There has been quiet talk over the past year or so of the coming of over-the-counter naloxone, known best by its brand name, Narcan. The approval of a drug going from prescription to OTC can be a long and difficult process. In the case of the over-the-counter naloxone nasal spray, the word is that the Food and Drug Administration (FDA) is fast-tracking this important drug through the process. Still, it has been about a year and we have not heard the outcome of this groundbreaking decision.
Why would the FDA reverse its plans for OTC Narcan?
While we expect the decision to make naloxone nasal spray available on pharmacy and grocery store shelves to go through, it is possible that the FDA will eventually backtrack and deny the approval. There are concerns amongst various groups that more freely available Narcan will increase opioid overdoses and deaths. How is this possible?
How could Narcan, an opioid overdose-reversal drug, increase the number of opioid overdose deaths?
The thinking goes as follows: if a heroin user on the street can easily get Narcan from nearly any store without education or counseling, they will feel safer from the dangers of having an overdose. They simply have to have a friend nearby with Narcan nasal spray in hand, ready to give a few sprays in the nostril to reverse any overdose that may occur. If heroin users think that they are overdose-safe, they will use fentanyl-tainted heroin at higher doses without fear. Inevitably, there will be slip-ups and, in the end, the number of deaths will increase.
Is the concern of more opioid overdose events legitimate?
These concerns about OTC naloxone seem suspect to me. Who could really think that making an overdose-reversal drug more freely available could be a bad thing? The same concern arose over seatbelts in cars. Law enforcement officials and politicians believed that drivers would drive their cars faster and more recklessly because of the false sense of security that comes from wearing a seatbelt.
What entities would suffer financially if Narcan goes OTC?
When it comes to OTC Narcan, there are people who would lose some business if the public had OTC access to the drug. Pharmacists and pharmacies would have less business. Currently, Narcan holds behind-the-counter status in many states. This means that a patient must speak to a pharmacist first before getting the drug. Because of this status, Narcan can not be sold on grocery store shelves in stores that do not have a pharmacy. If naloxone becomes OTC, people can buy it and skip the pharmacy altogether. Rehabs might have fewer clients. Hospitals might have fewer ER admissions. By making harm reduction more readily available, the recovery process for many individuals may be safer and more streamlined, not requiring the services of these institutions in the midst of the current opioid crisis.
How might recovery be easier with better access to Narcan?
Imagine this. You are addicted to heroin and you are on the streets, putting your life at risk every night because you never know if your heroin is tainted with fentanyl. Your mother or father, husband or wife, brother or sister, is able to buy OTC Narcan without any scrutiny. There is no questioning, disapproving look from a pharmacist or paperwork to fill out. They simply buy a pack of naloxone nasal spray along with their milk, eggs, and butter at the local grocery store. Now, as you are passing out in your bedroom from a deadly dose of opioids, your loved one crashes through the door and administers naloxone hydrochloride nasal spray. You have just had the scare of your life, a near-death experience. You may be motivated now to seek help from a doctor who treats opioid addiction. Of course, if you are in this situation, you should realize that the life-saving Narcan rescue may never come and you may not wake up at all.
When the FDA denied OTC approval for a life-saving drug in the 80s.
There was once a situation where the FDA was planning to approve a life-saving drug for over-the-counter use and then reversed its decision. This occurred in the 80s. In fact, the FDA, in a rare move, initiated the request itself to make this particular drug OTC. Then, special interest groups and politicians got involved, fought the decision and, ultimately, were successful. The drug in question was metaproterenol, an asthma rescue inhaler. Currently, there is only one inhaler for asthma that is OTC and it is dangerous. The available OTC drug contains pure adrenaline and can cause a heart attack, even in a healthy, young person. Metaproterenol is a much safer drug with relatively no downside compared to the existing alternative. How could it be bad to replace a dangerous drug with a safer one? Here is the problem. Pulmonary treatment groups were concerned that patients would self-treat their asthma without seeking out a specialist who might provide proper asthma treatment and education. Yet, they can already do this with the existing dangerous inhaler that is currently on store shelves. Do you see anything wrong with this? A life-saving drug that would have replaced a much more dangerous available drug was blocked from approval so lung doctors would not lose business. Wouldn’t a label warning have sufficed? Patients could read several sentences about the importance of follow up with a pulmonologist to administer long-term anti-inflammatory treatment. Yet, the public was denied easier access to this life-saving drug so specialists would not lose new patient visits.
How are naloxone products similar to metaproterenol?
While the drugs have nothing in common otherwise, what they do share in common is a similar public approval debate. Naloxone drugs include Narcan nasal spray and the Evzio auto-injector. These products can save lives and they are very safe. I recently went to a medical convention lecture where a medical expert on stage made a bold statement that he could walk around the lecture hall, which contained hundreds of doctors, and give everyone in the room a spray of naloxone in their nose without harming anyone, assuming that no one was currently taking opioids. Naloxone is that safe. Yet, there are various entities out there who imagine that somehow making naloxone more readily available will be a bad thing.
Ask the first responders and doctors working in emergency rooms what they think.
Instead of asking special interest groups and politicians what they think, let’s ask the people working on the front lines if OTC naloxone is a good idea. Community-based first responders don’t have enough naloxone to save everyone who needs to be saved from opioid overdoses. ER doctors are seeing heart-breaking cases that might have benefited from more bystanders carrying naloxone on them. There should be no stigma associated with carrying naloxone. We should all have it. Family members should be prepared at all times with naloxone nasal spray.
An overdose in recovery during a 12-step meeting.
An ER doctor once told me a story about a patient who had overdosed right in the middle of a Narcotics Anonymous meeting. The patient must have decided to shoot up one last time just before the meeting started. The members of the meeting were not prepared to handle an opioid overdose, other than by having cellphones ready to make the 911 call. This is an important point. It was not that long ago that cellphones were not commonplace. Fortunately, the world has changed and we all carry communications devices with us at all times. How many lives have been saved by this change in society where we are all prepared to make a call for help in case of emergencies? I posed a question to an NA discussion group online. Should NA groups have a supply of naloxone in case an opioid overdose occurs? The response was that NA groups do not have the responsibility to keep naloxone on hand. Other people, however, responded that individual meeting attendees can and should carry naloxone. Early administration of naloxone in an overdose before first responders arrive can make all the difference in saving a life.
Naloxone nasal spray is already available in pharmacies without a prescription.
In most states, we can already purchase naloxone without a prescription. While it is not fully OTC, people can walk up to a Walgreens pharmacy counter, for example, and get naloxone. It is as easy as getting a flu shot. For the time being, until the FDA makes naloxone available over-the-counter, we should all make the effort to approach the pharmacist and ask for an emergency rescue kit of naloxone nasal spray. By having naloxone on hand at all times, we increase the chances that someone who experiences an overdose will have a second chance at life and recovery.