As drug overdose reigns as the leading cause of accidental death in the United States, naloxone has emerged as one of the most promising solutions to the crisis. A safe, effective antidote to opiate overdose, naloxone access has become the battle cry for advocates working to save lives from drug overdose. Nineteen states have recently amended their laws to make this prescription-only medication more available to the public and over 200 community programs nationwide distribute naloxone to people at risk for opiate overdose and their loved ones. But despite many educational, legal and programmatic efforts to make naloxone widely available, progress is slow and delays result in more preventable deaths. The best solution to get naloxone quickly and effectively to people who can use it to save lives is to make it affordable and available over-the-counter. Here are a few reasons why:
1. Doctor's Visits Are a Barrier to Naloxone Access - Even for people with insurance, the investment of time and finances to schedule a doctor's appointment and obtain a prescription for naloxone is a major obstacle. For people at highest risk for drug overdose (those who may be using illicit drugs or taking prescription drugs other than as prescribed) asking a medical provider to write out a prescription for naloxone can be nerve-wracking and futile. Many medical providers are unwilling to prescribe naloxone because they believe it will encourage a person to use more drugs. Despite evidence showing that naloxone does not increase or enable drug use, many medical providers have bought into these myths and will let prejudice and stigma against drug users take precedent over their Hippocratic oath. Making naloxone available over-the-counter would remove the inconvenience of a doctor's appointment and the risk of encountering judgment and stigma from medical providers.
2. Naloxone is Safer and Easier to Use than Other Emergency Medications - Some argue that naloxone should not be available over the counter because other emergency medications, such as epinephrine (the EpiPen), for allergic reactions, and glucagon, for low blood sugar, are not. But unlike epinephrine and glucagon, which are dangerous when administered incorrectly, naloxone has no effects if administered to someone who is not experiencing an opiate overdose. In fact naloxone has no side effects at all except for withdraw symptoms in someone with opiate dependency.
Naloxone is very simple to administer (a quick injection into the muscle or a nasal spray), unlike glucagon, for example, in which the correct dosage must be mixed with a powder and liquid according to directions on a package before being injected. In fact, naloxone is so easy that a 2014 study found no significant difference in outcomes between people who were trained on naloxone administration and those who were not. This indicates that naloxone is easy enough for a person to figure out without instructions even in a situation as stressful as an overdose. The same study also reported no evidence of increased drug use among the nearly 5000 drug users who received naloxone.
3. Over-the-Counter Naloxone Would Create Equity of Access Between States - Overdose prevention advocates have devoted an enormous amount of time and resources to fighting for laws that expand access to naloxone and to implementing programs that distribute the antidote to people at risk for overdose. As a result, naloxone access varies widely state to state. In some states, naloxone is distributed through community programs, health departments, hospitals and other institutions, and people who administer the antidote and doctors who prescribe it are protected from liability. In others, a legal gray area forces naloxone distribution programs underground. Making naloxone available over-the-counter would even out access disparities between states and save time and resources for advocates who are fighting for legislation.
4. Many People Can't Afford Naloxone - Along with being available over-the-counter, naloxone also needs to be made more affordable. Though it can be purchased in many countries for less than a dollar per dose, prices in the United States are typically higher and have increased significantly in recent years. Prices vary depending on location and the buyer, but intramuscular naloxone costs about $20, while intranasal naloxone costs about $35. The price of a new auto-injectible naloxone, Evzio, is not yet known, but if similar products are any indication, it will likely be expensive. In order to ensure that naloxone is affordable, it should be available in a free, competitive environment with few regulatory hurdles so that it reaches the marketplace at a price similar to what it costs to produce.
5. The FDA Can Fast-Track Over-the-Counter Naloxone - In 2012 the Food and Drug Administration (FDA) met to discuss the possibility of over-the-counter naloxone. Not only does the FDA wield the power to make naloxone available without prescription if it meets certain safety guidelines, but they can also fast-track the process (as they did to approve auto-injectible naloxone). With overdose deaths still skyrocketing, the FDA should expand access to this life-saving medication.
To encourage the FDA to fast-track over-the-counter naloxone, the National Institute on Drug Abuse (NIDA) should prioritize funding for product development research (a precondition for the FDA to approve an over-the-counter product). Federal agencies should also step up and start advocating for more access and affordability for this life-saving product. Overdose prevention advocates will continue to fight for laws and programs that make naloxone more available, but there is only so much they can do. If we truly want to end this epidemic that has claimed so many lives, naloxone needs to be made affordable and available over-the-counter.