Identifying and Addressing Addiction in Medical Practices Joseph N. Ranieri, D.O.

Identifying and Addressing Addiction vs Dependence in Medical Practices Joseph N. Ranieri, DO, FAAFP, 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 no conflicts of interest for speaking engagements with any Pharmaceutical entity. Physician is an employee of Seabrook House. 2 Abuse / Misuse- use in a manner other than what the prescribing physician / medical provider intended. Tolerance is need to increase dose to achieve the same effect. Dependence - a physiologic process, which is a predictable event in the prescribing 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. Dependence Physiologic Response either to uncompensated increase in tolerance or to withdrawal of a drug. 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. 3 April 29 May 2, 2015 1

Identifying and Addressing Addiction in Medical Practices 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, 2013 4 Sustained recovery and an improved quality of life should be the expected goal of treatment for substance use disorders. 1. A broadly representative group of experts convened by the Betty Ford Institute in 2007 defined recovery as a voluntarily maintained lifestyle characterized by sobriety, personal health, and citizenship. 2. The American Society of Addiction Medicine (ASAM) defined recovery as a process of sustained action that addresses the biological, psychological, social, and spiritual disturbances inherent in addiction. This effort is in the direction of a consistent pursuit of abstinence, addressing impairment in behavioral control, dealing with cravings, recognizing problems in one s behaviors and interpersonal relationships, and dealing more effectively with emotional responses. Recovery actions lead to reversal of negative, self-defeating internal processes and behaviors, allowing healing of relationships with self and others. The concepts of humility, acceptance, and surrender are useful in this process. 3. The Substance Abuse and Mental Health Services Administration (SAMHSA) defines recovery from mental disorders and substance use disorders as, a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. 4. WORLD SERVICE BOARD OF TRUSTEES BULLETIN #29 -Regarding Methadone / Suboxone. One of the first things we heard was that NA is a program of complete abstinence. That is CORRECT. However, the only requirement for membership is a desire to stop using. Creating a New Standard for Addiction Treatment Outcomes A Report from the Institute for Behavior and Health, Inc.(1-3) 5 The Treatment of Medical problems and Mental Illness with Psychoactive medications that have abuse potential may result in surfacing the already predisposed Disease Of Addiction in patients with genetic predisposition & as well as those exposed to a history of environmental stressors ( i.e physical, emotional, sexual, and psychological trauma ). 6 April 29 May 2, 2015 2

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 rectal 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 ). 7 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 8 Patient has 3 different Uro-Gynecologists- 1. Dr A. Rx B & O Suppositories & Lyrica 2. Dr B. Rx Rectal 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 & 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 and Pain. 9 April 29 May 2, 2015 3

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, 5 MG, Tablet 90.00 30 Patient use 2 per day 10/02/2014 B & O Suppository 30 30 Patient use for exacerbation most 10 per month 10 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 0.5MG 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 11 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 12 April 29 May 2, 2015 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 13 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 14 15 April 29 May 2, 2015 5

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. 16 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. Opioids are often taken In larger amounts over a longer period then was intended.* 2. There is a persistent desire or unsuccessful efforts to cut down or control opioid use.* 3. A great deal of the time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects.* 4. Craving, or 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.** 7. Important social, occupational, or recreational activities are given up or reduced because of opioid use.* 8. Recurrent opioid use in situations in which it is physically hazardous.** 9. 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) 17 Standard Drug Addiction criteria has and continues to be unsatisfactory when attempting to characterize iatrogenic addiction. For Pain patients, some drug seeking behaviors are different from behaviors that are listed by standard criteria and are focused on obtaining Opiates from prescribers (aberrant behaviors- i.e. doctor shopping, frequent lost prescriptions, repeated request for early refills). Pain patients who are treated continuously with opioids may not manifest any aberrant behaviors because they are effectively receiving maintenance therapy. When Opiates suddenly are not available, addiction behaviors will emerge. Washington State Law regarding Opioid Ceiling Dose-the rule sets a ceiling ( in terms of daily morphine equivalent dose ) on the amount of opioid that can be prescribed for chronic (non acute or cancer ) pain without consultation with a pain specialist unless the individual is functioning well on a stable or tapering dose. This trend is emerging also, by manage care and insurance companies. This may cause emerging addiction behaviors on patients on existing opiates who do not have the opportunity or are unwilling to remain on same dose or taper in a timely manner. 18 April 29 May 2, 2015 6

NJ RX Prescription Monitoring System- Use It! It s not hard work to establish one More critical to share data between state when close to boarders 19 Multiple controlled Rx s per month More than one class of controlled Rx More than one prescriber More than one drug store or town Self prescribing is never, never OK. Long distance between prescriber and patient Suboxone-Buprenorphine Rx with other Controlled drugs Like Benzodiazepines/ Amphetamines / Opiates / Muscle relaxers. 20 To score them by risk: 1 year review 1 point for each class of controlled Rx-4 1 point for each prescriber -3 1 point for overlapping same class -2 2 points for each pharmacy -2 2 Points if different prescriber towns -0 6-7 some risk 8-10 higher risk Over 10 is a problem TL 11-Case Presentation 21 April 29 May 2, 2015 7

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25 Patients can present with red flags for alcohol and drug problems. Red Flag Complaints for Substance-Abuse Problems Frequent absences from school or work History of frequent trauma or accidental injuries Chronic Non-Cancer Pain Mental Illness / Depression or anxiety Labile hypertension Gastrointestinal symptoms, such as epigastric distress, diarrhea, or weight changes Sexual dysfunction Sleep disorders Multiple Providers ( NJ RX Reporting System ) 26 Results from the Epidemiologic Catchment Area study demonstrated that 47 percent of patients with a lifetime diagnosis of schizophrenia or Schizophreniform disorder met criteria for some form of substance abuse. Substance Abuse was found in: 83.6 % of patients with antisocial personality disorder 23.7% of patients with anxiety disorders 32% of patients with affective disorders Suspicion of substance abuse is important not only because of the prevalence of this disorder, but also because it is very difficult to treat Mental Illness if concomitant substance abuse is unrecognized.* *Urine drug Screening & Treatment Contracts in the Treatment of Mental Disorders & Chronic Pain / Dependence/Addiction/ Prescribing All Medications with Abuse Potential-Opiates & Tramadol-Nucynta, Benzodiazepines, Fioricet, Stimulants, Diet Pills, Medications for ADD/ADHD, some Muscle relaxers, Insomnia Medications, & Other Psychoactive Drugs With Sedative Properties. 27 April 29 May 2, 2015 9

History of alcohol or drug abuse History of trauma/physical/sexual abuse History of Mental Illness/depression/anxiety Current chaotic living environment History of criminal activity 28 29 The Current Opioid Misuse Measure (COMM) is a brief patient self-assessment to monitor chronic pain patients on opioid therapy. The COMM was developed with guidance from a group of pain and addiction experts and input from pain management clinicians in the field. Experts and providers identified six key issues to determine if patients already on long-term opioid treatment are exhibiting aberrant medication-related behaviors: Signs & Symptoms of Intoxication Emotional Volatility Evidence of Poor Response to Medications Addiction Healthcare Use Patterns Problematic Medication Behavior 30 April 29 May 2, 2015 10

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34 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. Risk of Fatal overdose maybe directly related to amount of Opiate prescribed on a daily basis Doses ( Morphine Equivalent ) 50-99 mg/day had a 3.7- fold increase in overdose risk. Doses ( Morphine Equivalent ) > 100mg/day ( 66.7mg/ day oxycodone ) had a 8.9-fold increase in overdose risk with 1.8% annual overdose rate. 35 Clinical features Patients Patients Who are with pain Addicted to opioids Compulsive drug use Maybe* Common Craving drug (when not in pain) Maybe* Common Obtain or purchase drugs Rare Common from nonmedical sources. Procure drugs through illegal activity Absent Common Escalate opioid dose without medical Maybe** Common instructions Supplement with other opioid drugs Unusual Common Demand specific opioid agents Maybe* Frequent Can stop use when effective alternative Usually Usually Not treatments are available Prefers specific routes of administration No Yes Can regulate use according to supply Sometimes* No */ ** presenters opinion ** subjective presentation of symptoms with or without manipulation ( change tolerance set point/hyperalgesia ) 36 April 29 May 2, 2015 12

Painful bladder syndrome/interstitial cystitis (PBS/IC) is a condition diagnosed on a clinical basis and requiring a high index of suspicion by the clinician. Simply put, it should be considered in the differential diagnosis of the patient who presents with chronic pelvic pain that is often exacerbated by bladder filling and associated with urinary frequency. The term Interstitial cystitis, was not at all descriptive of the clinical syndrome or the pathologic findings in many cases leading to the current effort to reconsider the name of the disorder and even the way it is positioned in the medical spectrum Tricyclic Antidepressants (Amitriptyline) have three major pharmacologic actions: (1) central and peripheral anticholinergic actions (2) block the active transport system in the presynaptic nerve ending responsible for reuptake of serotonin and noradrenaline (3) they are sedatives Antihistamines- Used since late 1950s, postulated that the local release of histamine may be responsible for, or accompany the development of, IC. Sodium Pentosan Polysulfate- A heparin analog, thought to decrease the epithelial permeability barrier (GAG layer) - 3% to 6% of which is excreted into the urine from oral pill Systemic corticosteroids Hormones Vitamin E Anticholinergics Antispasmodics Calcium channel antagonist (nifedipine) Cysteinyl leukotriene D4 receptor antagonist (montelukast) Oral L-arginine, an over-the-counter amino acid preparation, was purported to increase nitric oxide-related enzymes Dietary Restrictions April 29 May 2, 2015 13

The long-term, appropriate use of pain medications forms an integral part of the treatment of a chronic pain condition such as IC as Last Resort With the results of major surgery anything but certain, the use of longterm opioid therapy in the rare patient who has failed all forms of conservative therapy over many years may also be considered NSAID s and Acetaminophen Smoking Cessation Massage and Acupuncture Meditation and Mindfulness - (Jon Kabat-Zinn UMassMedSchool) Exercise and Sunshine PT and OT 41 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. Insomnia Sedating antidepressants Trazodone (Desyrel) Doxepin (Sinequan) Amitriptyline (Elavil) Mirtazepine (Remeron) Antihistamines Avoid Any Benzodiazepine including Atypical ( Ambien etc. ) 42 April 29 May 2, 2015 14

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 43 Opiates associated with fourfold higher hip Fx risk 70 % higher risk for hospitalizations Doubling of all-cause mortality compared with NSAID s A study by Franklin et al showed that opioids prescribed within 6 weeks of injury doubles the risk of disability one year later (Franklin, Stover, Turner, Fulton-Kehoe, & Wickizer, 2008). The United States consists of 4.6% the world s population and yet we consume 80% of the world s opioids (Solanki, Koyyalagunta, Shah, Silverman, & Manchikanti, 2011) 44 Hormonal Imbalance-A decrease in GNRH lowers sex hormone levels for both men and women. These low hormone levels will occur in over 50% of people on chronic opioid therapy (Reddy, Aung, Karavitaki, & Wass, 2010). Persistent low sex hormone levels produce multiple symptoms, which may include loss of libido, infertility, fatigue, depression, anxiety, loss of muscle strength and mass, alteration of gender role, osteoporosis, and compression fractures and, in men, impotence, and, in females, menstrual irregularities, galactorrhea and infertility (Katz, 2005) Sleep disorders Depression / Worsening of Mental illness 45 April 29 May 2, 2015 15

Prior failed treatment at a pain management program Regular tobacco use Regular alcohol use Multiple injuries or surgeries Family history of drug abuse COMM / Opioid Risk Tool Assessment 46 Failure to inform patients of the risk of driving while taking a medication, such as a benzodiazepine, 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 47 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. 48 April 29 May 2, 2015 16

49 50 10-12% of the population use benzodiazepines within the course of a year for: Psychiatric Disorders Insomnia Anxiety Agitation associated with Medical Illness / Mental Illness Pre-Medication for Surgery Procedural Anesthesia Convulsive Disorders Alcohol or drug detoxification Muscle spasm Off Label Adjunctive Medicine for additional Pain relief Most use is short-term 1-2% of the population taking benzodiazepines on a long-term basis. Most patients do not lose control of their use. 51 April 29 May 2, 2015 17

A problematic pattern of Sedative Hypnotic Anxiolytic use leading to clinically significant impairment or distress, as manifested by at least two of the following, occurring within a 12 month period: 1. Sedatives Hypnotics or anxiolyticss are often taken In larger amounts or over a longer period then was intended.* 2. There is a persistent desire or unsuccessful efforts to cut down or control sedatives hypnotics anxiolytics use.* 3. A great deal of the time is spent in activities necessary to obtain the sedatives hypnotics anxiolytics : use the sedatives hypnotics or anxiolytics; or recover from its effects.* 4. Craving, or strong desire or urge to use sedatives hypnotics anxiolytics.*** 5. Recurrent sedative hypnotic anxiolytic use resulting in a failure to fulfill major role obligations at work, school, or home.** 6. Continued sedative hypnotic anxiolytic use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of sedative hypnotic anxiolytic.** 7. Important social, occupational, or recreational activities are given up or reduced because of sedative hypnotic anxiolytic use.* 8. Recurrent sedative hypnotic anxiolytic use in situations in which it is physically hazardous.** 9. Sedative hypnotic anxiolytic use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the sedative hypnotic anxiolytic.** 10. Tolerance, as defined by either for the following: * a) A need for markedly increased amounts of sedative hypnotic anxiolytic, to achieve intoxication or desired effect. b) A markedly diminished effect with continued use of the same amount of the sedative hypnotic anxiolytic. 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 sedative hypnotic anxiolytic withdrawal syndrome. b) Sedatives Hypnotics Anxiolytics 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) 52 Use is FDA off-label Useful and adjunctive medication, resulting in decreased action potential for relief of skeletal muscle spasms due to reflex spasm to local pathology. Mechanism of action GABA receptors. Small study of 21, female patients. 62% were responders, moderate to marked improvement. 38%, no change 53 Benzodiazepines, all for almost immediate symptomatic relief or anxiety, can be quite appealing for many patients and clinicians. Before benzodiazepines, alcohol, and opiates were used for Centuries to numb anxiety. Early in the 20 th sensory, barbiturates promiscuity for the anxious about the risk of addiction and death from overdose. Meprobamate was introduced in 1955 and became an overnight sensation, the first psychotropic wonder drug in medical history. However, that success was nothing compared with the day view of benzodiazepines, beginning with chlordiazepoxide ( Librium,Limbitrol ) in 1960. 1963 Valium, diazepam ). For many years benzodiazepines were among the most frequently prescribed medications in United States. APA Task Force for benzodiazepines reported in 1990 that benzodiazepines were affective medications with mild adverse effects and low potential for abuse when prescribed properly. The year before 1989, New York State and that benzodiazepines should be dispensed as control substances. Pomerantz, risk vs benefits of benzodiazepines 54 April 29 May 2, 2015 18

Benzodiazepines bind stereo -specifically to use portions of GABA receptors that her large protein complex located on certain Neurons in the CNS. Benzodiazepines are prescribed for severe muscle spasms, tremors, acute seizures, insomnia, and alcohol and drug withdrawal symptoms But their main use is still for the treatment of anxiety disorders. The APA guidelines for the treatment of panic disorder activities to use of SSRIs, reserving benzodiazepines for the management of acute anxiety rather than for long-term treatment. With a moderate increase in SSRI use for panic disorders took place during the 1990s, more than thirds of this increase occurred as a part of concomitant treatment with a benzodiazepine. Pomerantz, risk vs benefits of benzodiazepines 55 The principal indication for BZDs is for short term treatment (2 to 6 weeks) of anxiety disorders. These conditions include generalized anxiety disorder, phobias, PTSD, panic disorder, and severe anxiety associated with depression, while waiting for the full effect of the antidepressant. Continuing BZDs beyond 4 to 6 weeks will result in loss of effectiveness, the development of tolerance, dependence and potential for withdrawal syndromes, persistent adverse side effects, and interference with the effectiveness of definitive medication and counseling. BZDs taken for more than 2 weeks continuously should be tapered rather than discontinued abruptly. There is evidence for the effectiveness of BZDs and other hypnotics in the relief of short term (1 to 2 weeks), but not long term, insomnia. The treatment period should not exceed 2 weeks. BZDs may be used for longer than 6 weeks in the terminally ill, in the severely handicapped patient, in certain neurological disorders (stiff person syndrome), and as an alternative to antipsychotics in the severely demented patient. There is no evidence supporting the long term use of BZDs for any mental health indication. At the time of BZD prescription renewal or medication review, the physician should discuss the risks of long term BZDs and the benefits of discontinuation (on cognition, mood, sleep, and energy level) and advise the patient to reduce or discontinue the BZD. For some patients this will be difficult or impossible, but the effort should be made. For many a reduction in dose, rather than discontinuation, will be the goal. 56 Improve Clinical recognition of Chronic Pain Increased use of non-opiate treatment modalities Better risk stratification of patients when opiates are used 57 April 29 May 2, 2015 19

58 Most patients who take prescribed narcotic analgesics, sedative hypnotics or stimulants, Which have abuse potential, use them responsibly and as directed. Drugs of this type generate scrutiny from the U.S. Drug Enforcement Agency (DEA) and other authorities because of there abuse Potential, overdose issues, and potential for illegal distribution. Two of the most common reasons that people consult a Physician / Medical Provider Are Pain & the Somatic Manifestations of Anxiety. Failure to provide relief from pain and anxiety disorders exacts an enormous social cost from lost productivity, needless suffering and excessive health care expenditures. With the advent of pain as the 5 th Vital sign and the side effects of NSAIDs Including GI bleeding and Cardiovascular issues. This lead to increased prescribing of opiates. Overprescribing ( Stimulants + opiates+ Benzodiazepines ) is the leading cause of investigations of Physicians / Medical Providers and of actions against the Providers licenses. Patient satisfaction takes on even greater importance as ACA provisions set to begin October 1, 2012, tie patient satisfaction to Medicare reimbursement, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. 59 60 April 29 May 2, 2015 20

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. 61 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. 62 63 April 29 May 2, 2015 21

64 65 Oxycodone Rx s increased 50% to 29 million Fentanyl Rx s increased 150% to 4.6 million Morphine Rx s increased 60% to 3.8 million 66 April 29 May 2, 2015 22

67 Nearly 40% of all pt s had no opiates on UDS 11% tested positive for illicit drugs Unprescribed opiates in 29% of samples Dr. Leider startling results Jefferson School of Population Health and Ameritox 68 It occurs more frequently in the young It is probably on the same receptor that produces euphoria It occurs with the first dose of an opioid and is exacerbated by each subsequent dose If the pain condition is stable and the pain is worse, the opioids are not the solution, they are the problem 69 April 29 May 2, 2015 23

Despite absence of direct organ-specific toxicity, opioids nonetheless produce many adverse effects Hyperalgesia -Mao, Pain, 2002 Respiratory depression Safety Studies associated with chronic use of opioids has simply not been studied - Farney, et.al., Chest, 2003 No long term studies for efficacy or safety- Furlan et al.,14 in a recent review of RCT of opioids for CNCP, concluded that the overall effectiveness of opioids for Pain was modest, and that the effect on function was small. Most of the RCT were shorter than 4 weeks, and none was longer than a few months 70 apparent opioid tolerance is not synonymous with pharmacological tolerance, but may be the first sign of opioid-induced pain sensitivity suggesting a need for opioid dose reduction. repeated opioid administration could lead to a progressive and lasting reduction of baseline nociceptive thresholds, hence an increase in pain sensitivity. Mao et al, Pain, 100 (2002) 213-217 71 72 April 29 May 2, 2015 24

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