Medications for Opioid Use Disorder

Listen in as our expert panel discusses medications for management of opioid use disorder. They’ll review strategies to optimize buprenorphine use and clarify the role of methadone and naltrexone.

Special guest:

• Tyler J. Varisco, PharmD, PhD
  • University of Houston College of Pharmacy 
    • Assistant Professor, Department of Pharmaceutical Health Outcomes and Policy
    • Assistant Director, The PREMIER Center

You’ll also hear practical advice from panelists on TRC’s Editorial Advisory Board:

• Stephen Carek, MD, CAQSM, DipABLM, Clinical Associate Professor of Family Medicine for the Prisma Health/USC School of Medicine Greenville Family Medicine Residency Program at the University of South Carolina School of Medicine, Greenville
• Craig D. Williams, PharmD, FNLA, BCPS, Clinical Professor of Pharmacy Practice at the Oregon Health and Science University

For the purposes of disclosure, Dr. Varisco reports a financial relationship [cardiology, inflammatory bowel disease] with HEALIX Infusion Therapy (research consultant).

The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.

This podcast is an excerpt from one of TRC’s monthly live CE webinars, the full webinar originally aired in March 2025.

TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist’s Letter, Pharmacy Technician’s Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.

Claim Credit

The clinical resources mentioned during the podcast are part of a subscription to Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber Insights: 

• FAQ: Management of Opioid Use Disorder
• Chart: Treatment of Opioid Withdrawal
• FAQ: Treatment of Acute Pain in Opioid Use Disorder
• FAQ: Meds for Opioid Overdose

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Chapters

• 0:00 Introduction
• 1:40 CE Information
• 2:26 Treatment Indications
• 4:53 Medications for Opioid Use Disorder
• 8:25 Prescribing Laws and Accessibility
• 12:20 Special Populations
• 14:59 Initiating Buprenorphine
• 19:17 Ancillary Medications
• 22:28 Barriers to Treatment
• 25:34 Emergency Supplies
• 29:39 Red Flags and Monitoring
• 34:35 Acute Pain in Opioid Use Disorder
• 36:46 Conclusion

Transcript

DISCLAIMER: 0:00

This transcript is automatically generated.

Tyler Varisco: 0:07

Our typical image, I think, of somebody with opioid use disorder is sort of your intravenous drug user or somebody who has had a long history of heroin use or something like that. But in all reality, we have a lot of patients that are receiving opioids for medical management of pain that may benefit from transitioning to a partial opioid agonist or to other modalities of treatment. And so really anybody with dependence and craving, even if that is coming from opioid use in a medical setting, could benefit from treatment.

Narrator: 0:43

Welcome to Medication Talk, the official podcast of TRC Healthcare, home of Pharmacist Letter, Prescriber Insights, and the most trusted clinical resources. Proud to be celebrating 40 years of unbiased evidence and recommendations. On today's episode, listen in as our expert panel discusses medications for management of opioid use disorder. They'll review strategies to optimize buprenorphine use and clarify the role of methadone and naltrexone. Our guest today is Dr. Tyler Varisco from the University of Houston. You'll also hear practical advice from panelists on TRC's Editorial Advisory Board, Dr. Steven Carek from the USC School of Medicine Greenville, and Dr. Craig Williams from the Oregon Health and Science University. This podcast is an excerpt from one of TRC's monthly live CE webinars. Each month, Experts and frontline providers discuss and debate challenges in practice, evidence-based practice recommendations, and other topics relevant to our subscribers.

CE Narrator: 1:41

And now, the CE information.

Narrator: 1:46

This podcast offers continuing education credit for pharmacists, pharmacy technicians, physicians, and nurses. Please log in to your pharmacist's letter, pharmacy technician's letter, or prescriber insights account and look for the title of this podcast in the list of available CE courses. For the purposes of disclosure, Dr. Varisco reports a relevant financial relationship by serving as a research consultant with HEALIX Infusion Therapy. The other speakers you'll hear have nothing to disclose. All relevant financial relationships have been mitigated. Now, let's join TRC editor, Dr. Stephen Small, and start our discussion.

Stephen Small: 2:26

Who qualifies for opioid use disorder treatment? Stephen, can you give us some ideas there of what we should be looking for?

Stephen Carek: 2:34

Oh, yeah. I mean, so opiate use disorder and treatment for this is something that I'm pretty new to clinically. And I think this is, I think to whatever's been so far, I mean, I see this as just chronic disease and this is well within the wheelhouse and hope for future generations of family physicians to provide for their patients. I think it's really important. And in terms of the patients who qualify for opiate use disorder treatment, I mean, correct me if I'm wrong, but I think really anyone who's been diagnosed with opiate use disorder probably warrants a conversation about being offered treatment. And today, we're talking about what medications. Certain patients may be eligible for, which patients may benefit from certain combinations of medicines. But as this kind of goes through here, I mean, those patients that meet opioid use disorder, which there's a DSM-5 criteria for, I mean, if you're taking more than is currently prescribed, it's affecting your social life or interactions with others, having cravings, withdrawal symptoms. I mean, all those are important factors to consider when making the diagnosis. Then upon making the diagnosis, I think offering treatment for this is really important and also offering some Safety measures and mitigation for overdose is also really important as part of that comprehensive plan and conversation with patients.

Tyler Varisco: 3:42

I can kind of tack on to that. So one thing that I think is really important to consider is we have a lot of patients that have been treated with opioid agonists for chronic pain. A lot of those patients will have physical dependence and withdrawing their opioids or attempting to rapidly taper them will likely lead to withdrawal. So for some of those patients, I think treatment with a partial opioid agonist could be appropriate. And there are some trials that show pretty good success in tapering patients off of full opioid agonists with a partial agonist like buprenorphine. And so our typical image, I think, of somebody with opioid use disorder is sort of your intravenous drug user or somebody who has had a long history of heroin use or something like that. But in all reality, we have a lot of patients that are receiving opioids for medical management of pain that may benefit from transitioning to a partial opioid agonist or to other modalities of treatment. And so really anybody with dependence and craving, even if that is coming from opioid use in a medical Absolutely.

Stephen Small: 4:48

And I like Dr. Varisco's mention about partial opioid agonists. That's a great segue into our question of what meds are available for opioid use disorder. It feels like we have an increasing supply of what we can use to help these folks. So what options should we share with our listeners and viewers?

Tyler Varisco: 5:05

So we use three medications predominantly for the management of opioid use disorder. The first is methadone, which is a full opioid agonist. And it essentially, it's a long-acting full opioid that binds opioid receptors in the brain and in the periphery and reduces craving in the same way that another opioid agonist like heroin or hydrocodone or oxycodone may function. Methadone, though, is very safe. It is currently administered through opioid treatment programs or OTP and usually administered via supervised administration. A patient will go into the clinic, usually daily at first. They will take their dose under supervision of a clinic employee and they go home, go about their day. You can imagine that this can be very, very inconvenient for a patient to have to go somewhere to have somebody watch them take their medication. So for patients who are a little more stable in treatment, we transition them to take-home doses and then they can have, I believe, up to a 28-day supply under current federal laws of methadone that they can use at home without supervision. A lot of providers are reluctant to provide take-home methadone, and so still inconvenience is an issue. And then in some states, more restrictive laws actually prohibit take-home doses of greater than three days, and so access remains a problem. Which brings us to naltrexone, which is another option. It's very, very different, and that is a full opioid antagonist. So it binds those opioid receptors and keeps other opioids from binding, but it does reduce craving to some extent. The downside with naltrexone is that unfortunately a patient needs to be fully withdrawn from opioids before they begin naltrexone. So a lot of patients will have to go 10 days or so before they can get that first dose. And so that's a long period of time where they're dealing with symptoms to withdraw and dealing with craving, and it can be quite harrowing. Naltrexone is unfortunately used very commonly among incarcerated patients with OUD. And I think that that paradigm comes from the fact that while they're already in jail, we might as well make them sweat it out. I don't think that that's the most ethical use of medication. Buprenorphine, though, on the other hand, is sort of somewhere in between these two medications. So buprenorphine is a partial opioid agonist. It binds opioid receptors, but it does not activate them entirely. And because it does not activate receptors entirely, it carries minimal risk of respiratory depression. In fact, only about 2% of all opioid overdose deaths involve buprenorphine. And 97% of those that involve buprenorphine also had another substance like a benzodiazepine or alcohol on board at the time of overdose. And so this is a very, very safe medication. It's great because currently it is the only treatment for opioid use disorder that can be dispensed in any community pharmacy. And since the passage of the MAT Act, it can now be prescribed by any provider with Schedule III controlled substance prescriptive authority, including physicians, nurse practitioners, PAs. So theoretically, this should be the most accessible medication. It can be prescribed for a full month at a time after induction. Patients do quite well on it and can stay on it for years.

Stephen Small: 8:17

Yeah, I like how you mentioned that buprenorphine offers this sort of sweet spot between these other options. I never really thought about it that way. So that's great. And then I You bring up a great point about who can prescribe opioid use disorder meds, and this has recently changed, correct? I believe in the past couple years, it's been a large shift. Are there any other aspects our listeners should know about with these laws? Could they change in the future? Are these set in stone? Could potentially other changes occur down the line for other meds for opioid use disorder?

Tyler Varisco: 8:47

That's a great question. So the Mainstreaming Addiction Treatment Act, which was passed in 2021 and signed into law, I want to say at the beginning of 2022, now allows any physician with Schedule 3 prescriptive authority to issue a prescription for buprenorphine. And that's not just physicians, by the way, that's any provider with Schedule 3 prescriptive authority. So the MAT Act really has made buprenorphine very, very accessible. Prior to the MAT Act, you had to have a data waiver from the DEA or have an ex-DEA registration to be able to provide, and you were limited as to the number of patients you could treat at a given time. Now, post-MAT Act, that has been opened up to everything. There are some other policies in the pipeline. One of them is the modernizing opioid treatment Act or MODA. If MODA is passed, then methadone will be prescribable in the community setting outside of the OTP model and pharmacies would actually be able to dispense methadone for patients with opioid use disorder. I don't think these policies are going to be walked back. I think at this point, we know that the outcomes related to the MAD Act have been superior. I mean, we have better buprenorphine access than ever. We do have a good legislative movement right now toward more accessible addiction treatment.

Stephen Small: 10:01

All right, jumping more and digging deeper into our opioid use disorder options and the clinical considerations, maybe for Stephen here, how do you decide which med to use first for patients with opioid use disorder? I know we mentioned buprenorphine here. Are there any other considerations that maybe lean us towards one option versus the other?

Stephen Carek: 10:22

Yeah, well, at least from a sort of outpatient family practitioner perspective, I mean, I rarely have ever prescribed methadone. I mean, I probably count on my hand how many times I've prescribed that just because of the nature of requiring daily dosing. A patient comes to clinic, specifically providers that are well-versed and familiar with using that. If I've ever done it, it's only been for a short period of time, maybe like I said, a day or so, so they can get to their methadone clinic for treatment. A lot of these medicines, I haven't had a whole lot of formal experience using in a regular basis just yet. But most of my knowledge is coming in use of buprenorphine. I think it's readily available now that we have the X waiver gone, that we can prescribe these medications and give refills for patients that are building out these protocols to initiate and maintain therapy. And that's where we're leaning into, at least our outpatient setting is using first line for medication from prescriber's perspectives. I think it is worth, you know, bringing up the patient side of these medications as well. You know, there's some advantages for buprenorphine. Again, you can use it at home. It'll help with some of their pain being a partial agonist, low likelihood of overdose using these medicines. So the benefits are pretty high for patients. There are those risks that potentially could be diverted, you know, if patients are still using other substances, you know, there's still the risk for overdose or side effects with those medications. And then naltrexone being one that, you know, we haven't initiated that in our clinic yet, but then that's given as a monthly injection, making sure that you have kind of patients, yeah, you identify the right patient for that, and that's willing to come in, able to come in for the recurrent injections. And then the component of the D You know, if they're not able to quit the medicine or detox from the medicine, that probably makes it less ideal for patients to utilize. And then also that the naltrexone does actually help with pain, helping counsel patients that, you know, we're trying to get you off these opiate medications, help maintain and decrease some of those cravings. Ultimately, I think from a primary care standpoint, I think buprenorphine is going to be probably where we're going to lean into pretty heavily with use of these. And again, identifying the right patients to utilize those medicines for.

Stephen Small: 12:21

I wanted to ask you, Tyler, from your perspective, are there certain patient populations where one option is favored for, for example, pregnancy? Is there anything our listeners should be thinking about with that?

Tyler Varisco: 12:34

That's a really great question. So I think it's important to talk a little bit about the pharmacology here. And I'm not a pharmacologist, but I'm going to do my best to convey this. So buprenorphine has very, very high affinity for the mu opioid receptor, which is one of the reasons that we do need patients to be showing some withdrawal symptoms usually before we initiate buprenorphine because it will dislodge full agonists from the mu opioid receptor precipitating withdrawal. That being said, buprenorphine's affinity for the mu opioid receptor is either equal to were slightly higher than affinity for naloxone to the same receptors. And so the naloxone component of buprenorphine has very limited utility in preventing overdose in general. I know that there is some thought that if buprenorphine is used inappropriately and injected, that that naloxone component will lead to overdose reversal. But unfortunately, the real world data has just not borne that out. And like I said, risk of overdose with buprenorphine alone is fairly low. The current guidelines that are available from SAMHSA and from ASAM though. do recommend using buprenorphine monotherapy or buprenorphine without naloxone for patients that are currently pregnant. I do think that there are other special populations that would benefit from buprenorphine monoproduct or buprenorphine monotherapy. In some states, particularly where states participate in the Medicaid drug rebate program, buprenorphine brand name is usually preferred by the Medicaid plan. So like in California, for instance, Medi-Cal prefers Suboxone, meaning those a lot of pharmacies will not stock generic buprenorphine naloxone. For that reason, monoproducts will almost always be cheaper in those states where it is available. So price considerations do come into play. And then, you know, for some patients that have oral lesions while taking buprenorphine naloxone combination product, there is some thought that transitioning them to monoproduct may prevent further oral damage. I do think, though, that injectable buprenorphine products may be And we can talk a little bit more about injectables later. But yes, there are special populations that would benefit from monoproduct. But ultimately, at the end of the day, if monoproduct is cheaper or more widely available or widely accessible to that patient, I think that that's a legitimate reason to put that patient on monoproduct, even with a compelling clinical indication to do so.

Stephen Small: 15:00

Excellent. Sort of jumping off of that, Tyler, how should these be initiated? Specifically, maybe buprenorphine, since that sounds like it's being used more. What should pharmacists maybe expect to see on prescriptions for these? Will they be range orders, things like that? What should we give as some tips to our listeners?

Tyler Varisco: 15:17

That's a really great question. So initiation is going to vary patient by patient. If you look at sort of the old version of TIP63, there's this really protracted multi-day induction strategy. And I think we're kind of moving away from that as there seems to be more and more guidance and more and more clinical trials coming out demonstrating that more rapid induction with buprenorphine can be acceptable and successful in patients. Bridge to Treatment, which is a national organization that supports transatlantic of care in the ED setting for patients with OUD has a protocol where the patient is discharged from the ED at a dose of 24 to 32 milligrams buprenorphine on the same day of induction. That differs greatly from sort of the TIP 63 version of an induction protocol, which gets the patient to maybe eight milligrams on the first day and 16 milligrams a couple of days later. And so we're seeing more and more providers rely on rapid induction, and I think that that will become more common moving forward. There's also a lot of interest in low dose buprenorphine protocols where we sort of start slowly without precipitate or without withdraw symptoms and then sort of gradually taper that patient up. I think evidence is still evolving around low dose induction protocols, but it really is going to vary greatly in the clinical set or by clinical setting and by patient. What pharmacists need to be aware of is that we don't really know where a patient is going to land. So, you know, patients may require 16 milligrams a day as they're being stabilized. They may require 32 milligrams a day. We really can't predict that. And so a provider may start an at-home induction and think that a patient is going to land somewhere around 16 milligrams a day, but that patient's still experiencing withdrawal symptoms. That could potentially lead to an early refill at the very beginning of therapy if they've sort of ran through that induction protocol faster than expected or had higher buprenorphine requirements than expected. And so it's important to give patients some leeway early in therapy and work with them and the provider to just make sure that the medical needs are being met and that patient is not experiencing withdrawal symptoms. Because having poorly managed withdrawal symptoms early in therapy is really unlikely to support long-term persistence and really optimize treatment outcomes.

Stephen Small: 17:32

And we're actually getting questions right now from the audience. And we get this one often. What is the daily max dose of buprenorphine? Because if you look at different recommendations out there, it seems like there's conflict. Tyler, what would you say to that? I might even open that up to the group if others have opinions there.

Tyler Varisco: 17:51

So the FDA has recently requested changes to labeling for buprenorphine products from manufacturers to clarify that a daily dose of up to 32 milligrams may be required. That being said, Historically, we've used a maximum daily dose of 16 milligrams a day. That was what was on the labeling. But guidelines suggested that up to 24 milligrams may be used. We do think that in the presence of fentanyl and other more potent opioid analogs, that doses up to 32 milligrams a day may be needed for some patients. And I mean, I don't think it's a far stretch to say that that may continue to evolve and we may see higher doses being used in certain circumstances. That being said, not every patient needs to be on 24 or 32 milligrams a day. A lot of patients are quite comfortable on lower buprenorphine doses and we should be responsive to patients that say they don't want to go up as well as, you know, increasing the dose unnecessarily can lead to some sedation, can lead to constipation, can lead to other side effects that we We associate with opioid agonism and we really want to be responsive to the patient, not sort of get to a target because that's what the guidelines say. We need to work with the patient to just make sure we're managing withdrawal without causing negative side effects of treatment.

Stephen Small: 19:11

Treating the patient and not the number of the dose. I like that. That's great. And then Stephen and Craig, what ancillary meds might be used for opioid use disorder withdrawal symptoms? We're talking about opioid agonists right now, but are there others we should be thinking about that maybe pharmacists will see as prescriptions along with these opioid agonists?

Craig Williams: 19:32

Yeah, definitely. I'll just jump in briefly and say that, you know, in the hospital setting where we're kind of pretty comfortable dealing with fairly severe withdrawal and listeners may be familiar with the opioid withdrawal kind of symptom scale. Think about the symptoms you get that kind of dictates the pharmacology. But things that are available that we certainly use commonly on the inpatient side, clonidine, ondansetron for nauseousness, lopiramide for diarrhea and gastrointestinal symptoms, and even hyosiamine as an anticholinergic for abdominal cramping and severe. So Those would be the four that kind of come up fairly commonly. It'd be hard to operationalize that, I think, in a number of outpatient settings, but all of those have some pharmacology that helps directly deal with the withdrawal symptoms. As far as really needing these medicines for the physiologic withdrawal symptoms, it's certainly days, not weeks.

Stephen Small: 20:23

And that's a great segue to another question we're getting right now from the audience is how long... Should patients be receiving opioid agonists for opioid use disorder? Is it forever? Is it just a couple years? Based on what the withdrawals, as we just said, are relatively short, how long should patients typically be on this therapy? I'll maybe open the floor to Tyler first.

Tyler Varisco: 20:43

That's a great question. This really, again, I know I keep saying this and I know it's a really nonspecific answer, but it really does depend on the patient. So there is no evidence to support a duration of treatment for opioid use disorder shorter than 180 days. And actually the National Quality Forum, their definition of continuity of pharmacotherapy for opioid use disorder is an episode of treatment with an opioid agonist of 180 days or more with no more than a seven day interruption in treatment. So that's not to say that six months is a maximum duration, but we never want to be shorter than that. A lot of patients will need to be on agonist treatment or want to be on agonist treatment for years. And if they're able to function and they're able to fulfill other aspects of their life, you know, work and familial obligations, and they're comfortable being on treatment, there is no real reason to discontinue that patient's opioid agonist treatment. On the flip side, though, if a patient is sort of ready to see if they can move on, then it can be time to taper. And really, that has to be a conversation between provider and patient, and it has to be a gradual process. We want to taper very, very slowly. I would say no more than 25% of the dose in the first couple of weeks and sort of reassess, withdraw symptoms, reassess pain before tapering further. But a good taper may take anywhere between six weeks and And there's some really loose guidance from SAMHSA on that, but it really does just sort of depend on the patient and how they're tolerating that taper.

Stephen Small: 22:24

Great. Many different approaches there. That's excellent. And jumping off of that, what are common barriers to patients getting adequate opioid use disorder treatment just in general?

Tyler Varisco: 22:34

Yeah, this is sort of my jam, right? This is what we focus on a lot. So unfortunately, although buprenorphine reduces risk of mortality dramatically, unfortunately, it's not available in most community pharmacies. So in the United States, data from various audit studies shows that anywhere between 40 and 60 percent of pharmacies stock buprenorphine and availability varies dramatically by state and dramatically by pharmacy chain. There was a study published in JAMA not too long ago. from Scott Wiener and his group. And they used data from Bicycle Health. This was, you know, essentially Bicycle Health employees calling pharmacies to ask if they could send a prescription there. And they found that only like 28% of Publix pharmacies in Florida stock buprenorphine. Pharmacies have an obligation to essentially carry medications that are evidence-based and are known to lead to improvements in public health. And buprenorphine is one of those medications. I make the diabetes analogy here a lot. Walking into a pharmacy and not having insulin available or not having a metformin available would almost be unthinkable. Yet buprenorphine is not available in many pharmacies. So the biggest barrier to access currently, in my opinion, is just pharmacy availability. But in addition to that, there are payer issues as well. Buprenorphine in a lot of states, a lot of buprenorphine providers and a remain cash pay in that they prefer to not accept insurance. And so that creates a lot of barriers for patients that just can't afford therapy. At the same time, a lot of patients who are on employer-sponsored health plans may not wish to use their insurance benefits to pay for substance abuse treatment. And I think that's kind of reasonable if you think about it. There is some concern that if your employer finds out that you are taking a medication for opioid use disorder or for other substance use disorders, that that could lead to employment consequences. And while that would be discriminatory behavior on behalf of the employer, nobody has time to get involved in a lawsuit, right? And a lot of these patients don't have the resources to defend themselves against an employer. And so the ability to pay for treatment remains problematic and is a significant barrier to treatment persistence.

Stephen Small: 24:49

Yeah, lots of room for improvement there. And step number one is stocking that medication for sure. Craig, from the inpatient side, are there any other perspectives there regarding maybe transitions of care and things like that?

Craig Williams: 25:00

Yeah, let me just piggyback on that conversation briefly to say that absolutely pharmacies should be stocking these. I will say that before the remover of the waiver, which as Tyler said is fairly recent, prescribing just was pretty low. So especially we've done some work with more rural areas in Oregon. And, you know, if no one's prescribing the drug in an area, pharmacy's not going to stock it. So I do think we're seeing more prescribing now as it becomes more available. And hopefully pharmacies will be responsive as prescribing picks up. But some of those communities where it's not being stocked, it might be hard to find a prescriber prescribing it as well.

Stephen Small: 25:31

And that moves on to a next question we sometimes get is, what should we do if maybe a patient has an initial supply, but now they've run out? in the community. What options do prescribers and pharmacists have at that time to get them the care they need so they don't go into withdrawal? Stephen, is there anything from the physician side or from your experience that's worked to ensure there aren't gaps in treatment?

Stephen Carek: 25:57

Yeah, that's a good question. We've encountered this a few times in the residency teaching clinic I'm in. And it sounds like there's a lot of community variability in terms of comfort and availability for a lot of these medications. To speak on kind of where I am in the upstate of South Carolina, I just don't think there's a lot of providers up here that are well-versed in being able to continue and maintain these medications or especially, you know, have much knowledge in what's available and what's accessible for patients. And so in terms of connecting patients and communities, you know, identifying clinics that may help with such Some of these may be independent of healthcare systems, maybe understanding at least within your own healthcare system, which clinics are providing this service. And I think decreasing some of the stigma and some of the fear regarding maintaining patients on these medications. I mean, if they're feeling they're on a stable dose, their symptoms are manageable, you know, trying to improve physician comfort and prescribing maintenance dose medicines like buprenorphine for patients.

Stephen Small: 26:51

And Tyler, are there any DEA laws that allow for emergency supplies here? What considerations should pharmacists think about here? Because I think about patients running out of opioids, asking for some, and my heart rate just goes up. What options do we have here for patients in that situation?

Tyler Varisco: 27:07

That's a great question. And it's a really complicated question to answer in a straightforward way, but I'm going to do my best. So are there any DEA laws that would prohibit a pharmacist from dispensing buprenorphine a couple of days early where a patient to deplete their supply? No, there are no explicit laws that would prohibit a pharmacist from filling that prescription a little bit early if necessary. A pharmacist must fulfill their corresponding responsibility when dispensing a controlled substance prescription. And as long as that pharmacist can demonstrate that they really have no knowledge of any intent to misuse or divert the medication, then that prescription can be dispensed. And there are a lot of very legitimate reasons that a patient may deplete their supply earlier than expected. These are normal people. They might have to take a work trip. They might be going on a family vacation. They're going to run out in the middle of the trip. They may need an early refill. That can be reasonable in the same way it would be reasonable for really a At the same time, a lot of patients are actually dividing buprenorphine doses. And so it's been shown that most buprenorphine preparations can be reliably cut into smaller doses using a technique where the patient measures the suboxone strip with a ruler and then cuts it with a razor blade into fourths or halves or whatever, that buprenorphine is evenly distributed across the dose. And so the downside of cutting doses is you can damage a strip or if the strip, the half is exposed to moisture in the bathroom, it can dissolve. And so if there's damage to dosage forms or loss of doses, then those could be legitimate reasons to fill that prescription a couple of days early. If a patient does run out, kind of piggybacking on what Stephen was saying, I think it's reasonable for providers to issue a bridge prescription. And this is common practice. Now, insurance companies may not be willing to pay for that early refill. So one thing that we think it's really important to do is to talk to your patients a little bit about pricing and what they can expect to pay at the pharmacy counter. We've heard horror stories of pharmacies essentially charging patients their normal copay for like a seven days supply. And that's not always doing that patient a favor. So I think it's important to teach patients to advocate for an appropriate drug price and sort of ask how that price was derived. More on the provider side, of course, to just make sure that patients understand what they're getting and are paying a fair price that they do need to pay cash for an early refill.

Stephen Small: 29:38

And let's say we get these prescriptions. How should pharmacy teams handle, quote, red flags on prescriptions? And where do maybe prescription drug monitoring programs fit into that?

Craig Williams: 29:51

Yeah, I mean, as we've heard, this is so individual for patients. No, I mean... common red flags. There are patients dealing with a lot in their life. On the inpatient side, I think it's quite a bit different than seeing a patient who's a bit more stable who's getting a follow-up on the outpatient side. But to the point we've talked about other medications, so certainly being aware of logging into your state's prescription drug program, knowing what other therapies the patient may be on. Hopefully, whoever is seeing them in follow-up, have a regular physician and or pharmacist are aware of those other medications. But if someone's saying, I'm not on anything else, I'm not on any other full agonists or centrally acting agents, and we find things in the state prescribing database, that's certainly a red flag for us. Red flags from the patient seeing symptoms that you wouldn't otherwise expect. So symptoms with the dose would be a little bit high. Fortunately for us, that's pretty uncommon. So to Tyler's comment, things as benign as kind of constipation might be the sign. So really signs of overt sedation. But if you're seeing any signs of withdrawal in the patient who says they're just there for the routine dose, that's certainly a red flag for us. And to the conversation you just had, if they don't appear to be managing the medication well or having trouble. So if it's, you know, the fourth time in the last six months, they're asking for early refills or saying they're on a different dose than what you have on your record. But it's really very individual and unfortunately, as we get more experience with this drug, I think these are becoming less common as we are more comfortable managing this medication with these patients. But those would be some of the common ones that we might see on the, at least from the pharmacist side.

Stephen Small: 31:24

Yeah. And Tyler, you've had a lot of work in your guideline regarding prescription drug monitoring programs. Any thoughts in addition to that?

Tyler Varisco: 31:33

So in our opinion, and the opinion of the expert panel that wrote our guidance, red flags essentially should be interpreted in the clinical context of the whole patient as much as possible. And PDMPs are decision support tools to help with that decision. So what we urge pharmacists to do is to avoid binary thinking, right? Just because a red flag is present does not mean that prescription should be denied. There should be some due diligence on behalf of the pharmacist to actually fulfill that corresponding responsibility and look into the etiology of that red flag. And if we still can't figure out what's going on, then maybe we consider contacting the provider, have a conversation. And if both of us feel that there is an issue here, then we think about either modifying therapy or potentially no longer dispensing to that patient. But that's should be an absolute last course of action. Our priority should always be treating opioid use disorder and dispensing medication to meet patient needs. But unfortunately, if there is misuse or diversion, we do have an obligation to control that. But really clinical judgment here is the most important aspect.

Stephen Carek: 32:42

Yeah, just to piggyback on that too from a provider lens, a lot of clinics will have controlled substance policies that are pretty rigid, I mean, for correct reasons, right? But with medications like buprenorphine, I mean, I think taking care of the patient first and understanding kind of patients may have multiple other substances they may be using concurrently with this and being able to address, hey, how are we addressing these other substances that under certain pain contracts or prescription monitoring services, they now be either a violation of the contract or maybe been fired from a clinic. But really just being mindful that these medications can save lives and help these patients significantly and trying to keep those prescriptions and that prescribing pattern may be separate from some of the other medications or substances they may be using. And just understanding the benefit of these medicines is really significant. And we may need to refine our controlled substance policies to acknowledge those differences.

Tyler Varisco: 33:34

Can I add one more thing onto that? So one of the things that I think is really important to remember is that when we start a patient on buprenorphine, for many reasons, this is like a new chapter in that person's life, right? So if we're looking back at the PDMP profile, and for the last six months, this person has had a history of multiple provider use or a history of multiple pharmacy use for full opioid agonists, and this is their first prescription for buprenorphine, that historical pattern of opioid use would to some extent be expected for this patient and should not preclude them from accessing treatment for opioid use disorder for the first time. So I think it's important to always frame things kind of like Steve was saying within the context of treating the problem at hand, not necessarily looking at historical issues and how those may have affected patient behavior in the past.

Stephen Small: 34:31

Great focus on context there and thinking about that over time. In our last couple minutes here, we actually are getting a question from the audience, and we actually get this one frequently. Can patients being treated for opioid use disorder receive opioids for pain, for example, for an acute issue? I know we've maybe hinted at this a little bit earlier, but Stephen, what's the verdict there?

Stephen Carek: 34:52

Yeah, I think it's going to be interesting to hear kind of everyone's perspectives on this. And we are very commonly going to address patients in hospital settings, post-operative settings, to where we have to really thoughtfully address their pain. And traditionally, in my practice, we started with Tylenol, Motrin, some of those other non-opiate analgesics to help with pain. However, there come certain patients where we may have to consider utilizing opiates. And my understanding in these kinds of situations, we just have to be mindful of the dose of the opiate that we're using with these patients. If they're on something like Suboxone, buprenorphine, you know, they may require higher doses of these medicines to help alleviate some of that pain. I'd be interested to kind of hear from you guys and guidance and like, how do we make sure we appropriately dose some of these medicines? Obviously we want to, you know, not use them liberally, be very thoughtful with duration, dose, frequency, et cetera. But I don't know if you guys can help inform me on, you know, what are the, what's the best way to go about dosing and frequency and making some of these decisions?

Stephen Small: 35:51

And Tyler, any other thoughts there from maybe the community perspective, maybe not in such an acute scenario that we see inpatient, any differences there?

Tyler Varisco: 35:59

No, and I'm going to go back to what Stephen said on this, actually. I think one of the most important things is to just be mindful of frequency and duration of therapy here. So if we are discharging a person on buprenorphine with a full agonist as well, I think it's important to make sure that that duration of therapy with the full agonist is as brief as possible if it's continuing into the outpatient setting, and that we have very close follow-up with that patient. So even if they're very stable on buprenorphine, I would want to see them in clinic sometime in the next week or so. after discharge to just reassess pain and determine if we can transition back to the higher dose of buprenorphine if we've had to lower a little bit. And really, my priority at that point in time would be returning them to partial agonist therapy and removing the full agonist as soon as possible.

Narrator: 36:47

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