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Listen to Leslie Erdelack and Jessica Bylander discuss the FDA's look into the potential for over-the-counter naloxone products to help reduce opioid overdose deaths.
Health Affairs This Week places listeners at the center of health policy’s proverbial water cooler. Join editors from Health Affairs, the leading journal of health policy research, and special guests as they discuss this week’s most pressing health policy news. All in 15 minutes or less.
00;00;37;06 - 00;00;52;14
Leslie Erdelack
Hey, everyone, you're listening to Health Affairs This Week. If you're new to the show, this is the weekly podcast where the editors at Health Affairs take turns talking about the health policy news and stories that captured our attention. I'm Leslie Erdelack.
00;00;52;29 - 00;01;30;27
Jessica Bylander
And I'm Jessica Bylander. So this week we're talking about a topic that's been in the headlines year after year. The U.S. has been in the midst of an opioid epidemic for decades. This epidemic includes the use of illicit opioids like heroin and fentanyl, as well as misuse of opioids that are prescribed like oxycodone. Just this past month, Walmart, CVS and Walgreens agreed to pay a total of more than 13 billion to settle lawsuits over those companies’ pharmacies roles in fueling the opioid crisis through what was viewed as the careless dispensing of prescription opioids that led to addiction.
00;01;31;17 - 00;01;58;14
Jessica Bylander
The CDC estimates that more than half a million people have died from overdoses involving any opioid from 1999 to 2020. And we know that the crisis has only intensified during the COVID-19 pandemic. We also know that these deaths are potentially preventable, not only through broader prevention efforts aimed at changing how opioids are prescribed or keeping illicit drugs like fentanyl from entering communities,
00;01;58;25 - 00;02;19;07
Jessica Bylander
but they can also potentially be prevented very acutely in the midst of an overdose. Leslie, I know this is a topic you're interested in and have been following. So in today's episode, I'm going to play kind of the interviewer role and ask you a bunch of questions. So first, what was the big news about this overdose drug that caught your eye this week?
00;02;20;05 - 00;02;48;07
Leslie Erdelack
So I think this is an important development related to the opioid crisis in the sense that we learned this week that the FDA plans to review an application from a drug company that wants to make the overdose reversal drug naloxone available without a prescription. If the application is approved, you'll be able to get naloxone over the counter for the first time in the U.S., the drug maker that submitted the application is Emergent BioSolutions.
00;02;48;07 - 00;03;15;06
Leslie Erdelack
This is the company that manufactures naloxone under the brand name Narcan, and there are a couple of naloxone products out there on the market, but this one is formulated as a nasal spray and it's basically a type of rescue medication that you give someone to reverse the effects of an overdose. And Narcan was the first intranasal form of naloxone approved by the FDA in 2015.
00;03;15;16 - 00;03;31;21
Leslie Erdelack
And naloxone products have become more readily available over the last several years. A lot of community harm reduction programs are distributing naloxone kits, first responders carry Narcan. And now we're seeing this push to expand access even more.
00;03;32;15 - 00;03;34;10
Jessica Bylander
So how does naloxone work?
00;03;34;26 - 00;04;04;03
Leslie Erdelack
So one of the things that happens during an overdose is respiratory depression. Opioids slow down the central nervous system, which slows down your breathing and your heart rate. They also bind to opioid receptors in the brain. Naloxone is what we call an opioid antagonist, and it binds to the to the same receptors, but it's a better fit. So when it reaches those receptors, it basically displaces those opioids and blocks their effects for a short amount of time.
00;04;04;03 - 00;04;33;28
Leslie Erdelack
It can restore normal breathing within about 2 to 3 minutes. But in the meantime, after you administer your naloxone, you still need to get that person help because the effects are temporary and it can bring on sudden opioid withdrawal symptoms in some people, which can be very severe and uncomfortable. I'll also mention there are two kinds of naloxone, a pre-filled nasal spray and also an injectable version.
00;04;34;12 - 00;04;46;07
Leslie Erdelack
Last year, most of the sales to retail pharmacies, I think more than 90% were for the nasal spray. So that's the product that's most widely used and the one that could become available over-the-counter.
00;04;46;23 - 00;05;08;14
Jessica Bylander
Yeah. I mean, to be honest, hearing you describe it and how it can reverse the effects of an overdose, restore normal breathing, it sounds kind of like a miracle drug in the face of this terrible overdose epidemic that we're in the midst of. So I assume as many folks as possible want to have access to it. Is naloxone easy to get currently?
00;05;08;28 - 00;05;35;09
Leslie Erdelack
Yeah. So that's been kind of the prevailing school of thought, right, to get people access to it, better access to it. And expanding naloxone access has really been kind of a centerpiece of the advocacy work at places like the American Medical Association, but also at the federal level. And for many years, we've seen this push to get naloxone into the hands of people like you and me and, you know, people outside of the health care setting.
00;05;35;18 - 00;06;01;10
Leslie Erdelack
They went from being the sort of I remember when they were just these sort of improvised kits. And now they're products that are kind of specifically made for people without formal medical training. And I've heard so many accounts from people who went from being really reluctant to to kind of consistently carrying naloxone with them because of how prevalent overdoses in their communities were becoming.
00;06;02;07 - 00;06;38;11
Leslie Erdelack
But as it stands, just in terms of availability. Naloxone hasn't been approved by the FDA for nonprescription use. So it technically requires a prescription. You can buy it at the pharmacy, but that's all you know, it's because most states, all states actually have some form of what we call naloxone access laws, where if you go and you talk to the pharmacist, they can dispense it to you because of provisions that allow for non patient specific prescriptions, meaning that prescribers can prescribe naloxone to someone who's not directly at risk of an overdose a friend, a relative, a caregiver.
00;06;39;03 - 00;07;06;03
Leslie Erdelack
And some studies have linked these naloxone access laws to better public health outcomes. But there's also this idea that these laws might not be enough, that they haven't expanded access to naloxone in the same way that a non-prescription product might. So two of the biggest barriers off the top of my head are cost, you know, not surprisingly, but also just this fear of stigma and discrimination.
00;07;06;03 - 00;07;11;22
Leslie Erdelack
When someone has to approach the pharmacist or go to the doctor to get naloxone.
00;07;12;01 - 00;07;33;04
Jessica Bylander
Yeah, I think that really gets at the intricacies of access and how even these subtle barriers can limit how many people use the product. So in this case, the status of the naloxone as kind of behind the counter at the pharmacy limits its uptake compared to, you know, if they could just get the naloxone off the shelf, it's openly available.
00;07;33;22 - 00;07;54;17
Jessica Bylander
I do think that could part of it could be that stigma of having to ask someone to get the drug for you versus being able to grab it for yourself more discreetly. I know there's a similar push to make hormonal birth control available over-the- counter as well. So tell me more about what FDA is doing to accelerate access to non-prescription naloxone.
00;07;54;29 - 00;08;23;00
Leslie Erdelack
Right. Well, the agency itself has been trying to make naloxone more widely available for a while now to from more from the regulatory side. So FDA issued a notice just a few weeks ago encouraging drug sponsors and the companies that make prescription naloxone products to contact FDA just to start those discussions around possibly switching from a prescription to a non-prescription status.
00;08;23;12 - 00;08;49;25
Leslie Erdelack
And this happened at the same time that FDA released a preliminary assessment saying that certain naloxone products might be safe and effective for non-prescription use. So it's not a final determination. FDA is saying it needs more data, of course, and it's the kind of data that they would expect to receive from the drug companies who are interested in bringing in non-prescription and naloxone product to the market.
00;08;50;26 - 00;09;10;15
Leslie Erdelack
And that's in part what Emergent did when it submitted the application to FDA earlier this week. They included data from studies on how people use Narcan, along with more than five years of post-marketing data, to try to demonstrate that their product can be safely used without a prescription.
00;09;10;20 - 00;09;37;28
Jessica Bylander
Yeah, that's let's get to my question of like, you know, why is there this barrier? You know, sometimes you get a medication and it has instructions for use and you have to follow them carefully. You know, you can't, you know, administer it wrong or it won't work or there could be safety concerns. So I was wondering with naloxone, whether there are potential safety concerns or the risk of kind of somebody doing it wrong and not having the chance to talk to the pharmacist beforehand.
00;09;37;29 - 00;09;39;27
Jessica Bylander
So what what are they thinking there?
00;09;40;29 - 00;10;04;21
Leslie Erdelack
Yeah, I think that's a great question. And so here's here's sort of my take. So first of all, naloxone is overall, it's considered a really safe medicine. The FDA approved naloxone back in 1971 as a prescription drug to treat overdoses. But back then, it was only an injectable drug. And that's kind of been, I think, the status quo.
00;10;05;01 - 00;10;30;19
Leslie Erdelack
And there are some people who think it's on the drug manufacturers. The drug companies are the ones who are resisting submitting the paperwork needed to make the switch. But then there's also been some criticism, too, that if we enable more widespread access to naloxone, if we think of it like a safety net drug, there's this fear. And it's actually this thing that economists call moral hazard.
00;10;30;28 - 00;10;56;23
Leslie Erdelack
It's this concern that if people have naloxone, they're going to start overusing it, they're going to start relying on it instead of focusing on preventing or intervening on the behaviors and the underlying causes of addiction in the first place. And I think we've seen this phenomenon debunked, and it doesn't actually ring true with people who use drugs and their own experiences with naloxone.
00;10;57;08 - 00;11;17;08
Leslie Erdelack
Although I do agree that with the people who view naloxone as complementary to other evidence-based harm reduction strategies that are out there. And I think from an educational standpoint, I would expect to see more of an emphasis on that if naloxone becomes available over-the-counter.
00;11;17;21 - 00;11;39;06
Jessica Bylander
Yeah, kind of part of the tool kit. I saw something else where it was also recommended that, you know, should physicians who are prescribing an opioid also at the same time write a prescription for naloxone, kind of going hand in hand. But of course, if if this goes through, that won't be necessary. So what happens next? What are some things we should be keeping an eye on?
00;11;39;18 - 00;12;09;17
Leslie Erdelack
So FDA is giving this company's application priority review with a decision expected in the next 3 to 4 months. So one of the major issues likely to come up is around cost. Naloxone is covered by many insurance plans, but not all of them. So if you're a cash paying customer, the cost can definitely be prohibitive. If there are changes to how the product is marketed, even though over-the-counter products, I think tend to be a little bit cheaper.
00;12;09;28 - 00;12;38;02
Leslie Erdelack
You know, how do we make sure people get it at a reasonable cost and that these community-based organizations distributing it aren't hit with exorbitant costs? The other thing is about making sure a switch to non-prescription naloxone doesn't divert supplies away from these organizations or create shortages. So FDA has rules around the simultaneous marketing of drug products with the same active ingredient.
00;12;38;16 - 00;13;06;00
Leslie Erdelack
And if there's no clinically meaningful difference between the prescription and non-prescription naloxone nasal spray, for example, it's my understanding that all manufacturers would need to switch their products from prescription to non-prescription. So if a company decides to stop marketing its product altogether rather than make the switch to non-prescription, this could, you know, conceivably contribute to a drug shortage.
00;13;06;00 - 00;13;15;00
Leslie Erdelack
And I can't comment on the likelihood of that happening. I don't know. But it's something to watch, I think, going forward for sure.
00;13;15;10 - 00;13;32;29
Jessica Bylander
Well, thanks so much for letting me pick your brain on this topic, Leslie. I definitely learned a lot. I think that's a great place to wrap up. Thanks for listening, everyone. If you like this episode, tell a friend, leave us a review and be sure to subscribe wherever you listen to podcasts. Thanks, Leslie.
00;13;33;21 - 00;13;42;03
Leslie Erdelack
Thanks, Jess.