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FDA panel OKs making Narcan available for over-the-counter use

Bethany Blankley | The Center Square

(The Center Square ) – A Food and Drug Administration advisory panel unanimously voted to recommend the agency approve Narcan, a life-saving drug for opioid overdoses, be made available to purchase over the counter without a prescription.

Narcan is accessible for free and low cost online, through a range of community organizations, and through pharmacies with and without a prescription and with or without insurance.

Here’s how Americans can get it.

All 50 states and the District of Columbia have “access laws or alternate arrangements in place that allow persons to obtain naloxone from a pharmacist without an individualized, in-person prescription,” Narcan.com reports. The majority of states and the District of Columbia have Naloxone standing orders, which allow adults to purchase the drug from a licensed pharmacy without a prescription, Rehabs.org explains.

The majority of states have also authorized third-party prescriptions, meaning pharmacists and doctors can prescribe and dispense Naloxone. All state health departments also have information about Naloxone training programs and resources to acquire the drug, including free access.

However, making the drug available over the counter will make it more accessible, those on the panel argued. On Feb. 15, the panel voted 19-0 to recommend the agency do so. The FDA has said it will make a decision by March 29, although the decision could come sooner.

In December, Emergent BioSolutions, which was first authorized to sell NARCAN Nasal Spray in 2015, announced the FDA had fast-tracked its application to sell the drug over the counter.

Greater access to Naloxone, law enforcement officers have told The Center Square, has the potential to save countless lives. It’s important to note that while Naloxone is successfully used in emergencies, it doesn’t replace emergency medical care, health officials warn.

Naloxone has been effective in treating fentanyl poisoning. Illicit fentanyl, a highly addictive synthetic opioid, is 50 times more potent than heroin and 100 times more potent than morphine. Two milligrams, roughly the weight of a mosquito, and small enough to fit on the tip of a pencil, is considered a potentially lethal dose.

In December, the DEA announced that in 2022, it seized enough fentanyl to kill more than everyone in the U.S. Since March 2021, Texas law enforcement officers have seized over 360 million lethal doses of fentanyl, enough to kill more than everyone in the United States. U.S. Customs and Border Protection officers in the last two years have also seized enough fentanyl coming through the southern border to kill everyone in the U.S. multiple times over.

The DEA has published several public safety alerts about the dangers of fentanyl. Florida’s One Pill Can Kill website and Fast Facts on Fentanyl toolkit include a DEA Emoji Drug Code to educate parents about how dealers are selling illicit drugs targeting minors through social media apps.

Children under age 14 are dying from fentanyl poisoning at a faster rate than any other age group in the U.S., according to a new analysis from Families Against Fentanyl. Fentanyl poisoning remains the leading cause of death among Americans between the ages of 18 and 45 years old, according to the CDC.

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