Two panels of medical experts have unanimously recommended to the Food and Drug Administration (FDA) that Narcan (naloxone) nasal spray, which can reverse an opioid overdose, be made available over the counter – a move Texas physicians have long championed.
FDA is scheduled to decide on the recommendation in the coming weeks.
The goal of the recommendation is to make Narcan, or naloxone, cheaper and more widely available so that more people can prevent opioid overdoses, says Mesquite pain management specialist C.M. Schade, MD, a member of the Texas Medical Association’s Subcommittee on Behavioral Health.
An opioid overdose slows respiration until a person stops breathing, he says.
“After that, you have about five minutes before you’re brain dead,” Dr. Schade said. “What that means is that you have to have [Narcan] rapidly available.”
Illicitly produced fentanyl causes most opioid overdoses in the U.S., including in Texas. In 2018, Texas saw 210 deaths associated with fentanyl, but that rose to 1,612 by 2021, according to the Department of State Health Services. In 2021, fentanyl was tied to 95% of all unintentional synthetic opioid deaths in the state, the agency says.
Fentanyl can be 50 times stronger than heroin and 100 times stronger than morphine, according to the Centers for Disease Control and Prevention. It is often mixed with other drugs to make them more potent and more addictive.
“When someone is exposed to fentanyl, it only takes the weight of a mosquito – 2 milligrams – [to cause an overdose], and the toxicology analysis of many illicit pills is showing fentanyl doses as high as 5 milligrams per pill,” Dr. Schade said. “That’s why people are dying from it.”
To make Narcan nasal spray more accessible, pharmacies in most states – including Texas – are allowed to use a standing order from a physician to provide the medication to anyone who wants to buy it. But people still must pay whatever copay their insurance requires, and that can drive up the price, Dr. Schade says.
Making Narcan available over the counter should lower the cost for consumers and make the medication as common as other over-the-counter medications, he says.
“If it’s over the counter, the price will go down and people will have it,” he said. “Through education, it will be widely available in first-aid kits and be omnipresent.”
Narcan nasal spray poses no safety risk for the public, even for children, says Austin addiction psychiatrist Carlos Tirado, MD, a member of TMA’s Subcommittee on Behavioral Health.
“Naloxone is incredibly safe,” he said. “In fact, it’s one of the safest medications out there. There’s really no reason this shouldn’t be over the counter.”
The recommendation for Narcan’s over-the-counter use came from a joint meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Their unanimous vote by the committees’ 19 members was nonbinding, but FDA typically follows recommendations by its expert medical panels.