A life-saving drug that can reverse an opioid overdose will be available on pharmacy shelves without a prescription this summer. It’s a deregulation that experts herald as an important step in managing the US opioid epidemic.
Currently, naloxone is officially classified as a prescription only drug, although it is under a standing order (a directive designed to increase access to public health interventions such as annual flu vaccinations) or by states with similar protocols. Also available from pharmacists. Participating pharmacies do not require individuals to have a prescription in their name to access naloxone, but they must speak directly to a pharmacist.
The Food and Drug Administration announced March 29 that it had approved Narcan, a nasal spray containing the drug naloxone, which stops opioid overdoses, in the retail section of pharmacies like typical cough and pain relievers. . In a statement at the time, Emergent Biosolutions, the Maryland-based company that makes Narcan, said the drug’s retail price is not yet known, but it expected the drug to hit shelves by the end of the summer. He said he expects
The move comes as the number of deaths from opioids continues to rise. In 2021, more than 80,000 people in the United States will die from opioid overdoses, according to the National Institutes of Health.
Kimberly Hsu, assistant professor at Yale University School of Medicine, said:
Scientific American We spoke to experts in harm reduction and opioid use disorders about what the FDA’s decision means, how naloxone works and what role it can play in stopping the crisis.
How does naloxone work?
During an overdose, molecules of opioids such as heroin, morphine, and fentanyl bind to structures called mu-opioid receptors throughout the body, especially in the brain and gut. When enough opioid molecules bind to receptors in the brain, breathing begins to stop.
Naloxone binds to the same receptors more strongly than opioids, so it can physically pull the opioids away from their receptors, stopping the overdose in the process. does not produce This process is not foolproof. Naloxone may take several doses to be effective and its effects last only about 30 minutes. Overdose may resume over time, but naloxone buys you important time to seek medical help.
Naloxone can be given intravenously at the point of care. Narcan, one of his nasal spray versions, will be marketed under new FDA approval. Another brand of nasal spray, Kloxxado, still requires a prescription.
What are the symptoms of an opioid overdose? How is naloxone spray administered?
The two main symptoms of opioid overdose are dyspnea and unresponsiveness. A person’s skin may also become discolored, and the pupils of the eyes may constrict in a pinching manner.
Administering naloxone nasal spray is relatively straightforward. Insert the tip of the nozzle into one nostril and depress the plunger. Even if the system turns out to be opioid-free, the procedure is safe because naloxone only binds mu. opioid receptor. Laura His Palombi, a public health pharmacist at the University of Minnesota and a specialist in Harm His reduction, said: The dangers of drug use in a compassionate, non-judgmental way.
After administering naloxone, call 911 and give artificial respiration if possible or turn on your side to reduce the risk of choking. If symptoms don’t subside within a few minutes, additional doses may be needed by alternating nostrils to stop the overdose.Paombi says he’s heard of cases requiring as many as eight sprays.
Harm reduction experts emphasize that naloxone works only for opioid overdoses. If someone is under the influence of alcohol or another class of drugs, this antidote will not help. “I would definitely recommend getting training on how to manage. [Narcan]’ says Allie McDevitt, recovery case manager at Minnesota youth shelter Life House. She used five doses of the drug to help an overdose near a tissue: “Like many things, it’s easier said than done until you’re actually in that situation.” she says McDevitt.
How would having naloxone available over the counter help people?
Naloxone is currently only available from pharmacists and through local harm reduction centers or similar programs. The FDA’s decision also made the drug available for sale online and in various stores, making it much more accessible to the general public.
Experts say this is important. “People suffering from addiction-related shame may be reluctant to talk to their health care providers about getting naloxone.” I think,” says Palombi. She hopes the move to make the drug available over-the-counter will also show people that it’s safe. There should be,” she says.
But experts still have many questions about how the move will play out, especially in terms of costs. The price is close to $50 for a box of 2 doses of Narkan. Some health insurance programs now cover naloxone, but typically do not cover over-the-counter drugs.
It is not yet clear whether the price tag will shrink after the drug no longer requires a prescription. [over the counter]it’s actually more expensive in some respects,” says Jonathan Watanabe, a clinical pharmacist at the University of California, Irvine.
Su also points to concerns about pricing, saying that structural inequalities prevent many patients from paying even $3 co-pays. “This doesn’t solve it falling into the hands of those who are most vulnerable to overdoses,” she says.
Regional mitigation centers may remain the best place to get naloxone for people on a tight budget, Palombi said.
But Kavita Babu, a medical toxicologist at the University of Massachusetts Chang School of Medicine, worries that lowering the regulatory hurdles could actually hurt such organizations. “I never want to hear that funding for the naloxone distribution program has been cut because it’s available in the US,” she says. Like others, Bab describes her FDA move as incremental progress. “Over-the-counter medicines are better than prescriptions. Free is better than over-the-counter,” she says.
Is Naloxone Alone Enough?
Some in the field say we will need far more drugs than naloxone to address the opioid crisis in the US.
“This is a very important step, but it has not quite reached the finish line. Seeking better access to some buprenorphine and methadone.
Even before deciding to sell over-the-counter, Edward Boyer, a medical toxicologist at The Ohio State University Wexner Medical, said, “We’ve been selling naloxone like candy for the last few years, and opioid mortality is on the rise. I continue to do so,” he said. center. According to Emergent BioSolutions, 44 million doses of his Narcan have been distributed since 2016 when Narcan first became available. But since then, deaths from opioid overdose have nearly doubled. About 47,000 people died from such overdoses in 2017, compared with 80,000 in 2021, according to the National Institutes of Health.
Babu blames it on fentanyl, a synthetic opioid far more potent than morphine or heroin, often mixed with other drugs and caught people unawares. I hate to think about what these numbers would look like without the programs that are in place and the energy, thought and money that are being put into preventing overdose deaths,” she says.
Sue emphasizes that there are real people behind all these figures. “It’s our family, our friends, our community, our patients,” she says. “Every death from an opioid overdose is a policy failure.”
