FDA Approves Over the Counter Narcan
April 1, 2023 Don Pumphrey, Jr. Criminal Defense, Drug Charges Social Share
There are many risks when it comes to using controlled substances. The person in possession of the substance can be arrested and face criminal charges. There is also the concern for the person’s health and wellbeing, which has become more of a dire need in terms of opioid usage in the United States. This week, the FDA approved the use of naloxone for over-the-counter purchases. This decision can help save the lives of those who experience opioid overdose.
This page will define Narcan and its use, along with the details of the FDA’s approval for over-the-counter purchase.
What is Narcan?
Naloxone (Narcan) is a type of medication used to reverse an opioid overdose. Narcan is available in multiple forms, including the following:
- Nasal Spray
The medication works by blocking the opioid effects on the brain, and restoring the person’s breathing to normal. Narcan had previously been administered by healthcare professionals, first responders, or family or friends of individuals who were suffering or at risk of an opioid overdose.
When Should Narcan be Used?
Narcan should be administered when a person is experiencing an opioid overdose. An opioid overdose is a life-threatening emergency, and can occur when using any of the following opioids:
- Prescription painkillers
The signs of an opioid overdose includes any of the following:
- Slowed breathing
- Stopped breathing
- Extreme drowsiness
- Pinpoint pupils
If there is a person suspected to be experiencing an opioid overdose, Narcan should be administered immediately. One thing to note is that even if the person wakes up and recovers after receiving Narcan, they should still seek medical attention from a professional for further evaluation and treatment.
Legality of Narcan in Florida
According to the Orange County Government of Florida’s site, Narcan is already available to obtain without a prescription.
Under Florida Statute Section 381.887, a person can receive a prescribed emergency opioid antagonist (like Narcan) from an authorized health care practitioner. The prescription can be in the form of a non-specific standing order for an autoinjection delivery system or intranasal application delivery system, which has specific instructions on the label for use.
The patient or caregiver is then authorized to store or possess the approved emergency opioid antagonist and, in an emergency where the physician or health professional isn’t available, has the authority to administer the product.
It does not matter whether that person has a prescription for the emergency opioid antagonist, if there is a person believed in good faith to be experiencing an opioid overdose, then an individual has the authority to administer the product such as Narcan.
Narcan will become even more widely available, as the FDA has now approved its sale for over-the-counter purposes.
FDA Approves Narcan for Over-the-Counter Purchase
On March 29th, 2023, the FDA released press announcing its approval for the very first over-the-counter Narcan spray. This is the first naloxone product of its kind which has been approved to be purchased and administered without a prescription. The FDA’s approval is for a 4 milligram (mg) worth of naloxone hydrochloride nasal spray.
In a statement by FDA Commissioner Robert M. Califf, he claimed that providing over-the-counter naloxone authorization had become a “dire public health need.”
Previously, most states allowed pharmacists to provide a standing prescription for those who may require naloxone for opioid overdose. Any person who requested a prescription should have received one. However, it was not uncommon for pharmacies to refuse not to prescribe Narcan, as they did not want to enable illicit drug use. A recent report indicated that out of 17 million naloxone doses that were distributed in 2021, only 2.64 million were provided by pharmacies.
Given the recent uptick in overdose fatalities happening across the U.S. in places such as college dorms, classrooms, night clubs, restaurants, and inside family households, the public health advocates who pushed for over-the-counter naloxone have the goal of preventing any future lives lost.
The good news: Narcan is easy to use. The palm-sized device can easily be administered by inserting the tip into the unconscious person’s nostril and dispensing the medicine. Typically, Narcan should kick in and reverse the effects of an overdose within two or three minutes.
The bad news: Although Narcan will be easier to obtain, that does not mean that it will necessarily be cheap. Some may feel deterred from purchasing the product, as its price has a range of $10 to $98, depending on where it is being purchased, whether the person purchasing it has health insurance, and how much they are intending to purchase.
In addition, Narcan is not the answer for every type of drug. The emergency opioid antagonist will not work for methamphetamines or xylazine. However, addiction experts have taken note that considering many illegal drugs have started to become laced with the highly dangerous opioid fentanyl, it is still beneficial to have Narcan on hand.
The following is a statement by Robert G. Kramer, the executive officer of Narcan’s company, Emergent BioSolutions, after the FDA’s announcement on Wednesday:
“We are dedicated to improving public health and assisting those working hard to end the opioid crisis—so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risk of opioid overdoses and the value of being prepared with Narcan can save a life.”
Narcan is expected to be available for over-the-counter purchase by late summer. It is expected to be available in big-box chain stores, supermarkets, convenience stores, online retailers, and vending machines.
The following is a statement by FDA Commissioner Robert M. Califf:
“The FDA remains committed to addressing the evolving complexities of the overdose crisis…Today’s approval of OTC naloxone where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Finding a Drug Charges Attorney in Tallahassee, Florida
In recent years, Florida has seen an increase in opioid deaths. Law enforcement takes drug offenses very seriously, and a person caught with a controlled substance may face harsh consequences such as paying expensive fines, imprisonment, or both. If you or someone you know has been arrested on a drug charge in Florida, it is in your best interest to speak with a defense attorney as soon as possible. A skilled Tallahassee criminal defense attorney will review the details of your case and work towards building a strong defense.
Don Pumphrey and his team have worked with clients across the State for various criminal allegations. We understand the stress that you’re under when facing a charge, and will do everything in our power to protect your rights and fight for your case. Contact Pumphrey Law Firm today at (850) 681-7777 or leave an online message for a free consultation regarding your case.
Written by Karissa Key