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Health Advisory Council Newsletter | Fall 2022

Updates from our Members

Alliance for Aging Research

The Alliance for Aging Research released new educational materials as part of its Our Best Shot campaign, emphasizing the importance of getting back on track with routine vaccinations. The materials also focus on educating about the potential serious impact of respiratory syncytial virus (RSV) on older adults—it’s not just a little kid’s disease. Materials include: 

  • RSV: Not Just a Little Kids’ Virus also available in a 60-second and 30-second PSA 
  • Pediatrician Don Schuessler Shares His Patient Story of Having RSV – also available as a 60-second PSA 
  • Getting Back on Track with Routine Vaccinations – also available in 60-second and 30-second PSA 
  • Getting Up to Date on Vaccinations: It’s Our Best Shot PSA 
  • Quick Guide to Vaccination: Brochure and Schedule 

ASHP

ASHP recently launched recruitment for Well-Being Ambassadors. Those who sign up to become a Well-Being Ambassador (WBA) will be empowered to take local action to mitigate occupational burnout in their healthcare organizations. The WBA program is the most recent in ASHP’s longstanding efforts to ensure the pharmacy workforce has the tools, resources, and critical support to protect patient safety and foster optimal medication outcomes. ASHP received a three-year grant from the Health Resources and Services Administration Health and Public Safety Workforce Resiliency Training Program to implement this critical initiative. 

BeMedWise

This October, BeMedWise, a NeedyMeds website and initiative, kicked off its 37th annual Talk About Your Medicines Month. The goal of Talk About Your Medicines Month is simply better health outcomes through education and improved communication. The 2022 theme is Medication Safety & Aging. Bodies change as they age. An important part of maintaining health is understanding how these changes affect the medicines you take. So, we’ve created a one-stop destination to help empower older patients to reduce med risks, boost med benefits, and provide tools so they can stay safe when it comes to their medications. Please partner with us by sharing the information and resources on the page and promoting the campaign on social media. Together, we can make a difference. 

Consumers for Quality Care (CQC)

For more than five years, Consumers for Quality Care (CQC) has worked to shine a light on the serious problems that consumers are facing when it comes to accessing quality, affordable health care. This fall, CQC honored Health Literacy Month in October by sharing consumer tips to avoid medical debt and choose the right health insurance plan during open enrollment. 

From calling out nonprofit hospitals for bad practices, to speaking out against harmful administration proposals like the NBPP, we have been working tirelessly to ensure that consumers are at the forefront of the health care debate and that is something we will continue to do moving forward as we demonstrate to policymakers the importance of quality care for all. To learn more about CQC’s recent work, check out these links; CQC’s partner sign-on letter supporting the proposed rule to amend Section 1557 of the Affordable Care Act (ACA), CQC board member Jim Manley’s op-ed in The Hill on medical debt, and consumer stories. 

Deterra Drug Deactivation and Disposal System (Verde)

Verde Environmental Technologies, Inc., creator of the Deterra® Drug Deactivation and Disposal System, is proud to announce two new partnerships designed to get drug misuse prevention resources into the hands of those who need them most.  

Verde has partnered with Optima Health, a health plan service of Sentara Healthcare, to pilot the distribution of at-home drug deactivation and disposal pouches to patients at more than 60 Sentara Family & Internal Medicine Physicians offices and surgical locations in Virginia and North Carolina. The new initiative aims to encourage proper medication disposal to prevent drug misuse and environmental harm.   

In New York State, the New York State Office for the Aging (NYSOFA), New York State Office of Addiction Services and Supports (OASAS), and aging services partners are bringing proper drug disposal efforts to older adults throughout the state.    

Through this program, NYSOFA and OASAS are shipping 100,000 Deterra Drug Deactivation and Disposal Pouches to aging services providers for distribution and delivery to older adults. Many older adults have multiple medications but are unable to visit take-back sites. An at-home deactivation and disposal option can help promote safe disposal and reduce the risk of medication confusion, misuse, theft and overdoses.   

Learn more about how at-home medication deactivation and disposal initiatives are making a difference in the fight against drug misuse at DeterraSystem.com.  

Healthcare Distribution Alliance

Over the summer, Dr. Nicolette Louissaint, Senior Vice President of Policy and Strategic Planning at Healthcare Distribution Alliance (HDA) joined Sally Greenberg in an episode of the We Can Do It! podcast to discuss the resilience of the healthcare supply chain during COVID-19 and preparing for the “next big thing.” Tune in to hear the insightful discussion via Apple Podcasts and Google Podcasts.   

HDA also launched a new animated video, which spotlights distributors’ work to make sure hospitals, pharmacies, providers and ultimately patients have access to critical medicines and healthcare supplies. The video emphasizes distributors’ role as the logistics experts of healthcare, ensuring the safe, efficient and reliable delivery of millions of medicines, vaccines and healthcare products daily. Read *here to learn more about the value provided by distributors. For more information, visit HealthDelivered.org. 

Pear Therapeutics

At Pear Therapeutics, we discover, develop, and commercialize prescription digital therapeutics, or PDTs. PDTs are designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. Pear was the first to receive FDA authorization of PDTs and has three products: reSET® for substance use disorder (SUD), reSET-O® for opioid use disorder (OUD), and Somryst® for chronic insomnia. 

Pear and other innovative PDT companies are working to change and improve healthcare with a new class of medicine, but access to PDT treatment remains the biggest barrier to adoption.  Together we’re making progress, and we’re asking for your help. 

In 2022, we’re asking congress to pass the Access to Prescription Digital Therapeutics Act of 2022.  If passed, this would create a Medicaid benefit category for PDTs, and more patients everywhere would have access to these important digital treatments people deserve. 

The Academy of Managed Care Pharmacy, or AMCP, has a turn-key way for citizens to let their members of Congress know that they support turning this bill into law. 

Please click on this AMCP link to generate a pre-populated email to let Congress know how you feel. 

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings.

  • Health Advisory Council Newsletter | Fall 2022

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      A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.

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    PBPA Commends HHS Funding to Support Maternal and Infant Health

    The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.

    “For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”

    The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.

    “Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued.  “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”

    The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.

    “In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg.  “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”

    Diverse research for a diverse America: The value of equitable, real-world research

    August 12, 2021/in Blog, Health, Prevention Blog Post

    By Sally Greenberg, NCL Executive Director

    While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.

    The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.

    Existing efforts to improve inclusion

    Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.

    Recognizing the potential for RWE in maternal health

    The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.

    Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.

    Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.

    The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.

    PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH

    WASHINGTON, DC, August 26, 2021 –

    Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.

    We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”

    Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.

    “Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”

    While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.

    ###

    ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE

    The Preterm Birth Prevention Alliance (PBPA) is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, the 15 partners in the PBPA seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org

    LEADING PATIENT ADVOCATES LAUNCH PRETERM BIRTH PREVENTION ALLIANCE TO PROTECT CRITICAL ACCESS TO THE SOLE FDA-APPROVED CLASS OF THERAPIES TO REDUCE RECURRENT PRETERM BIRTH

    WASHINGTON, DC, April 20, 2021 – Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the >Preterm Birth Prevention Alliance.

    Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.

    For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in America experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.

    However, in 2020, the FDA >proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.

    “We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”

    To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.

    “As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.

    The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.

    ###

    ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE

    The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.

    Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.

    MEDIA CONTACT:

    Carol McKay, carolm@nclnet.org

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