The opioid overdose remedy naloxone may soon be available right off the pharmacy shelf with no prescription, a move health officials and experts believe could further reduce barriers to the life-saving drug.
The U.S. Food and Drug Administration said last month it would consider such approvals, and on Tuesday, Maryland-based Emergent BioSolutions said it became the first to be granted a fast-track “priority review” for its nasal spray version of naloxone, called Narcan. The FDA’s goal is to begin approving applications as soon as the end of March.
“Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country,” said Robert G. Kramer, president and CEO of Emergent, in a statement.
Marylanders and residents of most states already can get the drug without an individual prescription from their doctor due to so-called standing orders, which is a blanket prescription from health officials. People, however, generally have to ask a pharmacist for it or get it when they get their addiction medications, steps that may hinder access.
If approved, naloxone could more easily be picked up from a store shelf or bought online.
Officials say they were looking to increase access at a time when fatal overdoses involving the powerful synthetic opioid fentanyl have gone up nationally. Many officials believe the pandemic was responsible for some of the jump, which federal statistics show topped 100,000 in 2021, because of stress from illness and isolation and financial strain. Some substance use treatment was also at least temporarily cut off.
“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said Dr. Robert M. Califf, FDA commissioner, at the time the effort was announced. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”
Naloxone has been in use since 2015 and the U.S. Centers for Disease Control and Prevention credited it with saving nearly 27,000 lives.
The drug required a prescription and training to use, and the Baltimore health commissioner at the time, Dr. Leana Wen, launched an aggressive educational and training campaign, as well as the first standing order in the state. Maryland health officials soon followed suit, covering all residents of the state, and the training requirement was dropped. Most states now have such an order.
Wen said after Emergent’s announcement that there is “overwhelming evidence for the safety and effectiveness of naloxone” administered by bystanders. The drug blocks the opioids and quickly restores normal breathing.
“It’s far past time for naloxone to be available as an over-the-counter medication,” Wen said. “This is a therapy that’s extremely easy to use and that can save someone’s life within seconds. Making it available without a prescription helps to reduce unnecessary and prohibitive barriers to access.”
She said other steps have to be taken, too, including ensuring insurance coverage so it’s low or no cost. She also said there needs to be education so that pharmacists stock it and patients know how to get it.
Maryland’s Medicaid program for low-income residents currently covers naloxone, and private insurance varies.
Officials from the Maryland Department of Health couldn’t immediately say how many prescriptions had been filled through the state’s standing order. But data from the department’s Center for Harm Reduction Services reported that there were 28,617 naloxone prescription fills at Maryland pharmacies billed to Medicaid in fiscal 2021, up nearly 11% from the year before and 24.5% from two years prior.
Chase Cook, a department spokesman, said the state continues to expand access to naloxone through 180 overdose response programs, which are community based organizations and local governments around the state authorized to distribute the drug along education.
Cook also cited a law passed during the last state legislative session called the Statewide Targeted Overdose Prevention Act of 2022 that aims to increase naloxone availability among high-risk populations. It allows emergency medical providers to distribute naloxone to someone who has had a nonfatal overdose. It also requires treatment providers and community groups to provide naloxone for free.
“Research shows that targeted naloxone distribution is one of the best tools that we have to save lives,” he said. “Distributing naloxone at a rate of at least 20 times the number of annual fatal overdoses locally can decrease overdose rates in a statistically significant manner.”