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1 Opioid Addiction: The Cure Sanford Silverman, MD Medical Director, Comprehensive Pain Medicine, Pompano Beach, FL Member: ASIPP, DAPM, FSIPP, DABAM, FSAM, FMA, BCMA Officer/Board Position: President FSIPP, Broward County Commission on Substance Abuse, Board of Directors BCMA, Assistant Clinical Professor, Dept. Surgery NOVA Southeastern University Expert Medical Advisor FL WC Publications: Articles in Anesthesiology, Canadian Journal of Anesthesia, Pain Physician No Commercial bias or disclaimer for this presentation Discuss definition of Addiction as diseases Define terms of Addiction, Dependence, Tolerance, Chemical Coping Epidemiology of prescription drug abuse Discuss good prescribing practices for opioids Discuss implementation of opioid guidelines and the identification of opioid abuser v. chronic pain patient Discuss specific risk management tools utilized for opioid therapy And Noah planted a vineyard. And he drank of the wine, and became drunken. And he was naked and dirty in his tent. And Ham saw the nakedness and filthy condition of his father, and told his two brothers. And Shem and Japheth took a garment...and covered the nakedness of their father; and they turned their faces away, so as to avert their eyes from their father's nakedness and shame. Ancient Sumeria c 3400 BC Egyptians 1300 BC Hippocrates 460 BC Pain killing narcotic Euphoria- recreational Very popular among 19 th century writers John Keats Elizabeth Barrett Browning - Genesis 9:

2 ~ 30,000,000 chemical compounds are known (Chemical Abstracts substance count) ~ 100 are addictive Nicotine Alcohol Psychostimulants (cocaine, amphetamines) Opiates Cannabinoids Barbiturates Benzodiazepines Many drugs produce physical dependence without addiction Caffeine, SSRI s Some drugs produce addiction without physical dependence Cocaine, Amphetamine Animals take addicting drugs in absence of physical dependence Pain significantly reduces addictive liability (maybe) Brain sites of addiction differ from brain sites that mediate physical dependence a primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing the development and manifestations. It is characterized by behaviors that include one or more of the following: Impaired Control over drug use Compulsive use Continued use despite harm Craving (ASAM, 2001) Addiction is a primary, chronic disease of brain reward, motivation, memory 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. Adopted by the ASAM Board of Directors 4/12/2011.

3 PHYSICAL DEPENDENCE: Pharmacologic effect characteristic of opioids; withdrawal or abstinence syndrome manifest on abrupt cessation of medication TOLERANCE: Pharmacologic effect characteristic of opioids; need to increase dose to achieve the same effect or diminished effect from the same dose PSEUDO-ADDICTION: Pattern of drug-seeking behavior of pain patients receiving inadequate pain management that can be mistaken for addiction; resolves with re-establishing analgesia CHEMICAL COPING: Behavior bears a resemblance to addiction because pill -taking is inappropriately used to manage stress PSEUDOTOLERANCE: Is the need to increase dosage not due to tolerance, but due to other factors such as disease progression, new disease, increased physical activity, lack of compliance, change in medication, drug interaction, addiction, and deviant behavior. Stimulator

4 The Hijacked Brain Hypothesis Addictive drugs act on the same brain-reward substrates and mechanisms as do natural biologically-essential rewards (e.g., food, sex, etc) Addictive drugs derive much of their addictive power by activating these brain-reward substrates and mechanisms more powerfully than natural biologically-essential rewards (e.g., food, sex, etc) Experimental evidence for this Progressive Ratio Self Administration Designed to progressively increase the workload on the experimental animal i.e. first push yields injection, then requires 2 pushes for injection, then 4, 8, 16, 32 Break point is defined as the ratio when the animal will abruptly STOP pushing to get injection Progressive Ratio Self Administration Break point Intravenously administered by Rhesus Monkey Diazepam 10:1 Morphine 200:1 Heroin 500:1 Cocaine 10,000:1 Progression of the disease of Addiction Recreational occasional use Recreational steady use Reward-driven use Habit-driven use No longer rewarding or only with first use of day Transition from ventral striatum to dorsal striatum Habit-driven use Compulsive use Denial, the Crash, Bottoming Out Treatment and achievement of abstinence Persistent vulnerability to craving and relapse Opioid withdrawal Neurochemistry - Autonomic withdrawal Opioids acutely depress NE activity in locus coeruleus Tolerance develops with chronic use and UPREGULATION of central noradrenergic activity,distal site Decreased efficacy (less analgesia) at local site of receptor (uncoupling, protein kinase) Withdrawal results in increased BP, HR, peristalsis, diaphoresis, and increased CNS irritability Opioid withdrawal Neurochemistry - Affective withdrawal Opioids acutely RAISE dopamine levels in mesolimbic pathway Tolerance develops with chronic use and DA transmission DECREASES over time Withdrawal results in anhedonia, dysphoria, depression, and anxiety

5 This is your Brain on Drugs Role of Dopamine Dopaminergic fibers in the reward/reinforcement circuitry appears to be the crucial addictive-drug-sensitive component. ALL addictive drugs have in common that the ENHANCE dopaminergic function at crucial dopamine reward synapses in the nucleus accumbens. Dopamine mediates the hedonic consequences of a reinforcing stimulus, promoting associative learning about the stimulus or anticipating its rewarding effects A physician understands risks and management of addictive disease. Persistent failure to treat addiction is poor medical practice Failure to prescribe opioids when indicated is also poor medical practice Physicians traditionally receive little or no education about pain management or the treatment of addiction.

6 Pain is undertreated Fear of patient harm Fear of regulatory, legal or licensing penalties Addictive disorder or risk for addiction Divert or misuse of medications Lack of Awareness <20% received any medical school training in identifying prescription drug diversion <40% received any training in medical school in identifying prescription drug abuse and addiction Inadequate Risk Management 43% do not ask about prescription drug abuse as part of patient history 33% do not request records from previous health care providers for new patients Inadequate Treatment of Patients 74% have not prescribed a controlled substance due to concern about patient abuse in the past year New era s Undertreatment of pain common Analgesia-induced addiction rare 1997 American Academy of Pain and American Pain Society advised all types of clinicians to consider the use of opioids in chronic pain patients BECAUSE THE RISK OF ADDICTION WAS LOW IN PAIN PATIENTS!! Liberal use of opioids for chronic nonmalignant pain Restricted use of opioids for chronic non-malignant pain. Use for cancer pain Boston Collaborative Drug Surveillance Project: 4 of 11,882 patients Survey of burn centers: 0 of 10,000 patients Survey of headache center: 3 of 2,369 patients Addiction rare in cancer and noncancer populations THEY WERE WRONG!! (Porter, 1980; Perry, 1982; Medina, 1977; Moulin, 1996)

7 Annual Numbers of New Nonmedical Users of Pain Relievers, by Age at Initiation: , SAMHSA Oxycodone Hydrocodone Methadone 51,225 (32%) 41,216 (25.7%) 42,810 (26.7%) 15,183 (9.5%) 9,160 (5.7%) Fentanyl Morphine Total = 598,542 Narcotic analgesics alone = 160,363 Adapted from the Drug Abuse Warning Network. DHHS Publication No , out of 3 visits were from nonmedical use of opioid analgesics in Of these, oxycodone and hydrocodone account for about 60%. Florida 9,201,731 Dose Units

8 Criminal Justice 17% Workplace 53% $4.6 billion $1.4 billion $2.6 billion Health Care 30% Total cost of prescription opioid abuse in the United States was $8.6 billion in 2001 and continues to grow. Birnbaum HG et al. Clin J Pain. 2006;22: Risk Management Strategies: The Cure? OPIOID THERAPY FOR CHRONIC PAIN? Efficacy Goal of therapy is pain relief and improved function Safety Predictable pharmacokinetics Evaluate interaction with alcohol GOOD PRACTICE Abuse Potential Long vs short acting Level of difficulty to alter delivery system Street value

9 Pain and Addiction Problem Pain and Addiction CAN coexist Addiction in General Population (6-15%) Varies with the drug, gender, economic status, race Addiction in Chronic Pain Population Probably increased (at least 15%) We use the same terms, with different meaning Lack of precision in definitions around abuse/dependency/addiction Sedatives Alcohol, benzodiazepines, barbiturates OTC product (Dramamine,Benadryl /dextromethoraphan) Withdrawal causes anxiety, insomnia, seizures Stimulants Cocaine, methamphetamine, amphetamines, methylphenidate Withdrawal causes profound depression Opioids Short acting (IR/CR) Long acting (methadone / bupenorphine) Withdrawal causes hyperadrenergic state, typically NOT seizures Hyperalgesia due to opioid abstinence syndrome AND high dose opioid therapy More Predictive Selling prescription drugs Prescription forgery Stealing or borrowing another patient s medications Injecting oral formulation Obtaining prescription drugs from non-medical sources Concurrent abuse of related illicit drugs Multiple unsanctioned dose escalations Recurrent prescription losses Less Predictive Drug hoarding during periods of reduced symptoms Requesting specific drugs Acquisition of similar drugs from other medical sources Unsanctioned dose escalation 1-2 times Unapproved use of the drug to treat another symptom Reporting psychic effects not intended by the physician Aggressive complaining about need for higher doses Misuse 40% Abuse: 20% Addiction: 2% to 5% Webster LR, Webster RM. Pain Med. 2005;6(6): Total Pain Population Low Risk Moderate Risk High Risk No past/current history of substance abuse Noncontributory family history of substance abuse No major or untreated psychological disorder History of treated substance abuse Significant family history of substance abuse Past/comorbid psychological disorder Active substance abuse Active addiction Major untreated psychological disorder Significant risk to self and practitioner LOW < 1% Short term exposure to opioids No history of addiciton HIGH 15-45% Long term exposure to opioids History of addiction Aberrant behaviors Unresponsive to opioid therapy WHERE IS YOUR PATIENT? Webster LR, Webster RM. Pain Med. 2005;6: Passik, 1998

10 The 5 D s Dated: doctors who have not kept up with standards of practice Duped: doctors easily manipulated by addicts, perhaps of difficulty in confronting patients, pride Disabled: doctors who are impaired by illness or chemical dependency Dishonest: doctors who willfully prescribe and use their licenses to deal drugs Denial: doctors who refuse to admit that they are wrong, I know what I am doing Risk management is a process of Assessing a product s risk-benefit balance Developing strategies and implementing tools to minimize risk and preserve benefits for the patient and the clinician Reassessing a product s benefit-risk balance and evaluating tool effectiveness Adjusting, as appropriate, the risk-minimization tools to further improve the benefit-risk balance Adapted from US Food and Drug Administration. Guidance for industry development and use of risk minimization action plans. March Risk Management Is a Shared Responsibility Health Care Providers Risk assessment Individualized therapy Patient/caregiver education Adherence monitoring Case Management Communication with provider Regulatory/Law Enforcement Patients Compliance and adherence Preventing theft Following pain treatment agreements Drug Companies Secure supply chain Tamper-resistant drug delivery Education for all (sales force to patient) Work with local, state and national agencies Pharmacies Educate patient/caregiver Vigilance for aberrant behaviors Report inappropriate prescribing Monitor drug inventory Total Population of Opioid Users and Prescribers Opioid User and Prescriber Demographics : Deciding the Future Misuser, Abuser, and Diverter Appropriately Treated Patients and Treating Prescribers Opioiphobic Patients and Prescribers Today (No RMP) Misuser, Abuser, and Diverter Appropriately Treated Patients and Treating Prescribers Opioiphobic P&P Future (No RMP) RMP = risk management plan; P&P = patients and prescribers. OR Misuser, Abuser, and Diverter Appropriately Treated Patients and Treating Prescribers Opioiphobic P&P Future (Effective RMP) High (Euphoria) X Pain Control Set realistic patient expectations for analgesia and functionality Smart goals Realistic pain control Improved functionality and productivity Improved quality of life Concomitant physical therapy to improve treatment outcomes Commit the patient to routine evaluation of treatment outcomes Adapted from Trescot AM et al. Pain Physician. 2006;9:1-40. Pain relief Physical and psychosocial function

11 Review comorbidities and pain diagnosis periodically Success continue therapy Stable doses Analgesia: decreased pain level (pain score) and increased level of function in postintervention reassessment No evidence or suspicion of abuse No unmanageable side effects Improved activity and quality of life Failure discontinue therapy Despite dose escalation or switching to other opioids Inadequate analgesia Inadequate improvement in function Intolerable side effects Abuse Noncompliance Hyperalgesia 1981 US Department of Defense instituted periodic and random drug testing of all servicemen Nearly 80% Fortune 500 companies were conducting pre-employment drug testing Resulting from Executive Order# 12564, and congressional public law # Department of Health and Human Service Guidelines publishedrequire a licensed physician to be responsible MRO s are born!, DOT involved by Adapted from Trescot AM et al. Pain Physician. 2006;9:1-40. Study I (2003) 1 Study II (2006) 2 Patients Abusing Controlled Substances (%) % No Adherence Monitoring N = 500 N = 500 9% Adherence Monitoring 1. Manchikanti L et al. J KY Med Assoc. 2003;101: Manchikanti L et al. Pain Physician. 2006;9: Make sure it IS what it says Get confirmatory analysis Make appropriate referral for addiction issues Take appropriate action for DIVERSION Appears inappropriate in my medical judgment Problem requires evaluation prior to symptomatic treatment are medicolegally acceptable. Request was refused isn t. If you say addict or drug seeking you must document an offer of substance abuse treatment. If you document diversion, you may report it under potential harm to self or others exemption to patient confidentiality. Psychological diagnoses must be assessed psychological or psychiatric evaluation. A second opinion should be offered when refusing to prescribe. Never refill chronic opioids at night or weekends. Take positive action when diversion or abuse are an issue Firing the patient is not positive action Recommend addiction treatment and document refusal Violate patient confidentiality for cases of diversion

12 Document every prescription and change. Document medical reason for each change. Never, ever meet a patient outside the office or hospital. Use an Opioid agreement if prescribing more than 30 days. DON T TAKE OFF IF YOU CAN T LAND!! PAIN MANAGEMENT OPIOID DISPENSING 1. Diagnosis with appropriate differential 2. Psychological assessment including risk of addictive disorders 3. Informed consent (verbal v. written/signed) 4. Treatment agreement (verballv.written/signed) 5. Pre/Post Intervention Assessment of Pain Level and Function Heit, Gourlay ASAM 2005

13 6. Appropriate trial of opioid therapy +/- adjunctive medication 7. Reassessment of pain score and level of function 8. Regularly assess the Four A s of pain medicine : Analgesia, Activity, Adverse reactions, Aberrant behavior 9. Periodically review pain diagnosis and co-morbid conditions, including addictive disorders 10. Documentation PAIN MANAGEMENT = RATIONAL POLYPHARMACY Ongoing PT, Psych, interventional mgt. If you really wanna score, you got to get into a pain clinic and stop begging for 20 Lortab from the ER. Pain docs don t t think anything about writing 100 tabs at a time, sometimes more. The best ones are just one guy or maybe two, not the big places. And don t t use headaches, that doesn t t work anymore. You can usually sell back pain if you say you were hurt a long time ago. Or if you ve had surgery tell them there s s pain way deep wherever the scar is. Tell them you don t t have insurance and are paying cash so they won t t order an MRI or nerve blocks. I tell them the doctor who used to treat me lives 1,000 miles away and has retired. Dude, I go to three different ones and get 200 Vikes, 120 Big Percs, and a bunch of Soma EVERY DAMN MONTH! Scoremore211; alt.drugs.hard, January 2003 This is important - if they straighten your leg out while you re sitting on the bed, tell them it hurts just like when they lift it while you re laying down. Scrape your gums with your fingernail hard enough to make a little blood, then when they want a urine pee over your finger. This puts enough blood in your urine to make them believe you passed a kidney stone. Put some Tabasco sauce on your finger and let it dry, then while your waiting for the doc, rub one eye and tell them that s the side the headache s s on- one look at that red eye and they always buy it. Alt.drugs.hard Oxycontin $20-80 Dilaudid $20-40 Crack $10-20 Heroin $12-20 MSIR $8-12 Percocet $8-15 Lortab $5-9 Xanax $3-7 Valium $2-4 MS Contin $ 3-12 Hydromorphone $8-15 Methadone $5-10 Oxycodone $5-8 Hydrocodone $3-7 Alprazolam $3-7 Soma $2-4 Diazepam $1-2 Roxicodone $ 15

14 Obtain pharmacy printout (subsequent visits PRN) Utilize your state s prescription monitoring system Complete history of drug/substance use Psychiatric history Pain quantifying scale (Magill, etc.) Urine drug screen Expectation of care document Agreement signed at first visit (preferably before) Summarizes clinic s treatment policies and philosophy Outlines patient s responsibilities Chronic pain is never an emergency and after hour calls will not be tolerated Opioid medication will not be prescribed at the first visit Screener and Opioid Assessment for Patients with Pain (SOAPP-R) Scored 0-4 per question > 22 = High Risk = Moderate Risk < 9 = Low Risk You Must define dependence, withdrawal, tolerance, addiction You must state that you discussed alternative therapies HAVE SPOUSE SIGN AGREEMENT Emphasize psychosocial and physical functional status as the guide Analgesia is a lesser concern Treat opioid-related side effects Look for behavioral changes suggestive of addiction development The 4 A s Analgesia Activities of daily living Adverse reactions Aberrant behavior

15 Signs: Hypertension Tachycardia Tachypnea Hyperthermia Diarrhea Mydriasis Rhinorrhea Chills Symptoms: Pain (abdominal cramps, myalgia, allodynia) Dysphoria (fear, anger) Insomnia Drug craving Must have physician-patient relationship Must have a chart with H&P Documentation of each Rx Document reason for early refills Document reason for any change in dosage Document expectation of treatment s effect Documentation of diagnosis causing pain Cannot predate Schedule II, but can use Do not fill until If prescribing for greater than 30 days, follow established principles and guidelines for chronic opioid therapy, opioid agreement etc. If patient requires opioids for greater than 30 days, get Pain Consult Monitor and document the 4 A s Be aware for signs of addiction and diversion Seek consultation when appropriate Know the street value of medications Ask about prior substance abuse Use due diligence to explore diversion Pharmacy sweeps Urine screens Alt.drugs.hard Use sustained release preparations over short acting Use of opioids may be necessary for pain relief Balanced multimodal care Treatment goals Improve independent function Improve activity level Decrease pain Apply risk management strategies Controlled substance agreement PDMP Screening tools Background checks Pill counts Urine drug testing Abuse deterrent products Communication with pharmacist Family and friend feedback Periodic reviews 89

16 91 Sanford M. Silverman, MD Comprehensive Pain Medicine 100 East Sample Rd, Suite 200 Pompano Beach, FL Phone: