6/8/2018. Primary Care Providers Can Treat Opioid Use Disorder and Help End the Epidemic. Disclosures. Outline
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1 Primary Care Providers Can Treat Opioid Use Disorder and Help End the Epidemic Adam Bisaga M.D. Division on Substance Use Disorders, Department of Psychiatry New York State Psychiatric Institute, New York, USA International Conference on Opioids, Boston, June 12, 2018 Disclosures Unpaid consultancy (Alkermes, Braeburn, Go-Medical) PI on research studies funded by Alkermes Royalties from the book Overcoming Opioid Addiction Outline Epidemic Opioid Use Disorder (OUD): Treatment OUD as a chronic brain disorder Treatment initiation Treating OUD in general medical setting Supporting providers 1
2 EPIDEMIC: OPIOID USE DISORDER OPIOID OVERDOSE DEATHS Emma: 35 year old female comes to ER with painful arm Emma presents with an abscess on her forearm and warm painful joints. She reports 6 months of IV heroin use but her urine positive only for fentanyl and THC. She is diagnosed with venous abscess, is admitted to the unit to undergo septicemia w/u. Once on the unit Emma becomes agitated, she has HR of 110 and dilated pupils. She complains of severe abdominal and muscle pain and requests opioids. What do you do? c/o Dr. John Sherman, St. Kilda Medical Centre 1. Prescribe hydromorphone with a plan to continue it for few days knowing this will immediately stabilize the patient 2. Put her on methadone taper with a plan to refer her to a residential program that offers 12-step based treatment but no addiction medications 3. Initiate treatment with buprenorphine 4. Treat w/d symptomatically with clonidine, clonazepam, NSAIDs for 5-7 days to w/d resolution and administer long-acting naltrexone Opioid epidemics across time Heroin Painkillers smoked opium morphine opium (West) heroin (East) morphine 1955 heroin inner-city painkillers 1975 inner-city young whites Vets painkillers 600k 1995 inner-city injectors, chic sniffers 2,000k 150k painkillers (CDC) (Courtwright, Dark Paradise, 2001) 2
3 TREATMENT Working with OUD patients What are providers reactions when they encounter patients with addiction in the medical setting? Sympathy/Compassion Contempt Anger Prejudice Therapeutic pessimism How these reactions are similar or different from encountering patients with other chronic psychiatric disorders? And why? When discussing the case of Emma, the hospital staff will undoubtedly treat the underlying cause of the abscess, the infection But are they equally likely to treat the real underlying cause, the opioid addiction? Would they think that addiction should be treated outside of the medical setting? How did we get here? Current addiction treatment system is primarily non-medical Traditional view of addiction as moral weakness and a character problem Public safety problem, to be dealt with through laws and punishments Addiction Treatment Programs focusing on correcting the behavior and character problems Medical attention was given only during detoxification, before the real treatment could start, done by peer counsellors Little need for physicians, medications, and modern healthcare Physicians were neither trained for, nor particularly eager to accept patients with addictions Most healthcare organizations eliminated addiction treatment Most medical training programs eliminated addiction education Very little has changed in the past 50 years The advances in treating other diseases did not occur in the segregated ATS 3
4 Treatment of OUD Most effective treatment for OUD involves a combination of several approaches: Pharmacological Treatment (MAT) involves use of medications in combination with intervention to increase adherence to medications Psychosocial/behavioral approach focused on helping patients develop skills necessary to maintain abstinence Self Help/Mutual Help support groups form social network supportive of recovery Recovery-oriented activities help patients develop satisfying lives Treatment of OUD should involve medication Traditional (non-medical) model of psychosocial treatment involves detoxification followed by treatment without medications: It has very high failure rate (>90% in 3 months) and therefore it should not be used as a first-line approach Moreover, detoxification without medications to prevent relapse increases the risk of overdose due to the loss of tolerance Kakko et al., 2003 D/B controlled trial of buprenorphine vs placebo All patients received intensive relapse prevention therapy/monitoring Number remaining in treatment % died 25% OPI + UTOX Time from randomization (days) FDA-approved Medication for OUD Methadone Full Agonist Buprenorphine Partial Agonist XR-Naltrexone Antagonist μ OR μ OR μ OR 4
5 FDA-approved Medications: AGONISTS METHADONE, BUPRENORPHINE Constant stimulation of opioid receptors stabilizes system s functioning Prevents withdrawal, relieves craving, stabilizes affect, minimizes pathological brain responses, blocks effects of other opioids By reducing drug-seeking, provides opportunity for the patient to begin changing their behavior and address other problems Limitations Regulatory oversight (less for BUP) Potential for side-effects (BUP has ceiling effect and is safer than MET) Risk of misuse and diversion Agonist-based Treatment Effectiveness Agonists reduce heroin use and improve treatment retention Reduction in opioid use by 10 days/month compared to no medication Treatment retention at 6 months: Methadone 75%, Buprenorphine 50% Better results are seen with longer duration of treatment Leaving treatment increases risk of OD death Opioid Use Treatment Retention Hser et al., 2016 FDA-approved Medications: ANTAGONIST NALTREXONE Limitations Prevents activation of opioid receptors stabilizes system s functioning Blocks effects of exogenous opioids and re-development of physical dependence, relieves craving, stabilizes affect Can only be administered after opioids are stopped and opioid withdrawal resolves (no physical dependence) 5
6 Antagonist-based Treatment Effectiveness XR-naltrexone reduce heroin use and improves treatment retention Treatment retention at 6 months after the 1 st injection: 50-60% Better results are seen with longer duration of treatment Treatment Retention Comparative effectiveness of buprenorphine vs. XR-naltrexone Two recent controlled studies: multi-site, community-based (Norway N=232, US N=570) More difficult to initiate treatment with XR-naltrexone (72% vs 94% success) BUP and XR-naltrexone were equally safe and effective in reducing relapse/craving TX RETENTION TX RETENTION CRAVING CRAVING (Tanum et al., 2017) (Lee et al., 2018) OUD: A CHRONIC BRAIN DISORDER 6
7 OUD: a Chronic Brain Disorder Addiction is an acquired bio-behavioral disorder affecting mood, cognition and decision-making abnormal reactivity to stress and environmental cues overwhelming craving impaired insight and the impaired ability to care for self chronic and relapsing course and highest mortality of all psych. disorders Facing Addiction in America, The Surgeon General s Report 2016 Disease Course Opioid Use Disorder (OUD) is a chronic condition The risk of symptom recurrence/relapse persist for many years Periods of symptom remission/exacerbation should be expected Recognizing the chronicity and the relapsing course of the disorder, that may occur even despite the treatment, should not imply that the treatment is ineffective and therefore useless One should not expect a cure after a one-time treatment episode However, the sustained remission (recovery) can occur (30-40% of patients), despite prior history of relapses Disease Course and Long-term Management Long-term management rather than repeated episodes of acute treatment Post-stabilization monitoring, education, link to community supports Medical/psychosocial/environmental interventions over a lifetime with intensity matching the severity of symptoms Frequent checkups to monitor stability/adjust medications Treating consequences and minimizing risk factors Helping patient develop self-monitoring/self-care strategies 7
8 Disease Course and Medications Relapse carries a significant risk of overdose and death, Treatment with agonist medications reduces the risk of death 2-3 fold The longer the patient remains on the medication, the better chance of benefiting from treatment It is not known if there is a duration of MAT that would eliminate the risk of relapse The risk of relapse should always be considered to be greater once the medication is stopped A decision to discontinue medications after a period of successful treatment should occur only after a careful discussion of risks between the clinician and the patient OUD Treatment Goals Treatment goals should be individualized Patient-centered of illicit opioid use Patient-directed Preventing Death Minimization of harms from use Abstinence from illicit opioids Primary goals Cessation of illicit opioid use Protection against risk of OD and death Improvement in physical and psychological health Abstinence from all substances Improved quality of life Sustained Recovery The ultimate goal is to maintain long-term and stable remission of symptoms and improvement in well-being (building strengths - recovery) Whether medications are necessary to achieve this goal is less relevant TREATMENT INITIATION 8
9 How to discuss MAT with the patient All patients should be educated about the chronic nature of the disorder and the need for long-term treatment Physician should discuss all available treatment options (shared decision making) Residential programs vs. office-based treatment vs. OTP Explain difference between medications Risks of treatment without medications Assess patient s motivation for treatment, goals, and preferences for any particular medication before a final recommendation When available involve a family member or a significant other First line of treatment: buprenorphine or methadone or XR-naltrexone Opioid Dependent Patients who are NOT Physically Dependent MAT: TREATMENT ALGORITHM Returning to High Risk Environment Increased stress Persistent Craving YES NO Relapse Prevention CBT Support Groups NALTREXONE PO or XR NALTREXONE XR BUPRENORPHINE Relapse Prevention CBT Support Groups MAT: TREATMENT ALGORITHM Patients who are actively using Abstinence Induction Using AGONIST Opioid withdrawal and Relapse Prevention Using ANTAGONIST METHADONE STABILIZATION BUPRENORPHINE STABILIZATION NALTREXONE XR STABILIZATION Response Response Response Yes Yes Yes METHADONE MAINTENANCE BUPRENORPHINE MAINTENANCE NALTREXONE XR MAINTENANCE 9
10 CHOOSING AGONIST VS. ANTAGONIST BASED TREATMENT METHADONE or BUPRENORPHINE XR-NALTREXONE Before starting treatment Detoxification is not needed Detoxification and a washout period are required in active users Delay Minimal delay 0-2 weeks before starting treatment Physical dependence Adherence with the medication Effect on craving/use Effect on preventing overdose Patients remain physically dependent, withdrawal symptoms if a dose is delayed or missed Improved, because patients may experience physical discomfort if the dose is delayed Decreased craving and opioid use After detoxification, patients are no longer physically dependent - no opioid withdrawal if dose is missed There is no discomfort if the dose is delayed, and patients may be more likely to stop medication prematurely Patients who are adherent with treatment are protected against overdose Increased risk of overdose after treatment dropout and stopping medication CHOOSING AGONIST VS. ANTAGONIST BASED TREATMENT (2) Potential for misuse Overdose risk Side effects Treatment of pain Opposition to treatment Availability METHADONE or BUPRENORPHINE Can be abused and diverted Methadone during induction Both when combined with sedatives (Early) Sedation, dizziness (Late) Constipation, excessive sweating Opioid painkillers can be used Stigma against methadone, limited acceptance in traditional treatment settings Barriers to availability of agonists in criminal justice system XR-NALTREXONE None None Insomnia, diarrhea, low energy, anxiety headache, depression, inj site reactions Usual doses of opioids not effective, specialist pain treatment Less stigma against in traditional treatment settings Few programs offer OUD TREATMENT: NEW PARADIGM 10
11 OUD treatment paradigm changes Chronic disorder model: different levels of care, medications, additional treatments needed over time Detox no longer a primary treatment, phasing-out detox units to become medicationinduction units Shift away from residential treatment towards long-term outpatient treatment Focus on offering patient choice of medication: methadone vs. buprenorphine vs XRnaltrexone Staged treatment: methadone buprenorphine XR-naltrexone Extended-release preparations to overcome nonadherence, the major challenge in medication treatment Expanding of care models (from low-threshold to comprehensive) Acceptance of other measures of treatment success than complete abstinence: harmreduction framework Incorporating recovery framework (peer advocates, community engagement) TREATING OUD IN GENERAL MEDICAL SETTINGS Emma: 35 year old female with OUD Once on the unit Emma becomes agitated, she has severe abdominal and muscle pain, dilated pupils, and she requests opioids. What do you do? 1. Prescribe hydromorphone with a plan to continue it for few days knowing this will immediately stabilize the patient 2. Put her on methadone taper with a plan to refer her to a residential program that offers 12- step based treatment but no medications 3. Initiate treatment with buprenorphine 4. Treat w/d symptomatically with clonidine, clonazepam, NSAIDs for 5-7 days to w/d resolution and administer long-acting naltrexone She was started on I.V. antibiotic and buprenorphine (BUP) 2 mg SL BUP was gradually increased to 16 mg on Day 2, she was no longer in withdrawal but she continued to have craving. BUP dose was increased to 24 mg on day 3, and the craving gradually subsided Emma s mood improved significantly, she became pleasant and cooperative with medical treatment and was open to considering continuing with BUP once she leaves the hospital. However, she was found to be infected with HIV. Where should she be treated? 11
12 OUD Treatment Gap Few of the 2.5 million individuals with OUD gain access to the fragmented drug treatment system Among those who receive care, most do not receive evidence based medical treatment In contrast to individuals who suffer from most other chronic disorders Most patients with OUD do not have access to treatment in their community Only 2-3% of physicians offer buprenorphine (90% in urban setting) Half of the counties do not have buprenorphine provider, only 1,500 OTPs (also urban) Less than 5% of treated OUD patients receive XR-naltrexone Very few programs offer all 3 FDA medications even though it is required by the law We need help from Primary Care providers In EU countries that overcame epidemics, help came from PC providers In France, >20% of physicians treat OUD, and >60% of patients are on medications (80% in Switzerland) OUD Treatment Gap (2) % Treatment Programs Offering FDA-approved SUD medications (Knudsen et al.,. 2011) (Jones et al.,. 2015) OUD Cascade of Care Treatment Gap (% not receiving) Opioid.amfAR.org (Williams et al., 2017) Lessons from Europe In major European countries drug overdose deaths were brought down since the peak of epidemics Switzerland (down by 2/3 rd from the height in early 1990 s), Portugal (down 75% since 2001) In France (1/5 th of US population) only 350 people die per year Most of Europe has expanded access to the medical model of treatment that include methadone or buprenorphine and services for drug users Possible by destigmatizing addiction which has helped attract physicians (family doctors and non-specialists) to treating opioid-addicted individuals Portugal decriminalized drug use and redirected money from policing to treatment Heroin users are not arrested but evaluated by physician/social worker Community outreach teams provide HR education and linkage to treatment Heroin use is seen as a health rather than a criminal issue Studies done in France show that primary care doctors treating opioid addiction with medications have similar outcomes to addiction specialists 12
13 Can OUD be treated in Primary Care? Primary Care is care is usually the first and often the only contact that these patients with have with medical providers Interventions delivered by non-specialists can be effective and sufficient, without need for referral to addiction specialists Potential benefits of providing addiction care in the Primary Care setting De-stigmatizing of the disorder Increased access to treatment Improved treatment engagement and adherence Better clinical and functional outcomes Increased patient satisfaction Decrease in overall healthcare costs Many benefits from MAT in primary care setting Expanding agonist treatment decreased heroin OD deaths (Baltimore ) Methadone promotes initiation of ART in patients with IVDU (Schwartz et al.,. 2013) (Uhlmann et al.,. 2010) Innovative Treatment Models involving Primary Care Hub and Spoke (Vermont) Collaborative Care Model (Massachusetts) Collaborative Opioid Prescribing (Co-OP) Model (Baltimore) Office-Based Opioid Treatment (OBOT) (Yale) Buprenorphine HIV Evaluation and Support (BHIVES) Collaborative Model One Stop Shop Model Project Extension for Community Healthcare Outcomes (ECHO) Medicaid Home Model for Those With OUD Southern Oregon Model Emergency Department Initiation of OBOT Inpatient Initiation of MAT Integrated Prenatal Care and MAT (Korthuis et al., 2017) 13
14 Participation in Opioid Agonist Treatment at 12 months (%) 6/8/2018 Integrated Health System for Addictions Treatment (VT) The established relationships between the hub and spokes promotes coordination and integration (warm handoff), including consultation with the hubs and transfer of care back to the hub as needed (VT Dept Health) Initiation of buprenorphine in ID Clinic 80 PATIENTS WITH OUD AND HIV Clinic-based BUP Referred to Tx (Lucas et al.,. 2010) MODELS FOR IMPLEMENTING OUD TREATMENT IN GENERAL MEDICAL SETTING 14
15 OUD treatment in general hospital Emergency Room SBIRT Treatment on Demand (Post OD Treatment; OUD Urgent Care) OD Prevention Training (Narcan) Hospital admissions SBIRT followed by Interim MAT All house staff and hospitalists trained in MAT OD Prevention Training on discharge Psychiatry/Addiction Consultation-Liason Service Case finding Assist house staff in MAT initiation Assist in management of complex cases (detox): polysubstance, cooccurring OUD treatment in general hospital Outpatient Services Case finding followed by referral to OUD clinic OUD Clinic Treatment of OUD (buprenorphine, XR-naltrexone) Coordinating care with other services Psychiatry Primary Care Pain Service Obstetric (NAS, pregnancy/postpartum) Adolescent medicine Infectious Disease Hospital-based Opioid Treatment Program (OTP) OUD Treatment Hub Treatment with all medications (methadone, BUP, XR-naltrexone) Treatment of complex cases Case-managed chronic care model Training and support of providers and volunteers (peers) Harm reduction services Telemedicine - providing MAT in rural communities SUPPORTING PROVIDERS 15
16 pcssnow.org 16
NALTREXONE DAVID CRABTREE, MD, MPH UNIVERSITY OF UTAH HEALTH, 2018
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