FDA approves Narcan for over-the-counter sales, here’s what you need to know

[MUSIC PLAYING] INTERVIEWER: And among the other top stories is the announcement from the US Food and Drug Administration that Narcan, a drug that reverses opioid overdoses will soon be available over the counter in a single-dose nasal spray. FDA commissioner Robert Califf said in a statement that this could help curb the rise in opioid overdose deaths around the country. In 2021-- the last year state numbers are available-- 978 people in Minnesota died of an overdose. That's more than twice the number from two years earlier.

Heather Blue says this is very exciting news. She's an Associate Professor of Pharmacy for the university of Minnesota Duluth and an Emergency Medicine Pharmacist at St. Luke's hospital in Duluth. Heather Blue's on the line. Welcome. And thanks for being on the program.

HEATHER BLUE: Yes. Thanks for having me.

INTERVIEWER: So the FDA has approved Narcan across the country. And that's one brand name of naloxone. Let's just kind of give folks a bit of a primer here. How do these drugs work exactly?

HEATHER BLUE: So if we think about how opioids cause overdose, they sit on the opioid receptors in our body. And while that can provide euphoria and kind of that high and as well as pain control, part of that opioid receptor can actually decrease your respiratory drive and so that urge to breathe. And so what we see in opioid overdoses is our patients will not breathe. They will not be breathing adequately or they will stop breathing altogether.

When naloxone or as you mentioned the brand name, Narcan, when that medication is administered, that medication goes into the body and then rips off the opioid off of that opioid receptor. And so what we see then is the patient is able to have that drive to breathe, be able to take breaths, as well as it does then cause some opioid withdrawal. But what we want that naloxone to do is to allow the patient to be able to breathe and of course, then prevent a fatal overdose.

INTERVIEWER: Mm-hmm. How might this decision by the FDA help increase access?

HEATHER BLUE: So I think the decision made today by the FDA to make naloxone-- and they did state that it is the nasal spray formulation. Naloxone can be given through many different mechanisms. We can give it IV.

We can put it intramuscularly. And so you can inject naloxone. But the intranasal is by far the most easiest administer medication to reverse opioid overdose deaths. And I think making it over the counter will really increase the accessibility of the medication for patients as well as patients family members to really obtain this and to be able to prevent those fatal overdoses.

I should also point out as we're talking about accessibility that it's not the patient or the person that is experiencing the opioid overdose that's going to be administering this medication. It is going to be the friends, the family members, the rescue workers that will be administering this medication. And so seeing that accessibility-- when it was just a prescription medication, there was some concern of whether or not that prescription should be written for the person that would be most likely to use that versus the patient that wanted to have it available. And so I would take care of a mother who had a child with opioid use disorder, and it was always that piece of whether or not that prescription should be in the mother's name or the child. And so by going over the counter, we've really taken that away and made it available for family members, anyone who wants to have naloxone on hand to hopefully, again, reverse that fatal overdose.

INTERVIEWER: I'm curious because the opioid epidemic has hit rural areas so very hard, how available is this drug right now in rural areas? And will this decision by the FDA help increase access?

HEATHER BLUE: Yes, that's an excellent question. So being that naloxone was currently before today available only with a prescription, that really limits where that medication can be. And so it limits it in pharmacies only.

And we know that especially in our rural Minnesota areas that we do have places that are pharmacy deserts, that it's a long ways away for some of our residents to be able to have a pharmacy. We don't know exactly where this naloxone over-the-counter will go, but this announcement by the FDA and this decision does make it available that it could be as similar as ibuprofen or acetaminophen be available in stores, grocery stores, gas stations even. So that can definitely increase the accessibility in our rural areas. You could be able to instead of having to go to a doctor and get a prescription or go to the pharmacy to pick up your naloxone, that it could be available is when you fill up your gas tank, you could also get the naloxone if that's something that you need or you'd like to have available for a family member or friend.

INTERVIEWER: Unclear about the cost at this point, though I'm sure we'll find out more about that.

HEATHER BLUE: That's definitely been the piece today as this announcement comes out because we had gotten to a point where insurance companies were covering the prescription naloxone fairly well, either at a no cost or a decreased co-pay. And so usually what happens when a medication goes over the counter a lot of private insurances will not cover over the counter products. So it is really unknown right now of where that coverage will lie. And again, that's a decision made by the insurance companies. And then where the price point is, so even if it's not covered by insurance making sure that it is still affordable for patients that want to have this available.

INTERVIEWER: So this FDA announcement is really has excited those who have been trying for a number of years advocating for this and as a way to help those who have opioid use disorder. But I'm wondering, when Narcan was introduced as you know, there were some concerns about it. Some doctors and researchers contended that easy access to Narcan could enable continued opioid abuse and maybe worsen the crisis. Are those concerns still out there in the medical community?

HEATHER BLUE: Oh, absolutely. I would say those concerns are still out there, but I would also categorize them as they also are fueling some of the stigma seen around this, both this product naloxone as well as the opioid use disorder in general. And I think as we look at the studies, we can see that when naloxone is available and some of their harm-reduction strategies such as safe use places, the use of opioids does not increase. We see those fatal overdoses decrease.

Now, again, all of these harm-reduction strategies, we need to be thinking at a broader the next step. So this naloxone will reverse an opioid overdose. However, it doesn't take care of the opioid use disorder. It doesn't think about preventing an additional overdose experience.

And so while that stigma still stands within health care practice, I think, there are equally amounts of studies showing that it doesn't increase. It doesn't increase that engagement, however, it does save lives. And then those lives save can move forward into thinking about how we can treat opioid use disorder in a in a more holistic way.

INTERVIEWER: Final question here for you. There are groups across the country in Minnesota universities training people on how to administer naloxone. There are guides online. How do you recommend that folks educate themselves about how to use this?

HEATHER BLUE: So naloxone uses is very easy in administering it. And there are, again, even just a quick Google search of naloxone, you can find YouTube videos. The packaging will have education. The current prescription packaging has pictures and diagrams as well as walking you through with words. And I know the over-the-counter product the FDA will ensure that there's that same education.

I think what you need to know about naloxone, it should be administered when a patient is suspected of opioid overdose deaths or opioid overdose. So that looks like them being really lethargic, sleepy, again, they're not able to breathe well. You may see some blue lips, a blue color to their skin.

The nasal form, which again will be over the counter, all you have to do is insert that into the patient's nostril, press the little trigger that gives the spray. And so even if they're not breathing adequately, you can absorb that medication within your nose. And then that, again, is going to go and kick that opioid off the receptor.

The other piece that I think is really important that people know is that often the opioid that's causing the overdose hangs around in the body longer than the naloxone. So even if you have the naloxone available and the patient does start to breathe again, that patient needs medical attention. So they either need to call 911 and have medical personnel there.

They need to be brought to emergency department because it's once the naloxone leaves the body, there is that chance that the patients will have an additional overdose. And so they may require additional naloxone. So it's really important that that people just know that piece of that while we have more naloxone available, that does not take the place of further health care needs for that patient as well as getting connected to some of the community resources and treatment for opioid use disorder.

INTERVIEWER: Good advice. Heather Blue, thank you so much.

HEATHER BLUE: Yes, thank you for having me.

INTERVIEWER: Heather is an Associate Professor of Pharmacy for the University of Minnesota Duluth and an Emergency Medicine Pharmacist at st Luke's hospital in Duluth. Yesterday you might remember we had a conversation with Indigenous Peoples Task Force director Sharon Day and Eric Rundell from the State Department of Human Services about their efforts to stop overdose deaths. You can find those interviews and read more about what the FDA had to say about this decision on our web site mprnews.org.