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NEWSLETTER December 2022
We are currently engaged for the Mpox outbreak, the surge in Respiratory Syncytial Virus (RSV) among the pediatric population, and the COVID-19 Pandemic. We are currently alert for the severe winter weather across the US.

Highlights

Healthcare Ready recently announced new board appointments. We are incredibly grateful for our newly appointed board officers, four leaders in the fields of infectious diseases, medical engagement, pharmaceuticals, and the U.S (United States) health care industry. Healthcare Ready is excited for their continued service as they support the ever-growing challenges to the healthcare supply chain, access to equitable healthcare, and most importantly the commitment to helping build resilient communities across the nation. We look forward to their valuable leadership!

We recently released an assessment in partnership with Region V for Kids, to evaluate regional supply chain practices amongst pediatric hospitals and health systems within the Region V for Kids consortium. The study sought to identify changes made to supply chain resiliency plans during the COVID-19 pandemic and provide recommendations to strengthen supply chain practices. For more on the importance of the supply chain, visit our supply chain page to view factsheets, whitepapers, assessments, and more.

Healthcare Ready has shared guidance explaining how emergency declarations can be used to strengthen public health capabilities and surge capacities in the current pediatric surge response.
 

A Note From Our Executive Director  

The new year represents an opportunity for fresh starts, refocusing, and a symbolic departure from the year before. But for pediatric providers across the country, 2023 is a continuation of the surge of respiratory viruses, including respiratory syncytial virus (RSV), that began in 2022 and became a full-blown national crisis in part because of a failure to issue a federal emergency declaration.

The warning signs were all there in October 2022: more than 70% of pediatric inpatient beds were occupied, parents and children faced potentially dangerous increased waiting times for care as pediatric units continue to close nationally, and a strained healthcare workforce struggled to respond locally to a challenge demanding a coordinated national solution. At Healthcare Ready, we were on calls with pediatric healthcare coalitions across the country who were desperate for the support and resources only an emergency declaration could have provided. But despite this urgency, those who could have made a difference never got the message. 

After each of those calls, I kept coming back to one question: have we learned nothing from COVID-19? Health and healthcare aren’t atomized, and our responses can’t be either. We need shared operating principles to ensure responsive decision-making up and down the healthcare system, including when to implement emergency declarations. The emergency declaration for COVID-19 spurred coordination, increased supply production, and gave providers and patients alike the support they needed to navigate the pandemic. I only wish our pediatric patients and providers had the same opportunity now. While HHS urged providers to apply the resources and flexibility of the COVID-19 emergency declaration to the pediatric surge response, the lack of an event-specific declaration meant many providers felt limited in how they could use these resources. Many providers, especially those in states that no longer have state-level emergency declarations, were hesitant to use regulatory flexibilities (such as certain requirements for Medicare, Medicaid, and Children’s Health Insurance Programs) for fear they may still be open to liability. Perhaps more importantly, a Federal emergency declaration would have signaled the need for and enabled cooperation at the national level.
 

IN-DEPTH

Pediatric Respiratory Surge Event

Impact to Healthcare 

The current surge in pediatric respiratory illnesses has led to an elevated demand for children's over the counter cold and flu medications. The Food and Drug Administration’s (FDA) commissioner, Dr Robert Califf, stated that the FDA is working to improve supply chain with producers and are currently urging people not to buy more medication than what is needed due to the unprecedented demand. The demand has pushed some of the largest pharmacy chains to limit purchases to allow for those who need it most.

As of December 22, the Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (HAN) Health Advisory to notify clinicians and public health authorities of the increase in pediatric invasive group A streptococcal (iGAS) infections. The health advisory provides guidance to prioritize antiviral treatment for influenza due to limited availability of Oseltamivir. The advisory highlights the current rise in iGAS infections in children, the increased seasonal risk for all age groups, and the importance of early detection, diagnosis, and lists appropriate treatment in children and adults.

Treatments for RSV and other Respiratory Illnesses  

On December 21, the US Department of Health and Human Services (HHS), announced that they would be making an additional supply of Tamiflu available to jurisdictions in response to the demand and increase for the antiviral drug this flu season. Jurisdictions are to work with their ASPR regional coordinators to assess any requests for Tamiflu through the Strategic National Stockpile (SNS) in order to ensure they are receiving assistance without affecting the nation’s future preparedness response to the pandemic flu.  

Mpox Virus Updates

Vaccination Strategy and Vaccine Accessibility  

On December 2, The US Department of Health and Human Services (HHS) Secretary Xavier Becerra, released a statement stating that HHS does not plan to renew the emergency declaration for mpox when it ends January 31, 2023. HHS will continue to monitor case trends and encourages all at- risk communities to get the free vaccine. The Biden Administration will continue to work with jurisdictions around the nation to monitor trends, specifically in disproportionately affected communities.

Vulnerable Populations

The Centers for Disease Control and Prevention (CDC) has released a report highlighting epidemiologic data and characteristics of mpox in transgender and gender diverse persons. The report emphasizes how the ongoing mpox outbreak has had a disproportionate impact on transgender and gender-diverse adults with the most commonly reported exposure being those with sexual contact with cisgender men, as they may have been in networks experiencing high mpox incidences. Addressing the health needs many transgender and gender diverse adults face is an important public health priority, as tailoring prevention and outreach efforts may possibly reduce the disproportionate impact of mpox in this population.

The Center for Disease Control and prevention released data on the JYNNEOS vaccine and its magnitude and durability of protection against mpox. It was found that among JYNNEOS vaccine eligible men between ages 18-49, mpox cases among unvaccinated individuals were 9.6 times as high as those that had received two vaccine doses and 7.4 times higher as those who has received only one dose. There was found to be no difference in protection between subcutaneous and intradermal administration. Although further analysis is needed to conclude the durability of protection, overall evidence has found that the JYNNEOS vaccine provides protection against mpox and if possible, vaccine eligible individuals should complete the 2-dose vaccination sequence.

On December 13, the Center for Disease Control and Prevention (CDC) has included considerations for treatment and prophylaxis of the mpox infection in individuals with  immunocompromised conditions. These considerations are for healthcare providers who are caring for immunocompromised patients taking immunosuppressive agents and lists issues to consider when caring for individuals exposed to mpox. The clinical considerations listed can be used to educate healthcare staff and healthcare professionals that are developing mpox treatment and prophylaxis plans for individuals who are immunocompromised or immunosuppressed from other conditions.


COVID-19 Updates


The Biden Administration has released a fact sheet announcing their COVID-19 winter preparedness plan. The administration has announced the plan to stay ahead of increased COVID-19 cases this winter as the virus has continued to evolve and cases are rising. The administrations COVID-19 winter preparedness plan includes efforts such as expanding easy access to free COVID-19 testing, making vaccinations and treatments readily available to all Americans, preparing personnel and resources, and focusing on protecting those at the highest risk. For more details on how the Biden Administration plans to make vaccinations, testing, and treatments more readily available and accessible, click here.

The Commonwealth Fund has released a new study that shows that COVID-19 vaccines have kept more than 18 million people out of hospitals and have saved more than 3 million lives. Researchers have found that the US would have had 1.5 times more COVID-19 infections, 3.8 times more hospitalizations, and 4.1 times more deaths without COVID-19 vaccines than it did in December 2020. The vaccination initiative also saved the US $1.5 trillion in medical costs. The Biden Administration, as well as President Biden’s Chief Medical Advisor, Dr. Fauci, is urging individuals to get vaccinated and boosted. As we head into colder months, it’s important for individuals to protect themselves and their loved ones to slow the spread. Find important information on COVID-19 vaccinations here

On December 8, The US Food and Drug Administration (FDA) authorized the updated Bivalent COVID-19 vaccines for use in children from 6 months of age. With this authorization, the Moderna COVID-19 Bivalent is authorized for “individuals 6 months through 5 years of age as single booster dose at least 2 months after completion of primary vaccination with the monovalent Moderna COVID-19 Vaccine.” The vaccine is also authorized for individuals 6 years and older and a single booster at least 2 months after completing the primary vaccination or the most recent booster dose with an approved monovalent COVID-19 vaccine. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, states that, “Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death.” The FDA is encouraging parents of children in any age group that is eligible for a primary vaccination or a Bivalent vaccine booster to consider vaccination, as it can serve as protection from COVID-19 especially as cases are currently increasing this winter season.

COVID-19 Updates Continued


As of December 15, individuals can order free at-home COVID-19 kits. As part of the Biden Administration’s COVID-19 Winter Preparedness Program, COVID-19test.gov is now open for a limited period of ordering. All US households can order up to four free at-home tests that can be mailed directly to your home residence. The Biden Administration is also ensuring test are available to those that are blind or have low vision. Those that have difficulty accessing the internet or are in need of additional support should call 1-800-232-0233.
 

Supply Chain Update


The FDA has updated their device shortage list, a list used to provide transparency to the American public, particularly those who use or purchase medical devices during the COVID-19 Public health emergency.  As of December 2, there is a shortage of Cardiovascular - Circulatory Support, Structural and Vascular Devices. The shortage is due to increased demand and discontinuance of a component or part of the device. The US FDA advises that health care facilities and providers use Getinge Maquet/Datascope IAB catheters or IABP devices, review the shortage notification letter, inform Getinge if you have any underutilized Maquet/Datascope IAB catheters or IABPs, and report any issues with the devices to the FDA. 

Healthcare Ready has released an assessment in partnership with Region V for Kids, to evaluate regional supply chain practices amongst pediatric hospitals and health systems within the Region V for Kids consortium. The study sought to identify changes made to supply chain resiliency plans during the COVID-19 pandemic and provide recommendations to strengthen supply chain practices. Region V for Kids is a Pediatric Disaster Care Center of Excellence (COE) funded by the US Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR). More on the findings can be found here.

Public Health and Community Engagement 

On December 12, The Biden Administration released the 2024 Notice of Benefit and Payment Parameters Proposed Rule that “aims to further advance the administration’s efforts to build on the Affordable Cares Act (ACA) that has been set in place to increase access to quality healthcare options for millions.” The proposed rule increases access to healthcare services, simplifies choice, improves the plan selection process, and makes it easier to enroll in coverage. Access to affordable healthcare has been a concern throughout the US. The ability to continue to advocate for policies that help make it easier for consumers to choose and maintain health coverage policies that best fits their needs is an important factor in making sure coverage is more accessible. For details on the proposed rule, view the factsheet.

HHS will award more than $130 million in 988 Suicide and Crisis Lifeline Grants to address the nation’s ongoing health and substance abuse crisis. $47 million dollars was awarded to states and US territories to expand the 988 Suicide and Crisis Lifeline Services. HHS also plans to award over $21 million in 988 lifeline tribal response grants and technical assistance to improve 988 responses in tribal communities. If you or a loved one are mentally struggling, there is help available. Call or text 988 or chat 988lifeline.org. Those that are looking for assistance with mental health or substance use, call the National Helpline at 800-662-4357 or visit findtreatment.samhsa.gov.

On December 22, the US food and Drug Administration (FDA) approved a new antiretroviral medication for adults living with human immunodeficiency (HIV). The FDA granted approval to Gilead Sciences. The medication, Sunlenca, would be used for individuals whose HIV infections cannot be successfully treated with other treatments due to intolerance or resistance. Sunlenca is administered as an injection under the skin once every six months and is the first of a new class of drugs called capsid inhibitors that would be FDA approved for treating HIV-1. Patients are advised not to take Sunlenca if “they are also taking other drugs that can cause reduced levels of Sunlenca, as it could possibly result in losing virologic response and the development of viral resistance.”

IN CASE YOU MISSED IT

COVID-19


Multiple infections could make us much sicker – strep A, RSV and flu are a dangerous mix | Daniela Ferreira | The Guardian
 
On the Two-Year Anniversary of the First COVID-19 Vaccine, Secretary Becerra Celebrates Administration's Progress in Protecting and Saving Lives During Pandemic | HHS.gov
 

Preparedness


FEMA’s National Preparedness Report Underscores Continued Threat of Climate Change | FEMA.gov
 
Biden-Harris Administration Announces Funding Opportunity for New Community Resilience Program | FEMA.gov
 

Public Health


Healthcare Ready developed a report explaining how emergency declarations can strengthen public health capabilities and surge capacities in this response.

FACT SHEET: The Biden-Harris Administration’s Efforts to End HIV/AIDS At Home and Abroad | The White House


Equity  

FACT SHEET: Biden-Harris Administration Announces Plan to Prevent and End Homelessness | The White House

UPCOMING EVENTS

2023 National Resilience EXCH Virtual Summit
January 24, 2023
Virtual
Registration
 
2023 Association of Healthcare Emergency Preparedness Professionals Annual Conference
February 27 – March 1, 2023
Scottsdale, Arizona
Registration
 
2023 Distribution Management Conference and Expo
March 12 – 15, 2023
Indianapolis, Indiana
Registration
 
2023 Preparedness Summit – Recover. Renew: Reprioritizing All-Hazards Preparedness  
April 24 – 27, 2023  
Atlanta, Georgia
Registration
 

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