May 31, 2017 Jeff Watts, MD Psychiatrist and Addiction Medicine Physician Cook County Health & Hospitals System

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Recipe Book for Medication-Assisted Treatment (MAT) Integration May 31, 2017 Jeff Watts, MD Psychiatrist and Addiction Medicine Physician Cook County Health & Hospitals System

Disclaimers and Appreciation I do not receive any funding honoraria, contractual, research, or otherwise from any pharmaceutical or healthcare company I do not have investments or ownership in any pharmaceutical or healthcare company Many of the graphical slides in today s presentation are from PCSS-MAT (the Providers Clinical Support System for Medication Assisted Treatment). I appreciate the use of these materials in today s presentation.

Teaching Objectives To understand the optimal staffing and patient care models for MAT services To learn about critical training and logistical issues needed for implementation To discuss common system and patient-care challenges with starting MAT services

Definitions of Addiction Is a primary, chronic disease of brain reward, motivation, memory and related circuitry that leads to characteristic biological, psychological, social and spiritual manifestations ASAM Is a mental, physical, and spiritual disease Big Book of AA Is a chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences NIDA An addict is not a bad person trying to get good, but is a sick person trying to get well

DSM-5 Criteria for Substance Use Disorder: Recommendations and Rationale Figure Legend: DSM-IV and DSM-5 Criteria for Substance Use Disorders a One or more abuse criteria within a 12-month period and no dependence diagnosis; applicable to all substances except nicotine, for which DSM-IV abuse criteria were not given. b Three or more dependence criteria within a 12-month period. c Two or more substance use disorder criteria within a 12-month period. d Withdrawal not included for cannabis, inhalant, and hallucinogen disorders in DSM-IV. Cannabis withdrawal added in DSM-5. SEVERITY INDICATORS: Use number of criteria met (from 2 to 11) as an overall severity indicator mild (2-3 criteria), moderate (4-5), and severe (6 or more) disorders. Hasin et al., 2013, Am J Psychiatry

Introduction to MAT MAT stands for Medication Assisted Treatment for addictive disorders or substance use disorders (SUDs) Currently refers to FDA-approved treatments for nicotine, alcohol, and opioid/heroin use disorders There are also medications that have been off-label due to known effects on SUDS Many clinical trials are examining novel medications, drugs and vaccines for possible MAT use

Currently Available Medications For Nicotine/Tobacco Use Disorders For cessation or relapse Nicotine replacement (gum, patches, spray, lozenges) Buproprion (Zyban, Wellbutrin) Varenicline (Chantix)

Currently Available Medications For Alcohol Use Disorders Acute Withdrawal (Benzodiazepines longer acting, or off-label anticonvulsants) Relapse Prevention Disulfiram (Antabuse) Acamprosate (Campral) Naltrexone (Oral tablets-revia; XR Injection- Vivitrol)

Currently Available Medications For Opioid Use Disorders Full agonist (methadone) from a specialized, certified, and licensed methadone provider Partial agonist (buprenorphine) For withdrawal, detox, or maintenance Available in tablets, SL films, buccal films, and now implant Brand names include Suboxone, Zubsolv, Bunavail, Probuphine (implant) Antagonist (Naloxone-Narcan; Naltrexone-ReVia, Vivitrol)

Comparison of Activity Levels 100 90 80 Full Agonist (e.g. heroin) 70 % Mu Receptor Intrinsic Activity 60 50 40 30 20 10 0 no drug low dose Partial Agonist (e.g. buprenorphine) Maximum opioid agonist effect is never achieved Even when all mu receptors occupied Antagonist (e.g. naloxone) high dose DRUG DOSE

What is the best recipe for a MAT Clinic Utensils and appliances needed Key ingredients Recipe with exact amounts Cooking/culinary skills Tasting/eating Making changes for the next time

What is the best recipe for a MAT Clinic? Utensils and appliances needed Site Visit, Pharmacy, Lab Issues Key ingredients Staff Hiring, Training Recipe with exact amounts Prescribers + Glue Person Cooking/culinary skills Direct care, procedures, logistics Tasting/eating Start seeing and treating patients Making changes for the next time Evaluation, lunch-n-learn, e-consults

Key Ingredients Opioid Addicted Patients Trained Prescribers MAT Coordinator

Key Ingredients Opioid Addicted Patients Heroin vs. Prescription Opioids 1 Motivated vs. Mandated vs. Monitored Patients Chronic Pain / Physiologically Dependent Patients Co-morbid medical illnesses or psychiatric disorders

Key Ingredients Prescriber of MAT Physicians must complete 8 hour waiver training and receive special DEA X-number As of end of 2016, Nurse Practitioners (APNs) and Physician Assistants (PAs) may complete 24 hours of training 2 and apply for prescriptive authority Number of allowed patients varies from 30 to 100 to 275 Most often reported barrier to MAT implementation is inexperience/concern for withdrawal in initial patient inductions 3,4

MAT Coordinator / Glue Person Key Ingredients Could be CADC, LCSW, MSW, LPN, RN, Other Is primary conduit between patients and prescribers Manages referrals, scheduling, medication availability issues, patient tracking May conduct on-site MAT groups or connects with community providers/groups Is available for patients and trouble shoots often on a daily basis

Utensils and Appliances Clinical Space Medication Availability Behavioral Treatment

Clinical Space Utensils and Appliances No specific requirements Helpful to have bathroom nearby for urine toxicology screens and GI issues in opioid withdrawal Ideal to have 2 patient rooms so that prescriber (MD, NP, PA) can be monitoring an induction while also seeing other MAT or primary care patients simultaneously No emergency equipment needed. COWS only requires phone/watch (for pulse) and pen light (for pupil dilation). Need a small conference or group room on weekly basis (if onsite MAT groups are to be facilitated)

Utensils and Appliances Medication Availability Bup/Nx tablets are now generic Most insurers have Suboxone, Zubsolv, and/or Bunavail are their formularies as well (occasional prior auth) Immediate availability of Bup/Nx will dictate the induction model (on-site observed vs. home non-observed) Partnering with on-site or nearby pharmacy for Bup/Nx Naltrexone XR (Vivitrol) is being added to more formularies but prior authorization is often required very expensive If stocking/storing Naltrexone XR, will need refrigerator

Utensils and Appliances Behavioral Treatment On-site MAT groups 12 Step groups (AA, NA, others) SMART Recovery Refuge Recovery Referral to IOP or other treatment program Individual Therapy

Skills Needed, Cooking Times Models of Induction Clinical Tools / Toxicology Tests Patient Flow/Scheduling Clinic Management/Common Problems Diversion, Other SUDs, Pain

Models of Induction/Care Delivery patient already inducted at another site Made from Scratch on-site assessment, induction, monitoring Out of a Box on-site instructions with home non-observed induction

Models of Induction/Care Delivery Comes to your clinic already on MAT From hospital ER 5 or inpatient ward 6 From correctional setting 7 From induction center (hub-and-spoke model) 8 From substance abuse tx center Detox, residential, sober living

Models of Induction/Care Made from Scratch Traditional model taught in waiver training 9 Inductions are on-site and observed (COWS Instrument) Requires prep time (pre-assessment), space for extended period (on induction day), med availability, and more staff time Ensures Bup/Nx taken correctly and able to monitor for precipitated withdrawal Proposed to have greater retention 10 and less diversion than the home induction model

Models of Induction/Care Out of the Box Patients are given a prescription and instructions written, online, video on when and how to take Bup/Nx Patients have to assess timing of their last use and severity of withdrawal before taking medication (SOWS instrument) Does not require extended clinic visit or space occupation Does not require on-site medication A very good option 11 in patients who have been previously prescribed Bup/Nx maintenance, who have been given Bup/Nx for detox purposes, or who have successfully used on the streets/via diversion

Observed vs. Unobserved Potential factors to consider Observed Unobserved Effective and tolerability +++ +(+) Establish treatment structure +++ - Development of therapeutic alliance ++ -/+ Confirm baseline withdrawal (and presence of physiologic dependence Convenience/preference MD Patient +++ -/+ * Resources/cost -- + -/+ -/+ +++ ++ Co-morbidity -/+ -/+ * Note: pt s can present for evaluation in mild withdrawal but start Bup out of the office 45

Clinical Tools / Toxicology Testing Screening and assessment tools Patient-centered educational materials (including Naloxone training), patient-provider agreement Other helpful documents sample induction notes/progress notes, policy/procedures, FAQs for covering physicians, billing information, protocol/algorithm, implementation checklist Prescription monitoring website

Clinical Tools / Toxicology Testing Toxicology Testing Urine vs. Saliva ease of use, $$, detection window Send-out lab know what is tested for POC testing likely need assay with high detection of opiates (eg 300 ng/dl) POC testing need separate methadone, buprenorphine, oxycodone, and, maybe, fentanyl

Patient Flow / Scheduling Three phases of treatment induction, stabilization, and maintenance Guidelines are continually changing (TIPS reference) After induction, a followup visit or call the next day is recommended At our sites, we provide a one-week rx for 4-6 weeks two week rx for the following 6-8 weeks, then monthly thereafter issues with lost rx, diversion, problematic tox results resets the process As in cooking, MAT clinic flow and scheduling is often dictated by the shape in which it was prepared. Your management may differ based upon staffing, space, capacity, etc. within your clinic.

Patient Management / Common Issues MAT Coordinator keeps tracking log to know when rx are due, most recent toxicology results, current schedule (weekly, biweekly, monthly), other Anticipate / Plan for Common Issues Urine toxicology positive for opiates, methadone, fentanyl Urine toxicology negative for buprenorphine Urine toxicology repeatedly + for THC, BZD, cocaine, PCP, amphetamine Patient seeking BZDs or prescription opiates / tramadol Lost/stolen prescriptions Missed/late appointments policy around walk-ins Patient seeking BZDs

Patient Management / Common Issues How to manage Opioid Dependence and Co-Morbid Psychiatry Issues Opioid Dependence and Other SUDs (alcohol, cocaine, BZD, other) Chronic Pain Acute Pain (surgeries, trauma, etc)

Medications as part of MAT services are not the solution, but may be a key part to it At best, the MAT component can help persons with SUDs reach sobriety/recovery sooner At worst, the MAT component may help prevent a person from overdosing and allow them to live one more day

The opioid epidemic is enormous in scope There is much funding/grants, trials, programs, task forces, clinical passion, and political fervor about how to address the epidemic Fortunately, a result of the hysteria is a complex but extensive support, education, training, and mentoring network for MAT As we tell our patients, don t be afraid to ask for help!!

References 1. Weiss, RD et al. Longterm outcomes from NIDA CTN Prescription Opioid Addiction Treatment Study (POATS). Drug Alcohol Depend (2015) 150: 112-119. 2. Waiver training curricula for NPs/PAs through PCSS-MAT http:// pcssmat.org or ASAM http://elearning.asam.org. 3. Kissin, W et al. Experiences of a national sample of qualified addiction specialists who have and have not prescribed buprenorphine for opioid dependence. J Addict Dis (2006) 25: 91-103. 4. Egan, JE et al. PCSS-B: a novel project to expand/improve buprenorphine treatment. J Gen Intern Med (2010) 25: 936-941. 5. D Onofrio, G et al. Emergency department-initiated buprenorphine/ naloxone treatment for opioid dependence: a randomized clinical trial. JAMA (2015) 313:1636-1644. 6. Liebschutz, J et al. Buprenorphine treatment for hospitalized, opioiddependent patients: a randomized clinical trial. JAMA Intern Med (2014) 174:1369-1376.

1. We 2. Wa References 3. Kis 4. Eg 5. D Ono 6. Lieb 7. Ludwig, AS; Peters, RH. MAT for opioid use disorders in correctional settings: an ethics review. Int J Drug Policy (2014) 25:1041-1046. 8. Gunderson, EW et al. Improving temporal efficiency of outpatient buprenorphine induction. Am J Addictions (2011) 20: 397-404. 9. Cassadonte, PP; Sullivan, MA. Buprenorphine induction. PCSS guidance from PCSS-MAT. (Updated Nov 27, 2013). http://pcssmat.org. 10. Fiellin, DA et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. NEJM (2006) 355: 365-374. 11. Gunderson, EW et al. Unobserved versus observed office buprenorephine/naloxone induction: a pilot randomized clinical trial. Addict Behav (2010) 35: 537-540.