Expert: Pharmacies Serving as Extenders for Opioid Treatment Programs May Help Significantly Decrease Deaths From Opioid Use Disorder

Pharmacy Times interviewed Jonathan Watanabe, PharmD, MS, PhD, BCGP, professor of clinical pharmacy and associate dean of assessment and quality at the School of Pharmacy and Pharmaceutical Sciences at the University of California, Irvine, on more effective approaches to treating opioid use disorder following the increase in opioid overdose deaths in 2021.

Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy Times. Joining me is Jonathan Watanabe, PharmD, MS, PhD, BCGP, professor of clinical pharmacy and associate dean of assessment and quality at the School of Pharmacy and Pharmaceutical Sciences at the University of California, Irvine, who is here to discuss an approach to treating opioid use disorder that may be more effective than our current approach, in light of the recent uptick in opioid overdose deaths in 2021.

So Jonathan, could you explain to me a bit about your background working in the opioid use disorder, or OUD, space?

Jonathan Watanabe: Thank you. I've been involved in several different levels over many, many years now. So it began, I was involved as an investigator on a federal—actually it was a geriatric program—part of the Health Resources and Services Administration Geriatric Workforce Enhancement Program, that included a sub-award actually to train clinicians, specifically nurses, on the use of academic detailing via pharmacists for nurses to instruct them on Naloxone, as well as opening the door for discussions on medications for opioid use disorder, specifically talking about buprenorphine, but also familiarizing them with things like methadone and naltrexone.

Then, I led research kind of concurrently with that examining patients on opioids, benzodiazepines, and muscle relaxants, who were at elevated risk of hospitalizations and ED visits—sadly, they were. And then using some national datasets looking at that association, and then, again, there were so many things at the time that were moving into this crisis. I was asked at the skilled nursing facility that I was providing care at to look at monitoring programs for opioid use. So, looking at pain management, as well as seeing if there were mechanisms for finding out if there were ways we could reduce opioid usage in that skilled nursing facility and to examine if there were mechanisms that we could better apply for medications for opioid use disorder.

That sort of dovetailed into me being asked by the National Academy of Sciences, Engineering, and Medicine to serve on, or to speak with the Medications for Opioid Use Disorder Saves Lives consensus study and then the later report. Then that segued into probably what we’re talking now is the National Academy of Sciences methadone workshop for opioid use disorder that was sponsored by the White House Executive Office of the President of the National Drug Control Policy Office, and continue to work with an array of different folks around the country to look at what we can better do to improve assets, specifically via pharmacies, but an array of different approaches. But one consistent with a lot of that messaging is we really could do a better job of utilizing pharmacies, community-based pharmacies, to aid in trying to contain this crisis.

Alana Hippensteele: Absolutely. What are some of the problems that have arisen in our country's current approach to managing OUD, and what are some specific examples of how community pharmacists’ involvement might be able to address this?

Jonathan Watanabe: You nailed that, just as we even began. I mean, for the first time ever, there was more than 100,000 deaths due to overdoses in a 1-year period. That's the most has ever been measured. There was 400,000 deaths that they've measured between 1999 and 2017. So, if you actually look at that, that's more than the total combat deaths in World War II. So this is just, in terms of lives lost, not just the mortality but also the morbidity, the lives that are affected by this crisis—it’s just startling that there actually isn't more discussion about it. I think that some of the challenges, the cracks in the system—I mean, they're more like canyons in the system—in terms of trying to improve access and availability. It continues to be a situation where patients are unable to get access or are even aware, sometimes, that access is possible.

There has been a lot of dialogue that's demonstrated that it can be more than a 2-and-a-half-hour drive from certain population areas to an opioid treatment program. So some of the challenges just in terms of the inability to access the medication, even where it is available, that many times they may not carry it. The challenge is that there was this kind of twindemic that was going on with the COVID-19 pandemic, that I was also researching, as well as these things were going on at the same time, then certainly, the COVID-19 pandemic made it more challenging for those that were coping, both I think in terms of turning to opioids, but also getting treatment for it.

So, you have this kind of twin challenge that really synergized in a bad way in the past few years to make it more challenging for patients with opioid use disorder. And I think that, as many know, there's more of a challenge with fentanyl. Not only is it that the mechanisms for getting treatment continue to be challenging, but also what's going on in terms of the illicit market is the availability of fentanyl, which explained a good chunk of the opioid deaths in the spike. I mean, they're talking about fentanyl getting into even things like cannabis and these other things. I think that the challenge of ensuring that we've got appropriate management has never been more important, because it almost seems like all of the challenges have gotten more complicated in the pandemic.

Alana Hippensteele: Right. Absolutely. That makes sense. What are some of the changes you would be advocating for especially coming from the perspective as an academic in health care specializing in this area and having a bit of a lens around some of the research in this area?

Jonathan Watanabe: I think what we'll continue to lean on is there's, just as you mentioned, a challenge in access. If we can find ways, particularly what we looked at with methadone is can we utilize mechanisms for making it less onerous--they have to go to an OTP, sometimes they can only get literally a dose per day. They have to go to the OTP to get their daily dose of methadone. During the pandemic, that's I mean, for many, they just didn't even feel safe. So the challenge is what we can potentially do to improve access to make it less difficult to get treatment.

So some of those that we looked at, this was truly a repeating theme, was that we were finding ways to use pharmacies to better to serve as extenders for opioid treatment programs. So they're the mechanism that's—and they've literally demonstrated that in in GIS kind of heatmaps, that it's much easier to get to a pharmacy than it is to an OTP. So if we could use those as places where you could get your methadone if you needed it, and you qualify to continue or initiate your treatment generally, that would be a huge boon to patients to be able to safely access. So that really came up quite often. And, there's even some precedent because we can learn the lesson for buprenorphine, where that can be accessed at pharmacies. So try to certainly look at what we can better make available in terms of pharmacy-based access to medications for opioid use disorder. That just makes sense. And that was even repeated by many of the addiction providers, that what can we do to improve access by pharmacies? What can we do to improve access to take-home doses? What can we do to make it less difficult for patients to qualify for OTP? I think all of these came up very routinely.

And then I think some of the other elements, we'll probably get to this, is just enforcement of currently available regulatory activities. The ADA, the American with Disabilities Act, already protects people with opioid use disorder. They have the right to access; you cannot discriminate solely based on that they have opioid use disorder or they're using a medication for opioid use disorder. Similar in the prison system where, just like if they had diabetes, they are entitled to treatment. If they have opioid use disorder, they are entitled to medications for opioid use disorder. So some of these are actually just making sure that we adhere and enforce some of the rules that are presently available to help these patients get their lives back.

Alana Hippensteele: Absolutely. How involved are pharmacists currently in OUD treatment programs? You've mentioned some of the ways that pharmacists involvement would really aid those programs, but where is involvement currently at?

Jonathan Watanabe: It's not occurring nearly enough. When you think, buprenorphine can be dispensed at pharmacies, so that basically even general practitioners that are waivered can prescribe a medication for opioid use disorder that can be provided by pharmacies. From that standpoint, pharmacies are currently involved in trying to treat with buprenorphine. But the challenge in that continues to be access. There have been certainly well-documented data that it is not available at pharmacies, that there's challenges certainly in stocking at certain moments, because that can trigger follow up from the DEA. There's a called corresponding responsibility, the fact that you have to discern whether you should be dispensing that, so the discretion that's left to the pharmacist sometimes gets in the way. So, even for buprenorphine, there certainly continues to be challenges for pharmacies. Now in terms of OTP extension or basically clinical services for things like methadone at pharmacies, it doesn't seem to be occurring in a high volume, at least in the United States. There's certainly some demonstration projects and some recent research that's been done, I believe in Maryland, that's looked at getting the appropriate basically sign offs that you can dispense from pharmacies for methadone, as extension from OTPs. But doesn't happen, you know, I think I can count on one hand, the number of papers I can recall where they've studied it. So, it needs certainly needs to be done a lot more. And I do know, there are an array of pharmacists in this field that are interested but getting together the right regulatory framework that's going to provide for that, I think we still need to do important work. I'm actually hoping that some of this discussion we’re doing right now will hopefully stimulate that. There are many times where you will have to get authorization from substance abuse, mental health services administration, SAMHSA, or DEA, or state regulatory bodies to sign off. Those things all need to be checked for some of these things can occur. But we need to do that, or we need to find some brave techniques of trying to reduce some of those barriers, so we can capitalize getting pharmacists more involved.

And actually, there was a lot that was noticed during the pandemic where they certainly opened up the door to more things like beginning prescription of from an OTP versus via telehealth, providing more take home doses, and the data was positive. We didn't see a massive increase in overdoses of methadone or diversion. There hasn't been any real signal to say that that poses a problem. If anything, it seems to have benefited. It met its goal which is continuing to provide care for opioid use disorder patients during the pandemic. And I think there's lessons learned that can probably be brought in, like we saw with COVID-19 treatment and what have you, that there were many lessons that we learned from during the pandemic that can aid us in treating opioid use disorder patients.

Alana Hippensteele: Absolutely. Do you have any thoughts on what pharmacists can do right now to advocate for some of the changes that you’re talking about in terms of bringing things further into the pharmacy and also pharmacists involvement in some of these programs? What can pharmacists do today or this year to try to make some of these changes happen?

Jonathan Watanabe: I think that trying to coordinate with, if they're interested, is reaching out to addiction specialists to find out if there are mechanisms that they could, like I said, if some of the bodies that are involved SAMHSA, DEA, Board of Pharmacy, Board of Medicine, finding out what it would entail to effectively get the waivers so they could begin some of these initiatives. Because in many places the pharmacists are knowledgeable about methadone. We use methadone for pain treatment. That's what's interesting is when I was working in long term care, we would see a good volume of methadone used for pain management. But the minute it's used, it's indicated for opioid use disorder, that's when all the barriers kind of fall down. So pharmacists are aware, and they have participated in tapering patients with methadone. So, in terms of the pharmacology, the pharmacodynamics, how to dose it, they're well equipped. So they're in a very good position for use with buprenorphine and with methadone. Just trying to find the mechanisms where they could do that becomes—I think an important step is letting them know that there is interest. And then there's things like basically some demonstration projects from CMMI that have supported potentially finding programs that could be set up to evaluate whether some of these novel approaches of getting pharmacists involved, not just in dispensing but also being involved in providing direct patient care for some of these folks, could also be utilized and potentially be reimbursed. And I think that's the other element that really becomes important is ensuring that there's actually coverage, that both for the patient and for the provider that some of that is better delineated. And there's been a lot of discussion of trying to ensure that, at least from the Medicare and Medicaid perspective, that gets better fleshed out is that there's going to be reimbursement for providers of all stripes, but certainly for pharmacists, that if they want to be integrated into this, there's going to be reimbursement that they will be paid for those paid for those services.

Alana Hippensteele: Absolutely. Any closing thoughts, Jonathan?

Jonathan Watanabe: I think that most of the problems when you've got something of this magnitude, it's that it's multifactorial. I think that the barriers that we're seeing are access barriers in terms of patient awareness, access barriers in terms of providers knowing what they can be involved in and how they can they can provide treatment for these patients, barriers in terms of reimbursement to ensure that, that patients and providers feel covered. I always think it's interesting, as one of the rare moments where you have basically universal coverage before you reach Medicare age is actually for pregnant women. That's a very important moment when they can get services for opioid use disorder in terms of coverage, where they actually have it. So ensuring that these medications are covered for those for patients, when they actually have coverage becomes very, very important. I've also mentioned again, just ensuring that the laws that are already in effect are adhered to and enforced. I think that right after our meeting, there was a press release that again, indeed, the American with Disabilities Act does protect those with the opioid use disorder. They cannot be discriminated against and their services need to be offered, including within people that are incarcerated. And then finally, the one maybe we should have started with is we just have to find a way to diminish the stigma that comes with patients. The list was long in terms of those lived experience that said that they wanted to get help, but they didn't know how; when they were being treated with methadone, they were told they were still addicts even though they were living now being able to maintain a comfortable living take care of their families; these kinds of things. Some of this, we’ve just got to diminish, eradicate, I think the stigma that comes to the opioid use disorder, because I think what you even have is some providers that are interested in being evolved, they don't want to have to deal with what some of the kind of perceived baggage of providing care for these people that need help. And I think the frustration with this, that just makes it worse. So I think it almost doesn't quite matter what your exact take on how you want to characterize these folks that actually have just a brain disorder. But it's the fact that these current mechanisms clearly are not affected. And if we want to do something about it, we're going to have to kind of modify our approaches. And these things are, are very, very sound. We're not talking about medications that are unknown. We're not talking about quantities, and certainly we're talking about a patient population that really is, that their options are few. It just seems that, like any other any other disorder, that we have this duty to provide care. This is one where we could certainly do much more to enhance what we deliver.