Make naloxone available over the counter

T.The Food and Drug Administration aims to conduct at least two priority reviews. product application For granting over-the-counter drug status to the intranasal formulation of naloxone, an overdose antagonist.

Naloxone prevents overdose death by binding to opioid receptors in the body. brain Block entry into competing opioids or push them away. The drug is marketed in three versions: a vial of naloxone for injection, an auto-injector (similar to EPIPEN), and an intranasal spray.

In response to this announcement, harm reductionists (including some of the strongest proponents of this regulatory transition) raising concerns This effort alone will not be enough to improve access for those most vulnerable to overdose. It is true that granting intranasal naloxone OTC status alone is an inadequate solution to the shortage of this life-saving drug in communities across the country. It could be an important and incremental step in reducing ingestion deaths.

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Critics worry that A shift in nasal spray formulations Changing to OTC status jeopardizes insurance coverage, as insurance generally does not cover OTC products.approximately $140 for 2 packs, this shift could significantly increase out-of-pocket costs for consumers. Many harm reductionists also point out that people who use drugs are the people most likely to use drugs. Witness an overdose and undo itnasal spray small percentage of naloxone distributed to these individuals.Therefore, some field experts quarrel Increasing access to this product does little to expand access to those who need it most.

I beg to differ.

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That’s all for last year 80,000 people In the United States, people died from opioid overdoses.Naloxone prevention thousand of additional deaths, and possibly tens of thousandsDue to its excellent safety profile, lack of abuse potential and near 100% efficacy, all states Pass some kind of law that would improve access to naloxone while keeping it behind pharmacy counters. these laws Varies greatly from state to state, but typically eliminates the need for a prescription or expands who is allowed to prescribe drugs.Nevertheless, naloxone is not extensively Adequate among those who need it most, including those using drugs family member and friends.

Concerns about keeping naloxone affordable are extremely important. Growing risk Because of their opioid overdose, they are more likely to die from such an overdose compared to wealthier people. However, OTC status does not inherently eliminate opportunities to help keep naloxone affordable. In the long term, research suggests that competition between products is increasing. at the market — can lead to moderate price cuthowever, this transition may still increase out-of-pocket costs for consumers if they lose access through insurance.

To mitigate the unintended consequences of making intranasal naloxone an over-the-counter product, the federal government could look to emergency orders implemented for another well-known public health crisis. it is temporary. Clause Made Covid-19 testing widely available insurance reimbursementSuch an approach could do the same for naloxone, at least until overdose rates are reduced.

Cost is not the only barrier to access to naloxone. Also, many social factors make it impossible to ensure that medicines are available to those who need them most. For many people, especially those living in rural areas, rarity and geographical distance of Community health and harm reduction programs make private, bureaucratic and paperless access to naloxone in pharmacies an essential option.

Even if naloxone is behind the pharmacy counter, people who want naloxone still have to interact with the pharmacist, and many report experiencing it. stigma during these interactions.of some statesindividuals wishing to purchase naloxone must provide identifying information (such as name and address), present a form of identification, or complete paperwork to receive it. I report that I encountered a pharmacist. lack of sufficient knowledge I refuse the medication because it violates the Naloxone Access Act.

FDA approval of naloxone as an OTC drug would address these challenges. Even if limited to intranasal formulations of naloxone, OTC status means consumers will see this life-saving drug on pharmacy shelves like aspirin and toothpaste. Increased visibility helps normalize medication and reduce the social stigma people may experience when purchasing naloxone from a pharmacist or grocery store checkout counter.

OTC status is a privacy violation as consumers purchasing naloxone no longer need to provide identification or personal information and may even have the option of using a self-checkout system instead of facing a cashier. Alleviates concerns about

Granting over-the-counter status, coupled with a prudent approach to controlling the cost of naloxone, significantly reduces the threshold for access to pharmacy-based medicines. friends and family members of the population, and individuals living in island areas, where harm reduction programs are illegal, or in geographically distant states, suddenly have immediate access to the drug. is the first step toward effectively defeating the opioid overdose crisis.

Stacey McKenna is a Resident Senior Fellow in the Integrated Harm Reduction Program at the R Street Institute.

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