Overdose Epidemic

Naloxone: FDA approves over-the-counter Narcan nasal spray with Bobby Mukkamala, MD


AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, medical education, advocacy issues, burnout, vaccines and more.

In today’s AMA Update, Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, joins to discuss what FDA's recent approval of OTC naloxone means for doctors and patients—as well as how to administer Narcan in an emergency. The life-saving medication can reverse an overdose from fentanyl, oxycodone and other opioids. AMA Chief Experience Officer Todd Unger hosts.

Visit the End the Epidemic site for more information on AMA’s efforts to end the overdose epidemic.

Access "Substance Use Disorders and Addiction Education to Meet New DEA Requirements" training via AMA Ed Hub™ and get Continuing Medical Education (CME) credit and satisfy new requirements issued by the DEA to meet conditions of the MATE Act for physicians and practitioners on treating and managing patients with opioid or other substance use disorders.

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  • Bobby Mukkamala, MD, chair, AMA Substance Use and Pain Care Task Force

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Unger: Hello and welcome to the AMA Update video and podcast series. Today, we're talking about the FDA's recent authorization of naloxone for over-the-counter sale and how it can help prevent overdose deaths.

I'm joined today by Dr. Bobby Mukkamala, immediate past chair of the AMA Board of Trustees and chair of the AMA Substance Use and Pain Care Task Force. He's calling in from Flint, Michigan. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Mukkamala, welcome back.

Dr. Mukkamala: Thanks, Todd. It's good to be back with you.

Unger: So this is big and great news, and something that the AMA has been advocating for a while. Tell us a little bit more about this development.

Dr. Mukkamala: Yeah. So indeed, it's very good news, Todd. But just to clarify, the FDA has approved only one naloxone product so far, and there's another application that the FDA is reviewing, but there's multiple naloxone manufacturers who have yet to submit over-the-counter applications. But in general, this isn't a moral or medical or ethical reason for naloxone manufacturers to delay submitting these applications now so that these steps can be taken.

And as for the actual naloxone product approved by the FDA, it's a nasal spray that reverses opioid overdoses. And so with this approval, it can now be sold over the counter, which is a great step forward, as you said, something the AMA has championed for a long time.

The expectation is that by late summer, it'll be for sale in big chain pharmacies and vending machines and supermarkets and convenience stores, gas stations, basically wherever it is that customers are buying products. And as we said, despite a lot more work to be done, this is really going to help transform how we compassionately and logically, frankly, respond to overdose epidemics. And more lives will be saved with this.

And honestly, if it weren't for naloxone, there'd be tens of thousands of more Americans dying from opioid overdose. And this is related to illicitly manufactured fentanyl, which has really driven this increase in deaths, a record number of deaths this past year.

Unger: We're going to talk a little bit more about that. Dr. Mukkamala, just first off, I mean, obviously, a lot of medications move from prescription status to over-the-counter. Any concerns with this move?

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Dr. Mukkamala: Not really with this one, Todd. I mean, one reason that the FDA approved naloxone for over-the-counter status is that it's very easy to administer and it's very safe. So anyone that's going to come upon a person who's slumped over, is unresponsive, slow, shallow breathing, signs of possible overdose just has to unwrap this palm-sized device that comes in these packages and insert it, the tip of it into somebody's nose and just depress the plunger.

And in most situations, this medication revives that person within two or three minutes. So it's very safe and effective. And with increased fentanyl access in our drug supply, it's going to save lives.

Unger: Now Dr. Mukkamala, if fentanyl wasn't bad enough, there's a lot of stories out there about the addition of xylazine to fentanyl. In that case and that combination, can naloxone help if there's an overdose on that combination of drugs?

Dr. Mukkamala: Yeah, absolutely. You know, and if you suspect somebody's overdosed, the AMA strongly encourages the use of naloxone. It's very unlikely that you're going to know what somebody is overdosed on when you come upon them and they're shallow or not breathing in front of you.

And there's a lot of news about illicit fentanyl, that's as you mentioned xylazine, which is an animal tranquilizer. But it's been an accessible veterinary drug approved for use in animals, but it's something that is now newly sort of mixed with fentanyl. And it's not the only thing that's mixed with fentanyl.

Methamphetamines, cocaine are all mixed with fentanyl. And so now what that means is there's really no downside to giving somebody naloxone when an overdose is suspected because we don't know what's in it. But chances are there will be some opioid, and this is going to reverse at least that component.

Unger: Well, given that all of those kind of potential combinations you talked about, do you see this as something that parents will want to have on hand that will be kept like aspirin or other kind of staple medications in the home?

Dr. Mukkamala: Yeah, I mean, and that's the goal. And with overdose fatalities occurring in college dorms and public libraries and apartments pretty much across the country, especially with their young people, the hope is that naloxone will become a staple of first aid kits and in family medicine cabinets. And I've also heard it compared to having a fire extinguisher and everything. There's really no downside to having it available.

But honestly, for that to happen, it's got to be more affordable. For this product, it costs a hundred bucks. That's something that's going to be prohibitive for a lot of people. So we strongly encourage that the price of this medication when it becomes over the counter become something that's affordable. It's inexcusable for manufacturers, honestly, to price their products to maximize profits over saving these 100,000 plus lives.

Unger: Well, in addition to cost as an obstacle, there also continues to be stigma associated with this type of drug. Can you talk a little bit about that and how we might be able to overcome that particular barrier?

Dr. Mukkamala: Yeah, no, you're absolutely right. Stigma does remain a major barrier. So prior to this, naloxone access laws in every state allowed pharmacists to have a standing prescription so they could dispense it to anyone that requested it. But many pharmacies chose not to do so just because of the stigma. They preferred not to engage customers around illicit drug use.

They just said, we don't want to deal with that. So there's a stigma there. And so the retailers' willingness to stock it on store shelves is going to be something that will help to overcome that stigma, and we encourage retailers to do that. And back to our conversation about pricing, pricing can also affect where a product is placed. And so if this is going to have $100 of value, it's not likely to be sitting on a counter where you can just sort of grab it and go to the self-checkout with it.

It's likely going to be behind a locked glass box or something that's going to require customers to go up and ask for access to it. So again, we're going to—even if it's over the counter, we have to figure out how to make it accessible and minimize those barriers to overcome that stigma.

Unger: Dr. Mukkamala, how can physicians out there help with this particular barrier that we talked about, which is the stigma?

Dr. Mukkamala: Honestly, physicians just have to be willing to talk to their patients about the risk of overdose. So every prescription I write for an opioid, after surgery my post-op patients, I look at the medication history of my patient. I look at their history of opioid use so that I can engage them in that conversation if I think there's a concern.

So using that data gives me the knowledge of the risk of overdose for any particular patient. And with naloxone, timely administration is the key to saving lives. And so making sure people know how to administer it beforehand, engaging them in the conversation about their risk, and then what they have to sort of mitigate that risk. Do they have it at home? If not, they should get it, how to use it.

And honestly, as we discussed last time, we also need to sort of fix the problems within our own house. Stigma is still a problem within the medical community. We're just now sort of starting to change that conversation about how physicians can help to treat people with substance use disorder and patients with pain. And that stigma still sort of is a barrier there and we need to deal with that stigma within the physician community as well. And that's with education.

Unger: Now I know that the AMA is also helping overcome that stigma. Can you tell us a little bit more about what we're up to here?

Dr. Mukkamala: Sure, yeah. So the AMA task force that you mentioned that I chaired, the substance use and pain care task force, is a group of about 30 leading national and state and specialty societies. And we strongly urge physicians to consider prescribing naloxone to individuals at risk of overdose. And more broadly, we've launched a new resource on the AMA Ed Hub, a great resource to help physicians and practitioners sort complete this new one-time, eight-hour training requirement issued by the DEA. When buprenorphine became over the counter, it was part of that—or sorry, became something that could be prescribed without an X waiver.

And so this page is going to have a one stop shop to sort of make the process as easily—as easy as possible to get DEA registered physicians to sort of meet this new CME requirement. And it's an important resource, and the epidemic of drug overdoses and deaths continues to get worse. So it's very important that we in the medical community begin that education early in medical school and residency so that we can continue to learn so we can meet the needs of our communities and our patients.

Unger: And Dr. Mukkamala, addressing this epidemic is a huge undertaking, and I know it sometimes feels like we've taken two steps forward and one step back. How does this recent authorization fit into our overall efforts to address this epidemic?

Dr. Mukkamala: Yeah, no, it's one critical piece of our AMA sort of broad advocacy efforts. And while it's an important one, there's a whole lot more work to do. So saving lives with naloxone at that critical moment is key, but working to prevent that critical moment from occurring in the first place has to be in our focus. And so we have to remove those barriers to evidence-based care of those patients with substance use disorder, and then that's what's going to reduce the stigma associated with it.

Health insurance companies, they should just immediately stop requiring prior authorization for medications to treat opioid use disorder. It's hard enough when a patient comes in and they finally sort of worked up the courage to bring up their substance use disorder with their physician. The last thing that we want to say as their physician in that critical moment when they're in our office asking for help—hey, thanks for coming in. We'll get back to you once your prior authorization comes in.

It's just not what we want to have to say to patients. And so when individuals want treatment but the health insurance companies are putting up barrier after barrier, we shouldn't be surprised when more people die. And so that's what's going to require a shift in the thinking in policy makers and insurance companies to make it easier for us to take care of our patients that are coming in for care of substance use disorder.

Unger: Well, thank you so much, Dr. Mukkamala, for being here today and for all of the work that you and the task force continue to do to address the overdose epidemic. That wraps up today's episode. We'll be back with another shortly to learn more about the AMA's efforts to end the overdose epidemic. And get involved. Visit end-overdose-epidemic.org.

We'll be back soon with another episode. You can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us and please take care.

Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.