The U.S. Food and Drug Administration has approved Narcan 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC) use, making it the first naloxone product to become available without a prescription.

The manufacturer, Emergent BioSolutions, expects OTC NARCAN® Nasal Spray to become available in U.S. retail stores and online by late summer.  The manufacturer determines the timeline for availability and price per dose. While many insurers cover some or all of the cost of prescription Narcan, OTC medications typically are not covered by insurance.

Saving Lives

Naloxone can be given to any adult who shows signs of an opioid overdose. Prescription Narcan is administered with a nasal spray or injected into the muscle, under the skin or into the veins. Naloxone restores normal breathing to a person who has overdosed, but it has no effect on someone who does not have opioids in their system.

Signs of overdose include:

• Unconsciousness
• Tiny pupils
• Slow or shallow breathing
• Vomiting
• Inability to speak
• Faint heartbeat
• Limp arms and legs
• Pale skin, purple lips and fingers

Naloxone saves lives by rapidly reversing and blocking the effects of heroin, fentanyl and opioids in certain prescription medications. When it is administered by non-medical personnel, it is essential to immediately call emergency responders. Its effect wanes within 30 to 90 minutes.

The FDA’s approval of OTC Narcan supports nationwide efforts to prevent overdose deaths. The opioid epidemic is an urgent public health concern. In the U.S., more than 101,750 fatal overdoses were reported in the 12-month period ending October 2022, with the majority of deaths linked to synthetic opioids such as illicit fentanyl. By comparison, about 50,000 people died from an opioid-involved overdoses in 2019.

The number of lives saved is more difficult to quantify, partly because the social stigma associated with drug use makes people reluctant to report incidents. A National Institute on Drug Abuse policy brief refers to a statistical model that suggests high rates of naloxone distribution among first responders and in the general public could prevent 21 percent of opioid overdose deaths. The brief also cites studies that show overdose deaths decreased by 14 percent in states that have enacted naloxone access laws. In Tennessee, the state Department of Mental Health & Substance Abuse Services documented at least 60,000 lives saved after Regional Overdose Prevention Specialists distributed more than 450,000 units of naloxone from October 2017 to March 2023.

Recommendations

In its employer toolkit on overdose prevention, the National Safety Council advises employers to follow this checklist before making naloxone available onsite:

• Assess workplace readiness for having naloxone in the workplace
• Ensure all legal and liability concerns are addressed
• Establish policies and procedures for responding to potential overdose scenarios
• Provide training on how to respond to an opioid overdose with naloxone

The Substance Abuse and Mental Health Administration’s (SAMHSA) Opioid Overdose Prevention Toolkit is also a helpful resource.

WorkCare’s Response

The workplace clinics staffed and operated by WorkCare stock naloxone (either nasal spray or pre-filled syringes/autoinjectors for intramuscular administration) in their emergency response kits. Standing orders support Narcan administration by trained onsite personnel within their scope of practice, explains Patrick O’Callahan, M.D., M.P.H., WorkCare’s vice president of onsite clinical operations.

WorkCare’s consulting medical directors advise client companies that do not have onsite clinics to incorporate training for Narcan nasal spray administration into the CPR, AED and first aid training curriculum for both non-medical (lay people) and medical emergency responders. Narcan can be added to emergency response kits once responders are trained.

Dr. O’Callahan doesn’t expect WorkCare’s recommendations for businesses to change significantly in response to the FDA’s approval of OTC Narcan. “Ideally, businesses should have a trained first response team whose members are certified in CPR, AED use and first aid measures, including Narcan administration,” he said. “There should be an appropriate number of first responders to cover all shifts. In situations where Narcan administration is indicated, it’s likely that ventilatory support and/or cardiopulmonary resuscitation will also be required. We will have best outcomes if lay responders have appropriate training and equipment.”

All states have naloxone access laws, and most states have expanded Good Samaritan protections to cover lay people who administer naloxone when they respond to a suspected opioid overdose.

Visit WorkCare’s Onsite Services & Clinics for more information.