An Introduction to. Medication Assisted Treatment OBJECTIVES TOPICS TO COVER OPIATE EPIDEMIC OPIATE EPIDEMIC 5/11/2016

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1 MISSY HENKE, MD MEDICAL DIRECTOR, HEARTVIEW FOUNDATION MAY 13, 2016 An Introduction to Medication Assisted Treatment OBJECTIVES TOPICS TO COVER Upon completion of this presentation, the participant will be able to: Identify the benefits of medication assisted treatment to the patient and the community Understand state and federal regulations governing opiate treatment programs Understand the scope of the opiate epidemic in our community Opiate Epidemic Addiction as a disease Medication Assisted Treatment Methadone Buprenorphine Naloxone Good Samaritan Laws Though the United States represents only 5% of the world s population we consume % of the world s prescription painkillers Since 1999, Opiate overdose deaths in this country have A. Doubled B. Tripled C. Quadrupled D. Remained unchanged 1

2 CDC statistics 1 in 20 people in the US ages 12 or older reported using prescription painkillers for nonmedical reasons in the past year Every day 1000 people are treated in Emergency Departments for misusing opiates Enough prescription painkillers were prescribed in 2012 for every adult in this country to have their own bottle of pills 259 million scripts In 2014 almost 2 million Americans abused or were dependent on opiates One out of every three (32%) opioid prescriptions is being abused Baby boomers are four times as likely to abuse opioids as Millennials Individuals living in America s lowest income areas as twice as likely to abuse opioids as those living in the highest income areas - NORTH DAKOTA New data lists top cities of opioid abuse (by percentage of prescriptions abused) Bismarck? In North Dakota ,000 scripts for opiates Increased to 1,493,000 in 2015 Top prescriber wrote more than 1900 scripts in one quarter Castlight Health study April 2016 Prescription Drug Monitoring Program data In 2009 was the first time that drugs have caused more deaths than motor vehicle accidents since the government started tracking drug-related deaths in 1979 Trend has continued every year since 2009 Heller School for Social Policy and Management 2

3 16,000 people die every year from prescription opiate overdoses (4,000 in the year 2000) Compared to 10,000 gun homicides Approximately one person dies every 30 minutes 42 people died in North Dakota in 2014 of documented opiate overdose CDC Data Deaths from prescription painkiller overdoses among women increased more than 400% during 1999 to 2010 compared to 237% among men Nationally more overdose deaths are caused by prescription drugs than all illegal drugs combined DISEASE OR MORAL PROBLEM Middle-aged adults have the highest rates of painkiller overdose People in rural counties are nearly twice as likely to overdose on painkillers as people in urban areas American Indian or Alaska Natives are more likely to overdose on painkillers 1 in 10 aged 12 or older used prescription painkillers for nonmedical reasons in the past year, compared to 1 in 20 whites and 1 in 30 blacks Addiction is similar to other chronic medical problems Treatment can remove or reduce the symptoms but does not affect the root cause of the disease Treatment requires significant changes in lifestyle and behavior on the part of the patient to maximize the benefit Relapses are likely and they serve as a trigger for renewed intervention Treatment should involve regular monitoring of medication adherence as well as encouragement and support of pro-health changes in lifestyle 3

4 CHRONIC DISEASE ADDICTION DOES NOT DISCRIMINATE McClellan et al OUT OF CURIOSITY OUT OF CURIOSITY If addiction is a medical problem, why is it managed by the legal system rather than the medical system? Less than % of non-incarcerated people with substance use disorders receive evidence-based care Of the 2.3 million inmates in our prisons and jails, 1.5 million meet the DSM-IV criteria for substance abuse or addiction and another 458,000 had histories of substance abuse Only 11% of all inmates with substance abuse and addiction disorders receive any treatment during their incarceration Source: CASA's 2009 Shoveling Up II: The Impact of Substance Abuse on Federal, State and Local Budgets report MEDICATION ASSISTED TREATMENT MEDICATION ASSISTED TREATMENT Has been shown to Evidence-based practice that combines pharmacological interventions with substance abuse counseling and social support Improve survival Increase retention in treatment Decrease illicit drug use Decrease hepatitis and HIV seroconversion Decrease criminal activities Increase employment Improve birth outcomes for babies born to opiate-dependent mothers 4

5 MEDICATION ASSISTED TREATMENT Methadone Buprenorphine (Subutex) Buprenorphine/Naloxone (Suboxone, Zubsolv) Naltrexone (Revia, Vivitrol) Naloxone (Narcan) Methadone gold standard for MAT with opiates Only available thru Opiate Treatment Program (OTP) Federally regulated State regulated OTPs in 48 states (not North Dakota or Wyoming) 2013 legislative session in ND, OTPs were approved 3 companies applied for licensure in West Fargo/Bismarck (Premier) and Minot/Mandan (Community Medical Services), Bismarck (Heartview Foundation) 83% of patients will not be using heroin within one year of treatment and with 4.5 years of treatment 92% of patients will not be using heroin 71-94% reduction in criminal behaviors, with the greatest reductions observed in patients that remained in methadone maintenance over 6 years % reduction in risk of HIV infection Treatment facilities are NOT associated with increased crime rates Treatment facilities are cost effective Good outcomes are contingent on length of treatment Patients who stay in MAT with methadone for less than three months usually show little or no continued improvement % of people who leave methadone treatment and pursue no additional treatment will relapse SOURCES: Ball & Ross 1991, Condelli & Dunteman 1993 et al, Sullivan et al 2004, N-SSATS 2011 Highlights, Condelli et al 1993, Hser et al 2001, McGlothlin et al 1981, Boyd et al 2012 Methadone Full mu agonist Long-acting synthetic opiate so can be dosed once daily (half life 8-59 hours) Higher doses are more effective at reducing heroin use usually mg daily Associated with overdose fatalities and cardiac arrhythmias Take home dosages 8 federal regulations that must be met before someone can have take home dosages No recent drug or alcohol abuse Regular OTP attendance No behavior problems at OTP No recent criminal activity Stable home environment and social relationships Acceptable length of time in treatment Assurance of safe storage of take home medications Determination that rehabilitative benefits of decreased OTP attendance outweigh potential risk of diversion 5

6 BUPRENORPHINE Take home dosages 1 st 90 days 1 dose/wk 2 nd 90 days 2 doses/wk 3 rd 90 days 4 doses/wk 4 th 90 days - 6 doses/wk but must report once per week After 1 year up to 14 doses but must report twice/month After 2 years up to 31 doses but must report monthly Buprenorphine Approved by FDA for treatment of opiate dependence in October 2002 Opioid partial agonist able to suppress withdrawal symptoms and less likely to cause euphoric high or lead to death by overdose Lower risk of abuse, addiction and side effects Administered sublingually No evidence of organ damage Office-based practice (do not need OTP) BUPRENORPHINE BUPRENORPHINE Buprenorphine Regulated by FDA Physicians (not mid-level practitioners) must take an 8 hour educational course in how to use the medication and then apply for a waiver from the DEA If approved, the physician will receive an XDEA number Limited to 30 patients at a time for the first year then apply for new waiver If approved, can prescribe for 100 patients at a time after that Subdermal implant (Probuphine) Phase III clinical trial is being conducted now and may be commercially available in 2016 Provides 6 months of medication Has demonstrated superiority to placebo implants and established non-inferiority to Suboxone Was rejected by the FDA in 2013 and again in February 2016 NALTREXONE NALTREXONE Oral Naltrexone (Revia) Mu antagonist Must be taken daily to be effective daily dose of 50 mg If opiates are in the patient s system, Naltrexone will immediately produce opiate withdrawal. May cause liver injury in high dosages and is contraindicated in patients with liver failure or acute hepatitis Black Box Warning Compliance is an issue IM Naltrexone (Vivitrol) Intramuscular shot given every 28 days Blocks the effects of narcotic medications and alcohol. Well tolerated FDA removed black-box warning found with oral naltrexone Expensive - $ /shot Covered by Medicaid, Medicaid Expansion, BC/BS of most states and Sanford 6

7 NALOXONE NALOXONE Available in community-based programs since 1996 As of June 2014 there were at least 644 local, community-based opiate overdose prevention programs in the United States to provide Naloxone to laypeople These programs reported 26,463 drug overdose reversals using Naloxone Safe, no side effects, inexpensive Can be given IV, SQ, IM, IN, IO As of July 15, 2015, 40 states (including ND) and the District of Columbia have amended their laws to make it easier for medical professionals to prescribe and dispense Naloxone In ND, the Board of Pharmacy rewrote the administrative rules last month and now pharmacists can prescribe Narcan without a prescription from a physician. Physicians in every state can prescribe naloxone Intranasal naloxone was recently FDA approved Source: Harm Reduction Coalition NALOXONE GOOD SAMARITAN LAWS Naloxone program in Massachusetts trained 2,900 potential bystanders Death rates from opioid overdose were reduced in communities where overdose education and naloxone distribution was implemented compared with not implemented This provides observational evidence that an overdose education and nasal naloxone distribution program is an effective public health intervention to address the epidemic of fatal opioid overdose 31 states (including ND) and the District of Columbia have laws in place to encourage people to seek aid in the event of an overdose In ND, up to three people will be granted immunity from prosecution for possession and ingestion if they seek emergency services and stay to provide information to law enforcement Walley et al 2013 TAKE HOME POINTS TAKE HOME POINTS Addiction is a chronic disease of the brain which benefits from long-term treatment Opiate addiction is increasing in our communities Opiate Treatment Programs are heavily regulated at both the state and federal level Medication Assisted Treatment includes Methadone, Buprenorphine, Naltrexone and Naloxone Medication Assisted Treatment is a positive tool in the fight against opiate addiction and overdose deaths Naloxone is underutilized Opiate Treatment Programs are coming to our community 7