Background

The U.S. Food and Drug Administration approved selling the leading version of naloxone without a prescription in March 2023. Addiction Policy Forum presented at the February 15, 2023, joint meeting of the Nonprescription Drugs and the Anesthetic and Analgesic Drug Products Advisory Committees for the US Food & Drug Administration (FDA) on the application to offer naloxone over-the-counter (OTC). This report summarizes key stakeholder feedback from patients, caregivers, and practitioners on considerations for over-the-counter availability that was presented to the FDA’s advisory committee.

Addiction Policy Forum aims to eliminate addiction as a major health problem by translating the science of addiction and bringing all stakeholders to the table. The organization also works to elevate awareness around substance use disorders and help patients and families in crisis. Founded in 2015, Addiction Policy Forum empowers patients and families to bring innovative responses to their communities and end stigma through science and learning.

Naloxone is a safe and effective medication that reverses an opioid overdose and saves lives. Expanding naloxone availability is a step that communities can take to enhance public health and reduce overdose fatalities. Effective nationwide naloxone distribution programs provide training and distribute doses to first-responders, community-based organizations, public health departments, people who use drugs and their caregivers, employers, school systems, transportation partners, and jails and prison systems. Another approach that states have implemented is co-prescribing of naloxone with opioid prescriptions (Banjo, 2014).

Naloxone Research

A 2013 study of the Massachusetts Overdose Education and Naloxone Distribution Programs (OENDPs) found that opioid overdose death rates reduced by 21% in communities where OENDPs were implemented, compared with communities with no implementation (Townsend, 2020).
A recent study using a decision-analytic model to analyze the cost-effectiveness of eight naloxone distribution strategies found that maximum distribution of naloxone to laypeople, police and firefighters, and paramedics could reduce overdose deaths by 21% compared to minimum distribution of naloxone (Walley, 2013).
A study found that 87% of naloxone rescue attempts were performed by people who use drugs, that the person performing the rescue was usually a friend of the person who overdosed, and that naloxone was successful in 98% of the rescue attempts (Townsend, 2020).
According to a study conducted in Lorain County, OH, after police officers began carrying naloxone nasal spray, overdose deaths decreased by 18% (Rando, 2015).

The numerous methods of naloxone distribution programs fall into two main categories – proactive and passive distribution. OTC naloxone is a passive strategy and would increase access to individuals who take the initiative to purchase the medication.

Proactive Distribution	Passive Distribution
Overdose Education and Naloxone Distribution Programs (OENDPs)	Naloxone is available to those who seek it out
Community-based harm reduction programs	Vending machines
Jail/Prison reentry programs	Pharmacies
Emergency Departments/Hospitals	Over-the-counter
Co-prescribing with opioid medications	AED cabinets

Over-The-Counter Access

In February 2023, a government advisory committee for the FDA voted unanimously to recommend naloxone nasal spray, a medication used to reverse opioid overdoses, be sold and distributed over-the-counter (OTC) and without a prescription. The vote serves as a recommendation to the FDA as the agency considers making the product available OTC.

The Addiction Policy Forum provided comments during the meeting of the advisory committee, sharing perspectives and considerations from the patient, practitioner, and caregiver community. In preparation for the presentation, Addiction Policy Forum engaged with key stakeholders to collect feedback in order to share recommendations and input from our network. This report is a summary of Addiction Policy Forum’s findings.

Methods

The Addiction Policy Forum developed this environmental scan in preparation for comments to the FDA. The project team would like to thank all of the stakeholders, patients, family members, and practitioners who generously devoted their time and expertise to create this report.

Addiction Policy Forum collected the data between February 2 and March 10, 2023. The listening sessions and interviews were conducted by CITI trained staff. A total of 18 participants from 12 states participated in qualitative interviews (Figure 1). Participants varied in geography, race/ethnicity, gender, and stakeholder lane, including patients, family members, and practitioners from healthcare, criminal justice, harm reduction, recovery support, and other community-based organizations (Figure 2).

Authors

Jessica Hulsey, Addiction Policy Forum

Kayla Zawislak, LSW, CADC, Addiction Policy Forum

Braeden Kelly, Addiction Policy Forum

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Suggested Citation. Hulsey, J., Zawislak, K., & Kelly, B. (2023). Considerations for Over-The-Counter Naloxone: Patient, Caregiver, and Practitioner Perspectives. Addiction Policy Forum.