FDA Approves Veklury for COVID-19, Issues EUA for Bamlanivimab

In late October, the FDA approved the antiviral drug Veklury (remdesivir) for IV use as the first official treatment of COVID-19 requiring hospitalization.

This drug has been approved to treat patients 12 years of age and older, weighing at least 40 kilograms (88 pounds) and should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care.

This approval does not authorize use across other populations covered in a previous Emergency Use Authorization (EUA) issued back in May.

The approved drug label includes dosing recommendations for patients on and off ventilators, and Veklury is not recommended for patients with renal impairment. The FDA notes that all patients, prior to receiving Veklury and during such treatment, should receive renal and hepatic laboratory testing, as Veklury may increase levels of liver enzymes.

Potential side effects include liver injury and allergic reactions, which can consist of changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, or shivering.

Veklury should not be taken with chloroquine phosphate or hydroxychloroquine sulfate, as such combined use can reduce antiviral activity.

Later in November, the FDA issued an emergency use authorization (EUA) to bamlanivimab for the treatment of mild-to-moderate COVID-19.

Bamlanivimab is an investigational monoclonal antibody; monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

An EUA is not an FDA approval; an EUA is a declaration that circumstances exist to justify the emergency use of drugs and biological products that have not been FDA-approved, particularly when no other effective alternatives are available, assuming the benefits appear to outweigh the risks.

Bamlanivimab is authorized for COVID-19 patients who are 12 years of age and older, weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. Bamlanivimab is administered intravenously as a single dose by a health care provider.

While the safety and effectiveness of bamlanivimab continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Tags: FDA, COVID-19, drug approval, approval, Veklury, remdesivir, bamlanivimab, EUA, emergency use authorization

Legalization and Decriminalization: Marijuana and More

During the Presidential election, several states featured measures on the ballot regarding the legalization of marijuana, as well as the decriminalization of other Schedule I drugs.

Several of these measures passed, indicating that the nation’s views on certain drugs continues to evolve. We have seen this change in social acceptance trickle down into healthcare, including workers’ comp.

Voters in four states passed measures to legalize recreational marijuana, bringing the total number of states with legalized recreational marijuana to 15. Meanwhile, two states legalized medical marijuana, bringing the total states with legalized medical marijuana to 41.

Arizona Proposition 207 passed, legalizing limited marijuana possession, use, and cultivation by adults aged 21 or older. Criminal penalties for possession are set to be amended, while also allowing for the expungement of marijuana offenses. Smoking marijuana in public is banned and a 16% excise tax on marijuana sales will be in effect.

Mississippi Initiative Measure 65 passed, legalizing medical marijuana for qualified patients with debilitating conditions, as certified by Mississippi licensed physicians. The list names 22 qualifying conditions, including cancer, epilepsy, seizures, multiple sclerosis, and ALS. According to the ballot, over 228,000 Mississippi residents signed petitions to put this initiative on the ballot.

Montana passed Initiative No. 190, legalizing the possession and use of limited amounts of recreational marijuana for adults over the age of 21. The initiative requires the Department of Revenue to license the regulation, cultivation, transportation, and sale of marijuana and marijuana-infused products. A 20% tax on non-medical marijuana will be put in place, and individuals serving marijuana-related sentences can apply for resentencing or expungement.

New Jersey Public Question No. 1 passed, amending the state Constitution to legalize recreational marijuana for adults aged 21 and older. The State commission created to oversee the State’s medical cannabis program would also oversee the new, personal use cannabis market. Cannabis products would be subject to the State sales tax, and if authorized by the Legislature, a municipality may pass a local ordinance to charge a local tax on cannabis products.

South Dakota Constitutional Amendment A passed as well, legalizing the possession, use, transport, and distribution of recreational marijuana and marijuana paraphernalia by people aged 21 and older. Individuals may possess or distribute one ounce or less of marijuana. Marijuana plants and marijuana produced from those plants may be possessed under certain conditions.

Furthermore, the State Department of Revenue will control licenses for commercial cultivators, manufacturers, testing facilities, and more. A 15% sales tax on marijuana sales will be imposed.

It is no secret that support for medical marijuana is at an all-time high, and as the drug occasionally finds its way into workers’ comp for the treatment of chronic pain, seizures, and other conditions, the clinical impacts of continuing legalization are important to track. Another consideration: as recreational marijuana use continues to grow common with legalization, injured workers in certain states may be utilizing marijuana outside of their work-related injury, which could impact drug therapy and claims management.

But marijuana isn’t alone in this conversation. Oregon passed Measure 110, which, among other initiatives created to tackle rampant drug addiction in the area, removes drug penalties for a sweeping number of scenarios, reducing them to Class A misdemeanors instead of felonies. The ballot reduces the following possession scenarios to Class A misdemeanors:

  • Peyote, if in connection with good faith practice of a religious belief, or in a manner not dangerous to the health of the user or others in proximity of the user
  • LSD if possession is limited to less than forty units
  • Psilocybin if possession is under 12 grams
  • Methadone if possession is limited to under 40 units
  • Oxycodone if possession is limited to under 40 units
  • Heroin if possession is limited to under a gram
  • MDMA if possession is limited to under one gram or less than five units
  • Cocaine is possession is limited to under two grams
  • Methamphetamine if possession is limited to under two grams

This measure was intended to help direct individuals with substance abuse disorders to treatment, reserving more serious criminal penalties to those who sell narcotics. While these actions are certainly sweeping, there is more to be said about psilocybin and MDMA.

Oregon also passed Measure 109, giving certain patients legal access to psilocybin, the active ingredient in “magic” mushrooms for mental health treatment in supervised settings, with a complex framework of how this is to be managed.

In related news, Washington D.C. passed Initiative Measure 81 to decriminalize psychedelic plants, which covered substances such as psilocybin, mescaline, peyote, and more.

These measures are particularly noteworthy, as clinical research surrounding psilocybin has shown promise for the treatment of major depressive disorder and post-traumatic stress disorder (PTSD). Phase 3 clinical trials are currently under way for certain psychiatric disorders, and the John Hopkins University launched the Center for Psychedelic and Consciousness Research in September of 2019.

In the next several years, psilocybin, or some derivative of psilocybin, could potentially see an FDA approval, meaning healthcare, and workers’ comp, would have to learn more about the drug.

And a similar thing could be said for MDMA (methylenedioxymethamphetamine), also known as the street drug “ecstasy” or “molly.” Clinical research supports the potential use of MDMA-assisted therapy for the treatment of PTSD, so much so that in 2017, the FDA granted Breakthrough Therapy designation to MDAM-assisted psychotherapy for PTSD, agreeing to special protocol assessment for Phase 3 clinical trials. At the moment, approximately 20 clinical trials are underway involving MDMA.

Tags: Marijuana, legalization, recreation, medical, psilocybin, MDMA, decriminalization, clinical research, Montana, Oregon, Mississippi, South Dakota, Washington D.C., Arizona, New Jersey

COVID-19 Infection Risks and Mental Health Impact Among Grocery Workers

Throughout the COVID-19 pandemic, essential workers have remained in physical workspaces to keep necessary services operational, putting themselves at risk of viral exposure in the process.

Much of the scientific research and literature on these workers has been geared towards healthcare workers and first responders, as their line of work brings them more directly in contact with infected individuals. However, a new study from Occupational and Environmental Medicine investigates the COVID-19 infection rate, transmission, and exposure risks among grocery retail employee, as well as their use of PPE, social distancing, and their perception of COVID-19’s impact on their mental health.

This cross-sectional study was conducted in May 2020 in a single grocery retail store across 104 workers in Boston, Massachusetts. Paper-based questionnaires were used to collect basic demographic information, COVID-19-related exposure information, and PPE usage information. Two validated mental health screening tools – the General Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9) – were used to measure for anxiety and depression, and COVID-19 tests were also conducted.

Approximately 20% of retail grocery store workers (21 workers) tested positive for COVID-19, a rate of transmission significantly higher than surrounding communities. Among infected workers, 67% of cases were asymptomatic, and 91% of positive cases held positions with significant direct customer exposure. Employees with direct customer exposure were five times more likely to test positive for COVID-19.

In regard to mental health, 24% of workers had at least mild anxiety, and employees able to practice social distancing in the workplace had a significantly lower risk of anxiety or depression. Researchers found this surprising, as it was hypothesized that increased PPE use would improve mental health concerns, but the data found this had little impact on mood.

Furthermore, confirmed COVID-19 exposure in the past 14 days and commuting to work via public transportation or shared rides was strongly associated with depressive mood.

Tags: COVID-19, infection, retail, grocery, mental health, anxiety, depression

California Voters Keep Rideshare Drivers as Independent Contractors

Over the past few years, there has been much debate over whether certain roles within the gig economy qualify as employment or independent contracting. This determination is of serious importance, as independent contractors are not entitled to benefits such as workers’ comp, disability, unemployment, and more.

In California, a combination of action from state Supreme Court and the state legislature created the ABC Rule, a series of criteria that must be met to qualify work as independent contracting, which essentially categorized a vast amount of gig work as employment. This meant that a large portion of the workforce would be entitled to various employee benefits.

Specific to rideshare services, Uber and Lyft drivers were scheduled to become categorized as employees, but during the election, California voters passed Proposition 22, which creates an exemption for app-based transportation and delivery companies from providing employee benefits to certain drivers.

According to the proposition’s language, “Yes” votes supported drivers’ wish to remain contractors so they could remain free to work when, where, and as often as they liked, at the cost of standard benefits and protections, saving hundreds of thousands of jobs. Meanwhile opposition language claims that “No” votes would prevent billion-dollar app companies from creating exemptions to California law which they could profit from by denying drivers benefits.

Regardless of political viewpoints on the subject, the passage of this measure means that an expected rehauling of employment status, and the corresponding benefits requirement, will not take place for a large portion of the workforce. However, other states have followed California’s lead on the ABC rule, and at this time it is unknown if other states will create similar exceptions for rideshare drivers, or go through with significant changes.

Tags: California, rideshare, Uber, Lyft, independent contractors, ABC test, election, ballot

Healthesystems at NWCDC 2020

In light of the COVID-19 pandemic, the National Workers’ Compensation and Disability Conference (NWCDC) – the largest annual conference in the workers’ comp industry – will continue to offer digital content throughout the year.

While we may not be able to enjoy seeing industry colleagues in person, the digital nature of this year’s sessions gives everyone the opportunity to tune in from the comfort of their homes, as well as enjoy new content each month.

Among the presentations, Healthesystems’ VP of Clinical Services, Silvia Sacalis, BS, PharmD, will cohost Empathy & Engagement: The Process of Putting Patients First in Workers’ Comp on Wednesday, December 9th, at 2:00 PM EST.

Dr. Sacalis, along with Adam L. Seidner, MD, MPH and Chief Medical Officer of The Hartford, will explore workers’ comp patients’ sometimes negative experiences within the workers’ comp system, and how empathetic, patient-centered care can improve the journey to recovery and deliver superior outcomes.

Session attendees will be presented with real-world examples of how empathy and engagement can be incorporated into the overall design of medical/pharmacy management programs.

Click here to register.

Tags: Healthesystems, Silvia Sacalis, NWCDC, empathy, engagement, conference, presentation