The latest FDA naloxone approvals and Overdose Awareness Day with Bobby Mukkamala, MD

. 13 MIN READ

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.

On International Overdose Awareness Day, Bobby Mukkamala, MD, chair of the AMA Substance Use and Pain Care Task Force, joins to discuss the current state of the overdose epidemic in the U.S. Dr. Mukkamala provides an update on over-the-counter naloxone approvals, offers advice for physicians and shares how the AMA is working to combat this crisis. AMA Chief Experience Officer Todd Unger hosts.

Speaker

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

AMA Recovery Plan for America’s Physicians

After fighting for physicians during the pandemic, the AMA is taking on the next extraordinary challenge: Renewing the nation’s commitment to physicians.

Unger: Hello and welcome to the AMA Update video and podcast series. In recognition of International Overdose Awareness Day, we're talking today about the state of the overdose epidemic in the U.S. and the most pressing challenges in our fight to end it. I'm joined today by Dr. Bobby Mukkamala, chair of the AMA Substance Use and Pain Care Task Force in Flint, Michigan. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Mukkamala, it's great to have you back.

Dr. Mukkamala: Thanks, Todd. Always great to share the screen time with you.

Unger: Well, the last time that we talked, the FDA had just authorized its first naloxone product for over-the-counter sale. Just for starters, how is that going?

Dr. Mukkamala: Yeah, so you're right, Todd. So the FDA has now approved two naloxone products for over-the-counter sale, which is great news, and hopefully soon, we'll see naloxone in big box chains and vending machines and supermarkets, convenience stores, gas stations and available even through online retailers without a prescription. And so even qualifying public service entities can currently purchase and get bulk quantities of the nasal spray shipped to them. And these manufacturers, they need to be approved, but they include EMS, fire departments, police departments and other community organizations.

And so another issue that we've got to talk about here, though, is price. And as we discussed last time, over-the-counter approvals don't mean much if people can't afford to buy the treatment. And one of the manufacturers has announced that it would price this over-the-counter nasal spray at about $50 for a kit of two 4-milligram doses. But unfortunately, this is still going to be out of reach for a lot of people with substance use disorder. And some physicians have even reported patients that can't even pay their $30 copay that sometimes require by prescription naloxone.

So it's really irresponsible for manufacturers to price this lifesaving product to maximize profits over saving lives. And the AMA really urges health insurers to cover naloxone, whether it's obtained through a prescription or over-the-counter, at no or low cost. And I'd like to highlight, actually, a really positive story that came out just today. So Blue Cross Blue Shield of Massachusetts will cover naloxone at no cost to patients. And it's such a great decision that really shows that they understand what's at stake here. So hopefully, other insurers will follow their leadership on this issue.

Unger: That is great news. Well, something that may help with that as well is that more manufacturers are applying for over-the-counter approval of their products. Where does that stand?

Dr. Mukkamala: Yeah, you're exactly right, Todd. So every naloxone manufacturer should submit this over-the-counter application. There's no reason for other manufacturers to delay because it could help make the pricing more competitive. And there's also another opioid reversal product that's approved by the FDA called nalmefene. And so, while nalmefene is an opioid antagonist, just like naloxone, it works for a longer period of time and has a higher potency.

And because it's a different medicine, though, we urge physicians and policymakers to learn about its indications and potential risks and benefits, just like any new medication. So overall, it's a public health benefit to have a variety of medicines to help reverse an opioid overdose, but nalmefene should have, or could have, unintended consequences. And so it shouldn't be used as a substitute for naloxone.

Unger: Given the move to the over-the-counter status, should physicians continue to recommend and prescribe naloxone?

Dr. Mukkamala: Yep, yep, for sure. The AMA continues to strongly support naloxone in all its various forms for widespread distribution and use. And it's already saved hundreds of thousands of lives over the years. And having it widely available will continue to do so, which we so desperately need. So we encourage physicians to prescribe naloxone to any patient at risk of a drug-related overdose. And we continue to urge manufacturers to make this life saving medication more affordable.

People with severe risk of allergies carry an EpiPen. People at risk of overdose should carry naloxone. And so we also continue to urge policymakers to support the harm reduction organizations, who do incredible work to get naloxone directly into the hands of people who use drugs. And so the combination of over-the-counter naloxone and physicians and policymakers' support for that product is just the start. So the AMA is going to closely monitor whether retailers stock it in a visible location, on store shelves for quick access in emergency situations, similar to other first aid items.

Opioid overdose epidemic podcasts

Access expert discussions and insights to help physicians and other health professionals address the epidemic of opioid overdoses.

Unger: Dr. Mukkamala, as trends with naloxone and other opioid overdose reversal medicines are going in the right direction, how are things trending with overdose deaths and other key metrics here? Have we seen any improvements there?

Dr. Mukkamala: I'm afraid not, Todd. I wish I could answer that differently. But in fact, the numbers of deaths due to opioids continue to get worse. According to the FDA, in the 12-month period that ended in February of 2023, more than 105,000 people died from fatal overdoses that were primarily driven by synthetic opioids, like illicit fentanyl. And so the number of annual drug related overdose deaths first topped that 100,000 mark in 2021. And it continues to go up. And illicitly manufactured fentanyl is now showing up in 70% to 80% of overdose deaths, according to the DEA.

And so if you remember, policymakers once said that all we had to do was reduce the number of opioid prescriptions, right? And the AMA urged physicians to take a closer look at our own prescribing habits to see what we were prescribing, and we changed. But our focus also included the need to ensure treatment for patients with pain and those with substance use disorder. And that's really what we need to focus on.

Unger: Well, then, what does the data reveal about that approach?

Dr. Mukkamala: Yeah, so as I mentioned, the opioid prescriptions have decreased by nearly 50% nationwide. But the nation's drug overdose and death epidemic continues to worsen. So of the 40 million people nationwide with a substance use disorder, 93% still get no treatment, right? That's a major problem.

So patients with pain also continue to suffer from state laws and health insurer and pharmacy chain policies that deny opioid therapy. There's a new KFF tracking poll that came out just earlier this month that shows that two-thirds of U.S. adults have been impacted in some way by the nation's substance use crisis. So this was just an incredible number. And it means that we have a lot more work to do.

Unger: Well, I know, in addition to increased access to naloxone, that the AMA is fighting for other changes to get those numbers down that you're talking about. Dr. Mukkamala, will you tell us about some of those efforts?

Dr. Mukkamala: Yeah, a big area of focus for us is removing many of the barriers that just prevent physicians from being able to prescribe these medications for their patients that need them, whether it's medication for opioid use or for the relief of pain. And so as part of these efforts we provided comments to the CDC, whose updated opioid prescribing guideline includes nearly all of those AMA recommendations, including removing those arbitrary thresholds on dose and quantity that have already harmed tens of thousands of patients.

And we've also worked with multiple states, including Minnesota and Oklahoma, to help physicians who treat patients with pain to provide individualized care, even when that care may go outside these arbitrary numeric thresholds, because even though the CDC has adopted our thinking on these numeric thresholds, there's still plenty of entities out there that are still using them to restrict access to care.

And at the federal level, we supported the Biden administration's national drug control strategy focus on harm reduction and encouraged the administration to continue to remove these barriers to medications for opioid use disorder. But policymakers aren't the only ones who need to act. Now the AMA is calling on health insurance companies to just stop requiring prior authorizations for medications to treat opioid use disorder.

When a patient comes in seeking care for a substance use issue, it took a lot for them to get to that point. To then just put up a stop sign and delay getting them the care because of prior authorization, it's just bad policy, and it's bad care. And they also need to get rid of these quantity limits on buprenorphine. Physicians should be able to treat patients as individuals. And just not every patient is going to need the same dose.

For example, leading physicians are telling us that doses greater than the 24 milligram of buprenorphine that's oftentimes set as a limit are still helpful for individuals who are using fentanyl. But health insurance companies and state Medicaid agencies are just pushing back and denying and delaying access to these medications at those doses. So when individuals want treatment, but the payer is putting up barrier after barrier, we shouldn't be surprised to see more people dying.

Unger: Well, on the same topic, then, of these kinds of burdens and obstacles, the AMA has also been active in addressing health plan violations of parity laws that are designed to protect patients with mental illness or substance use disorder. Can you tell us more about what's at stake here?

Dr. Mukkamala: Yeah, and what the issue here is the insurers' sort of continued failure to comply with the Mental Health Parity and Addiction Equity Act. It's a federal law that generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder benefits from imposing limitations on those benefits that are different than other medical and surgical benefits that they cover.

So when health plans violate these laws, patients with a mental illness or a substance use disorder, they're prevented from receiving the treatment they need. So since this act was first implemented way back in 2008, the combined lack of enforcement and compliance with it have been a significant factor that drive the nation's mental health crisis that we're all also keenly aware of now, including the substance use disorder.

And so the AMA is fighting this and joined by representatives from the Kennedy Forum and the American Psychiatric Association. We recently testified at the National Conference of Insurance Legislators at its summer policy meeting on the next steps needed to address these violations. And these include improving state laws to provide regulators with increased enforcement authority, conducting oversight to ensure that payers are complying and working with regulators and state attorneys, to get more compliance with these state laws.

And in fact, in late July, we strongly supported the Biden administration's commitment to addressing these violations and urged the administration to provide the Labor Department with the resources to make oversight and enforcement a top priority. So we hope that the Labor Department, as well as the states, will increase efforts to regularly review plans to ensure that they're in compliance. And we need to hold insurers accountable if they're not. And it's tough to give care to our patients already in this situation. It shouldn't be tougher because of an insurance company.

Unger: Dr. Mukkamala, before we leave, what can physicians do to track efforts like that or get involved?

Dr. Mukkamala: Yeah, so for sure, that the simplest thing is just to go to the end-overdose-epidemic.org website. So if you just type in "end-overdose-epidemic.org" and add the AMA, you'll go right to our website. But physicians' advocacy also includes what we do on our own practices, right? So we can help by having conversations with patients about safe storage and disposal of opioids and the risks of overdose and how to access and use naloxone.

So just as we talk with our patients about other stigmatized medical conditions, whether that's obesity, whether that's depression, anxiety, we can do a better job to normalize the fact that a patient with pain or a substance use disorder deserves our care and compassion.

And with the elimination of the x-waiver, all physicians can prescribe buprenorphine now. And so we're working hard to preserve the ability of physicians to prescribe this via telehealth, as they did during the COVID emergency, and providing this effective telehealth as another focus, which is in our AMA recovery plan, to preserve the ability to take care of patients remotely.

And as you talked about last time, this is a preventable epidemic. It's getting worse, and it's not going to get better until our patients received more evidence-based care. And this means that we've got to all work together—physicians, law enforcement, policymakers organized medicine. We've got the tools to end this epidemic. It's up to all of us to put them to good use.

Unger: Thank you so much. I just want to mention two things. You heard Dr. Mukkamala mention that important site, end-overdose-epidemic.org. Make sure to check that out if you want to continue to track progress on that issue. He also mentioned the AMA's Recovery Plan for America's Physicians. Very important work there that speaks to some of these obstacles that Dr. Mukkamala outlined, especially on the prior authorization front. Find out more about that on the AMA website as well.

Dr. Mukkamala, thanks again for being here today and for all the work that you and the task force continue to do to address this devastating epidemic. We'll be back soon with another episode. And you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today 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.

FEATURED STORIES