On March 29, 2023, the US Food and Drug Administration approved Narcan for over the counter sales. Narcan is the 4 milligram nasal spray version of naloxone, a drug that can quickly reverse opioid overdose.
The FDA’s approval of over-the-counter naloxone means it will be available without a prescription at more than 60,000 pharmacies nationwide. That means naloxone nasal spray will be available at a pharmacy for 90% of Americans within 5 km of home. It will also likely be available at gas stations, supermarkets and convenience stores. The transition from prescription to over-the-counter status is expected to take several months.
We are pharmacists And public health experts who want to increase public acceptance of and access to naloxone.
We believe making naloxone available over the counter is an essential step in reducing overdose deaths and destigmatization opioid use disorder. Over-the-counter access to naloxone will allow more people to carry and administer it to help others who overdose. In addition, increasing the over-the-counter availability of naloxone will send the message that the risks associated with substance use disorder warrant ubiquitous intervention, as with other diseases.
Deaths from opioid overdoses in the US nearly tripled since 2015. Between October 2021 and October 2022, about 77,000 people died of opioid overdoses in the US. As of 2016, the synthetic opioid fentanyl accounts for the majority of the drug-related overdose deaths in America.
What is Naloxone?
Naloxone reverses the overdose of prescription opioids such as fentanyl, oxycodone, and hydrocodone and recreational opioids such as heroin. Naloxone works by competitively binding to the same receptors in the central nervous system that opioids bind to for euphoric effects. When naloxone is administered and reaches these receptors, it can block the euphoric effects of opioids and reverse respiratory depression when an opioid overdose occurs.
There are two common ways to administer naloxone. One is through the pre-packaged nasal sprays, such as Narkan And Kloxxado or generic versions of the drug. The other method is through auto-injectors such as ZIMHIthat deliver naloxone via injection, similar to how epinephrine is delivered by an EpiPen as an emergency treatment for life-threatening allergic reactions.
The FDA will file a second over-the-counter application for it naloxone autoinjectors at a later date. While no interaction with a healthcare provider is necessary to purchase over-the-counter naloxone, when naloxone is purchased from a pharmacy, a knowledgeable pharmacist can help people choose a product and explain directions for use.
Research shows that when people who are likely to witness or respond to an opioid overdose have naloxone, they can save patients’ lives. This includes both bystanders and first responders such as police officers and paramedics.
But until now, people could intervene in those situations only if they carried prescription naloxone or knew where to get it quickly. Friends and family of people taking opioids often get prescriptions for naloxone for emergency use. Over-the-counter naloxone will help make the drug more accessible to members of the general public.
Reducing stigma and saving lives
Naloxone is a safe drug with minimal side effects. It only works for people with opioids in their system, and is unlikely to do any harm if accidentally given to someone who is not actively overdosing on opioids.
Since about 40% of overdoses take place in the presence of someone else, we believe public access to naloxone is extremely important. People may want to have naloxone on hand if someone they know is around increased risk of opioid overdoseincluding people with an opioid use disorder or people taking large amounts of prescription opioid medications.
Community centers and recreational facilities may also have naloxone on hand, similar to the placement of automatic external defibrillators in public areas for emergency use when someone has a heart attack.
There is a longstanding public stigma that suggests addiction is a moral failure rather than one chronic but treatable health condition. Those requesting naloxone or who have an opioid use disorder experience stigma and often feel uncomfortable disclose their drug use to others or seek medical attention. Removing naloxone’s prescription requirements by making it available over the counter could reduce the stigma individuals experience as they no longer need to request it from a healthcare provider or behind the pharmacy counter.
In addition, we encourage healthcare providers and citizens use less stigmatizing language when discussing addiction.
Questionable accessibility
Often, medications are switched from prescription to over-the-counter medications not covered by insurance. It remains unclear whether this will be the case with Narcan. If so, the cost shifts to the patient, which is the reason to continue support programs that offer naloxone for free remains important.
In addition, over-the-counter access could paradoxically lead to a decrease in the drug’s availability. An increase in purchases could make it more difficult to buy naloxone if the manufacturer’s supply fails to keep up with increased consumer demand. The US has experienced something like this shortage of over-the-counter medicines late 2022 during the nationwide spikes in flu, respiratory syncytial virus and COVID-19.
Federal and state governments could reduce these potential barriers by subsidizing the cost of over-the-counter naloxone and working with drug manufacturers to provide manufacturing incentives to meet public demand.
The effects of nationwide access to over-the-counter naloxone on opioid-related deaths remains to be seen, but making this drug more widely available is an important next step in our nation’s response to the opioid crisis.
