A little bit of pharmacological cavalry is coming for first responders and others who are on the front lines of the overdoes tsunami that claimed over 100k lives in fiscal year 2022 in America. A nasal spray version of the standard opioid overdose treatment Narcan, naloxone hydrochloride, in over-the-counter and nonprescription form has been approved by the FDA.
Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online.
The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.
Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl.
More Narcan in more hands and places means quicker access in the critical moments means more lives saved. But it has to get into the overdosing person to work.
Back in 2016 in Huntington, WV, a particularly nasty batch of heroin cut with far more fentanyl than heroin led to at least 26 overdoses in just a few hours, and in cluster spots within the city. With first responders sometimes having to administer two doses to a single overdosing patient, authorities were quickly left scrambling for more. Policy proposals to distribute Narcan in places like colleges and universities, public health facilities, and other places of potential high need are limited when it comes to prescription drugs, as is the previous need to inject Narcan. The OTC nasal spray is an answer to both problems.
But Narcan is not a magic bullet. While it does stop an overdose if used in time, it has its own downsides. Narcan can, and usually does, put someone who is a habitual opioid user into nearly instant withdraw, meaning the rate of people who go looking for their next fix as soon as the first responders leave, or they are released from medical care, is really high. It also affects the user in ways that risk an even worse overdose as they try to self-medicate. Narcan is a last-ditch effort to revive a overdosing person that thankfully is pretty effective, but without the other structural needs of addiction care at hand can be part of the vicious cycle that is drug dependency.
The need for more accessible Narcan is a result of having made so little progress against the present opioid crisis, the wider “war on drugs” debacle of the last 40 years, and in treating addiction in general. Drug addiction is a cycle for the addicted, and a society that wants to pick and choose only the convenient parts of that cycle to step in and intervene will be perpetually feeding the rest of that cycle when only politically expedient half-assed measures are applied to the most obvious parts. Every opioid overdose is also a bomb going off with a blast radius that affects not just the user but first responders, the health care system, often the criminal justice system, and the wider community as well. And at the bottom of all that, besides all the policy, and politics, and budgets issues, and health care & policy debates, there is also a human life that otherwise could be a productive member of society. If they don’t overdose. If they can get some Narcan in a timely manner if they do. If they can get further treatment and help afterwards. If the community doesn’t turn it’s nose up and close their budgets to things like treatment and mitigation programs. If the community can be made to care at all. If the addict can be helped to start caring for and about themselves.
If, if, if…
The FDA approving nasal spray Narcan is an improvement on the last-ditch efforts to save the lives of opioid overdose patients. That’s a fine, needed thing. But unless wider society, we, all of us, start taking the opioid crisis serious, it will be just another last-ditch effort to try and reverse all the other things being done wrong when it comes to opioid addiction, both by omission and commission. The WHO declared COVID-19 a pandemic after 4,291 deaths across 114 countries. America had 101,750 reported fatal overdoses, and who knows how many unreported, in fiscal year 2022 alone. While a shot or nasal spray of Narcan can revive the overdosing user, we have yet to develop anything that can inject a dose of give a damn into the American people for the crisis. As long as the dropping bodies are “them over there” and death and wrecked lives don’t happen to the right folks in the right places to be bothersome or inconvenient. You could say we have more than a few folks that are addicted to comfort, success, and not being bothered by those who have neither, desperately using technology to give them another hit of whatever news and information keeps their carefully curated world spinning the right way. We as a society are practically overdosing on instantiations, judgement and group think through the power of social media, happily searing everyone held up virtually or otherwise while filtering our pictures, profiles, and public brands to cut out all the ugly parts, lest someone judge us next.
Interesting which addictions are socially acceptable, and which are not.
Good on the FDA for quickly, by their standards, taking this step and getting Narcan in more hands for more folks in crisis. Now if we could just get a review process for the rest of America on how we are dealing with opioid crisis to result in a shot in the nose for a country that needs to get a handle on its, our, opioid problem.
I wonder if they’re gonna offer citizen training in how to administer it, like CPR training exists. (And also: there may need to be ‘good Samaritan laws” for this – many states have them for CPR, on the grounds that sadly, most of the time CPR patients don’t make it, and those that do often wind up with broken ribs, and there have been isolated cases of families trying to sue the CPR-giver).
I admit I am not very knowledgeable about the “in the trenches” part of dealing with opioid addiction; I am not sure I have ever known anyone who abused them. But I could see it becoming part of the mandatory training faculty do, how to reverse an OD. (And knowing how to administer would be useful in other settings, of course….I suspect a person would more likely spot someone ODing in the local grocery store than in a college lab….)Report