FDA Approves Kloxxado for Opioid Overdose

The FDA approved Kloxxado (naloxone hydrochloride) nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

This approval is unique, in that the product comes in an 8 mg dose, while previous naloxone nasal sprays were only approved in 2 mg and 4 mg doses.

According to the drug label, like all naloxone products, Kloxxado is not a substitute for emergency medical care. If a patient is given Kloxxado for an opioid overdose, that patient still requires medical care, as the opioids in that patient’s system may reactivate overdose once the naloxone has run its course. Furthermore, as naloxone negates the effects of opioids, patients who are physically dependent on opioids may enter withdrawal.

Tags: FDA, naloxone, Kloxxado, opioid, overdose

RxInformer Summer 2021 Edition Now Available

RxInformer is a trusted source for information on trending and influential topics in workers’ comp, with in-depth articles and infographics authored by a team of expert clinicians, policy experts, and industry thought leaders.

The Summer 2021 edition of RxInformer covers diverse topics such as:

  • The future of telemedicine and practical tips to make it effective in workers’ comp
  • Mental health concerns among remote workers who may experience extensive isolation
  • Embracing the patient as a mitigator of claims complexity
  • The increasing use of Voltaren gel for pain management
  • And more

Read these stories online now at RxInformer.

Tags: RxInformer, Healthesystems, Summer 2021

FDA Revokes Emergency Use Authorization for Bamlanivimab for COVID-19

The FDA has revoked the emergency use authorization (EUA) that allowed for bamlanivimab – an investigational monoclonal antibody – for the treatment of mild-to-moderate COVID-19.

This change reflects the use of bamlanivimab when administered alone. Bamlanivimab is still authorized for use when combined with other monoclonal antibodies, such as etesevimab.

In November of 2020, the FDA granted bamlanivimab an EUA because clinical evidence at the time found that bamlanivimab alone could benefit patients with mild-to-moderate COVID-19. However, based on ongoing analysis of emerging scientific data, there has been a sustained increase of COVID-19 viral mutations that are resistant to bamlanivimab when administered alone.

At this time, there are currently no testing technologies available that enable healthcare providers to test individual patients for COVID-19 viral variants prior to the start of treatment with monoclonal antibodies. Monoclonal antibody treatment should utilize drugs that are more broadly expected to work across all viral variants, and for these reasons the EUA for bamlanivimab has been revoked.

Tags: COVID-19, bamlanivimab, mutation, viral variant, EUA, emergency use authorization, revoked

Department of Labor Hints at Changes to Worker Classification

News from the Department of Labor (DOL) could potentially lead to updated regulations surrounding worker classification.

Most recently, Secretary of Labor Marty Walsh stated that many gig workers should be classified as employees who are entitled to benefits, and the Secretary’s work at the DOL is expected to have an impact on U.S. workplace laws and regulations. It is quite feasible that the DOL could take action on employee classification, as the current administration has been revisiting the subject much lately.

The DOL notably rescinded a rule adopted in January by the previous administration that made it easier to classify workers as independent contractors, and in March they sent a new proposal regarding independent contractor status to the White House, though the proposal was not made public

Over the past several years, there has been much debate over whether certain roles within the gig economy qualify as employment or independent contracting. This determination has implications within the property & casualty sector, including workers’ comp, as independent contractors are not entitled to benefits such as workers’ comp, disability, unemployment, and more, while employees are.

It is likely that the federal government is taking greater interest in the worker classification debate as more and more states pass their own legislation and rulings regarding worker classification. According to the National Council on Compensation Insurance (NCCI), 13 states are currently considering worker classification legislation.

West Virginia Senate Bill 272 was signed into law in March, establishing their own criteria to differentiate employees and independent contractors, and many have criticized this law, claiming it allows for the reclassification of employees as contractors who should be entitled to benefits.

And on the west coast, California’s ongoing saga regarding the gig economy has taken many turns. The state Supreme Court originally created the “ABC” test to determine criteria that would differentiate independent contractors from employees, and the criteria proved popular enough for other states to embrace it. The ABC test was later put into legislation that was enacted, but special interest groups then lobbied for a ballot initiative that created an exemption for rideshare drivers, which passed into law.

Though the DOL’s exact plans remain unknown, as more and more states embrace varying legislation, federal regulation could come soon and impact worker classification nationwide.

Tags: Department of Labor, DOL, worker classification, gig economy, employee, independent contractor

Healthe Leaders in the Media

Healthesystems’ executive leaders regularly lend their expertise to various industry publications, offering their insight into issues and trends impacting workers’ comp.

Business Insurance recently published an article on the shift away from opioids to alternative pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and dermatological agents. While this shift is a great step forward, there are some unintended consequences as more expensive medications are being prescribed when cost-effective alternatives are available.

When reaching out to clinical experts for their insights, Business Insurance spoke with Healthe’s VP of Clinical Services, Silvia Sacalis, BS, PharmD, who commented upon the use of private-label topicals, which are not FDA-approved due to a lack of clinical studies that demonstrate safety or efficacy.

Dr. Sacalis notes that not only are these drugs ineffective, they are often dispensed directly by physicians, bypassing typical pharmacy safeguards that can flag drug and disease interactions.

In other news, the International Association of Industrial Accident Boards and Commissions (IAIABC) released the latest edition of their “Accidentally” monthly podcast – which shares insights, ideas, and information on workers’ comp issues – featuring Sandy Shtab, Healthe’s AVP of Advocacy & Compliance.

The episode, Social Media and the Workplace, features a discussion between host Jennifer Wolf, Executive Director of IAIABC and Sandy Shtab, covering the pros and cons of social media across workers’ comp. The discussion addresses:

  • Opportunities for spreading thought leadership
  • The ability to highlight and explore trends
  • Lingering resistance against social media among senior leaders
  • Using social media to increase connectivity among industry colleagues
  • The different strengths and weaknesses across social media channels
  • Being thoughtful of the content posted on social media

Tags: Healthesystems, Healthe, Business Insurance, opioid alternatives, topicals, private-label topicals, PLTs, Sandy Shtab, IAIABC, social media