Mainstreaming Naloxone

Drug News from Preferred Medical …

Naloxone medications (the generic naloxone or brand names Narcan and Evzio) are opioid antagonists that block the effects of an opioid in the brain, effectively reversing an overdose from a prescription or illegal opioid. First responders around the country use these drugs on a daily basis (130 people every day on average die from an opioid overdose) but teachers, librarians and children have also been trained in its use. The drug has literally saved thousands of lives each year, even more important as opioid-related mortality increases due to COVID-19 and the corresponding “deaths of despair.”

Keep in mind, however, that administration of naloxone is only the first step to recovery. The CDC documented “About 1 in 20 patients treated for a nonfatal opioid overdose in an emergency department (ED) died within 1 year of their visit, many within 2 days … Two-thirds of these deaths were directly attributed to subsequent opioid-related overdoses.”

With lives at stake, the FDA recently increased the opportunity for patient awareness of the potential danger from opioids. A new requirement was announced on July 23 that “drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.” This last sentence is important because it means the patient will see it on the medication counseling guide that the pharmacy provides when a prescription is filled.

The FDA outlined recommendations for both patients and healthcare professionals. If taken seriously by both stakeholders, this should facilitate a better-informed decision whether naloxone should be co-prescribed.

Interestingly, the FDA release does not mention any specific drug(s) but just “opioid pain relievers” and “medicines to treat opioid use disorder (OUD).” That means this new requirement applies to every opioid. Surprisingly, it also includes medications for treatment of OUD (typically buprenorphine, naltrexone or methadone). This treatment typically includes a weaning process to lower opioid use that should result in less chance of overdose. However, adding this messaging for prescribers and patients may create a platform for an honest discussion about the reasons for the weaning process.

The CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain stated “clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.” Interestingly this new FDA requirement mentions no MME threshold, which means all dosages will be subject to this messaging.

While this new requirement could increase overall costs with naloxone prescribed in conjunction with opioid and OUD medications, overall opioid prescriptions could decline as both stakeholders understand more clearly the overdose possibilities. However, with no expected timeline for compliance or apparent penalties for non-compliance, there will likely be no immediate impact.