Outline. Opioid Addiction: A National Epidemic. Buprenorphine Maintenance Treatment Update. David Best, D.O. Best Medical Services, PLC

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1 Buprenorphine Maintenance Treatment Update David Best, D.O. Best Medical Services, PLC Outline Define Problem of Opioid overdose epidemic Making the diagnosis of Opioid use disorder Discussing Risk Factors Treatment options Case Studies Opioid Addiction: A National Epidemic In 2013 in the U.S. approx. 4.8 million reported misuse or abuse in the last month 4.5 million people reported non-medical use of Rx pain relievers 289,000 reported using heroin Substance Abuse and Mental Health Services Administration (SAMHSA) 2014 Report 1

2 Prescription Drug Overdose: Facts In 2013 of 43,982 overdose deaths in U.S., 22,767 were related to pharmaceuticals. 71.3% involved opioids, 30.6% involved benzodiazepines Leading cause of injury death in U.S. Opioid Dependence and Addiction Defies stereotyping Review of 725,679 UDS from individuals 50 and over: 28.1% of UDS contained non-prescribed drug 31.8% of UDS where prescribed drug was not detected 7.6% contained illicit drug R. Frei. Study: Potential Medication Misuse in Older Pain Patients. Pain Medicine News. Aug :1,16. Need for responsible opioid prescribing REMS Benefit vs. Risk assessment Point of care drug testing Use Prescription Monitoring Program (MAPS) Controlled substance agreements When to diagnose opioid use disorder and know about treatment options NMSAS, ATS, Harbor Hall, CHS, AA/NA Opioid Maintenance Treatment 2

3 Addiction Is a disease, not a choice. Common addictions Alcohol Nicotine Opioids Benzodiazepines Stimulants Cocaine Marijuana Overeating Change with DSM V (May 2013) New classification for addiction problems: Substance Use and Addictive Disorders Defines more clearly that addiction is a brain disease Potential to reduce guilt, shame, and stigma associated with addiction and promote treatment DSM V Substance Use Disorder Patient must meet at least 2 of 11 criteria for the diagnosis Mild 2-3 Moderate 4-5 Severe

4 DSM V Diagnostic Criteria 1. Continuing to use opioids despite negative personal consequences 2. Unable to carry out major obligations (work, school, home) 3. Recurrent use in physically hazardous situations 4. Continued use despite persistant or recurring social or interpersonal problems 5. Tolerance: more needed to achieve intoxication or desired effect, or markedly diminished effect with use of same amount 6. Withdrawl syndrome or substance used to prevent withdrawl 7. Using greater amounts or using over longer time period than intended 8. Persistant desire or unsuccessful efforts to cut down or control use 9. Spending a lot of time obtaining, using or recovering from using opioids 10. Stopping or reducing activities (social, occupational, recreational 11. Consistent use despite knowing harm or difficulties from using opioids 12. Craving or a strong desire to use opioids Risk Factors for Addiction Family Parents or siblings use Emotional, physical, or sexual abuse Adverse Childhood Experiences (ACE) questionnaire Environment Poverty, Peer group use; opioids considered #1 Gateway Drug (WHO document) Individual Anxiety, Depression, ADHD, Poor school performance, delinquency Clay SW: Risk Factors for Addiction. Osteopathic Family Physician (2010) 2, Risk Factor for Addiction: Sexual Abuse Systematic review shows history of child sexual abuse is a statistically significant riskfactor. Early traumatic experience may contribute to other forms of psychopathology (PTSD for example) that then increases risk of substance abuse. Maniglio R. The Role of Sexual Abuse in the Etiology of Substance Related Disorders. J Subst Abuse Treat 2011; 30:

5 General Categories at risk Chronic pain patients who end up misusing opioids Professionals: Doctors, Nurses, Pharmacists who have access to medications Recreational use of prescription drugs or use of illicit drugs. Treatment that works Counseling 12-step meetings (Mutual Self Help) Plus Medication Assistance History of Medication Assistance Treatment Harrison Act of 1918 Opioids cannot be prescribed to treat opioid addiction Methadone clinics started in 1972 Buprenorphine Maintenance treatment started in 2002 Also now have naltrexone (Revia or Vivetrol) 5

6 Drug Addiction Treatment Act of 2000 DATA 2000 permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act to treat opioid addiction with Schedule III, IV, and V opioid medications or combinations of such medications that have been specifically approved by the FDA for that indication. Such medications may be prescribed and dispensed. OBOT (or BMT) Office Based Opioid Treatment FDA approved the use of buprenorphine in the treatment of opioid dependence in Alternative to Methadone maintenance clinics Increase from 20,000 patients receiving buprenorphine in 2003 to 600,000 in As of 2014 there were 25,000 physicians with government waiver. Waivered Physicians Have XDEA number for buprenorphine Rx Only 12,000 out of 25,000 with waiver are treating patients. 7,000 have limit of 100 patients 5,000 have limit of 30 patients Max potential patients = 850,000 Potential to treat 17.7% of 4.8 million opioid abusers 6

7 Improve Community by Providing OBOT Reduce inappropriate prescribing Improve access for treatment Provide treatment for high-risk patients Decrease new cases of HIV or Hep C Improved quality of life for patients and their families Less driving all-over trying to score Opioid replacement plus counseling and/or 12-step programs allows patient to get their life in order Potential Barriers to Care for opioid use disorder Distance between home and clinic Between home and addiction counselor Lack of Motivation Not ready for change in behavior Stigma and discrimination against patients Lack of providers providing affordable care Insurance not covering medication No methadone clinic nearby Quality Improvement for Addiction Treatment The Institute of Medicine (IOM) has noted that health policy and reimbursement processes need to be improved. Improved outcomes will come more readily from improving the system than by trying to improve the skills of the practitioners. Chapter 31, Principles of Addiction Medicine, The Essentials

8 Medication-assisted treatment Buprenorphine maintenance treatment (BMT) review article Results: BMT indicated high level of evidence for its positive impact on treatment retention and illicit opioid use Less neonatal abstinence symptoms with BMT vs. MMT Buprenorphine maintenance treatment Conclusion: BMT is associated with improved outcomes compared with placebo for individuals and pregnant women with opioid use disorders. Psychiatric Serv, 2014 Feb 1; 65(2): Harm Reduction Approach Harm reduction benefits people who use drugs, their families and the community. Is not mutually exclusive of efforts to promote abstinence. Harm reduction reminds clinicians of the supreme importance of keeping drug users alive and avoiding irreversible damage. Chapter 30, Principles of Addiction Medicine, The Essentials

9 Cost Effective Treatment Opioid dependence treatment reduces illicit opioid use and its associated health and social costs. Estimated every $1 invested in opioid dependence treatment programs may yield a return of as much as $12 due to: Reduced drug-related crime, criminal justice costs Health care savings 2004 WHO/UNODC/UNAIDS position paper. Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention. NY Times Article, Aug 4, 2014 Dealing with opioid use would pay for itself. Modern view of opioid dependency is that it s akin to a chronic disease, like diabetes or HTN, which requires maintenance therapy Long-term treatment with methadone or buprenorphine Reduced spending on other types of healthcare Reduces hospitalizations and ED use Reduce social cost of disease Patient Treatment Agreement Review each item with patient. Need to get commitment from them to: Show up for all appointments Establish with or continue with substance abuse treatment program. Go to support group meetings: AA or NA Urine Drug Screens, pill counts. 9

10 Get a Thorough History Why now? In the patient s words document their motivations for starting treatment. Severity and duration of substance abuse. Environmental factors. Family life, work life, education and goals. Current or past involvement with the legal system. Buprenorphine formulations buprenorphine/naloxone sublingual tablet (8mg/2mg, 5.7/1.4, 2/0.5, 1.4/0.36) sublingual film (12mg/3mg, 8/2, 4/1, or 2/0.5) buccal film 4mg/1mg buprenorphine Sublingual tablet (8mg or 2mg) Pharmacology - buprenorphine Mechanism: binds to opioid receptors partial mu receptor agonist delta receptor agonist Kappa receptor antagonist Blocks dysphoria from kappa receptor activity Metabolism CYP450; 3A4 substrate Excretion bile/feces 68%, urine 27%; ½ life hours 10

11 Safety Ceiling effect Agonist effect increases linearly until moderate dose (16-32mg) and then reach a plateau. Higher dose unlikely to produce greater effect. Lower risk of fatal overdose than full agonist opiates. Effective treatment because Partial mu receptor agonist that can hinder priming for opiates (lack of tolerance build-up) Has greater affinity for receptors than other opioids Kappa receptor antagonistic properties that may improve dysphoric mood I feel normal again Easier induction than methadone Greater access for patients than methadone maintenance clinics Fareed A. Effect of Buprenorphine Dose on Treatment Outcome. J Subst Abuse Treat 2012; 31: BMT: Improving function Typical starting dose is 8-16mg buprenorphine daily. Proper treatment will greatly reduce cravings and provide emotional and physical relief in patients Allow for more meaningful participation in counseling program. Good prognosis: sober peer group; working 11

12 Gradual Dose Reduction Within 3-6 months, patient may be ready. Within 9-12 months, solid recovery can be reality and dose often 8-12mg daily. Meds to help reduce withdrawl Catapres, vistaril, valium Be aware of risk of failed dose reduction. Long Term Treatment Consider for patient who prior to treatment has: Suffered an overdose Potential for loss of family, work, career if relapse occurs Previous Incarceration for narcotic related offenses Opioid use of long duration and previous failed abstinence based treatment(s). Typical dose 2-12mg daily. Mental Health Parity and Addiction Equity Act of "No state legislature would put a time limit on medications for any other chronic disease, such as diabetes or hypertension," said ASAM President Stuart Gitlow, MD. "Yet there is a patchwork of such policies across the country on addiction medications. Example: MDCH policy: 12 month limit on buprenorphine maintenance treatment. Record Eagle Forum Article, May

13 Healing The Addicted Brain By.Harold Urschel, MD (2009) Recommend this book to your patients, to your colleagues. Other resources: Principles of Addiction Medicine: The Essentials B, 29 year old pregnant female Seen first in October 2011 Lives about 70 miles from clinic 13 weeks pregnant IV Morphine 5 days ago Prescribed opiates for back pain from 2002 to 2009 Severe cravings Always worried about slipping up. Ashamed about track marks (admits to sometimes shooting up water due to cravings) Wants to be able to provide stable home for her children and her fiancee PMH Hepatitis C FH: F-alcoholic; sister: opioid abuse Social smokes 1ppd; works as a waitress; on probation now (was in jail for 9 months, got out 5 months ago.) 13

14 Early Remission After 1 week Going for weekly counseling sessions and weekly NA meetings Taking buprenorphine 8mg bid. Has cravings when at work. UDS at court was positive for opiates; UDS in my office +only for buprenorphine Recovery After 6 weeks Happy to be sober. Brighter affect and more confident. Feels stable with 12mg daily. Had increase cravings after an argument with her fiancee last week. Talking with her sponsor helped. Working full-time. Success through pregnancy At 37 weeks. OB visits going well. Denies cravings with 6mg daily dose. For about 6 months after delivery of healthy baby girl she had regular follow-up and consistent drug screens. I last saw her in the Fall of Had probation violation and went to jail and has not shown up for appointment at my new office. 14

15 B, 29 year old male Seen first in July Mis-use of opiates for about 15 years. First use at age 14 with a friend (who took oxycodone from parent) Multiple rehabs, relapses. Was on methadone program in the past More History Self-employed, tattoo artist Has lived in Las Vegas, Minneapolis, and now in rural Northern Michigan Family history for addiction: PGF with alcoholism Knows many people who have overdosed Getting started Suboxone 8/2 film 1 daily mostly eliminated cravings and allows for stable mood Supportive girlfriend and family Better adherence to 12-step program starts to pay dividends within a couple of months Appointments every two weeks for first 2 months, then monthly 15

16 Recovery Early recovery from opioid use 6 months into treatment: Still smoking marijuana and occasional beer Started reading Healing the Addicted Brain in March 2013 Still misses faster pace of life in bigger city June : last drink and off marijuana Long-term recovery Keeping busy with work. Better income and better quality of work. Now on zubsolv ½ tab daily; appointment every 2 months. Thank You Experience keeps a dear school, but fools will learn in no other Ben Franklin 16