FDA Approves New Acetaminophen Injection Dose
The FDA recently approved a new acetaminophen injection for the management of mild to moderate pain, and for the management of severe pain with adjunctive opioid analgesics.
While oral acetaminophen has been available for decades, intravenous (IV) formulations are relatively new and have previously only been available in 1000mg doses. This new approval includes a 1000mg and 500mg dose.
According to the drug label, this injection may be given as a single or repeated dose, but only as a 15-minute IV infusion. Like any form of acetaminophen, long-term use of this drug can cause liver toxicity. Patients already at risk of liver disease should not receive acetaminophen.
Tags: FDA, approval, acetaminophen, injection
2021 Workers’ Comp Industry Insights Survey Report
In the fall of 2020, Healthesystems conducted its third annual Workers’ Compensation Industry Insights Survey in collaboration with Risk & Insurance® magazine. We approached it with the same goal as the past two years – to better understand current trends, challenges, innovations, and outstanding needs regarding workers’ compensation medical care.
But as COVID-19 undeniably disrupted business as usual for all of us, we devoted portions of this year’s survey to gathering feedback specifically about the pandemic’s impact on our industry.
A total of 602 industry stakeholders from across the workers’ comp industry responded to this survey. These stakeholders shared their opinions on:
The 2021 Workers’ Comp Industry Insights Survey Report provides a broader and deeper view of what industry stakeholders are thinking, including detailed survey results and charts, insightful key findings, comparative perspectives by job roles and organization type, and more.
Healthe Clients can directly receive a copy of this report from their Account Manager.
Tags: Healthesystems, industry survey, report, survey report, Risk & Insurance
New York and New Hampshire Rule in Favor of Marijuana Reimbursement
Within the last few weeks, two State Supreme Courts have ruled that payers must reimburse medical marijuana within workers’ comp claims when medically necessary.
In response to an Appeal from Andrew Panaggio, a former police officer injured on the job in 1991 and deemed permanently injured, the New Hampshire Supreme Court ruled that his workers’ comp insurer must reimburse him for medical marijuana payments after he was accepted into the state’s therapeutic cannabis program.
And in the case of Quigley v. Village of East Aurora, the New York Supreme Court ruled that a police officer, classified as partially disabled after two work-related incidents, should be reimbursed for provider-prescribed marijuana meant to treat his pain and decrease his opioid use. His requests for reimbursement were turned down initially, until the case made its way to the Supreme Court.
Currently, five other states – Connecticut, Maine, Minnesota, New Jersey, and New Mexico – have ruled that medical marijuana is reimbursable in workers’ comp, while three states – Florida, North Dakota, and Michigan – explicitly exempt medical marijuana from workers’ comp reimbursement.
Marijuana continues to make regulatory wins, especially as the Virginia legislature passed a law to legalize recreational marijuana within the state. It is likely that marijuana regulation, in all forms, will continue to see permissible laws and rulings pass as time goes on, especially after a recent study from the National Bureau of Economics Research (NBER).
The study found that in adults aged 40-62, workers’ comp claim frequency declined in response to recreational marijuana laws, as did benefits paid. According to the research data, both claim frequency and benefits paid decreased by 20% from 2010 to 2018. Study authors claim that lower rates in non-traumatic workplace injury and work-limiting disabilities were due in part to these recreational marijuana laws, indicating that injured workers were self-medicating with marijuana.
The primary driver of these reductions is an improvement in work capacity, attributed to access to an additional form of pain management – marijuana. Findings such as these could sway public policy in favor of marijuana use across workers’ comp.
Tags: marijuana, reimbursement, New York, New Hampshire, Virginia, NBER
FDA Issues EUA for Third COVID-19 Vaccine
The FDA issued an emergency use authorization (EUA) for a third COVID-19 vaccine at the end of February, this one a single-dose vaccine manufactured by Janssen.
Similar to the vaccines currently in use from Moderna and Johnson & Johnson, an EUA is not the same as 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.
In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. who did not have evidence of SARS-CoV-2 infection prior to receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received saline placebo.
Overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. The vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.
The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.
Tags: COVID-19, vaccine, Janssen, EUA