Implications of over-the-counter access to opioid antagonist naloxone

An expert panel with the United States Food and Drug Administration, or FDA, recently recommended that Narcan, a brand of naloxone, be sold over the counter.

The nasal spray is used to reverse opioid overdoses and has been a key tool in combating the opioid crisis that worsened during the COVID-19 pandemic. Currently, naloxone is available for emergency medical providers in all 50 states. Otherwise, it is only available with a prescription, however, pharmacies in many states have found ways to provide it for free upon request.

Some advocates believe that making naloxone readily available could help fight the stigma associated with opioids and save lives, while other others worry that increased accessibility could prevent health care providers from intervening and helping patients with their addiction.

The FDA is not bound by the panel’s recommendation. If the agency approves it, which could happen later this month, naloxone could be readily available in schools and supermarkets as soon as this summer. With this issue under discussion, Karen Marlowe, director of the Harrison College of Pharmacy’s Center for Opioid Research, Education and Outreach, explains some of the implications of wider naloxone access.

Do you think a decision to make naloxone available over the counter was inevitable considering the seriousness of the national opioid crisis?

In 2021, more than 80,000 people in the United States died of overdoses related to opioids. In Alabama, hundreds die each year from opioid overdoses. Making naloxone accessible is one part of the solution for this crisis in our state.

Currently in Alabama, anyone can discuss their need for naloxone with their pharmacist and purchase naloxone. In 2016, HB379 was signed into law, providing the State Health Officer, or a county health officer, the authority to write a standing order for dispensing naloxone. If a prescriber writes a prescription for Naloxone, it may be covered by insurance as well. The decision by the FDA to make naloxone over the counter will increase accessibility of this important agent in our community.

Is making naloxone more readily available a good move in helping prevent overdoses?

Naloxone is safe and, in the forms available from a pharmacy, is easy to administer. However, pharmacists can be very helpful to patients and their families in helping recognize signs of overdose and learning about what to do after administering naloxone. It is very important to call 911 once naloxone is administered. Health care professionals, including pharmacists, can also help families find resources for treatment of substance use disorders.

A concern about making naloxone available over the counter is the reliability of untrained users to administer it safely and effectively. Do you see this as a potential issue?

Naloxone is available in an injection and a nasal spray, which are both easy to administer. No matter what agent that is responsible for an overdose, naloxone is a safe agent. Naloxone should be in every household where an opioid is present, where someone is in recovery and any location where people gather, such as houses of worship, education facilities and workplaces with large numbers of employees.

That being said, COACH has focused resources to train first responders and community leaders on naloxone in the past. How important is this kind of outreach?

The Center for Opioid Research Education and Outreach, or COACH, continues to provide education for both community and health care professionals related to naloxone. Education can be accessed on our website under the treatment section.

Since COACH was established in 2019, what all has the center done to address the opioid epidemic in Alabama?

As part of the Opioid Training Institute, more than 1,000 individuals received education related to the opioid epidemic. More recently, more than 2,500 individuals have accessed educational materials related to our Substance Use Disorders in Alabama project. The project was sponsored by the Alabama Department of Mental Health, and the educational materials are accessible on the COACH website.

Of the more than 2,500 individuals trained, more than 350 were health care professionals who completed courses associated with the project and obtained continuing education credits through their participation. These webinars will be accessible online through at least September 2024.

Also, almost 300 individuals attended the Alabama Department of Public Health’s 2023 Substance Misuse Summit in early February. The summit was organized and executed by Harrison College of Pharmacy faculty and staff affiliated with COACH.

Lastly, the Alabama Department of Public Health is sponsoring a series of interactive Prescription Drug Monitoring Program, or PDMP, programs taking place in the form of local town halls with educational design and content delivery being completed by COACH. The next town hall will be held in Tuscaloosa on April 26 at the Bryant Conference Center.