OTC Naloxone Expands Access, but Cost and Distribution Gaps Still Limit Overdose Prevention

Expanding over-the-counter (OTC) access to naloxone nasal spray represents an important step toward making the opioid overdose reversal medication more widely available. However, cost, geographic availability, public awareness, and persistent misconceptions may continue to prevent naloxone from reaching individuals who are most likely to experience or witness an overdose.

In an interview with Pharmacy Times, Alison Newman, MPH, program operations specialist with the Center for Community-Engaged Drug Education, Epidemiology, and Research at the Addictions, Drug & Alcohol Institute at the University of Washington, discusses the significance of OTC naloxone availability and the barriers that remain despite the introduction of additional products. Newman explains how pharmacists can identify patients at risk for opioid overdose, provide nonjudgmental education, and encourage patients to involve friends and family members in overdose response planning. She also addresses misconceptions that naloxone encourages riskier drug use or that fentanyl overdoses always require substantially higher naloxone doses. Looking beyond overdose reversal, Newman emphasizes that reducing opioid-related deaths will require low-barrier access to methadone and buprenorphine, continuity of care, and services that address the broader circumstances contributing to substance use.

Pharmacy Times: The FDA recently expanded access to over-the-counter naloxone nasal spray. From your perspective, how significant is this decision in the broader effort to reduce opioid overdose deaths?

Alison Newman, MPH: Having naloxone available over the counter sends a powerful message that it is a very safe medication, and it will hopefully continue to make naloxone more accessible. However, at least in my community, most of the naloxone that gets used is distributed through nonprofit organizations, health departments, or other community-based organizations.

OTC availability helps reduce some of the administrative barriers associated with ordering and distributing naloxone. Most individuals at risk for overdose are not necessarily purchasing naloxone over the counter at a pharmacy or retail store because of the price. However, the change has made it easier for organizations to order naloxone and distribute it, which is a major benefit. Having more products on the market will also hopefully continue to drive down the price and make naloxone more accessible.

It is also important to recognize that naloxone is only one part of reducing overdose deaths. Naloxone can reverse an overdose and save someone’s life, but medications such as buprenorphine and methadone have much greater effects on reducing a person’s overall risk of dying. Naloxone must therefore be part of a larger strategy.

Pharmacy Times: What barriers to naloxone access still remain, even as more products become available over the counter?

Newman: One barrier is ensuring that there are enough organizations distributing naloxone and that people can easily obtain it where they live, particularly in rural areas.

Here in Washington state, we have seen innovative approaches to naloxone distribution, including vending machines and repurposed newspaper boxes placed in communities. People can open the box, take a naloxone kit, and go. Approaches like these are important because they make naloxone extremely easy to access.

Health care providers should also have kits available to distribute when a patient mentions opioid use or any other type of drug use. There is both a people component and a location component to naloxone access. We must make sure everyone who may need naloxone understands why they need it and how to use it, that their friends and family members are also informed, and that every community has enough convenient locations where naloxone is available.

Pharmacy Times: What role do pharmacists play in ensuring that expanded OTC naloxone availability translates into meaningful patient access and overdose prevention?

Newman: Pharmacists can identify patients who may be at risk for opioid overdose, including those who are picking up an opioid prescription or a medication for opioid use disorder, such as buprenorphine. They can then have a gentle, thoughtful, and educational conversation with the patient about overdose prevention and response.

A key part of that conversation is making sure other people know the individual may be at risk for an overdose because a person cannot administer naloxone to themselves once they have overdosed. When possible, pharmacists can educate friends or family members directly or encourage patients to teach the people around them how to recognize and respond to an overdose.

Pharmacy Times: Who should consider keeping naloxone on hand today, and what misconceptions still exist about who can benefit from having it available?

Newman: Anyone who uses opioids should have naloxone. That includes people using drugs purchased on the street or online who may not know exactly what those products contain. Friends and family members of people who use drugs should also carry it, as should anyone who is concerned that they may encounter an overdose.

I carry naloxone with me, and I place it in my community pantry so that anyone who wants a kit can take one. People at particularly high risk include those with opioid use disorder who are leaving jail or prison because they have experienced a break in their opioid use. People with opioid use disorder who were recently hospitalized and are not receiving medication for opioid use disorder may also face a higher risk.

Any person who regularly uses opioids and then experiences an interruption in use may be at greater risk because their tolerance can decrease. More broadly, anyone who uses opioids should have naloxone available and let other people know where it is.

Pharmacy Times: In your experience working in overdose prevention, what is the biggest misconception the public has about naloxone?

Newman: One misconception I have heard frequently is that having naloxone available will cause people to use drugs more recklessly because they believe naloxone will protect them. However, when you speak with people who use opioids, they generally do not want naloxone administered to them because it can precipitate immediate withdrawal, which can be intensely uncomfortable both physically and emotionally.

Withdrawal is something people are actively trying to avoid. Naloxone does not make people more likely to use drugs or to take greater risks with their drug use.

Another common misconception is that a fentanyl overdose always requires more naloxone. The same naloxone doses that have worked for overdoses involving other opioids can also work for fentanyl. We want people to administer the first dose and then wait approximately 2 to 3 minutes before giving another dose, rather than administering several doses at once.

Naloxone remains highly effective when fentanyl is involved. People should administer it when they suspect an opioid overdose and allow time for each dose to take effect.

Pharmacy Times: Looking beyond this FDA decision, what additional steps do you believe are needed to further reduce overdose deaths and improve access to life-saving interventions?

Newman: We know that medications such as methadone and buprenorphine, including buprenorphine/naloxone, are highly effective at reducing overdose deaths, decreasing opioid cravings and withdrawal, and improving quality of life. Increasing access to these medications is essential.

Access must also be low barrier. Programs should have flexible hours and be located in places where people feel welcomed and respected. Patients must be able to return to treatment even if they begin using drugs again so that continuity of care is maintained.

We also need to support whole-person care. There are many reasons people use drugs, and if we want to help them stop or reduce their use, we must address those underlying circumstances. Ultimately, we should make it easier for people to access and continue taking buprenorphine or methadone than it is for them to use fentanyl.