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Department of Health Professions
 
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Board of Medicine
 
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Regulations Governing Prescribing of Opioids and Buprenorphine [18 VAC 85 ‑ 21]
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9/19/22  2:24 pm
Commenter: Victor McKenzie Jr

Updating the term "Naloxone"
 

SAARA of VA’s mission is to transform Virginia communities through hope, education, and advocacy for addiction prevention, treatment, and recovery.  SAARA is the leading voice in Virginia on substance use disorder and recovery. We provide individuals and communities with education, advocacy, and support.

We support the proposed co-prescribing rule (18VAC85-21-70) regarding the treatment of chronic pain with opioids that states: “Naloxone shall be prescribed for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME/day, or concomitant benzodiazepine is present.” The rule will ensure that those receiving exceptionally high doses of opioid medication are educated on the potential risk for overdose. People receiving high doses of opioid medications are at elevated risk for overdose and providing a reversal agent can reduce that risk significantly.

We are asking the Board to update this rule by changing the term “naloxone” to either:

  • "Naloxone or other opioid antagonist," which is consistent with other Virginia code sections
  • "FDA-approved opioid reversal agent," consistent with recent Substance Abuse and Mental Health Services Administration (SAMHSA) grant notices of funding opportunities.

 

Main Points

  • This update would turn the co-prescription rule into line with language in § 18.2-251.03, § 54.1-3408, § 32.1-45.4, and § 32.1-127
  • Several organizations are currently working on reversal agents that utilize molecules other than naloxone
    • Virginians need access to these innovative therapies, and this rule must allow physicians maximum flexibility to provide any reversal agent that they deem appropriate
    • Naloxone-specific language in this rule would create a barrier to new reversal agents for physicians and people at risk of overdose
      • These products from innovative organizations have the potential to be valuable tools to combat the overdose crisis.
  • Recently, the National Institute on Drug Abuse (NIDA) reported that 1 in 20 people who present in an emergency room for an overdose die in the next year of an overdose. Two-thirds of those individuals die from a subsequent opioid-related overdose. NIDA’s data demonstrates that the people at the highest risk of overdose do not have sufficient access to reversal agents even after being in a hospital for a previous overdose.
  • Fentanyl is now responsible for the majority of overdoses and it is clear that faster, stronger, and longer-acting reversal agents are needed in order to counter it
  • According to research published in the Annals of Internal Medicine, patients who received an opioid overdose antagonist with their long-term opioid prescription had 47% fewer opioid-related emergency room visits after six months and 63% fewer after one year, compared to patients who did not receive an opioid antagonist.
    • Physicians must be able to provide any reversal agent, not just naloxone for this co-prescribing rule to be as effective as possible.
CommentID: 128875