and reporting

Adapting to Meet Changing Needs

The largest health system in Indiana now requires predictive supply health metrics and reporting

By Daniel Beaird

Dennis Mullins

Indiana University (IU) Health is the largest network of physicians and hospitals in the state of Indiana.

The system includes a unique partnership with the IU School of Medicine, giving patients access to one of the nation’s leading medical schools, to leading-edge medicine and treatment options. While COVID-19 response continues to consume significant healthcare resources and require heightened precautions, IU Health saw increases in surgical cases and outpatient care in the first quarter of 2021.

“Over the past year IU Health has adapted to meet changing healthcare needs amid unprecedented challenges posed by the global pandemic,” said Jenni Alvey, senior vice president and chief financial officer for IU Health. “We expect the rest of 2021 will require continued resilience to manage operations and finances while making new investments to serve patients who depend on us, especially in these critical times.”

“Due to COVID-19, IU Health now reviews manufacturer and distributor throughput to include their sourcing strategy outside the U.S.,” said Dennis Mullins, senior vice president of supply chain for IU Health. “This allows us to properly forecast our supply ordering and have confidence in the reliability of our suppliers to manage their end-to-end supply chain process from raw material to the product delivery to our hospitals.”

In addition, IU Health increased its knowledge base regarding how overseas manufacturing plays a vital role in how the U.S. supply chain operates to include the logistical complexities of ships, shipping ports and customs operations.

“Prior to the pandemic, we maintained a 60-day safety stock of PPE for all acute locations at our Integrated Service Center, which consolidates and handles inventory for

our 16-hospital system,” Mullins said. “Now, we are positioned to maintain 120 days of PPE safety stock.”

IU Health’s supply planning approach before the pandemic was based on historical usage. “But pandemic planning required more of a future forecast where we were required to look at the COVID-19 positive population at a global level, and it could impact the U.S. and IU Health,” Mullins said.

IU Health entered into several supply assurance programs with distributors and manufacturers. These programs were designed to stabilize and sustain stocking levels required to support its increased demand.

“We created a strategic communication structure with multiple suppliers where discussions about supply levels occurred weekly, daily, and sometimes, hourly depending on the need,” Mullins explained. This resulted in better reporting being distributed to IU Health from vendors, including data related specifically to the pandemic like allocation amounts, and how and why certain products were used.

Since the pandemic, IU Health has engaged with its distributors to: ʯ Require predictive supply health metrics and reporting ʯ Preapprove substitute products to avoid disruption due to backorder where possible ʯ Contract to guarantee supply commitments on critical PPE categories ʯ Partner to identify and approve credible alternate supply sources and avoid scams in the market ʯ Create more frequent communication tailored to the critical item needs of IU Health and how to best resolve those issues in the fastest way possible without impacting patient care

“Post-pandemic we expect closer assignments of pandemic-exposed capabilities of suppliers and distributors, their countries of origin and long-term risks,” Mullins said. “We expect even closer relationships with our distributors and vendors to capitalize on what they have learned during the pandemic about our processes and how we function as a healthcare system. This will improve communication on critical questions.”

Supply assurance contracts enabled IU Health to supply clinicians with needed PPE they were familiar with, rather than lower quality alternatives. And IU Health never had a zero balance of critical PPE.

“Our command center was set

IU Health Integrated Service Center

up to maintain constant contact with one another to resolve any issue that arose as efficiently as possible, sometimes within minutes of hearing about an issue,” Mullins said.

Ready for Respiratory Season?

Experts say distributor reps should “remain nimble” as RSV, COVID could create uncertainty

Anticipating the upcoming respiratory season is like

expecting a baby: An ultrasound may give you some idea of what the little one will look like, but you never really know what you’re getting until delivery. “There is always significant uncertainty with the respiratory season, and now that COVID-19 is part of the mix, it only increases that uncertainty,” says David Morris, principal product manager, SEKISUI Diagnostics.

The incidence of non-COVID respiratory diseases, particularly influenza and respiratory syncytial virus (RSV), was greatly affected in the 2020-21 season due to infection control measures like social distancing, stay-athome orders and mask usage, he says. “While these incidence rates were at historic lows in 2020-21, we are already seeing an increase in RSV incidence as infection control measures are being dropped. This is a good indicator that we should start to see similar increases in infections and testing of other non-COVID respiratory diseases.

“Our preparations for the 2021-22 respiratory season are more similar to what we traditionally did before the emergence of COVID-19,” he says. “The drop in childhood vaccinations [administered during the pandemic] appears to be correlated with reduction in doctor visits due to concerns related to the pandemic. Now that visits are trending back to normal, we expect respiratory-related testing and routine vaccinations to also trend back toward historic norms in the upcoming year.”

Ready for Respiratory Season?

Pediatricians are concerned about the potential impact of missed childhood visits and vaccinations during the pandemic. “We are concerned that children are not up to date on a number of vaccines and may be at risk for transmission of vaccine-preventable diseases,” Bonnie Maldonado, MD, FAAP, chairperson of the American Academy of Pediatrics’ Committee on Infectious Diseases, and Professor, Departments of Pediatrics and Health Research and Policy at Stanford University School of Medicine, told Repertoire this spring. As of June, the U.S. was behind on childhood vaccinations by over 11 million doses since the first surge of the pandemic in March 2020.

Your growing respiratory toolbox

During public health emergencies (such as the SARSCoV-2 pandemic), the Food and Drug Administration can issue emergency use authorizations (EUAs), which authorize unapproved medical products or unapproved uses of approved medical products for diagnosing, treating or preventing serious or life-threatening diseases or conditions. Companies whose diagnostic products received EUAs for respiratory-related tests include:

ʯBD: Received EUA in February and March 2021 for the BD® SARS-CoV-2/Flu assay, which is run on the

BD MAX™ System; and the BD Veritor™ System for

Rapid Detection of SARS CoV-2 & Flu A+B test.

ʯCepheid: In September 2020, received EUA for

Xpert® Xpress SARS-CoV-2/Flu/RSV for qualitative detection of the viruses causing COVID-19, Flu A, Flu

B, and RSV infections from a single patient sample.

ʯQuidel: In October 2020: received EUA to market the Sofia® 2 Flu + SARS Antigen FIA, to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer.

ʯAbbott: In March 2021, received EUA for the Alinity™ m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test.

ʯSekisui: In March 2020, Mesa Biotech received an EUA for the AcculaTM SARS-CoV-2 test, which is distributed by SEKISUI Diagnostics.

Children who are behind schedule or overdue for their vaccinations will be at risk for developing respiratoryrelated illness, says Joseph Mann, BD’s global medical science liaison. “Furthermore, the more individuals who are unvaccinated and without immunity, the more transmissible the infection will be in the community. Therefore, vaccination not only protects the individual from infection, but also protects the community as a whole, since vaccinated individuals are unable to develop and transmit the infection to other people. This concept is commonly referred to as ‘herd immunity.’”

Not everyone will get vaccinated, but Mann believes the level of herd immunity will be sufficient to cancel the ill effects of the past year’s reduction in childhood vaccination rates. “With the exception of influenza, I don’t believe one year of lower vaccination rates in children will result in a significant increase in respiratoryrelated tests due to the concept of herd immunity. Again, the vast majority of the general public likely remains immune, which makes it difficult for these infections to spread. [But] if a trend of reduced childhood vaccination rates continues, we will undoubtedly see outbreaks happen, as we saw at Disneyland and other places recently with measles.”

RSV

Health officials are concerned about a potential spike in RSV this coming respiratory season. In June, the Centers for Disease Control and Prevention (CDC) issued a health advisory about increased interseasonal RSV activity across parts of the Southern United States. (Typically, in the United States, RSV infections occur primarily during the fall and winter cold and flu season – not the spring and summer months.)

RSV can be associated with severe disease in young children and older adults, and is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States.

Due to the reduced circulation of RSV during the winter months of 2020–2021, older infants and toddlers might now be at increased risk of severe RSV-associated illness, because they have likely not had typical levels of exposure to RSV during the height of the pandemic, according to the agency. In infants younger than six months, RSV infection may result in symptoms of irritability, poor feeding, lethargy and/or apnea with or without fever. In older infants and young children,

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Ready for Respiratory Season?

rhinorrhea and decreased appetite may appear one to three days before cough, often followed by sneezing, fever and sometimes wheezing. Symptoms in adults are typically consistent with upper respiratory tract infections, including rhinorrhea, pharyngitis, cough, headache, fatigue, and fever. There is no specific treatment for RSV infection, nor is there a vaccine for it.

Due to the increased RSV activity, CDC is encouraging broader testing for RSV among patients presenting with acute respiratory illness who test negative for SARS-CoV-2.

Looking ahead to the 2021-2022 respiratory season, Sekisui’s David Morris advised Repertoire readers to remain nimble. “While we currently expect a trend toward normalcy, new breakthrough variants of COVID could rapidly change the current trend overnight.”

Meanwhile, BD’s Jeffrey Andrews offered advice applicable not only to Repertoire readers, but providers, patients and consumers: “Get vaccinated against COVID19! Get vaccinated against flu in the fall! Don’t expose others when you are feeling ill!”

Coming up: mRNA

Much-heralded messenger RNA (mRNA) vaccines for SARS CoV-2 from Pfizer-BioNTech and Moderna are probably just the first of a new family of vaccines for influenza, RSV, even cancer.

Instead of putting a weakened or inactivated germ into our bodies, like traditional vaccines, mRNA vaccines teach our cells how to make a protein – or even just a piece of a protein – that triggers an immune response inside our bodies, according to the Centers for Disease Control and Prevention. mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). But as soon as information about SARS-CoV-2 became available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine. Here’s some of what’s happening today.

In June 2021, Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinicalstage mRNA therapeutics company, initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and effectiveness of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. That same month, Sanofi announced it would invest €400 million annually in an mRNA Center of Excellence. Approximately 400 employees will work on the project in Cambridge, Massachusetts, and Marcy l’Etoile, Lyon (France).

In February 2021, GlaxoSmithKline plc and Vir Biotechnology Inc. signed an agreement giving GSK exclusive rights to collaborate with Vir on the development of monoclonal antibodies (mAbs) for the prevention or treatment of influenza. (Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.) These include VIR-2482, an intramuscularly administered investigational mAb designed as a universal prophylactic for influenza A, which has completed a Phase 1 trial, as well as next generation antibodies for the prevention or treatment of influenza during a three-year research period.

In July 2021, Moderna Inc. announced the first participants were dosed in the Phase 1/2 study of mRNA-1010, the company’s quadrivalent seasonal influenza mRNA vaccine candidate. This study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 in healthy adults 18 years and older in the U.S. The company said it also plans to explore potential combination vaccines against flu, SARS-CoV-2, respiratory syncytial virus and human metapneumovirus (hMPV).

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*Emergency Use Authorization Information for the SARS-CoV-2 and SARS-CoV-2 & Flu A+B assays: • These products have not been FDA cleared or approved; but have been authorized by FDA under EUA for use by authorized laboratories • The BD Veritor™ System for Rapid Detection of SARS-CoV-2 has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and, • These products are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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