The FDA has suggested making the opioid overdose antidote Narcan available without a prescription over-the-counter, allowing customers to buy the crucial nasal spray in locations such as gas stations and grocery shops.
According to the FDA's Joint Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee, consumers should be able to obtain opioid reversal medication without a doctor's prescription, which would greatly increase access to the product and potentially save thousands of lives.
Narcan (naloxone) is a 4-milligram dosage nasal spray that is licensed to reverse the symptoms of an opioid overdose and, in many circumstances, prevents deadly overdoses from occurring with both prescription painkillers such as Oxycodone and illegal opioids such as heroin and fentanyl.
Opioids are responsible for 70% of drug overdose deaths in the United States, and the nasal spray has been hailed as a vital component of the national effort to combat the opioid addiction and misuse problems that have afflicted communities across the country in recent years.
Narcan is currently exclusively available through pharmacies, but the FDA advisory committee decision may force the government to enable the opioid reversal drug to be sold over the counter.
According to a World Health Organization research from 2014, the availability of Narcan over the counter might save tens of thousands of lives each year. The FDA invited naloxone manufacturers in November to apply for over-the-counter approval of the medicine.
While the FDA is not compelled to adopt the advisory committee's guidance, the fact that the FDA was already requesting firms to apply for OTC clearance, as well as the committee's unanimous decision, implies that the FDA will most likely follow its recommendations.
The opioid crisis in the United States has worsened, hitting an all-time high and being hastened by difficulties associated with the COVID-19 pandemic, largely due to irresponsible prescribing by doctors. According to health experts, the move to allow Narcan over-the-counter sales might save thousands of lives.
The committee cautioned that the risk of overdose is now too severe to prohibit the medicine from being available over the counter. Drug overdoses are the greatest cause of unintentional mortality in the United States. Prescriptions for naloxone grew from 359,000 in 2017 to 1.5 million in 2021.
The committee found that using Narcan without medical supervision is safe. The medicine has no impact when administered to someone who is not suffering from an opioid overdose.
It is simply delivered by spraying it into the nasal tube of someone who is suffering from an overdose. Subsequent dosages can be given two to three minutes after the initial dose, with no negative consequences.
Not all pharmacies maintain the medication on hand to complete prescriptions. The new policy would make opioid-reversal medication readily available at pharmacies, convenience stores, grocery stores, and even vending machines.
The suggestion will be forwarded to the FDA, which will make a final decision on March 29.
