FDA Insight: Episode 11 – Transcript
>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the deputy commissioner for Medical and Scientific Affairs here are the FDA. Thank you for joining us for another great episode. This week, we'll be discussing America's opioid epidemic and also how it's been impacted by the COVID-19 pandemic. To do that, I'd like to welcome my guest today, Megan Moncur, associate director for Opioid Policy here at the FDA. Megan, welcome to FDA Insight.
>> Megan Moncur: Thank you for having me on the show.
>> Anand Shah: Can you tell us about what opioids are and why these products have become a public health crisis?
>> Megan Moncur: So, opioid pain relievers are medicines that are used to help manage pain. And they are to be used when other treatments and medicines are not able to provide enough pain relief, or they can't be used because of safety concerns. And certain opioid medicines are also used to treat opioid use disorder. So, examples of opioid include prescription medicines like oxycodone, hydrocodone, codeine, morphine as well as illegal drugs like heroin and synthetic opioids such as fentanyl. Now, all opioids including prescription opioids have serious risks including misuse and abuse, addiction, overdose that can lead to death. So, these risks must be carefully considered not only when deciding whether to prescribe an opioid, but if the opioid is prescribed, they must be carefully monitored and managed. So, we have a pain medicine that provides needed relief for many patients who suffer from severe pain. And some may not have other options available, but these medicines also have very serious risks.
And further, these serious risks can extend beyond the patient for whom the opioid was prescribed. For example, family members, friends, or others may be exposed to these drugs either accidentally or intentionally. And these exposures can also result in the serious consequences that we've talked about. So, I think we've all heard, we've all read, you know, that this epidemic has had profound emotional, physical, and financial impacts on us.
>> Anand Shah: So how do prescription opioids get misused or abused?
>> Megan Moncur: Well, let me start by saying that one important way to mitigate the serious risks of prescription opioids is to take them exactly as directed or exactly as prescribed by your physician or other healthcare professional. Now, we hear this all the time, take as directed, take as prescribed. So, what does this really mean? And this includes taking the dose prescribed at the frequency prescribed and the way it was prescribed and for the duration that it was prescribed.
So, if we go back to misuse and abuse, misuse and abuse are both terms that describe taking the opioid medicine in a way other than it was as directed by a healthcare professional. And the difference between misuse and abuse is the reason for the so-called not as directed opioid use, and is it being used for a medical reason or not. So, in the case of misuse, someone may be using the opioid to treat pain, which is a medical purpose, but they are also using it in a way other than it was prescribed. So, this can include taking too much medicine, taking it too often, or taking somebody else's medicine. And abuse we describe as the use of an opioid for a non-therapeutic or, in other words, a non-medical purpose to even one time and being — having it being used for desirable psychological or physiological effects. And this would include taking the medicine to get high.
>> Anand Shah: Megan, has the COVID-19 pandemic affected the opioid crisis?
>> Megan Moncur: I think the experts are saying it's too soon to have definitive data on the pandemic effects, but what we are hearing is definitely concerning. So, for example, recently, the AMA or the American Medical Association, caution that at least 30 states have reported increase in opioid fatalities since the start of the pandemic. And the opioid crisis is challenging under any circumstances, but it becomes increasingly more challenging when we add what's been happening with the pandemic. So, as we know, people are dealing with anxiety, grief, isolation, changes, you know, at home, school, work. They may have financial worries and there's just an ongoing sense of uncertainty. And as we know, you know, unhealthy responses to these stressors can lead people to turn to substance use. So, this is difficult for any of us, but people with opioid use disorder or in recovery are facing unique challenges. And actually — let me just pause for a minute because I think I used the term opioid use disorder earlier. And I just wanted to let your listeners know that this is a diagnostic term, but it includes things like addiction to opioids, which may be a more familiar concept to people.
So again, what are some of the ways that the pandemic has impacted those dealing with opioid use disorder? So, shelter in place orders have pushed people into isolation. And on the one hand, we've heard reports that being isolated or staying isolated may be helping to keep people who are in recovery away from their peers who are using drugs, but it's also cutting them off from family or other critical support structures. Further, it's leading people with excess unstructured time. And additionally, isolation can be dangerous in the sense that if somebody overdoses, there may not be anybody nearby to help them. So, people are also experiencing decreased access to treatment. And early in the pandemic, I think, there was a lot of concern about seeking any kind of medical treatment. I mean, even going to an emergency room, because we were all afraid of contracting with COVID-19, that even when people with opioid use disorder did seek treatment, they were faced with closed treatment centers, cancellations of in-person recovery meetings, or difficulty in accessing their opioid use disorder medications.
So, one of the positive things that has happened is that to comply with social distancing recommendations. The federal agencies that regulate access to opioid use disorder medicines have implemented a number of flexibilities to make treatment more accessible. So, for example, telemedicine is being used for some aspects of treatment that would typically require an in-person medical visit. And also, patients are able to obtain larger supplies of medications. So, the option for telehealth has been critical for some people. It has been extremely helpful, while for others, it may not even be an option; and still for others, you know, they may feel that it doesn't have the same impact as having face to face contact with health care providers. But researchers are definitely paying close attention to the outcomes of these new flexibilities, because if the outcomes are good, this may be a way to improve access to treatment in the future.
>> Anand Shah: Your team has been devoted to combating the opioid epidemic. What are some of the recent actions FDA has taken to help reduce opioid overdoses and deaths?
>> Megan Moncur: Sure. Well, first, let me provide your listeners with some context for FDA's focus, and then I can provide some examples of some of our recent activities. So, our work to address this opioid crisis falls into four main domains or buckets, if you will. And those include decreasing exposure to opioid analgesics and preventing new addiction, supporting the treatment of those with opioid use disorder, fostering the development of novel pain treatment therapies, and taking action against those who contribute to the illegal importation or illegal sale of opioid products.
One of the things that we have been working very hard on is the implementation of the SUPPORT Act, which was signed into law in October of 2018. And SUPPORT Act stands for Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. And what this legislation has done is provide us with new authorities or new tools to not only build on our efforts to confront the opioid crisis across all four of those domains that I mentioned, but also to adapt to its changing nature.
Now, regarding recent activities, I will focus on two that just actually recently happened. So, in June of 2020, we and the Department of Commerce announced our collaboration on a pilot program with internet domain name registries. And that program is focused on combating the illegal sale of unapproved opioids online. So again, that gets at the — taking action against those who contribute to the illegal importation.
Now, the second example is an action that we took in July 2020 to increase patient and community access to naloxone. And naloxone is a medication that can help reverse opioid overdose to prevent death. So, in July, we required manufacturers of opioid pain medicines and medicines to treat opioid use disorder and these medicines including like buprenorphine, methadone, naltrexone; and we required the manufacturers to update their package inserts to include recommendations about naloxone.
Now these changes will officially take effect in early 2021. But we want to encourage prescribers and patients to start thinking about naloxone now. So, the new package inserts recommend that healthcare professionals discuss naloxone with all patients and their caregivers, both, when starting or renewing treatment with an opioid pain medicine or one of those medicines that we mentioned to treat opioid use disorder. And as part of this critical discussion, providers should also assess each patient's need for naloxone prescription. And they should assess that based on the patient's risk factors for overdose. So, risk factors can include taking opioid pain relievers while also needing to use benzodiazepines or other medicines that depress the central nervous system, but also having a history of opioid use disorder or a history of a prior overdose.
Now, patients that are taking an opioid use disorder medicine have a lower risk of opioid overdose than those who have not been treated. However, they are still at risk of relapse and overdose and could benefit from having naloxone available in case of an emergency. So now, as we also talked about earlier, the risks of an opioid prescription extend beyond the patients and those that are around them. So, we also want healthcare professionals to consider prescribing naloxone if a patient has household members, including children or other close contacts that are at risk for accidental ingestion or opioid overdose.
I guess the other thing that I wanted to mention is that the — if naloxone is prescribed then the package insert includes some really important counseling messages. And I know we don't have time to go into all of them today, but I'll mention two that may not be as intuitive. And the first is that naloxone is never a substitute for emergency medical treatment. So, prescribers need to explain to their patients, and caregivers, that the effects of naloxone are temporary. Not only may multiple doses being necessary, but therefore, they should always call 911 or get emergency help right away in all cases of known or suspected overdose, even if naloxone is administered. And the second is that patients should be instructed to keep their naloxone in a place where friends and family can easily access it in emergency, because it likely won't be the patient administering it to themselves.
And I guess, you know, although this is not part of the updates to the package insert, we also want healthcare providers to consider prescribing naloxone to individuals at a high risk for opioid overdose, even if they're not receiving a prescription for an opioid pain reliever or a medicine to treat opioid use disorder.
>> Anand Shah: Megan, can you tell us a little bit about best practices that consumers should take for storing opioid medications?
>> Megan Moncur: Yes. So, one of the most important things about storing opioid medicine is to store it in a safe and secure place. And so, what does that look like? Well, it needs to be kept in a place where it can't be reached by children or taken by anyone for whom it wasn't prescribed. Because a dose that is safe for the patient could cause an overdose or death for someone else. And it also needs to be kept in a place that is secure because opioid medicine is vulnerable to theft. So, in some cases, safe and secure may mean opioid medicines need to be put in a lockbox. And we also recommend that people taking opioid medicines keep track of the amount of medicine that they have to more quickly determine if something is missing.
Now, since we discussed naloxone earlier, I just wanted to make the point that if you also have naloxone, remember that naloxone should be accessible in an emergency. So, do not store your naloxone with your opioids. Lock up your opioids but make your naloxone accessible.
>> Anand Shah: That's really good advice. And what about best practices for disposing of unused opioids?
>> Megan Moncur: So, keeping unused, unneeded, expired opioids in the home creates a serious health risk, especially if children live with you or you have children that visit you. So, to safely dispose of unused opioids, we recommend the following. So, if it's readily available, the preferred option is a medicine take back — to take it to a medicine take back location. Now, if that's not available, check to see if your medicine can safely be flushed down the toilet. And you can do this by checking the product label or any patient information that came with your prescription. Or you can also check FDA's flush list. And if it's safe to flush, flush it immediately. Otherwise, throw it away in your household trash. But first, you need to mix the medicine with an unpalatable substance. And I will say, the more revolting, the better. So, we're looking at things like dirt and used kitty litter. And then put that in a container such as a sealed plastic bag and throw it in your trash.
>> Anand Shah: Patients and consumers are the essence of everything we do with the FDA. How is the agency incorporating the patient voice into the development of new opioid products?
>> Megan Moncur: So, I'm really glad that you're asking this question. And as you've already alluded to, but I will just start by saying that FDA is committed to ensuring that the patient voice is incorporated in the development of not only opioids but of all medical products. And patient voice includes things like the patient experiences, their perspectives, needs, priorities. So, it's ensuring that these things are captured and meaningfully incorporated into the medical product development and evaluation. And we have been working to ensure that this happens systematically. Now — so, for example, one of the things we've been doing is we've been holding public workshops to inform development or a series of methodological guidances. And these guidances will help advance the use of systematic approaches to collect patient input that is both robust and meaningful. And then that input can be used for medical product development and also regulatory decision making.
Another way that we do this is through patient focused drug development meetings. Now, these are disease specific meetings that provide FDA with an opportunity to hear directly from patients and also their caregivers about what matters to them most about living with their condition. So, this includes things like the most significant symptoms, the impact of their condition on daily lives, and their views on available treatments. And to date, we've held over 25 of these meetings including for conditions like autism and sickle cell anemia.
And in 2018, we held two meetings that are relevant to today's discussion. One where we got to hear from patients living with chronic pain and another where we heard from patients with opioid use disorder.
>> Anand Shah: What opioid use disorder treatment options are available right now during this pandemic?
>> Megan Moncur: So, as we've heard, the pandemic has impacted access to treatments, but all treatments are still available. And treatments include not only the FDA-approved medicines for treating opioid use disorder that we've already mentioned, buprenorphine, methadone, naltrexone, but also, these treatments are typically combined with more comprehensive approaches that include counseling and other behavioral therapy. And as we said, in the counseling support groups, you know, some of these things are available online. So, these are unquestionably trying times. And, you know, we're all feeling pretty vulnerable right now. So, I wanted to give your listeners a couple of things that they can do if they or someone they are close to needs access to treatment, either for mental health or substance use disorder.
So, what they can do, they can start by going to SAMHSA's website. And I'll spell that out for you in a second. But SAMHSA is one of our federal partners, and SAMHSA stands for Substance Abuse and Mental Health Service Administration. So, if you go to their website, they have a "find treatment" link at the top of their website. And that will take you to another page that has a list of available helplines and also various treatment locators, and other locators for both substance use and mental health disorders. So, that website is — and I'll go ahead and spell it out, SAMHSA.gov.
And finally, if you or someone you know are at risk for opioid overdose for any of the reasons that we've discussed today, we want to encourage you to talk to either your healthcare provider about how to obtain the naloxone or to talk to another healthcare provider like a pharmacist. Because in many states, you may be able to get naloxone directly from the pharmacist without a patient's specific prescription.
>> Anand Shah: Megan, as we wrap up, I want to thank you for taking the time to join us this week on FDA Insight and educate our listeners. I certainly learned a lot from you.
>> Megan Moncur: Thank you so much, and you're welcome. This was a great conversation on this important topic. And we appreciate the opportunity.
>> Anand Shah: Thank you. In future episodes, we'll be discussing more topics including e-cigarettes and nutrition. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. If you haven't already, please subscribe on your favorite podcast app such as Apple Podcasts, Google Podcasts, Spotify, and Pandora. Thanks for listening.
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