Researchers endorse widespread naloxone over the counter to prevent drug overdose deaths

In 2021, 100,306 Americans died from drug overdoses—a 28.5 percent increase from the prior year—with 75,673 attributed to opioids. Synthetic opioids, primarily fentanyl and natural and semi-synthetic opioids, are major contributors. In addition, illicitly manufactured fentanyl often is added to other recreational drugs because of its low cost and increased potency.

As a result, the risk of fatal overdose increases for all users, especially first-time or occasional users. About six out of 10 fentanyl-laced illegal drugs sold on the street now contain a potentially lethal dose of fentanyl.

Naloxone is an opioid receptor antagonist that rapidly reverses or blocks the effects of opioids, restores normal respiration and heart rhythm, and reverses the potentially fatal effects of an overdose. Although naloxone is included in the recommendations by the United States Centers for Disease Control and Prevention, the drug is currently prescribed to less than 1 in 70 patients prescribed high-dose opioid prescriptions.

In a commentary published in The American Journal of Medicine, Florida Atlantic University Schmidt College of Medicine researchers and collaborator, provide opportunities and challenges to health care providers and their patients on Naloxone to impact the increasing U.S. epidemic of premature deaths from drug overdose.

"Now is the time to become more proactive in the fight against opioid-related deaths," said Allison Ferris, M.D., corresponding author, chair of the Department of Medicine, program director of the internal medicine residency program, and an associate professor in FAU's Schmidt College of Medicine. "We propose a call to action for all health providers and state medical societies to ensure the widest distribution and easy availability of naloxone, including over the counter, which is likely to be FDA-approved very soon."

The researchers say that patients for whom the benefit-to-risk ratio is positive include, but are not limited to, the 22.5 million people, or about 8.5 percent of the U.S. population ages 12 or older, who need professional treatment for an illicit drug or alcohol use disorder.

Only 4.2 million, or approximately 18.5 percent, of those who needed therapy received any professional treatment in the same year. In contrast to those prescribed high doses of opioids, two-thirds of patients who are participating in syringe service programs, detoxification, or opioid treatment programs previously had witnessed an overdose. However, only 17 percent had naloxone available to them at the time.

The FAU researchers believe that health care providers in programs treating substance use disorder should include nasal or auto-injector naloxone in their treatment program, both teaching how to use it as well as providing it upon discharge from the program. They note that cost could be cited as a potential barrier, but the average retail price of Naloxone is under $100, far less expensive than the approximately $400 for epinephrine auto-injectors for emergency treatment of anaphylaxis.

"The United States accounts for less than 4.5 percent of the world's population but accounts for more than 13 percent or 2.1 million of the more than 16 million people with opioid-use disorder as well as more than 20 percent or about 100,000 of the more than 500,000 deaths worldwide," said Charles H. Hennekens, M.D., Dr.PH., senior author and the first Sir Richard Doll Professor, and senior academic advisor in FAU's Schmidt College of Medicine.

The authors say it would seem beneficial to have nasal or auto injector naloxone available wherever there are portable defibrillators, especially since the drug could be lifesaving for those who have cardiac arrest due to opioid toxicity. Naloxone access laws to increase availability and access are presently under the control of each individual state.

"About 1 in 5 patients prescribed opioids for chronic pain have overdosed and more than half take other prescription drugs that may cause overdose as well as abuse alcohol. Many patients who are prescribed high doses of opioids have witnessed overdoses but fewer than 3 percent have naloxone available for immediate use," said Hennekens.

The authors conclude by emphasizing to health providers the necessity to counsel patients who use drugs as well as their families to have a nasal spray or auto-injector of naloxone in the household. Health providers should more widely provide naloxone, and increasing the distribution to emergency personnel could avert about 20 percent of opioid overdose deaths.