FDA Approves New Opioid: RoxyBond

The FDA has approved RoxyBond® (oxycodone hydrochloride) tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The following language is extracted from the RoxyBond product label:*

RoxyBond will be available in 5mg, 15mg and 30mg tablets, with a dosing range of every 4-6 hours as needed for pain.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, RoxyBond should be reserved patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):

  • Have not been tolerated or are not expected to be tolerated
  • Have not provided adequate analgesia or are not expected to provide adequate analgesia

*Information presented is from the product label and does not necessarily reflect Healthesystems’ recommendations for opioid prescribing.

For further information, read the FDA label or approval letter.


Tags: Opioid, Opioids, Product Approvals, FDA


Not-So Science Fiction: Innovative Technologies in Workers’ Comp

As medical technology continues to evolve, fascinating new opportunities emerge which can potentially benefit the injured worker. Technologies such as brain-computer interface, 3D printing, exoskeletons, and virtual reality represent significant advancements that can improve patients’ function and quality of life. But with new technology comes new considerations for determining appropriate utilization in patient care.

BRAIN-COMPUTER INTERFACE

Brain-computer interface (BCI) involves capturing electric activity in the brain (primarily through an electrode cap or an electrode implant in the brain) and sending it to a computer system that translates that activity into a command, which is sent to an external device.

Potential Applications in Workers’ Comp

Restored communication

BCI allowed patients suffering complete motor paralysis to answer yes-or- no questions by thinking their answer and having it displayed on a computer screen, partially restoring their ability to communicate.1

Enhanced mobility

BCI allowed a paraplegic subject to pilot an exoskeleton by simply thinking about walking.2 BCI was also used to bypass a paralyzed patient’s spinal cord, sending electric signals from his brain to a special sleeve of electrodes on his arm, allowing him to move his hands with a fair degree of accuracy.3

Continue reading the complete article at RxInformer clinical journal.


Tags: RxInformer, Virtual Reality, Brain-computer interface, exoskeletons, exoskeleton, 3D printing, innovation


Utah Bill May Allow Insurers to Enforce Opioid Prescribing Policies

Utah House Bill 90, Insurance Opioid Regulation, authorizes workers' compensation insurers (along with commercial insurers, the state Medicaid program, and public employee insurers) to develop, implement and enforce an opioid prescribing policy tied to evidence-based guidelines.

Such guidelines must minimize the risks of opioid addiction and overdose, and may include the 2016 Center for Disease Control Guidelines for Prescribing Opioids for Chronic Pain, or the Utah Clinical Guidelines on Prescribing Opioids for the treatment of pain.

The bill specifically requires that such prescribing policies must target:

  • Chronic co-prescriptions of opioids with benzodiazepines and other sedating substances
  • Prescription of very high dose opioids in the primary care setting
  • The inadvertent transition of short–term opioids for an acute injury into long-term opioid dependence

Furthermore, the bill requires insurers to facilitate non-narcotic treatment alternatives for patients with chronic pain, as well as medication-assisted treatment for patients with opioid dependence disorders.

This bill went into effect May 9th, and Utah insurers must submit a written report to the Utah Insurance Department by September 1st, regarding whether they have adopted a policy, and a general description of the policy.

For further information, read Utah House Bill 90 in full.


Tags: Utah, evidence-based medicine, CDC, opioid guidelines, legislation


Are Opioid-Related Deaths Underreported?

The Centers for Disease Control and Prevention (CDC) released Deaths Associated with Opioid Use and Possible Infectious Disease Etiologies Among Persons in the Unexplained Death (UNEX) Surveillance System – Minnesota, 2006–2015, a study which screened the toxicological reports of unidentified deaths in Minnesota for opioid toxicity.

3.5% of deaths in Minnesota’s Unexplained Death (UNEX) surveillance system had evidence of opioid use. Of those deaths, 54% involved pneumonia and opioids, where it is possible that respiratory depression, an adverse event of opioids, could have exacerbated the respiratory effects of pneumonia, leading to death.

This has led many to speculate that opioids may be a contributing factor in more deaths than previously thought, as cause of death may be attributed to an infection or other condition that was worsened by opioids. Considering that this study covers only the state of Minnesota, and only their UNEX system at that, there is the possibility that opioid–related deaths could be underreported on a national scale.

For further information, read the CDC’s report..


Tags: Opioid, Opioids, CDC, Opioid-related deaths, respiratory depression


WorkCompWire Interviews Daryl Corr

At this year’s RIMS conference, WorkCompWire conducted a series of interviews with executives from the workers’ comp industry, including Healthesystems’ President and CEO, Daryl Corr. The full article is available online at WorkCompWire.

What do you believe will be the most significant development in the workers’ comp industry for this year?

I’m going to address this from the area of the market we know best, which is pharmacy and ancillary services management, although it also has a significant impact on the industry overall – and that’s the magnitude of states moving forward with very significant, work–comp specific initiatives intended to correct systemic problems, primarily one of the largest cost drivers, which is pharmacy.

We’ve seen an outpouring of regulatory activity throughout 2016 and into this year to address overall drug management, much of which has been focused on opioids. On a high level, there has been a volume of state–specific formulary activity, notably the California DWC, which is geared up to implement a formulary this summer that will impact the care of hundreds of thousands of injured workers.

Then there are other complementary initiatives we’ll continue to see a lot of – initial opioid prescribing limits, legislation mandating PDMP checks by prescribers, and new rules in states including Ohio and Vermont that only allow opioids to be reimbursed in the workers’ comp setting if they follow treatment guidelines. Many of these initiatives should help facilitate positive change.

Read the full article at WorkCompWire.


Tags: Daryl Corr, WorkCompWire