Opioids

The opioid epidemic and emerging public health policy priorities

According to statistics from a National Survey on Drug Use and Health, 11.4 million Americans misused opioids in 2017, and 2.1 million had an opioid-use disorder.

In his presentation at the 2019 AMA National Advocacy Conference, Adm. Brett P. Giroir, MD, the assistant secretary for health at the U.S. Department of Health and Human Services, reviewed the state of opioid abuse in America. Dr. Giroir, also discusses potential solutions.

Below is a lightly edited full transcript of his presentation. You can also listen to the full episode on Apple Podcasts, Google Play or Spotify and follow along with Dr. Giroir’s presentation deck.

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Dr. Giroir: Just to level set where we are, there are multiple data sources, and you hear lots of numbers, but the national survey on drug use and health—and is the survey that gives us our best, deepest data on the state of opioid misuse in the country—our latest data show about 11.4 million people misused opioids, about 2.1 million people actually had an opioid use disorder, 53% still receive their pain reliever from a friend or a relative. So, the extra pain relievers that are in the medicine cabinet are still a large issue in the country.

Every four months during takeaway day, we get about a million pounds of opioids gathered from the country. That's enough to fill three 757s, stem to stern, with opioid tablets.

Thirty-six percent receive it from a prescription health care provider. That number is actually going somewhat down. And the number of people doing doctor shopping has gone down tremendously because of … work with PDMPs and organizations. As was pointed out, most people misuse opioids because of pain. That's the No. 1 issue.

And if you've heard me speak anytime, we cannot solve the nation's opioid crisis until we solve the nation's pain crisis. We are very excited about the pain management task force report, but it is a very patient centered, provider-sensitive document that tries to make sure that, although we have guidelines, it's still about the doctor and the patient fundamentally.

Where we stand right now, these are the official numbers released by CDC for 2017. Over 70,000 drug overdose deaths in the United States. This number is U.S. residents who died in the U.S. of drug overdoses.

That is still underreported because we … have autopsies that are still out. Almost 48,000 of those are related to opioids, and I think we all understand that the main problem now is the synthetic opioids, such as fentanyl and carfentanyl.

Looking back from June 2017 to June 2018, heroin deaths are down, prescription pill deaths are down, methadone deaths are down. It's the synthetic opioids.

It's the illegal fentanyl that are up, but we can't forget the old nemeses. Cocaine is up significantly, and psychostimulants, primarily meth. So, these are returning in a major way. Meth on the West Coast, fentanyl all over the country, but more importantly on the East Coast. And I will say some new data that are there, but when you look at the cocaine deaths, 70% of those also have opioids detected. The majority of those are fentanyl. So, we're in a … polydrug use situation that's affecting the country.

As a pediatric critical care physician, I deal with fentanyl in two mics per kilo. You probably deal with it in 50 or a hundred mics. So, when you see things like this—customs and border patrol sees 254 pounds of fentanyl coming across the border, enough to kill 50–60 million people—you understand the issues that are involved. Now, that’s shocking to everyone.

The most shocking thing to me is the street value of all that fentanyl is only $3.5 million. You can kill 20% of the American population for $3.5 million street value, and you can buy that from the Chinese elicit market for orders of magnitude less than that.

So, it is a horrible situation. Again, most of this comes illegally from China, either directly into the mail or to Mexico and Canada and then smuggled across the borders.

As a pediatrician, I'm very concerned with illicit substance use among pregnant women. This [slide] just looks at the percent of women who used illicit substances within the last month. It's only looking one month back. You can see on the left side of that screen, the percent is up to about 8.5% in 2017.

The majority of that is marijuana used during pregnancy. You'll hear a lot more about that from the surgeon general and our administration coming up, but tobacco products and alcohol are still on the way up.

That has led to a sort of silent epidemic with neonatal abstinence syndrome in children. This is something I took care of infrequently as a pediatric critical care physician in Dallas. It's one thing to have a baby with the shakes. You can certainly withdraw them, swaddle them, get them over. The problem is they are often 24-weekers or 26-weekers. Now we're seeing that many of these children—a high percentage have developmental disorders. So, they have long-term neurocognitive disorders that we're going to have to deal with that we're just learning about.

This [slide] was just a report that got me very concerned as well. Gastroschisis is something I deal with as a pediatric ICU doc. Frequently, we're starting to see these associations where the rates are going up, and it correlates exactly with the opioid misuse and opioid use among mothers within the regions.

What are we going to see coming down the pike? I don't know, but it's certainly concerning. It's not just opioids. Methamphetamine-related use during pregnancy and amphetamines were associated with a high degree of preterm delivery—and also severe morbidity and mortality among the mother and of the child.

Again, this is an issue that we're dealing with across the board. All of you know this. About 10% of HIV is associated with the IV drug use. Hepatitis C has gone up 300–400%. All types of weird skin, bone and joint infections. There was this report of wound botulism—nine cases in California. So, all the weird kind of stuff is really happening in the population.

The problem: You might send a person home with a port-a-cath or with a PICC line. It’s very hard to send a person who's an IV drug user home with the main line so they could use the drug. So, a lot of these people stay in the hospital—resources, multidrug resistance, everything is there. We're sensitive to all of that.

The HHS plan—and I won't bore you with this because I know all of you know this, but this is still our slide—we really emphasize better addiction prevention treatment and recovery services. Better data: What is happening where, and how quickly can we determine that so we can act regionally? Better pain management is absolutely key. I think all of you know, and I was certainly part of the generation where pain was the fifth vital sign. This was taught, this was emphasized. And as we know, most people who use heroin, at least now, started with prescription opioids. … Better targeting of overdose-reversing drugs like naloxone. And, of course, research across the board. …

So, what is evidence-based treatment? I spent a lot of time on the road making sure that everybody understands that any one of these is partially effective, but the best effect is all of these put together.

FDA-approved medication-assisted therapy: I think all of you know that the data are pretty clear that people do better on a MAT than they do off MAT. How long do they need to be on it? When can they be tapered off? How do you taper them off? What people need it? What kind of therapy? These are all open clinical questions. We know a lot, but there's a lot we don't know, and we don't know a lot more than we do know, but that's clearly there.

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Psychosocial therapies and recovery services are very important. We work with the faith-based community a lot because people need jobs, they need employment, they need housing, they need education, they need to be loved in a community setting where they're accepted without stigma.

And finally, naloxone, which all of you are, I'm sure, familiar with. I just want to highlight a couple things to this group. This was data published by Chris Jones and Elinore McCance-Katz, who's the assistant secretary in charge of SAMHSA, that looked at clinician prescribing behavior of buprenorphine.

There is always a push and push and push to have more people waivered, which I think is a good thing—opening up different disciplines who could prescribe buprenorphine.

But, fundamentally, the issue is people who are waivered don't prescribe enough. They're not even close to their limits. In this study, clinicians prescribing at or near their limit was only 13.1%. There's a huge amount of capacity in the system. What we have been focusing on more and more is just the barriers.

The number one barrier is lack of patient demand, that people are not seeking treatment or getting channeled into treatment, which is an incredible issue. We're working on that from the ER, where you can start therapy and channeling them with a warm handoff, to any opportunity to get people in therapy.

Time constraints in practice—that relates to a lot of the things that we all know about that are constraining yourself in practice. We're trying to eliminate some of that in insurance requirements. Again, trying to knock that out individually, and we can talk about that a little bit later.

Naloxone is something we've been pressing a lot. The CDC guidelines talk about co-prescribing naloxone. If your patient's on MME greater than 50, or certainly if they're gone greater than 90, if they’re co-prescribed benzodiazepines, if they have a number of other conditions, the surgeon general has taken this on as a major issue, but still we see a lot of opportunities.

This was data published by the CDC in August that looked at almost 12,000 opioid deaths from a new database that we have. If you looked across the board and read, of all of these overdoses, between 41 and 45% had a bystander present during the overdose, but yet naloxone was only administered by a bystander between 0.8 and 4.4% of the time.

These are tens of thousands of people dying every year that we could have the possibility of reversing and channeling them into treatment. The illicit opioids have more than the prescription opioids because people tend to inject in a group setting, and then there tends to be naloxone there in case someone gets into trouble. That's just the social nature of doing this, but there's still a huge amount that we can do.

We looked at some data across the board. If you look at the CDC guidelines for suggested co-prescription for MME greater than 50—this is with the PDX database, that's almost in 8,600 pharmacies—the rate of naloxone co-prescription was only 0.3%, and 40% of those were never filled. So, the co-prescription rates are very, very low.

When you look at Medicare, and we will be publishing this data very soon, MMEs 90–120 was still only 1.6%, or greater than 120 was 5.2%. And this was entirely driven by the states who have mandatory co-prescribing on their laws.

I still think we have a long way to go, so please consider co-prescribing. It's not the answer to everything. It may only move the needle 4 or 5 or 6%, but it's still a very important aspect. And we put out new guidance in December that reemphasizes the importance of co-prescribing.

How have people done? So, if you look from the start of the administration, January 2017, to the last public data that we've released in November 2018, this is all your groups. These are physicians and clinicians working through guidelines, working in professional societies to more appropriately prescribe opioids.

And it's dramatic. I don't think I've ever seen this dramatic of a shift, certainly in recent memory. Total MMEs have declined by almost 26%. The number of unique patients receiving buprenorphine are up about 22%. Naltrexone prescriptions are up 47%, and Naloxone prescriptions, despite that we still need to do it more, are up by 340%. Just in that period of time.

This is tremendous progress and this is really all the physician and clinician community doing it with themselves. This is not laws that mandate x, y or z. And we try to stay away from that, to get the government out of the practice of medicine to the degree that we can.

The number of individuals who misuse pain relievers from 2015-2017 did decrease by 1.4 million and we've had a 300,000 decrease in people with opioid use disorder.

This doesn't mean we've won—we still have 70,000 people dying. But the things that we're doing are starting to make an impact. So again, the transition is often from prescription opioids to heroin or to heroin and fentanyl. Between 2016 and 2017, there was a 61% decrease in first-time heroin users, and it's down even more dramatically between 2015 and 2017.

Again, it doesn't mean we've solved the problem, but it means all the work that you're doing, that we're doing together, is starting to have an impact.

This [slide] is another new data source that looks at ED visits for drug overdoses and looks at percent change. Our latest data is Q2 2017 to Q2 2018. Overdose visits are down almost 7%, and for opioids down 14.5%. Again, going in the right direction.

Looking 12 months, year to year, our overdose deaths are down 0.9% in the country. Still, not saying that we've conquered this, but it's starting to go in the right direction.

And then if you look at the rolling 12 months, so the number of deaths at the 12-month period, the last 12-month period that we reported on was in January, which looked at June 2017–June 2018, and basically you can see the shape of the curve. We seem to have reached a peak of mortality and we sort of come over that peak, but we're in a very bad flat area right now. I'm very concerned that, over the past three or four months, we've not continued our trajectory downward. And again, we're looking at that, and a lot of it relates to synthetic opioids in the mid-Atlantic. So we're really focusing on that.

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There are some states that have had tremendous progress. We're going to look at New York—New York state has done really, really well with opioids and there's some things they are doing a little bit different. We're going to try to see if that could explain it.

So, what are we doing in the upcoming year? First of all, I think a lot of you know about the SUPPORT Act. I'm sure the AMA was very involved in the provisions of the SUPPORT Act. There are a lot of things going on there that we will be implementing. My office will be running the implementation for HHS.

We actually have a 25-page spreadsheet of actions that HHS is required to do. Most of them are very positive. A lot of them are paperwork, but on average this is a really, really good act that will improve our abilities to provide care. Something I'm very concerned about is, although we are in a crisis, in a public health emergency, we really have to transition from a crisis framework into an integrated, sustainable, predictable and resilient public health system for preventing and treating substance use and other behavioral health disorders.

It's nice to have a billion dollars in SAMHSA grants, but we really need to align reimbursement so people can get paid for the right therapy, that you don't have to go through 16 different mechanisms. It is a crisis, but we need to build a system and a structure to make this work, because this is not going to go away in the next year.

This is going to be with us for decades to come. So, we need to face it and build that and, in my mind, we're really focusing on what are people doing right now that is sort of the Band-Aid way or trying to get a workaround and build that into the system. Some of these are going to be iterated in alternative payment models, like the Maternal Opioid Misuse Model that's currently on the streets to look at the way to bundle services for moms.

There'll be another one coming out very soon, about integrated services for kids. And you'll see more comprehensive opioid models from CMMI (the CMS Center for Medicare and Medicaid Innovation) coming out in the next six months. We're also building some national infrastructure. There's no real way to understand what happens to a baby with NAS (neonatal abstinence syndrome) at six months or 12 months when they get lost in the system.

This was a national convening that we had, and the first lady has been to two of these with us. We're working with Vanderbilt and a number of other medical centers in order to create the infrastructure—not just for opioids, but for what's going on with babies exposed to marijuana, methamphetamine, the whole gamut. We have some cross-cutting initiatives that we're very excited about. I'll just highlight a couple of them.

The CDC … is working on sort of a meta-analysis of indication-specific opioid prescribing guidelines. So not, “Don't do this, or don't give this much.” Let's look for the 40 most common indications. What are all the societies saying about them? It's really no new data, but it's sort of a meta-analysis and congregation of the guidelines that are already there. …

And then opioid rapid-response teams, where the public health service will be going out into communities when requested with our behavioral health and our treatment assets to support communities. But also to be there so that if the DOJ has to take down pill mills and those patients are left with nowhere to turn, that we can be there until we can give a warm handoff to other providers within the community.

The last thing I'll say is: This is partially related to IV drug use, but I'm very excited about our opportunities in HIV. Seven hundred-thousand Americans have lost their lives to HIV since 1981. It accounts for $20 billion in annual expenditures. Shockingly enough, there are 40,000 new cases of HIV every year in the U.S., despite the fact that we have the medications and the technologies to completely stop this in its tracks.

I think you saw in the State of the Union, which we were very excited about, that the president announced our plan to end the HIV epidemic in the United States. This has been an effort that five of us—Bob Redfield, Tony Fauci, George Sigounas at HRSA, Admiral Mike Weahkee from the Indian Health Service, and me from the Office of the Secretary—have been working on for months. This is a bold but very doable plan to decrease the number of infections by 75% in five years and 90% in 10.

We will start focusing on the 48 counties, DC and San Juan, that account for 50% of the infections. This is really a striking number, because we don't have to go through 3,000 counties to start—you could focus in a public health way to get this done.

I think as all of you know, that if you can get a person treated and virally suppressed, they are unable to transmit the virus to a partner. The data are overwhelming. …

This is expansion of prep, so that people at risk—only about 10%, maybe 15% of those who need prep are actually on it—respond to public health emergencies. Most importantly, we are going to be, very soon, supplementing local health departments to put boots on the ground at the local level, because this is a community and local issue. We have to reach people who are very difficult to reach.

This, as the opioids is really a whole-of-society initiative. I'm in the federal government now, I won't be in some time coming up. We will change our places. Feds can't do this alone, states can't do it alone, professional societies can't. Whether it's opioids or HIV, it really is a whole-society approach.

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