In an effort to reduce the epidemic number of overdose-related deaths and injuries associated with the misuse of opioid analgesics, many states have been looking to enact legislation to help curb this trend. One way states have tried to accomplish this is to establish prescribing quantity limits on opioid analgesics. They are also establishing guidelines on how and when opioids should be prescribed to treat acute and chronic pain. As regulatory reform is evolving, it is often mandating the review of Prescription Drug Monitoring Programs (PDMPs) by pharmacists and prescribers prior to prescribing and dispensing opioids. There is also increasing discussion, training, funding and access to medications, most notably naloxone that can prevent death from overdose.
Clinical value and history
To understand the seemingly sudden interest in naloxone for overdose prevention, it is helpful to understand its clinical value and history. The U.S. Food and Drug Administration (FDA) first approved Narcan®, known generically as naloxone, in 1971. Naloxone is an opioid antagonist. The medication works by temporarily reversing the effects of opioid analgesics, specifically the potentially fatal respiratory depression, sedation and low blood pressure associated with overdose. Naloxone does not, however, work to reverse effects of non-opioid medications and may actually increase the effects of non-opioid medications in cases of mixed medication overdose.
While naloxone is not a new medication, it has generally been unavailable as a take-home medication and was reserved for use by EMS or ER medical personnel. This changed in 2014 when Evzio® became the first FDA-approved naloxone auto-injector available in the U.S. market for use by a patient (claimant), family members or caregivers in situations of opioid analgesic overdose. The injector device is small and portable, with an unseen retractable needle that injects naloxone when pressed against the skin. Visual and voice instructions for use are provided with the device, as is a trainer device.
Another product formulated as a naloxone nasal spray, Narcan Nasal Spray, entered the market in 2016. Similar to Evzio, Narcan Nasal Spray is a single dose, ready-to-use unit that does not require any preparation for administration. The medication is unique in that it is the only naloxone medication currently FDA-approved that is not administered by injection, rather it is sprayed into the nose.
While both products make it easier to administer naloxone, there are a couple key differences between the two. Narcan Nasal Spray requires the patient to be lying on their back for proper nasal administration whereas Evzio may be given with the patient in any position. The recommended injection site is to the thigh. Evzio also has a significantly higher Average Wholesale Price (AWP) than Narcan Nasal Spray and other available naloxone injectables.
Rising use and the future of naloxone in workers’ compensation
We are seeing an increase in naloxone prescriptions across our book of business, with a notable increase this year. Anesthesiologists, physical medicine and rehabilitation (PMR) physicians, physician assistants, nurse practitioners and pain management specialists are writing the majority of naloxone prescriptions, which is consistent with prescribing patterns for opioid analgesics. The increase in prescribing may be attributed to several factors, such as regulatory and legislative reform facilitating greater access to naloxone medications and the elevated awareness and better understanding of how opioid analgesics can affect the major body systems (PDF). Regardless of cause, we anticipate the trend of rising naloxone prescribing in workers’ compensation to continue. Opioid analgesics remain the most frequently prescribed category of medication used to treat pain in workers’ compensation. Statistics also show there are far too many situations of death from misuse and abuse of opioids in our country and that naloxone may be a needed medication for the patient with identified risk factors. Thus, as we continue to work together to make sure claimants receive safe, efficacious and cost-effective care, payers are encouraged to keep in mind(PDF):
- The use of opioid analgesics should be carefully considered, especially if the claimant is at an increased risk for overdose.
- Alternative medication therapy, such as antidepressants, anticonvulsants or non-steroidal anti-inflammatories (NSAIDs) and/or nonpharmacologic treatment might be a safer, more efficacious plan of care than opioid analgesic therapy.
- It is often easier to manage a claimant’s use of opioid analgesics when there is a goal-oriented plan of care in place.
- Monitoring and managing adherence to the therapy regiment using tools such as medication agreements, pill counts, urine drug testing and ongoing communication with the claimant and their prescriber help ensure a claimant’s medication regimen is safe and effective.
- Clinical case management, a medication review, peer-to-peer review or another type of intervention might be warranted for claimants on a chronic opioid analgesic treatment regimen.
For more information on prescribing naloxone, your pharmacy benefit manager and/or managed care provider may also be a valuable resource. Click here to download the complete paper.
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