The latest buzz is the Food and Drug Administration approved over-the-counter (OTC) sale of Narcan (naloxone) nasal spray to reverse opioid overdose. Without a prescription, this renders an important emergency treatment widely accessible.
Narcan is a pure opioid antagonist that competes and displaces opioids at opioid receptor sites. It has the greatest affinity for the mu receptor and acts by competing for the mu, kappa, and sigma opiate receptor sites in the central nervous system. It reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
Narcan nasal spray comes in two 4mg doses of 0.1ml; to allow for another dose should an individual not respond to the first. It requires no special training to administer. Guidance for using Narcan correctly for patients and family members/significant others as follows -
Administer initial dose as soon as possible. Do not prime or test the device prior to administration. Administer in alternating nostrils with each dose. Place the individual in the supine position and provide support to the back of the neck to allow the head to tilt back. Following administration, turn the individual on their side. Each container contains a single intranasal spray, do not reuse; if repeat administration is necessary a new container must be used. Dosage may be repeated every 2-3 minutes.
Guidelines strongly recommend consideration of Narcan to reduce the risk of death due to opioid overdose in the following patients –
Patients who are prescribed opioids who:
- Are taking an opioid dose of 50 morphine mg equivalents or greater.
- Have respiratory conditions such as COPD or obstructive sleep apnea (regardless of opioid dose).
- Have been prescribed benzodiazepines (regardless of opioid dose).
- Have a non-opioid substance abuse disorder, excessive alcohol use, or a mental health disorder (regardless of opioid dose).
- Use heroin, illicit synthetic opioids, or misuse prescription opioids/
- Use other illicit drugs, including stimulants (e.g., methamphetamine, cocaine) which could potentially be contaminated with illicit synthetic opioids (e.g., fentanyl).
- Receive treatment for opioid use disorder, including treatment with methadone, naltrexone, or buprenorphine.
- Have a history of opioid abuse who were recently released from a controlled setting (eg, incarceration) who have lost opioid tolerance.
Considerations to keep in mind –
- Recurrence of respiratory and/or central nervous system depression is possible if the opioid involved is long acting.
- Reversal of partial opioid agonist and mixed agonist/antagonist, such as buprenorphine and pentazocine, may be incomplete so larger or repeat doses of naloxone may be required.
CMS’ approved compendium, Micromedex Red Book, lists Narcan as DEA regulatory status of OTC, previously prescription, with an average wholesale price (AWP) of $150 for a package of two single-dose prefilled nasal spray.
The FDA press release states the timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.
FDA Commissioner Robert M. Califf, MD, commented: “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
ExamWorks Compliance Solutions’ Doctors of Pharmacy offer opioid risk-benefit evaluation, potential opioid tapers, risk mitigation strategies, optimization of nonopioid agents, alternatives to high cost Medicare-covered medications, and clarification of drug regimens to provide the most accurate and defensible MSA. The goal of the program is to impact medication therapy to improve safety and clinical outcomes, and mitigate MSA drug costs by consulting with the treating provider on the clinical rationale for the medication regimen. ExamWorks utilizes technology and compendia databases, which are recognized and supported by the CMS to support inclusion or exclusion of a drug under the Part D benefit. We will continue to monitor changes in medication pricing as well as availability of generic equivalents within the marketplace.
For questions about medications, please contact Nahla D. Rizkallah, PharmD, MSCC, at 678.256.5086 or firstname.lastname@example.org.