Narcan is now available over the counter

Photo: sturti/Getty Images

The Food and Drug Administration has approved Narcan as the first nonprescription over-the-counter naloxone nasal spray.

Naloxone is a medicine that can reverse an opioid-related overdose. The move to make it available without a prescription will pave the way for the life-saving medication to be sold directly to consumers in drug stores, convenience stores, grocery stores and gas stations, as well as online.

With FDA approval of nonprescription Narcan, 4 milligram naloxone hydrochloride nasal spray, HHS will launch a department-wide approach to work with stakeholders to implement the Narcan switch from prescription to nonprescription status, facilitate the continued availability of naloxone nasal spray products during the time needed to implement the transition, and help ensure appropriate coverage and continued access to all forms of naloxone, according to the Department of Health and Human Services.

Two advisory committees voted to recommend to the FDA that naloxone, the overdose-reversing drug, be available over the counter.

Dr. Bobby Mukkamala, chair of the American Medical Association Substance Use and Pain Care Task Force, testified at the hearing. 
 
"Making naloxone over the counter is a safe and vital step to ending the nation's overdose epidemic," Mukkamala said. "This will help community-based organizations purchase and distribute naloxone to those who need it most. Rather than sitting behind a pharmacy counter, naloxone needs to be readily available to save lives." 
 
Making it available over the counter also will help destigmatize obtaining and using naloxone, he said. 

"The AMA believes greater access will occur when naloxone for overdose risk is just as easily accessible in a pharmacy, grocery store and other common locations as acetaminophen for a headache or a decongestant for a stuffy nose," Mukkamala said. 

National Council for Mental Wellbeing president and CEO Chuck Ingoglia asked the agency to keep the drug affordable. "We won't accomplish much if people can't afford to buy Narcan," Ingoglia said. "Making Narcan available over the counter represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths."

WHY THIS MATTERS

Naloxone has been shown to be a critical tool that prevents fatal overdoses, connects more people to treatment for substance use disorder and saves lives, according to the Department of Health and Human Services.

"We can prevent overdoses and save lives by making naloxone more accessible, and at the same time, we can ensure equitable access to essential health care," said HHS Secretary Xavier Becerra. "Today's FDA action to allow access to naloxone without a prescription is another strong step forward in advancing HHS's Overdose Prevention Strategy."

THE LARGER TREND

HHS's Overdose Prevention Strategy expands the scope of the crisis response and helps advance the administration's National Drug Control Strategy.

Over the past year, the Biden Administration has taken steps to expand access to naloxone and other harm reduction interventions, such as:

• permitting the use of federal funding for state and local public health departments to purchase naloxone.
• focusing on state development of naloxone saturation plans.
• issuing guidance aimed at making it easier for harm reduction programs to obtain and distribute naloxone to at-risk populations.
• prioritizing the review of nonprescription naloxone applications as appropriate. 

In addition to being used by healthcare professionals, naloxone is increasingly being distributed to first responders and to family members who may witness and respond to an opioid overdose. 

As a result of these actions, the latest CDC overdose data show a steady decrease or flattening of overdose months for seven reports in a row, HHS said.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org

Stephanie Chia, Russ Hinz and Susan Tolin will offer more detail in the HIMSS23 session "Equity on Chicago's South Side: Connected Care Technology." It is scheduled for Wednesday, April 19 at 1 p.m. - 2 p.m. CT at the South Building, Level 1, room S103.