Risk Management During Opioid Analgesic Prescribing for Chronic Pain Erik Gunderson, MD University of Virginia, Charlottesville © AMSP 2012

Chronic Pain ↑Opioid Rx since Mid 90s 20-40% prevalence Costly & Disabling Healthcare Employment General Function ↑Opioid Rx since Mid 90s Animated 2 © AMSP 2012

Rx Opioid Problems Rising prescribing paralleled by: 67% ↑Rx opi use Dx (‘91-’01) 100% ↑Emergency admits (‘04-’08) 400% ↑Treatment admits (‘98-’08) 3 © AMSP 2012

MD Dilemma Rx Pain Avoid risk 4 © AMSP 2012

This lecture covers Definitions Universal Precautions Recognition Rx opi problems Management 5 © AMSP 2012

3 Cases A: 70 F ↓pain, ↑fxn, stable meds B: 50 F ↓pain, ↑fxn, extra meds C: 45 M↑↑dose for pain & stress 6 © AMSP 2012

Definitions Opiate (e.g., morphine) Semi-synthetic (oxycodone) Opioids used in Rx: Opiate (e.g., morphine) Semi-synthetic (oxycodone) Synthetic (fentanyl) 7 © AMSP 2012 7

Definitions Opioids Standard UDS Opiate + Semi-synthetic +/- 8 © AMSP 2012

Definitions, cont. Misuse Abuse Dependence Physiological dependence Pseudoaddiction Hyperalgesia 9

Misuse Reason other than intended Unsanctioned route Diversion Non-medical use Reason other than intended Unsanctioned route Diversion Purpose: To present the current DSM-IV-TR diagnostic criteria for alcohol dependence Key Points: Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period: Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms Loss of control (ie, drinking larger amounts or over a longer period than was intended) Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use) Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect) Important social, occupational, or recreational activities are given up or reduced because of alcohol use Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000. Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001:2561-2566. 10 © AMSP 2012 10

Abuse 1+ criteria in 12-months: Failure to fulfill roles Risky situations Run-ins with law Interpersonal problems Purpose: To present the current DSM-IV-TR diagnostic criteria for alcohol dependence Key Points: Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period: Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms Loss of control (ie, drinking larger amounts or over a longer period than was intended) Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use) Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect) Important social, occupational, or recreational activities are given up or reduced because of alcohol use Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000. Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001:2561-2566. Never dependent on this drug 11 © AMSP 2012 11

Dependence 3+ criteria in 12-months: Tolerance Withdrawal Larger amounts Desire/attempts to cut down ↑Time spent Give up activities Ongoing use despite problems Purpose: To present the current DSM-IV-TR diagnostic criteria for alcohol dependence Key Points: Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period: Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms Loss of control (ie, drinking larger amounts or over a longer period than was intended) Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use) Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect) Important social, occupational, or recreational activities are given up or reduced because of alcohol use Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000. Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001:2561-2566. 12 12

Dependence 3+ criteria in 12-months: Tolerance Withdrawal Larger amounts Desire/attempts to cut down ↑Time spent Give up activities Ongoing use despite problems Physiological Dependence Purpose: To present the current DSM-IV-TR diagnostic criteria for alcohol dependence Key Points: Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period: Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms Loss of control (ie, drinking larger amounts or over a longer period than was intended) Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use) Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect) Important social, occupational, or recreational activities are given up or reduced because of alcohol use Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000. Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001:2561-2566. 13 13

Withdrawal 3+ criteria if ↓chronic opioids (DSM) Dysphoric mood Nausea or vomiting Muscle aches Tears and/or runny nose ↑Pupils, “goosebumps,” sweating Diarrhea Yawning Fever Insomnia Purpose: To present the current DSM-IV-TR diagnostic criteria for alcohol dependence . Just to note: IV and IVTR are identical for all Dx criteria. Key Points: Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period: Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms Loss of control (ie, drinking larger amounts or over a longer period than was intended) Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use) Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect) Important social, occupational, or recreational activities are given up or reduced because of alcohol use Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000. Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001:2561-2566. 14 14

Definitions, cont. Pseudoaddiction Not official dx Not meet DSM dx Under treated pain → Drug seeking behaviors NOTE: Hyperalgesia is the term that is here to be defined so I re-added it but with animation Hyperalgesia: ↑ Pain sensitivity 15 © AMSP 2012 15

This lecture covers Definitions Universal Precautions Recognition Rx opioid concerns Management 16 © AMSP 2012

Universal Precautions Goal: ↓pain, ↑fxn, ↓risk A:↓Structure, periodic monitoring B: Medium structure+monitoring C: ↑Structure, referral Considerations in cases 17 © AMSP 2012 17

Core Components Dx pain etiology Conservative Rx start Assess risk Opioid treatment agreement Adherence monitoring Documentation You might need some text in outline to cover this. 18 18

Dx Pain Etiology Hx/PE Review tests Seek consultation as needed Review prior treatment/response Document synthesis 19 19

Conservative Rx Initiation Non-pharmacologic Non-opioid meds Minimally effective opioid Rx Time-limited trial Monitor + document response 20 20

Assess Risk Inquire about hx of: Family/personal substance Dx Illicit substance use Psychiatric Sx & Dx Opioid misuse Preadolescent sexual abuse Legal problems 21 21

Opioid Rx Agreement Sets expectations Clarifies treatment structure Limited data Favored by some MDs Some concerns 22 © AMSP 2012 22

Adherence Monitoring Urine Drug Screening (UDS) Rx monitoring programs Pill counts Corroboration Must be documented 23 © AMSP 2012 23

Urine Drug Screening Must consider: How often Sample collection monitoring Laboratory vs. office testing Opiate vs. opioid specific tests Quantification drug/metabolites 24 24

Urine Drug Screening New case example: 30 F on hydrocodone (Vicodin) Opioid specific test: Animated Hydrocodone + hydromorphone What happened? 25 25

Prescription Monitoring Programs (PMP) Online state registry with Rx info: Drug name Date Quantity Where filled Prescriber Animated Limitation: lag time, often 1 state 26 26

Adherence Monitoring, cont. Pill counts Corroboration Must be documented Family Healthcare providers Pharmacy 27 © AMSP 2012 27

This lecture covers Definitions Universal Precautions Recognition Rx opioid concerns Management 28 © AMSP 2012

Recognizing Opioid Misuse Hx: - Non-medical use - DSM criteria Stress relief Energy Sleep Euphoria Unapproved route 29 © AMSP 2012 29

Recognizing Opioid Misuse PE: - Intoxication (DSM) Euphoria Pupils constricted Drowsiness Slurred speech Attention or memory impaired “Nodding out” Animated - Withdrawal if Rx out early - Nose, skin, etc. signs 30 30

Recognizing Opioid Misuse UDS/PMP/Pill Corroboration: Rare false+ Discussion opportunity Review Rx plan Modify structure/monitoring 31 © AMSP 2012 31

Behavioral Factors Less Risk Stable use pattern Improved function Concerned about side effects Follows Rx plan Has leftover meds 32

Behavioral Factors Higher Risk Loss of control ↓Function Unconcerned adverse effects Not follows Rx plan Preoccupied with opioids 33 33

Assessment Repeatedly Document: All signs/symptoms (no 1 is key) Review indicators of pain/function: Stability Concern Emphasize misuse/ SUD 34 © AMSP 2012 34

The 3 Cases A: ↓Pain, ↑fxn, no concerns > Continue present Rx B: ↓Pain, ↑fxn, some concerns > Treat, but change plan? C: Many concerns > Management change 35 35

This lecture covers Definitions Universal Precautions Recognition Rx opioid concerns Management 36 © AMSP 2012

Opioid Misuse or SUD Options Continue Rx with ↑structure Stop opioids Referral Opioid refill clinic SUD program Pain program 37 37

Summary ↑Rx opioids →consequences Common MD dilemma Implement universal precautions Tailor Rx structure & plan Document findings 38 38