PSAM Review Fall 2024

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A House Divided

Welcome to the Inaugural Edition of PSAM Review

It is with great pride and excitement that I get to introduce the first edition of the PSAM Review, a publication written by Addiction specialists, for Addiction specialists, to support and strengthen our medical community. As the field of Addiction Medicine continues to evolve, the importance of a dedicated space for sharing knowledge, experiences, and insights among providers of addiction care has never been greater. This publication marks the culmination of a long-held goal of mine, conceived during my time as president of our professional organization, to create a space where we can share knowledge, insights, and experiences directly with one another.

With the help and support of our current president, Kristin Van Zant MD, our co-editor, Olapeju Simoyan, MD, MPH, and the rest of our executive board, the PSAM Review stands as a testament to our collective commitment to advancing the field of Addiction Medicine and addressing the challenges of addiction treatment. Some topics and challenges that we plan on tackling in this, and future editions, include stigma, medication for opioid use disorder (MOUD), modernizing opioid treatment access (MOTA), and integrating 12 step and medication assisted treatment philosophies, to name but a few.

There will be recurring columns such as a message from our president and a message from our editor. Other recurring columns will include “Legislative Update,” “A Fellows Column,” “Medical Pearls,” and a feature article (or two).

But the PSAM Review is not just about science and medicine. It is also about the lives we lead outside of our roles as physicians and providers. Addiction Medicine specialists are regular people with interests, hobbies, and passions beyond clinics, offices, hospitals, and treatment facilities. Many of us are artists, poets, writers, photographers, and athletes. In this publication, you’ll find a unique mix of professional articles and personal reflections, showcasing the diverse experiences of our medical community. Whether it’s discussing advancements in treatment, highlighting the voices of those working tirelessly for change, tackling the challenges that persist in our communities and offices, or sharing an outside passion, PSAM Review is a space for open dialogue and growth. I encourage each of you to become an active participant in this adventure. Submit an article, a poem, a story, or a picture. Share with us who you are and what you are interested in, within or outside of the field of Addiction Medicine. My hope is that we will have a recurring column devoted to human interest.

We at the executive board can guide this publication, but if it is truly going to be a success, we need our members to become involved. Thank you for joining us in this new endeavor. I look forward to seeing what we will accomplish together through this platform. Welcome to the journey.

William Santoro, MD, FASAM, DABAM

President’s Address

Welcome to the inaugural newsletter of the Pennsylvania Society of Addiction Medicine!

PSAM has had a unique 20+ year history of leadership, education, and advocacy in Pennsylvania. Over the last year, it has been an honor to contribute to the growth and advancement of PSAM as President. PSAM is an important state chapter of ASAM and has a unique role in aligning the goals and advocacy of our national organization with supporting the professional needs of our Pennsylvania chapter and membership.

PSAM’s updated mission now reads:

“The mission of the Pennsylvania Society of Addiction Medicine is to provide a collaborative community and resource for the physicians and associated professionals dedicated to excellence in advancing the science and best practices of substance use research, education, and clinical care for individuals and families living with substance use disorders. Our shared humanitarian goals are to improve and save lives.”

Pennsylvania remains at the epicenter of the devastating opioid epidemic. Pennsylvania’s unique urban and rural geography, with an easily accessible and complex transportation system, makes it it an easy drop for the delivery of the most potent and toxic substances our communities have seen. Toxicologists and clinicians are racing to stay ahead of the dangers of the latest chemical permutation in the drug supply. Though there has been progress in bringing life-saving harm reduction and evidence-based programming and practices to communities, there remain significant areas of medication, treatment, and insurance deserts across our state. Therefore, the collective work and advocacy from our more than 450 members, representing a diversity of specialties and experience, is of profound significance.

From the ground up, PSAM has been in an exciting phase of “laying the groundwork” for future strategic growth. We have had exciting and important “firsts” over this past year. With revisions in the bylaws, we were able to recruit new members to the Executive Board to reflect clinical, academic, and experiential diversity from across the State of Pennsylvania. Each member of the Board has brought energy, expertise, and their own unique voice to the strategic planning processes.

Another exciting “first” step was to develop and implement a new website and enhanced social media presence. After a search and review of proposals, we chose to work with Phil Sasso from Sasso Marketing, Inc. Phil has helped us to develop and implement a functional, and inspiring, website that PSAM can be proud of. The website continues to evolve and has been a work in progress as new ideas and resources

are added.

Next, we were able to build our first Annual PSAM Addiction Medicine Symposium “From Policy to Practice,” as a virtual conference last March 2024. It was an honor to host an outstanding group of speakers, made possible by the excellent IT support from PaMED. The day was a huge step forward in the performance of our organization.

As a next step to engage more of our PSAM

Though

there has been progress in bringing life-saving harm reduction and evidence-based programming and practices to communities, there remain significant areas of medication, treatment, and insurance deserts across our state.

colleagues, we have expanded the Public Policy Committee and added an Education Committee. Dr. James Latronica, PSAM President- Elect, has been leading the work of the Public Policy Committee. Dr. Lara Weinstein, Dr. Greg Dobash, and Dr. Peter DeMaria have joined me in the Education Committee. We are actively at work on PSAM’s Addiction Symposium and a poster event for Pennsylvania Addiction Medicine and Addiction Psychiatry. Save The Date for March 1st, 2025, PSAM’s Second Annual Addiction Medicine Symposium. We are applying for CME and will once again offer a day of excellent speakers and learning. Stay tuned for details!

2025 will see the Practice Pathway to Addiction Medicine Board Certification come to a close. Personally, as a participant in this multi-year-long endeavor, I am most grateful to have had this kind of life- and careerchanging opportunity. Moving forward, the focus will turn to growing the next generation of specialists. The number of both Addiction Medicine and Addiction Psychiatry fellowships has grown across Pennsylvania. To highlight the accomplishments of Pennsylvania’s Addiction Medicine and Addiction Psychiatry fellows, PSAM is developing a 2025 Poster event for fellows which will also be paired with the Addiction Symposium. We will take a full hour of the Addiction Symposium and ask 4 fellows to speak on a topic of choice. This is an exciting project and another “first” for PSAM.

PSAM has another “first” through the efforts of editors Dr. William Santoro and Dr. Olapeju Simoyan, along with Hoffmann Publishing Group, in bringing PSAM a permanent chapter newsletter. To PSAM colleagues across the state, please share your voice, vision, and creative energies in the world of Addiction Medicine and beyond.

PSAM is on the move!

STAYING CURRENT

How to Keep Up with the Addiction Medicine Literature

Part 1: Point-of-care learning vs. keeping up with the literature

Addiction medicine is a constantly evolving field, and as clinicians and researchers we have a professional obligation to keep our medical knowledge current. The American Medical Association code of ethics, which has been adopted by the American Society of Addiction Medicine, says, “The physician must engage in continuous

The “medical literature” is an ever-ballooning collection of information, and it is easy to be overwhelmed by the huge number of articles released monthly, weekly, and even daily.

learning throughout professional life in order to maintain and develop professional knowledge and skills.”1,7 There are two different ways “to engage in continuous learning” as you practice medicine. There is point-of-care learning, where you look things up as you go about your clinical day. This is vital — if you are unsure of something, you must double-check it — but there are two limitations with this strategy. The first is that you may assume you know something and do not need to confirm the information, but actually you have an unrecognized knowledge gap. For example, you may remember from your training that you treat alcohol withdrawal with benzodiazepines, and not be aware that there are newer benzodiazepine-sparing protocols that can be more effective.

The second problem is that doing only point-of-care learning does not help you expand your knowledge beyond your personal experience, and you become less able to function in unfamiliar situations. For instance, to manage complex withdrawal you may need to consider novel contaminants in the drug supply, even if you haven’t

encountered them previously and aren’t sure of how they might be contributing to the clinical picture. Because of these limitations of point-of-care learning, you need additional knowledge about things that are new and you don’t encounter in your day-to-day practice. You might call this keeping current or keeping up with the literature.

The “medical literature” is an ever-ballooning collection of information, and it is easy to be overwhelmed by the huge number of articles released monthly, weekly, and even daily. In 2022 alone, nearly one million articles were indexed in MEDLINE.6 This medical publishing bloat and proliferation of information can make it a struggle to identify the most relevant new developments. There is also time pressure on busy clinicians, and it’s easy for the daily clinical work (and other things in life) to take precedence over reading and studying. However, the task is not impossible; a deliberate process can make sure you use your limited time and brain space wisely and find the newest published research that will be most helpful to your career and your patients.

Part 2: Building a personal study plan

When tackling a large and diffuse task like “keeping up with the addiction medicine literature,” you need to develop a strategy that is correctly motivated, realistic, effective, and you can stick with consistently. This first step is to find your motivation. Why do you want to keep up with the literature and what is your goal? Identifying your personal motivation allows you to not only choose what you’re going to do, but also to discard things that are not serving you.

Your plan should also be realistic to allow for consistent progress. Consistency is more important than perfection; you will never be able to learn everything, and if you try, you will get bogged down and discouraged. A realistic study plan should allow you to keep moving forward, even if there are busy times in which you haven’t met all your goals.

After you’ve considered these 5 steps, it’s time to get started! Here are some of my favorite addiction medicine resources:

Email alerts

Google Alerts

https://www.google.com/alerts

Evidence Alerts https://www.evidencealerts.com/

Email newsletters

Recovery Research Institute https://www.recoveryanswers.org/

ASAM weekly (with an associated podcast!) https://www.asam.org/ publications-resources/the-asam-weekly

Alcohol, Drugs, and Health: Current Evidence https://www.bu.edu/aodhealth/about-thenewsletter/

Podcasts

Addiction Medicine Journal Club https://arslonga.media/channels/podcasts/ addiction-medicine-journal-club/

The Curbsiders Addiction Medicine Podcast https://thecurbsiders.com/addiction

Online learning modules

Providers Clinical Support System (PCSS) https://pcssnow.org/

ASAM eLearning https://elearning.asam.org/

YouTube channels

The Curbsiders Addiction Medicine https://www.youtube.com/watc h?v=xzfFoz4ViAo&list=PL5oEc yJ-glk5pgzJhAQgdm2nvv0LTlIK5

The Addiction Files https://www.youtube.com/@ theaddictionfiles/

Journals

The Journal of Addiction Medicine https://www.asam.org/ publications-resources/ the-journal-of-addiction-medicine

JAMA Network Open, Substance Use and Addiction Medicine

https://jamanetwork.com/collections/5921/ substance-use-and-addiction-medicine

Substance Use and Addiction Journal https://journals.sagepub.com/home/sajb

Conferences

Pennsylvania Society of Addiction Medicine https://psam-asam.org/

American Society of Addiction Medicine https://www.asam.org/

American Academy of Addiction Psychiatry https://www.aaap.org/

Make sure your learning is active — you will need to do something with your new knowledge to make it stick. If the new information is immediately forgotten, the learning time has not been used well. Active learning can take more time than passive exposure to information, but in the end the time will have been more productive.

Finally, make all your learning count twice (or more). We are all busy, so use your study time to accomplish additional professional goals like getting CME or writing lectures for resident education.

Part 3: Let’s get to it!

Follow this outline to develop a personal plan to keep up with the literature.

1. MOTIVATION: Why do you need to keep up with the medical literature? What is your unique personal goal? “I need to keep current” or “I want to be a good doctor” are too vague. Some specific goals might include:

a. I want to make sure my lectures are current.

b. I need to pass the boards.

c. I want to provide updated patient care by keeping up with new developments.

d. I need to add a new skill to my clinical practice.

e. I am developing a new med student curriculum.

f. I do research and have to keep up with other research in my area.

2. TIME: How much time do you have to spend on your learning, and when and how is it allotted? Be realistic and specific, not just how about much time you have, but when and where that time occurs. For example, you could:

a. Dedicate a full week to the ASAM annual conference once a year.

b. Study for 15 minutes every morning on workdays.

c. Read for 1 hour each weekend morning.

d. Spend 20 minutes reading in your office at the end of the day before you go home.

e. Use your commuting time to listen to educational podcasts 4 hours per week.

3. RESOURCES: What type of learning do you like the best, and what will be your gateway to the information you need? Remember, you can’t study everything, so focus on resources you can access conveniently and that align with your goals.

a. What type of learning do you enjoy? It is easier to stick with things that you like, and you can learn via videos, podcasts, email newsletters, print journals, phone apps, inperson conferences, and more.

b. Choose your gateway to find the information. Dealing with medical knowledge has become an industry unto itself. There are abstracting services, board prep resources, newsletters, textbooks, conferences, YouTube channels, journal clubs, professional society updates, summary journals, and many more.

3. ACTIVE LEARNING: How can you make it stick?

a. As you learn, take personal notes, make slides for mini lectures, or write up patient information handouts.

b. If you teach, update your lecture slides whenever you find new information or immediately turn your notes into lecture slides to be used later.

c. Add in half a day after a conference to digest the material.

d. Engage with other people in person or online. Go to a conference or start your own journal club with colleagues. Comment in an online forum.

5. MAKE IT COUNT TWICE (OR MORE): Use your learning to accomplish additional professional goals.

a. Learn from resources that give CME and MOC.

b. Turn your reading notes into slides for future lectures.

c. Focus your learning on a new skill that will advance your career.

d. Join a research project in an area you want to study.

e. Give medical education sessions on topics that will further your own scholarship and learning.

References:

1. American Society of Addiction Medicine. Medical Ethics in Addiction Medicine Public Policy Statement. American Society of Addiction Medicine. April 3, 2024. Accessed September 29, 2024. https://www.asam.org/advocacy/public-policystatements/details/public-policy-statements/2024/04/07/ public-policy-statement-on-medical-ethics-in-addiction-medicine

2. Chen, F, Chen, W, Isaak, R, Xu, S. Acquire, Curate, Diversify: Staying Current With Key Medical Education Literature. Academic Medicine. 99(2):p 235, February 2024. | DOI: 10.1097/ACM.0000000000005300

3. Geisler, BP. Interpreting the Medical Literature. Lecture published online. March 6, 2019. https://www.slideshare.net/slideshow/ interpreting-the-medical-literature/135527765

4. Lie, M, Trivedi, SP, Graham, K. Learning Habits, Time Management, and Leadership: Wisdom from Dr. Kelly Graham. CORE IM Podcast. May 15, 2023. https://www.coreimpodcast.com/2023/05/15/learning-habits-timemanagement-and-boundaries-an-interview-with-dr-kelly-graham/

5. Maggio, LA, Artino, AR. Staying Up to Date and Managing Information Overload. J Grad Med Educ. 2018 Oct;10(5):597-598. doi: 10.4300/JGME-D-1800621.1. PMID: 30377482; PMCID: PMC6194894.

6. MEDLINE. Medline Citation Counts by Year of Publication. National Library of Medicine. January 2023. Accessed September 29, 2024. https://www.nlm. nih.gov/bsd/medline_cit_counts_yr_pub.html

7. Parsa-Parsi, RW. The International Code of Medical Ethics of the World Medical Association. JAMA. 2022;328(20):2018–2021. doi:10.1001/jama.2022.19697

8. Shaughnessy, AF. Keeping up with the medical literature: how to set up a system. Am Fam Physician. 2009 Jan 1;79(1):25-6. PMID: 19145962.

Bromazolam Brief Review

Background:

Bromazolam, first conceived in 1976, is a “designer” benzodiazepine similar to alprazolam (where bromazolam is brominated, alprazolam is chlorinated); (Ehlers, 2024; Hikin et al., 2024). Never approved for therapeutic use, it had previously faded away until resurfacing in Sweden in 2016 (Ehlers, 2024). It recently gained notoriety in Spring of 2024 when there was a string of emergency department visits following the ingestion of a white powder in a bag labeled “Demon.” Analysis of the substance found bromazolam, caffeine, quinine, fentanyl, and xylazine (What Is “Demon?,” 2024). Not isolated to the east coast, the National Forensic Laboratory Information System (NFLIS) data shows that law enforcement seizures involving bromazolam have increased from no more than 3 per year from 2016-2018 to 2913 in 2023 (Ehlers, 2024). Additionally, in Illinois, deaths involving bromazolam increased from 10 in 2021 to 51 in 2022. Furthermore, there has been a reported surge in bromazolam-related deaths in San Francisco as well as Travis County, Texas (Ellefsen et al., 2024; Rodda, 2024). This article aims to briefly characterize some of the limited available clinical and pharmacologic data to make providers aware of another rising designer benzodiazepine.

Pharmacology:

While data is sparse, given its close structural relation to alprazolam, it is thought that bromazolam functions similarly (Hikin et al., 2024). Bromazolam is described as a non-selective GABA-A agonist with the same clinical effects common to other hypnotics including sedation, muscle relaxation, analgesia, and amnesia (Hikin et al., 2024). Part of the difficulty in the characterization of bromazolam (similarly to alprazolam) is that it is unlikely to appear in many standard

References:

1. Demystifying Benzodiazepine Urine Drug Screen Results. (2019, March 1). MedCentral. https://www.medcentral.com/pain/chronic/demystifying-benzodiazepine-urine-drug

2. Ehlers, P. F. (2024). Notes from the Field: Seizures, Hyperthermia, and Myocardial Injury in Three Young Adults Who Consumed Bromazolam Disguised as Alprazolam — Chicago, Illinois, February 2023. MMWR. Morbidity and Mortality Weekly Report, 72. https://doi.org/10.15585/mmwr.mm725253a5

3. Ellefsen, K. N., Smith, C. R., Simmons, P. D., Edelman, L. A., & Hall, B. J. (2024). The Rise of Bromazolam in Postmortem Cases from Travis County, Texas and Surrounding Areas: 2021-2023. Journal of Analytical Toxicology, bkae079. https://doi.org/10.1093/jat/bkae079

4. Hikin, L. J., Coombes, G., Rice-Davies, K., Couchman, L., Smith, P., & Morley, S. (2024). Post mortem blood bromazolam concentrations and co-findings in 96 coronial cases within England and Wales. Forensic Science International, 354, 111891. https://doi. org/10.1016/j.forsciint.2023.111891

urine immunoassays that target nordiazepam and oxazepam (Demystifying Benzodiazepine Urine Drug Screen Results, 2019; Wagmann et al., 2021). The route of administration is primarily oral via tablets, capsules, solutes, “candies” and “gummies” (Hikin et al., 2024). Usually not sought out on its own, bromazolam is often sold under the guise of being alprazolam, added to fentanyl to perpetuate the opioid effect, mixed with alprazolam to potentiate its effect, mixed with gabapentenoids, and mixed with cocaine (postulated to be for “speed balling”) (Hikin et al., 2024).

Clinical Features:

As expected, clinical intoxication produces a similar presentation to known benzodiazepines. Described in one forensics study of individuals pulled over with erratic driving behavior, intoxication effects showed slurred speech, incoordination, and lethargy (Bierly et al., 2024). However, in a morbidity and mortality weekly report published by the CDC, 3 cases were shown with clinical features including seizures, myocardial injury, and hyperthermia in patients with only bromazolam isolated on LCMS testing (Ehlers, 2024).

Conclusion:

Currently, there are not clear guidelines for management of bromazolam especially in the context of its combination with other substances. The general ebb and flow of novel benzodiazepines is that they appear, rise in use, disappear, and may appear later. “Designer” benzodiazepines raise an even greater concern, given their higher potency than approved benzodiazepines. Especially if there is concern for “Demon,” providers should consider sending urine and serum specimen for public health analysis as well as alerting Poison Control.

5. J, B., Dm, P., & Bk, L. (2024). Bromazolam in Impaired Driving Investigations. Journal of Analytical Toxicology. https://doi.org/10.1093/jat/bkae074

6. Rodda, L. N. (2024). The surge of bromazolam-related fatalities replacing other novel designer benzodiazepines-related fatalities in San Francisco. Addiction (Abingdon, England), 119(8), 1487–1490. https://doi.org/10.1111/add.16520

7. Wagmann, L., Manier, S. K., Felske, C., Gampfer, T. M., Richter, M. J., Eckstein, N., & Meyer, M. R. (2021). Flubromazolam-Derived Designer Benzodiazepines: Toxicokinetics and Analytical Toxicology of Clobromazolam and Bromazolam. Journal of Analytical Toxicology, 45(9), 1014–1027. https://doi.org/10.1093/jat/bkaa161

8. What is “Demon?” (2024). Retrieved October 6, 2024, from https://www.poison.org/articles/demon-drug

A Case of Delusional Parasitosis Associated with Xylazine Use

Authors: Megan Stafford BS1, Andrea Carter MD2, Max B Hurwitz DO3, Raagini Jawa, MD, MPH, FASAM4

Affiliations:

1 University of Pittsburgh, Pittsburgh, PA

2 University of Pittsburgh Medical Center, Pittsburgh, PA

3 Department of Physical Medicine and Rehabilitation, University of Pittsburgh School of Medicine

4 Center for Research on Healthcare, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA

Corresponding Author: Raagini Jawa, MD, MPH, FASAM

Assistant Professor of Medicine University of Pittsburgh School of Medicine Center for Research on Healthcare, 3609 Forbes Ave, Pittsburgh, PA 15213, USA rjawa@pitt.edu, +1-603-966-8608

Author Contributions: AC, MH originated the project and MS, AC, MH drafted the initial manuscript. MS, AC, MH, RJ contributed to the writing of the manuscript, provided critical feedback to the manuscript, and approved the final manuscript draft for submission.

Funding: National Institute of Drug Abuse K12DA050607 (RJ). The funding organization had no role in the preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Conflicts of Interest: none

Abstract word count: 250/250

Manuscript word count: 1605

Number of references: 21

Pre-print Policy: This manuscript has not been peer reviewed and has not been published by other journals.

Keywords: xylazine; harm reduction; opioid use disorder; injection drug use; delusional parasitosis

Abstract:

Background:

Xylazine is an α 2 -adrenergic and kappa opioid receptor agonist that has been increasingly present in the unregulated U.S. drug supply. While xylazine-adulterated opioid use has been associated with necrotic skin wounds, prolonged sedation, and withdrawal, there have been no prior reports of patients presenting with delusional parasitosis (DP) among patients with confirmed xylazine toxicology.

Case summary:

We present the case of a patient in Pennsylvania with a polysubstance use disorder, who presented to the hospital with necrotic wounds on his forearms and experienced symptoms consistent with secondary DP. The patient had several preceding healthcare encounters for a suspected “lice” infestation and tried multiple antiparasitic and over-the-counter treatments without relief. The patient selfreported polysubstance use (specifically, opioid and cocaine use disorder) and had prior urine toxicology positive for xylazine, fentanyl, cocaine. We discuss pathophysiology of DP, potential management and harm reduction strategies. For this patient, he received xylazine wound management, was eventually given a trial of Risperidone for DP and referred to his PCP to initiate on buprenorphine and given xylazine test strips to reduce the potential continued exposure to a drug supply containing xylazine.

Clinical significance:

This report presents a unique case of secondary DP in the setting of using xylazine-adulterated opioids. There is urgent need for more reporting of such cases as well as rigorous research to understand the potential impact of xylazine on people who use drugs.

Abbreviations:

DP, delusional parasitosis; PWUD, people who use drugs; PCP, primary care provider

Introduction:

Delusional parasitosis (DP) is a mono-symptomatic, delusional disorder characterized by severe pruritus and a belief the skin and body are infested by an arthropod or parasite without corroborating medical evidence.1,2 DP is a rare psychiatric disorder which is subcategorized into primary and secondary forms. Primary DP is independent of underlying medical or psychiatric causes. 1 Secondary DP develops as a result of a psychiatric condition, medication or drug use. 3-5 Amphetamines, cannabinoids, and other prescription medications which enhance central nervous system dopamine signaling, have been associated with DP or dermatillomania (skin picking/ neurotic excoriation); however, no prior report has linked the potential relationship between the use of confirmed xylazineadulterated opioid.

Xylazine, which is intended for use as a veterinary tranquilizer, is an increasingly prevalent adulterant in the non-medical opioid supply in the United States. Xylazine acts as an αlpha2 adrenergic and kappa-opioid receptor (KOR) agonist and has been associated with prolonged sedation, necrotic skin wounds,6 and acute poisonings.7,8 Xylazine associated wounds can occur in injection and non-injection sites and the pathophysiology has been purported to be multifactorial with localized vasoconstriction contributing to tissue ischemia and necrotic lesions, coupled with repeat trauma from injections.9 There have also been some reports that the KOR agonist may contribute to pruritus10 and anecdotal reports of dermatillomania.3 In this case report, we seek to highlight a case of a patient presenting with DP secondary to xylazine use.

Case Report:

The patient is a 59-year-old man with opioid and cocaine use disorder who was admitted to an inpatient general medicine service for necrotic skin ulcers with cellulitis. The patient reported that these wounds began six months

prior as scattered small ulcers on his bilateral forearms and progressed to larger and deeper coalescing necrotic wounds on his arms and legs. Several days prior to admission, the ulcers had become increasingly painful, and he developed subjective fevers prompting presentation to the emergency department. The patient reported injecting 10-20 bags a day of what he believed was heroin, likely adulterated with xylazine, and snorting cocaine a few times a week.

He reported that for the past several months, aside from the xylazine wounds, he has been experiencing pruritus all over his body which he believes is due to a persistent lice infestation. The patient did not have any previously documented psychiatric history. He described that the infestation initially started as “lice” in his groin area which over time had spread to all areas of his body. He denied contact with anyone with lice infestation or prior pediculosis infections. Due to the sensation of whole-body infestation, he had alerted his primary care physician (PCP) several times to be evaluated and had attempted to use various home remedies including shampoo, creams, tea tree treatments, and had even shaved his head and eyebrows in an attempt to get rid of the lice without relief. He described the louse as the “size of a grain of salt” and with claws. He said, “I looked at them under a magnifying glass and online. And I know what I was talking about. I wasn’t hallucinating or nothing.” He described that the lice would get into his forearm wounds, and he would have to pick them out because he believed that their bites contributed to the wound being inflamed.

Of note, the patient had presented twice to the emergency department and twice to his PCP in the 6 months prior to this admission for concern of a lice infestation where no lice, nits, or other parasites were found on clinical exam. During one of these PCP encounters, the patient had brought a piece of paper with “lice” specimens taped to it that appeared to be lint on exam. In the 6 months preceding his hospital admission,

he had received treatment with topical permethrin two times and oral ivermectin once.

At the patient’s admission exam, he was afebrile, blood pressure 134/76 mmHg, heart rate 97 beats per minute. He was alert and oriented, had normal heart, lung, and abdominal exams. His bilateral lower extremities had numerous scattered cratered wounds in various stages of healing, some with adherent black eschar, some with some purulent drainage and surrounding erythema. Throughout the exam, he was scratching and picking at his skin and showed clinical team members evidence of “lice” on his arms and scalp that on inspection were small pieces of flaked skin or lint. He had no definitive evidence of lice, nits, or other parasites. His urine toxicology screen was positive for opiates, fentanyl, and cocaine (and prior encounter urine toxicology was positive for xylazine). His white blood cell count was elevated and the remainder of his labs were within the normal ranges.

He was evaluated by the plastic surgery team who felt the most likely diagnosis for his wounds was xylazine skin necrosis with surrounding cellulitis. During the admission he was treated with intravenous vancomycin and piperacillin/tazobactam for 2 days with improvement of purulence and erythema and then transitioned to oral doxycycline to complete a 5-day course for cellulitis. The wounds were too painful for sharp bedside debridement, so he was treated with topical wound care with honey calcium alginate dressings. He was additionally treated with standing oral oxycodone for opioid withdrawal management plus intravenous hydromorphone as needed for severe pain. Despite the absence of lice or nits on exam, he was retreated with empiric topical permethrin and discharged to home with plans for continuing outpatient wound care.

In the three months after hospital discharge, the patient continued to use heroin adulterated with xylazine and cocaine and contacted his PCP two additional times about ongoing concerns about lice infestation.

Given his symptoms persisted for over one month, his PCP made the diagnosis of DP. He was willing to try buprenorphine to cut down on his illicit opioid use, start a trial of Risperidone for his DP, and was given xylazine test strips to test his drugs prior to consumption.

Discussion:

Our case is one of the first documenting xylazine associated secondary DP. Secondary DP among PWUD has been reported among those using psychostimulants, cannabis, codeine, or opiates or among those withdrawing from heroin or alcohol (i.e.; formication).11 Interestingly, xylazine acts as an alpha 2 and KOR agonist.12 KOR are expressed in human epidermal keratinocytes and are involved in the pathophysiology of pruritis and prior reports have demonstrated that KOR agonists have been used to treat paraneoplastic, uremic and cholestatic pruritus13 and other alpha 2 agonists (ie: Guanfacine) have been used in the treatment of DP. 14 While our case report highlights a patient using xylazine with secondary DP, more research is needed to understand if xylazine has an impact on the pruritis pathway, or whether DP symptoms are a consequence of withdrawal from the drug, akin to formication.15

Addiction providers should recognize that the symptoms of secondary DP may be very distressing to the patient.16 While this case highlights a patient with a secondary DP diagnosis, it is important to note that this is a diagnosis of exclusion which should be made after thorough investigation and treatment of potential infection and if symptoms persist for at least one month. PWUD, especially those who are unhoused, are at risk of infections with lice, fleas, bedbugs, ticks or mites which may have overlapping symptomatology to DP.17,18 Patients with secondary DP may believe that their cutaneous symptoms have a somatic origin, often providing intricate descriptions of the perceived pathogen, including their life cycles and behaviors, and compulsively gathering samples of

evidence.1,5,16 These patients may request to see multiple specialists for their symptoms,1,2 attempt selfremedy,16 and in severe cases selfmutilation to excise the pathogen.19 Recognizing the extent to which symptoms of disorder can cause distress, addiction providers should take care to holistically address both the physiological and psychological aspects of the disorder.

Though the pathophysiology of DP is not fully understood,19,20 successful treatment of secondary DP from drug use requires a multimodal approach that addresses reducing or elimination of exposure to the underlying substance (ie: xylazine-adulterated opioids). Given many PWUD have experienced healthcare stigma and trauma, treatment for those experiencing secondary DP should start first with empathic relationship building, that meets the patient where they are. Patient driven, collaborative and goal directed care can help overcome some of the challenges of medical distrust and allow the person experiencing secondary DP to maintain sovereignty, despite the power dynamics in a patient-physician relationship. If interested, patients can be initiated on medications for opioid use disorder to help reduce cravings and use of unregulated opioids or be advised to test their opioids for xylazine adulteration prior to consumption (ie: xylazine test strips). Pharmaceutical treatment for DP can also be considered and includes antipsychotics such as pimozide, risperidone or olanzapine. 14 Patients may also benefit from cognitive-behavioral therapy to address emotional distress and further mitigate other maladaptive behaviors because of the delusions.21

This case report of secondary DP in the setting of patient using xylazine-adulterated opioids, highlights diagnostic and multimodal management challenges. There is urgent need for more reporting of such cases as well as rigorous research to understand the potential impact of xylazine on people who use drugs.

References:

1. Vulink NC. Delusional Infestation: State of the Art. Acta Derm Venereol. Aug 23 2016;96(217):5863. doi:10.2340/00015555-2412

2. Freudenmann RW, Lepping P. Delusional infestation. Clin Microbiol Rev. Oct 2009;22(4):690-732. doi:10.1128/CMR.00018-09

3. Meehan WJ, Badreshia S, Mackley CL. Successful treatment of delusions of parasitosis with olanzapine. Arch Dermatol. Mar 2006;142(3):352-5. doi:10.1001/archderm.142.3.352

4. Al-Imam AML. A systematic literature review on delusional parasitosis. Journal of Dermatology & Dermatologic Surgery. 2016/01/01/ 2016;20(1):5-14. doi:https:// doi.org/10.1016/j.jdds.2015.11.003

5. Alec H. Fisher, B.A., Cornel N. Stanciu, M.D. Amphetamine-Induced Delusional Infestation. American Journal of Psychiatry Residents’ Journal. 2017;12(12):12-13. doi:10.1176/appi.ajp-rj.2017.121204

6. Reyes JC, Negron JL, Colon HM, et al. The emerging of xylazine as a new drug of abuse and its health consequences among drug users in Puerto Rico. J Urban Health. Jun 2012;89(3):519-26. doi:10.1007/s11524-011-9662-6

7. Zagorski CM, Hosey RA, Moraff C, et al. Reducing the harms of xylazine: clinical approaches, research deficits, and public health context. Harm Reduct J. Sep 30 2023;20(1):141. doi:10.1186/s12954-023-00879-7

8. Hochheimer M, Strickland JC, Rabinowitz JA, Ellis JD, Dunn KE, Huhn AS. Knowledge, Preference, and Adverse Effects of Xylazine Among Adults in Substance Use Treatment. JAMA Netw Open. Feb 5 2024;7(2):e240572. doi:10.1001/jamanetworkopen.2024.0572

9. Bishnoi A, Singh V, Khanna U, Vinay K. Skin ulcerations caused by xylazine: A lesser-known entity. J Am Acad Dermatol. Aug 2023;89(2):e99-e102. doi:10.1016/j.jaad.2023.04.009

10. Kim BS, Inan S, Stander S, Sciascia T, Szepietowski JC, Yosipovitch G. Role of kappa-opioid and mu-opioid receptors in pruritus: Peripheral and central itch circuits. Exp Dermatol. Dec 2022;31(12):19001907. doi:10.1111/exd.14669

11. Kemperman P, Bruijn TVM, Vulink NCC, Mulder MMC. Drug-induced Delusional Infestation. Acta Derm Venereol. Mar 8 2022;102:adv00663. doi:10.2340/actadv.v102.183

12. ML B. Xylazine is an agonist at kappa opioid receptors and exhibits sex-specific responses to naloxone administration. bioRxiv. 20 23;doi:10.1101/2023.09.08.556914

13. Phan NQ, Lotts T, Antal A, Bernhard JD, Stander S. Systemic kappa opioid receptor agonists in the treatment of chronic pruritus: a literature review. Acta Derm Venereol. Sep 2012;92(5):555-60. doi:10.2340/00015555-1353

14. Verma KK, Kitrell B, Truitt J, Tarbox MB. Guanfacine treatment for a patient with delusional parasitosis causing dermatillomania presenting with shared psychiatric disorders. Proc (Bayl Univ Med Cent). 2024;37(2):326329. doi:10.1080/08998280.2023.2291719

15. Kimsey LS. Delusional Infestation and Chronic Pruritus: A Review. Acta Derm Venereol. Mar 2016;96(3):298302. doi:10.2340/00015555-2236

16. Mumcuoglu KY, Leibovici V, Reuveni I, Bonne O. Delusional Parasitosis: Diagnosis and Treatment. Isr Med Assoc J. Jul 2018;20(7):456-460.

17. Badiaga S, Raoult D, Brouqui P. Preventing and controlling emerging and reemerging transmissible diseases in the homeless. Emerg Infect Dis. Sep 2008;14(9):13539. doi:10.3201/eid1409.080204

18. Brouqui P, Stein A, Dupont HT, et al. Ectoparasitism and vector-borne diseases in 930 homeless people from Marseilles. Medicine (Baltimore). Jan 2005;84(1):61-68. doi:10.1097/01.md.0000152373.07500.6e

19. Huber M, Karner M, Kirchler E, Lepping P, Freudenmann RW. Striatal lesions in delusional parasitosis revealed by magnetic resonance imaging. Prog Neuropsychopharmacol Biol Psychiatry. Dec 12 2008;32(8):196771. doi:10.1016/j.pnpbp.2008.09.014

20. Vaughan RA, Foster JD. Mechanisms of dopamine transporter regulation in normal and disease states. Trends Pharmacol Sci. Sep 2013;34(9):48996. doi:10.1016/j.tips.2013.07.005

21. Reich A, Kwiatkowska D, Pacan P. Delusions of Parasitosis: An Update. Dermatol Ther (Heidelb). Dec 2019;9(4):631-638. doi:10.1007/s13555-019-00324-3

Addressing Social Determinants of Health

Is Critical for Responding to

the Opioid Crisis

Social determinants of health (SDoH)—including, but not limited to, healthcare access, gender inequality, mental health, race/ ethnicity, socioeconomic status, and transportation—can be a barrier to providing care for those with opioid use disorder (OUD). Pursuing community-based solutions that address SDoH to improve the lives of those struggling with OUD is critical in effectively responding to the opioid crisis.1

Generally, there are higher rates of opioid-related mortality in counties with the highest poverty rates, highest percentage of unemployment, highest uninsured rates, and lowest percentage with four-year college.1

The risk of death from an opioid overdose is 30 times higher for those who have experienced homelessness.1

“ ”

Black and Latino clients generally have up to 30% lower odds of receiving MOUD compared to their White counterparts. Furthermore, rates of fentanyl-specific deaths have increased from 2011 to 2016 for Black clients (+140.6% per year) and for Latino clients (+118.3% per year).2

“ “ ” ”

Spotlight: Massachusetts Access to Recovery (ATR)3

ATR is a 6-month program in Massachusetts that provides care for individuals in recovery from substance use disorder.

ATR offers a number of recovery support services to participants, such as access to basic needs, career services, recovery coaching, and housing services that may help address SDoH inequities.

Care coordinators work one-on-one with participants to assess their needs, guide them along their recovery paths, connect them to resources in the community, and provide them with support throughout the program.

References:

99%

1. Bohler R, Thomas CP, Clark TW, Horgan CM. Addressing the Opioid Crisis Through Social Determinants of Health: What Are Communities Doing? Opioid Policy Research Collaborative at Brandeis University. Published 2021. Accessed September 2024. https://www.opioid-resource-connector.org/resources/addressing-opioid-crisis-through-social-determinants-of-health-what-are-communities-doing

2. Guerrero E, Amaro H, Khachikian T, Zahir M, Marsh J. A bifurcated opioid treatment system and widening insidious disparities. Addict Behav. 2022;130:1-2. doi:10.1016/j.addbeh.107296

3. Massachusetts Access to Recovery. Accessed September 2024. https://www.ma-atr.org/ of participants have successfully refrained from using drugs and alcohol at the 6-month discharge from ATR.

A HOUSE DIVIDED

The Future of Recovery: A Unified Approach to Addiction Treatment

“A house divided against itself cannot stand” is a famous excerpt from Abraham Lincoln’s acceptance speech.

I do not believe that utilizing NA, AA, or any other 12-step model is comprehensive treatment for substance use disorder. But I do recommend some form of 12-step meetings for most patients who enter my office. Furthermore, I also do not believe that the use of the medical model is comprehensive treatment for substance use disorder. But I do prescribe medication for substance use to most patients who enter my office. For many years these two prize fighters have needlessly battled each other. For many years I have spoken in favor of uniting these two models into one powerful understanding and philosophy. Medication alone may help some, maybe even many, but medication alone will fail for many. The 12-step model alone may help

some, maybe even many, but the 12-step model alone will fail for many. But together, clearly many more will be helped.

When approaching the treatment of substance use disorder with only medication, the goal is to pharmacologically work with issues like receptor binding, mechanism of action, metabolism, clearance, half-lives, and efficacy. Pharmacology can reduce the cravings and has been proven to reduce the consumption of illicit substances. Pharmacology can address the “what,” “where,” “how,” and “when” of substance use disorder. But pharmacology cannot address the “why” of substance use disorder. And if the “why” is not addressed, there will always be a high risk of relapse. The use of medication alone can be compared to painting over rust. The project will look good on the surface, and it will look good for a certain

length of time, but because the underlying problem was not addressed, the rust will ultimately return. Furthermore, it is common knowledge that providers often see patients in 15-minute intervals. Providers are often rushed to move from one patient to the next and not given the time to truly get to know the patient. These are some of the criticisms that medication providers hear from those who believe in 12-step programs.

When approaching the treatment of substance use disorder with only a 12-step model the goal is to work from within the patient, addressing the person’s spiritual needs, and with their environment, which includes their social support system to accomplish complete abstinence. A quote from an NA pamphlet states:

“NA has no opinion on the practices of any organizations or practitioners outside NA. However, within the context of NA and its meetings, we have generally accepted principles, and one is that NA is a program of complete abstinence. By definition, medically assisted therapy indicates that medication is being given to people to treat addiction. In NA, addiction is treated by abstinence and through application of the spiritual principles contained in the Twelve Steps of Narcotics Anonymous.”

– Narcotics Anonymous and Persons Receiving Medication Assisted Treatment, PR Pamphlet

One may rightfully ask for a definition of “abstinence.” We need to explore some possibilities. Does abstinence mean one must be free of one’s drug of choice? Does abstinence mean one must be free of any mood-altering substance? According to the first possibility, medication for substance use would not be contrary to abstinence. Based on the second possibility, one would also need to be free of substances such as caffeine and nicotine to be considered abstinent.

Nobody can argue that when it works, the 12-step model is successful. But that’s like the famous John Madden saying, “if someone doesn’t tackle that football player, he’s going to keep on running.” Of course, he’s going to keep running if not tackled, and of course something that is working is successful. But what about the people who are unable to succeed in attaining abstinence utilizing spiritual, personal, and social self-help?

Too often we hear people say things like, “it works if you work it” or “if you want what I have, do what I do.” But these statements are circular in reasoning, just like the John Madden quote. Furthermore, to say “…addiction is treated by abstinence…” is a false equivalent. In substance use disorder, abstinence is the goal, not the means of

treatment. It seems to be the same as Coach Madden saying his strategy to win a game is by scoring more points than his opponent. No coach, this is too simplistic, the measure of winning a game is one team must score more points than the other team. But the strategy of how to score more points is the question at hand, just as the strategy of how one goes about achieving and remaining abstinent is also the question at hand. These are the criticisms that 12-step followers hear from those who believe in the medical model of treatment.

There was a time, not long ago, that medication for substance use did not exist. Intelligent, visionary men and women created a philosophy, system, and model to

In substance use disorder, abstinence is the goal, not the means of treatment.

help treat people with the disease of addiction. Those who adhere strictly to the medical model should acknowledge and respect what was accomplished without medication.

We now have several medications for the treatment of certain substance use disorders. Intelligent, visionary scientists worked in labs for years to figure out the appropriate medications, dosages, and potential side effects. Those who adhere strictly to the 12step model should acknowledge and respect what was accomplished with medication. Those firm believers in the 12-step model should be encouraged to accept medication as part of the treatment of substance use disorder. Those firm believers in the medical model should also be encouraged to accept the 12-step program/philosophy as part of the treatment of substance use disorder.

I realize that people on both sides will disagree with some of the points I have made in this article; that was my objective. I believe we all must first accept that we are all in one house. When we allow ourselves to be divided, we are not the only ones who lose, our patients also lose. There is no reason a provider who prescribes medication should not embrace the tenants of the 12-step model. Just as there is no reason followers of the 12step model should not embrace the benefits of medication. “A house divided against itself cannot stand.”

Incorporating Trauma-Informed Care in Addiction Treatment

It is no surprise that many of our patients with a substance use disorder (SUD) have grown up in challenging and traumatic environments where they may have experienced poverty, food insecurity, homelessness, interpersonal violence, parental serious mental illness or substance use, and other traumas. The term adverse childhood experiences (ACEs) has been used to describe these traumatic situations.1

ACEs typically create an environment of chaos and unpredictability with lifechanging outcomes which can include violence and death.

Table 1 lists ACEs described on the website Number Story, an educational website for individuals and health care professionals. An estimated 85 - 100% of patients with a SUD have at least one ACE. Research has demonstrated that each additional ACE positively contributes to the risk of the development of a SUD.1 A history of trauma is especially commonplace for women with a SUD.2

Beyond the statistical correlation is the impact of ACEs on a person’s psychological development. ACEs typically create an environment of chaos and unpredictability with life-changing

outcomes which can include violence and death. Experiencing and witnessing these events, particularly when they occur repeatedly over time, can affect the developing nervous system, and create a state of heightened “fight or flight.”

Growing up in this environment requires a person to develop ways to cope with the uncertainty and chaos. Survivors frequently describe their lives as “walking on eggshells” and being on-guard. To survive, children learn what is and what is not safe to say and do and learn that at times not telling the truth or blatantly lying is needed to prevent dire consequences.

These patterns develop over time and become reinforced and generalized. Understanding this developmental framework can inform how patients interact with addiction treatment providers.

Consider the typical health care provider’s interaction with a new patient. Both provider and patient are sizing each other up. The clinician is attempting to understand the patient and develop a therapeutic relationship. The patient may be unaware of what to expect and fears the worst.

Hopefully, both enter the relationship with a sense of trust and best intentions. However, imagine if you grew up in an environment with multiple ACEs where you had to learn how to survive, constantly questioning everything, always being on alert, waiting for something bad to happen, and coping with the reality of what you have experienced in the past.

Operant conditioning research demonstrates that this intermittent, variable reinforcement schedule with both positive and negative reinforcers produces the greatest behavior change. Having experienced negative consequences so many times in the past causes you to exercise caution in all relationships, even the ones that are meant to be therapeutic. How could you think otherwise? The very people you were meant to trust, parents or primary caregivers, may have already let you down, or worse, hurt you –emotionally, physically, or sexually. How might this play out in the health care setting?

The patient may present hesitantly and not completely engage in conversation. They may answer but not expand. They may take an offensive stance from the start, anticipating the need to fight. Or, as the clinician listens, something tells them that the patient may not be telling the truth. Sadly, these are common experiences in working with patients with a SUD. It is easy to attribute them to a “drug addict mentality.” However, that is not helpful and tends to result in a derailed and failed therapeutic interaction. Is it possible to better understand the behavior and prevent such a failed encounter?

Clinicians and researchers have developed a greater understanding of the impact of ACEs

which can also be viewed as traumas. They have argued for what is termed trauma-informed care which takes into consideration the impact of ACEs. The Substance Abuse and Mental Health Services Administration (SAMHSA) has created a monograph to help clinicians.3 Table 2 lists the six key principles of SAMHSA’s trauma-informed care which include: safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment and choice, and cultural, historical and gender issues. Incorporating these principles into addiction treatment will help improve the clinicianpatient interaction. How does this play out in clinical practice?

The therapeutic alliance, the relationship between provider and patient, stands as a pillar of clinical care. The approach to patient care has fortunately shifted from medical paternalism to shared decision-making. Unfortunately, some of the dynamics of a patient with a SUD can lead to a morphing of the relationship back to that of medical paternalism.

The patient presents with the chief complaint that their life is out of control due to their substance use. The clinician, dedicated and wanting the patient to gain control and move towards recovery, can feel, unconsciously or even consciously, the need to introduce control into the patient’s life with strong recommendations or dictates. On the surface, this seems appropriate and clinically indicated. Many of the recommendations, put forth are perfectly reasonable.

However, in the case of a patient with a history of ACEs, these recommendations can seem like mandates and can recreate the situations in which they grew up, where they had no control and were forced to endure the unknown, and sometimes difficult or painful consequences. Facing this, the patient may resist and fight the recommendations creating an uncomfortable interaction, or worse, they may flee treatment.

Following SAMHSA’s key principles of trauma-informed care, adjustments in the treatment approach can lead to significantly improved results. Clinicians should not expect patients to trust them; it will need to be earned. The clinician can help create a trusting space by sitting down in a private setting and listening to a patient’s concerns. They should explain procedures and decision-making so the patient understands them, even if the patient does not agree. To empower the patient, present options rather than dictate a treatment plan. Openly tell the patient that your relationship is a collaborative one, and that they are the ultimate one to make any decisions. This, of course, is true of any patient encounter but for the patient with a history of ACEs (traumas), it needs to be explicitly stated, reinforced, and followed.

As the provider, there are things you will and will not be able or willing to do, but people prefer being given options and being able to choose. Explaining the options to the patient will allow them to understand your thinking

Following SAMHSA’s key principles of trauma-informed care, adjustments in the treatment approach can lead to significantly improved results.

process. Acknowledging that the two of you may not always agree but that you will respect their opinion is empowering, even if difficult when a patient makes a decision that is not in their best interest. Creating patient access to peer support can go a long way to help a patient understand policies and procedures, support your recommendations, and build trust.

Finally, being aware of cultural, historical, and gender differences and adopting an attitude of cultural humility will further help build a trusting therapeutic relationship. Some clinicians may find these recommendations obvious, trivial or feel that they already conduct their practice in this way. However, patients with a significant ACE/trauma history will be super-focused on every statement or move a clinician makes.

Think about it, they have had to develop these qualities in order to survive their growing up. They have learned that telling the truth does not always lead to a positive result. Lying may have been the only way to avoid severe punishment. An approach which empowers a patient and seeks to be collaborative will help the patient who fears the clinician may manipulate or hurt them.

It may take time and repeated reinforcement for the patient to trust the clinician and unfortunately, this approach may not always succeed. Acknowledging this and expressing a desire to work with the patient will help. Utilizing a “three strikes and you are out” policy can lead to the patient leaving treatment, relapsing, overdosing, and dying. Given that retention in treatment is the best predicter of a positive treatment outcome, many patients will need more than three attempts.

Assisting patients with a SUD move into sobriety and ultimately recovery is rewarding. The journey can be a rough road. Increased awareness of the prevalence and impact of ACEs and a trauma-informed approach to treatment will help make the path to recovery smoother and lead to better therapeutic outcomes.

References:

1. Leza L, Siria S, López-Goñi JJ, Fernández-Montalvo J. Adverse childhood experiences (ACEs) and substance use disorder (SUD): A scoping review. Drug Alcohol Depend. 2021;221:108563. doi:10.1016/j.drugalcdep.2021.108563

2. Substance Abuse and Mental Health Services Administration. (2021). Addressing the Specific Needs of Women for Treatment of Substance Use Disorders. Advisory.).Available at: https:// store.samhsa.gov/sites/default/files/pep20-06-04-002.pdf

3. Substance Abuse and Mental Health Services Administration. SAMHSA’s Concept of Trauma and Guidance for a Trauma-Informed Approach. HHS Publication No. (SMA) 14-4884. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014. (available at: https:// store.samhsa.gov/sites/default/files/sma14-4884.pdf).

Table 1. Adverse Childhood Experiences (ACE)

Physical abuse

Sexual abuse

Emotional abuse

Physical neglect

Emotional neglect

Intimate partner violence

Mother treated violently

Substance misuse within household

Household mental illness

Parental separation or divorce

Incarcerated household members

(Source: https://www.numberstory.org)

Table 2. The Key Principles of Trauma-Informed Care

1. Safety

2. Trustworthiness & transparency

3. Peer support

4. Collaboration & mutuality

5. Empowerment & choice

6. Cultural, historical & gender issues

(Source: https://store.samhsa.gov/sites/default/files/sma14-4884.pdf_)

ADHD SUD & A Pediatrician’s Perspective

Although I believe that Addiction Medicine should be a primary specialty, there is an advantage to having another specialty, as in my case Pediatrics. I have been a pediatrician for over 40 years with an expertise in ADHD. Additionally, I have been practicing addiction medicine for all ages for over 17 years. I would like to talk about what I see in my patients as opposed to what other specialties may see. I believe that my observational insight for the thousands of patients I have treated may add a different treatment and direction for our patients.

ADHD is mostly a genetic disorder. 5-12% of the world’s population have it and 70-80% do not outgrow it and should be treated for the rest of their lives. The primary class of drugs that are most effective are stimulants. I understand all the recent thoughts that a patient with SUD should not be given a controlled medication like a stimulant. This information is incorrect as physicians are not looking at the genetic basis and alteration in brain chemicals involved with this disorder.

The genes involved in ADHD have been recovered back to the Neanderthal period. In Thom Hartmann’s book, ADHD, A Different Perspective, he looked at the time when we were hunters and farmers. It seemed that the traits of ADHD fit into the hunter’s makeup: things like thrill seeking, not focusing on time, but rather achieving their exciting goals of feeding the tribe are among the traits. The inheritance is very high. On a scale of 0-1, height is the closest to 1. How tall will the child be? Look at the parents. A major risk factor for asthma is family history. This runs about 0.4 on that scale. ADHD runs 0.8.

Going further, the big breakthrough on ADHD were PET scans in the early 1990s. Before that time, when I was in medical school, we called the use of stimulants for Minimal Brain Dysfunction, now called ADHD, a paradoxical reaction. Speed slows some people down. After the PET scans, we realized people with this condition used more of the primitive posterior portion of the brain, the “go” portion, and the prefrontal cortex, the “stop” areas, were not kicking in. The nerve-to-nerve signal is described as a pitcher throwing a ball to 50 catchers. By using a stimulant, we block the uptake of norepinephrine so that there will be more chemical to hit the target. Thus, most patients with ADHD do not and usually can not abuse the drug. Studies have shown that divergence is low in this population. In fact, the people who may divert the drug are the parents with the same condition, so that they can use the medication to treat themselves. If you are going to self-medicate, nicotine, caffeine, cocaine or methamphetamines are used. Ask your patients using cocaine or meth what happens when they use. Commonly I hear, “Oh yes, people laugh

at me because I fall asleep.” If you treat those patients for ADHD with stimulants, frequently the cocaine and meth will disappear.

Why not use a non-stimulant? Because it is not as effective as a stimulant. Atomoxetine, in particular and everyone’s “go to” drug, is probably the least effective for treatment of all the approved medications. When we look at the effect size of medications used, longacting stimulants on a scale of 0-1 come in at 0.95. Short-acting stimulants come in at 0.90. Dr. Josphine Elia, when she was at CHOP, did a genetic study that showed Atomoxetine coming in at 0.65. Thus, it has a limited genetic profile. If the patient’s genetic picture fits the criteria for atomoxetine, then if would work. Unfortunately, in my experience, even when it works, it may take up to 6 weeks.

With a stimulant, I always tell the parent of a child it is an “Oh My God” medication. What does that mean? It means if you call me in 2-3 days, and start the conversation with, “Well…” the dose is incorrect. When the dose is correct, I hear, “OH MY GOD!!!” It is day and night. Proper dosing should be reached within 1-1½ WEEKS, not months! Make your adjustments every 2-3 days.

With a new patient coming for treatment of SUD, I give them a screener for depression, anxiety, adult ADHD, and an ACE screener for childhood trauma. I am not a big believer in adult-onset ADHD. By definition, the symptoms start under the age of 12. I feel that adult ADHD is a missed diagnosis as a child, or a non-pediatrician seeing anxiety or depression as misdiagnosis. A screener for children, out of Canada, called Preventur, found that 4 positive answers on their screener were 90% predictive of future drug use. Those answers were: impulsiveness, thrill seeking, anxiety, and hopelessness. We could look at each one individually, but if I wanted to classify these symptoms under a disorder, I would call that disorder ADHD. Impulsiveness and thrill seeking I think you see. The children tend to get anxious because of the stress of not completing their work, studying for a test and then not remembering anything the next day, etc. Because, especially boys, they cause disruption in class and the teacher constantly calls their names and they hurt other children on the playground because of the inability to monitor their aggressiveness, they lose friends, and other parents tell their children to avoid that “bad” kid. Now the child feels they are no good and do not know how to fix the situation thus causing hopelessness and depression.

Studies have shown that children medicated with stimulants had future substance use equal to children without ADHD. Those not treated or treated with non-stimulants had a twice fold chance of SUD. Studies have shown that comparing behavioral therapy alone, stimulant therapy alone, or both therapies together, the

combination was the most effective treatment. However, stimulants alone were not statistically different. 25% of patients with SUD have ADHD and I believe it is even higher than that. A recent study in JAMA, March 2024 cited a 2-fold increase in unnatural deaths when not treated. When medicating, it is very important to have the proper dosing and not be afraid of “too much.” Inadequate dosing causes problems. When the medication wears off, the patient will be cranky, irritable, tired, and out of sorts. Sleep issues with medications seem to be a concern. But the reality is that under dosing is the cause of most sleep problems. When you ask a patient if the reason they can’t sleep is because their minds will not “turn off,” usually the answer is yes. When you give a stimulant around dinner time, they usually sleep like a baby. Of course, as a pediatrician, I do not know if that is a good thing because infants are in REM sleep every 20-30 minutes whereas the adult cycle is 2-3 hours, but you get my point.

With a stimulant, I always tell the parent of a child it is an “Oh My God” medication. What does that mean? It means if you call me in 2-3 days, and start the conversation with, “Well…” the dose is incorrect. When the dose is correct, I hear, “OH MY GOD!!!” It is day and night.

The point of my article is to make my cohorts aware and develop a deeper understanding of this condition. Withholding stimulants for this condition is a big mistake. Commonly, after I treat the ADHD, anxiety and depression improves, and the patients’ recovery improves because their relationships get better, their work gets better, their lives get better, and this is a very positive goal in their treatment.

In conclusion, my observational thoughts are that 90% of our patients with SUD had childhood trauma. Furthermore, I have found that SUD is mostly a genetic disorder too. I know we claim in research that it is 40-60% genetic. However, this is not what I see in real life. My guess is at least 80% or more. So, we have 2 genetic diseases, SUD and ADHD, that did not start with your patient. The trauma from growing up with a parent or 2, both with untreated diseases, leads to future drug use in their children. And the parents did not start the gene pool either. It started above them and above them and the beat goes on. Do we want to curb and decrease SUD? Educate more physicians; look deeper into your patient’s diagnosis; treat what we can and encourage therapy to address those childhood traumas. WAKE the pediatric community up to get a head start in identifying those children at risk. For us, identify and treat ADHD with stimulants to curb future drug use and help our patients now!

ASAM ADVOCACY

When Tuesday, September 24, 2024 arrived, not even the dark clouds and rain could dampen the excitement and enthusiasm of the more than 110 physicians and allied health professionals from across the country, gathered on the steps of the iconic Capitol Hill for the group photo. “Hill Day” had arrived and participants were ready to walk to the Senate and House Office Buildings to meet in orchestrated meetings with legislators.

Each

group was trained to be able to discuss critical highlights of three important bills during their meetings with Senators and Representatives.

ASAM Leaders, including CFO Kelly Correador and President-Elect Dr. Steven Taylor, had laid out the mission and action steps for the day of advocacy. On Monday participants were organized in groups according to their home state and districts. For Pennsylvania, there were nine professionals representing districts across the state: Arielle Bivas (PA-05), Dr. William Clark (PA-12), Dr. Mitchell Crawford (PA-11), Dr. Jeffrey Jaeger (PA-03), Dr. Margaret Jarvis (PA-09), Dr. Sarita Metzger (PA-03), Bernard Steutz (PA-01), Dr. Aleksandra Zgierska (PA-10), and Dr. Kristin Van Zant (PA-03 and NJ-10).

Each group was trained to be able to discuss critical highlights of three important bills during their meetings with Senators and Representatives. Each Legislator was then asked to Co-sponsor the bills:

1. Modernizing Access to Methadone treatment for OUD, or MOTAA: Currently access to Methadone for OUD is restricted to 2100 federally certified opioid treatment programs (OTPs) while Methadone prescribed for pain can be dispensed from any widely accessible pharmacy. Passage of MOTAA would allow addiction specialists and OTP clinicians to prescribe methadone for OUD treatment that can be picked up at local pharmacies.

2. Maintaining Telemedicine Access to Addiction Medicine, or TREATS Act: During the COVID pandemic, federal agencies allowed audio-visual or audio-only telemedicine initiation of Buprenorphine, but these flexibilities are set to expire December 2024. Passage of the “TREATS Act” would make permanent existing audio-video and audio-only telehealth evaluation exceptions to the Ryan Haight Act’s inperson exam requirement for initiating Schedule III-V medications approved for the treatment of SUD, including Buprenorphine.

From left to right top row, Dr. Mitchell Crawford, Dr. Walter Clark, Dr. Sarita Metzger, Bernard Stuetz, PA, Dr. Margaret Jarvis; from left to right bottom row, Dr. Jeffrey Jaeger, Arielle Bivas, NP; Dr. Aleksandra Zgierska, Dr. Kristin Van Zant
Dr. Sarita Metzger, PSAM Secretary, Dr. Stephen Taylor, ASAM President-Elect

3. Covering Residential Addiction Treatment

Under Medicare: There is a significant prevalence of untreated substance use in older adults. It is estimated that over 5 million Medicare beneficiaries have past-year SUD, but less than 25% receive any treatment. Passage of the Residential Recovery for Seniors Act would create a Medicare Part A benefit for residential addiction treatment programs meeting nationally recognized standards categorized as Level 3.1, Level 3.5, and Level 3.7, and establish a prospective payment program.

At the conclusion of the meetings, many of the congressional staff were asked by the Pennsylvania team whether the discussions had helped in any way to enhance the understanding of the issue. Their answers were consistent: hearing directly from constituents and advocates was very important in shaping the direction of the sponsorship of the bill and vote. In fact, congressional aides said that hearing personal stories was deeply impactful and often a very moving way to highlight the importance of an issue. The Pennsylvania team completed the day with a great deal more than 10,000 steps walking through the maze of hallways, tunnels and stairs in the congressional buildings. It was a happy exhaustion of working toward impactful policy changes for the greater good of individuals with substance use disorders across the state of Pennsylvania, and country. We’ll be back next year!

From left to right, Dr. Kristin Van Zant, Bernard Stuetz, PA, Dr. Sarita Metzger, Dr. Walter Clark, Dr. Aleksandra Zgierska, Dr. Margaret Jarvis, Arielle Bivas, NP, Dr. Mitchell Crawford, Dr. Jeffrey Jaeger
At the Office of Representative Dwight Evans: Dr. Sarita Metzger, Dr. Jeffrey Jaeger
At the Office of Representative Mary Scanlon: Dr. Jeffrey Jaeger, Bernard Stuetz, PA, Dr. Sarita Metzger

SAMHSA Updates: OTP Clinic Regulations

SAMHSA Rule Changes for PAs/NPs – 2024.

The final rule1 promotes practitioner autonomy, removes stigmatizing or outdated language, supports a patient-centered approach, and reduces barriers to receiving care. These elements have been identified as being essential to promoting effective treatment in OTPs and reflect an OTP accreditation and treatment environment that has evolved over the past 20 years.

Accordingly, these final changes reflect evidencebased practice, language that aligns with current medical terminology, effective patient engagement, and promotion of a skilled and robust workforce providing services in OTPs. To this end, the definition of a qualifying practitioner has been expanded to include a practitioner who is appropriately licensed by the state to prescribe (including dispense) covered medications. Where state law allows, this includes nurse practitioners and physician assistants.

Admission criteria have been updated to remove significant barriers to entry, while also defining

References:

the scope and purpose of the ‘initial’ and ‘periodic’ medical examinations. The final rule also includes new definitions to expand access to evidence-based practices such as split dosing, telehealth, and harm reduction activities, and it promotes the chronic disease model of management.

The Code of Federal Regulations (CFR)2 includes the regulations that guide opioid treatment programs (OTPs); these went into effect in 2001. The U.S. Department of Health and Human Services (HHS), SAMHSA revised these regulations and released the final rule in February 2024.

The revisions take historic steps to increase access to lifesaving, evidence-based medications for opioid use disorder (MOUD) and to advance retention in care through promoting patient-centered and compassionate interventions. These rules went into effect on April 2, 2024, compliance date October 2, 2024, allowing time for OTPs to prepare and for states to review their regulations that impact how this rule is implemented.

1. https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/42-cfr-part-8/faqs

2. https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/42-cfr-part-8

Harnessing the Power of Music & Art for Better Health

Physician, Professor, Dept of Psychiatry, Drexel University College of Medicine

MD, MPH, BDS, FAAFP, DFASAM, FAMWA, Addiction Medicine

I recently attended a conference jointly hosted by the International Association for Music and Medicine (IAMM) and the International Society for Arts and Medicine (ISfAM), held in Berlin, Germany. This was an opportunity to interact with professionals from very diverse backgrounds but with similar interests, to discuss various ways in which music and other art forms are being incorporated in health care. For example, a group of researchers discussed how recreational choir singing led to clinically significant improvements in depression, neuropsychiatric symptoms and quality of life. We also learned about the use of creative arts in the prevention of drug use. In this project, attendees reported reduction in negative affect, anxiety and depressive symptoms.

Another project that was presented focused on relapse prevention, with the working hypothesis being that music engagement can repair damaged pathways through deep relaxation, meditative states and evoked imagery. The intervention targets the dysregulation of the emotional, behavioral and nervous systems through listening to music and instrument playing, while leveraging the impact of music on the dopamine reward system.

In addition to inducing pleasure, music has been shown to enhance the experience of connection with something greater. This is demonstrated in the quote from a patient below.

“Do you know why your music does me so much good? It’s because your soul is speaking to my soul.”

– 84-year-old patient with Alzheimer’s Disease

Indeed, music and other art forms have the potential to impact our overall health and well-being in ways that are deeply meaningful, even if they are sometimes hard to quantify.

This was one of several patient quotes that was shared by Claire Oppert, a cellist and art therapist, during a live performance titled “The Schubert Treatment” – When Music Meets Care.

Indeed, music and other art forms have the potential to impact our overall health and well-being in ways that are deeply meaningful, even if they are sometimes hard to quantify. Regarding the aspects that can be quantified, the good news is that the National Institutes of Health (NIH) is funding numerous studies to explore the connections between music and health through its Sound Health initiative. One of the aims of this initiative is to establish evidence-based practices for music interventions to enhance well-being and for the treatment of specific conditions.

I believe that engaging in extraprofessional activities, including the creative arts, is essential for our own well-being. Our non-clinical interests can contribute to our own personal growth and development, in addition to helping us to connect with our patients.

On my way to the IAMM conference referenced earlier, I visited the Silent Night Museum and Chapel in Oberndorf, a small village outside of Salzburg, Austria. The Silent Night Chapel was built as a memorial at the location of the church where the Christmas carol “Silent Night” was first performed on Christmas Eve in 1818. I had spent the previous few months reading about the stories behind several Christmas carols, in the process of writing my book, I Played My Best for Him - The Inspiring Stories Behind the Little Drummer Boy and Other Christmas Favorites. Visiting the location where such significant events took place over two centuries ago brought the story to life in a way that simply reading about it could never have done.

I encourage whoever is reading this to take time to slow down and relax every once in a while. Whether it’s visiting a local museum, a foreign country, playing a musical instrument or simply taking a walk in the park, the potential benefits are priceless.

Dr. Simoyan can be contacted at www.thedoctorwriter.com.

The International Association for Music & Medicine is a registered nonprofit organisation formed in 2009 to encourage and support the use of music in medical contexts including research into the benefits of music, and its specialised applications in healthcare.

The International Society for Arts and Medicine (IsFAM) was established in 2023 with the primary aim to highlight the important connection of arts and medicine.

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Pennsylvania Issues a Licensing Alert Incorporating Updates

As anyone engaged in the care of people with Opioid Use Disorder (OUD) is aware, the use of methadone for the care of people with OUD is governed by a complex set of federal and state regulations. The federal regulations, are codified in Part 8 of Title 42 in the Code of Federal Regulations, otherwise known as 42 CFR Part 8. These regulations are the ones that stipulate, in part, the necessity of in person visits to an Opioid Treatment Program (OTP) to acquire methadone; the need for a certain frequency of urine drug testing; and the mandates for a specified amount of addiction psychotherapy for patients receiving methadone.

For years, a chorus of patients, activists, and addiction professionals have been clamoring for changes to 42 CFR Part 8 with only marginal progress towards reform. The COVID-19 pandemic accelerated the reform process, as the risks of in-person care at OTPs compelled supervising bodies to quickly modify many of these guidelines. Almost overnight, OTPs were compelled (and permitted) to provide care via telehealth and to provide doses of methadone for at-home consumption.

During the “natural experiment” created by the pandemic, a body of research emerged which demonstrated no increase in negative outcomes associated with the relaxation of regulations. Patients, providers, and advocacy organizations pushing for reform were able to compel the Substance Abuse and Mental Health Services Administration (SAMHSA) to draft modifications to the existing regulations. In April 2024, SAMHSA released its modifications, incorporating many of the pandemic-era changes that had proven workable for both OTPs and their clients. Individual state agencies were given 6 months to issue their own guidance incorporating these changes.

On September 27, 2024, Pennsylvania Department of Drug and Alcohol Programs (DDAP) released Licensing Alert 07-2024 for providers, entitled “Exceptions related to 42 CFR Part 8”. This Alert incorporates all elements of the SAMHSA modifications which do not require changes to existing regulations of the State Board of Medicine and State Board of Nursing. The alert takes the form of a series of modifications to title 28, Chapter 715 of the PA Code, entitled Standards for Approval of Narcotic Treatment Programs, the section of Pennsylvania law that delineates the conditions under which OTPs must operate. Importantly, the guidance in this alert is effective immediately, and providers can follow the federal regulations listed in this licensing alert without requesting an exception.

The Licensing Alert is brief, and a quick read. Anyone providing care for people with OUD is encouraged to read it and become familiar with the changes, as they represent major change, and create opportunities to update care of OUD in ways that will improve access to care. Below are eight important take-home points regarding

Pennsylvania’s state-specific interpretation and implementation of the SAMHSA guidelines:

1. Removal of age limits: OTPs will no longer be restricted in the age of patients getting treatment, allowing for the use of MOUD in patients below the age of 18.

2. Relaxation of the “one year” requirement: DDAP will allow an exception to the rule that a person must be dependent on a narcotic drug for at least one year prior to starting MOUD, provided that the OTP has a trained person to diagnose the client using medical criteria and documents the reason for MOUD treatment in the record.

The Licensing Alert is brief, and a quick read. Anyone providing care for people with OUD is encouraged to read it and become familiar with the changes, as they represent major change, and create opportunities to update care of OUD in ways that will improve access to care.

3. Acceptance of verbal consent: OTPs will no longer be required to obtain written consent before treatment, allowing for the use of verbal consent. Note that a face-to-face visit is still required at MOUD initiation, so it is not clear how impactful this change will be.

4. Relaxation of urine drug testing rules: DDAP will allow exceptions to the rule requiring OTPs to perform monthly urine testing, changing to a looser requirement for at least 8 tests per year.

5. Expansion of who may determine dosage: The Licensing Alert allows for an exception to the rule requiring that a physician decide on dosage changes. It will now be possible for any licensed practitioner (including an appropriately trained Advanced Practice Practitioner) acting within the scope of his or her practice to execute dose changes based on an individualized determination.

6. Relaxation of “take-home” rules: DDAP will allow exceptions to the rule delineating strict time frames before an OTP can allow take-home medications, provided that the OTP assures that the benefits of “take-homes” are greater than the risks.

7. Relaxation of rules regarding psychotherapy: DDAP now allows an exception to the provision of mandatory minimum amounts of monthly therapy to qualify for MOUD and codifies that a refusal or therapy cannot be used as a reason to deny a patient MOUD therapy.

8. Removal of limits on duration of detox: There is no longer any limitation on how

long a patient and OTP can engage in methadone (or other opioid) detoxification.

Importantly, DDAP did not relax the rules stipulating a face-to-face meeting with a patient at intake. This requirement often poses as a barrier to successful uptake of MOUD and is a major barrier for the initiation of MOUD for the large population of patients who, for a variety of reasons, have no way to get to an OTP in person (e.g. patients in skilled nursing facilities, or patients with mobility-limiting disabilities). This regulation had been relaxed during the pandemic with no evidence for negative consequences, and removal of this requirement is a major component of the SAMHSA guidance. However, as the requirement for an in-person meeting at the initiation of a controlled medication is a component of Pennsylvania Department of State (DOS) regulations, a change to this rule would be a much “heavier lift” and would require engagement from a broader set of stakeholders. In the Licensing Alert, DDAP assures the addiction community that such conversations are ongoing, and it is hoped that in the near-term future, DDAP and DOS will find a way to incorporate this change into the updated guidance.

Most importantly, the guidance from SAMHSA and the subsequent Licensing Alert from the Commonwealth of Pennsylvania reflect a welcome update in the understanding of addiction and OUD as complex chronic brain diseases. The changes allow for an increase in the use of clinical judgment and patient preference in deciding how to use methadone and other MOUD for this most vulnerable group of patients, who are as deserving as any citizens of individualized, evidence-based, patient-centered care.

NET ADDICTION RECOVERY PROGRAMS

Embracing the possibility of recovery for life

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7520 State Road, Philadelphia PA, 19136

NET Centers (NET) provides individualized treatment, specialized services, and ongoing support to sustain recovery that focuses on trauma informed care and evidence based programing. The recovery continuum in both traditional and medication assisted modalities includes:

• Medications for opioid use disorder (Methadone, Buprenorphine, and Naltrexone/Vivitrol)

• Outpatient and Intensive Outpatient (IOP)

• Prison-based treatment (opioid use disorders only)

• Residential treatment

We also offer a unique after-care resource called the NET Works Recovery Support Center, completely managed by people in recovery. We support innovative programming such as our CCBHC and the Integrated Care and Wellness Center, providing an integration of physical and mental health services along with substance use services in one location.

In addition to our recovery programs, NET is committed to offering support and help to individuals and families at times of great stress in their lives, including child welfare, juvenile justice, and mental health services.

LEARN MORE about our compassionate care

LET MY PEOPLE GO!

To any pharmacy to get their prescription for singleingredient buprenorphine filled!

Iam currently practicing on the front lines, battling the opioid crisis. Over the past nine years, I have witnessed four major factors that are impeding access to single-ingredient buprenorphine sublingual tablets, an armamentarium to aid me in this battle:

1

The few pharmacies that honor prescriptions for single-ingredient buprenorphine charge up to $10 per pill, amounting upwards of $600 per month for patients who require two pills per day.

2

Another barrier is the fact that health insurance companies frequently restrict coverage for the subset of enrollees that are receiving medication for opioid use disorder who have intolerance to various forms of the Schedule III combination buprenorphine formulation and require the Schedule III single-ingredient buprenorphine. As a result, patients end up having to pay out of pocket for this lifesparing medication.

The justification for denying coverage often has to do with concerns about diversion. Ironically, these restrictions are not applied to Schedule II medications like oxycodone, fentanyl, hydrocodone, and hydromorphone. Seems like a real disconnect to me!

3

Reluctance of pharmacies to fill these prescriptions

Most of my patients are prescribed the combination buprenorphine formulation. However, a sizeable minority simply cannot tolerate the combination formulation (e.g., Suboxone). The intolerances include allergic reactions, nausea, severe headaches, and the unpleasant taste of the combination tablets. Pharmacies honor prescriptions for full agonist opioids but commonly refuse prescriptions for buprenorphine, a partial agonist, unless it is the combination formulation, regardless of intolerance concerns.

Several patients travel across state lines from Ohio and West Virginia to Pennsylvania to find physicians willing to recognize their Suboxone intolerance and prescribe single-ingredient buprenorphine, but we can only do so if we can find that rare pharmacy that will honor the prescription and can also take on additional customers.

4

Arbitrary quotas imposed on pharmacies by distributors

Recently, one of the pharmacies I work with that is known for their respectful attitude towards patients and does not engage in price inflation was hit with a notice from their distributor, something I found quite unsettling. The “red flag” notice indicated that the pharmacy had been prescribing more single-ingredient buprenorphine than combined buprenorphine formulations. The letter requested an explanation for this, as well as evidence that steps were being taken to ensure legitimate use.

An excerpt from the DEA’s website reads:

“This guidance document clarifies that neither the Controlled Substance Act (CSA) nor the Drug Enforcement Administration (DEA) regulations establish quantitative thresholds or place limits on the volume of controlled substances DEA registrants can order and dispense.”

– Excerpt from EODEA258, DEA-DC-065, January 20, 2023

Distributors are basically going against the guidance from the DEA by imposing arbitrary quotas on pharmacies when it comes to prescribing single-ingredient buprenorphine.

Summary

By treating all opioid medications as equally risky without considering the nuances of each, authorities, pharmacies, distributors, and health insurance companies are failing to recognize the critical role that partial-agonists like single-ingredient buprenorphine play in recovery, with profound ramifications.

Patients who are unwilling or unable to take the combination buprenorphine formulation are left in a precarious situation and often end up resorting to illicit substances to cope with debilitating withdrawal symptoms, increasing their risk of overdose and death. As practitioners, we are witnessing firsthand the devastating impact of these systemic failures on our patients’ lives.

Distributors and insurance companies should reevaluate their policies to accommodate the unique needs of patients with opioid use disorder. Restrictions based on a lack of understanding of single-ingredient buprenorphine’s role in treatment only serve to further alienate and marginalize those who are truly seeking help. A more inclusive approach to insurance coverage could be transformative, enabling patients to access the medications they need without the added financial burden.

Ultimately, tackling the opioid epidemic will require a collaborative effort that brings together healthcare providers, pharmacies, insurance companies, distributors, the DEA, and policymakers. Only through a unified approach can we hope to dismantle the barriers and ensure that all individuals struggling with opioid use disorder have access to the care and support they need to reclaim their lives.

Pharmacies play a pivotal role in the treatment continuum, and their policies should reflect an understanding of the unique needs of individuals struggling with substance use disorders. The refusal to fill prescriptions for single-ingredient buprenorphine not only exacerbates the challenges faced by patients

but also sends a damaging message that their recovery is not valued.

Price inflation undermines the very essence of harm reduction and recovery, making it impossible for individuals to comply with their treatment plans and achieve long-term sobriety. It is vital that we advocate fair pricing practices that prioritize the health and wellbeing of patients over profit margins.

Patients who are unwilling or unable to take the combination buprenorphine formulation are left in a precarious situation and often end up resorting to illicit substances to cope with debilitating withdrawal symptoms, increasing their risk of overdose and death.

Health insurance companies must also be held accountable for their restrictive coverage policies. By denying access to necessary medications for those with a documented intolerance to the combination buprenorphine formulation, they are effectively limiting treatment options and perpetuating the cycle of addiction. Comprehensive coverage that includes single-ingredient buprenorphine prescriptions is essential for ensuring that all patients have the opportunity to receive effective care tailored to their individual needs.

My heart has been repeatedly warmed by the multitude of success stories volunteered by my patients, who have reclaimed control over their destinies, are gainfully employed and have restored relationships with family members. Without legal access to singleingredient buprenorphine, these patients would likely return to illicit use and become victims of the opioid crisis. So, my plea is: LET MY PEOPLE GO! To any pharmacy to get their prescription for single-ingredient buprenorphine filled without discrimination and price inflation!

As of 2019, drug overdoses are a leading

cause of injury-related deaths in the US.1

In 2022, 81.8% of drug overdose deaths involved at least one opioid. Illegally made fentanyls were the most commonly involved drug class and were found in 74.6% of overdose deaths. 2

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time. Our purpose is to bring science-based, life-transforming treatments to patients. We strive to help eliminate the stigma of addiction.

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