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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
 

9/19/22  2:34 pm
Commenter: Todd Lacksonen, Opiant Pharmaceuticals

Comments in Support of Petition 372
 

Dear President Marchese and members of the Board,

Currently, I serve as Chief Scientific Officer at Opiant Pharmaceuticals.  While serving as the Director of the National Institute on Drug Abuse’s Division of Therapeutics and Medical Consequences, I led the team developing the 4mg naloxone nasal spray that is now the ‘gold standard’ for treating opioid overdose.

On behalf of my organization and the dedicated researchers who contributed to the development of the 4mg naloxone nasal spray, we wish to offer our support for the proposed amendment to the Commonwealth of Virginia’s Board of Medicine co-prescribing rule (18VAC85-21-70) that would expand the current rules governing co-prescribing of naloxone under certain conditions to also include anticipated future FDA-approved overdose treatments that are different from naloxone. The proposed agent agnostic language is intended to ensure that physicians have all therapeutic options available when contemplating the most suitable opioid overdose reversal agent.

 

High-potency synthetic opioids like fentanyl are now responsible for almost 90% of opioid overdose deaths in the United States, and innovative reversal agents are being developed which may be better suited to reverse an overdose caused by synthetic opioids. As these agents become available, they will offer practitioners additional choices to offer to their patients, but the existing rule currently limits those options. We ask that the language be expanded to the drug class instead of being limited to naloxone. Updated language suggestions include:

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

The following are references of the Virginia statutes that reference opioid antagonists:

·       § 18.2-251.03. Arrest and prosecution when experiencing or reporting overdoses.

  • § 54.1-3408. Professional use by practitioners.
  • § 32.1-45.4. Comprehensive harm reduction programs.
  • § 32.1-127. Regulations.

This language update in the Virginia Board of Medicine Rules is necessary because there are multiple overdose reversal agents products in development that utilize active ingredients other than naloxone. An example of one of these innovative products is Opiant’s nalmefene nasal spray, which we are in the process of filing our NDA. This rule will ensure that physicians in Virginia can exercise their clinical judgement and select any reversal agent they deem appropriate.

When updated, the co-prescribing provisions of the rule will allow all opioid-reversal agents to be considered and ensures that Virginians are not left without critical tools to combat opioid overdose.

Updating Molecule-Specific Language:

In 2017, the National Institute of Health asked to “work with private partners to develop stronger, longer-acting formulations of antagonists, including naloxone, to counteract the very-high-potency synthetic opioids that are now claiming thousands of lives each year.[1]” Opiant and other innovators in overdose reversal want to ensure that Virginia residents will be able to access any FDA-approved reversal agent.

Co-Prescription

Co-prescription of opioid overdose reversal agents is one of the most effective strategies available for preventing overdose death. According to research published in the Annals of Internal Medicine[2], 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 it an opioid antagonist. Co-prescription rules exist in 15 states and have been seen as an effective way to identify at-risk individuals and ensure they receive a consultation on an overdose reversal agent.

 

This administrative rule change will help ensure that Virginians have access to all opioid reversal agents.  We would be happy to answer any questions or address concerns any members of the Board may have. Thank you for your consideration.

Sincerely yours,

 

 

 

Phil Skolnick, PhD., DSc. (hon.)

Chief Scientific Officer



[1] (Nora D. Volkow, 2017)

[2] (Phillip O. Coffin, Emily Behar, Christopher Rowe, Glenn-Milo Santos, & Diana Coffa, 2016)

CommentID: 128876