. We expect patients will be vigilant if they develop symptoms of respiratory infections like influenza and COVID-19 and seek testing.
Repertoire: Besides PPE, what product categories, or even raw materials, will the supply chain need to monitor for any possible disruptions?
Berdela: All diagnostic tests for COVID-19, as well as sample collection media and swabs will be in high demand.
Understanding the Differences
What are the differences between Influenza (Flu) and COVID-19? The CDC explains.
Influenza (Flu) and COVID-19 are both contagious respiratory illnesses, but they are caused by different viruses, according to the CDC.
“COVID-19 is caused by infection with a new coronavirus (called SARS-CoV-2) and flu is caused by infection with influenza viruses,” the CDC said on its website. “Because some of the symptoms of flu and COVID-19 are similar, it may be hard to tell the difference between them based on symptoms alone, and testing may be needed to help confirm a diagnosis. Flu and COVID-19 share many characteristics, but there are some key differences between the two.
While more is learned every day, there is still a lot that is unknown about COVID-19 and the virus that causes it. The following table compares COVID-19 and flu, given the best available information to date.
Signs and symptoms
Similarities
Both COVID-19 and flu can have varying degrees of signs and symptoms, ranging from no symptoms (asymptomatic) to severe symptoms. Common symptoms of COVID-19 and flu include:
- Fever or feeling feverish/chills
- Cough
- Shortness of breath or difficulty breathing
- Fatigue (tiredness)
- Sore throat
- Runny or stuffy nose
- Muscle pain or body aches
- Headache
- Some people may have vomiting and diarrhea, though this is more common in children
than adults
Differences
Other signs and symptoms of COVID-19 may include change in or loss of taste or smell. (More symptoms may be added following this issue.)
How long symptoms appear after exposure and infection
Similarities
For both COVID-19 and flu, 1 or more days can pass between a person becoming infected and when he or she starts to experience illness symptoms.
Differences
If a person has COVID-19, it could take them longer to develop symptoms than if they had flu.
COVID-19
- Typically, a person develops symptoms 5 days after being infected, but symptoms can appear as early as 2 days after infection or as late as 14 days after infection, and the time range can vary.
Flu
- Typically, a person develops symptoms anywhere from 1 to 4 days after infection.
How long someone can spread the virus
Similarities
For both COVID-19 and flu, it’s possible to spread the virus for at least 1 day before experiencing any symptoms.
Differences
If a person has COVID-19, they may be contagious for a longer period of time than if they had flu.
COVID-19
- How long someone can spread the virus is still under investigation. It’s possible for people to spread the virus for about 2 days before experiencing signs or symptoms and remain contagious for at least 10 days after signs or symptoms first appeared.
- If someone is asymptomatic or their symptoms go away, it’s possible to remain contagious for at least 10 days after testing positive for COVID-19.
Flu
- Most people are contagious for about 1 day before they show symptoms. Older children and adults with flu appear to be most contagious during the initial 3-4 days of their illness but many remain contagious for about 7 days. Infants and people with weakened immune systems can be contagious for even longer.
How it spreads
Similarities
- Both COVID-19 and flu can spread from person-to-person, between people who are in close contact with one another (within about 6 feet).
- Both are spread mainly by droplets made when people with the illness (COVID-19 or flu) cough, sneeze, or talk.
- These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.
- It may be possible that a person can get infected by physical human contact (e.g. shaking hands) or by touching a surface or object that has virus on it and then touching his or her own mouth, nose, or possibly their eyes.
- Both flu virus and SARS-CoV-2 may be spread to others by people before they begin showing symptoms, with very mild symptoms or who never developed symptoms (asymptomatic).
Differences
While COVID-19 and flu viruses are thought to spread in similar ways, COVID-19 is more contagious among certain populations and age groups than flu. Also, COVID-19 has been observed to have more superspreading events than flu. This means the virus that causes COVID-19 can quickly and easily spread to a lot of people and result in continuous spreading among people as time progresses.
People at high-risk for severe illness
Similarities
Both COVID-19 and flu illness can result in severe illness and complications. Those at highest risk include:
- Older adults
- People with certain underlying medical conditions
- Pregnant people
Differences
COVID-19
- School-aged children infected with COVID-19 are at higher risk of Multisystem Inflammatory Syndrome in Children (MIS-C), a rare but severe complication of COVID-19.
Flu
- Young children*
* The risk of complications for healthy children is higher for flu compared to COVID-19. However, infants and children with underlying medical conditions are at increased risk for both flu and COVID-19.
Complications
Similarities
Both COVID-19 and flu can result in complications, including:
- Pneumonia
- Respiratory failure
- Acute respiratory distress syndrome (i.e. fluid in lungs)
- Sepsis
- Cardiac injury (e.g. heart attacks and stroke)
- Multiple-organ failure (respiratory failure, kidney failure, shock)
- Worsening of chronic medical conditions (involving the lungs, heart, nervous system or diabetes)
- Inflammation of the heart, brain or muscle tissues
- Secondary bacterial infections (i.e. infections that occur in people who have already been infected with flu or COVID-19)
Differences
Additional complications associated with COVID-19 can include:
- Blood clots in the veins and arteries of the lungs, heart, legs or brain Multisystem Inflammatory Syndrome in Children (MIS-C)
Source: CDC website, www.cdc.gov/flu/symptoms/flu-vs-covid19.htm#table
Building Resiliency in the Supply Chain
AHRMM Director of Supply Chain: America’s supply chain teams are working constantly to meet today’s challenges
Heading into the upcoming respiratory season, there remain a number of challenges for hospital and health system supply chain teams, said Mike Schiller, AHRMM director of supply chain. “First and foremost personal protective equipment (PPE) has been, and continues to be, strained since this pandemic began,” he said. “Worldwide demand for PPE, which is unlike anything we’ve ever experienced, and the recent increase in patient cases will put more stress on an already overtaxed and fragile health care supply chain.” To meet current demand, hospitals continue to turn to non-traditional or novel manufacturers and suppliers to bridge their current supply needs and to increase their emergency stockpiles.
Testing requirements and the supplies necessary to support testing is another area of focus and remains a challenge – inside and outside of the health care environment. Hospitals are building their safety stocks of critical pharmaceutical products including sedatives, neuromuscular and vasopressors in preparation for an expected surge this fall in COVID cases.
Finally, with the pending availability of a vaccine, Schiller said supplies that support vaccinations must be front of mind including alcohol wipes, syringes and basic PPE to health care workers administering the vaccine.
Key areas
While it’s early, there are a number of key areas supply chain professionals are focusing to build resiliency into their supply chains, Schiller said. Increasing on-hand inventory levels and relaxing Just-In-Time inventory principles. Contracting will change with some considering moving to multisource vs. sole source contracts, and opportunities to continue, or to strengthen sourcing relationships with local or regional companies that have been established over the past few months.
Longer-term objectives include the adoption and utilization of data standards, including the Unique Device Identifier (UDI); needed transparency, inventory availability and utilization data upstream and downstream within the health care supply chain; improved/robust analytics capabilities.
“Given all of these challenges, America’s hospitals and health systems are working constantly to meet the challenges of the COVID-19 pandemic, to protect our front line heroes, caregivers and patients,” Schiller said.
Planning for Fall
How one leading health system was mapping out its supply chain strategy
for the expected flu/COVID-19 season in the fall.
To say that requirements for PPE on-hand for healthcare providers has varied by location would be an understatement. Generally, it’s been managed at the state level, said Brad Alexander, vice president of business analytics and decision support resource engineering hospitality group, Providence St. Joseph Health.
“The different markets and different states have different requirements around what we have to keep on hand depending on the phase of reopening that we’re in and the extent to which we are opening up our hospitals for elective procedures,” said Alexander.
Which makes it tricky for healthcare providers with facilities in several states and markets. For instance, Providence’s organizations include 51 acute care facilities spread across seven states and markets from Alaska to Texas. In each market they must coordinate with state and local officials on PPE supplies needed is no easy task.
Plus, the situation and requirements have been fluid. In Mid-June in Washington, providers needed seven to 10 days of PPE supplies on hand, but in urban settings in the Oregon market that number was much higher. California was like Washington in PPE requirements, but at press time the state was considering legislation that may have required hospitals to have on hand six months of supplies based on normal usage patterns.
Figuring out how much PPE to have on hand was just one piece of the puzzle. Another was where to put all those supplies. “It’s a huge challenge,” said Alexander.
Fortunately, Providence has been able to keep adequate stock on hand in its own facilities and maintain transparency with the state and local agencies around that. Alexander said the supply chain team built and deployed new tools in order to be able to track those inventories more dynamically and have “really good visibility on what we’ve got on hand at any given moment.”
Providence also maintained space for its own inventory in the distribution centers of its distribution partner. “It’s referred to as the 3PL, but it’s basically just a space in their warehouses and their distribution centers where we own the inventory, we can pull on it as needed; as opposed to distributor-owned inventory that’s subject to their allocation and all their other customer demands. So, we can store and stockpile there instead of building out warehouse space in the hospitals or elsewhere offsite.”
Alexander said that arrangement provides an outlet valve to maintain higher inventory levels. “Because when you look at some of these PPE categories, things like gowns, they’re incredibly bulky,” Alexander said. “Even 10 days of supply in crisis times for something like isolation gowns ends up taking huge amounts of space.”
Through its current infrastructure, Providence can rebalance inventories dynamically across its broader network of hospitals. For instance, a hospital in the Seattle market may have lower inventory levels, but a hub location at one of the larger Seattle hospitals has more surge capacity to draw from, along with additional bulk stock at the distribution centers. “In this way, we can rapidly respond to the crisis as it evolves across our network of facilities.”
Modeling the upcoming season
Alexander said Providence was using an effective epidemiology modeling capability to map out as best they could the upcoming weeks and months. The organization’s leader of clinical analytics, Ari Robicsek, chief medical analytics officer at Providence St. Joseph Health, runs the group and function. He has partnered with external think tanks and other academic medical centers. “He is constantly going back and forth with other experts about their disease modeling and projections,” said Alexander. “And so, we partner with them and we build off of their modeling.”
But even as effective as their work is, it’s hard to tell what the fall is going to look like, Alexander said. “We can kind of predict out ahead of us a couple of weeks or as much as maybe a month or so, but getting beyond that, you’re really starting to guess a little bit. With the onset of flu season in the fall, that’s where it becomes a lot harder to tell what’s going to happen.”
Providence has made infection prevention a focus, with an open dialogue around each protocol and what the supply chain can handle. “We’re working to try as best we can to accumulate 60 to 90 days of supply, given our use rates, for a possible surge associated with flu season, and maintain those in our hub sites and at our central distribution center. And then we want to make sure that we are able to effectively pull on those inventories, rebalance across our sites as we need to.”
The second part of preparation involves maintaining very tightly controlled inventory management practices. The supply chain team wants good transparency around critical supplies on hand. “The final part is partnering with our sourcing organization so that they are managing more flexible supply channels than we’ve had in the past, where we’ve got the ability to pull on greater quantities as we need to,” said Alexander. “That’s been a big challenge given all of the competing demands for PPE, but that team has done great work maintaining a little bit higher level of flexibility in those supply channels.”
Sidebar:
About Providence
Providence is a national, not-for-profit Catholic health system comprising a diverse family of organizations and driven by a belief that health is a human right. With 51 hospitals, 1,085 physician clinics, senior services, supportive housing and many other health and educational services, the health system and its partners employ more than 120,000 caregivers serving communities across Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington, with system offices in Renton, Washington, and Irvine, California.