Preface: this article marks the onset of a new Pharmacist Consult series that highlights a handful of news releases on a monthly cadence that are relevant to the world of pharmacy and public health.
With ongoing news cycles contrastingly seeming both cyclic and endless, it is easy to potentially lose track of what events happen over time. This recap discusses a few of the key news releases that were announced during the month of November 2020 that affected the world of pharmacy and public health.
The ongoing COVID-19 pandemic is crowding out many other relevant news stories across all industries, and this sentiment also rings true for the healthcare professions. Although there were many exciting announcements about new therapeutics and advancements unrelated to COVID-19, this discussion has a heavy emphasis on pandemic-related content.
Pfizer and Moderna Both Apply for COVID-19 Vaccine Emergency Use Authorization (EUA)
On November 20, Pfizer and BioNTech submitted an application to the United States Food & Drug Administration (FDA) to approve an emergency use authorization (EUA) for their COVID-19 vaccine candidate following news that the vaccine is greater than 95% effective. At the time of this article publication, the FDA is still performing a review of this EUA application.
On November 30, Moderna followed suit and submitted an EUA application to the FDA for their own COVID-19 vaccine candidate following news that the vaccine is around 94% effective. At the time of this article publication, the FDA is still performing a review of this EUA application.
Related links:
- What is an EUA?
- What is the process of issuing an EUA?
- Understanding mRNA COVID-19 Vaccines
- How HHS Plans Vaccines Will Be Distributed
Three Different COVID-19 Medicines Issued EUAs by the FDA
Throughout the month of November 2020, the FDA issued EUAs for three different medicinal therapies to help treat patients with COVID-19. These three therapies are bamlanivimab, baricitinib/remdesivir, and casirivimab/imdevimab.
Back in early October 2020, it was widely publicized that US President Donald Trump received an ‘experimental antibody treatment’ from the manufacturer Regeneron. That treatment from Regeneron specifically was a combination of casirivimab and imdevimab, and it officially was issued an EUA from the FDA on November 21. Bamlanivimab, a product of Eli Lilly, was also issued an EUA on November 9.
Both bamlanivimab and casirivimab/imdevimab are indicated for the treatment of mild-to-moderate COVID-19 cases in adults and pediatric patients 12 years of age and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing and who are at high-risk for progressing to severe COVID-19 and/or hospitalization.
Baricitinib is a medication that is already on the market and it is approved for the treatment of rheumatoid arthritis. However, on November 19, the FDA issued an EUA for baricitinib when given in combination with remdesivir (Veklury) for patients with COVID-19 (hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation). This EUA was issued as trial data showed evidence that baricitinib has efficacy in the setting of COVID-19 when used in combination with remdesivir.
Related links:
- FDA Approves First Treatment for COVID-19 – Remdesivir (Veklury)
- FAQs About EUA of Bamlanivimab
- FAQs About EUA of Baricitinib + Remdesivir
- FAQs About EUA of Casirivimab + Imdevimab
Wearing a Mask Can Help You and Others
In the early days of the pandemic, the Centers for Disease Control and Prevention (CDC) and the White House COVID-19 Task Force emphasized that wearing a mask is an important precaution to help protect others from the spread of COVID-19.
However, there is increasing evidence that wearing a mask can help protect the mask wearer in addition to others. Although this does not alter universal recommendations to wear a mask while around others when possible, it helps to compile additional proof that wearing a mask is one important precaution to take for all members of society.
Related links:
- CDC Considerations for Wearing Masks
- Face Masks: Benefits and Risks
- The Lancet Respiratory Medicine – Use of Face Masks During the COVID-19 Pandemic
New CVS Health CEO Highest Ranking Female CEO in the Fortune 500
On November 6, US healthcare giant CVS Health announced that Karen Lynch will take over from Larry Merlo as the CEO of CVS Health on February 1, 2021. CVS Health is considered to be one of the world’s biggest healthcare providers and is currently 5th on the Fortune 500 list behind Walmart, Amazon, Exxon Mobile, and Apple.
Karen Lynch currently serves as an Executive Vice President of CVS Health and President of Aetna. This transition will not only be a big step forward for CVS Health, but it will be an empowering step forward for female leadership in the world of healthcare and business.
Related links:
Global Hydroxychloroquine Shortages
Hydroxychloroquine is a medication that is a maintenance therapy for many patients that have autoimmune diseases (most notably rheumatoid arthritis and lupus). It can also be used to help treat or prevent malaria. However, a worldwide shortage of hydroxychloroquine has negatively affected patients with these types of conditions.
For hydroxychloroquine to be effective, it needs to be taken consistently on a daily or weekly basis, depending on the patient. When the medication started to become unavailable due to high off-label prescribing trends for COVID-19 based on preliminary data, patients being treated for autoimmune conditions or malaria became negatively impacted by this shortage.
In the early stages of the COVID-19 pandemic, there was an initial belief that hydroxychloroquine and/or chloroquine may be effective for the prevention and treatment of COVID-19. However, this has since been debunked as there is lacking evidence to support their usages in the setting of COVID-19.
Related links:
$26 Billion Opioid Litigation Settlement
On November 5, it was reported that drug manufacturer Johnson & Johnson and wholesalers (drug distributors) McKesson, Cardinal Health and AmerisourceBergen came to a $26 billion settlement with cities and counties that sued them for damages related to the ongoing opioid epidemic.
Although there are a few logistical steps that still need to be worked out regarding this settlement, this settlement is one part of the largest federal court case in American history.
Related links:
- Johnson & Johnson Pharmaceutical Products
- Overview of the US Opioid Epidemic
- Understanding the US Opioid Epidemic
- Purdue Pharma $8B Opioid Settlement
The above links in this discussion are a sampling of some of the most relevant pharmacy news that stemmed from the month of November 2020. In early January 2021, Pharmacist Consult will deliver a recap of relevant news that stemmed from the month of December 2020.
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