APF report shares perspectives from patients, families, and practitioners on how OTC naloxone access is one key part of responding to the addiction crisis—in addition to the importance of treatment and naloxone access and affordability.
(April 6, 2023) Bethesda, MD – Addiction Policy Forum, a nonprofit organization dedicated to eliminating addiction as a major health problem, today released a new report summarizing feedback from patients, caregivers, and practitioners on the U.S. Food and Drug Administration’s (FDA) decision to allow individuals to access naloxone without a prescription. Following APF’s presentation of stakeholder comments gathered ahead of the FDA’s decision, the agency approved over-the-counter Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray, on Tuesday, March 30. Naloxone is a potentially life-saving medication used to reverse an opioid overdose in an emergency.
The report includes five key themes based on feedback from patients, family members, and providers. The feedback stresses the need for naloxone access, affordability, links to treatment, and incorporating over-the-counter naloxone as one piece into a broader strategy to address addiction. The considerations are as follows:
Widespread stakeholder support for over-the-counter naloxone.
Over-the-counter naloxone should supplement not supplant current naloxone distribution systems.
Address potential accessibility challenges and barriers in pharmacy settings.
Ensure that over-the-counter naloxone is affordable.
Safeguard linkage to treatment after overdose reversal.
“We are thrilled that the FDA approved naloxone to be available over-the-counter,” said Jessica Hulsey, founder and executive director of Addiction Policy Forum. “While this is a monumental step forward in increasing access to a potentially live-saving medication, we need to ensure that these changes do not affect existing funding streams and resources for free naloxone and active distribution programs. We also need to ensure that measures are in place to prevent price gouging, making the medication unaffordable to American families.”
Addiction Policy Forum conducted listening sessions and interviews to understand patient, family, and practitioner perspectives on the possible implications of an over-the-counter version of naloxone. Participants included individuals in recovery, impacted family members, physicians, community organization representatives, and criminal justice practitioners.
Five key themes and recommendations were identified from the listening session:
What patients, family members, and providers say is critical for naloxone access and addressing addiction:
1. Widespread stakeholder support for over-the-counter naloxone. Participants largely voiced support for accessing naloxone over-the-counter without a prescription, citing the benefits of additional methods to obtain the life-saving medication to help expand access nationwide.
"Making Naloxone available over-the-counter helps to normalize it's use which in turn helps to reduce the stigma associated with the medication,” shared an impacted family member. “By removing the need for prescriptions patients can feel more empowered to take control of their own healthcare and be more willing to seek treatment without shame or embarrassment."
2. Over-the-counter naloxone should supplement not supplant current naloxone distribution systems. Participants recommended that decision-makers ensure that over-the-counter availability does not affect the funding and resources for free naloxone and active distribution of naloxone to at-risk populations, including emergency departments, harm reduction programs, and criminal justice systems.
“[Our state] works very hard to be able to make naloxone available at no cost to as many agencies as possible,” a criminal justice practitioner shared. “I like the idea of OTC as long as there is no price gouging and these free programs still operate.”
3. Address potential accessibility challenges and barriers in pharmacy settings. Concerns were expressed about potential barriers or restrictions in pharmacy settings, including storage of naloxone behind the counter or behind locked shelves as part of anti-theft measures, as well as the training that pharmacy staff will receive to ensure individuals do not encounter stigma or unfair treatment when accessing naloxone.
“If there are too many roadblocks or barriers, or you have to show a license, I think it will make it less accessible,” shared an individual recovery. “The allergy medicine analogy is really important, because those of us who are in recovery don't want to put a light on our heads if we go ask for it because of the stigma that exists.”
4. Ensure that over-the-counter naloxone is affordable. Participants emphasized the importance of affordability, urging the FDA and industry to ensure that the price point does not create a financial barrier for American families and that payers continue to cover naloxone through a prescription insurance plan.
“If it's prohibitively expensive, I think that may be a downside,” an individual in recovery shared. “But if it's available, and people know where to get it. I think there can only be benefits.”
An addiction physician shared: “The insurance companies may decide well if they get it over-the-counter we don't have to cover it. So those are things to consider. We want to protect the public when we implement a new policy.”
5. Safeguard linkage to treatment after overdose reversal. Stakeholders expressed concern that purchasing an over-the-counter medication does not lend itself to the same opportunity for education and linkage to care, which would in effect represent a lost opportunity to engage patients with needed treatment. The current system of naloxone education and distribution creates a “touchpoint” with a healthcare professional, addiction specialist, or other practitioners, which allows for positive interactions with the healthcare system that can lead to rapport building, education, safety, possible treatment options, and other harm reduction strategies
“My only concern is that a focus on naloxone does not address the underlying opioid use disorder (OUD), an addiction physician shared. “I want my patients on medication for OUD. I want them engaged in a recovery program. If everybody has naloxone, they’re not coming to see me for treatment.”
The full report can be accessed here.
About Addiction Policy Forum
Addiction Policy Forum is a nationwide nonprofit organization dedicated to eliminating addiction as a major health problem. Our national headquarters are located in North Bethesda, MD with resources and services in every state. More information on our mission and projects is available at our website, https://www.addictionpolicy.org.