Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
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Advisors from the U.S. Food and Drug Administration (FDA) unanimously voted 19-0 on Wednesday to make Narcan, or naloxone, available for over-the-counter use.
Narcan is currently available without a prescription in all 50 states but must be purchased through a pharmacy. However, not all pharmacies carry the drug. However, making the opioid reversal agent available over the counter would allow greater access to the treatment for drug overdoses.
Narcan comes as a prefilled nasal spray or an injection and is widely used to treat overdoses. The medication begins working immediately after administration. However, many panel members voiced concerns about instruction labels and if inexperienced users could safely administer the medication in an emergency situation.
Nonprescription drugs are required to be labeled in a way that allows consumers to self-administer medications without a healthcare provider. There also must be little risk of the medication being used incorrectly and the benefits of the medication should outweigh the risk. These label concerns were one of the main topics of discussion among panel members.
MODIFIED INSTRUCTIONS
Emergent BioSolutions, the manufacturer of Narcan, plans to modify the five-step set of instructions to be more clear for users. The company will move all the directions to a single panel and add pictograms in line with the FDA’s suggestions.
Jody Green, an official at the FDA’s nonprescription drug division, told the advisory committee, “If naloxone becomes a nonprescription product, it may be sold in many venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets, and big-box stores, just like other nonprescription products.”
Health experts are hopeful that making Narcan more widely accessible will be another key step in addressing the opioid crisis.
“There is no reason to keep this as a prescription, let’s get it out there and save some lives,” said Elizabeth Coykendall, a paramedic at PM Pediatrics in Raleigh, North Carolina, and a temporary voting member of the FDA committee. The FDA is set to make a decision by the end of March, if the agency approves the change, Narcan could be available as an over-the-counter drug by summer.
According to the National Institute on Drug Abuse (NIDA), more than 100,000 people in the U.S. died from drug-involved overdose in 2021, which includes illicit drugs and prescription opioids. The numbers continue to increase significantly each year with opioids being the main cause of overdose deaths. In 2022, the CDC reported that more than 110,000 people died within a 12-month period from a drug overdose. This increase has been linked to the spread of fentanyl, which can be made to look like pills, candy, powders, and hidden in other substances.
The Centers for Disease Control and Prevention (CDC) is working to prevent overdoses by improving and promoting guiding principles that address health disparities and implementing strategic priorities to monitor trends, raise public awareness, and partner with state and public health organizations.
Research shows that wider availability could save lives as U.S. opioid overdose numbers have increased more than six-fold and overdose deaths have surpassed 750,000 since 1991, and has been declared a public health emergency since 2017. Health experts are hopeful that greater access to Narcan will save more lives.