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Transcript: Incorporating MOUD in Primary Care

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Dr. Sybil Marsh: Welcome to the NEOMED online learning module: Treating Alcohol Use Disorder and Opioid Use Disorder in your medical practice. We are your hosts: Sybil Marsh, MAMD, FASAM, and Christina Delos Reyes, MD, DFASAM. Those letters after our names mean that we are physicians trained in addiction psychiatry and addiction medicine. We hope this presentation will help those of you in those roles to feel enthusiastic about treating patients with alcohol use disorder (AUD) and opioid use disorder (OUD) in your own practices. Please take a minute for our pre-test. If you don’t [00:01:00] have a good answer, don’t worry. By the end of our presentation, you will have clear reasons for prescribing medication for alcohol use disorder and opioid use disorder in your practice, and you can feel comfortable with the decision making needed to prescribe these lifesaving medications to diverse patients in a variety of situations.

As a healthcare professional, I feel comfortable identifying, assessing, and treating alcohol use disorder in my office setting. We wanted to know how strongly you agree or disagree with this statement before we get started.

As a healthcare professional, I feel confident documenting and billing for an alcohol use disorder encounter in my office setting. How strongly do you agree with that statement?

As a healthcare professional, I feel comfortable identifying, assessing, and treating opioid use disorder in my office setting. What are your [00:02:00] thoughts here?

As a healthcare professional, I feel confident documenting and billing for an opioid use disorder encounter in my office setting. How strongly do you agree or disagree with that statement?

As a health care professional, I am familiar with the legal requirements related to the treatment of opioid use disorder in my state. We’re in Ohio, but rules can differ from one state to another.

As a health care professional, I’m confident handling a variety of situations that might occur: a patient with multiple medications and drugs, patients with later life opioid use disorder, a patient in relapse, rethinking recovery, a pregnant or postpartum patient, choice seeking patients, patients with chronic pain and alcohol use disorder or opioid use disorder, a patient wanting to drink safely, and a non [00:03:00] compliant patient.

Here are the learning objectives for this module. Participants will describe the goals and rationale for treating alcohol use disorder and opioid use disorder in an office-based setting. List steps to identify, assess, and treat AUD and OUD with appropriate medications and psychosocial interventions. Review how to efficiently document and bill for AUD and OUD office-based encounters. Identify the current legal requirements for treating OUD in Ohio, and practice new strategies for treating AUD and OUD through a series of real-life cases.

When you are taking a new journey, it’s always helpful to have a road map. As we move towards comfort and confidence treating patients with AUD and OUD, we’ll go through a series of steps. First, identifying the problem in our own role. Why should we get involved? Next, thinking [00:04:00] about what we need to care for these patients. We will follow the same steps that we’d use caring for any chronic, progressive, potentially life-threatening illness. We’ll identify patients who need assessment and are appropriate for treatment and we’ll consider assessment tools and treatment planning that works best for our patients, practice, and workflow. We’ll learn the basics of prescribing medication for AUD and OUD and how to involve additional supports for recovery in the patient’s treatment plan. We’ll explore the most efficient ways to document and the optimal ways to bill for these visits. We’ll challenge ourself with some real-life cases and gather some references that will provide even more support on our journey. As we will see, these patients really need us, and we can save lives by learning the simple skills and committing to use them.

Dr. Chris Delos Reyes: Hello! This is Chris [00:05:00] Delos Reyes. I am trained as an addiction psychiatrist. In this next group of slides, I would like to share some data that helps to make the case for using medications to treat opioid use disorder, also known as MOUD. To start with, we know that overdose deaths continue to rise through the end of 2022, which is the latest year for which we have complete data. We also know that medications such as naltrexone, methadone, and buprenorphine are essential and life saving treatments for many individuals who have opioid use disorder. And yet, especially in the case of buprenorphine, despite having 20 plus years of experience with this medication, it is clear that physicians, nurse practitioners, and physician assistants are not prescribing this medicine at full capacity. I will review some recent data regarding the barriers and facilitators to the use of buprenorphine in the hopes of increasing your understanding about how to decrease [00:06:00] barriers while increasing the facilitators to using MOUD.

The chart on this slide is from the Centers for Disease Control and Prevention and shows that nearly 108, 000 persons in the United States died from a drug involved overdose in 2022, which was the highest number of deaths recorded in one year since 1999. The graph also shows the number of deaths by gender, with females represented by the orange line and males represented by the yellow line.

The chart on this slide is also from the CDC and breaks out United States overdose deaths by specific drug or drug category. The gray line shows the dramatic rise in deaths due to fentanyl, especially since 2019. In fact, nearly 70 percent of the 108,000 drug overdose deaths recorded in 2022 involved fentanyl. [00:07:00] Overdose deaths involving stimulants, specifically methamphetamine, which is the yellow line, and cocaine, which is the orange line, have continued to steadily rise since 2019 as well.

What do we know about the number and distribution of buprenorphine prescribers in the United States ? As background, recall that the ability to prescribe buprenorphine for opiate use disorder has been in place for almost 25 years since the year 2000. In the early days, there was a limit of 30 patients per physician in the first year after obtaining the data waiver, and this was possible only after completion of an eight-hour training course. After one year of having the waiver, that limit was increased to 100 patients per physician, and then eventually for a certain subset of physicians, the limit was increased to 275 patients. In an effort to expand access to buprenorphine, nurse practitioners [00:08:00] and physician assistants became eligible to prescribe buprenorphine in 2016, but they had to complete 24 hours of training as opposed to eight. According to a paper by Rosenblatt and colleagues that was published in 2015, only 2. 2 percent of all U. S. physicians had actually obtained the data waiver. So that’s a little bit more than one out of 50. The same paper also looked at the geographic distribution of buprenorphine prescribers and found that more than half of all the counties in the United States, 53.4%, did not have a single physician with a data waiver. And most of those counties were classified as rural counties.

As you may be aware, in 2021, the 8-hour training requirement to receive a data waiver was removed after new Health and Human Services practice guidelines were published. Additionally, there was no longer a need to get a special X DEA number. Any [00:09:00] clinician could treat up to 30 patients without completing the eight hour or 24-hour training course, and clinicians could use their regular DEA number. Jones et al. did a cross-sectional survey in 2023 to look at the impact of the 2021 HHS practice guidelines in the prescribing practices of clinicians. In this study, three different groups of clinicians were surveyed. The first group of about 1,300 was called the prior data waiver clinicians. These were clinicians who had taken the required data waiver training in the 12 months prior to the new guidelines. The second group of 550 individuals was called the concurrent data waiver clinicians. These were clinicians who got their waiver in the first six months after the guidelines were published and who happened to actually take the eight-hour training even after it was no longer required. [00:10:00] The third group of about 800 clinicians was called the practice guidelines clinicians. These were clinicians who also got their data waiver in the first six months after the guidelines came out, but they did not take the eight-hour training. The study then looked for differences among the three groups of clinicians in terms of demographics and geographic data, as well as prescribing practices. One important finding from this study was that the third group, the practice guidelines clinicians, were more likely than the other two groups to be physicians, to practice in urban or suburban areas, and to practice in an emergency department or urgent care setting. I think it’s fair to conclude that one positive outcome of the 2021 HHS guidelines was to increase access to MOUD in particular settings in the US. However, across all three [00:11:00] groups of clinicians, more than one third of clinicians reported that they had not prescribed any buprenorphine at all since obtaining their waiver. More details on that on the next slide.

So, what were the reasons given by clinicians in the Jones study as to why they did not prescribe any buprenorphine since obtaining the data waiver? The most common reason given was the lack of patient demand. And this ranged from 38 to 59 percent of clinicians, depending on which subgroup they were in. For each of the reasons cited, you will see that there’s some variation among the three groups of clinicians. In descending order, other reasons cited by clinicians for not prescribing buprenorphine were lack of access to psychosocial or behavioral health practitioners, lack of access to addiction specialists for consultation, lack of access to psychiatric services, resistance from practice partners or staff, [00:12:00] or a lack of institutional support, and then finally, the inability to find a supervising physician. As an editorial comment, I wonder if the so-called lack of patient demand and resistance from partners, staff, and institutions has to do with the pervasive addiction related stigma in society at large, and particularly in healthcare, such that patients and their family members are ashamed and afraid to reach out for life saving treatment. It’s also evident to me that many clinicians are fighting an uphill battle because the overall healthcare system is fragmented and it’s difficult to access the psychosocial and behavioral services needed by patients with an opiate use disorder.

There’s one other study I would like to share with you, done by Lanham and colleagues in 2022. This was a study of clinicians in Texas who all attended a Data 2000 training. Of those 126 responding to the survey, about half ended up getting [00:13:00] their X waiver. And of this group, only 36 percent were actually prescribing buprenorphine. In the group who got the X waiver, versus did not get waivered, the barriers were listed as: the complexity of the process, a perceived lack of professional support, and the difficulty in getting started. In the waivered group, who were prescribing versus not prescribing, the main barriers were again listed as getting started, but also accessing reimbursement for treatment was difficult. Not surprisingly, in the second column, the most prominent facilitators were reported as taking action to reduce the burden of the waiver training, as well as simplifying the overall waiver process. All of the respondents agreed that the training itself was not enough and that a network of support was needed. Specifically, the non-wavered clinicians wanted to [00:14:00] have active mentors and to be connected with an experienced clinician as they began the process of using MOUD with their patients. While the clinicians who were already prescribers were hoping for a connection to an established opiate use disorder care network, such as an addiction specialist.

Which hopefully serves as a reminder that you, as an individual clinician, can help patients who have opioid use disorder in many different ways: by starting in a safe way, by using drug screens as a therapeutic tool rather than as a punishment, and by connecting your patients to recovery supports that will strengthen their ongoing recovery. And yes, there are laws that are affecting the treatment of patients with MOUD, but the regulations have become easier to navigate over the last several years, particularly in Ohio. It is my hope that the laws will serve as guardrails to excellent clinical care, rather than barriers that prevent you from treating patients who so desperately need life [00:15:00] saving and evidence-based interventions.

Remember that the use of medications for alcohol use disorder and opioid use disorder has goals on several levels and the healthcare system level. On the individual patient level, both MAUD and MOUD reduce the risk of relapse, morbidity, and mortality related to substance use disorders. On a larger community level, MAUD and MOUD helps reduce the family and societal disruption caused by illness, incarceration, and death. Finally, at the level of hospitals and healthcare, MAUD and MOUD reduce the burden of substance use disorder-related illness and injury, including but not limited to, conditions such as heart disease, stroke, brain injury, dementia, HIV, hepatitis C, cirrhosis, and other liver conditions.

I also want to point out that there are several goals [00:16:00] that relate to the healthcare provider, which are listed on this slide. Prescribing medications for AUD and OUD can fulfill the clinician’s personal goals of wanting to impact a life-threatening condition for which there is a great need in our society. Other personal goals include the feeling of competence and confidence that comes with providing evidence-based care. There’s also the benefit of witnessing sometimes dramatic improvement in a chronic condition over time. From a workflow and billing process, treating patients with substance use disorders is quite manageable and straightforward. I encourage you to think about your own goals and motivators related to treating this population.

Dr. Sybil Marsh: What would it take to prescribe medication for AUD or OUD in your healthcare setting? You might start with an interest in helping just one patient, someone you know from your practice. Plan to treat that patient as you would in your [00:17:00] usual scope with medication for alcohol or opioid use disorder as an extra way to provide evidence-based care for them. Let staff and other co-workers know that you are offering this service, and you’ll be able to answer their questions and calm any unfounded fears. If you have some templated notes ready in your EMR, you’ll be ready to go. And if you’re an MOUD provider who needs to complete eight hours of Category 1 CME to renew your DEA certification, you’ll be all the more ready to do that. In Ohio, we need to complete eight hours of CME related to substance use disorders every two years to continue providing MOUD. This is a win-win since you can also count this education towards your general CME [00:18:00] requirement when you’re renewing your license.

The steps to follow are the same as for treatment of other chronic diseases. We identify by screening and using diagnostic tools, assess severity, comorbid illnesses, social determinants, and readiness to change. Treat the problem by creating a plan, prescribing appropriate medications, and encouraging psychosocial and non-pharmacologic supports. Then we’ll document capturing essential elements of care in our note, and bill using simple, appropriate, and familiar codes.

Identify, assess, treat, document, and bill. Here’s what I do for patients with diabetes in my family medicine clinic, and you can see that the steps I take to treat a patient with substance use disorder are very similar. There’s a different screening tool and different medications, but the process is the [00:19:00] same.

One of the things primary care physicians know very well is how to manage chronic disease. We have great opportunities to identify and treat people with alcohol use disorder and opioid use disorder. Many patients are comfortable in primary care and don’t want to seek specialty treatment programs, and others simply can’t find a place in one. There is not enough capacity. Substance use disorders have much in common with other chronic medical conditions we treat. For example, type 2 diabetes, as we’ve seen, where there’s an interplay of genetics, environment, physiology, and behavior. And there is a bonus for us and the patients; providing office based opioid treatment for opioid use disorder with buprenorphine has been shown to improve the care and outcomes of co-occurring chronic medical conditions, [00:20:00] especially HIV and hepatitis C.

Step two, assess. We know the severity of the illness, whether it’s alcohol use disorder, opioid use disorder, or both, from our DSM 5 criteria. These also tell us if a patient might have problematic use of alcohol or opioids without reaching the level of a disorder. We’ll assess the patient’s understanding of what’s happening, their understanding of treatment, and their understanding of medication choices that they can make. You might be familiar with the importance and confidence rulers of motivational interviewing or other ways to assess the patient’s self-efficacy and readiness for change by exploring how important it seems to make a change and how confident they are that they could do so. And remember, even those who do not express readiness [00:21:00] still benefit from medication for alcohol use disorder or opioid use disorder. Far from being a crutch or a new addiction, properly prescribed medication can be empowering and supportive as the patient clarifies goals for their health and their life. We’ll assess for comorbidities and decide what is within our scope and what requires referral. We’ll assess for use of other substances, and together with the patient, we’ll use this knowledge to make a treatment plan. One of the tools we’ll make use of is a drug test. Whether this is familiar to you or unusual in your own practice, we know with certainty that it will yield either expected or unexpected results.

Drug testing in my office? Here’s an anxious question. Will the patient or prescriber be in trouble if the urine drug test is positive, and they’re getting a prescription for buprenorphine, a controlled [00:22:00] substance? If I identify opioid use disorder, which is ongoing, do I need to stop treatment? Well, the simple answer is no. A natural experiment occurred during the pandemic. Patients were isolated and they couldn’t attend their appointments in person. They also couldn’t attend the lab to test, and there was a decrease in the amount of urine drug screening that went on through the whole pandemic. But we found that drug testing did little to improve clinical outcomes. In fact, in the past, we’ve used it as a way to exclude patients from treatment by denying them treatment for the very disorder that causes the positive drug test. So, there’s no requirement to drug test patients you are treating for problematic alcohol use or [00:23:00] alcohol use disorder, but with shared decision making, you might decide that it would help that patient to see what is on their drug test when their main drug of use is alcohol. As you’ll see, testing is required at random when we’re treating patients for opioid use disorder, and it can be a useful therapeutic tool. A test that shows illicit opioids, expected or unexpected, can prompt a discussion about whether the dose or form of treatment is effective. And, if other drugs appear, especially unexpected ones, discussion about how they fit in and their effects might lead to a goal of stopping their use or reducing the potential harms associated with using those drugs as the patient pursues their treatment for opioid use disorder.

The treatment [00:24:00] steps consist of prescribing and encouraging recovery supports and then of understanding expectations as you develop a relationship with your patient moving forward. There are three effective medications for opioid use disorder, with a variety of routes: sublingual, buccal, subcutaneous, or intramuscular. There are three oral medications that are known to be helpful for alcohol use disorder and for binge or heavy alcohol use: naltrexone, acamprosate , and a group of anti-seizure medications that includes gabapentin and topiramate. Naltrexone is also effective as a monthly intramuscular injection. We’ll see these medications pop up later in the module.

What about recovery supports: [00:25:00] counseling therapy, treatment programs, and so on? Well, there’s a great variety of recovery supports, those mentioned above, and some unexpected ones that patients might define and describe themselves. But it’s appropriate to prescribe medications whether the patient engages in formal counseling, meetings, and other recovery supportive activities, or declines to do so. We can encourage any use of these supports and not necessarily just for substance use. Counseling or therapy with any goals that are engaging for the patient can lead to more assessment and consideration of how the drug and alcohol fits into the patient’s goals. This in turn can lead to decreased use of substances and new goals, even if the substance use is not the patient’s most pressing area of concern when you’re starting down the road.

[00:26:00] Treatment works better when the clinician and patient understand and agree on expectations. Reviewing medication choices and co-signing a standard treatment agreement that clearly lists patients and providers expectations is a good way to start treatment. You’ll note that the treatment agreement is not really a contract as we’ve called it in the past. A contract is an agreement where money is exchanging between the two parties, and this is not one of those, it’s a therapeutic understanding of the treatment plan and of how to keep safe when we’re using medications for opioid use disorder and alcohol use disorder. The team should be oriented so that they know that they’re making a valuable contribution to the patient’s care and their expectations should be clear also. Using a staff meeting for education [00:27:00] time allows the whole staff to review the biopsychosocial disease model of substance use disorder and the lifesaving role of treatment, even if the patient’s attendance and drug screens are seen not to be perfect. It’s reasonable to have an expectation that patients will be punctual and polite as we expect for any patient, and the flip side is that we as staff and as professionals will speak respectfully to and about patients with substance use disorder, as we would for any other patient. Scheduling staff might need to be prompted to understand the needs of patients who must have regular, timely appointments at predictable intervals to help them schedule for success and not to run out of medications or to miss appointments.

The big picture here is the patient’s overall health. We want to [00:28:00] know that patients are being screened for infections associated with alcohol and illicit opioid use and that we’re monitoring for other diseases and comorbidities. Before we prescribe naltrexone, we need to know if a patient is pregnant, but buprenorphine can be prescribed to a patient at any stage of pregnancy. We would plan to treat or refer for management of co-occurring problems or health states, like pregnancy, medical ones, surgical, dental, and behavioral. If they’re out of our usual scope of practice and not what we would normally be providing care for, we can provide or direct the patient to primary care if we’re not a primary care provider so that the patient can obtain preventive care and connect to social and behavioral health services. And for those of us who are primary care providers, we know that a [00:29:00] patient coming for AUD care or OUD care can easily integrate into our practice and have a yearly checkup and get their preventive care and chronic illnesses attended to. Again, the treatment agreement encourages patients to seek and accept care for their whole selves, not just for their substance use disorder. When the treatment agreement is understood and signed treatment can begin.

Again, in a big picture way, we’re going to focus on principles of treatment. The details, doses, schedules, adjunctive medications are readily available in some of the excellent resources that we’ve used in making this module. And when you’re ready, you can download those, find them online and get excellent instructions in how to begin. Treatment for alcohol use disorder begins with making an assessment and deciding with the patient if [00:30:00] they would like to use a medication as part of their recovery plan. . Generally, that kind of medication can start right away. For opioid use disorder, treatment also starts with making a plan about when to initiate medication and whether to do it at home or in the office. An initial urine drug screen is helpful here, because of the nature of the medications that we’re using: buprenorphine and long-acting naltrexone. We don’t need to exclude or refuse the patient on the basis of the results of our urine drug screen. But if we see illicit opioids present, we do want enough time to elapse between the last use of those opioids in the beginning of a buprenorphine or naltrexone prescription to know that we’re not going to cause a precipitated withdrawal. This can happen if the [00:31:00] buprenorphine or naloxone is taken when receptors are already occupied by a potent illicit opioid- and we like to avoid that because it’s so unpleasant for the patient. We can use a COWs, or seen a scale to quantify withdrawal if we would like, and we can instruct the patient and how to use that scale at home to decide when they’re in mild or moderate withdrawal, and at that point, it’s safe for the patient to start their buprenorphine or to get their long-acting naltrexone. If we use a templated, initiation note, all of these prompts will be there for us in the note, and we can then use a follow up note as we would for other patients with chronic diseases to track progress.

The next two slides show some SAMHSA Treatment Improvement [00:32:00] Protocol 63 tables. TIPS 63 is a nice resource. It’s in our resource list and you can easily just call it up and download it or read it online. Again, it’s SAMHSA TIPS 63. This is a very good resource that gives much of the detail that we like to have when we’re planning to do medication for opioid use disorder. You can see this is a detailed table that shows the buprenorphine transmucosal products that we can prescribe for opioid use disorder, and it can be hard to stick to the big picture when you’re wondering how complicated it’s going to be to do that prescribing. Well, I think what we see from this table is that it’s not really that hard. There’s a variety of products. It might depend on a patient’s [00:33:00] insurance, which ones they could use. It might depend on if they would prefer to have a tablet or a film. And you can see that there are strengths that match up to the dose that the patient might use. And that there are pretty clear target doses and a range of dosing that the patient will likely be in. Patients might choose to continue the formulation they start with. They might switch to a different transmucosal product, or they might switch to one of the injected forms that we’ll see later. The guidelines are clear, but there’s still a lot of flexibility.

This second table shows you the kind of detailed information you can have easy access to when you are looking for advice about when to increase a dose of buprenorphine or when to decrease the dose. I think, you’ll find when we review medications for alcohol use [00:34:00] disorder that the dosing is really simple and that there’s not a lot of judgments to make. For opioid use disorder, there are very clear guidelines about how to get to the right dose, individualized for your patient.

Here are our long-acting preparations. Sublocade and Brixadi are brand names for time release, subcutaneous buprenorphine products, and Vivitrol is the brand name for long-acting naltrexone. All are simple to dose, and patients might prefer them for a variety of reasons.

The founders of Alcoholic Anonymous described alcohol use disorder as cunning, baffling, and powerful. The same label applies to substance use disorders of all kinds. It’s useful to see the patient frequently initially, especially when they might be ambivalent about whether they want to do the work required to be in treatment or not. [00:35:00] Patients with alcohol related problems are good to see so that we can check on their tolerance of the medication they’ve chosen and to encourage psychosocial supports. And patients with opioid use disorders are good to see to determine a stable dose and to modify the treatment plan as needed. A stable patient might have an appointment to assess their substance use disorder and its treatment. And to review a prescription every one to two months- though at the beginning of their treatment, a weekly visit or a visit every two weeks is useful to determine that they’re in a stable place. We can’t let those appointments slide for intervals of more than 90 days, because buprenorphine is a schedule III opioid, and it’s a requirement to see the patient within that three-month period. Besides, these patients often have other [00:36:00] health issues that can be addressed one step at a time during these visits, and they might even need to make some separate appointments to give co-occurring problems the time and attention they deserve. We may track the patient’s participation in mutual help groups, counseling, therapy, and other activities that strengthen recovery, though it’s not a requirement. And we might continue to assess other behavioral and medical issues, deciding to follow them ourselves if they’re within our scope of practice, or to refer. Communication between the MOUD prescriber and consultants might be helpful and is generally easy in a well-functioning EMR.

This is a reminder that help is always available in so many different ways once you decide that you are interested in prescribing medication for alcohol use disorder or opioid use disorder. You’ll see [00:37:00] more about these resources later in the module . And you’ll also see that you might have personal resources within your system or within your practice- addiction medicine and psychiatry colleagues, and other prescribers who can help you sort through any puzzling situations. You might wish to join an ECHO program, which is an online program that takes place by Zoom, where you can connect to other prescribers and to other experts who can provide advice. And when it’s time to obtain your first DEA number or to renew your number, that eight-hour education that you’ll choose to complete will reinforce the knowledge you have and provide even more.

Now we’re on to step four: documenting the visit for alcohol use disorder. Here are typical parts of the visit [00:38:00] for an alcohol use disorder encounter, with the initial visit more detailed and the subsequent visits: investigating, reviewing, and reinforcing, as needed. You might find, by surprise, that a patient you’ve seen for some time actually is struggling with alcohol. And in that case, you can think about having an initial visit to gather information that you might have missed or that they might not have felt comfortable sharing before now. You can see that these recommendations for what to include in the visit derived mostly from recommended standards of care that you’ll see in some of the authoritative documents that are in our references. They come from the American Society of Addiction Medicine and governmental agencies that distill research and expert opinion into recommendations, like the ones you see here.

When it comes to documenting the visit for opioid [00:39:00] use disorder, we do have an extra layer. It’s Ohio Administrative Code 4731-33-03. This is the law that tells us what we must do when we’re prescribing buprenorphine naloxone for opioid use disorder, and it exists mostly because this is a controlled substance. It also provides guidelines for how to produce a high-quality visit, and this law has been revised recently in ways that are really helpful to us. So don’t be afraid of OAC 4731-33-03. It’s just the law that tells us what we need to do as prescribers. Chris will go into more details about improvements to this law that have been made recently, but if you focus for a moment on the highlighted parts: assess the patient, gather information, [00:40:00] educate the patient about medication and non-medication options, gather the data to justify the treatment, do a history exam and lab testing, document your visits and treatment plan, use a treatment agreement as you would for other controlled substances, and revise the treatment plan, as needed. You can see it’s not asking for anything very different from that alcohol use disorder visit or any visit we might have with a patient. These are all things that we’d like to attend to and to document. It’s just asking for appropriate patient education, information gathering, treatment planning, and documentation. Now, next comes the part of the law that talks about those psychosocial and behavioral interventions that are often recommended for people with substance use disorder.

And here it is. This is the psychosocial part of [00:41:00] 4731-33-03. Again, it’s a lot of words in that intimidating New York Times font, but when you focus on the highlighted part, it’s basically telling us to assess the patient’s psychosocial needs, refer appropriately to a professional- like a counselor or psychologist, if we don’t provide those services ourselves, and that we might also refer to non-licensed paraprofessionals, like case managers and peer supporters. There’s a lot of flexibility here. We know from the ASAM National Treatment Guideline update of 2020 that psychosocial treatment alone is not effective treatment for opioid use disorder. But in both alcohol use disorder and opioid use disorder, a psychosocial intervention, like counseling or mutual help group membership, can help the patient cope with co-occurring illnesses and life stressors, [00:42:00] and can help improve self-efficacy and quality of life. The law instructs us that we should not and do not need to decline or discontinue office based opioid treatment, if a patient is unable or unwilling to engage in psychosocial interventions while they’re receiving medication for opioid use disorder. Even without those psychosocial interventions, the medication itself is lifesaving. Similarly, for patients with alcohol use disorder, they may or may not be interested in a medication and they may or may not be interested in counseling or mutual help group membership. We can provide them with what they are interested in and engage them in whatever way might be helpful. When they note improvement, they might be interested in pursuing [00:43:00] one of those other pieces of treatment that can lead to further improvement.

So here is what the revised law that was adopted on October 31st, 2024, says we need to document: a thorough history and an indication for medication for opioid use disorder; a thorough review of systems and exam; a thorough lab evaluation; education about the different medications available; and a choice that the patient has made by shared decision making. We document the encounter, including referrals, results, and a treatment plan. We must also document some harm reduction advice. All patients with opioid use disorder- whether they’re using medication or not, should have a prescription for nasal or injected naloxone. This is the overdose [00:44:00] reverser. They should include another person who knows how to use it. So that in the event of an overdose, their own or another person’s, they’ll naloxone and reverse the overdose. Patients should also be instructed to go to the emergency department if anywhere along the way they’re in severe withdrawal or if they feel over sedated by anything they’ve either something illicit or a medication that’s prescribed. You can see that these pieces of the note are legally required, but they’re also standard of care. We’d want a patient to have that information and to have that medication to use in the case of an emergency anyway, even if it weren’t part of the law.

These items should be included in the treatment plan: discussion of available medications, the choice of medication and the reason for that [00:45:00] choice, discussion of non-medication options if the patient declines medication, though the standard of care is medication for opioid use disorder, not treatment programs that don’t include medication. Patient education that can be covered in the treatment agreement that you review and sign together. Consent for treatment is also included in the treatment agreement and a plan for random drug screens, which I do at random appointments, documented discussion of psychosocial interventions that are available, and documentation of referrals, and those that are accepted or declined, and a revision of the plan as needed. So, don’t these simple legal requirements make sense? These are all things that we’d like to document anyway in a thorough visit. You might wonder what is meant by this word thorough- a thorough exam, a thorough lab [00:46:00] investigation. You will see through the module and by using some of the resources that, by expert consensus, we know that we want to ensure that a patient has the investigations they need to look for an infectious disease, or to look for an injury, or a comorbidity that might be associated with their substance use, or that might be neglected because they haven’t sought care. Generally, that thorough investigation will seem pretty sensible to you as primary care providers and that there’s not a kind of a strict definition of what those thorough investigations need to include.

These simple requirements made sense to the lawmakers at the Ohio Statehouse, who approved them in October 2024, after some concerted expert opinion from [00:47:00] the Addiction Medicine and Psychiatry community. I salute our Ohio Statehouse because the legislators really did simplify the law and reduce barriers to prescribing. So, we appreciate them for this and there will be more from Chris later.

To end our section on documentation, here are some of those links I talked about linking to some templated notes and treatment agreements that might be useful in your own practice. You might find that someone within your system has already developed a treatment agreement or a templated note that you can simply import, or you might decide to make your own note and put together your own treatment agreement. Either way, you are going to have a quick and complete way to be prompted to include all the information you need in the visit with the patient.

We’ll conclude our [00:48:00] five step journey to prescribing MOUD and MAUD with some thoughts about billing. Happily, billing is fairly simple for these visits. While there are many codes concerning screening and brief intervention, screening for depression, etc. mostly used during a Medicare visit, we don’t need to use those codes for individual components of a visit. There’s a whole set of unfamiliar building codes that are designed to be used by treatment programs, not by us in primary care. We don’t need to use them, and we can just use our regular CPT codes. In general, an initiation visit will be a 99204 and the activity and documentation required, even for a routine maintenance visit with renewal of prescription, meets criteria for 99214. If the visit is more complicated, especially if we’re managing co-occurring [00:49:00] disorders, it might even be a 99215 and you may spend more time in that visit. Seeing the patients for reasons other than their substance use disorder and prescription renewal might generate codes of 99213 to 99215 as it would for any patient. A diagnosis related to heavy, harmful, or binge drinking or alcohol use disorder, or a diagnosis of opioid use disorder, is the only diagnosis necessary, but you can add additional diagnoses or codes for anything else that you’ve covered in the visit as you normally would. Like all patients, patients with alcohol use disorder, or opioid use disorder, need a yearly health maintenance visit and preventive care. We should have a separate appointment for that purpose, and you would [00:50:00] bill that visit as a health maintenance visit according to how the patient is insured.

This is the bottom line here. We are going to identify, assess, treat, document, and bill. Specifics about dosing and adjunctive medications in the initiation and maintenance phase are discussed in the authoritative references that you’ll find at the end of the module. Alcohol use disorder and opioid use disorder management are easier than many of the things that you already do with some degree of expertise. The legal and documentation requirements really rely on standard of care. We’re familiar with this approach and we aspire to achieve it. Where medication for opioid use disorder is concerned, some standardized templated note forms and treatment agreements will always be able to include all that the law requires, [00:51:00] and then we can focus on the patient, not on the red tape.

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Transcript: Case Studies

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Dr. Chris Delos Reyes: As Dr. Marsh pointed out, the process of office-based MAUD and MOUD can be broken down into the five steps of identify, assess, treat, document, and bill. In step one, identify, remember that patients may come to you without any overt signs or symptoms of a substance use disorder. A key step then is to screen every patient at least once a year for two reasons. One, the clinician will be able to identify the illness in a much earlier stage when the condition is easier to treat. And two, this will normalize and decrease the stigma surrounding addiction. If you make screening for addiction a routine part of care, patients will begin to feel safer bringing up the issue in your office. [00:01:00] Now, for those patients who are already presenting with signs and symptoms of a substance use disorder, or who are specifically asking for help with drinking or drug use, the clinician can go straight to the diagnostic interview and testing, leading to possible diagnosis. I will be reviewing how to make the diagnosis of a substance use disorder, but first I want to talk about the screening process in more detail.

There are many validated screening tools to identify the misuse of alcohol in a single question screener, which typically leads to a longer screening tool, such as the AUDIT, which is the Alcohol Use Disorders Identification Test, or the DAST, the Drug Abuse Screening Test. You can find links to all of these and other screening tools in the resource slides at the end of the presentation. Once you complete a screen and it comes up positive, the next step is to confirm the diagnosis. For those patients who come into your office already seeking help for a substance use disorder, express [00:02:00] empathy for their struggle and confirm the diagnosis. It is also vital to rule out other co-occurring behavioral health conditions, such as depression or anxiety. Even if you cannot completely finish the diagnostic process, it is safe to start MAUD and MOUD as long as the patient is not actively suicidal or acutely psychotic and appears to be able to manage starting the medications. Other components of the history that are important at this stage include the client’s use of any other substances, including tobacco, and any previous history of substance use disorder treatment. Basically, you’re taking a general medical history that is appropriate to your scope of practice.

There is a new brief screening tool to screen for drug use in a primary care setting, was developed in 2015 by Tiet and colleagues, and it is [00:03:00] called the screen of drug use, sometimes shortened as SODU. It has two questions, which are listed here. The first one being, “How many days in the past year, have you used drugs other than alcohol?” An answer of seven or more is considered a positive screen. The second question is, “How many days in the past year have you used drugs more than you meant to?” Where an answer of two or more is considered a positive screen. Having positive responses to both questions was found to be highly sensitive and specific for the presence of a drug use disorder in their study of more than 1,200 primary care patients. I will also mention that getting a positive screen should generate interest from the clinician and prompt further questioning about the frequency, quantity, and impact of drug use. For example, you can ask quantity and frequency questions such [00:04:00] as: “How often were you using?”, “How much were you using?” And in the case of question two, “What happened during those times that you used more than you meant to?” “What were the consequences?” Another useful question at this stage is, “How do you feel your drug use fits into your overall life?”

Now, I would like to review how to confirm the diagnosis of a substance use disorder using the DSM 5 criteria. The 11 items are divided into four symptom categories, which include one: impaired control, two: social impairment, three: risky use, and four: pharmacologic or physiological dependence. As you listen for these criteria in your clinical interview, remember to pay attention to the number of items that have been present within the last 12 months and look for a recurrent pattern of behavior versus a single- or one-time event. [00:05:00] In terms of the two physiological criteria, tolerance and withdrawal, note that symptoms of tolerance and withdrawal that occur during appropriate treatment with prescribed opioids, sedatives, or stimulants are specifically not counted when diagnosing a substance use disorder. This basically means that if a person is using specific prescribed medications under medical supervision, then you would not count tolerance or withdrawal to those medications in making your diagnosis. Finally, once you have counted up the number of items present during the last 12 months, you can get an indication of disease severity. So, if your patient answers yes to two or three of the 11 criteria, then they are diagnosed with a mild substance use disorder. If that number [00:06:00] is four or five items, then they have a moderate substance use disorder, and if they have six or more criteria, that’s considered to be a severe substance use disorder.

So, now we’d like to move into some cases so that you can increase your comfort and confidence. As you listen to these cases and review them, just think if you recognize any of these patients, and if you’ve ever had any of these reservations about prescribing medications for MOUD. Just to assure you, these are very, very common cases, and we do have some answers for you.

Case one is the patient on multiple meds and drugs. So, in this case, there’s a 28-year-old man who started using oxycodone at the age of 21 after an injury. He’s now also using heroin to stay out of withdrawal. His girlfriend overdosed, and he became depressed and wants to stop using. He does [00:07:00] have a diagnosis of lifelong anxiety and uses Xanax that he gets from an elderly doctor in the next town, but he doesn’t have a primary care provider. He thinks he might have ADHD and gets Adderall from a friend. He smokes marijuana at night and uses edibles when he can get them. He can’t afford the marijuana card. So, some of the questions that come up with this case are, “Is it ever okay to mix buprenorphine, and what about illicit or legal marijuana?”

In the Beresh article written in 2021, having a positive test come up for a non-opioid substance, such as cocaine, marijuana, or benzodiazepine, can be used to prompt further discussion on the effects of these drugs and to talk about measures that can minimize harm. In general, the use of other drugs is not a reason to [00:08:00] discontinue buprenorphine because doing so would put the patient at risk for overdose and death. So, the answer to that question is that yes, there will be situations in which you will be prescribing buprenorphine, and the patient will also be using other substances. Some of the important things to note in this situation are to assess them specifically for a benzodiazepine use disorder and if that comes up positive to treat it appropriately. It would be important to communicate with the prescriber of the Xanax to explore other approaches to anxiety. So, this would be a case where a release of information would be extremely important. There was a study in 2023 that showed that in the period between July of 2019 and June of 2021, buprenorphine involved [00:09:00] overdose deaths accounted for about 2. 2 percent of all drug overdose deaths and 2. 6 percent of opioid involved overdose deaths, and many involved other respiratory sedatives like fentanyl. The bottom-line suggestion here is to set clear expectations about the management of benzo use and opiate use disorder, but to continue MOUD, specifically buprenorphine naloxone, because of its favorable risk profile.

Dr. Sybil Marsh: Next, the patient with later life opioid use disorder. A 78-year-old woman with chronic pain has used prescribed oxycodone since it was approved by the FDA in 1976. After a fall, she was admitted for workup and oxycodone was discontinued. She was discharged with acetaminophen and had mild withdrawal symptoms. [00:10:00] She has been back to the emergency department three times in three weeks, calls your office daily to try to get her pain medication back, and her family members have contacted you to say, please don’t do it. You wonder… She seems to have an opioid use disorder. She had withdrawal. She wants medication despite its potential harmful consequences, like recurrent falls, and it’s interfering with the relationship with her family. But can I prescribe buprenorphine naloxone to a patient who identifies pain as her problem, not opioid use disorder? Well, if you use the steps, the answer will be yes. Using the diagnostic tools and the steps: identify, assess, and treat, you’ll find that your initial impression is true. Opioid use disorder is present, [00:11:00] but it’s okay to focus on pain management if that’s what engages the patient. Medication for opioid use disorder will have some analgesic effects, but it will also calm craving and opioid seeking that we’re seeing in this patient. This makes it easier for the patient to accept non-opioid medications and non-medication modalities, so that they will build a multifaceted pain management program to replace the former reliance only on that opioid. Buprenorphine naloxone products do provide some analgesic effects. Naltrexone does not. If the patient does not have opioid use disorder, but they do have a high tolerance for prescribed opioids, they’re going to be better to use a buprenorphine product [00:12:00] developed for management of mild to moderate chronic pain, such as Butrans Patch or Balbuca Buccal Patch, instead of the much more potent buprenorphine naloxone designed for patients with OUD.

Are there special concerns for geriatric patients with opioid use disorder? Absolutely. They are at risk for reduced tolerance over time, but they may also be sensitized so that decreasing their opioid increases pain disproportionately. They might seek illicit opioids if this has been their pattern in the past but are unlikely to start looking for illicit opioids if they’ve never done so in their previous life. Patients with dementia might forget to seek an opioid and can respond well to supportive treatment that replaces the opioid that they’ve used for many years with other medications and modalities. We’ll talk more about chronic pain soon [00:13:00] in another case, since it’s such a challenging part of our patients care. We need to be aware of alcohol use in this generation. It may be hidden or overlooked, and it increases the risk of over sedation. Though, it’s better for a patient to have a controlled dose of buprenorphine than an unpredictable dose of a pure mu agonist opioid like oxycodone or morphine. The bottom-line suggestion is that if medication is indicated for opioid use disorder, age is not a barrier. Start low and increase slowly. Our goal is to maximize non-medication support for treatment of pain, non-opioid medications, and to get to a dose of buprenorphine that is the lowest effective dose, enough to provide some pain relief and [00:14:00] to stop the patient’s opioid seeking and pain behaviors. They might, over time, decide that looking back, they can see the presence of an opioid use disorder. They might never really accept that diagnosis, but we can still treat the opioid use disorder that we know is there and protect the patient from use of other opioids.

Dr. Chris Delos Reyes: Case 3 is the relapsed patient who tapered off methadone in a treatment program and confidently left after three months of counseling. After two years of being abstinent, she needed an emergency surgery. She went home with only 10 tablets of oxycodone, but when her cousin died unexpectedly, she found that she needed more. She got a few from a friend and they helped. She’s now been using fentanyl intranasally for the last year and recently lost her job. She’s also started drinking in the evening to help with [00:15:00] sleep. She is embarrassed to go back to the methadone program, and she wants to be able to go back to work on first shift.

So, in this case, what medication choices are available for a patient who’s relapsed after a period of abstinence- in this case, two years of abstinence? Are there other interventions that might strengthen her recovery? So, in this case, all three medications for MOUD would be available. She could certainly go back to the methadone clinic. It sounds like you would have to, you know, counsel her about that and assure her that it would be okay to return even after some time away. That’s the pure mu agonist. She could certainly benefit from being put on buprenorphine naloxone, which is the partial mu agonist. And of course, she could also decide to go on the naltrexone injectable, which is the mu antagonist. In this case, because she’s also drinking, the naltrexone could also [00:16:00] help her to feel a decreased craving for alcohol. And while you don’t need to demand abstinence from alcohol, abstinence is preferred. But you and she could work on alcohol goals through a shared decision-making process. It isn’t something that should stop you from prescribing one of the other three medications. And also in this case, looking at sleep hygiene, as well as non- medication or medication ways of managing her anxiety, would help to replace the alcohol.

In terms of other interventions that could strengthen this patient’s recovery, particularly helpful, depending on family members, you could carefully select family members that could get involved in her care. She would need primary care to monitor her medical needs, and I think a return to counseling would be warranted. And here you would decide whether that would be better in- [00:17:00] person versus virtual. Certainly, a focus on trauma informed counseling and a focus on grief management, given her recent loss, would also be suggested and ongoing drug testing to get feedback about her progress in her recovery. So, the bottom-line suggestion in this case, when someone is coming back to treatment after a period of abstinence, I think it’s important to convey that, MOUS is a choice and it’s not an accomplishment, where the real accomplishment is being alive and being in recovery. Whatever that takes. So, MOUD is a tool for recovery and returning to it is certainly a choice, and it’s never a failure. And so, hopefully, that will help to reframe the situation for this patient.

As a bit of a sidebar, this case brings up the question of: “Can a person that is taking medication for opiate use disorder [00:18:00] still go to 12 step or AA meetings?” The answer is yes, of course they can, and they do. As you may be aware, going to an AA meeting does not require a diagnosis of anything. Basically, AA members all share the desire to stop drinking or to avoid drinking if they’re currently not drinking now. Having opiate use disorder or any other diagnosis is not an exclusion to AA. And like other private medical information, it does not need to be discussed with anybody in the meeting. The focus in going to meetings should be on using the 12 steps and not on the specific substance in question. So, our bottom-line suggestion is if there is a particular meeting that is causing discomfort or is uncomfortable for a patient, it’s really because of the individuals that are attending it- not because of the 12-step program. In this case, I would advise them to take [00:19:00] what they like and leave the rest, try a few different meetings in their area.

Dr. Sybil Marsh: Let’s look at a patient with a growing family. A postpartum patient isn’t sure if she should continue buprenorphine naloxone, now that she’s had the baby, but she no longer needs to see her obstetrician. And she’s seeing you for one of the regular reasons you’d see a patient.

What should you advise her? The CDC says this: the postpartum phase is a vulnerable one, according to the American College of Obstetricians and Gynecologists and to the Substance Abuse and Mental Health Services Administration. They both say that people with an opioid use disorder should continue medication as prescribed after the baby is born. The healthcare provider should monitor during that time and adjust the [00:20:00] dosage as needed. If the patient wishes to discontinue treatment, that should be delayed until the baby is consistently sleeping through the night and has completed breastfeeding. But it can be considered if the mother and child are stable, well bonded, and safe with a stable home and social environment. However, people can safely continue medication for opioid use disorder for as long as they need, and this can range from a month to a lifetime, since the risk of relapse is high, and illicit opioids may be fatal. Many patients choose to continue medication for opioid use disorder instead of considering it a temporary phase during pregnancy, and they should be encouraged to continue if they feel it will be helpful.

So, now that the patient isn’t seeing the obstetrician, you decide to take over the [00:21:00] patient’s medication for opioid use disorder. Does she need a dose adjustment? How will you know? Again, the CDC advises that doses for a postpartum patient resuming regular care may continue, increase, or decrease simply on the basis of symptoms, craving, and use. They remind us that the patient with opioid use disorder who decides to end medication for that illness, even safely and gradually, is at a high risk for relapse. Parenting may be an incentive to stay in recovery and even to remain abstinent from other drugs and opioids without medication for opioid use disorder. But parenting is also a stressor that increases the risk of relapse. The bottom-line suggestion is to continue to see all decreasing and tapering [00:22:00] patients regularly, if that’s what they choose to do, to help them to build a relapse prevention plan that includes stress management, sleep hygiene, 12 step meetings, or other recovery promoting meetings, and other activities that enhance their recovery and stress management. We could avoid prompting people to reduce their dose or to stop MOUD simply because the stressor of their pregnancy has resolved. But if a patient does choose this path, we’ll invite them to increase or resume their MOUD whenever they wish to. And we’ll monitor them during that tapering down process.

Are you surprised to learn that this patient who’s had opioid use disorder and been using buprenorphine naloxone is breastfeeding? Well, the family [00:23:00] doctor or obstetrician providing prenatal care and prescribing the buprenorphine naloxone would have told the patient that breastfeeding is beneficial in women using either methadone or buprenorphine for their opioid use disorder and has been associated with decreased severity of neonatal withdrawal, less need to medicate the infant, and a shorter hospital stay for the parent and the child. Transfer of both methadone and buprenorphine into breast milk is minimal, so the American Academy of Pediatrics recommends breastfeeding regardless of the dose of medication. There’s no need for a patient who plans to breastfeed to reduce their dose of methadone or of buprenorphine. Breastfeeding contributes to attachment and provides immunity that might reduce stressful neonatal infections. It should be encouraged in women who are stable on their opioid [00:24:00] medication and who don’t have other contraindications, such as an HIV infection. For harm reduction, a patient should be counseled to suspend breastfeeding if they relapse to illicit drugs that might contain harmful contaminants.

So, for all these reasons, the bottom-line suggestion is to plan for and encourage breastfeeding when a patient is stable on MOUD for as long as possible. The World Health Organization is now recommending breastfeeding for up to two years or more for babies all over the world. While you’ll want to avoid or adjust some medications to accommodate the breastfeeding, we don’t have to worry, as I’ve said about the buprenorphine that you might prescribe in your office. Long-acting naltrexone, on the other hand, is commonly not used during pregnancy because there’s inadequate evidence [00:25:00] of its safety. But this recommendation might change, and it does appear to be safe during breastfeeding.

Dr. Chris Delos Reyes: Case number five is the choice seeking OUD patient. And in this case, it’s a 24-year-old patient that doesn’t really do well. They really want their treatment for opiate use disorder to remain confidential. They tell you that they’re needing to move around a lot, and they are worried about losing their box of medication, or having it taken from them. Hopefully, you’re prompted to think about some of the social determinants of health. This person may have some housing insecurity, as well as food insecurity. So, you may want to assess for those as well, but we’ll also get back to the question at hand.

So, what can we offer to this patient who’s seeking some different choices? I think the two things to think about here are Vivitrol and the [00:26:00] injectable formulation of buprenorphine, which is marketed as two different medications now, Sublocade and Brixadi. So going back to the Vivitrol for a second, remember that this requires seven to 10 days of abstinence from the opioid before starting this injection, and this injection is given on a monthly basis. For buprenorphine, it requires a brief period of abstinence, typically a week or less, and it also requires a brief, initial oral phase. So, you’re giving them some oral buprenorphine prior to starting the injection. Sublocade does come as a monthly injection in two different sizes, and the Brixadi comes as both a weekly injection for the induction period as well as a monthly formulation. So, certainly these are ways in which the patient could have privacy and some [00:27:00] confidentiality, and they also would not have to worry about remembering to take their medication, or they would not have to worry about it getting stolen from them or taken.

Here’s a brief sidebar, which just reviews the current buprenorphine formulations that are available in the United States. And they are listed here in order of when they were approved. So, Brixadi was the latest to be approved in 2023, and it goes all the way back to Buprenex, which was approved in 1981. It’s important to look at the fourth column, which shows you the indication for use. So, you can see that the medications that are indicated for opioid use disorder currently are Brixadi, Sublocade, Probufine, and Subutex. Whereas, the other medications, Belbuca, Butrans, and Buprenex are indicated for severe pain. [00:28:00] And so as you are choosing which medication to use, please stick to the ones for opioid use disorder if that’s the disease that you’re treating. It’s actually not recommended to use Belbuca, Butrans, or Buprenex for the ongoing treatment of opioid use disorder since they do not have that indication.

Dr. Sybil Marsh: Now, let’s look at the patient with chronic pain. A 48-year-old patient, who uses pronouns they/ them, with an opioid prescribed for chronic pain due to fibromyalgia and lumbar stenosis has a routine yearly urine drug screen return positive for ethanol, cocaine, and fentanyl. They reveal a recent DUI, but they depend on the alcohol for stress relief, and they really need their pain medication. In addition to assessing the patient for alcohol [00:29:00] use disorder, and providing advice and resources for management of alcohol use and stress…

We’d want to know how frequent is opioid use disorder in patients treated with an opioid for chronic pain, and should we be pursuing that possibility? It’s clearly not true that everyone who uses an opioid develops opioid use disorder, and rates vary depending on the population studied and the definition used. But in two major studies, described here, we see things settling out at about 10 percent of people- the same rate at which people who use alcohol develop an alcohol use disorder. Consider that people with a pre-existing substance use disorder that are at higher risk of development of an opioid use disorder, and that people with substance use disorder are more likely to have the kinds of injuries and illnesses that result [00:30:00] in chronic pain and potentially a chronic opioid, as this patient has. You can see that this is a cycle that can lead to misuse, abuse, high tolerance, and consequences of use of an opioid that are different from the consequences of an opioid use for a patient who doesn’t have opioid use disorder.

DUI, the potential for sedation, and our knowledge that opioids are not first line treatment for fibromyalgia or for low back pain, provide an opportunity for us to think about what medications might be safer and more effective for this patient than renewing the oxycodone. In any situation where we think the prescription that we’re giving might contribute to an unsafe situation for [00:31:00] the patient, we should feel comfortable not prescribing, and deprescribing that medication that might have contributed to a potentially harmful situation. Happily, we know that there are many non-opioid medications proven to be more effective for chronic pain: duloxetine and pregabalin or gabapentin for fibromyalgia. Nonsteroidals and acetaminophen in patients who can use those. Injectable steroids, muscle relaxants, except for the one called Soma. Ketamine infusion that patients can have access to through a pain management specialist, and while there’s inadequate evidence to recommend cannabinoids and hallucinogens for treatment of chronic pain, these substances are under investigation and having a good quality [00:32:00] research applied to them. A partial muagonist opioid, like buprenorphine, will provide some pain reduction for patients with opioid use disorder or who are at risk of developing opioid use disorder, especially if they have a divided dose. So, this might be another go to for us if we determine that the patient really does need to have an opioid for their chronic pain and other medications and modalities either are contraindicated for them or haven’t been effective enough to restore them to some good quality life. The bottom-line suggestion, really more than a suggestion, because we have enough research to tell us confidently that opioids are not first line for chronic pain in any patient, but that we might offer them judiciously with shared decision making as an adjunct to other therapy, medications, and non-pharmacologic [00:33:00] therapy. Here is a link to a very useful resource if you don’t know it. It’s AAFP’s chronic pain management toolkit. And if you would like to read more about these medications and about the research that has prompted us to really move away from prescribing opioids for chronic pain , as well as a variety of screening tools and other useful things, I highly recommend this resource to you.

When opioid use disorder is suspected or confirmed in a patient with chronic pain, we might deprescribe the opioid and really try to use non opioid treatments for chronic pain. But when we do choose to prescribe an opioid, opioid agonist therapy with buprenorphine or methadone is a better option. And for a patient with an opioid use disorder, the methadone would come from an [00:34:00] opioid treatment program, not from our office. Buprenorphine is the easiest to access. We would prescribe it as buprenorphine naloxone, the combination product, and clinicians who are prescribing opioids for chronic pain can switch to prescribing buprenorphine often after an incident like a fall or an emergency room visit or a patient overusing their medication and running out. There’s an opportunity for that patient to have some time without their opioid so that when they start the buprenorphine naloxone, they are not in any danger of precipitator withdrawal, and they also are going to notice an analgesic effect from that new medication.

Let’s not forget all the non-medication interventions that have evidence for effectiveness in chronic pain : exercise in general, including walking, yoga, [00:35:00] acupuncture, physical therapy to restore the range of motion and movement, and cognitive behavioral therapy all have good evidence that they’re more helpful for chronic pain than an opioid prescription is. And again, here’s a link to the toolbox to read more about those interventions that we should be offering our patients and helping them to get access to.

Dr. Chris Delos Reyes: In case number seven, which is called the “would be lower risk drinker”, a 42-year-old woman tells you that she’s sometimes drinking more than she intends to up to four to five drinks in an evening. She has said some embarrassing things, has had some minor injuries and hates having the hangover the next day. However, she doesn’t want to stop drinking completely but rather, her intention is to drink more safely at a lower risk zone.

So, what can we offer to this [00:36:00] patient? Does a patient necessarily need to admit to having the diagnosis of an alcohol use disorder or to self-identify as an alcoholic in order to change their behavior? Actually, they do not. I would suggest that you start with screening and assessment for an alcohol use disorder, as was mentioned earlier, and to offer her office-based medications for alcohol use disorder, in addition to psychosocial resources. If things change in the future, you can have plans for giving her more assistance, such as a referral to an inpatient or an outpatient treatment program. The bottom-line suggestion in this case is to encourage a patient that has any interest in reducing alcohol use, whether or not they endorse a diagnosis of alcohol use disorder. Particularly in primary care, medications such as naltrexone, acamprosate, gabapentin, [00:37:00] and topiramate are safe to prescribe.

This slide shows you first and second line medications for alcohol use disorder relapse prevention and/or reduction of alcohol use, and it’s taken from the article, by Kowalchuk et. al. Published in 2021. So, in terms of the first line meds, there are acamprosate, as well as naltrexone, which are both FDA approved for alcohol use disorder. Gabapentin and topiramate are second line medications, and you would be using these medications in an off-label way. The chart basically gives you a little bit of information about the recommended dosage, the adverse effects, and any precautions and comments.

On this slide are listed some third line medications for alcohol use disorder. It [00:38:00] is definitely harder to use these medications in an office setting. And typically, we would recommend that you refer out to a behavioral health provider or an addiction specialist, if you’re thinking about these medications. Again, taken from the same article by, Kowalczyk et. al. and these medications are baclofen or disulfiram. And as you remember, disulfiram is also known as antabuse.

Dr. Sybil Marsh: Finally, let’s talk about that non-compliant patient. We’ve all had one, and let’s see what we’ll do with this 35-year-old patient who has missed visits with us, had a drug screen three months ago positive, as expected for the prescribed buprenorphine naloxone, but also positive for cocaine and marijuana, which weren’t expected. Is it time for us to quit trying and refer them elsewhere, like to a treatment program or mental health facility? They have called asking for a [00:39:00] referral of the buprenorphine naloxone and we’re not sure what to do.

Well, very new are the American Society of Addiction Medicine’s newest recommendations. The summary would be: not yet. Don’t give up. Try this approach instead. So, here are 10 steps that ASAM gives us to retaining patients in treatment when they’re going through a rough patch, or haven’t quite engaged, and to try to prevent overdose deaths by giving patients some what we would call the benefit of the doubt . The exception is if we think our prescribing is really adding to hazard for the patient, then we wouldn’t, but chances are prescribing that buprenorphine naloxone and renewing that prescription is going to decrease hazard for that patient, not increase it. They [00:40:00] say cultivate patient trust by creating a nonjudgmental environment and for us all to be sensitive to the trauma that patients with substance use disorder have experienced in childhood, adolescence, and adulthood. That make it difficult for them to engage or to carry through with plans once they’ve made them. They say we don’t need to require abstinence from opioids or from other drugs as a condition to retain people in treatment. That, even for that patient who is showing up with an unexpected opioid, the prescription itself is reducing their risk of having an unintended overdose death. Optimize clinical interventions to promote patient engagement and retention. That might mean working with the patient on a healthcare issue that’s important to them, even if it seems [00:41:00] unrelated to their substance use disorder. Administrative discharge for not attending appointments or not paying bills should be used as a last resort. We should try to avoid that kind of discharge. We should try to re-engage an individual who themselves drifts away from care by calling them or having our staff set up a new appointment with them and conveying to them that they’re welcome to come back. Thinking about those patients with substance use disorder who aren’t ready to seek treatment and to connect with them through providing preventive care, immunizations, care for their children, and so on. And there are many ways to engage with those patients, so that we’re ready when they become ready to seek MOUD or MAUD, and to make some different goals for their lives. Cultivating [00:42:00] staff acceptance and support for those patients even if they’re not – you know, doing everything perfectly. It really helps when you have a practice where you have a couple of patients getting medication for alcohol or opioid use disorder who are becoming more successful and healthier over time. Staff often has to contend with patients who aren’t doing well and helping them to have some positive experiences with clients and patients who are doing well can go a long way. Keeping our frontline staff, so that patients can develop some relationship with our staff, as well as with us as the prescriber . And they also say aligning our procedures with the commitment to improve engagement and retention of all patients- not just our patients with substance use disorder. I’m sure we’re all trying to do that all the time- measuring progress and striving for [00:43:00] continuous improvement of engagement and retention. This would be an interesting quality improvement study to do when it’s time for us to do that… quality improvement project for the ABFM, for example. So, I think of these points, that issue of being tolerant for patients not fully meeting the requirements of their treatment agreement but working towards those things is the recommendation that the American Society of Addiction Medicine has for us.

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Transcript: Legalities and Resources

[00:00:00]

Dr. Chris Delos Reyes: So, the new Ohio laws became effective on 10/31/24. The rules in Ohio regarding office based opioid treatment do get looked at approximately every five years. So, those were previously updated in 2019 and before that in 2015. These laws refer specifically to OBOT or office based opioid treatment, which means that the pharmacotherapy is taking place in a private office or a public sector clinic. There are sites that are excluded from these laws. For example, if you work in a correctional setting, if you work in a hospital, or if you work in an actual addiction [00:01:00] treatment setting, then these rules would not apply. So, I wanted to be sure and point that out. You can go to the Ohio Administrative Code website at any time to see these rules and regulations. So, the administrative code on opioid treatment actually has four sections, and I will only be going over the section, which is in office based opioid treatment, highlighted in red. So, the first section has definitions. The second section talks about withdrawal management, formerly known as Detox, and the fourth section talks about medication assisted treatment using naltrexone.

So, rule 4731- to six paragraphs. I will be going over the highlights of each paragraph, one at a time. So, for paragraph A, this is where it notes that you have to complete the eight hours of [00:02:00] Category 1 CME every two years. This paragraph also covers assessment and documentation. One interesting change that’s happened is that the assessment does not have to be completed in full prior to starting the medication, and basically, if you can’t complete every part of the assessment, the law basically says you have to complete it as soon as possible following the initiation of treatment. In terms of documentation, they’ve streamlined this part and basically are just asking for what you would document on every other patient that you take care of- accurate, objective, and complete documentation of the encounter, including your referrals, test results, and any significant changes to the treatment plan.

So, for paragraph B and paragraph C, I put them both on the same slide [00:03:00] because they basically talk about treatment plan and treatment protocols. So, paragraph B specifically talks about the components necessary i n a treatment plan, and it has to include the six components that you see in the left-hand column. First, your rationale for selecting the specific drug that you’re going to be talking to the patient about, including patient education, a note about random urine drug screens, the importance of having a signed treatment agreement, documenting psychosocial interventions, and then a statement saying that you have to revise the treatment plan if the patient is not showing improvement. And then in paragraph C, there is a note to use an acceptable protocol, and here the Ohio law refers to two particular protocol, the first of which is TIP 63 from SAMHSA, [00:04:00] which was updated in 2021, and the second of which is the ASAM National Practice Guidelines for the Treatment of Opioids Use Disorder, which was updated in 2020. And both of these are available when you click the links that are on the slide.

So, paragraph D talks about psychosocial interventions. Again, the keynote in this section is that you don’t have to stop or decline OBOT if the patient is unable or unwilling to engage in psychosocial interventions, which is quite different from the previous set of rules in 2019 interventions to all patients, but if they are unable or unwilling to participate, that does not mean that they cannot get the medicine. You can [00:05:00] continue the medicine. So that’s extremely important to note. This section also defines psychosocial treatment with the following list of different kinds of treatment, including cognitive behavioral treatment, motivational interviewing, 12 step facilitation, and they also added other therapies based on individual needs, which is great because that gives you increased flexibility. The other thing that they changed in this section is they initially said refer as necessary to qualified mental health and behavioral health providers, as well as community addiction services, but it appears that they have added paraprofessionals, such as case managers or peer support specialists, which is different than the last set of rules.

So, paragraph E talks about overdose reversal medication that needs to be co-prescribed with [00:06:00] any office based opioid treatment. Physicians have three ways of doing this. They can write a prescription, they can directly provide the patient with the medication, or they can direct the patient to an easily accessible source to get the medication. There’s also advice that the patient and if possible, those who live with the patient get education on how to use the overdose reversal drug. In this case, it would be naloxone. If the patient, used the naloxone kit or if the drug expired, then the physician should offer the patient a new prescription. Now, if the patient refuses the prescription, then the physician is exempt from this requirement. However, you must document that you provided the patient with information on where to obtain overdose reversal drugs without a prescription.

Paragraph [00:07:00] F covers some miscellaneous items including buprenorphine monoproduct, frequency of visits, reducing risk, dosage, and co-prescribing other medications. So typically physicians are supposed to use the buprenorphine combination product, which is buprenorphine naloxone, and they can use the buprenorphine monoproduct, but only in the following four situations: a) if the patient is pregnant or breastfeeding, b) when converting a patient from buprenorphine monoproduct to buprenorphine naloxone combination, c) in a formulation other than tablet or film, or d) when the patient has a genuine allergy or intolerance to the combination product. [00:08:00] Secondly, in terms of the physician co-prescribing other opioids, benzos, sedative hypnotics, soma, gabapentin, or tramadol, along with buprenorphine, the physician has to document that this co-prescription is medically necessary. They need to verify the diagnosis. And also, coordinate care with the prescriber for the other medication. If you happen to be the prescriber for both medications, you would again have to verify the diagnosis and state that this is medically necessary. In terms of frequency of visits- during the induction phase, the law says you have to see the patient at least weekly but realize that induction usually doesn’t take any more than a week. And then for the [00:09:00] first 12 months of treatment, you’re not allowed to prescribe at more than a one-month supply at a time. This part of the law also provides information on how to reduce risk associated with prescribing buprenorphine, and it includes things such as using the lowest possible effective dose, having the appropriate frequency of office visits, using random pill counts, checking the OARRS report, and of course doing drug testing- whether that’s urine, blood, or testing to assess adherence to the medication. In terms of dosage for sublingual buprenorphine, there’s a lot of change. Just in this section. So, the previous law basically said that you needed to carefully document if you were going over 16 milligrams and the maximum [00:10:00] dosage that a person could take in a day was 24 milligrams. The 2024 laws basically state that you can use up to 24 milligrams per day. If you’d like to go higher than 24 milligrams a day, you would have to obtain a consultation from an addiction specialist. If you are already an addiction specialist, obviously you don’t have to get a consult, and you can go up to 32 milligrams per day. So, the maximum dose was reset basically to 32 milligrams per day versus the old set of laws.

Dr. Sybil Marsh: Now that we’ve reviewed the revised amended Ohio laws, we’re likely more comfortable with them. What about these situations? Remember that patient with the multiple medications and the benzodiazepines? We should still prescribe medication for their opioid use disorder or their alcohol use disorder. [00:11:00] The risks of overdose with an opioid outweigh risks of combining the medication that we would use for their alcohol use disorder or their opioid use disorder with a benzodiazepine. Um, not uncomfortable. We ought to prescribe. That geriatric patient with alcohol and/or opioid use disorder, let’s prescribe for that patient comfortably, they might respond to lower doses and co-treatment of pain, anxiety, and depression and become more stable than they were without that MOUD or MAUD. A patient in a relapse- let’s prescribe for that patient. They might need a transition from their current illicit opioid to buprenorphine or to naltrexone and, if they have been on methadone in a methadone treatment program, they’ll need to have an increased dose. Our goal is to have them [00:12:00] return to stability. Psychosocial supports and supportive medications can help that patient. The bottom line is for them to be out of their relapse with stability, we should feel comfortable prescribing for them. That postpartum patient returning to care- we know that continuing medication for opioid use disorder is safe and appropriate, and medication for alcohol use disorder may also be appropriate for a patient. Shared decision making helps us to decide about the dose and duration of treatment. For that patient with a history of opioid use for chronic pain, who is revealed to have an alcohol or opioid use disorder, we can see that a partial mu agonist opioid may help them to feel more stable and to have better quality of life and less pain than when they were reliant on that mu [00:13:00] agonist opioid that constantly kept them in a state of craving and at risk of an overdose. Patients might sometimes prefer to stop all of their opioids and to switch to naltrexone LA and to non-opioid management of their chronic pain. If that’s the case, we can stand by to evaluate whether a patient is better off without an opioid or return to that partial mu agonist: buprenorphine naloxone. If we are going to use an opioid in that setting where we know there’s an opioid use disorder, we would say that if you’re treating concurrently for alcohol use disorder- don’t use oral naltrexone with, or long-acting [00:14:00] naltrexone, with methadone or buprenorphine. Use acamprosate or gabapentin or topiramate instead.

Here’s another set of formerly uncomfortable situations. A patient who declines a daily medication or oral medication. They just don’t want it. Well, think about an injectable form of MOUD. Think about injectable naltrexone for alcohol use disorder. Work with the patient, to get to a point where their goals are achieved. A patient with alcohol use disorder or high-risk drinking, could we prescribe that medication? Especially if they think they’re going to manage their alcohol use disorder by going to mutual help meetings and getting some counseling and having a pretty strong psychosocial part of their program. Well, yes, we should prescribe because we know that those medications reduce the number of heavy drinking [00:15:00] episodes and the amount, per episode, for those with or without a diagnosis of alcohol use disorder. Patients with severe alcohol use disorder might respond better to a goal of alcohol abstinence rather than control. But those medications are another way to help a patient to change their drinking behaviors, and they work very well in combination with those behavioral psychosocial approaches. There is nothing about the 12-step program that tells its members that they shouldn’t use medication prescribed by a physician for a particular purpose that’s going to enhance their health. MAUD is that type of medication that a patient doesn’t need to talk about at a meeting because they’re gonna be focusing on using the 12 steps to improve their life today, and they don’t need to share that [00:16:00] confidential medical information. And then there’s that non-compliant patient who just isn’t sticking with the office rules and is falling off their treatment agreement. What do we do there? Well, we say, let’s continue the MOUD. Let’s use administrative discharge as a last resort. And let’s think about if we might be able to meet that patient halfway. Like, thinking about whether our office is flexible enough for them, or if they need to referral to a different treatment setting. We know that, as for any patient, we can’t have tolerance of threatening hostile or violent speech or behavior in our offices, but we do know that patients can be irritable, can get discouraged, and any kind of encouragement we can give to the patient to continue their treatment while they’re starting to feel the effects of their medication and how beneficial it is for them is [00:17:00] appropriate to roll into our conversations with the patient, rather than just chastising them about the rules they haven’t been able to follow- recognizing what they have been able to do and any amount of progress that they’re making.

Well, as we’re getting near the end, you might say, well that’s all good, but no, I’m really not a substance use disorder or mental health expert. I’m not sure if I really should get into this game. Wouldn’t a dedicated treatment program be better for the patient? So, the answer is no, for a variety of reasons. Don’t ever think that because you’re not an expert, you can’t save lives by prescribing medication for alcohol use disorder and opioid use disorder. There’s a vital role for primary care and other non-substance use disorder specialists, and there’s good evidence to support the fact that treating alcohol use disorder and [00:18:00] opioid use disorder in primary care settings is cost effective. It improves outcomes for both opioid use disorder and alcohol use disorder, and it improves outcomes for other medical comorbidities. It’s highly acceptable to the patient, and we have a role in treating these potentially fatal disorders.

You can help patients with alcohol use disorder and opioid use disorder. Here are some of the ways that we have proven that. It is a kind of a nice way to expand our practices and to provide better care for our patients, to see successes, which we seldom see in the area of chronic pain management, but you’ll see patients who actually do improve their health and their lives, which is rewarding for them and for [00:19:00] us . We have still not gotten to the point where we’re not seeing opioid overdoses in our community, even though our efforts as a medical community of primary care, psychiatry, nurse practitioners, physicians, community workers, our combined efforts appear to have reduced the frequency of opioid overdose that is fatal, but there’s still so much work to do. We hope that you will join us in it and that you’ll consider prescribing medication for patients in your practice with alcohol use disorder, opioid use disorder, or high risk of either one of those.

Just to draw your attention to some of our resources, here is the PCSS, the Provider Clinical Support System. It’s SAMHSA funded, and it is a program on substance use disorder, alcohol use [00:20:00] disorder, and opioid use disorder. Their resources are online- you can download them, you can print them, and they are excellent.

Some primary care, review resources are here.

National practice guidelines that help us to generate our policies and our standards of care.

Dr. Chris Delos Reyes: I just wanted to talk through some of the resources, including links to the screening tools. There are multiple screening tools for alcohol use disorder and opioid use disorder, and many of them are listed on this slide, including the single question screeners, more commonly known as the pre-screen questions- and that includes the single alcohol screening question, as well as the single question screening test [00:21:00] for drug use. Also included are links to the AUDIT-C. The AUDIT-C is a three-question version, whereas the full AUDIT is typically 10 questions. There’s an A version of the Michigan Alcohol Screening Test, which is labeled G for a geriatric version. And then we’ve also included the DAST, or the Drug Abuse Screening Test, which is a 10-question screen. I also added an extra link for multiple other screening tools and additional information from the NIDA website, if you would I’d like to take a look at that.

You can see the resources for prenatal and postpartum care. The first one is the American College of Obstetricians and Gynecologists, or ACOG. This is their Committee Opinion 711 on Opioid Use and Opioid Use Disorder in Pregnancy. The other very useful resource is the [00:22:00] Centers for Disease Control, or the CDC recommendations, and those are entitled Treatment of Opioid Use Disorder Before, During, and After Pregnancy.

This slide shows you just a few key resources in terms of buprenorphine and chronic pain. There are many, many more, but these are the ones that we wanted to highlight. The articles talk about collaborative care and the actual treatment of pain in an office-based setting.

So, this slide summarizes the resources in terms of IO law that just came out here in 2024 and includes the Clinical Disorder Center of Excellence. It also includes the State Medical Board of Ohio three pager that has FAQs at the end, and then finally, you can see the full [00:23:00] copy of the law at any time at the Ohio Administrative Code website.

Also listed here for your reference are additional articles that we used in the preparation of this training module, including some of the geographical characteristics and prescribing patterns of clinicians, as well as the new screening tool, then a couple of articles about it increasing the primary care utilization of medication assisted treatment.

Dr. Sybil Marsh: Thank you for using our module. We hope it’s been informative and that it will inspire you to get started on the road to prescribing medication for alcohol use disorder and opioid use disorder. Now, it’s time for the post-test.

As a healthcare [00:24:00] professional, I feel comfortable identifying, assessing, and treating alcohol use disorder in my office setting. We wanted to know how strongly you agree or disagree with this statement before we get started.

As a healthcare professional, I feel confident documenting and billing for an alcohol use disorder encounter in my office setting. How strongly do you agree with that statement?

As a healthcare professional, I feel comfortable identifying, assessing, and treating opioid use disorder in my office setting. What are your thoughts here?

As a healthcare professional, I feel confident documenting and billing for an opioid use disorder encounter in my office setting. How strongly do you agree or disagree with that statement?

As a health care professional, I am familiar with the legal requirements related to the treatment of opioid use disorder in my state. We’re in [00:25:00] Ohio, but rules can differ from one state to another.

As a health care professional, I’m confident handling a variety of situations that might occur. A patient with multiple medications and drugs. Patients with later life opioid use disorder. A patient in relapse, rethinking recovery. A pregnant or postpartum patient. Choice seeking patients. Patients with chronic pain and alcohol use disorder or opioid use disorder. A patient wanting to drink safely. And a non-compliant patient.

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Transcript: Pregnancy and Substance Use Disorder: Ethics and Care Considerations for all Providers

[00:00:00]

Dr. Mishka Terplan: Hi there. I’m Mishka Terplan and I’m an obstetrician gynecologist and addiction medicine provider, and I’m gonna be talking today about pregnancy and substance use disorder, ethics, and care considerations for all providers.

I have no disclosures for this talk.

So, I wanted to begin with the question: Why would a pregnant person use drugs? Doesn’t she know she’s harming herself and her baby to be? And I want to start with this question because it’s a question that we hear asked in the media, by our colleagues, and from our politicians, as well. And I wanna show how this is not the [00:01:00] correct question to ask.

…Because most adults in the United States have used substances to which some people become addicted. We’ve known this for decades. Here on the left hand side is a figure from research from the early nineties that demonstrates the proportion of people who become addicted to a substance per year. And you might have heard of this calculus, like how quote unquote “addictive” a substance is. Well, one way to look at this is to create a fraction. And in the denominator is the number of people who’ve used a substance in the past year, and in the numerator would be the number that meet criteria for a use disorder, and you can organize substances from that metric. And you can see here that about a third of people who’ve used tobacco or nicotine in the past year meet [00:02:00] criteria for a nicotine use disorder. It’s about a quarter of people who’ve used heroin, about 20% of people who’ve used cocaine and other stimulants. And it’s roughly 5 to 10% of people who’ve used cannabis. And this surprises people- ’cause some folks think that anyone who’s used heroin must be addicted to it. And other people think that nobody who uses cannabis has an addiction to it. And these numbers reflect the fact that addiction is more than the substance exposure itself. As illustrated on the right hand side here, clearly you need to be exposed to a substance in order to develop a use disorder, but that exposure is insufficient in the development of use disorder. And you can see here that there are other things that figure into the vulnerabilities for addiction. There’s a biological or genetic component, but there’s also this large bucket that’s called in [00:03:00] this cartoon here. Environment and that includes, you know, proximity to substances, age at first use, adverse childhood experiences, and more.

So what is addiction? There’s really two main ways we talk about it. One is from the American Society of Addiction Medicine. This is the current definition of addiction. It’s a treatable chronic medical disease involving complex interactions among brain circuits, genetics, the environment, and an individual’s life experiences. People with addiction, use substances or engage in behaviors that become compulsive and often continue despite harmful consequences. P revention efforts and treatment approaches for addiction are generally as successful as those for other chronic illnesses.

And diagnostically, we use the DSM criteria, and these are the [00:04:00] criteria for opioid use disorder markedly similar to other use disorders, and you can see tolerance and withdrawal- although their two categories are not valid if we’re talking about opioids taken as prescribed. And tolerance really is a physiological principle, as is withdrawal. Tolerance, meaning you have to increase the dose to maintain the effect. Withdrawal, meaning if you stop taking something, you have symptoms. Those are true of opioids. They can be true of alcohol. They can be true of some substances to which people develop use disorder, but they’re also true of many medications that we prescribe for chronic medical conditions to which people don’t develop a use disorder, SSRIs, anti-hypertensive agents and et cetera. All of those, you know, induce both tolerance and withdrawal. So the main bucket of DSM diagnosis are actually behaviors. And you can see these under the categories of loss of control and [00:05:00] use, despite negative consequences. So putting it together, I think of addiction as a brain centered condition. It affects the whole body, but the visible symptoms are behaviors.

And addiction is a chronic condition because it behaves like other chronic conditions. These are data from the early part of this century, a paper that really changed my perspective on the field. And in it, the authors contrasted what they called relapse one year following the diagnosis of a disease. You can see here relapse rate for diabetes, addiction, hypertension, and asthma are roughly similar. In other words, addiction’s a chronic condition because it behaves like a chronic-

-condition, but the goal of addiction treatment is not more treatment. The goal is recovery, and recovery is not a destination. [00:06:00] It’s not a place on the map. It’s actually a process of self-directed action. The movement towards wellness rather than a single outcome state. Abstinence may be one of the outcomes, and it may or may not fully occur. But in and of itself, recovery does not equal abstinence. It’s a movement, a process, a journey towards wellness. And it takes place across all of these dimensions illustrated here from SAMHSA’s working definition.

So taking that context, I want to readdress that question I led with: Why would a pregnant person use drugs? Because that’s not the right question. The right question is: What happens when people who use drugs get pregnant and stay pregnant? These are data from the National Survey of Drug Use and Health, looking [00:07:00] at past 30 day substance use, separating out people who are pregnant from those who aren’t, and then, you know, separated by substance and stratified by trimester, and you can see a couple of different things. People who aren’t pregnant are far more likely to report past 30 day substance use. Use decreases through the course of pregnancy, and it differs by substance. People cut back alcohol the most, cigarettes the least, and elicit substances- which are, you know, roughly 80% cannabis in these data. Somewhere in between. So I look at these, you know, this figure, and to me it supports the statement that all pregnant people are motivated to maximize their health and that of their baby to be. Some people can stop using in pregnancy, others can’t. Those that continue to use a substance in pregnancy, [00:08:00] generally speaking, are going to meet criteria for a substance use disorder.

So when we’re talking about drug use in pregnancy, we’re not talking about people who begin to use a substance in pregnancy. I’ve never seen that. What we’re talking about is where a reproductive health life course, getting pregnant, staying pregnant, delivering an infant, intersects with an addiction life course, use proceeding to misuse, and then the, you know, the development of use disorder and all of this within a specific point in time of pregnancy.

So for the talk today, I want to go through and already have what addiction is. I next want to talk about screening and testing, focus on treatment, and end with a discussion of stigma and discrimination.

So [00:09:00] how do we assess whether or not somebody uses drugs or has a use disorder? There are two terms underneath assessment that often get conflated and confused, so I want to define them first. When I use the term screening, I mean using a validated instrument or talking to a patient. When I use the term testing, I mean looking at a biological matrix such as urine or blood for the presence or absence of parent compounds or their metabolites.

And when we think about drug testing, we need to differentiate the two technologies that we primarily utilize. The first we call presumptive that is EISA technology of an antibody assay. This is the same technology that’s utilized in the rapid COVID test. It can be a point of [00:10:00] care. It can be in a laboratory, but the results of presumptive tests are reported within minutes to hours in the lab, and they’re reported as binary present or absent. In contrast, definitive tests utilize the technology of gas chromatography mass spectrometry. This is similar or more similar to a COVID PCR in that the results are specific and quantified. You get the actual compound and a measurement of concentration, usually nanograms per deciliter. Not every laboratory has this machine and the results, you know, consequently, it’s more costly and the results take days to week to report.

Regardless of testing technology, there is an inherent bias in a drug test. As seen here in the table two on the right. [00:11:00] Tests capture what’s present in the biological compartment at a particular moment in time. Therefore, things that stick around longer are more likely to be positive, and things that clear the biological compartment more rapidly are more likely to be negative. Alcohol, for example, in most measurements we use for alcohol, it’s something that that clears rapidly. Cannabinoid metabolites, you know, can stick around for weeks or even months in people with heavy use. So there’s an inherent bias in all drug tests towards those things that stick around longer. There’s also a specific problem with presumptive tests. Immunoassays can cross react in particular with commonly prescribed medications leading to a false positive test [00:12:00] result. Here is a table, a partial list of medications known to cross-react on, you know, presumptive tests. Several of these medications are ones that we commonly use during prenatal care, and in particular the birthing hospitalization.

Now, even if the test is correct, we might misinterpret the source of the exposure. For example, these are three studies that look at newborn positive toxicology for fentanyl, and where the source of the fentanyl was the maternal epidural in labor. So if you do not know that maternal epidurals can lead to a positive fentanyl drug test in a newborn, you might misattribute the source of that fentanyl to illicit fentanyl and [00:13:00] institute a cascade of events that are harmful to the patient, to the child, to her family and community.

Finally, health professionals actually are not good at interpreting drug test results. This is a seven item survey that was administered across Canada to general practitioners and other health professionals. I would label the level that they’re testing what I would expect a medical student to know. Yet nobody who was surveyed scored a hundred percent. The average score was 50%, and health professionals who said that they utilized drug testing in clinical practice scored on average one point lower than people who did not.

So putting this together, [00:14:00] drug testing is not recommended for the assessment of use disorder by any major medical professional society or public health agency in the United States. A drug test is not an assessment of addiction. Remember, addiction’s a chronic behavioral condition. The symptoms of addiction are behaviors. There’s nothing in a drug test result that tells you anything about a person’s behavior. The American Academy of Pediatrics states that a drug test is not a sign of health or of ill health, not evidence of harm, and not actually criteria for patient discharge. The American Society of Addiction Medicine states that if your results of a drug test are going to inform decisions with major clinical or nonclinical implications, you want the piece of that [00:15:00] point of information not to come from a presumptive test, but from a definitive test. And I would say every drug test done during the birthing hospitalization has major nonclinical implications for the patient. And finally, all medical s ocieties are clear that if you’re going to drug test, informed consent is required. In contrast, what is recommended is screening- using a validated instrument and ideally that screening is applied universally across the patient population. And finally, ACOG, SAMHSA, and CDC go further and state that participation in screening should be voluntary. In other words, that participation reflects autonomy and rests on the right of refusal.

There [00:16:00] is great confusion and misinformation around state statutes related to mandated reporting for substance exposed newborns. This is a document that is updated from If, When, How that has cataloged, um, each every single state statutes, and this is what they say about Ohio. That drug testing of a pregnant person is not required. The drug test of a newborn is not required, and if a newborn tests positive, the provider must report. But that does not apply to cannabis and does not apply to medications for opioid use disorder or other medications as prescribed. So, drug testing is not required by law in the state of Ohio.

In place of drug testing, as mentioned, screening is what is recommended- and which screening [00:17:00] instrument should you use? Well, there are two studies both listed here that compare the performance of different screening instruments in pregnancy. And I’ll say that none emerged as like the best one. All perform relatively similarly. Probably whatever screening instrument you have in your EHR is sufficient, especially if it’s one from the list of these. But more importantly to me is what we do before we screen. In particular, I think we need to ask permission before we ask people questions that the results of which might be potentially harmful. In other words, ask something like, is it okay if I ask you some questions about smoking, alcohol and other drugs? If the person says, no, don’t ask. The entirety of behavioral health [00:18:00] rests upon establishing a therapeutic alliance. That’s the work. Without the alliance, we cannot do the work that we’re supposed to do, that we want to do, that patients want us to do. So, asking somebody’s permission and respecting what they say goes a long way in establishing that therapeutic alliance. And for those of you who work in environments in which people return to care, such as prenatal care, other outpatient medicine, you’re going to see this person back. So, establishing, you know, asking for permission, respecting what they say goes a long way in establishing the foundation upon which the work we do rests.

The reason to screen is to put people into these categories of quote unquote “risk.” And this is sort of the classic pyramid that we formulated for the specific [00:19:00] context of pregnancy. People who don’t, haven’t recently used drugs, you know, never had a problem with a use disorder, who they, you know, they need positive reinforcement. You know, brief advice. People at the top of the pyramid who meet criteria for a use disorder, they need treatment. And we’ll talk more about that. And then people in the middle, the moderate risk people who’ve used in the past but maybe quit, you know, in pregnancy. Um, folks who are using at a low level but don’t meet criteria for a use disorder. That’s the population of people you know who benefit from brief interventions that are grounded in motivational interviewing.

I think we have forgotten the middle of this clinical pathway. The purpose of screening is to identify people who might have the disorder. So, screening should be followed by diagnosis, and those people who meet [00:20:00] criteria for the use disorder, they need treatment. One of the problems with the experts screening, brief intervention referral to treatment is that there’s 1. no diagnosis in that pathway, and 2. treatment is something that happens. Afterwards, rather than being integrated into the care services that you all provide. So, I would say this is the most important slide of this slide deck: screen, diagnose, treat.

So what do we mean by treatment in pregnancy? The gold standard, which has been described in the literature for 50 plus years is comprehensive co-located service delivery, the provision of both prenatal care and addiction treatment in the same time and place.

One of the principles in prenatal care is [00:21:00] captured by the axiom healthy mother equals healthy baby. We know that we improve birth outcomes by managing chronic conditions in pregnancy. This is true of diabetes, hypertension, seizure disorders, and true of use disorder as well. These are data from Massachusetts in which I’ve separated out the prevalence of various outcomes listed here amongst those without a use disorder, what those who have treated addiction and those with untreated addiction. And you can see from this the population health burden of preterm birth, low birth weight, fetal death, neonatal mortality, and et cetera, is primarily and most strongly in the column of those with untreated addiction. And those with treated addiction look more like, and for some of these as are, have rates that are actually identical to those without a use [00:22:00] disorder.

These are recent data that demonstrate, you know, actually quantify the effectiveness of medications of buprenorphine in this case for opioid use disorder. In this, they calculated the number needed to treat to prevent one adverse pregnancy outcome with Buprenorphine is 20. This is a number needed to treat that is very low. That is actually lower, significantly lower than the use of magnesium sulfate to the prevention of seizures that we use routinely during the birthing hospitalization. So this captures nicely, I think the summary estimate of the benefit of medications for opioid use disorder in pregnancy, in improving both newborn health and maternal health.

I’m going to talk about other use disorders as well, but let’s begin with [00:23:00] opioid use disorder. Methadone and buprenorphine are the safest, most effective medications for opioid use disorder in pregnancy, and both the Buprenorphine alone and the Buprenorphine Naloxone products are equally safe and effective in pregnancy. In other words, there’s no reason to switch somebody from, you know, so-called mono product to combination product, or from a so-called combination product to mono product. There are now long-acting formulations of Buprenorphine, and amongst them, there’s both weekly and monthly. The weekly ones are likely superior to the monthly ones for two reasons. One, we see people weekly, especially as gestation progresses. So having a monthly injection is not super helpful from a clinic visit perspective. Two, it’s not uncommon to have to increase the dose of buprenorphine as pregnancy progresses. And you can do [00:24:00] that more easily on a weekly rather than a monthly way. And three, you know, the incipient in the monthly formulation is associated with reproductive toxicities in animal models, where that’s not true of the incipient for the weekly, long-acting formulation. For alcohol use disorder- and just know that alcohol is the leading cause of preventable intellectual disability in the United States. Yet, we grossly under diagnose and even more undertreat alcohol use disorder in pregnancy. There is limited safety and almost absent effectiveness data for medications for alcohol use disorder. However, naltrexone, acamprosate and gabapentin are clearly safer than alcohol is. Disulfiram is not recommended in pregnancy, due to clear evidence of toxicity and harm. [00:25:00] Smoking and nicotine are common in pregnancy. And there is actually a large literature of medications for smoking cessation in pregnancy. That overall summary of the literature demonstrates really a limited effectiveness of the medications. And in part that’s because, not ’cause they don’t work per se, ’cause we know those medications work in general. The limited effectiveness represents the fact that at least 50% of people quit or cut back smoking in pregnancy. That’s the natural history of cigarettes in pregnancy. So it’s hard to show an effectiveness of a intervention like a medication above that. Therefore, it’s a case by case, individualized decision making, but nicotine replacement therapy, bupropion and varenicline are all likely safer than tobacco- and should be [00:26:00] considered for people who are having difficulty quitting or cutting back.

As you probably know, there are no medications approved for the treatment of both stimulant use disorder and cannabis use disorder. There have been many medications that have been studied for the treatment of stimulant use disorder, and many addiction medicine providers have some familiarity in using some of those medications on a really case by case basis. The way I approach stimulant use disorder is also to treat what you can. Like, does the patient have some other co-occurring condition- a psychiatric condition, another use disorder, something else for which there is medication? And start with that. Um, and then consider medications if needed, like a little bit down the road. There are no medications as mentioned for cannabis use disorder, and really the treatment rests on both [00:27:00] contingency management or cognitive behavioral therapy. In other words, on behavioral, not pharmaceutical interventions.

So, all of that that I’ve just gone through, illustrating the effectiveness to some extent of medications for the substance use disorder in pregnancy and certainly the effectiveness of treatment that treated disease has towards normal birth outcomes. And untreated disease is really where we see the population burden of preterm birth and low birth weight amongst people with use disorder. But despite that, most people receive no treatment in pregnancy. Most people receive no treatment for use disorder in the United States. Only 11% of people who meet criteria for any SUD report receipt of any treatment in the prior year- a number that is unchanged over the past several decades. Rates are slightly higher in pregnancy. And about a [00:28:00] third of people with an opioid use disorder report receipt of any treatment in pregnancy. But still that means the majority of people do not receive care in pregnancy for use disorder.

Now, even if people get care within the specialty addiction treatment system, do they receive evidence-based care? These are looking at admissions to the specialty addiction treatment services across the United States. Um, and you can see that roughly 50% of people admitted in pregnancy with a diagnosis of opioid use disorder, only 50% receive medication- a number that’s actually also unchanged for the past 20 years.

And even if people do get medications, there are marked racial inequities in terms of which medication and whether the dosage is sufficient. [00:29:00] The left hand side here shows data from the state of Massachusetts looking at the odds of any treatment. And you can see that black non-Hispanic pregnant people have 0.4 times the odds of receiving any medication compared to white, non-Hispanic people. This likely reflects structural inequities in access to care. On the right hand side, this is looking at the mean methadone dose at the time of delivery in a specific hospital system in Philadelphia. And you can see, whereas white non-Hispanic people were receiving 145 milligrams a day, black non-Hispanic folks were receiving less than a hundred milligrams a day. This likely means that they were undertreated and this likely reflects discrimination at the level of the healthcare provider in the healthcare setting. So, an interpersonal racism as opposed to [00:30:00] structural racism.

So when we put this together there’s the universe of pregnant people with an addiction of whom you know, maybe a third, receive any treatment of whom half maybe receive medication of whom a smaller proportion receive comprehensive co-located service delivery, which has been described as the standard of care for at least 50 years.

And this lack of care becomes like compoundedly worse in the postpartum period. We have an epidemic of maternal deaths in the United States, and drug overdoses are contributing increasingly to that burden. And most drug overdose maternal deaths occur in the postpartum period, not during pregnancy, where people have contact with systems through prenatal care. [00:31:00] Postpartum where folks really get abandoned where there’s insurance churn, where there’s the realignment of welfare benefits, and all of that- child welfare involvement, all of that is reflected in the increasing rates of maternal deaths. But there’s a couple.

Other things that I think all of you- in particular, those that are not prenatal care providers need to be attentive to sort of what we talk about syndemics, the intersection of the opioid crisis and infectious disease burden and in particular for hepatitis C and for syphilis. These are data now from a little bit ago, 2018, that demonstrated the market increase in particular among white, non-Hispanic folks in Ohio from 2006 to 2015. And you can see the increased rate of hepatitis C diagnosed at the time of [00:32:00] delivery. And we are doing a very poor job of 1. treating hepatitis C like postpartum and in particular following the infants to assess whether or not they seroconverted from birth. And this is concerning from a population health perspective, looking ahead several decades.

The second thing I’m sure you have heard: rates of syphilis have increased markedly similar to where they were in the United States in the 1950s and in particular, we’re also seeing rates of increase in syphilis in pregnancy, and so-called congenital syphilis. And there’s an association between people between drug use and syphilis that probably has nothing to do with drugs and really, and very little also to do with syphilis, but a lot to do with the fact that people who use drugs are legitimately afraid to seek services [00:33:00] for fear of child welfare reporting. And so one it’s important, you know, the screening not just for substance use, but really also looking at hepatitis C and syphilis screening and treating, and with syphilis, nothing has changed in how we treat syphilis over the last several decades. The medications work as well as they did before. There’s no resistance. This is really an issue related to access and to identification, not to gaps in any kind of basic biological science.

So the last section. I’ve been demonstrating how like treatment works, but most people don’t get it. And I’ve identified or touched on some barriers to that. And one big barrier to treatment is stigma.

And there’s a large [00:34:00] literature on stigma. We know that stigma for drug addiction is greater than it is for other mental illness. We know that stigma, addiction stigma is common among medical providers. We know that people’s experiences of stigma is directly correlated to how long they stay in treatment and how long it takes to get to treatment the first time and whether they get treatment at all. And we know that stigma is associated also with a devaluation of public acceptance of supportive policies related to substance use disorder.

In the context of pregnancy, stigma, which means like deviation from social norms, drug use collides with images and simplistic understandings of what [00:35:00] motherhood is. And people who use drugs in pregnancy have legitimate fear of quote unquote “detection” is what it was called in this one article here. Especially identification at birth, reporting to child welfare and removal of their children. In fact, everybody who was interviewed in this article, who used illicit substances, expressed concern about that, and people engage in various strategies to avoid this quote unquote “detection.” About a third of people stated that their concern led them to be more, quote unquote “honest” with providers and led them to actually seek treatment. But other people described this worry as leading to social isolation or even denial of pregnancy, and over half stated that they avoided medical care because of the concern with reporting.

Drugs and pregnancy have are [00:36:00] fodder for the mainstream media. And you can see here the number of stories related to substance exposed newborns. And you can also see here the amount of sort of misinformation and stigmatizing language within it. The identification of babies or the labeling of babies as being addicted when is false. If remember, addiction’s a chronic behavioral condition. Chronic conditions cannot be present at birth. The symptoms of addiction are behaviors such as craving compulsive use continued use despite adverse consequences. Those behaviors are not behaviors that an infant can have. What infants do have can is dependence and they can go into withdrawal. But that is not the same as as addiction. So this language, which is common, which we all see [00:37:00] and hear all the time, we have to be vigilant about resisting this terminologies.

Terminologies.

So addiction stigma, this is common in particular in the context of the birthing hospitalization. Here are data from a survey of neonatal intensive care unit nurses in which over 25% said that they frequently blamed the mother of an infant with NAS for the infant’s health problem. 40% said that they felt that it was dealing with the mothers to be stressful or upsetting. However, less than half stated that they felt that they had enough knowledge about addiction to appropriately deal with mothers of infants with NAS.

Amongst medical students and residents, we also see addiction stigma. Overall towards 50% of [00:38:00] people surveyed here said they felt angry towards women who use drugs while they are pregnant. Well, 40% said that the mothers who use drugs during pregnancy should not be allowed to retain custody and towards half felt like mothers who used drugs, overutilized healthcare resources. The good news here is as you see as people move from medical student to intern to resident, the proportion that endorse these stigmatizing statements decreases. So exposure and learning and context can help in reducing endorsement of stigmatizing statements.

But I wanna pause for a moment because I don’t particularly like the term stigma. Stigma, comes from the stigmata to the wounds of the crucifixion of Christ. It’s a mark of otherness. Stigma can really be seen as a [00:39:00] them problem. I prefer the term discrimination. Discrimination captures how we relate to other people. Discrimination is more of an us problem, and it’s something we can do something about. And one of the ways that we often articulate discrimination is through prejudice.

So discrimination is rooted, I think, in both ignorance, but it can also be intentional. Discrimination emerges amongst folks who are unfamiliar with the concept of addiction as a disease, who are unfamiliar with what treatment is, what recovery is, and what the actual consequences to the newborn from a child developmental perspective are related to substance exposure. But as mentioned, some people intentionally utilize prejudice [00:40:00] in order to punish folks that they deem to be undeserving. And all of you should know that discrimination of people with a substance use disorder is a violation of their human rights and is illegal in the United States.

So how do we respond to stigma and discrimination? One is by paying attention to the words that we use. Use person first language- language that reflects the worth and dignity of all people. Second, our language should reflect the medical nature of addiction and focus on treatment and promote the recovery process. And we should avoid perpetuating negative stereotypes and biases through the use of slang and idioms.

Second, we can build a trust [00:41:00] through clinical discussion with folks in particular by asking open-ended questions that center on their autonomy and on their dignity. And these are some examples of this. What is the most important thing to you about treatment or recovery? What do you know about methadone? Or buprenorphine? Do you have any fears or concerns from previous treatment experiences? What do you need to feel safe? What are you looking for in a provider, and how do you feel your care is going so far?

Because really what we’re talking about is utilizing clinical empathy. And to operationalize that- that means using people’s names when we speak to them. Making eye contact. Smile, listen, listen sincerely, don’t interrupt. Tune into their non-verbal communication. Be fully [00:42:00] present when you’re with them by taking also a personal, sincere interest in who they are as people.

And this works. Interventions to reduce stigma have been shown to be affected, in particular in the state of Ohio. These are data here from your perinatal quality collaborative that did a questionnaire intervention and follow up. And you can see in table two the change in score over time for each attitude question. They showed a stable response in the success of their intervention. And so there are really good bones of good public health work happening in Ohio. And this is one example of a really successful enterprise.

So overall, when we think of the work that we do it, this is like a [00:43:00] landscape that’s peopled with false dichotomies. You know, the right of the pregnant person versus the fetus, the mother versus the newborn, the pediatrician versus the obstetrician, the doctor versus the nurse, everybody versus the social worker. These false dichotomies are problematic. They lead to conflict and they miss the big picture. We need to reset the lens of what we do to center on the dyad. And the best definition of the diad is the one that here quoted from Dr. Winnicott. He was a pediatrician who retrained as a psychiatrist. He described the blanky, the attachment a small child might have to an object and he said there’s no such thing as a baby. If you set out to describe a baby, you will find you are describing a baby and someone, a baby cannot exist alone, but is essentially part of a relationship. In other words, all of those false dichotomies split the [00:44:00] dyad, which is impossible and problematic.

So finally, I want to think about mistrust and what we can do. I would say that drug use in pregnancy is an environment of mutual mistrust. Health professionals do not trust what patients say to us, and the patients do not trust us like when they come to care, but our mistrust as health professionals is often misplaced and it’s rooted in discrimination and in prejudice, whereas a patient, their mistrust is warranted. It’s warranted by their personal experiences of discrimination within healthcare settings and also due to historic trauma and cultural memory. So what happens if I trust a patient I [00:45:00] should not have trusted? The consequences of my misplaced trust are minor. What happens if a patient trusts me, but she should not have trusted me? The consequences of her misplaced trust can be severe. And this points to the, it reflects the power differential within healthcare settings, but it also points to the responsibility for overcoming mistrust. It rests with us, not with the people that we serve. It’s our responsibility. To make care safe, to make care welcoming and to make it acceptable for the disclosure of potentially problematic pieces of information. So I don’t want to ever read a chart again that says, patient refuses to state how much substance she use or that type of judgmental language, because the responsibility of creating a [00:46:00] welcoming environment where disclosures can be safe- that responsibility is ours, and of the systems in which we work.

So with that, I want to thank you all for your attention to this. I have some resources here listed on this slide in case you’re interested, which are educational resources that dive really deep into what I have only touched on, which is that intersection of the birthing, hospitalization, drug testing, in particular the child welfare report. So thank you again. Thank you for all of your attention. Goodbye.