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Strategies to expand access to naloxone (Narcan) for the prevention of opioid overdoses were explored during a webinar hosted by the Reagan-Udall Foundation for the FDA on Tuesday.

Over 100,000 people over a 12-month period ending in April 2021, according to CDC's provisional data.

Stigma, regulatory barriers, and lack of education prevent people with substance use disorders, as well as their close friends and family members, from accessing the drug, experts said.

"Here we have an essential medication that people have literally run into pharmacies, thinking it's going to be there, and it's not there. And people have died," said Jeffrey Bratberg, PharmD, a clinical professor in the College of Pharmacy at the University of Rhode Island.

All three FDA-approved formulations of the drug -- injectable, auto-injector, and intranasal -- require a prescription.

Over the Counter (OTC) Access

One way to make naloxone easier to obtain is to make it available over the counter instead of by prescription.

"Over the years, we have explored all options available under our authorities and acknowledge that the transition to OTC remains challenging," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research (CDER).

Legally, the FDA can transition naloxone from a prescription drug to an OTC product, but not without collaboration from manufacturers.

According to FDA statute, non-prescription drugs must be safe and effective for the general public without the supervision of a healthcare professional. To receive approval for OTC use, a manufacturer must complete "product-specific testing of device instructions," showing that it is easy for the general public to understand and use the product, said Marta Sokolowska, PhD, associate director for controlled substances at CDER.

In an effort to encourage manufacturers to seek OTC approval for naloxone, the FDA tested and validated a for OTC naloxone -- one of the key requirements needed to approve an OTC product, she noted.

Understanding instructions on the use of the vials and syringes involved in the intramuscular formulation could be challenging for people who aren't accustomed to injecting products, she pointed out. "This may be more straightforward for relatively user-friendly formulations such as nasal spray or auto-injectors."

However, Nabarun Dasgupta, MPH, PhD, senior scientist at the University of North Carolina Gillings School of Global Public Health and co-founder of Project Lazarus, argued that intramuscular products need to be available over the counter. They have been sidelined by stigma and misinformation, but are "often preferred" over the nasal device, because they cause fewer withdrawal symptoms and are "30 times cheaper," he said.

As for needle-phobia, "the needle used for intramuscular naloxone is the very same tool that we use to give vaccines to babies," he noted.

State Policies, Standing Orders

States can help improve access to naloxone in different ways, but they cannot unilaterally make drugs available over the counter, explained Josh Bolin, associate executive director of federal affairs and strategy at the National Association of Boards of Pharmacy.

A decade ago, Rhode Island passed the first "statewide collaborative practice agreement" with pharmacies, explained Bratberg. These policies allow pharmacies to accept prescribing authority, delegated to them by another licensed practitioner, and have the effect of expanding the pharmacist's scope of practice, according to a .

All states and the District of Columbia have "some form of ," noted Sokolowska, including "standing orders" for pharmacies. However, not all pharmacists are aware of these standing orders, and not all are willing to provide naloxone to consumers without an individual prescription, she added.

Bratberg said that these policies push pharmacists outside their "comfort zones." However, through advocacy and collaboration with public health officials, thousands of pharmacists and pharmacy students have been trained in overdose response and in prescribing naloxone either independently or through standing orders, he explained.

A year ago, the American Pharmacists Association (APA) passed a policy aimed at increasing the availability of naloxone, in both prescription and non-prescription form, to "ensure equitable access and affordability of at least one formulation regardless of prescription status," Bratberg said.

On the issue of affordability, pharmacists are advocating for "mandatory insurance coverage" and affordable co-pays, he noted. While some insurers cover naloxone with no co-pay, others charge up to $80 and that's "inhibitory," he added.

The APA also called for "fair reimbursement to dispensers of naloxone," because conversations about naloxone are difficult, take time, and are currently not reimbursed, Bratberg said. "If we want greater access, reimbursement appropriately for our services is desperately needed."

Bobby Mukkamala, MD, chair of the American Medical Association's Board of Trustees, noted that it is important that pharmacies stock naloxone. "There are too many reports of pharmacies not carrying the medication because they don't want to attract that population ... so we need to combat the stigma forcefully."

Stigma is a challenge, and another wrinkle is demand, said Bratberg. When there isn't demand for a product, pharmacists lose money putting it on the shelf, he explained.

"Standing orders at the pharmacy counter are ... only effective when they're used and we need to be honest that they're just not used very often," Mukkamala noted.

Pharmacies must also work to eliminate "perceived barriers" for at-risk people who incorrectly believe that they can't get naloxone without an individual prescription or that they can't afford it, he added.

Physicians' Role in Expanding Access

In addition to calling on physicians to prescribe naloxone to their at-risk patients, the AMA has encouraged physician leaders, such as state surgeons general, to sign statewide standing orders for naloxone and to write standing orders for harm-reduction organizations, which would allow them to purchase naloxone in bulk, explained Mukkamala.

As long as physicians need to have conversations and prescribe their patients naloxone, they should, but "the overall goal is to get rid of that step ... [and] to minimize the number of hurdles between a patient that's at-risk and the naloxone that they need," he said.

Reaching the Most Vulnerable

While Mukkamala said that harm-reduction programs are effective in distributing naloxone, Dasgupta countered that they face tremendous hurdles in accessing the drug.

Fear of federal action based on naloxone's "prescription-only status" has made manufacturers "overly risk averse," Dasgupta noted. Despite both the FDA and AMA saying that naloxone is "safe enough" to eliminate physician involvement, manufacturers can only release prescription drugs to doctors and pharmacies due to industry regulations.

Many manufacturers and distributors require not only a medical license to ship naloxone to a harm-reduction program, but also a DEA license number, despite the fact that naloxone is not a controlled substance. Additionally, if a program operates at multiple sites, distributors often ask for a separate physician license for each address.

To that end, Dasgupta argued that community groups should be exempt from wholesale distribution regulations, particularly during a public health emergency, so that they can more easily purchase and distribute naloxone.

He also pointed out that the greatest increase in overdose deaths occurred in communities of color, and the harm-reduction groups serving these communities are the least likely to have access to physicians who can order naloxone.

"Due to generational hostility and harassment encountered within the healthcare system, these groups are understandably reluctant to waste their time begging doctors they don't know to purchase naloxone for them," he explained. "If we honestly want to dismantle structures of injustice, we have to make it easy for them to get naloxone, and pay their outreach workers and then we need to step out of the way."

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