The 2018-2019 flu season is coming. Already.
It’s summertime. For many, that means weekend trips to the beach, outdoor concerts, baseball under the stars, and such. But for supply chain executives, it’s time to seriously prepare for the 2018-2019 flu season. At least, it should be, given the suddenness and severity of the 2017-2018 season, which many consider to have been the worst in years.
“According to the Centers for Disease Control and Prevention, [the 2017-2018] flu season was dominated by the H3N2 strain, which has a propensity to be more severe in nature and with an increase in mortality related to the virus,” says Kristi Kuper, PharmD, BCPS, senior clinical manager, infectious diseases center for pharmacy practice excellence, Vizient. “What was somewhat unusual was that this strain not only affected those most vulnerable – such as the elderly and children, those with chronic health conditions, and the immunocompromised – but there were also flu-related deaths in patients with no reported underlying health conditions.
“Although we did not see as many influenza cases and deaths as we did during the 2009-2010 H1N1 (pandemic) flu season, this season was one of the busiest on record,” she continues. “What was unique about this past season was the timing of the disease. Typically, we see a gradual increase in flu diagnoses as it geographically spreads across the country. However, this year, almost every state and territory was reporting widespread flu activity by the end of 2017, so it basically hit the U.S. all at once.”
Says Steve Ellis, director, corporate supply chain services, Palomar Medical Center Escondido (California), “This was the worst flu season in memory, eclipsing even the H1N1 pandemic in 2009. The flu hit early, with patients flooding the Emergency Department shortly after Christmas. We saw an average increase of about 60 to 100 patients per day for several weeks following the initial surge.”
Surge tents
Palomar Medical Center was one of many facilities around the country that set up surge tents to assist with triage efforts.
“Our EDs experienced considerable volume increases, causing longer wait times and challenges with space needed to accommodate patients needing initial screening, diagnosis and treatment,” says Ellis. The tent – which was set up by the hospital’s facilities management and emergency management teams – was in place for three weeks during the extreme peak period, beginning Dec. 30.
“It felt like it happened overnight,” says Ellis, referring to flu onset. “There was no gradual increase. One weekend, I went in to the ER in our busiest facility; it was overflowing; standing room only. The demand was so high, with limited space to triage folks doing initial diagnoses, we set up the tent primarily for triage purposes. We would process quickly those with the most severe situations.”
Meeting demand
Keeping up with the demand for flu-related products and protective wear kept supply chain officers busy in the first quarter of 2018. The difficulty of keeping clinical areas supplied was exacerbated by product shortages from hurricane-stricken Puerto Rico, as well as the depleted ranks of supply chain departments, themselves succumbing to flu and flu-like illness.
“Various market factors – including hurricane damage to Puerto Rico-based manufacturing facilities – constrained the availability of IV solutions, resulting in manufacturers imposing limited allocations on products in order to manage inventory and mitigate shortages,” says Stephanne Hale, PhD, RN, senior clinical manager, sourcing operations, Vizient. “The already serious IV solutions shortages were exacerbated by a surge in demand caused by the season’s widespread flu activity and associated hospitalizations and need for IV medication and fluids for patient treatment.
“In addition, some pharmacies, especially in the retail setting, reported difficulty obtaining oseltamivir [Tamiflu], which is the most common antiviral for treating influenza,” she says. “On the positive side, we did not see any shortages of the flu vaccine or personal protective equipment, including masks and gloves.”
Palomar’s purchasing and distribution teams exerted “substantial effort” to source products and replenish the surge tent and other areas within Palomar Health hospitals, says Ellis. Products in demand included hand sanitizer, personal protective equipment (masks, gowns, gloves, etc.), disinfectant wipes/cleaners and lab supplies (influenza testing kits), he says.
Despite the fact that Palomar maintained a substantial safety stock of protective masks in its warehouse, “we were going through them almost quicker than we could source them,” says Ellis. “It wasn’t a doubling or even tripling of normal usage; it was 10 to 20 times normal.” Usage of the masks soared not only among clinical staff and hospital employees, but visitors too. Any visitor presenting with flu- or cold-like symptoms, such as coughing and sneezing, were given masks. Influenza test kits presented significant challenges as well, he says. “We were exhausting our regular suppliers, so we sourced from a variety of resources.”
All the while the Palomar team was hustling to fill demand, they were doing so with a proverbial hand tied behind their backs.
“Part of the challenge we experienced with supplying the tent and other locations involved our staffing levels, as we were not exempt from the flu or flu-like illness,” says Ellis. “From time to time, staffing levels within Supply Chain and other departments were affected due to illness as well. I don’t know of many people who were able to stay healthy through it all,” himself included.
“So our patient volume was much higher than usual, and we had a less than optimal workforce.”
Health systems demonstrated creativity not only in sourcing supplies, but in using them efficiently. And they got help doing so.
Christi Guess, senior director, member input and clinical solutions for Vizient, says that the GPO was able to serve as a “vital intermediary” between members, suppliers and distributors. “We provided various resources to members, including clinical guidance on conservation strategies for IV solutions, which resulted in reported reduction in utilization well in excess of 25 percent for many providers. We partnered with our members in escalating urgent needs with manufacturers and in prioritizing urgent shipments.
“We served as a unified voice to industry in pressing for concerted mitigation strategies, which resulted in suppliers assessing their own vulnerabilities in the face of shortages and constrained supplies caused by both disaster and the flu-related surge in patient demand.”
As a result of efforts such as these, some suppliers obtained FDA approval to import products from manufacturing sites overseas, and to extend the shelf life of certain products, says Guess. Others ramped up production at other manufacturing sites in North America and allocated shipments based on historical purchases.
Lessons learned
If the 2017-2018 flu season had any kind of silver lining, it was in the lessons learned by providers and suppliers.
“Organizations should have an influenza shortage mitigation strategy in place that addresses and triages needs from the various care settings,” says Tim Franke, RPh, senior director, pharmacy, laboratory and imaging contracting, Intalere. “That includes prioritization of patient types, influenza vaccination settings, intra-company product allocation, and vaccine logistics within a centralized or decentralized distribution model.
“Developing and improving engagement strategies with caregivers, particularly in the ambulatory setting, will enable greater visibility into the needs of those clinicians and more predictability in forecasting demand for the upcoming influenza season,” he adds.
Sharon Carlson, director of emergency preparedness for Sharp HealthCare, says, “We practice for a ‘surge of patients’ consistently, and we need to continue to do so.” Sharp Grossmont Hospital in La Mesa, California, set up a surge tent for a short time this winter to screen incoming patients with flu-like symptoms.
“Supplies may run low,” she continues. “Sometimes it may be supplies that one doesn’t plan to run short of. We ran low on blood culture tubes, but were able to work with vendors and share with other hospitals.”
The 2017-2018 flu season validated some practices already in place at Palomar, says Ellis. Those practices include:
- Have a good emergency management plan with an up-to-date call list. “The increased volume began around the Christmas and New Year’s holidays. Much of the work involved management and staff not scheduled to work due to the holidays.”
- Make sure supply reorder points/quantities of basic and normally needed supplies have an adequate safety level built to accommodate periodic spikes in usage. Create emergency stock within your inventory location if the space is available or with key distributors.
- Maintain flexibility within the support services areas to create awareness on the core mission with capabilities to flex and respond to urgent situations to meet community needs.
Christi Guess from Vizient points out that Vizient’s contracts require suppliers to have a business continuity plan. “In general, most medical device and product manufacturers do have contingency plans and redundant supply chain strategies in place,” she says. But surges such as those experienced in the most recent flu season can uncover weaknesses in those strategies. “In these cases, including this most recent episode, Vizient has joined with members to formally challenge our supplier partners to improve, and we will hold them accountable to do so now and in the context of future competitive bids.”
Adds Kuper, the 2017-2018 flu season demonstrated the need for healthcare facilities to review current policies regarding preparedness and prevention efforts, and enhance them as necessary.
“Patients and staff need to get an annual flu vaccine,” she says. “Even though the vaccine’s effectiveness against the predominantly circulating strain was low this year, it still protects against other circulating strains, e.g., H1N1 and influenza B, which can cause flu.
“Hospitals and health departments learn from every outbreak, whether it is the flu or something more deadly, such as Ebola,” she says. “They are sharing their experiences and refining their approach to treating patients and protecting the health of their communities.”
A look to 2018-2019
Contracting professionals and their teams should prepare for the upcoming flu season with adapability, creativity and hard work, according to those with whom the Journal of Healthcare Contracting spoke.
“While influenza vaccine suppliers continue to focus on incentivizing healthcare organizations to standardize their influenza vaccine selection, there is inherent value in diversifying product selection to mitigate product shortages and ensure influenza vaccine is available for patient care,” says Franke. “Healthcare providers need to find the appropriate balance of those two sometimes competing forces.
“The market continues to move toward premium influenza vaccine products, such as high dose, which contributes to the year over year cost increase to vaccinate a population,” he continues. (The high-dose vaccine, approved for use in the United States in 2009, is designed specifically for people 65 and over and contains four times the antigen as the regular flu shot.) “It is imperative that healthcare providers develop and implement an evidence-based vaccination approach to effectively manage the various patient segments and associated costs.”
Says Stephanne Hale, “Flu prevention and treatment during outbreaks is a collaborative effort. Identify all of the key stakeholders and engage them as early as possible. Convene a group of experts to review how the hospital managed the 2017-2018 season. This would include evaluating the supply of personal protective equipment and the accessibility by staff. In addition, work with Pharmacy to assess antiviral stock and availability in the wholesaler. This should help identify opportunities for improvement.
“It is important to do this over the summer so that the health system is well prepared before the 2018-2019 season begins this fall.”
H3N2 a formidable foe
A Rice University study predicts that this fall’s flu vaccine – a new H3N2 formulation – will likely have the same reduced efficacy against the dominant circulating strain of influenza A as the vaccine given in 2016 and 2017, due to viral mutations related to vaccine production in eggs.
“The vaccine has been changed for 2018-19, but unfortunately it still contains two critical mutations that arise from the egg-based vaccine production process,” Michael Deem, Rice’s John W. Cox Professor in Biochemical and Genetic Engineering and professor of physics and astronomy, was quoted as saying “Our study found that these same mutations halved the efficacy of flu vaccines in the past two seasons, and we expect they will lower the efficacy of the next vaccine in a similar manner.”
Annual flu vaccines are formulated to protect against one type of influenza B and two strains of influenza A, one H3N2 strain and one H1N1 strain, according to Rice. The H and N refer to hemagglutinin and neuraminidase, two proteins that cover the outside of invading flu particles that can cause infection when inhaled. The human immune system targets these particles for destruction based on their H and N sequences, and flu viruses constantly evolve the sequence of amino acids in these proteins to evade detection.
Most flu vaccines are produced with a decades-old process that involves culturing viruses in hundreds of millions of chicken eggs. Because the strain of flu that infects people is often difficult to grow in eggs, vaccine producers must make compromises to produce enough egg-based vaccine in time for fall flu shots, according to Rice. Unintended effects of this process have reduced vaccine efficacy against H3N2 the past two years, Deem said.
Nasal vaccine gets CDC backing for 2018-2019
After refusing to recommend the nasal flu vaccine FLUMIST® QUADRIVALENT for the past two flu seasons, the Centers for Disease Control and Prevention is recommending it (in addition to injectable flu shots) for the 2018-2019 flu season. The recommendation follows the presentation of positive results from a U.S. study in children between the ages of 2 to <4 years evaluating the shedding and antibody responses of the H1N1 strain in the live attenuated influenza vaccine, according to drug company AstraZeneca.
FLUMIST QUADRIVALENT is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FLUMIST QUADRIVALENT is similar to MedImmune’s trivalent influenza vaccine, except FLUMIST QUADRIVALENT provides protection against an additional influenza strain.