Opiate Use Disorder and Opiate Overdose

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Opiate Use Disorder and Opiate Overdose Irene Ortiz, MD Medical Director Molina Healthcare of New Mexico and South Carolina Clinical Professor University of New Mexico School of Medicine Objectives DSM-5 Diagnosis of Opiate Use Disorder Psychological and physical vulnerabilities Prescriber role in addiction Pharmacists and pharmacy technician clinical opportunities in opiate dependence June 26, 2016 2 DSM-IV Diagnosis Substance abuse and substance dependence are not combined as substance use disorder Recurrent legal problems was dropped Craving or strong desire has been added 3 4 DSM-5 Opioid Disorder Opioid Use Disorder Opioid Intoxication Opioid Withdrawal Other Opioid-Induced Disorders DSM-5 Opiate Use Disorder Diagnostic Criteria 1A problematic pattern of opioid use leading to clinically significant impairment or distress, as manifested by at least two of the following, occurring within a 12-month period: 1 Opioids are often taken in larger amounts or over a longer period than was intended 2 There is a persistent desire or unsuccessful efforts to cut down or control opioid use 3 A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects 4 Craving, or a strong desire or urge to use opioids 5 Recurrent opioid use resulting in a failure to fulfill major role obligations at work, school, or home 6 Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids 5 6 1

DSM-5 7 Recurrent opioid use in situations in which it is physically hazardous 8 Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance 9 Tolerance, as defined by either of the following: 1 A need for markedly increased amounts of opioids to achieve intoxication or desired effect 2 A markedly diminished effect with continued use of the same amount of an opioid (Note: This criterion is not considered to be met for those taking opioids solely under appropriate medical supervision) 10 Withdrawal, as manifested by either of the following: 1 The characteristic opioid withdrawal syndrome 2 Opioids (or a closely related substance) are taken to relieve or avoid withdrawal symptoms (Note: This criterion is not considered to be met for those individuals taking opioids solely under appropriate medical supervision) DSM-5 Mild: 2-3 criteria Moderate: 4-5 criteria Severe: 6 or more criteria 7 8 Location of Mu-Opioid Receptors Opioid Abuse in Chronic Pain Misconceptions and Mitigation Strategies Nora D Volkow, MD, and A Thomas McLellan, PhD N Engl J Med 2016; 374:1253-1263 March 31, 2016 http://wwwnejmorg/doi/full/101056/nejmra1507771#t=article 9 Volkow ND, McLellan AT N Engl J Med 2016;374:1253-1263 Opioid Use Opioid 12 2

Tolerance and Physical Dependence Opiate Use to Abuse Tolerance = decrease in opioid potency over time Physical dependence = increased higher dose is needed to maintain the initial level of analgesia opiates opiates opiates Misconceptions Risks for Addiction Addiction is the same as physical dependence and tolerance Addiction is simply a set of bad choices Pain protects patients from their addiction to opioid medication Only long-term use of certain opioids produces addiction Only patients with certain characteristics are vulnerable to addiction Medication assisted therapies are just substitutes for heroin or opiates Medication Risks Daily dose greater than 100 MME (morphine mg equiv) Long-term use greater than 3 months Patient-related Risks Depression Substance Use Disorder including alcohol Adolescence Volkow ND, McLellan AT N Engl J Med 2016;374:1253-1263 Volkow ND, McLellan AT N Engl J Med 2016;374:1253-1263 15 16 Risks for Overdose Medication Risks Long-acting extended formulations, ie morphine, fentanyl Combination with benzodiazepines Two weeks after initiation of long-acting or extended-release formulations Daily dose greater than 100 MME (morphine mg equiv) Long-term use greater than 3 months Patient-related Risks Age greater than 65 Sleep disordered breathing Renal or hepatic disease History of overdose Depression Substance Use Disorder including alcohol Mitigation Strategies Rewarding effects of opiates contributes to the risk of diversion, overdose and addiction Restricting the type of opioid prescribed, selecting patient type does not eliminate risks 17 Volkow ND, McLellan AT N Engl J Med 2016;374:1253-1263 3

Mitigation Strategies Michael Botticelli, US Drug Czar People hear heroin, and they become very, very, very scared This epidemic is really being driven by prescription medication Volkow ND, McLellan AT N Engl J Med 2016;374:1253-1263 DETERMINING WHEN TO INITIATE OR CONTINUE OPIOIDS FOR CHRONIC PAIN 1 Nonpharmacologic treatment and nonopioid pharmacologic treatments are preferred for chronic pain Opioids are not a first-line option and should be combined with nonpharmacologic therapy and nonopioid medications if appropriate 2 Treatment goals should be established with all patients when initiating therapy Continuation of opioid treatment should occur only if improvement in pain and/or function continues to outweigh the risks of the treatment 3 Discussion of the risks and realistic benefits of opioid therapy should occur with patients at initiation and during the treatment course CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016 MMWR Recomm Rep 2016;65(No RR-1):1-50 OPIOID SELECTION, DOSAGE, DURATION, AND DISCONTINUATION 4 When starting opioid therapy for chronic pain immediate-release opioids should be used initially Extended-release/long-acting opioids are associated with a higher risk of overdose when treatment is initiated with these; therefore, extended-release/long-acting opioids should be used only for patients with severe, continuous pain and only after a patient has received immediate-release opioids for at least 1 week 5 Opioids should be prescribed at the lowest effective dose Avoid dosages greater than 90-mg morphine equivalents per day, (60 mg oxycodone) and exercise caution at doses greater than 50-mg morphine equivalents per day (35 mg oxycodone) 6 Because most chronic pain is initially treated as acute pain, when treating acute pain be sure to use the lowest dose, and prescribe only the amount anticipated to be required for the acute injury/complaint Prescriptions of longer than 7 days for acute pain are usually not necessary OPIOID SELECTION, DOSAGE, DURATION, AND DISCONTINUATION 7 Evaluate the benefits and harms of opioid prescription within 1-4 weeks of initiation or dose escalation Always consider tapering or discontinuation if goals are not being met 8 Evaluate risk factors for opioid-related harms both when initiating medications and periodically during treatment Risk factors include a history of substance use disorder, high opioid doses, or benzodiazepine use ASSESSING RISK AND ADDRESSING HARMS OF OPIOID USE 9 Review patients prescription drug monitoring program to help determine the risk for overdose Intervals of review may range from when each prescription is given to every 3 months 10 Utilize urine drug screening when initiating medication and periodically (at least annually) Discuss all unexpected results with the lab, patient, and possibly toxicologist Repeatedly negative urine drug screens indicate the patient is not taking a prescribed opioid, and therefore medication can be discontinued without a taper 11 Avoid prescribing a benzodiazepine and opioids concurrently because of a higher risk of fatal overdose 12 Arrange treatment for patients with opioid-use disorder such as referral to a medication-assisted treatment center for buprenorphine or methadone treatment 4

SPECIAL POPULATIONS Patients with sleep-disordered breathing Any patient with moderateto-severe sleep-disordered breathing, including sleep apnea, should avoid opioids if possible Pregnant women and reproductive age women Patients older than 65 Because of decreasing renal function, this population is at risk for the accumulation of opioids and may be unable to tolerate nonopioid pharmacologic therapy such as NSAIDs as a result of comorbidities When opioids are necessary, the recommendations indicate a need for fall risk assessment, monitoring for cognitive impairment, and an appropriate bowel regimen Patients with mental health conditions These patients pose a high risk for overdose both because of polypharmacy, specifically benzodiazepine use, and mental instability Patients with substance use disorders Those who use illicit substances contribute to a significant proportion of deaths related to opioid use Medication Assisted Treatment =Medication combined with behavioral therapy Opiate Agonist Methadone Buprenorphine Implant approved by FDA in May, 2016 Opiate Antagonist Naltrexone (immediate, extended release) MAT Behavioral Therapies, Federal requirement that Medication Assisted Treatment (MAT) contain counseling programs which can include the following: Individual and group counseling Inpatient and residential treatment Intensive outpatient treatment Partial hospital programs Case or care management Recovery support services 12-Step fellowship Peer supports Harm Reduction Public health strategy for substance abusers for whom abstinence is not possible Examples Medication Assisted Therapies Low-threshold pharmacologic interventions not related to drug-free programs but to immediate health protection Needle/syringe exchange programs Emphasis on non-injection routes of administration Overdose prevention Naloxone 28 Opiate Agonist Therapy 80% of patients who use behavioral therapy alone return to drug use Opiate agonist treatment has retention rates of 60% to 80% with only 15% returning to drug use Wakeman Am J of Med, 126;5; May 2016 Naloxone Mechanism: Blocks opioid receptors and can reverse overdose effects Delivery: Intranasal, subq, IV injection 30 5

Naloxone Candidates Per SAMSHA those who: 1 Take high dose opioids for long-term management of chronic pain 2 Receive rotating opioid medication regimens 3 Recent opioid OD 4 Take extended-release or long-acting opioids 5 Are completing an opioid detox or abstinence programs Abuse-deterrent Formulations Diverted opiates are shared or sold for rewarding effects They are often crushed, snorted, smoked or injected which intensifies the drug effect Abuse-deterrent formulations have been developed to prevent misuse of opiates in this manner 31 32 Evidence-Based Behavioral Therapies Evidence-Based Treatments for Pain Cognitive-Behavioral Therapy Motivational Enhancement Therapy Community Reinforcement Approach 12-Step Facilitation Family Behavior Therapy Acceptance and Commitment Therapy Mindfulness-based Therapy Biofeedback Neurofeedback 33 34 Evidence-Based Treatments for Pain Biofeedback Neurofeedback Recovery = a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their full potential 35 36 6

4 Dimensions of Recovery 1 Health overcoming or managing one s disease(s) or symptoms for example, abstaining from use of alcohol, illicit drugs, and non-prescribed medications if one has an addiction problem and, for everyone in recovery, making informed, healthy choices that support physical and emotional well-being 2 Home having a stable and safe place to live 3 Purpose conducting meaningful daily activities, such as a job, school volunteerism, family caretaking, or creative endeavors, and the independence, income, and resources to participate in society 4 Community having relationships and social networks that provide support, friendship, love, and hope Recommendations for Pharmacists and Pharmacy Techs Provide counseling for new opiate patients receiving extended-release opiates Offer counseling for all patients receiving > 90 MME per day Offer counseling/naloxone when benzodiazepines are co-prescribed Offer counseling when a patient is age 65 37 38 Recommendations for Pharmacists and Pharmacy Techs If a patient is on an antidepressant we know that depressed patients are higher risk for OD If a patient is on an antipsychotic we know that bipolar patients are higher risk for OD Offer parental and patient counseling for patients age 18 Do not hesitate to offer or discuss Naloxone If patients shares concerns about dependence pharmacists can be provide counseling on addiction and alternative Questions? 39 40 7