Health Advisory Council Member Updates | Summer 2020

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The Alliance for Aging Research

The Alliance for Aging Research and the Eldercare Locator released a new fact sheet that highlights the importance of staying safe at home during the coronavirus crisis. The resource details how patients, caregivers, and their loved ones can safe and healthy during this public health emergency. The fact sheet is available to download here. The Alliance and National Foundation for Infectious Diseases jointly developed and released a resource that addresses commonly asked questions and answers related to the coronavirus. The resource titled, “Common Questions and Answers About COVID-19 For Older Adults and People With Chronic Health Conditions”, is available to download here.

There are more than 600 Area Agencies on Aging around the U.S. that provide home and community-based volunteer services for older adults. Due to the COVID-19 crisis, many requests for volunteer services have increased since older adults are staying home to protect themselves. Many of the volunteers that provide these services are older adults themselves, so the drop off in volunteers has been significant. 

To help address the gap in services, the Alliance for Aging Research is currently working with the National Association of Area Agencies on Aging to connect potential volunteers and area agencies to assist older adults and individuals with disabilities with meal prep/delivery, check-in calls and grocery assistance amid the COVID-19 crisis. If you are interested in volunteering, or would like to circulate this opportunity, see below for more details.

In need of volunteers for older adult assistance amid COVID-19 pandemic

There are more than 600 area agencies on aging around the U.S. that provide home and community-based services for older adults. Requests for important volunteer services have increased since older adults are staying home to protect themselves, including:

  • delivery
  • check-in calls, and
  • grocery assistance

Many of the volunteers that typically provide these services are older adults themselves, so the drop off in volunteers has been significant. The Alliance for Aging Research is connecting potential volunteers with local agencies through the National Association of Area Agencies on Aging.

To volunteer, a previous basic background check is required, along with a kind heart and time to help. If you are interested in volunteering to assist older adults in your region, this is what we need from you:

  • Services from the list above that you would like to provide
  • Name, Email, and Location (city/town and state)

Please reach out to Kelsey Allcorn at kallcorn@agingresearch.org directly if you are interested, as soon as possible. Thank you!

 

AMAG Pharmaceuticals, Inc.

AMAG has worked closely with key opinion leaders to increase education for two of its products – Intrarosa and Vyleesi – and is grateful for their efforts to share data with the scientific community. Highlights of recent publications include “Instruments for Screening, Diagnosis, and Management of Acquired HSDD,” published in the Journal of Women’s Health, which examines screening and diagnostic tools available for the assessment of hypoactive sexual desire disorder. A second manuscript, “Hypoactive sexual desire disorder (HSDD) is not “female erectile dysfunction (ED)”: challenges with the characterization of HSDD in women based on a systematic literature review,” was published in Current Medical Research and Opinion and the abstract, “Effect of Bremelanotide on Ambulatory Blood Pressure When Administered for Up to 16 Consecutive Days,” is featured in the May issue of Obstetrics & Gynecology. A new animated educational video, designed to help providers better understand the underlying etiology of HSDD, was also recognized as a 2020 Muse Creative Award gold winner. Additionally, at the American Urological Association’s virtual annual meeting, the abstract “Prevalence of Urinary Tract Infections in Women with Genitourinary Syndrome of Menopause and the Impact of Vaginal Prasterone on the Rate of Urinary Tract Infections,” was featured. The on-demand poster and accompanying voice recording can be accessed here.

 

American Society of Health-System Pharmacists (ASHP) — COVID-19 Resource Center

ASHP is committed to supporting our members, as well as their healthcare team colleagues and patients, in response to the COVID-19 pandemic and is regularly communicating updates on this crisis. We have opened access to our evidence-based online resources and tools on ashp.org, making them widely available to all pharmacists and healthcare professionals, and our COVID-19 Resource Center is updated frequently and includes ASHP’s Evidence Table for COVID-19 treatments as well as our advocacy communications. ASHP has also launched a new COVID-19 Community on Connect, which serves as a forum for any healthcare providers to ask questions, share experiences, post resources, and more.

 

BeMedWise

During the early weeks of the COVID-19 Coronavirus pandemic, BeMedWise.org saw a significant increase in visitors seeking information about the safety of NSAIDS (such as ibuprofen) for treating worsening COVID-19-like symptoms. To help consumers and patients better understand safe and appropriate OTC use (acetaminophen and NSAIDs) if they are experiencing mild cold or flu-like symptoms, the BeMedWise Program at NeedyMeds developed a website page – Pandemic tips for treating mild symptoms with OTC‘s, and resource links from key BeMedWise stakeholders, including the FDA’s public health communication stating “At this time, FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms.” BeMedWise disseminated this information with a social media toolkit to the BeMedWise Supporters and Partners. BeMedWise also developed an informational web page on Hydroxychloroquine.

The NeedyMeds’ Research Department has put together a one-stop COVID-19 Resource Center to help those experiencing financial hardships and struggling with healthcare expenses due to the COVID-19 coronavirus. If your organization or company offers a resource that offers medical assistance, please send that information to COVID-19 Resources so that we can add it to the NeedyMeds COVID-19 Resource Center.

To learn more about our initiatives including opportunities to collaborate on webinars, educational program development and the 35th Annual Talk About Your Medicines Month (TAYMM) in October, contact Deborah.Davidson@needymeds.org. The TAYMM theme for 2020 is Medication Adherence. Read the latest NeedyMeds blogs including: Acetaminophen Facts and Safety Information.

 

CDC PROTECT | Centers for Disease Control and Prevention (CDC)

PROTECT partners, Drs. Dan Budnitz and Preeti N. Malani, recently co-authored a JAMA Patient Page on safe medicine storage. Each year, approximately 50,000 children younger than 6 years are brought to emergency departments after unintentionally taking medicine when a caregiver was not watching. It is always important to be attentive to keeping medicine safely stored away from children, especially as families are currently spending more time at home together due to COVID-19.

The Up and Away campaign also promoted ways to keep children safe around medicine in the home during a March 2020 Poison Prevention Week rally. This year’s strategy centered around: highlighting new research from the Journal of Pediatrics about accidental ingestions; engaging a celebrity voice through a video featuring Miss America 2020, Camille Schrier; and conducting a radio media tour with campaign spokesperson Dr. Kathleen Wilson, a member of the American Association of Nurse Practitioners. Overall, the rally garnered over one million impressions.

 

Consumer Healthcare Products Association (CHPA)

Educational Foundation amplifies medicine safety education during COVID-19

In April, the CHPA Educational Foundation launched a COVID-19 FAQ page on KnowYourOTCs.org to provide answers to some of the most common questions consumers have regarding the pandemic, while also reiterating our safety messages related to safe use, storage, and disposal.

To promote the page, we developed a short, animated video identifying the types of OTC products to have on hand during the pandemic, including fever-reducers and cough medicines. To date, we have seen about 2,500 visits to the page and we continue to update the FAQ with information in real-time.

In addition, with families sheltering in place, schools and daycare centers closed, and parents multi-tasking, the risks of accidental medicine ingestions have increased. Thanks to a generous donation from Johnson & Johnson, we are amplifying education for the Up and Away campaign to promote safe medicine storage nationwide and protect young children. We are currently promoting our highest impact content through a paid media buy, targeting both English and Spanish-speaking families across the nation on Facebook and Instagram. To date, the targeted buy has garnered more than 1 million video completions.

 

Food and Drug Administration (FDA): Center for Drug Evaluation and Research

Janet Woodcock on Twitter

Janet Woodcock, Director, Center for Drug Evaluation and Research, communicated on the Twitter platform in March. She goes by @DrWoodcockFDA on Twitter.

COVID hand sanitizer initiative and kids accidentally drinking hand sanitizer

The agency has issued three guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. These include a policy for compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities, as well as manufacturing firms.

As a result of the agency’s significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer (as of April 27, 2020). The addition of denaturants to alcohol is necessary to render the product more bitter and less appealing to ingest, particularly for young children. This is important to ensure the safety of FDA-regulated products for consumer use. More information about safety concerns can be found here.

Insulin switching to BLA March 23, 2020

Insulin, pancreatic enzymes, and several other protein products had their applications transitioned from new drug applications (NDAs) to biologic license applications (BLAs) on March 23, 2020. These drug products are considered biological products that had to be transitioned to the BLA pathway due to the “Deemed to be a License” provision of the Biologics Price Competition and Innovation Act of 2009. Given the complexity of protein molecules and limitations of current analytical methods, it may be difficult for manufacturers of proposed protein products to demonstrate that the active ingredient in their proposed product is the same as the active ingredient in an already approved product through the ANDA pathway. With the switch to BLAs, sponsors can now seek approval of products that are biosimilar to, or interchangeable with, these transitioned products. More information about the transition and provision can be found here.

Nitrosamines in OTC ranitidine/nizatidine and product removal

Recalls due to the presence of nitrosamines in ranitidine products have been occurring over the last several months. On April 1, 2020, however, the FDA requested for all sponsors to voluntarily remove all ranitidine products from the market. The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. Some nizatidine products have also been recalled, although a market withdrawal has not yet been requested from the FDA. More information about recalls, market withdrawals, and safety alerts can be found here.

Rx-to-OTC Switch

 Thus far in 2020, three products completed Rx-to-OTC Switch:

  1. Voltaren Arthritis Pain (diclofenac sodium), a topical gel
  2. Pataday Twice Daily Relief (olopatadine hydrochloride, 0.1%), and
  3. Pataday Once Daily Relief (olopatadine hydrochloride, 0.2%). Eye drops for temporary relief of itchy eyes due to certain allergens. More information about products that have completed Rx-to-OTC Switch can be found here.

 

FDA Office of Women’s Health (OWH)

On November 26, 2019, the Office of Women’s Health (OWH) announced the selection of Kaveeta Vasisht MD, PharmD, as the Associate Commissioner for Women’s Health. Dr. Vasisht joined OWH in early 2019 and initially served as the Acting Associate Commissioner and Deputy Director. Under her leadership, OWH has worked to advance the health of women through scientific programs, policy development, research and outreach that incorporates an understanding of sex differences.

Dr. Vasisht is board certified in both internal medicine and adult endocrinology and holds a Doctor of Pharmacy degree. She received her training in internal medicine and adult endocrinology, diabetes, and metabolism at The University of Chicago Hospitals. She has also completed a hospital pharmacy practice residency. Dr. Vasisht obtained her medical degree from the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School. Prior to joining OWH, Dr. Vasisht served as the Deputy Director for the Division of Clinical Trial Quality in the Office of Medical Policy, FDA Center for Drug Evaluation and Research (CDER). She began her career at the FDA as a medical reviewer in CDER’s Division of Metabolism and Endocrine Products. She combines her patient care, regulatory review, and policy experience to promote and protect the health of women.

Additionally, this past February, OWH recognized American Heart Month with the launch of a new heart health educational video. This educational video is part of the office’s new KNOWH the Difference campaign, which focuses on sharing important knowledge and news on women’s health (KNOWH). The new video, titled “Getting A Beat On What Women Know About Heart Health” can be viewed here: www.fda.gov/womenshearthealth. Finally, during the month of May we celebrate National Women’s Health Week 2020. Please refer to our webpage for tips to help you manage your health and updated resources like our NWHW digital partner social media toolkit.

 

Healthcare Distribution Alliance (HDA)

Allied Against Opioid Abuse (AAOA) was honored to sponsor the recent Rx Drug Abuse & Heroin Summit (Rx Summit). This annual event (held virtually in 2020) is attended by thousands of leaders in the drug abuse and prevention space. AAOA participated in this year’s virtual exhibition hall to connect with leaders across the country working to prevent the misuse and abuse of prescription opioids in their communities.

Resources focused on safe storage and disposal have been increasingly important as we are all staying home during COVID-19. While this year’s DEA Prescription Drug Take Back Day was canceled, AAOA continues to provide tips for consumers to safely store and dispose of prescription opioids. We encourage you to share our consumer resources with your networks to help educate patients and their families during this challenging time.

AAOA also interviewed Anne Burns of the American Pharmacists Association (APhA) to learn more about how APhA and pharmacists across the country are working with patients to mitigate the prescription opioid epidemic. The Q&A addresses how APhA is keeping pharmacists informed about the opioid epidemic and the important role they play in educating patients and their caregivers on everything from dosage to safe storage and disposal.

To learn more or become a partner, visit our website (www.AgainstOpioidAbuse.org) and follow AAOA on Twitter (@AAOA_Tweets).

 

Johnson & Johnson

At Johnson & Johnson, we’re mobilizing our global reach, deep scientific expertise, and extensive partnerships to address the critical needs of families, communities, healthcare professionals and our employees around the world while working toward mitigating and ultimately ending the COVID-19 pandemic. We are committed to bringing a safe and effective vaccine to the public on a not-for-profit basis for emergency pandemic use. Our vaccine development technology and strong global manufacturing capabilities provide us a unique ability to rapidly develop vaccine candidates and upscale production to ensure we can get it in the hands of those who need it most as quickly as possible. Johnson & Johnson has:

  • Selected a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020
  • Significantly expanded the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA)
  • Signed strategic collaboration agreements to accelerate and rapidly scale the company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.

Additionally, Johnson & Johnson is mobilizing to provide equipment, training, our products, and financial donations to support organizations and health care workers on the front lines. Among other initiatives, the Johnson & Johnson Family of Companies and the Johnson & Johnson Foundation committed $50 million dollars to support and supply frontline health workers – from meals to protective equipment, extra training to mental health support. This commitment expands upon a $250 million multi-year commitment made earlier this year to support those at the frontlines guided by the Johnson & Johnson Center for Health Worker Innovation.

 

National Community Pharmacists Association (NCPA)

NCPA’s top priority has been supporting the nation’s COVID-19 response by working to ensure that the community and long-term care pharmacists on the frontlines in this pandemic have what they need to continue serving their patients. NCPA has advocated successfully for provisions in the Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Paycheck Protection Program and Health Care Enhancement Act that support community and long-term care pharmacists. NCPA has been heavily involved in collaborative efforts with the Administration, Centers for Medicare & Medicaid Services (CMS), and other federal agencies to ensure that regulatory guidance supports pharmacists’ ability to participate fully in COVID-19 response efforts related to testing, compounding hand sanitizer, and providing vaccinations.

NCPA continues to urge CMS to end some of the most harmful pharmacy benefit manager (PBM) activities during the COVID-19 crisis, such as direct and indirect remuneration (DIR) fees. Also, due to the COVID-19 pandemic, oral arguments in Rutledge v. PCMA, the landmark case on whether Arkansas (and by extension other states) can adopt meaningful regulations on relationships between PBMs and pharmacies, have been delayed and will be rescheduled for a later date. NCPA continues to work with the Arkansas Pharmacists Association in monitoring and supporting this case.

 

United States Pharmacopeia (USP)

USP is helping to accelerate the work of scientists and manufacturers developing vaccines and treatments, supporting front line workers impacted by shortages of critical drugs and personal protection equipment and helping to build a more resilient global medicines supply chain. Below are several recent USP announcements and other initiatives related to COVID-19. Please feel free to share these updates, as appropriate, with your constituents and to contact Amy Sonderman (amy@usp.org) for further discussion.

  • Supporting frontline healthcare workers:
    • Developed Operational Considerations for Sterile Compounding, to include assigning beyond-use dates for compounded sterile preparations to mitigate drug shortages, as well as considerations for certification and recertification of primary and secondary engineering control and cleaning and disinfecting a facility.
    • Created a comprehensive toolkit for hand sanitizers to support pharmacies, manufacturers, and others, including distillers, seeking to address hand sanitizer shortages.
    • Responded to shortages of garb and personal protective equipment (PPE) for compounding with conservation strategies. USP also donated 4,000 critical N-95 and surgical masks to practitioners involved in direct patient care.
    • Due to current shortages, USP is accepting comments on a Draft Compounded Preparation Monograph to help facilitate patient access for Hydroxychloroquine Sulfate Compounded Oral Suspension.
  • Helping scientists and manufacturers accelerate the development of COVID-19 treatments, vaccines, and essential medicines with free technical assistance and resources:
    • USP scientific experts are offering free technical assistance to developers of COVID-19 vaccines and treatments, as well as free access to general chapters and monographs to support the public health response to the COVID-19 pandemic. Register today for a free live webcast on May 19 at 11 a.m. ET to learn about USP lessons learned from our public outreach and have your questions answered.
    • USP is working to ensure an uninterrupted supply of reference standards, including enhanced shipping and customer service.
    • USP is offering a 75% discount for education courses on dosage form quality, including specifications, analytical method validation, and pharmaceutical quality practices. Courses are available virtually and on-demand.