When Mental Health Issues Emerge in My Patient Population From an Addiction Perspective

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When Mental Health Issues Emerge in My Patient Population From an Addiction Perspective Joseph N. Ranieri, DO, FAAFP, FASAM Diplomate-American Board Of Addiction Medicine Medical Director Bridgeton, NJ Westfield, PA Cherry Hill, NJ Northfield, NJ Morristown,NJ 1 The Presenter, Dr. Joseph N. Ranieri, has declared an interest for speaking engagements with Alkermes Ironwood Pharmaceutical entity. Physician is an employee of Seabrook House. 2 May 4-7, 2016 1

History of present illness: Patient is a 30-year-old female presents to the office with a history of interstitial cystitis diagnosed approximately 15 years ago with periods of exacerbation and remission. Other medical problems include Gastroparesis, Anxiety / Panic, MDD-Depression, PTSD-relationship verbal abuse, Nephrolithiasis Medications include: Oxycodone (Daily range 100-120mg), Hydromorphone 8-12mg / day, Buprenorphine-Suboxone-( 12-16mg/ day ) ( i.e. and other opiate medications B & O suppositories ) at various interval times. Other medications include: Diazepam intravaginal suppositories, Klonopin 0.5 mg twice a day, Soma 350 mg 4 times a day as needed, Seroquel 50 mg at bedtime, Remeron 30 mg at bedtime, Zoloft 50mg daily, B & O Suppositories Substance Abuse History / Alcohol use history-unremarkable DAST-21 Questionnaire + one question for experimenting with drugs yrs ago. Mother is present during the history and physical as an advocate Review of symptoms; other 10 point review of symptoms were negative except for Patient Comfort Assessment Form, Anxiety Rating Scale Zung, PHQ-9 Depression Questionnaire. Allergies: Compazine, Reglan, Phenergan, nonsteroidal anti-inflammatory medications ( upset stomach dyspepsia ). 3 Social history; divorced with associated verbal /emotional abuse. Occupation, teacher. Patient ; + nicotine ½ ppd x 16 yr. started age 14 Family history father with kidney cancer Urine drug screen positive for buprenorphine, benzodiazepines. Vital signs include pulse 114, temperature 98.1, blood pressure 99/81. Physical exam unremarkable. Assessment and plan: 1. Chronic pain syndrome secondary to interstitial cystitis-prescribe buprenorphine off FDA- label for pain management 8 mg twice a day 2. Gastroparesis-proton pump inhibitor-prilosec, recent Gastric Device Placed. 3. Anxiety/depression, history of trauma, emotional-verbal, medications include Remeron, clonazepam, diazepam, Seroquel, d/c -Soma, Oxycodone,-140mg/ day d/c Marinol ( patient claims filled but not taken ) 4. Chronic Nephrolithiasis-asymptomatic 5. Recommend support management via support group, interstitial cystitis, recommend meetings for recovery awareness at our office. 6. Coordination of care-with other providers psychiatrist, Uro-Gyn, holistic provider to limit / eliminate Psychoactive Medications, Sedatives, Muscle relaxers, Opiates 7. Review NJ RX Reporting System monitoring,!2 step recovery, CBT 8. Coordinated Care amongst specialist to minimize duplication of medications. 9. Transdermal Pain Cream-Tertracaine, Lidocaine, Baclofen, Clonidine, Neurotin, ibuprofen, Elavil 4 May 4-7, 2016 2

Patient has 3 different Uro-Gynecologists- 1. Dr A. Rx B & O Suppositories & Lyrica 2. Dr B. Rx Vaginal Diazepam & Oral Diazepam, Various Opiates. 3. Dr C. Rx. Multiple Opinions Patient Has 1 primary care provider & Multiple Urgent Care Centers ( Rx Antibiotics ) Patient Has Holistic Medicine Provider Rx. Soma Patient Has 2 Ob-Gyn Providers Patient Has Psychiatrist Rx Clonazepam, Remeron, Seroquel, Zoloft. Patient Has a Therapist which she underutilizes. Patient now Has an Addiction Specialist Rx Suboxone for Pain Management of Substance Use Disorder ( Patient in denial ) Goal is to eliminate duplications of medications in the same pharmacologic class and engage patient in the Bio-Psychosocial aspect of the Disease Treatment of Dependence Pain & Addiction. 5 Fill Date Product, STR, Form Quantity Days Pt ID 10/17/2014 Diazepam Suppository 2MG 1 daily Patient use 1or 2 per day 60 30 10/23/2014 Suboxone 2MG, 8 MG, Film, Soluble I twice a day 60 30 10/02/2014 Clonazepam, 0. 5 MG, Tablet Patient use 2 per day 90.00 30 10/02/2014 B & O Suppository Patient use for exacerbation most 10 per month 30 30 6 May 4-7, 2016 3

Fill Date Product, STR, Form Quantity Days 09/24/2014 Suboxone, 2MG, 8 MG, Film, Soluble -1 twice a day 60 30 09/18/2014 Diazepam Suppository 2MG -1 daily Patient use 1 or 2 per day 9/10/2014 B & O Suppository Patient uses 10 per month 9/6/2015 Oxycodone 10mg /325 Patient use one q6hr x 3 days, holding suboxone 09/05/2014 Clonazepam, 0.5 MG Tablet- Patient use 2 per day 9/4/2015 Lyrica 150mg Patient uses as needed 1-2 per day exacerbations 09/01/2014 Dronzabinol, 2.5 MG, Capsule 1 daily Prescription filled but not used for Gastroparesis 8/20/2014 Diazepam, 2MG, suppository Patient use 1-2 per day 60 30 30 30 30 5 90 30 60 30 45 20-30 60.00 30 8/24/2014 Suboxone 8mg Film 1 twice a day 60 30 8/12/2014 Clonazepam, 0.5mg, tablet Patient uses 2 per day 8/12/2015 B & O Suppository Patient use 10 per month 7/19/2014 Soma 350mg Patient uses as needed 90.00 30 30 30 120 30 07/29/2014 Suboxone, 2MG, 8MG, Film, Soluble 60 30 07/18/2014 Clonazepam, 0.5mg, tablet Patient uses 1-2 per day 90 30 7 Fill Date Product, STR, Form Quantity Days 7/2/2014 Oxycodone 10mg/325 Patinet used 1 q6hr prn x 2 days 07/2/2014 Diazepam, 2MG, TaBlet Patient uses in addition to vaginal supposoitory 07/01/2014 Clonazepam, 0.5MG, Tablet Patient use 2 per day 30 5 60.00 30 90.00 30 06/28/2014 Suboxone, 2 MG; 8 Mg, Film, Soluble 60 30 06/05/2014 Carisoprodol, 350 MG, Tablet 15.00 4 06/05/2014 Oxycotin 40mg Patient used for 5 days, holding suboxone 06/04/2014 Clonazepam, 0.5 MG, Tablet Patient uses 2 per day 05/24/2014 Diazepam, 2MG, Tablet Patient use as needed in addition to Vaginal suppository 05/21/2014 Suboxone, 2MG; 8MG, Film, Soluble Patient using one daily 05/09/2014 Clonazepam, 0.5 MG, Tablet Patient uses 2 per day 05/05/2014 Oxycotin 40mg Patient uses one twice a day 5 5 90.00 30 60.00 30 30 30 90.00 30 60 30 05/01/2014 Alprazolam,.25 MG, tablet 20.00 5 04/22/2014 Suboxone, 2MG; 8 MG, Film, Patient uses as needed 20.00 10 04/13/2014 Oxycodone 5, 325mg acetaminiphen 15 4 8 May 4-7, 2016 4

Fill Date Product, STR, Form Quantity Days 04/08/2014 Alprazolam, 0.5 MG, Tablet 60 30 04/08/2014 Oxycodone Hydrochloride, 15 MG, Tablet 30 30 04/08/2014 Oxycotin, 40 MG, Tablet, Film Coated, Extended Release 60 30 04/04/2014 Oxycodone Hydrochloride, 30 MG, Tablet 90 30 04/04/2014 Lorazepam, 0.5 MG, Tablet 10 7 03/30/2014 Hydromorphone Hydrochloride, 2MG, Tablet 20 3 03/15/2014 Lorazepam, 0.5 MG Tablet 10 30 03/11/2014 Suboxone, 2MG, 8 MG, Film, Soluble 60 30 03/08/2014 Carisoprodol, 350 MG, Tablet 120 30 02/10/2014 Carisoprodol, 250 MG, Tablet 120 30 02/10/2014 Suboxone, 2Mg, 8 Mg, Film, Soluble 60 15 01/27/2014 Suboxone, 2Mg, 8 Mg, Film, Soluble 30 15 01/08/2014 Clonazepam, 1 MG, Tablet 60 15 12/30/2013 Oxycodone and Acetaminophen, 325 Mg, 5 Mg, Tablet 30 5 9 Fill Date Product, STR, Form Quantity Days 12/30/2013 Suboxone, 2MG;8MG, Film, Soluble 30.00 15 12/24/2013 Clonazepam, 1MG, tablet 60.00 15 12/16/2013 Suboxone, 2MG;8MG, Film, Soluble 30.00 15 12/13/2013 Oxycodone and acetaminophen, 325 Mg; 5MG, Tablet 20.00 20 12/09/2013 Suboxone, 2MG;8MG, Film, Soluble 10.00 5 12/01/2013 Suboxone, 2MG;8MG, Film, Soluble 18.00 9 11/30/2013 Suboxone, 2MG;8MG, Film, Soluble 2.00 1 11/25/2013 Suboxone, 2MG;8MG, Film, Soluble 10.00 5 11/23/2013 Clonazepam, 1 MG, Tablet 120.00 30 11/14/2013 Suboxone, 2MG;8MG, Film, Soluble 20.00 10 11/01/2013 Oxycodone Hydrochloride, 30 MG, Tablet 120.00 30 10/31/2013 Carisoprodol, 350 MG, Tablet 120.00 30 10 May 4-7, 2016 5

Major Gaps exists between the Diagnosis and Treatment of Addiction (i.e. Substance Use Disorders Alcohol Use Disorders), Substance-Medication induced mood disorders, Primary Mental Illness (i.e. Any Mental Illness and Serious Mental Illness e.g. Anxiety, Depression, Mood Disorders), SUD & Co- Occurring Disorders in The United States. Screening tools exist to aid the clinician in proper diagnosis. The PRISM is a semi-structured clinician administered interview that measures DSMIII, DSMIIIR, and DSMIV diagnoses (current and past) of alcohol, drug, and psychiatric disorders and continuous measures of severity, organic, etiology, treatment, and functional impairment. ( 1-3 hrs ). Another tool is the Addiction Severity Index that measures severity of Addiction. ( 1 hr+ ). More Practical PHQ-9 for Depression, Zung Anxiety Rating Scale, and Mood Questionnaire Scale for Bipolar Disorder. Further screening tools consist of the DAST-Drug Abuse Screening Test, AUDIT- Alcohol Screening Test which are examples of SBIRT (Screening Brief Intervention Referral Tools) can be used initially and periodically once treatment initiated. Often psychiatric illnesses are present as Substance-Alcohol Induced Mood Disorders or a combination of both Substance and /or Alcohol Use Disorders along with Co-Occurring Mental Illness. Chronicity of the Substance and /or Alcohol use is imperative in relation to the Diagnosis of the Mental Disorder as a component of evaluation and management. An invaluable test, often not thought off during the initial evaluation and management presentation of the constellation of mental illness symptoms is the consideration of a Urine Drug Screen (i.e. for drugs of abuse and Ethyl Glucuronide for alcohol abuse). Often, Addiction is a disease of denial and Patients are not forthright. Dependence, with aberrant behaviors, also fall into a category of denial & lack of honesty at times. 11 Mental health issues are frequently unrecognized and even when diagnosed are often not treated adequately 8,14 Recognition and treatment of mental illness are significant issues for primary care physicians, who provide the majority of mental health care. 15,16 8.Callahan EJ, Jaén CR, Crabtree BF, Zyzanski SJ, Goodwin MA, Stange KC. The impact of recent emotional distress and diagnosis of depression or anxiety on the physician-patient encounter in Any Mental Illnessly practice. J Fam Pract. 1998;46(5):410-418. 14 Tiemens BG, Ormel J, Simon GE. Occurrence, recognition, and outcome of psychological disorders in primary care. Am J Psychiatry. 1996;153(5):636-64415.Gallo JJ, Coyne JC. The challenge of depression in late life: bridging science and service in primary care. JAMA. 2000; 284(12):1570-1572.16.Williams JW Jr. Competing demands: Does care for depression fit in primary care? J Gen Intern Med. 1998;13(2):137-139 12 May 4-7, 2016 6

Identifying Substance Use Disorder, Dependence with Aberrant Behaviors, Substance / Medication Use Disorder, Co- Occurring Disorder & Primary Mental Disorders. Psychoactive Medication Discontinuation Syndrome Disorders 13 Abuse-Misuse - use in a manner other than what the prescribing physician / medical provider intended. Dependence - a physiologic process, which is a predictable event in the prescription of opioids, benzodiazepines, barbiturates and stimulants. Dependence is dose-, time- and potency-related and may result in tolerance (to side effects and to therapeutic effects) and withdrawal. Physiologic dependence is not necessarily addiction. Understanding the differences among these terms helps physicians/ medical providers understand the liability risks and helps patients overcome the stigma of getting hooked on a legitimately used controlled substance as well as recent introduction Of CDC Opioid Prescribing Guidelines for Chronic Pain. Addiction: Part II. Identification and Management of the Drug- Seeking Patient, April 15th 2000. American Family Physician 14 May 4-7, 2016 7

Brain Reward Center: Median Forebrain Nucleus Accumbens Ventral Tegmental Area Dopamine Addiction is a primary, chronic disease of brain reward, motivation, and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social, and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors. Addiction is characterized by inability to consistently abstain, impairment in behavioral control craving, diminished recognition of significant problems with one s behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. WITHOUT TREATMENT or engagement in recovery activities, addiction is progressive and can result in disability or premature death. THE ASAM CRITERIA, Treatment Criteria For Addictive, Substance-Related and Co- Occurring Conditions, American Society Of Addiction Medicine, Third Edition, 201316 May 4-7, 2016 8

Dr. Howard Markel author of "An Anatomy of Addiction: Sigmund Freud, William Halsted, and the Miracle Drug Cocaine" For most patients with opioid use disorder, the use of medications (combined with psychosocial treatment) is superior to withdrawal management (combined with psychosocial treatment), followed finally by psychosocial treatment on its own (2). This Is true for both agonist,partial agonist, and antagonist medications (1) Evidence suggests that methadone maintenance treatment is superior to withdrawal Management alone and significantly reduces opioid drug use. Further, mortality is lower in patients on methadone, as compared to those not in treatment. Methadone also lowers the risk of acquiring or spreading HIV infection (1). In clinical studies, evidence favors buprenorphine, compared to no treatment, in decreasing heroin use and improving treatment retention (1). Finally, evidence supports the efficacy of both oral naltrexone and extended-release injectable naltrexone versus placebo for the treatment of opioid use disorder (1). Comprehensive Opioid Response with the Twelve Step ( Medication Assisted Treatment ) Approach Model offered By Hazelden / Betty Ford is paving the way to Introduction of MAT Buprenorphine & Injectable Naltrexone for 0-18 months in selected patients in Abstinence Based Treatment Facilities they have recognized that one size does not fit All. 1. ASAM Treatment Guidelines page 60 2. Primary mode treatment at the majority of facilities in the United States is a complete abstinence model on discharge. 18 May 4-7, 2016 9

New Jersey Prescription Monitoring Program 1. Required to Consult PMP First time a DEA scheduled II medication is prescribed to a new patient for acute or chronic pain 2. Required when you continue to prescribe a regimen of DEA scheduled II medications for acute or chronic pain quarterly during the regimen. 19 Q: What is required of prescribers? A: Once the new PDMP is fully operationalized, prescribers are required to query the system: 1. For each patient the first time the patient is prescribed a controlled substance; or 2. If a prescriber believes or has reason to believe, using sound clinical judgment, that a patient may be abusing or diverting drugs. Once the new PDMP is fully operationalized, prescribers are required to indicate the information obtained from the system in the patient s medical record if: 1. The individual is a new patient; or 2. The prescriber determines a drug should not be prescribed a furnished to a patient based upon the information from the system 20 May 4-7, 2016 10

Addiction Severity Index-Non-Practical for primary care PHQ-9 for Depression Zung Anxiety Rating Scale Mood Questionnaire For Bipolar Disorder Jasper Goldberg Adult Add Questionnaire Psychiatric Research Interview for Substance and Mental Disorders ( PRISM)-Non Practical for primary care ( Addiction & Co-occurring Mental Illness) Drug Abuse Screening Tool-21 Audit Screening Tool- Alcoholism Current Opioid Misuse Measure (COMM) Opioid Risk Tool ( ORT ) 21 22 May 4-7, 2016 11

23 24 May 4-7, 2016 12

DSM-5 does not separate the diagnosis of substance abuse and dependence as in DSM-IV, rather, criteria are provided for substance use disorder, accompanied by criteria for intoxication, withdrawal, substance/medication-induced disorders, and unspecified substance-induced disorders. DSM-5 substance use disorder criteria are nearly identical to DSM-IV substance abuse and dependence criteria combined into a single list with two exceptions. The DSM-IV recurrent legal problems, has been deleted, and a new criterion, craving or strong desire to use a substance, has been added. In addition, the threshold for substance use disorder in DSM-5 is a set of 2 or more criteria, in contrast DSM-IV, 1 or more criteria for substance abuse, 3 or more criteria for dependence Severity criteria: 2-3 mild, 4-5 moderate, 6 or more severe. Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) released at the American Psychiatric Association s Annual Meeting in May 2013 25 A problematic pattern of opioid use leading to clinically significant impairment or distress, as manifested by at least 2 of the following, occurring within a 12 month period: 1. Impaired Control: Opioids are often taken In larger amounts over a longer period then was intended.* 2. Impaired Control: There is a persistent desire or unsuccessful efforts to cut down or control opioid use.* 3. Impaired Control: A great deal of the time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects.* 4. Impaired Control: Craving, or strong desire or urge to use opioids.*** 5. Social Impairment: Recurrent opioid use resulting in a failure to fulfill major role operations at work, school, or home.** 6. Social Impairment: Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids.** 7. Social Impairment: Important social, occupational, or recreational activities are given up or reduced because of opioid use.* 8. Risky Use: Recurrent opioid use in situations in which it is physically hazardous.** 9. Risky Use: 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.** 10. Tolerance, as defined by either for the following: * a) A need for markedly increased amounts of opioids, to achieve intoxication or desired effect. b) 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 11. Withdrawal, as manifested by either of the following: * a) The Characteristic opioid withdrawal syndrome. b) Opioids are taken to relieve or avoid withdrawal symptoms. Note: This criterion is not considered to be met for those individuals take opioids solely under appropriate medical supervision. Severity criteria: 2-3 mild, 4-5 moderate, 6 or more severe * DSM-IV Dependence **DSM-IV Abuse ***DSM-5 addition ( Formerly DSM-IV Abuse-recurrent substance related legal problems) Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) released at the American Psychiatric Association s Annual Meeting in May 2013 26 May 4-7, 2016 13

Deaths from drug overdose have been steadily rising over the past two decades and have become the leading cause of injury death in the United States. Every day in the United States, 120 people die as a result of drug overdose & another 6,748 are treated in the ER for misuse or abuse. Nearly 9 out of 10 poisoning deaths are caused by drugs. Drug Overdose was the leading cause of injury death in 2012. Among people 25 to 64 years of age,drug overdose caused more deaths than motor vehicle traffic accidents. In 2013 drug overdose deaths, approximately 51% were related to pharmaceuticals drugs. Even with acute low dose opioids (1 36 mg/day morphine equivalent dose or MED), patients are at increased risk for developing opioid use disorder (OUD). The likelihood of developing OUD ranges from a 3-fold increase for acute low dose opioids, to a 122-fold increase for chronic high dose opioids ( 120mg/day MED) compared to patients who are not prescribed opioids. Over a median follow-up of 299 days, opioids were dispensed to 91% of patients after an overdose, 7% of the patients had a repeated opioid overdose. after the index overdose the following occur: 1. After 2 years, the cumulative incident of repeated overdose was 17% for patient s receiving high dosages of opioids 2. 15% for those receiving moderate dosages opioids 3. 9% for those receiving low dosages opioids 4. 8% of those receiving no opioids pain patients,dunn KM et al Ann Intern Med Jan 19 2010 Overdose and prescribed opioids: Associations among Chronic non-cancer http://www.cdc.gov/injury/wisqars/fatal.html Edlund MJ, Martin BC, Russo JE, DeVries A, Braden JB, Sullivan MD. The role of opioid prescription in incident opioid abuse and dependence among individuals with chronic noncancer pain: the role of opioid prescription. Clin J Pain 2014;30:557-64. Opioid prescribing after non- fatal overdose and Association with repeated overdose: A Cohart 27 Study Annals of Internal Medicine January 2016, volume 164, No 1 1. In the 1980s and 1990s, however, both the substance abuse and mental health communities found that a wide range of mental disorders were associated with substance abuse, not just depression (e.g., De Leon 1989; Pepper et al. 1981; Rounsaville et al. 1982b; Sciacca 1991). 2. During this period, studies conducted in substance abuse programs typically reported that 50 to 75 percent of clients had some type of co-occurring mental disorder (although not usually a severe mental disorder). 3. Studies in mental health settings reported that between 20 and 50 percent of their clients had a co-occurring substance use disorder. (See Sacks et al. 1997b for a summary of studies and Compton et al. 2000 for a more recent study.) 28 May 4-7, 2016 14

COD (replaces dual diagnosis disorders-dd) refers to cooccurring substance-related and mental disorders. Clients said to have COD have one or more substance-related disorders as well as one or more mental disorders. At the individual level, COD exists when at least one disorder of each type can be established independent of the other and is not simply a cluster of symptoms resulting from a single disorder. Definitions and Terms Relating to Co-Occurring Disorders. Tech. no. Overview Paper 1. Substance Abuse and Mental Health Services Administration, n.d. Web. 19 Jan. 2013. <http://www.samhsa.gov/>. Coming to be thought of as an outdated term Overlap with Substance Use Disorders ( Addiction Disorders ) & Co- Occurring Mental Disorders. Traditionally 2 systems (not 2 diagnoses or even a diagnosis at all) Influenced by the biases, perspectives, experience and training of the evaluator Substance / Medication Induced Mental Disorders can cause Diagnostic Confusion ( Chronicity / Timeline important ) Psychoactive Medication Discontinuation Symptoms can cause further Problems and Diagnostic Confusion. Extremely Difficult To Treat in Primary Care or for that matter for Addiction Medicine Specialists & Psychiatrists. May 4-7, 2016 15

Drug Disorder Cocaine and Methamphetamine Stimulants LSD, Ecstasy & psychedelics Alcohol, sedatives, Sleepaids & narcotics PCP & Ketamine Schizophrenia, paranoia, anhedonia, compulsive behavior Anxiety, panic attacks, mania and sleep disorders Delusions and hallucinations Depression and mood disturbances Antisocial behavior Drug States Withdrawal Acute Protracted Intoxication Chronic Use Symptom Groups Depression Anxiety Psychosis Mania Rounsaville 90 May 4-7, 2016 16

Antidepressants: Withdrawal symptoms (FINISH syndrome): Flu-like symptoms, Insomnia, Imbalance, Sensory disturbances, Hyper arousal. Symptoms usually begin & peak within one week, last one day to three weeks, & are usually mild. Antipsychotics: Recurrence of neuropsychiatric symptoms. Withdrawal symptoms (best-documented with clozapine): sweating, salivation, runny nose, flu-like symptoms, paresthesia, broncho-constriction, urination, gastrointestinal symptoms, anorexia, vertigo, insomnia, agitation,anxiety, restlessness, movement disorders, psychosis. Clonidine: Withdrawal syndrome: rebound hypertension, headache, restlessness, anxiety, insomnia, sweating, tachycardia, tremor, muscle cramps, hiccups, nausea, salivation; rarely encephalopathy, stroke, death. ( Prescribers Letter March 2016 Common Oral Medications That Need Tapering ) 34 Reeves and Brister VA Med Center Jackson, MS April 2007 SMA Journal May 4-7, 2016 17

MENTAL DISORDERS Schizophrenia Bi-polar Schizoaffective Major Depression Borderline Personality Post Traumatic Stress Social Phobia others ADDICTION DISORDERS Alcohol Use Disorder Cocaine/ Amphetamine Opiates Use Disorder Cannabis Use Disorder Sedative Hypnotic Poly-substance combinations Prescription drugs Dependence Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health 38 May 4-7, 2016 18

Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health 39 Up to half of people living with mental illness also have substance abuse issues.1,2,3 The highest rates of substance use disorders occur in the late teens and the twenties1,2,3 1. Director s Blog: Mental Health Awareness Month: By the Numbers. National Institute of Mental Health Web site. http://www.nimh.nih.gov/about/director/2015/mental health awaren ess month by the numbers.shtml. Accessed January 27, 2016. 2. Dual Diagnosis. National Alliance on Mental Illness Web site. https://www.nami.org/learn More/Mental Health Conditions/Related Conditions/Dual Diagnosis. Accessed January 27, 2016. 3. American Society of Addiction Medicine. Drug Testing: A White Paper of the American Society of Addiction Medicine (ASAM). http://www.asam.org/docs/default source/publicy policy statements/ drug testing a white paper by asam.pdf?sfvrsn=2; page 66. Published October 26, 2013. Accessed January 27, 2016. May 4-7, 2016 19

Hall 77 Poor out-pt attendance, discontinue Rx Alterman 85 More mood changes, intensive staffing Solomon 86 More noncompliance, arrests Safer 87 Over twice hosp. rate and criminal behav Drake 89 More hostility, noncompliance Barbee 89 More psych symptoms Lyons 89 More noncompliance, ER, jail, rehosp. Chen 92 Worse treatment course Risk Factor Cocaine use Major Depression Alcohol use Separation or Divorce NIMH/NIDA Increased Odds Of Attempting Suicide 62 times more likely 41 times more likely 8 times more likely 11 times more likely ECA EVALUATION May 4-7, 2016 20

Bio Mental Illness Labs-UDS Meds (anti-depressants, etc.) Alcohol-Substance Use Labs-UDS Meds (withdrawal, craving, etc.) Psych Social Psychotherapy Education groups Process groups Couples conf. D/C planning housing, Matrix family program etc. Step work Groups AA Meetings Intervention Sober housing May 4-7, 2016 21

Urine Drug Testing What took me so Long? 46 How do you or would you introduce UDT to your patients? Aids in screening, assessing and diagnosing a substance use disorder. Can affect clinical decisions on a patient s substance use that effects other medical conditions. Increases the safety off prescribing medications by identifying the potential for overdose or serious drug interactions. Can affect clinical decisions about pharmacotherapy, especially with controlled substances. Prevents dangerous medication interactions during surgery or other medical procedures. Identifies the risks for women, who want to become pregnant, and are using drugs and alcohol. Verifies, contradicts, or aids to a patient s self-report or family members report of substance use. Identifies of relapse to substance use. Helps clinicians with risk stratification to assess patient s for chronic pain management compliance and current concomitant use of other medications or drugs. ( Clinical Drug Testing Primary Care Tap 23 ) May 4-7, 2016 22

Urine drug testing is a standard part of care for all my patients prescribed certain medications. It s necessary to help make sure this treatment is as safe as possible for you. Gourlay DL, Heit HA, Caplan YH. Urine Drug Testing in Clinical Practice: The Art and Science of Patient Care. Edition 6. 2015; PharmaCom Group, Inc. Substance Abuse and Mental Health Services Administration. Managing Chronic Pain in Adults With or in Recovery From Substance Use Disorders. Treatment Improvement Protocol (TIP) Series 54. HHS Publication No. (SMA) 12 4671. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011. Substance Abuse and Mental Health Services Administration. Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-50). Rockville, Maryland: Substance Abuse and Mental Health Services Administration. September, 2015. May 4-7, 2016 23

CDC 2010-38,329 died from drug overdose / 2000-2014- 47,005 1. Opiate overdose deaths 16,651 2. Pharmaceutical drugs 22,134 deaths 3. Oxycodone, Hydrocodone & Methadone16,651 4. Benzodiazepines ( anti-anxiety ) 30 % involved in 6,497 anti-psychotic drugs 6 % 1,351 5. Deaths involving more than one drug or drug class are counted multiple times and therefore are not mutually exclusive. 6. Patients with mental health or substance use disorders are at increased risk for nonmedical use and overdose from prescription painkillers as well as being prescribed high doses of the drugs. Appropriate screening identification and clinical management by healthcare providers are essential parts of both behavioral health and chronic pain management CDC Director, Tom Frieden, MD MPH. Opioids drive continued increase in drug overdose deaths Drug overdose deaths increase for 11th consecutive year http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html MMWR weekly Jamuary 1, 2016 / 64(50); 1378-82 50 Many patients do not take medication as prescribed 1. Side effects 2. Lack Of Efficacy 3. High Out-Of-Pocket expense 4. Non-Compliance ( Discontinuation ) 5. Self Adjustment Of Dose / Misuse 6. Inconsistent Adherence Mitchel AJ and Selmes T. Why don t patients take their medicine? Reasons and solutions in psychiatry. Adv Psych Treatment. 2007;13:336 346. May 4-7, 2016 24

Symptomatic relapse 1. Relapse risk is 5 times higher in those discontinuing antipsychotic drug therapy Negative impact on functioning and course of illness 1. Increased use of emergency psychiatric services, hospitalizations, arrests, violence, suicide. Higher overall health care costs. 1. Robinson D, Woerner MG, Alvir JM, et al. Predictors of relapse following response from a first episode of schizophrenia or schizoaffective disorder.arch Gen Psychiatry. 1999; 56(3): 241-7. 2. Higashi K, Medic G, Littlewood KJ, Diez T, Granström O, De Hert M. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systematic literature review. Ther Adv Psychopharmacol. 2013; 3(4): 200-18. The clinician must choose testing method based on the needs dictated by the patient s history, presentation, community factors and treatment plan goals. The clinician s rationale for test and the analytes ordered must be documented in the patient s medical record. May 4-7, 2016 25

1. Center for Substance Abuse Treatment. (2012).Clinical drug testing in primary care. Technical Assistance Publication (TAP) Series, 32. DHHS Publication No. (SMA) 12-4668. Rockville, MD: Substance Abuse and Mental Health Services Administration. Available: http://www.kap.samhsa.gov/products/manuals/pdfs/tap32.pdf May 4-7, 2016 26

218,927 specimens; 23 analysts Laboratory immunoassay (IA) screen with reflex of positives to quantization (only IA positives are sent for more definitive testing) Direct definitive testing/quantitative (DQ) approach Kirsh K et al. An Analysis of Laboratory Immunoassay Screen with Reflex of Positives to Quantification Versus Definitive Laboratory Quantitation Methodologies for Medication Monitoring. Poster presented at International Conference on Opioids, June 2014, Boston, MA. The high clinical false negative rate associated with testing by immunoassay followed by reflex of positives to confirmation may lead to: Missed opportunities for intervention Missed relapses for those with substance abuse Less effective treatment and treatment decision making Higher risk for drug interactions Greater potential for increased side effects for patients Kirsh K et al. An Analysis of Laboratory Immunoassay Screen with Reflex of Positives to Quantification Versus Definitive Laboratory Quantitation Methodologies for Medication Monitoring. Poster presented at International Conference on Opioids, June 2014, Boston, MA. May 4-7, 2016 27

Numerous factors may contribute to unexpected UDT results1,2,3: Patient medication use Time of the last dose Undiscovered or unknown over-the-counter or prescription medication use Type of testing Pharmacogenetics Drug-drug interactions 1. Gourlay DL, Heit HA, Caplan YH. Urine Drug Testing in Clinical Practice: the Art and Science of Patient Care. PharmaCom Group, Inc. http://www.pharmacomgroup.com/udt/udt5.pdf. Accessed March 14, 2013. 2. Christo PJ, Manchikanti L, Ruan X, Bottros M, et al. Urine Drug Testing in Chronic Pain. Pain Physician. 2011; 14: 123 143. 3. Reisfield GM,Goldberger, BA, Bertholf RL. False positive and false negative test results in clinical urine drug testing. Bioanalysis. 2009. 1(5): 937 52. Indicates how long after administration a person excretes the drug and/or its metabolite(s) at a concentration above a specific test cutoff concentration 1 to 3 days for most drugs and metabolites Gourlay DL et al. Urine Drug Testing in Clinical Practice. 4th ed. 2010 Pharmacon Group, Inc. SAMHSA. Clinical Drug Testing in Primary Care. Technical Assistance Publication (TAP) 32. HHS Publication No. (SMA) 12 4668. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012. May 4-7, 2016 28

Benzodiazepines Stimulants Anti-epileptics Tricyclic Antidepressants SSRIs and SNRIs Antipsychotics Alcohol/AlcoholMetabolites Barbiturates Natural& Semi-Synthetic Opioids Synthetic Opioids Muscle Relaxants Illicit Drugs Synthetic Cannabinoids (Spice) Cathinones (Bath Salts) Other Over 100 drugs and metabolites (over 400 brand name medications). Industry leader in offering tests for newer drugs of abuse, including synthetic agents. Millennium, Quest, Labcorp Oral fluid testing is also a viable choice for medication monitoring Collection almost anywhere Easier to observe collection Reduced risk for adulteration or substitution Turn Around time for results 5-7 days Heltsley R, Depriest A, Black DL, et al. Oral fluid drug testing of chronic pain patients. II. Comparison of paired oral fluid and urine specimens. J Anal Toxicol. 2012 Mar;36(2):75 80. May 4-7, 2016 29

SAMHSA recommends to consider drug testing when assessing a patient presenting with mood or behavior changes to: Aid in diagnosis Help determine whether the psychiatric symptoms are substance use or withdrawal related Help identify a co-occurring SUD Monitor for recent use of controlled medications 1. Substance Abuse and Mental Health Services Administration. (2012). Clinical drug testing in primary care. Technical Assistance Publication (TAP) 32. HHS Publication No. SMA 12 4668. Rockville, MD: Substance Abuse and Mental Health Services Administration. It is appropriate to consider periodic random drug testing for all psychiatric patients, and especially young patients and those with a history of substance use disorders, particularly when they have been prescribed Psychoactive Medications and Benzodiazepines. American Society of Addiction Medicine. Drug Testing: A White Paper of the American Society of Addiction Medicine (ASAM). http://www.asam.org/docs/default source/publicy po licy statements/drug testing awhitepaper by asam.pdf?sfvrsn=2; page 66. Published October 26, 2013. Accessed January 27, 2016. May 4-7, 2016 30

About 1.6 million people in the U.S. are current non-medical users of stimulants1 Over 10% of teenagers have misused or abused prescription stimulants Medication adherence may be less than 12% in adult ADHD patients taking stimulant medications Data suggests more than 50% of true amphetamine positives missed by POC 1. Substance Abuse and Mental Health Services Administration. Behavioral Health Trends in the United States: Results from the testing4 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15 4927, NSDUH Series H 50). Rockville, Maryland: Substance Abuse and Mental Health Services Administration. September, 2015. 2. The Partnership Attitude Tracking Study.. Partnership for Drug Free Kids.. Teens & Parents 2013. http://www.drugfree.org/wpcontent/ uploads/2014/07/pats 2013 FULL REPORT.pdf. Accessed January 29, 2016. 3. O Callaghan P. Adherence to stimulants in adult ADHD. Atten Defic Hyperact Disord. 2014; 6(2): 111 120. 4. Millennium Health, Primary Care Practice Profile, 2013. About 30% of drug overdoses involve benzodiazepines, often in combination with opioids Alprazolam (Xanax ) is one of the top three diverted prescription medications in the U.S. Benzodiazepine treatment center admissions nearly tripled between 1998 and 20083 High cutoff levels and lack of sensitivity with POC tests may prevent detection of therapeutic doses and identification of specific benzodiazepines 1. Opioids drive continued increase in drug overdose deaths. CDC Newsroom. Published February 20, 2013. http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_dea ths.html. Accessed January 29, 2016 2. 4DEA Fact Sheet. Benzodiazepines. January 2013. http://www.deadiversion.usdoj.gov/drug_chem_info/benzo.pdf. Accessed January 29, 2016. 3. Substance Abuse Treatment Admissions for Abuse of Benzodiazepines. The Treatment Episode Data Set. Published June 2, 2011. http://atforum.com/documents/teds028benzoadmissions.pdf. Accessed January 29, 2016. May 4-7, 2016 31

Anxiety disorders Antidepressants (most) Buspirone (Buspar) Anticonvulsants (valproic acid [Depakene], gabapentin [Neurontin]) Selected antihypertensives (beta blockers) Atypical neuroleptics (olanzapine [Zyprexa], quetiapine [Seroquel], risperidone [Risperdal])-No Indication for anxiety / Consider Avoiding / Recommend Psychiatric Consult. ( Can cause Metabolic Syndrome ) Insomnia Sedating antidepressants Trazodone (Desyrel) Doxepin (Sinequan) Amitriptyline (Elavil) Mirtazepine (Remeron) Antihistamines Avoid Any Benzodiazepine including Atypical ( Ambien etc. ) Pharmacologic Alternatives to controlled Drugs Presenters Opinion 66 Attention-deficit disorder Pemoline (Cylert) Bupropion (Wellbutrin) Desipramine (Norpramin) Venlafaxine (Effexor) Clonidine (Catapres) Selective serotonin reuptake inhibitors Pain Nonsteroidal anti-inflammatory drugs Topical Compounding Creams ( avoid Ketamine ) Acetaminophen Antidepressants Corticosteroids Muscle relaxants Pharmacologic Alternatives to controlled Drugs Presenters Opinion 1 67 May 4-7, 2016 32

Why Should I Care? Excessive alcohol use is the 3 rd leading cause of preventable death in the US. Tobacco is the leading cause of preventable death in the US. Illegal drug use is alarmingly prevalent: Around 9% of the population aged 12 or older reports using illegal drugs within the past month (SAMHSA 2010). Approximately 8.9% of the population over 12 met DSM-IV criteria for substance abuse or dependence (substance use disorder in DSM-5). http://www.sbirttraining.com/ 68 Why should you make this change to your practice? SBIRT is an evidence-based best practice that is strongly supported in the literature. For example, in one study, 6 months following SBIRT interventions: Rates of illicit drug use were 67.7% lower (p<0.001). Rates of heavy alcohol use were 38.6% lower (p<0.001). Success was seen across clinic settings, gender, race/ethnic, and age subgroups. (Madras et al. 2009) http://www.sbirttraining.com/ 69 May 4-7, 2016 33

Failure to inform patients of the risk of driving while taking a medication, such as a Benzodiazepine / Opioid / Stimulant may lead to a claim of negligence against the prescribing Physician / Medical Provider. Given the liability risks, Providers should apprise patients of these concerns and document this in the medical record. FORMULATE & UTILIZE A TREATMENT CONTRACT Routinely Use The Prescription Monitoring Program for Your State. Addiction: Part II. Identification and Management of the Drug-Seeking Patient, April 15th 2000. American Family Physician & APA Position Editorial Feb 1991 70 When a controlled substance is being considered as a treatment option, patients should be informed of the potential for physical dependency and the possibility of mild to moderate rebound effects even with gradual tapering. The physician / medical provider should carefully review the benefits and risks of the chosen medications, as well as other treatment choices. Formulate a Treatment Contract for all controlled drugs. Addiction: Part II. Identification and Management of the Drug-Seeking Patient, April 15th 2000. American Family Physician & APA Position Editorial Feb 1991 71 May 4-7, 2016 34

Dea Scheduled Monitoring contract 72 Dea Scheduled Monitoring contract 73 May 4-7, 2016 35

Dea Scheduled Monitoring contract 74 Dea Scheduled Monitoring contract 75 May 4-7, 2016 36

Patients who abuse prescription drugs may exhibit patterns, such as: escalating use drug-seeking behavior doctor shopping Physicians / Medical Providers must say NO and stick with it when patients exert pressure to obtain a prescription drug. Medical Providers who overprescribe can be characterized by the four Ds : Dated Duped Dishonest Disabled Maintaining a current knowledge base, documenting the decisions that guide the treatment process and seeking consultation are important risk management strategies that improve clinical care and outcomes. Routinely utilize the States Prescription Monitoring Program. ( NJ is Mandatory ) and Urine Drug Testing. Addiction: Part II. Identification and Management of the Drug-Seeking Patient, April 15th 2000. American Family Physician 76 The street value of controlled prescription drugs has been estimated by the DEA to be second only to the street value of cocaine, and greater than the street value of marijuana and heroin. Paradox for Physicians/ Medical Providers: the desire to relieve pain, anxiety and other discomfort must be weighed against the fear of creating addiction, of being investigated by law enforcement or licensing authorities, and of being scammed by the occasional patient who abuses opioid analgesics, sedative hypnotics or psychostimulants. These competing concerns often leave Providers feeling uncomfortable about prescribing controlled substances, to the detriment of the majority of patients who suffer legitimate illnesses and are often left undertreated or feeling stigmatized. Addiction: Part II. Identification and Management of the Drug-Seeking Patient, April 15th 2000. American Family Physician 77 May 4-7, 2016 37

The patient who has been diagnosed with Substance Use Disorder / Alcohol Use Disorder should be referred to an ADDICTION MEDICINE SPECIALIST / Inpatient or Outpatient treatment center. These steps give the patient a solid start on the recovery process. * If It is possible to detoxify the patient on an outpatient basis. The patient then can be referred to Alcoholics Anonymous or Narcotics Anonymous for sustained follow-up support. * Whatever treatment the patient undergoes, it is important for the family physician / medical provider to be supportive of the patient and the family in recovery. Physicians / Medical Providers should be careful about prescribing Mind & Mood-Altering Drugs. The Medical Practitioner can play a pivotal role by dealing with the patient and family in a Nonjudgmental Manner. All Patients with Opiate use disorders, Dependent on Opiates for Non-Cancer Chronic Pain should have a Narcan-naloxone antidote kit to reverse and prevent Opiate Overdose. *( Based on ASAM placement Criteria ) Addiction: Part II. Identification and Management of the Drug-Seeking Patient, April 15th 2000. American Family Physician 78 1. George M. is a 37-year-old divorced male who was brought into the emergency room intoxicated. His blood alcohol level was.152, and the toxicology screen was positive for cocaine. He was also suicidal ( I'm going to do it right this time! ). He has a history of three psychiatric hospitalizations (lasting 3 days each -all AMA) and two inpatient substance abuse treatments. Each psychiatric admission was preceded by substance use. George M. has never followed through with mental health care. He has intermittently attended Alcoholics Anonymous, but not recently. True or False 1. Question: Does George M, have Alcohol Use Disorder with Co-Occurring Mood Disorder? 79 May 4-7, 2016 38

1. Answer: False For example, if George M.'s psychiatric admissions were 2 or 3 days long, usually with discharges related to leaving against medical advice, decisions about diagnosis and treatment would be different (i.e., it is likely this is a substance-induced suicidal state and referral at discharge should be to a substance abuse treatment agency rather than a mental health center) than if two of his psychiatric admissions were 2 or 3 weeks long with clearly defined manic and psychotic symptoms continuing throughout the course, despite aggressive use of mental health care and medication (this is more likely a person with both bipolar disorder and alcohol dependence who requires integrated treatment for both his severe alcoholism and bipolar disorder). 80 2. Teresa G. is a 37-year-old divorced female who was brought into a detoxification unit 4 days ago with a blood alcohol level of.150. She is observed to be depressed, withdrawn, with little energy, fleeting suicidal thoughts, and poor concentration, but states she is just fine, not depressed, and life was good last week before her relapse. She has never used drugs (other than alcohol), and began drinking alcohol only 3 years ago. However, she has had several alcohol-related problems since then. She has a history of three psychiatric hospitalizations for depression, at ages 19, 23, and 32, All responded to various antidepressant. After Discharge from the Detoxification unit, she reports to her primary care provider 8 weeks later, claiming she has been sober. Her symptoms include becoming increasingly depressed, with anhedonia, and associated sleep disturbances, passive thoughts of despair and if she should drink again, she wants her next binge drinking episode to be "I just to fall asleep forever. " Also, she is unmotivated to continue her employment. These symptoms have been for the past 8 weeks since Alcohol Cessation. 24 True or False 2. Teresa G, Diagnosis has Alcohol Use Disorder (in early remission with recent acute relapse) with Co-Occurring Major Depression. 81 May 4-7, 2016 39

Answer: True 2. Teresa G. had become increasingly depressed and withdrawn over the past 8 weeks, and had for 8 weeks experienced disordered sleep, poor concentration, and suicidal thoughts, she would be best diagnosed Alcohol Use Disorder (in early remission with recent acute relapse) with Co- Occurring Major Depression. rather than substance-induced mood disorder secondary to her alcohol relapse. 24 82 True or False 3. Urine Drug screening could be an effective tool in determination of proper diagnosis of Substance Induced disorders with or without Mental Illness. Ethyl Glucuronide a metabolite of ethanol is often included in the panel ordered. 83 May 4-7, 2016 40

Answer: False 3. When ordering urine drug screen panels, often Ethyl Glucuronide needs to be specifically ordered. Also, You need to familiarize your-self with the various panels offered for urine drug screens. Opiate ( immunoassay ) screens for morphine heroin,codeine and metabolites but not oxycodone, tramadol, fentanyl. 84 May 4-7, 2016 41