By Georgea Kovanis, Detroit Free Press [Reprinted from the 3-29-23 edition]

The U.S. Food and Drug Administration on Wednesday approved Narcan ― which can reverse an opioid overdose if given correctly and in a timely manner ― for over-the-counter sales.

The move to make Narcan more easily available is an attempt to quell the nation's drug overdose epidemic, which claimed almost 107,000 lives in 2021. The transition to over the counter status will take months and the FDA said pricing is up to the manufacturer. The agency expects the decision to eventually lead to Narcan availability on the shelves of drugstores, grocery stores, and make online sales possible.

What will that mean in Michigan, which has allowed Narcan to be sold without a prescription since 2017 and also allows Narcan to be distributed free by nonprofit harm reduction agencies?

Will retail costs come down?

Will they go up?

Will the overdose death rate decline?

Take a look:

What is Narcan?

Narcan (generic: naloxone) is a medication that reverses opioid overdoses. Outside of hospital settings, it is usually administered via nasal spray. It only works on opioid overdoses, which includes fentanyl, heroin, pain relievers such as oxycodone (OxyContin), hydrocodone (Vicodin) and hydromorphone (Dilaudid). Since most street drugs, including cocaine, are laced with the powerful synthetic opioid fentanyl, Narcan should be given in all cases of overdose. If it turns out the overdose wasn't caused by an opioid, that's OK. Narcan, won't cause any harm.

What's the protocol for getting Narcan from a pharmacy now?

Every state in the nation has some sort of accommodation for getting Narcan without a prescription. In Michigan, a standing order enacted in 2017 made it possible to get Narcan from a pharmacy without a prescription. But only about 59% of the pharmacies in the state participate in the standing order program.

And those that do participate, don't usually give away Narcan for free. Some insurances - including Medicare and Medicaid ― pay for Narcan. Currently, a box of Narcan contains two 4 mg doses of the opioid overdose reversal drug. Without insurance, the can cost up to $143, according to GoodRX, which tracks prices and offers coupons ― including one that brings the price down to $23 at RiteAid - to offset those costs. (The RiteAid coupon expires April 3, though goodrx.com will undoubtedly have others.)

Despite being available without a prescription, Narcan is still classified as a prescription drug and has been kept behind the counter in Michigan pharmacies. Which means you have to ask a pharmacist to get it for you.

As part of Michigan's standing order, a member of the pharmacy staff needs to instruct people on how to use Narcan, said Victoria Tutag Lehr, a pharmacist and a pharmacy professor at Wayne State University who is a specialist in pain management and opioid use disorder therapies. "And a lot of times, the pharmacist will spend up to 45 minutes with that." The pharmacist also will share resources for seeking treatment, she said.

How will things change when Narcan is available over-the-counter?

First of all, only the 4 mg dose of nasal Narcan has been approved for over-the-counter status; intramuscular Narcan, delivered with a needle, is not included with the FDA change.

Experts say over-the-counter status could further normalize Narcan, which is also available free through health departments and non-profit harm reduction agencies. "It could help reduce stigma on accessing Narcan," said Andrew Coleman, who supervises harm reduction programs at ACCESS in Sterling Heights. "I'm for anything that makes accessing harm reduction resources easier."

Narcan could move from behind the counter to a self-service shelf, just like other medications bought over-the-counter (think: aspirin and antacids). Being able to pick it up oneself rather than have to ask for it would be more convenient for shoppers. Again, experts say, normalization.

"There is a stigma of having to come into a pharmacy, talk to a pharmacist to obtain naloxone," said Lehr.

"Every step counts towards reducing the stigma of addiction," said Gina Dahlem, a University of Michigan nursing professor who has instructed thousands of people on how to use Narcan.

Narcan manufacturer Emergent BioSolutions said that over-the-counter Narcan will not be available until late summer. Until then, it's availability is status quo. The current supply of Narcan in pharmacies is not labeled for over-the-counter sales and cannot be sold as such, the manufacturer said.

Eventually, over-the-counter status could mean that more stores ― even party stores and gas stations - that don't have pharmacies could sell it, just like they sell aspirin.

But it's unclear whether anyone would be required to provide people buying it with instruction on how to use it.

What about the cost?

That's also unclear and concerning.

The FDA said on Wednesday that the price of Narcan as an over-the-counter drug is up to the manufacturer.

Insurance doesn't usually cover over-the-counter (OTC) medications. And that has the potential to make Narcan cost prohibitive, said Dahlem. "If the insurance companies decide not to cover the OTC naloxone and the OTC price is not reasonable, then I am unsure if increased availability would lead to increased uptake by the community," she said.

Dahlem believes the FDA should look at making intramuscular Narcan available over-the-counter; it's much less expensive than the nasal spray variety of Narcan.

But Stella Resko, a Wayne State University professor who studies substance use, believes Narcan prices will likely go down "because companies need to remain competitive." Still, she added: "The question is when and how much will the cost go down?"

Because drugs are more potent than ever, due largely to illicit fentanyl, which is responsible for more overdoses than any other drug, first responders and drug users say it's not unusual to need multiple doses of Narcan to reverse an overdose. In addition, it's possible for drugs to outlast the impact of Narcan, which means it's possible for someone to re-overdose on the drugs they've already ingested once the Narcan wears off. Buying Narcan, especially without a price break, could become profoundly expensive.

Will overdose deaths decline if Narcan is easier to purchase?

Drug overdose deaths in Michigan are already trending down, according to statistics from the Michigan Department of Health and Human Services as well the U.S. Centers for Disease Control and Prevention. During the 12 months ending in October 2022, drug overdose deaths decreased 5%, according to the CDC. Those who work in the field of substance use believe easy access to Narcan has played a role in that decline.

Despite the decline, preliminary data from the CDC indicates there were an estimated there were 2,889 deaths related to opioid overdoses during that time period.

"Even if naloxone is moved over the counter, the issue of getting it in the hands of people that need it still remains," said Resko.

Doesn't all this Narcan just enable drug users?

No. People who are addicted to drugs are going to use them whether or not they have Narcan. That's the nature of addiction.

Providing Narcan is a basic tenet of harm reduction, the latest strategy to curb the epidemic of drug overdose deaths. The idea is to keep addicts alive until they're ready for treatment but not casting them aside if they never get to that point.

Nothing else has worked to stop the epidemic of drug overdose deaths.

Over-the-counter Narcan is "a good thing," Lehr said. "It's one more avenue of access. Any way we can get naloxone out there ..."

Where can I get free Narcan right now?

You can get naloxone free by mail: nextdistro.org

A number of organizations offer free Narcan training and provide those in attendance with free Narcan after completion of the training. Most offer trainings for workplaces or groups.

Among them:

Care of Southeastern Michigan's Recovery United Community Center in Fraser offers drive-up naloxone training. It also offers training for workplaces and groups. For info: careofsem.com/recovery-community-center or 586-552-1120.

Families Against Narcotics offers virtual and in-person Narcan training. Some of the trainings are open only to Macomb County residents, others are open to all Michigan residents. For info: familiesagainstnarcotics.org/naloxone or 586-438-8500.

Alliance of Coalitions for Healthy Communities, based in Troy, offers twice-weekly virtual Narcan trainings. For info: bit.ly/3KauFYS or 248-221-7101.

Many syringe services programs, which provide clean syringes to drug users, also distribute Narcan. To find a syringe services program: bit.ly/3JSNRsR

And Narcan vending machines are popping up. Among the locations: the Oakland County Jail, the Ann Arbor Public Library and Wayne State University's undergraduate library. Others have been placed at centers that provide drug treatment services.

Contact: Georgea Kovanis, gkovanis@freepress.com