A panel of individuals from the Food and Drug Administration voted unanimously to make Narcan available over the counter in the United States. Narcan is a nasal spray administered to an individual if they are suspected of an opioid overdose.
According to The Centers for Disease Control and Prevention, opioids are currently the primary drug responsible for overdose deaths in the United States. As opioid-related deaths continue to increase, there is a pressing need to expand access to overdose reversal treatment.
According to The National Institute on Drug Abuse, over 106,000 people died from opioid overdoses in 2021.
The FDA's panel of Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committee and nineteen independent experts met and voted unanimously to make Narcan an over-the-counter drug.
However, if the FDA approves, Narcan's access will be easier at pharmacies. In that case, Narcan could be made available at convenience stores, supermarkets, and vending machines at health facilities, libraries, bars, supermarkets, and more.
Changing the availability of this drug could have more effects than just the ability to save lives. This switch could help remove the stigma surrounding the drug. This change would demonstrate that the drug is safe and can be administered by anyone. No healthcare knowledge is required.
According to Joshua Lynch, a clinical associate professor of emergency and addictive medicine at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, bystanders are present in nearly half of the fatal overdoses. However, Narcan is only administered in a small percentage of those cases. Improving access to this drug can reduce the number of opioid-related deaths.
Narcan nasal spray meets all the FDA requirements to switch to an over-the-counter drug. The drug is easy to use for all, does not require a healthcare professional to administer, and has a low potential for use for purposes other than what it was designed for.
Narcan is not a drug that can be successfully abused. The drug cannot make an individual high and will not affect someone unless they have opioids before the Narcan administration. The drug is not poisonous. It can help save them. The benefits outweigh the potential risks of giving this drug over-the-counter status.
The panelists raised a concern about the drug's instructions and packaging. There was worry that the instructions were confusing and simplicity plays a vital role in the product's effectiveness. There is an indication that the company will change the packaging and instructions of Narcan that comply with the FDA's suggestions.
All fifty U.S. states currently have access laws allowing pharmacists to dispense Narcan without a doctor's prescription. However, access barriers still come into play. The FDA has warned that the current level of Narcan distribution does not match the number of at-risk patients. Therefore, the vote for making Narcan an over-the-counter drug has come to help reduce the amount of opioid-related deaths.
The FDA is set to decide on the matter by March 29th. If this is cleared, then Narcan would become the first to transform its prescription-status approval into over-the-counter approval.
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