Identification and Treatment of Opioid Use Disorders in Primary Care Settings

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Identification and Treatment of Opioid Use Disorders in Primary Care Settings 17th Annual Primary Care Symposium February 24, 2018 Kelly S. Barth, DO Associate Professor, Psychiatry & Internal Medicine Medical University of South Carolina

Conflicts of Interest -No conflicts -Will discuss non-fda indicated use of medications 2

Outline I. Identification of Opioid Use Disorder (OUD) in Primary Care II. Treating Opioid Use Disorder in Primary Care using Medication Assisted Treatment (MAT) III. Future Directions and state-wide opportunities

Diagnosing OUD in Primary Care is Not Easy 4

How to Identify OUD in Primary Care Clinical Assessment Poor Functioning Emotional Depression/Anxiety Physical Sedation/in bed/ed Social Pt or Family Concern Aberrant Behaviors Running out early Rx from another provider Use of illicits Screening scales NIDA Quick Screen COMM DAST SOAPP-R ORT

DDX for a Poorly-Functioning Pain Patient Psychiatric co-morbidity Depression Anxiety, esp early-life trauma Psychologic co-morbidity Chemical coping Personality disorders Opioid Use Disorder (OUD) Psychotherapy +/- Meds Psychotherapy MAT Pseudoaddiction/tolerance Maximize nonopioids 6

When does a poorly-functioning patient with pain cross the line to addiction?

Start opioid Pain Euphoria Tolerance Doc mg Tolerance Pt mg How does an OUD start? Use for stress sleep high Try to Change source Run out early Return to drug pain sleep w/d

RECOGNIZING OUD Aberrant Behaviors More clear Forging Steal/borrowing IV use Obtained on street Abuse other drugs Multiple dose Recurrent Rx loss (Passik & Portenoy 1998) Less clear Request mg Hoarding Asking specific Rx Doc shopping * 1-2 dose Rx another sx Psychic effects 9

Intoxication RECOGNIZING OUD Signs Withdrawal Euphoria Constricted pupils Slurred speech The nods Pain/Distress Dilated pupils GI upset/diarrhea Goosebumps 10

DSM-V Opioid Use Disorder Maladaptive pattern of use leading to impairment or distress

Failure to fulfill major role obligations Important social, occupational, or recreational activities are given up Decline in functioning Tolerance (not with prescribed medications) Withdrawal (not with prescribed medications) Taken in larger amounts or over a longer period than was intended Persistent desire or unsuccessful Loss of efforts control to cut down or control use Great deal of time spent to obtain/use/recover from the substance Craving or a strong desire or urge to use a specific substance Continued use despite negative consequences Continued use despite Use despite recurrent physical or psychological problem exacerbated by the substance consequences Recurrent use in situations in which it is physically hazardous

Risk Factors for Inadvertent Prescription Opioid Overdose Higher doses of opioids 100mg morphine equivalent or higher Using with sedatives or alcohol Co-morbid mental health or medical issues Recent abstinence (recent hospital detox) Other substance abuse Aberrant behavior (running out early) Using alone Bohnert, et al. JAMA. 2011;305(13):1315-1321

Screening Tools NIDA Single-Question Screener: How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons? (where a response of 1 is considered positive).

Drug Abuse Screening Test -10

Screen & Opioid Assessment For Patients With Pain Revised ( SOAPP -R)

SOAPP-R (con t)

Current Opioid Misuse Measure - COMM

Opioid Risk Tool (ORT)

Failure to fulfill major role obligations Important social, occupational, or recreational activities are given up Decline in functioning Tolerance (not with prescribed medications) Withdrawal (not with prescribed medications) Taken in larger amounts or over a longer period than was intended Persistent desire Loss or unsuccessful of control efforts to cut down or control use Great deal of time spent to obtain/use/recover from the substance PAIN Craving or a strong desire or urge to use a specific substance Continued use Continued despite negative use despite consequences Use despite recurrent physical or psychological problem exacerbated by the substance consequences Recurrent use in situations in which it is physically hazardous

Approach to the Patient With Addiction + Pain Express Concern + Provide Feedback I am concerned about your health and safety. This is the 3rd time you have run out of pain medications early. You have been to the ED 6 times in the past 3 months. I am concerned that you are showing several signs of addiction. Validate Pain + Set Boundary I believe you are suffering/in pain. I can Rx non-opioid pain meds. I cannot safely prescribe you opioids at this time. Provide Education + Support I want you to know that there is excellent medication for opioid addiction that can help with pain and prevent withdrawal. We can try this. I hope we can continue to work together to get you feeling better.

HAVING THE CONVERSATION Empathy (pt is suffering) Focus = safety & functioning Professionally set boundary Lifesaving tx available! 22

LIFESAVING TREATMENTS Naltrexone Antagonist Buprenorphine Partial Agonist Methadone Agonist + + + + + + + + + + + + + + + + + + +

Medications for the treatment of opioid use disorder Naltrexone (Vivitrol, ReVia ) Buprenorphine/ Naloxone (Suboxone ) Methadone Mechanism Opioid antagonist Opioid partial agonist/partial antagonist Opioid agonist Availability Extended-release injection, tablet Sublingual, Buccal, Implant, Injection For treatment of OUD in a methadone clinic, usually in syrup form Prescribing Restrictions None any prescriber can prescribe Must receive a DATA 2000 waiver to prescribe Patients must obtain from a methadone clinic Initiation Must wait to initiate until patient has been free of opioids for 7 to 10 days Must wait to initiate until after withdrawal symptoms have started to appear May initiate immediately to avoid withdrawal Abuse Potential No abuse potential Less likely than methadone: only a partial agonist; dissolution and injection may induce withdrawal Low compared to other opiates Very low within methadone clinic Patient Population/ Other Concomitant alcohol dependence Highly motivated pts Patients with mandated use (medical boards, etc) Improving insurance coverage Usually requires preauthorization for now Decreases mortality in heroin users Not yet covered by insurance in SC (~$15/day) Decreases mortality in heroin users

What is Medication-Assisted Treatment (MAT)? Addiction is a bio-psycho-social disease Medication alone is not sufficient for someone to enter full recovery from addiction It is recommended that medications for OUD be combined with psychosocial treatment for best long-term outcomes

Methadone Maintenance Treatment Lifesaving option for those who need optimum structure Severe addiction Co-morbid personality disorders Polysubstance and/or IV drug use Fail naltrexone and/or Suboxone Daily dosing in a methadone clinic Counseling provided on-site Those with addiction and severe pain? Weigh risks and benefits Decrease in barriers to care in SC under way

Methadone Clinics in SC

DRUG ADDICTION TREATMENT ACT OF 2000 An Amendment to the Controlled Substances Act Allows a waivered physician (DEA X number) to prescribe an opioid (buprenorphine) to a patient with an opioid use disorder for the treatment of opioid use disorder, with certain restrictions.

Buprenorphine/Naloxone Sublingual buprenorphine has good bioavailability, sublingual naloxone has poor bioavailability. Opioid-dependent person takes a buprenorphine/naloxone tablet sublingually, predominantly buprenorphine effect. Opioid-dependent person dissolves and injects a buprenorphine/naloxone tablet, predominantly naloxone effect (and precipitated withdrawal). Formulation: abuse/diversion deterrant 30

Buprenorphine/Naloxone Tablets 2mg/0.5mg 8mg/2mg

SUBOXONE Film For complete Prescribing Information, visit suboxone.com. SUBOXONE Sublingual Film is a registered trademark of Reckitt Benckiser (UK) Ltd.

Zubsolv Sublingual Tablets Available doses (BUP/NX): 1.4 mg / 0.36 mg; 5.7 mg / 1.4 mg Recommended maintenance dose: 11.4 mg/ 2.8 mg

Bunavail Buccal Film Available dosages (BUP/NX): 2.1 mg / 0.3 mg; 4.2 mg/0.7 mg; 6.3 mg/ 1.0mg Recommended maintenance dose: 8.4mg / 1.4mg

Buprenorphine Implant -6mo maintenance treatment in clinically stable pts on buprenorphine 8 mg or less

Injectable Buprenorphine 2 formulations considered by FDA -Once monthly injection of 100 or 300 mg (Indivior) -Once weekly injection of 24 or 32 mg (Braeburn) Advantages: less opportunity for misuse, diversion and nonadherence FDA approved coming to market soon

37

Opioid substitution decreases mortality in OUD Comparison of risk of death in patients exposed or not exposed to opiate substitution treatment by duration of treatment. (Boxes are interquartile ranges (with median); lines are 95% confidence intervals) Cornish, et al. BMJ. 2010 Oct 26;341:c5475.

while in treatment Adjusted risk of death, compared with not being on treatment, during and after opiate substitution treatment. Cornish, et al. BMJ. 2010 Oct 26;341:c5475.

OUD VS. DEPENDENCE Symptoms OUD Loss of control in function Dependence Tolerance Withdrawal Use despite negatives Compulsive use No loss of control Functioning well Craving 40

Looking Forward -Longer-term studies -Use of naltrexone -Funding: Training & Support in SC -Initiating treatment in ED settings -Outcomes of Policy/Guideline implementation

Long-term studies POATS 42-month follow-up (n=375/653) Long-term outcomes = clear improvement from baseline 32% were abstinent from opioids & not on agonist therapy 29% were receiving opioid agonist therapy, but met no symptom criteria for current OUD Agonist treatment was associated with a greater likelihood of Month-42 abstinence (<.0001) -90/113 (80%) on agonist treatment were abstinent -98/193 (51%) not on agonist treatment were abstinent 8% initiated IN heroin use and 10% initiated IV heroin use 5 deaths Drug Alcohol Depend. 2015 May 1; 150: 112 119

JAMA Psychiatry. 2017;74(12):1197-1205.

-Sponsored by Norwegian government -Unblinded RTC, daily observed dosing buprenorphine -Mostly IVDU -49/79 (62%) buprenorphine completed 12 week trial -56/80 (70%) naltrexone completed 12 week trial -UDTs weekly, missing counted as + -Mean buprenorphine dose 11mg (avg in Norway 13mg)

Naltrexone XR after outpt detox Am J Psychiatry 174:5, May 2017

Policy/Guideline Outcomes Overdose reversal data Utilization in medicare population High resumption of opioids after OD reversal 93% success rate in preventing death, but 1 in 10 don t survive the next year CDC guideline implementation Recommendation with highest level of evidence = ID and treat OUD with MAT SC MAT guidelines in process Prescription opioid limitations from payers

Looking Forward - Funding President s FY 2017 Budget $1 billion to expand access to OUD treatment 28k doctors authorized to Rx buprenorphine 46% Psychiatrists 37% PCPs 27% Other specialties 6k currently write 90% of total prescriptions U.S. Dept HHS proposal increase buprenorphine patient prescribing limit South Carolina Expand providers able to prescribe MAT Expand # of bup patients/physician to 200 Expand access to naloxone for OD reversal Provide free trainings and support (ECHO) 48

329 OUD pts in ED (mostly heroin) 1:1:1: RCT with primary outcome 30d tx retention Screening + treatment referral (SRT): 38/102 (37%) SBIRT: 50/111 (45%) SBIT with bup/nlx: 89/114 (78%) P<.0001

Project ECHO for Addiction Tele-mentoring and Educational Sessions using statewide tele-conferencing First module: Addiction Anticipated second module: Chronic Pain Address barriers to implementation of MAT in primary care Access to specialty consultation Prior Authorizations (support and best practice sharing) Access to mental health care (linking) CME provided www.scmatacess.org

www.scmataccess.org Upcoming topics for Project ECHO Opioid Use Disorder Tele-mentoring and Educational Sessions 2/16/18 Overdose Prevention Dr. Kelly Barth 3/2/18 Medication Update: Buprenorphine Formulations (focus on new monthly injection) Dr. Dan McGraw 3/12/18 Urine Drug Testing & Alcohol Testing ECHO Faculty 4/6/18 Motivational Enhancement Techniques for Primary Care Caitlin Kratz, MSW Charleston Center 4/20/18 Tapers: If/How/When Dr. Kelly Barth 5/4/18 Special Populations: Use of Medication-Assisted Treatment in Pregnancy Dr. Constance Guille

Summary Identifying and treating OUD with MAT is the most evidence-based intervention in treating those with chronic pain Medications for OUD include both opioid and non-opioid treatments in addition to counseling Treating OUD can decrease overdose mortality Free training and support is available for providers in SC to treat OUD

Questions? Slides, scales, and other practice tools are available on our website: www.scmataccess.org Kelly Barth, DO stephen@musc.edu (843) 792-5380