FDA Approves Narcan To Be Sold Over The Counter

FDA Approves Narcan To Be Sold Over The Counter

This week, the FDA approved selling Narcan — the leading nasal spray version of naloxone — without the prescription, making it the first opioid treatment sold available over the counter.

Celebrating a huge move in increasing access to the life-saving treatment, advocates have long-sought to make Narcan more widely available.

With the power to reverse overdoses from heroin, fentanyl and oxycodone when correctly administered, Narcan has been instrumental in harm reduction and death prevention. Fatal overdose rates reached the highest total in two decades in 2021 with nearly 2,700 drug related overdose deaths across the city and more than 100,000 deaths a year nationwide

Distributed primarily to people most likely to be around overdoses, advocates have equipped and trained people using drugs and their relatives on how to administer naloxone. Police and first responders have also been equipped with the naloxone. In New York City, activists have worked to equip bars and restaurants with Narcan kits and training as part of the Narcan Behind Every Bar program, codified into law this year by Councilman Ossé’s Intro 56 bill.

With prescription restrictions removed, Narcan could become more widely accessible and administered.

“While Narcan provides a practical solution to a pervasive problem, making it available over the counter demonstrates our humanity," Chuck Ingoglia, president and CEO for the National Council for Mental Wellbeing, said in a statement Wednesday. "Narcan represents a second chance. By giving people a second chance, we also give them an opportunity to enter treatment, if they so choose."

Here’s everything you’ll need to know:​

How will the NARCAN over-the-counter work?

Narcan will be available in pharmacies over-the-counter by late summer, according to Emergent BioSolutions. Other brands of naloxone and injectable forms will not be available for the time being but could be soon, with the FDA now requiring manufacturers of generic naloxone to submit applications to switch their drugs to be sold over the counter.

Emergent BioSolutions has not yet announced the price of the drug, which can cost around $130 to $140 for a kit that includes two doses, as opposed to generic brands which can cost between $20 and $40 per dose.

FDA Commissioner Robert Califf urged Emergent to make the drug available “at an affordable price.”

Narcan's over-the-counter status could also affect insurance coverage for the previously prescribed drug. In New York, the multi-step nasal spray costs about $85 and the single step $150 for uninsured patients.

Does the FDA’s OTC ruling make Naloxone more accessible?

The ruling would make Narcan more widely-attainable and could open the door for places without pharmacies, like convenience stores, supermarkets and online retailers to stock and sell the life-saving treatment, making it more widely accessible to people not actively seeking services or in recovery.

It also removes barriers for people concerned about getting naloxone at pharmacies because it will alert their insurers. Removing the prescription can also help ease the stigma for people picking up the treatment. According to Ramona Cummings, Chief Programing Officer of Prevention Services at New York City Harm Reduction Clinic and health center, Alliance for Positive Change, the stigma around the life-saving treatment can often hinder people from accessing Narcan.

"Many individuals addressing substance use issues have dealt with a great deal of stigma from providers," says Cummings. "Not just pharmacists, but the medical community in general. They don't normally utilize traditional pharmacies to access Narcan."

Cummings also notes the associated cost of the drug as a leading barrier still top of mind in light of the FDA verdict, with alternatives like harm reduction centers offering free naloxone to clients, "From our perspective, clients are coming into community organizations like ours where they feel greeted by staff who are knowledgeable and nonjudgmental and provide a space for them to be able to get their needs addressed with respect and in an expeditious way, where there's not a lot of bureaucracy involved.  The FDA ruling could help lift the institutionalrestrictions around the treatment, though individual barriers remain. "I think the strategy here is to really save lives and not create barriers," says Cummings. 

How can you get NARCAN in New York?

Not all pharmacies currently carry NARCAN. In New York State pharmacies can dispense naloxone with non-patient specific prescriptions, meaning you do not need to have your own prescription to obtain naloxone.

In New York City, there is no age limit to obtain naloxone, but pharmacists may refuse to give it to people under age 16. They may also ask to see an ID for record-keeping, but ID is not required to obtain naloxone.

Pharmacists should provide a short training and written instructions on administering the easy-to-use overdose intervention. The New York State Department of Health also offers training sessions and videos on best practices on harm reduction.

To Cummings, increasing access to Narcan, means increasing options for people using and recovering from drugs, adding to the toolkit of harm reduction responses available. "It's about giving people choices and options," says Cummings, citing services like harm reduction counseling, and fentanyl testing working in tandem with naloxone education and intervention.

"The FDA approval is a step in the right direction and an opportunity to open more conversations about the value of harm reduction services, and the availability of choices for participants," says Cummings. "It really is about providing life saving resources for our clients and strategies that strengthen our community."

Photo via Getty/ UCG