Riverside Patch: Saving California Lives In The Fentanyl Era

By Toni McAllister

 

As fentanyl deaths mount across California and the country, a product to rapidly reverse overdoses is expected to hit retailers' shelves in coming months, according to news from the U.S. Food and Drug Administration.

On March 29, the FDA announced it approved the 4-milligram dose of Narcan naloxone hydrochloride nasal spray for over-the-counter, nonprescription use. First responders routinely carry naloxone — commonly known under the brand name Narcan — to save lives when responding to fentanyl overdose calls.

With the FDA's latest action, Narcan can be sold directly to consumers in places like drug stores, convenience stores, grocery outlets, gas stations and online. Golden State residents can expect to see the product on retailers' shelves this summer, according to the California Department of Public Health.

Some pharmacies in California already sell naloxone without a prescription — thanks to standing orders and state laws — but the treatment is generally only available "behind the counter," meaning a patient has to ask for it, which comes with stigma for some.

That's poised to change, but what's not clear moving forward is whether the FDA-approved over-the-counter Narcan will be affordable for all. Uninsured consumers are currently paying in the range of $36 per 4mg dose of naloxone hydrochloride nasal spray. For the insured, not every plan covers the full cost. When asked whether there might be pressure from the state to mandate low- or no-cost Narcan amid the fentanyl crisis, the CDPH did not offer comment.

FDA Commissioner Robert M. Califf, M.D. said over-the-counter Narcan will help reduce fentanyl overdose deaths throughout the country but it must be affordable.

"We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price," Califf said in a released statement.

Patch reached out to Emergent BioSolutions, Narcan's manufacturer. The company has not yet disclosed an over-the-counter price for the drug.

There are concerns that if the cost is too high, people most at risk for fentanyl overdoses won't be able to afford it. Amanda Fialk, Ph.D., is a partner and chief of clinical services at The Dorm, a treatment provider that offers a range of services for young adults, including substance abuse, with locations in New York City and Washington, D.C. She argues naloxone should be free to anyone who needs it.

"While I am thrilled that Narcan will be available over the counter and be accessible to more people, right now we do not know the pricing of OTC Narcan. Narcan saves lives and I believe it should be free and accessible to all, both inside and outside pharmacy walls," Fialk told Patch. " ... it is imperative that people of all identities and socio-economic statuses have access to this life-saving intervention. Additionally, it is important that companies producing Narcan don't engage in price gouging or use this life-saving intervention as a tool for profit."

Not everyone pays for Narcan in the Golden State. California's "Naloxone Distribution Project" administered by the Department of Health Care Services to combat opioid overdose-related deaths provides Narcan free to qualified entities such as first responders, emergency medical services, fire authorities, law enforcement, courts, criminal justice partners, veteran organizations, homeless programs, schools and universities, libraries, religious entities and community organizations. Police and firefighters, for example, carry Narcan received through the NDP to treat people who are overdosing.

While millions of federal taxpayer dollars help fund the NDP, the program was never intended to distribute naloxone directly to average citizens. Instead, the state recommends that patients "check with their insurance plans" to understand how naloxone might be covered.

Clearly, countless California lives have been saved because of the NDP, but some on the frontlines of the fentanyl crisis now say the program needs to be tweaked in a different way.

The Riverside County Sheriff's Department receives Narcan through the NDP. The law enforcement agency can order large quantities, but the individual 4mg doses are not high enough, according to Sheriff Chad Bianco.

Bianco has thrown his support behind state Senate Bill 641 introduced earlier this year by Senator Richard D. Roth (D-Riverside). If passed, the legislation would ensure FDA-approved stronger dosage formulations of naloxone be made available through the NDP.

"Because today's synthetic opioids, like fentanyl, are 50-100 times stronger than the traditional opioids that were found on the streets when Narcan was introduced, it makes 4mg almost ineffective now," according to Riverside County Sheriff's spokesperson Sgt. Sergeant Deirdre Vickers.

In 1971, the FDA approved naloxone to treat overdoses — a time when heroin deaths were more common. Narcan nasal spray was approved for use in 2015 and was the first FDA-approved nasal spray for emergency treatment or suspected overdose.

The Riverside County Sheriff's Department wants to see an FDA-approved 8mg dose of naloxone available through the NDP.

"We cannot simply administer two [4mg] Narcan doses simultaneously because that's not how we are trained to use Narcan and that's not how the FDA has approved Narcan to be used," Vickers said.

Every second counts in fentanyl poisonings. Even if multiple doses are administered, not every deputy carries an infinite Narcan supply, Vickers explained.

"What happens when we end up using our 2-3 Narcan dispensers and the ambulance or your backup is still several minutes away? Now, our deputies or officers are left without Narcan and the patient's chances of survival drastically reduces," she said. "Under the same circumstances, if we can administer a stronger dose from the onset and it doesn't work immediately, we will most likely have 1 or 2 left until backup arrives. The chances of saving their life increases simply because there is more medication in their system helping to counteract the overdose prior to medical personnel arriving."

Vickers contends that Hikma Pharmaceutical has offered the state "a price parody" for its 8mg naloxone product, Kloxxado. Narcan and Kloxxado would cost the state the same, according to the sergeant.

"So, if first responders end up using less because the 8mg product is more effective, the state also has to distribute less, which in turn equates to less money spent on purchasing naloxone," Vickers said.

Generic naloxone is also available through the NDP in an intramuscular injection form.

The fentanyl crisis is not just about dollars and cents. Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl, according to the FDA. Comparable state data was not yet available.