Overview of Prescription Drug Abuse and the Interface With Pain

1. Overview of Prescription Drug Abuse and the Interface With Pain Kenneth L. Kirsh, Ph.D. Assistant Professor Pharmacy Practice and Science University of Kentucky Clinical Psychologist, Researcher The Pain Treatment Center of the Bluegrass Lexington, KY

2. Pain Facts • Dichotomy: Rx drug abuse increasing, but pain still undertreated • 50 million people in USA have chronic pain 1-3 • 40-60% have difficulty getting pain adequately treated 4-6 • Dembe AE, Himmelstein JS, Stevens BA, Beachler MP. 1998 • Osterweis M, Kleinman A, Mechanic D. 1987. • Verhaak PFM, Kerssens JJ, Dekker J, et al. 1998 • Glajchen M, Fitzmartin RD, Blum D, et al. 1995 • Ramer L, Richardson JL, Cohen MZ, et al. 1999 • Ward SE, Goldberg N, Miller-McCoulry V, et al. 1993

3. Pain Treatment Today • Wherever pain is treated, a market can be expected to grow vying for access to controlled substances for misuse • All pain management in our society goes on against a backdrop of addiction, diversion and misuse • All stakeholders (practitioners, patients, regulators, insurance companies, pharmaceutical companies) need to develop realistic strategies for the use of pain medicines in a drug abusing world (including use of PMP systems where available)

4. New* Illicit Drug Use in the US: 2006 *Past-yr initiates for specific illicit drugs among persons aged ≥12 yrs SAMHSA. (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series: H-32, DHHS Publication No. SMA 07-4293). Rockville, MD

5. Source of Pain Relievers for Nonmedical Use: 2006 *Past-yr use among persons aged ≥12 yrs SAMHSA. (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series: H-32, DHHS Publication No. SMA 07-4293). Rockville, MD.

6. The Pendulum Rarely Stops in the Middle • Avoidance • “Will not prescribe opioids for any reason” • Driven by fear of regulatory action or being “burned” • Widespread Use • “Less than 1% will ever become addicted” • Prescribing without recognition of dangers • Balance • Rational pharmacology • Driven by continued prescribing with close monitoring

7. Responsibility of Healthcare Providers • Acknowledge: Rx drug abuse is real – not isolated or purely media hype • Evaluate: Conduct medical evaluation + risk hx before starting opioids (use PMPs if available) • Recognize limitations: Available time, psychiatric expertise, setting, resources, etc. • Obtain: Consultations as needed • Employ: Rational pharmacotherapy • Comply: with state/federal guidelines

8. Embracing Common Definitions Opioid versus Narcotic Tolerance Physical Dependence Pseudoaddiction Substance Abuse Addiction

9. Identifying Addiction – The 4 C’s • Continued use of drug despite harm • Loss of Control re: taking the drug • Compulsive use of the drug • Cravings for the drug Note: Tolerance and physical dependence do not play a defining role

10. Setting the Stage Challenges of Treating Pain in Kentucky: Cultural Influence

11. Any NASCAR fans?

12. Kentucky Facts Cottage Industry #1: Moonshine

13. Kentucky Facts • Kentucky runs 3rd or 4th in marijuana production • Daniel Boone National Forest is often target for growing crops (690,000 acres of public property to avoid personal loss or responsibility) • KY forests are deemed to be the “marijuana belt” – good soil and climate conditions • 206,908 plants eradicated by DEA in 2003 (“drop in the bucket”) Cottage Industry #2: Marijuana

14. Kentucky Facts • 19,366 doses of diverted pharmaceuticals were captured in Kentucky in 2003 (another “drop in the bucket”) • Eastern KY leads the nation in grams of narcotic pain medications distributed on a per capita basis • DEA: “Anecdotal information suggests that OxyContin abusers may switch to heroin and/or methadone in response to a diminished availability of OxyContin in a given region “ Cottage Industry #3: Prescription Drugs

18. Newsweek (Sept, 2004)“Kentucky's Pain” • Three years into the war on OxyContin abuse, the casualties continue. But there's hope where it all began… • Police raids, like this one in Hazard, Ky., have led to the arrest of hundreds, including teenagers and even grandmothers

20. Kentucky Facts • Sources: • “Hillbilly” meth – cheaper, lower quality, homemade goods • Mexican/Hispanic organizations – higher quality, more expensive Cottage Industry #4: Methamphetamine production and use is on the rise on Kentucky

21. Prescription Drug Abuse KY Data • Used chart review to study abusers entering drug treatment • Set the stage for the prospective study that followed

22. Seeking Treatment for OxyContin Abuse: A Chart Review of Consecutive Admissions to a Substance Abuse Treatment Facility(Commentary: What Oncologists Should Know About Prescription Opioid Abuse and Diversion)Lon Hays, MDKenneth L. Kirsh, PhDSteven D. Passik, PhDJNCCN, 2003; 1 (3): 423-428.(Journal of the National Comprehensive Cancer Network)

23. JNCCN Article - Results • 491 admissions to Addictive Disease Unit in 15-month period • 258 (52.5%) admitted for abuse with prescription opioids • 169 men, 89 women • 219 rural, 39 urban • Mean age – 34 (SD 10.6) • 162 (62.8%) for OxyContin, 96 (37.2%) for any other opioid Hays, Kirsh Passik. JNCCN, 2003; 1 (3): 423-428

24. JNCCN Article –OxyContin Specific Results(n = 162) • Profile: • 117 men, 45 women • mostly rural (n = 148, 91.4%) • Majority admitted to buying on the street (n = 160, 98.8%) • Only 48 (29.6%) had ever obtained it through legitimate rx • 78 (48.1%) also used other opioids (either hydrocodone products or methadone) • Mean dose: 181.3mg for average of 19.7 months • Administration (initial): oral (82%), snorting (16%), IV (1%) • Administration (admission): snorting (58%), IV (21%), oral (21%) Hays, Kirsh Passik. JNCCN, 2003; 1 (3): 423-428

25. JNCCN Article –Chronic Pain Subset • 77 patients (47.5%) reported chronic pain issues • 60 of these still had chronic pain issues at time of admission • Subset of 60 pain patients were older • mean age = 36 years vs. 29 years in rest of sample (t1,160 = 4.46, p<.001) • Administration (initial): • oral (78%), snorting (10%), IV (0%) • Administration (admission): • snorting (70%), IV (27%), oral (10%) Hays, Kirsh Passik. JNCCN, 2003; 1 (3): 423-428

26. The Prospective Study • Rationale: • The retrospective chart review had several limitations and it was felt that a prospective survey was needed to confirm and expand the findings • especially with regard to greater detail in the understanding of pain in these patients • Thus, we aimed to • better characterize prescription opioid abusers seeking addiction treatment • describe the correlates and predictors of prescription drug abuse Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

27. Participants • Patients seeking admission to the Ridge Behavioral Health Addiction Unit in Lexington, KY • Eligibility: • over 18 years of age • could read and write English • did not have cognitive limitations so severe so as to compromise the ability to give informed consent • Recruited: • A total of 109 patients whose chief complaint was prescription drug abuse • A subset of 20 also submitted urine sample and blood serums to check for the presence of • Fentanyl • Oxycodone • Methadone Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006; 20(2): in press

28. Demographics • Prescription drug abusers (n = 109) • Age: • mean age of 30.95 years (SD = 10.21) • Gender: • 75 men (69%) • 34 women (31%) • Race: • Caucasian (n = 107, 98%) • Education: • attended some college (n = 38, 35%) • completed high school (n = 30, 28%) • attended some high school (n = 26, 24%) • Marital status: • single (n = 52, 48%) • married (n = 42, 39%) • Employment (prior to hospitalization): • working full time (n = 46, 42%) • disabled (n = 30, 28%) • unemployed (n = 20, 18%) Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

29. Demographics cont’d • Smoking Status: • majority (n = 80, 73%) were smokers • average = 1.19 packs-per-day (SD = 0.57) • Habit length = 12.87 years (SD = 9.81) • Alcohol Use: • 53 (49%) stating that they used alcohol on occasion • 56 (51%) stating that they did not drink at all • General Health Status: • few health problems overall (chronic pain treated separately) • hypertension (n = 14, 13%) • renal problems (n = 7, 6%) • seizure disorders, diabetes, and hepatitis (n = 5, 5% for each) Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

30. SCID Results • All patients met criteria for current opioid abuse and or dependence • Sixteen (15%) of the patients met criteria for a diagnosis of opioid abuse and dependence and an additional Axis I disorder such as • depression • bipolar disorder • panic disorder • post-traumatic stress disorder (PTSD) • generalized anxiety disorder • Polysubstance abuse (n = 34, 31%) • Polysubstance abuse plus an additional mental health disorder (n = 49, 45%) Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

31. Prescription Drug Abuse and Pain • Majority (n = 92, 84%) had legitimately been given a prescription for opioids for pain at some point from a primary care physician • 66 (61%) had chronic pain problems • 0-10 pain scale: • pain at its worst (mean = 8.2, SD = 2.0) • pain at its least (mean = 3.9, SD = 2.4) • pain on average (mean = 5.8, SD = 2.0) • All of the subjects (n = 109, 100%) reported abusing prescription opioids • corroborated by their urine toxicology and blood serum tests. Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

32. Opioid Exposure and Abuse Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

33. Opioid Preference and Cost Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

34. Preferred Modes of Alteration Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

35. Distress Levels • Distress Thermometer • high amount of distress (mean = 6.5, SD = 3.0) • Concerns: • pain (n = 83, 76%) • anxiety (n = 60, 55%) • depression (n = 58, 53%) • insomnia (n = 56, 51%) • fatigue (n = 51, 47%) • issues with work/school (n = 37, 34%) • issues with housing (n = 33, 30%). Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

36. Within Group Findings • Older patients: • reported higher levels of pain on average (r = .28, p<.01) • experienced greater degrees of interference due to their pain (r = .33, p<.001) • Those with high Distress Scores: • experienced more interference in their daily functioning due to pain (r = .28, p<.01) • Non significant factors: • Gender, ethnicity, education level, marital status, DSM-IV diagnosis, smoking status, and alcohol use were not significantly related to level of distress, pain, or interference in daily functioning due to pain. Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

37. Conclusions – Profile of Addiction • Those entering treatment for prescription drug abuse were most likely to be young, rural, Caucasian men • Most were smokers and approximately half also drank alcohol on occasion • They tended to be polysubstance abusers with multiple additional psychiatric complications such as anxiety, depression, or PTSD • This profile sheds light on the complex drug abuse problems inherent in this region of the country • The pain management offered these complex patients is often in settings where adequate pre-screening is often limited Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

38. Conclusions – Drug Preferences • Hydrocodone class abused most often overall, but OxyContin was the single most preferred drug for abuse • likely a mixture of a regional effect combined with availability issues • OxyContin abuse nearly always entailed alteration of delivery system to create a more rapid, short-acting effect • thus, the top three medications preferred for abuse (OxyContin, Lortab and Percocet) were all short-acting medications in the way they were abused • Drug abusers do not seek out long-acting medications with an intact delivery system • rather, they prefer bolus doses with rapid onset and rapid offset action • thus, the schedule of an opioid is less important than the ease of rapid administration • Considering schedule III medications “safer” than schedule II medications is a gross oversimplification, and a miscalculation often made by physicians Passik, Hays, Eisner, Kirsh. J Pain Pall Care Pharmacotherapy, 2006

39. What Should Prescribers Be Doing Better?And, Why Can’t They Just Look at Patients and Identify The Addicts?

40. Physician-Ranking of Ab. Behs.(Passik, Kirsh, et al, J Pain Pall Care Pharm, 2002)

41. Documentation: The 4 A’s • Analgesia (pain relief) • Activities of Daily Living (psychosocial functioning) • Adverse effects (side effects) • Aberrant drug taking (addiction related outcomes) Passik and Weinreb, 1998; Passik, Kirsh et al, 2004; 2005

42. Population of Rx Opioid Users Is Heterogeneous “Self-Treaters” “Adherent” “Chemical copers” “Recreational users” “Substance abusers” “Substance abusers” “Addicted” (SUD) “Addicted” (SUD) Nonmedical Users Pain Patients

43. Differential Diagnosis of Aberrant Drug-Taking Attitudes and Behavior • Addiction • Pseudoaddiction (inadequate analgesia) • Chemical Copers • Other psychiatric diagnosis • Encephalopathy • Borderline personality disorder • Depression • Anxiety • Criminal Intent (Passik & Portenoy 1996)

44. Management of Risk Is a “Package Deal” • Screening & risk stratification • Use of PMP data • Compliance monitoring • Urine screening • Pill/patch counts • Education regarding drug storage & sharing • Psychotherapy & highly “structured” approaches • Abuse-deterrent formulations

45. Opioid Prescribing: In & Out of the Box Pain syndrome in which opioid use controversial Dose <180 mg MSO4 equivalents daily Dose >180 mg MSO4 equivalents daily Older age Cancer & perioperative pain Active psych disorder or substance abuse Lack of active psych or substance abuse Contact with nonmedical users Limited contact with nonmedical users Younger age

46. Conclusion • Pain management is under intense scrutiny • However, chronic pain is still under-treated in this country • We must use standards of good practice • Documentation, rational prescribing, opioid agreements, urine screens, etc. to protect ourselves and our patients • We must not be afraid to ask the difficult questions of our patients about their lives, loved ones, and social circles

47. Resources • Websites of interest: • http://www.emergingsolutionsinpain.com • http://www.painknowledge.org • http://www.npecweb.org • http://www.painedu.org

48. Contact Kenneth L. Kirsh, PhD UK College Pharmacy 725 Rose St., 201B Lexington, KY 40536-0082 klkirsh@email.uky.edu (859) 323-3849