Just a week after International Overdose Awareness Day, the first overdose reversal drug approved for nonprescription sale, Narcan® (naloxone HCl), will appear on retail store shelves and online this week. It will be available at many large retail pharmacy chains with a suggested retail price of $44.99 for a box including two doses. Narcan®, manufactured by Emergent BioSolutions, is one of two overdose reversal drugs approved for nonprescription availability this year. The other is ReViveTM from the not-for-profit Harm Reduction Therapeutics, approved in July 2023. The two overdose reversal drugs are both naloxone HCl, designed to be easy-to-use as a nasal spray, and differ only in milligrams per dose, with Narcan at 4 mg and ReViveTM at 3 mg. Harm Reduction Therapeutic’s product is expected to be available primarily for harm reduction organizations and state governments in early 2024. Narcan® continues to be available to state and local government programs, community organizations, and first responders at a recently lowered public interest price of $41 per two-dose unit.
This nonprescription availability is an important milestone for states and territories, community organizations, harm reduction advocates, those working to prevent overdose, and people at risk for overdose. State policy has evolved since the initial FDA approval of naloxone in 1971 to reduce access barriers and allow distribution to laypersons for emergency response. More than 20 years ago, harm reduction organizations spearheaded efforts to distribute naloxone to laypersons, particularly people who use drugs and their friends and families. Significant research has demonstrated naloxone is safe and effective for layperson use even with brief training. The first statewide standing order was established in 2007 to allow pharmacists to dispense the medication without an individual prescription. All 50 states had passed pharmacy naloxone access laws by 2017, and Puerto Rico began allowing the sale of naloxone without an individual prescription in 2019.
Benefits of nonprescription naloxone
Nonprescription naloxone (sometimes referred to as “over the counter”) brings many advantages and implications for increased access. While statewide standing orders intended to make naloxone more accessible without a prescription, pharmacy access remains challenging in many states; many pharmacies have not dispensed freely due to stigma or misinformation and have not kept the medication in stock. The nonprescription approval may increase access in pharmacies, although retailer choice about location of the medication may determine whether the benefits are realized. Rite Aid has announced that Narcan will be available at the pharmacy counter and in aisles alongside pain relief products. In CVS, it will be available at the front register. For many of these retailers, it will also be available for purchase online.
This change brings increased access opportunities beyond its presence on retail shelves and online. It may encourage people to purchase naloxone who were previously concerned about having the medication in their prescription drug history, for fear of insurance discrimination. It may also mean fewer barriers for businesses that want to keep naloxone onsite as part of an emergency first aid kit and reduced administrative barriers for naloxone distribution programs. This change may also contribute to a reduction in the stigma of carrying naloxone. Increased retailer access for those who can afford the medication may also allow publicly funded naloxone distribution programs to focus their resources on those most at risk who cannot afford to purchase it.
Potential impacts and policy considerations
State, territory, and community naloxone distribution programs remain critical, especially for ensuring access for those who are most likely to witness or experience an overdose. Most naloxone is currently distributed by government programs and community-based organizations (84%), leveraging bulk purchase agreements, donations, and public interest pricing. An estimated 16.95 million doses of naloxone were distributed in 2021.
Statewide standing orders will likely remain in place. Some states have provisions indicating their standing order expires upon availability of nonprescription naloxone; however, since other formulations and generic naloxone products remain prescription-only, these standing orders are likely to remain active. Healthcare providers will likely continue issuing individual prescriptions for naloxone as well, given co-prescribing requirements alongside opioid prescriptions in many states.
The change to nonprescription has implications for insurance coverage, and state and federal legislators could step in to address coverage of nonprescription naloxone. As a prescription drug, Narcan® and other naloxone products have been covered at least in part by most insurers, including Medicaid and Medicare programs. With the shift of Narcan® to nonprescription, some insurers may choose to continue covering it. Blue Cross Blue Shield of Massachusetts has announced they will cover “over the counter” naloxone. Other insurers may not cover nonprescription Narcan®, while continuing to cover generic and other naloxone formulations which still require prescriptions or use of statewide standing orders. At least two bills have been introduced this year in state legislatures to require certain insurers to cover nonprescription naloxone (Connecticut and California) and six state Medicaid programs plan to cover it (Missouri, California, Massachusetts, Washington, Rhode Island, and Oregon).
After decades of layperson naloxone use and community distribution, FDA approval of two nonprescription overdose reversal agents represents a significant milestone in addressing the ongoing overdose crisis. More than 110,000 people fatally overdosed in the past year in the United States. Governors continue to invest in overdose prevention and pilot new strategies, significantly increasing the scope and scale of overdose reversal drug distribution in recent years. States and territories are increasing access through many innovative strategies, including deploying naloxone vending machines, leveraging partnerships to offer mail order naloxone, and empowering EMS to issue naloxone kits post-overdose. The NGA Center for Best Practices Behavioral Health team is available to support states and territories in their work on overdose reversal drug education and distribution, as well as other substance use and mental health initiatives.
Thank you to Mr. Jon Woodruff, Esq. of the Legislative Analysis and Public Policy Association (LAPPA) for his presentation about nonprescription naloxone on May 18, 2023, to the Opioid State Action Network. Please contact Dana Heilman (dheilman@nga.org) for more information.
