Narcan Is Safe to Sell Over the Counter, Advisers to the F.D.A. Conclude

Two federal panels of addiction experts on Wednesday unanimously recommended that Narcan, the overdose-reversing nasal spray, be made widely available without a prescription, a significant step in the effort to stem skyrocketing drug fatalities.

Making Narcan an over-the-counter drug has been urged by doctors, patient advocacy groups and the Biden administration.

The unanimous vote by the committees, which advise the Food and Drug Administration, makes it highly likely that the F.D.A. will approve an over-the-counter version, also known generically as naloxone, next month. It could potentially become available in vending machines, schools, convenience shops, big box stores and supermarkets by summer.

As the overdose crisis worsened in recent years, the use of Narcan has become commonplace, but the millions of doses have been administered largely by outreach workers, health care providers and emergency responders. For people who use drugs as well as their friends and relatives, ready access to the prescription medication has been elusive.

Many public health experts believe that if more people were to have the spray readily available at home, or in their pockets or knapsacks, many fatalities could be averted.

Fentanyl Overdoses: What to Know

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Devastating losses. Drug overdose deaths, largely caused by the synthetic opioid drug fentanyl, reached record highs in the United States in 2021. Here’s what you should know to keep your loved ones safe:

Understand fentanyl’s effects. Fentanyl is a potent and fast-acting drug, two qualities that also make it highly addictive. A small quantity goes a long way, so it’s easy to suffer an overdose. With fentanyl, there is only a short window of time to intervene and save a person’s life during an overdose.

Stick to licensed pharmacies. Prescription drugs sold online or by unlicensed dealers marketed as OxyContin, Vicodin and Xanax are often laced with fentanyl. Only take pills that were prescribed by your doctor and came from a licensed pharmacy.

Talk to your loved ones. The best way to prevent fentanyl use is to educate your loved ones, including teens, about it. Explain what fentanyl is and that it can be found in pills bought online or from friends. Aim to establish an ongoing dialogue in short spurts rather than one long, formal conversation.

Learn how to spot an overdose. When someone overdoses from fentanyl, breathing slows and their skin often turns a bluish hue. If you think someone is overdosing, call 911 right away. If you’re concerned that a loved one could be exposed to fentanyl, you may want to buy naloxone, a medicine that can rapidly reverse an opioid overdose and is often available at local pharmacies without prescription.

The Biden administration has made expanding access to the medicine a priority in its efforts to combat the overdose crisis, which reached a record 107,000 deaths in 2021. The rising fatalities include people addicted to opioids as well as those who illegally purchased prescription medications like Xanax or Percocet that had been tainted with the deadly synthetic opioid, fentanyl. Experts at Wednesday’s daylong hearing noted that even stimulants like methamphetamine and cocaine are being mixed with fentanyl, leading to even greater numbers of accidental overdoses.

In recommending that the spray become as easily available as ibuprofen, the 19 voting panelists determined that naloxone, which was approved as an overdose-reversal injection in 1971, is abundantly safe and effective even in infants, with almost no potential for misuse or abuse. And, the panels concluded, naloxone does not require medical training to use.

Side effects, typically symptoms associated with withdrawal, were relatively negligible compared with the medicine’s far greater lifesaving benefit, panel members said. Naloxone, which comes in a nasal spray, a vial and preloaded syringes, is believed to have saved hundreds of thousands of lives.

The drug blocks the effects of opiates on the brain. Opiates can depress the respiratory system and other bodily functions. By interrupting that connection before it’s too late, Narcan can wake a person from a lethal stupor. The instructions on the two-pack carton say that the Narcan administrator should apply one dose in the nostril of a person suspected of having overdosed and then call 911. If the person does not rouse within two or three minutes, a second dose can be applied in the other nostril.

The unusual unanimity of the vote “underscores the importance of moving this drug to greater access and also highlights the terrible risk of not acting in terms of making the drug more accessible,” said Maria C. Coyle, chairwoman of the advisory panel and an associate clinical professor at the Ohio State University College of Pharmacy.

The panel said that over the years that Narcan had been deployed, a handful of severe outcomes, such as death, had not been directly connected to Narcan itself but to attendant issues, such as delayed application or other drugs involved.

The F.D.A. had encouraged companies to submit applications to be considered for over-the-counter naloxone; the manufacturer of Narcan, Emergent BioSolutions, stepped forward.

Many voting and nonvoting experts, who included emergency responders, toxicologists, pharmacists, pediatricians and addiction medicine specialists, said that improvements were needed in the proposed labeling and packaging of over-the-counter Narcan. They suggested improvements to the company’s font, color choices and pictograms, which are intended to quickly guide panicky helpers through administering the medicine.

The Opioid Crisis

From powerful pharmaceuticals to illegally made synthetics, opioids are fueling a deadly drug crisis in America.

  • Tranq Dope: A veterinary tranquilizer called xylazine is infiltrating street drugs, deepening addiction and causing wounds so severe that some result in amputation.
  • In New York City: Driven by fentanyl’s prevalence and the pandemic, drug overdose deaths in the city have soared, reaching their highest point since the health department began tracking them.
  • Pregnant Women: The Biden administration plans to expand the use of medication to treat substance use disorders in pregnant women as part of its effort to combat the drug crisis.
  • A Daring Addiction Strategy: Rhode Island is the first state to legalize supervised drug consumption sites, which some experts believe will help lower overdose rates.

Such refinements were important, they said, also recommending that instructions specify the number of doses. They also said that the manufacturer had not evaluated whether young children can follow the directions and administer the medicine to siblings and parents. But the panelists emphasized that such adjustments should not be an impediment to releasing an urgently needed drug.

Still, Dr. Leslie R. Walker-Harding, a panel member who is a pediatrician at Seattle Children’s Hospital, criticized the company for not enrolling people under 15 in studies looking at whether children could readily understand how to use the drug.

“What is traumatizing to a kid is watching their loved one be unconscious, dying, and not being able to do anything about it,” she said, adding, “Children can protect us and protect themselves and are humans all on their own.”

The price of the drug and insurance coverage were not issues before the panel, but they were raised during the public comments section of the hearing. Jessica Hulsey, the executive director of the Addiction Policy Forum, said that over-the-counter availability of Narcan should not replace funding for distribution of free Narcan to people who use drugs, especially those in high-risk populations, including prisoners.

She also raised concern about how Narcan would be showcased on the shelves. “Will it be behind the counter at a pharmacy?” she asked. “In lockboxes with razors and other products?” she added, pointing out that such placements could further stigmatize Narcan and its potential customers.

Many states already permit pharmacies to stock Narcan under what is known as a “standing order.” But because of deep-seated stigma toward people who use drugs, pharmacists are often reluctant to carry supplies or to engage with consumers, who may in turn become hesitant to ask for it.

Ms. Hulsey noted that, with the probable widespread release of the spray, staff at pharmacies and supermarkets should be trained in how to treat Narcan customers respectfully, not only to help dispel stigma but to encourage purchases of the lifesaving medication.

Dr. Scott Hadland, a pediatrician and addiction specialist at Massachusetts General Hospital, who testified as an independent expert in favor of approval, said that a key aspect of making Narcan widespread would be in normalizing it. Doing so would “really battle stigma and worries that people have about intervening in these moments. This is an unprecedented time where more than 100,000 people are dying every year, and we need to change the public’s outlook and the public’s response.”

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