OTC Naloxone Part 3: How Policymakers Can Improve Naloxone Access in their Communities
Roughly every five minutes in the United States, one person dies of a drug overdose. Because most of these deaths are driven by opioids, improving layperson access to the opioid antagonist medication naloxone is an essential tool in efforts to save lives. To this end, in 2023, the U.S. Food and Drug Administration approved several intranasal naloxone products for over-the-counter (OTC) retail sale. The move has the potential to reduce stigma, drive down costs, and improve low-barrier access to the life-saving medication. However, as seen in earlier parts of this series, retail access—while important—is imperfect. Even with competition bringing cost down, high prices remain a barrier to many people who use drugs—and real-world availability is not sufficient to meet needs.
We highlight several policies that, when operating in complement to OTC sales, can optimize community naloxone saturation.
Naloxone Access Laws and Liability Protections
Laws that lower barriers to behind-the-counter naloxone—especially those that allow pharmacists to distribute the medication “without patient-specific prescriptions”—have generally been associated with improvements in layperson naloxone access. By giving people a route to access prescription naloxone products without a prescription, these laws reduce out-of-pocket costs for individuals with insurance, and ensure access to a wider variety of formulations, including injectables.
In addition to naloxone access laws, many states also have liability protections for prescribers, distributors, and administrators of naloxone. Such legislation works in complement to naloxone access laws and aims to encourage people to acquire and use the medication.
Since 2017, every state and Washington, D.C. has had some sort of naloxone access legislation. It is important that lawmakers do not allow this low-barrier behind-the-counter access to expire just because several intranasal products are now available OTC. Furthermore, in some states, these laws require excessive paperwork or proof of identity, both factors that can prevent people from seeking naloxone at the pharmacy. States can ensure continued low-threshold access to a wide variety of naloxone products by taking a comprehensive approach, including: improving existing laws to ensure the lowest access threshold possible; updating or implementing standing orders in perpetuity; allowing pharmacist prescribing; permitting dispensing or prescribing of the drug to a third party; and expanding liability protections.
Public Health Insurance Coverage of OTC Naloxone
While OTC access to naloxone has encouraged some competition and lowered the medication price a bit, cost remains a significant barrier to many people who use drugs or who care about someone who does. Public insurers like Medicaid and Medicare cover the cost of prescription-only naloxone products, making them much more affordable for consumers. By extending this coverage to the OTC products, insurers would effectively remove one of the most significant barriers to naloxone access, although purchases might need to be processed through a pharmacy, which could undermine some of the privacy benefits of OTC status. Nonetheless, at least six state Medicaid programs and Blue Cross Blue Shield of Massachusetts have already announced they plan to cover OTC naloxone, which would give consumers the option to go through insurance.
Government as a Bulk Purchaser and/or Primary Distributor
While pharmacies—including both OTC and prescription— undoubtedly provide an important route to access naloxone, retail sales account for a relatively small proportion of doses (about 2.64 million out of more than 10 million in 2021) that make it into the community. Rather, community-based organizations, such as syringe services programs that are facilitated by bulk purchasing, remain the primary distribution channels for this life-saving medication.
While some bulk purchasing of naloxone occurs through nonprofit organizations, such as Remedy Alliance/For the People, a growing number of states have also taken up the task thanks to State Opioid Response grants and Opioid Settlement Funds.
While combating the overdose crisis requires a multi-pronged approach that includes expanded access to evidence-based treatment as well as a range of harm reduction interventions, states should not overlook naloxone purchasing now that some formulations of the medication have gone OTC. Furthermore, states should look to people who use drugs, and the organizations who serve them—including harm reduction organizations—to help make decisions about which formulations to prioritize.
First Responder Naloxone Leave-behind Programs and Associated Immunity
Medical first responders, such as emergency medical technicians (EMTs) and firefighters, are an important resource in efforts to prevent deaths due to overdose, but most states underuse them. Medical first responders are often the first non-laypeople on scene, and they are already trained and equipped to administer naloxone. However, as important as professional first responders are, the most frequent overdose rescuers are people who use drugs, their friends, and family members.
As such, allowing EMTs, firefighters, and other first responders to dispense as well as administer naloxone is an effective way to leverage their existing role to get more of the medication into the community in the hands of the individuals who need it most. And research shows that first responder leave-behind programs are successful across a range of environments: Uptake is high (over 85 percent in one study), they reduce overdose deaths, and increase recovery and support-seeking behaviors.
Public Naloxone
The majority of witnessed and unwitnessed overdose deaths occur in a home or other private setting. This is why it is so important to educate people who use drugs on the importance of not using alone, and to equip them, as well as their friends and family members, with naloxone. However, public overdose is a real concern in many communities. For example, research from Massachusetts found that almost one third of overdoses leading to death occurred in a public setting. And in recent years, some places are seeing an increase in public overdose as a proportion of total overdose deaths. In New York City, for example, the percent of overdose deaths “that occurred in a public outdoor setting increased from 10.6% to 16.0%” between 2019 and 2022.
This supports the case for both OTC retail sales of naloxone—most of us, even if we don’t use drugs or think we know somebody who does, should carry naloxone so long as there is not a supply shortage—and for strategically placing the medication in public places. More than 30 states already allow and provide support for the stocking and administration of naloxone in educational settings. In some places, such as Arizona, OTC status of naloxone reduces red tape for grassroots harm reductionists wanting to make the medication available in places like fraternity houses. And some efforts go beyond that. In December 2023, the Biden-Harris administration released guidance that all federal facilities include naloxone in their on-site safety stations. In July 2024, the American Medical Association called for public venues, from stadiums to subway stations, to add naloxone kits to any place where they already have defibrillators.
Conclusion
Allowing naloxone to be sold OTC at retail pharmacies, grocery stores, and similar places is one important tool for improving community saturation. However, policymakers must not overlook the additional ways they can improve naloxone access. From optimizing naloxone access laws to authorizing first responder leave-behind programs and promoting naloxone stations in public places, governments will have the biggest impact on the overdose crisis by taking a comprehensive approach.