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Naloxone Regulations
Naloxone Prescribing Policies

Released: January 29, 2024

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Key Takeaways
  • Naloxone can safely and effectively reverse opioid overdose if administered in time.
  • Some naloxone formulations are now available over the counter.
  • Although naloxone may be available without healthcare professional intervention, healthcare professionals still have a key role in ensuring access to this lifesaving medication by counseling patients and offering prescriptions where appropriate.

Opioid overdose is a continuing public health crisis, with more than 80,000 reported opioid-involved overdose deaths in the United States in 2021. In addition to these deaths, an unknown but likely large amount of overdose-related morbidity occurs among individuals who survive opioid-induced hypoxia. Much of this death and disability is preventable with the timely administration of naloxone.

Naloxone, a pure opioid antagonist, has been approved for the reversal of opioid-induced respiratory depression for more than 50 years. It is not a controlled substance, has no abuse potential, and produces no clinically significant effects when administered to a person who has not taken opioids. It can precipitate withdrawal when given to an opioid-dependent individual, but serious adverse events are rare.

Naloxone previously was available only to healthcare professionals (HCPs), including first responders. In the past decade, however, governmental and nongovernmental organizations increasingly have recognized that ensuring the availability of naloxone at the scene of an overdose can reduce morbidity and mortality. The Biden-Harris administration has encouraged housing providers and schools to make naloxone readily available, and all states have passed laws designed to increase access to the medication. There is some variation in state laws, but most permit naloxone to be dispensed or distributed without a patient-specific prescription, and many permit it to be distributed and administered by laypeople. Most also provide immunity to individuals who prescribe, dispense, and administer the medication. Largely because of these governmental actions, many public health departments, harm reduction organizations, and other agencies and organizations now distribute naloxone to the public.

In 2023, the FDA approved 2 naloxone products for over-the-counter (OTC) use. One of these, Narcan, a 4-mg/0.1-mL nasal spray, previously was previously available as a prescription-only medication. Several generic versions of Narcan also are available. In addition, a 3-mg/0.1-mL nasal naloxone product, RiVive, is available OTC. Both products are packaged in 2-dose units. Other formulations of naloxone, including 0.4-mg/mL vials for injection and an auto-injector, remain prescription only.

Despite the OTC availability of naloxone, there is still a need for HCPs to ensure that they are prescribing the medication where indicated. The CDC recommends that naloxone be prescribed to all individuals at risk of overdose, and the FDA requires the labels of opioid medications to recommend that HCPs discuss naloxone with patients when prescribing those medications. Some states have gone further than national recommendations and now require that naloxone be prescribed or recommended to some patients. As of early 2023, 11 states (AZ, AR, FL, IN, NJ, NM, NY, RI, VT, VA, WA) require 1 or more medical professionals to prescribe naloxone under certain circumstances, whereas 7 states (CA, CO, IL, KY, OH, SC, TN) require that a prescriber, pharmacist, or physician offer naloxone.

The circumstances that trigger these requirements vary. Although most states require that naloxone be prescribed or offered when opioids are prescribed at more than a certain morphine milligram equivalent (MME) per day, this is not always the case. When an MME requirement is present, the triggering level ranges from 50 MME (AR, RI, SC) to 120 MME (VA). Most states also require naloxone to be prescribed or offered when the patient meets another criterion for being at increased risk of overdose, such as a history of substance use disorder. HCPs should be aware of requirements that might apply in their states.

In addition to state requirements, HCPs should be sensitive to insurance coverage and cost differentiations in prescription vs OTC naloxone. The 2 approved OTC formulations retail for approximately $45 per 2-dose package. Because some insurance plans cover OTC medications to the same extent as prescription medications when the patient has a prescription for the OTC medication, HCPs may wish to continue to issue prescriptions for OTC naloxone products. They also should ensure that patients know OTC products are now widely available, including for purchase through many online retailers and at no cost through many governmental and nongovernmental organizations.

Many opioid overdose deaths are preventable. HCPs should identify patients who may themselves be at risk of opioid-related overdose or who may be in a position to respond to such an overdose with naloxone. In addition to discussing strategies to reverse overdose and other adverse events with those patients, HCPs should be familiar with policies in their state and either prescribe naloxone or counsel patients that several naloxone products are available without a prescription.

Your Thoughts?
Are you familiar with the use of naloxone and related policies in your state? Answer the polling question and join the conversation in the comments. For more information on naloxone, take a look at the patient- and HCP-focused downloadable resources on our website.

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How knowledgeable do you feel about naloxone regulations in your state?

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