J. Paul Seale, M.D., FAAFP Daniel P. Alford, M.D., M.P.H., FACP, FASAM

1. An SBIRT Approach To Managing Pain and Prescription Opioid Abuse: Maximizing Benefits and Minimizing Risks J. Paul Seale, M.D., FAAFP Daniel P. Alford, M.D., M.P.H., FACP, FASAM H. E. Woodall, M.D., FAAFP, FAAHPM October 30, 2013

2. Module 1: Initial Assessment and Baseline Measurement J. Paul Seale, M.D., FAAFP Daniel P. Alford, M.D., M.P.H., FACP, FASAM H. E. Woodall, M.D., FAAFP, FAAHPM October 30, 2013

3. Scope of the Problem

4. Epidemiology of Prescription Drug Misuse and Abuse • In 2006, an estimated 7.0 million persons were current users of prescription drugs taken nonmedically (2.8 percent of the U.S. population). This class of drugs is broadly described as those targeting the central nervous system, including drugs used to treat psychiatric disorders (NSDUH, 2007). • Pain relievers: 5.2 million • Tranquilizers: 1.8 million • Stimulants: 1.2 million • Sedatives: 0.4 million

5. Epidemiology of Prescription Drug Misuse and Abuse • It is generally believed that the broad availability of prescription drugs (e.g., via the medicine cabinet, the Internet, and physicians) and misperceptions about their safety make prescription medications particularly prone to abuse. • Among those who abuse prescription drugs, high rates of other risky behaviors, including abuse of other drugs and alcohol, have also been reported (a good reason to be doing urine toxicology tests in your clinic). • Prevalence of prescription opioid abuse requiring substance abuse treatment is highest (80 percent) with persons 30 years and younger (SAMHSA/TEDS, 2007).

6. Most Commonly Abused Classes of Prescription Drugs • Opioids, such as OxyContin and Vicodin, which are most often prescribed to treat pain • Central nervous system (CNS) depressants, such as Valium and Xanax, which are used to treat anxiety and sleep disorders • Stimulants, which are prescribed to treat certain sleep disorders and attention deficit hyperactivity disorder (ADHD), and include drugs such as Ritalin and Adderall

7. Scope of issue • In 2010, enough opioid pain relievers (OPR) were sold to medicate every adult in the United States with the equivalent of a typical dose of 5 mg of hydrocodone every 4 hours for 1 month, a 300% increase in the sales rate over 11 years. • This rise in distribution of OPR is concomitant with increasing rates of drug overdose death, and chronic, nonmedical use of OPR. CDC/Morbidity and Mortality Weekly. July 5, 2013 / 62(26);537-542

8. Consequences • Deaths from opioid pain relievers (OPRs) increased fivefold between 1999 and 2010 for women; OPR deaths among men increased 3.6 times. • Women are more likely than men to be prescribed OPR, to use them chronically, and to receive prescriptions for higher doses of OPR (6,7). • This might be because the most common forms of pain are more prevalent among women, and pain is more intense and of longer duration in women than men. CDC/Morbidity and Mortality Weekly. July 5, 2013 / 62(26);537-542

9. Opioid Users’ Pyramid Loss of Control Compulsive use Continued use despite harm Craving Addiction (4 Cs) Recurrent problems: Failure to fulfill major obligations Use in hazardous situations Substance-related legal problems Continued use despite social/interpersonal problems Prescription Drug Misuse Illegal activities Missing/lost prescriptions Non-adherent with monitoring Deterioration in function Resistance to change therapy Runs out of Rx early Requests specific brand Requests increased dose Non-adherence with other therapies Concerning/Aberrant Medication-Taking Behaviors and/or Multiple Risk Factors Low-Risk Patient With No Concerning Behaviors No concerning behaviors (no early refill requests or dose escalation; keeps appts, brings pill bottle; Rx count correct, UDS OK )

10. Level 1: Low-Risk Patient With No Concerning Behaviors • Initial risk assessment identifies patient as low risk • No requests for early refills or dose escalation • Keeps regularly scheduled appointments • Brings medication container • Medication counts always correct • Urine drug test (UDT) results are as expected • “Right drug” is present • “Wrong drugs” are absent

11. Level 2: Concerning/Aberrant Medication-Taking Behaviors The Spectrum of Severity Note: For most of these, need to track pattern and severity over time Butler et al., 2007

12. Level 3: Prescription DrugAbuse • Recurrent problems related to prescription drug use • Failure to fulfill major role obligations at work, school, or home • Use in physically hazardous situations • Substance-related legal problems • Continued use despite persistent or recurrent substance-related social or interpersonal problems (e.g., arguments with spouse, physical fights)

13. Level 4: Addiction Concerning Medication- Taking Behaviors Savage et al., 2003 • A clinical syndrome presenting as… • Loss of Control • Compulsive use • Continued use despite harm • Craving • Not equal to physical dependence

14. SBIRT Approach • Screening • Initial assessment: Before prescribing, assess for risk factors and obtain baseline measures using the PEG/Six As • Implement universal precautions: agreement, urine drug tests (UDT), pill counts, prescription monitoring program (PMP) • Monitor for benefit and concerning behaviors • Brief Intervention • Address concerning behaviors: Express concern, ask patient to explain • Increase monitoring • Taper if there is no benefit or behaviors continue • Referral to Treatment: If abuse/addiction, refer for detox, buprenorphine, or methadone

15. Risk Levels: Loss of Control Compulsive use Continued use despite harm Craving Level 4: Addiction (4 Cs) Level 3: Rx Drug Misuse Illegal activities Missing/lost prescriptions Non-adherent with monitoring Deterioration in function Resistance to change therapy Runs out of Rx early Requests specific brand Requests increased dose Non-adherence with other therapies Level 2: Aberrant Rx- Taking Behaviors, Multiple Risk Factors Spectrum of severity Level 1: No Concerning Behaviors Not at all 0 1 2 3 4 5 6 7 8 9 10 Extremely cm Recurrent problems: Failure to fulfill major obligations Use in hazardous situations Substance-related legal problems Continued use despite social/interpersonal problems No concerning behaviors (no early refill requests or dose escalation; keeps appts, brings pill bottle; Rx count correct, UDS OK ) 1

16. Prescription Opioid Monitoring Framework: Guidelines for Discontinuing Opioids: Funded by: www.sbirtonline.org 2 Rev. Apr 2013

17. Screening Initial assessment: Before prescribing, assess for risk factors and obtain baseline measures using the PEG/Six As Implement universal precautions: agreement, UDT, pill counts, PMP Monitor for benefit and concerning behaviors using PEG/Six As and compliance with agreement

18. Initial Assessment • Starts before the office visit • Obtain records from previous MDs • Check state prescription monitoring program • Scan available hospital and/or clinic records • Defer prescribing if data are unavailable

19. Ask About Risk Factors Ives et al., 2006; Reid et al., 2002; Michna et al., 2004; Akbik et al., 2006; Liebschutz et al., 2010 • Known risk factors for all types of addiction are good predictors of problematic prescription opioid use • Past cocaine use, history of alcohol or cannabis use • Lifetime history of alcohol or substance use disorder • Family history of alcohol or substance abuse • History of legal problems • Tobacco dependence • History of severe depression or anxiety

20. Risk Assessment Screening Tools www.opioidrisk.com/; Passik et al., 2008; Webster & Webster, 2005; Chou et al., 2009; Belgrade et al., 2006; Butler et al., 2008; Coambs et al., 1996) ORT: Opioid Risk Tool DIRE: Diagnosis, Intractability, Risk, Efficacy SOAPP/SOAPP-R: Screener and Opioid Assessment for Patients With Pain, Revised SISAP: Screening Instrument for Substance Abuse Potential

21. ORT: Opioid Risk Tool

22. Ongoing Assessment Screening Tools www.opioidrisk.com/; Butler et al., 2007; Chou et al., 2009; Wu et al., 2006; Chabal et al., 1997; Adams et al., 2008; Dowling et al., 2007; Holmes et al., 2006; Passik et al., 2008; Compton et al., 1998; Compton et al., 2008; Passik et al., 2004; Jackman & Mallett, 2008) COMM: Current Opioid Misuse Measure ABC: Addictions Behavior Checklist Chabal 5-point Prescription Opioid Abuse Checklist PMQ: Pain Medication Questionnaire PDUQ: Prescription Drug Use Questionnaire PADT: Pain Assessment and Documentation Tool Six As

23. Assessment: The Six As Jackman & Mallett, 2008 Analgesia Affect Activities Adjuncts Adverse effects Aberrant (concerning) behaviors

24. Analgesia, Affect, and Activity (PEG) Krebs et al., 2009 • What number best describes your pain on average in the past week? (0 = no pain – 10 = pain as bad as you can imagine) • What number best describes how, during the past week, pain has interfered with your enjoyment of life? (0 = does not interfere – 10 = completely interferes) • What number best describes how, during the past week, pain has interfered with your general activity? (0 = does not interfere – 10 = completely interferes) [add these 3 numbers to generate PEG score]

25. Pain Assessment Note with PEG (Sample)

26. Pain Assessment Note with PEG (Sample—side 2)

27. Adjuncts “What else have you done to try to reduce or manage your pain?” • Nonopioid drugs • Exercise with flexibility training • Nondrug treatments • Physical therapy • Complementary therapies • Cognitive behavioral therapy • Injections • Pumps

28. Adverse Effects CONSTIPATION Nausea Sedation Decreased cognition Loss of control Hyperalgesia Hypogonadism Urinary retention

29. Concerning Medication-Taking BehaviorsThe Spectrum of Severity Note: For most of these, need to track pattern and severity over time Butler et al., 2007

30. View Video 1—Pain Management: Assessment with the 6 A’s Observe this physician-patient assessment encounter with a 46-year-old new patient whose records from her previous physician showed occasional escalation of dose due to complaints of increased pain and no urine drug testing. The Prescription Monitoring Program showed prescriptions only from her gastroenterologist. Her score on the Opioid Risk Tool (ORT) is 3 (low risk).

31. Practice Session • Conduct ROLE-PLAY 1 • Assessment With the Six As Supporting materials including role play scripts may be found at www.sbirtonline.org