Since it was created more than 50 years ago, naloxone has done one thing exceptionally well: save lives from an opioid overdose. Thanks to timely administration of naloxone by first responders, Good Samaritan bystanders, as well as friends and family members of people who use drugs, there are tens of thousands more Americans alive today -- fathers, mothers, sons, and daughters.
Naloxone is safe. It is easy to administer. It is readily available. And thanks to overwhelming support from an advisory panel to the FDA, it may soon be available over-the-counter to all who need it.
This is a critically important step if we are going to reduce the more than in the U.S. each year. As both a practicing physician in private practice in Flint, Michigan, and chair of the American Medical Association's (AMA) Substance Use and Pain Care Task Force, I've seen the tragedy of drug overdose in the lives of those it leaves behind.
In recent years, we've seen improved access to this life-saving medication. Physicians have increased naloxone prescribing, pharmacies continue to support naloxone dispensing, and harm reduction organizations are essential partners who distribute naloxone and provide essential, life-saving education and other services. Last year, FDA removed some of the regulatory barriers to allow harm reduction organizations to purchase naloxone directly from manufacturers. That has likely saved thousands of lives already. Most recently, the FDA advisory panel's 19-0 vote in favor of over-the-counter naloxone was a clear signal that this medication must be available everywhere.
However, we're at a point in the nation's overdose and death epidemic where barriers to naloxone persist, including the fact that naloxone is most often tucked away behind the pharmacy counter or sometimes not stocked at all. Removing the prescription status of naloxone will make it easier for community-based and charitable organizations to purchase and distribute naloxone to those who need it most. Making naloxone available over the counter would send a powerful message that naloxone is a critical public health tool for everyone, and reduce the stigma around its use.
Individuals should be able to pick up a package of naloxone without having to face the potential stigma or shame of having to ask for this life-saving medication. Naloxone should be just as easily accessible in a pharmacy, grocery store, or other common locations as acetaminophen for a headache, antacids for heartburn, or antihistamines for allergies. Naloxone should be available on the shelves for everyone to pick up and purchase. I carry naloxone because I never know when someone in a public space might need it. The nation's overdose epidemic is killing people old and young, rural and urban, with deaths growing fastest among young people, and Black and Brown individuals. We all can save a life with naloxone.
Making naloxone available over-the-counter is the next, long-overdue step to normalizing harm reduction initiatives in the community, among law enforcement, and for policymakers. But it must be accompanied by key actions from manufacturers, retail businesses, health insurance companies, and other payers. For over-the-counter naloxone to be a success, the following must occur:
- Expand insurance coverage. All payers must continue or start to cover naloxone at no- or low-cost. There are multiple OTC preventive health medications that are covered by insurance, such as aspirin, vitamin D, and fluoride. Naloxone should be added to that list.
- Price naloxone responsibly. Manufacturers must responsibly price their products and work constructively with payers and pharmacy benefit managers to ensure OTC naloxone is affordable to those with and without insurance. Naloxone manufacturers have already delayed OTC applications for years -- if their pricing strategies make their products unaffordable, OTC will not mean a thing.
- Leverage state funds. The AMA urges states to use opioid litigation settlement funds to purchase naloxone and distribute it to emergency departments and other locations where naloxone can be put directly in the hands of those at-risk of an opioid-related overdose as well as in the hands of individuals and loved ones who can help prevent an opioid-related overdose from leading to death.
- Broaden access everywhere. OTC naloxone will allow for many more health clinics, colleges, universities, high schools, and physician offices to better distribute naloxone. We encourage owners of grocery stores and gas stations to stock naloxone just as they stock many other OTC products. Many businesses and public places already have AEDs to save lives from heart attack -- let's make sure they also have naloxone and overdose prevention education to save lives from overdose.
I strongly support making naloxone available over-the-counter to help end the nation's overdose and death epidemic. I am pleased that some manufacturers have finally submitted applications to offer it over-the-counter. I urge all manufacturers to do so.
There is no moral or medical reason for naloxone to be hidden behind the pharmacy counter. If -- as expected -- the FDA approves naloxone's over-the-counter application, there is much more work to do. As health professionals, we must all keep pushing for expanded access to this life-saving medication as well as treatment for substance use disorder.
is a board-certified otolaryngologist in Flint, Michigan, immediate past Board Chair of the AMA and Chair of the AMA's Substance Use and Pain Care Task Force.