Over-the-Counter Pharmacy Supply of Naloxone

Research SummaryPublished Dec 19, 2023

Makes naloxone available as an ordinary retail purchase that does not require a prescription. For this policy, assume that the U.S. Food and Drug Administration (FDA) has changed the prescribing status of naloxone from prescription-only to over-the-counter (OTC) status.

A panel of experts rated how they expect this type of policy to affect four outcomes: naloxone distribution through pharmacies, opioid use disorder (OUD) prevalence, rates of nonfatal opioid overdose, and opioid overdose mortality. Another panel of experts rated the policy on four implementation criteria: acceptability to the public, feasibility of implementation, affordability from a societal perspective, and equitability in health effects.

Policy Recommendations According to Expert Ratings

Oppose Uncertain Support
No
No
Yes

Summary of Expert Ratings

Outcomes Effect Rating
Harmful Little-to-no Beneficial
Naloxone Pharmacy Distribution
No
No
Yes
OUD Prevalence
No
Yes
No
Nonfatal Opioid Overdose
No
Yes
No
Opioid Overdose Mortality
No
No
Yes
Criteria Implementation Rating
Low Moderate High
Acceptability
No
No
Yes
Feasibility
No
No
Yes
Affordability
No
No
Yes
Equitability
No
Yes
No

Summary of Expert Comments

  • Experts expect the policy to increase naloxone pharmacy distribution by making it readily available to anyone regardless of opioid use status and to decrease fatal overdoses because of its potential to destigmatize acquiring naloxone.
  • Experts think the policy would be acceptable to the general public because FDA approval for OTC status signals the safety of naloxone.
  • Experts believe the policy involves feasible changes to prescriber and dispenser practices because it would only require pharmacies to stock and carry naloxone.
  • Experts generally rated the policy as affordable, although some raised concerns about patient out-of-pocket costs.
  • Experts believe the policy to be only moderately equitable due to concerns about the prohibitory retail costs of OTC naloxone for low-income persons.

Outcome Summaries

Naloxone Pharmacy Distribution

Amount of naloxone dispensed through retail pharmacies (e.g., chain pharmacy stores, independent community pharmacies).

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial
(selected)
 Significantly removes (supply-side) barriers to naloxone distribution. "Of the options so far, this seems to create the fewest barriers to distribution"
Little-to-no Concerns that the policy depends on pharmacy participation, patient and public awareness of and views about naloxone, and the costs of naloxone. "While this decreases a lot of barriers, not everyone who needs one will know to buy it. It needs to be accompanied by marketing/public health messaging. And not sure if it is covered by insurance if OTC, so that may be a barrier"
Harmful N/A N/A

Opioid Use Disorder Prevalence

Percentage of the general population with a pattern of opioid use leading to clinically and functionally significant impairment, health problems, or failure to meet major responsibilities.

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial N/A N/A
Little-to-no
(selected)
 No credible mechanism linking OTC pharmacy supply and OUD prevalence. "Not the target of OTC naloxone (nor an unintended consequence)"
Harmful Potential for revival from overdose could (1) have a small, indirect, and mechanistic impact on OUD prevalence due to increased survivorship (rather than new cases of OUD) and (2) lead to continued opioid misuse. "I see increases because of the normalization of naloxone, more access means more nonfatal [overdoses], and perhaps more people alive to seek treatment"

Nonfatal Opioid Overdose

Per capita rates of nonfatal overdose related to opioids, including opioid analgesics (e.g., oxycodone), illegal opioids (e.g., heroin), and synthetic opioids (e.g., fentanyl).

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial Potential destigmatization of naloxone due to its OTC status could have unintended positive consequences. "Hopefully would increase naloxone, destigmatize with OTC status and assured safety, and could have an effect if gets into the hands of people who use drugs and their community"
Little-to-no
(selected)
 No credible mechanism linking over-the-counter pharmacy supply and nonfatal overdoses. "I don't think naloxone access has much if any impact on the prevalence of nonfatal opioid overdose"
Harmful Potential for revival from overdose could (1) have a small, indirect, and mechanistic impact on nonfatal overdoses due to increased survivorship and (2) lead to continued opioid misuse. "Making Naloxone more accessible to anyone who wants it and removing the barriers to get it (such as seeking out a prescription from a doctor) would lead to more nonfatal opioid overdoses and less fatal opioid overdoses"

Opioid Overdose Mortality

Per capita rates of fatal overdose related to opioids, including opioid analgesics (e.g., oxycodone), illegal opioids (e.g., heroin), and synthetic opioids (e.g., fentanyl).

Effect Rating Summary of Expert Opinion Representative Quotations
Beneficial
(selected)
 Significant increase in naloxone pharmacy distribution would yield meaningful decreases in fatal overdoses. "Given the large increase in provision, this should be one of the most successful policies in reducing fatal opioid mortality"
Little-to-no Minimal impact if expensive or not linked to treatment. "No effect without linkage to treatment"
Harmful N/A N/A

Implementation Criteria Summaries

Acceptability

The extent to which the policy is acceptable to the general public in the state or community where the policy has been enacted.

Implementation Rating Summary of Expert Opinion Representative Quotations
High
(selected)
 FDA approval for OTC status would signal the safety of naloxone. "Improving access to medications that are generally deemed to be safe would probably be seen as a benefit for the public"
Moderate Moral hazard concerns with the loss of oversight. "Some of the public would support, a minority might see this as risky because of ceding any oversight"
Low N/A N/A

Feasibility

The extent to which it is feasible for a state or community to implement the policy as intended.

Implementation Rating Summary of Expert Opinion Representative Quotations
High
(selected)
 Only requires pharmacies to stock and carry naloxone. "Just need the shelf space and for pharmacists to stock it!"
Moderate Depends on cost, insurance coverage, market stability, and ability of pharmacies to stock naloxone. "Hard to know. If naloxone became OTC, it would not be covered by insurance, its price would fall, and manufacturers could leave the market. If this happened there would be little states and communities could do about it"
Low N/A N/A

Affordability

The extent to which the resources (costs) required to implement the policy are affordable from a societal perspective.

Implementation Rating Summary of Expert Opinion Representative Quotations
High
(selected)
 Minimal input costs and cost-effective in the long run. "This could both reduce societal costs by reducing fatal overdose, as well as reducing costs associated with seeking naloxone because it would not require an office visit, and instead someone could go to a pharmacy in the community whenever it is open. There would be lesser administrative costs for pharmacies compared to the collaborative practice model or the standing order model"
Moderate Depends on the costs of naloxone. "The stability of pricing for naloxone after it is made OTC is a huge concern"
Low High cost of naloxone. "The price of naloxone would have to reduce significantly to make it a viable OTC medication. It would need to continue to be available through provider prescription, standing order, pharmacist driven, etc. to give patients with prescription drug coverage the opportunity to obtain naloxone with insurance assistance and less out of pocket"

Equitability

The extent to which the policy is equitable in its impact on health outcomes across populations of people who use opioids.

Implementation Rating Summary of Expert Opinion Representative Quotations
High Increases access while reducing stigma, need to have a health care provider to obtain naloxone, and the (potentially biased) role of prescriber and dispenser decisionmaking. "Why not let the population decide to receive the medication for others. Most equitable approach"
Moderate
(selected)
Concerns about prohibitory retail costs of OTC naloxone for low-income persons and gaps in areas without pharmacies. "Making naloxone available for anyone to purchase would seem to be equitable, but the current cost of naloxone would be prohibitory for low-income persons leading to disparity in availability and outcomes. With a significant reduction in price/cost, OTC naloxone availability would be highly equitable as long as it was carried uniformly and did not vary in availability by neighborhood or pharmacy"
Low N/A N/A
Cover: Over-the-Counter Pharmacy Supply of Naloxone

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Over-the-Counter Pharmacy Supply of Naloxone. Santa Monica, CA: RAND Corporation, 2023. https://www.rand.org/pubs/research_briefs/RBA3054-9.html.
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