Expanding Naloxone Access Needs Normalizing First-Aid Use, Keeping Purchase Records Private
Executive Summary
Opposition to making naloxone available OTC remains strident because of stigma surrounding drug overdoses, says Bobby Mukkamala, a head and neck surgeon and an AMA Board of Trustees member.
Normalizing naloxone as a first-aid tool and keeping information on sales of the opioid antagonist private are needed for expanding access and use in addition to OTC switch applications, according to emergency medicine and overdose prevention experts
Naloxone isn’t a controlled substance and has no potential for abuse yet opposition to making it available OTC remains strident because of stigma surrounding drug overdoses, said Bobby Mukkamala, a head and neck surgeon and an American Medical Association Board of Trustees member since 2017, and other experts during a recent Reagan-Udall Foundation webinar on naloxone access.
Mukkamala, who practices in Flint, MI, said the drug industry, health care professionals and consumers should analogize naloxone to epinephrine, the emergency treatment for anaphylaxis.
“If someone gets stung by a bee and goes into anaphylaxis, we don't criticize or look down at that person. We shouldn't look at a patient with a peanut allergy different than we look at a person with a substance use disorder,” he said
He added during the discussion on 29 March that pharmacists sometimes are biased against providing naloxone, blaming the individual and saying, “this person keeps overdosing.”
Personal shame also keeps some consumers – friends and families of opioid users as well as the users themselves – from asking for naloxone prescriptions. They’re afraid a record of naloxone prescriptions could harm them later, such as when applying for employment or for insurance, Mukkamala explained.
Three-Step Approach Against Stigma
He proposed three steps to combat the stigma. “The first step we can take is to continue the work to normalize naloxone as a standard first-aid tool.”
Secondly, states should enact laws and policies prohibiting the use of information about a consumer's a naloxone prescription "from being used against them in any way,” Mukkamala said.
Prime Time Appeal
The topic of OTC naloxone access recently reached prime time TV on HBO’s “Last Week Tonight” show.
"Almost 2 million people have seen a YouTube clip in the last two days from John Oliver on Last Week Tonight basically asking the FDA to remove a prescription-only status and do it right now,” Bratberg said.
Also, echoing others in the discussion, manufacturers should submit new drug applications to the Food and Drug Administration to make naloxone inhalers available OTC, he said.
Without naloxone switch NDAs submitted to the FDA, the door will remain closed for OTC access despite any progress against cultural or society biases, said Josh Bolin, the National Association of Boards of Pharmacy’s associate executive director for federal affairs and strategy.
“States do not have the same drug approval authorities as the FDA. Once the FDA has made a product as being prescription-only, the states don't have that authority to move it to an over-the-counter status,” Bolin said.
Jeffery Bratberg, clinical professor at the University of Rhode Island College of Pharmacy, pointed out the American Pharmacists Association has passed a policy to “not only increase the availability of naloxone, supporting it as both a prescription and nonprescription medication.”
Harm Reduction Therapeutics Inc., which launched following the FDA’s study creating a model Drug Faces label for nonprescription naloxone, is developing a switch NDA and recently reported the primary endpoints for its phase 1 clinical trials of its OTC naloxone intranasal spray were met. (Also see "HRT Reports 'Remarkable Achievement' In OTC Naloxone Phase 1 Clinical Trial Results" - HBW Insight, 1 Mar, 2022.)
A study published in 2020 in the Journal of the American Medical Association showed the potential impact of OTC naloxone access. An Ohio law allowing pharmacists to provide naloxone without a prescription led to a near 2,500% increase in orders dispensed in the state in the first year. (Also see " Ohio Study Shows Access To Naloxone Soars Without Rx Requirement" - HBW Insight, 11 Feb, 2020.)
Currently a prescription-only drug in the US, naloxone initially was approved by the FDA in 1971 as an injectable, which no longer is commonly found in pharmacies; more common are an auto-injection format approved in 2014 and a nasal spray in 2015.
Naloxone is available by standing order in 47 states and Washington, DC; the three states without standing orders allow pharmacists and trade community groups to dispense naloxone without a prescription.
Standing orders are agreements, commonly used for flu shots and during the COVID-19 pandemic for vaccines to the virus, which allow pharmacists to provide certain drugs to consumers without each patient having a prescription. This dispensing authority, typically is ranted by a state's board of pharmacy, differs among states, and several states without laws specifically for naloxone standing prescription orders still allow dispensing without prescription.