Psychological and Legal Ramifications of High-Dose Opioids in Non-Cancer Pain

Transcription

1 Psychological and Legal Ramifications of High-Dose Opioids in Non-Cancer Pain Binit J. Shah, MD, FAPA Ohio Hospital for Psychiatry Columbus, OH

2 Binit J. Shah, Disclosures Financial o Medtronic, Buckeye Community Health Plan The planning committee for this CME activity has reviewed and determined these affiliations have not influenced the context of this presentation. Drug/Product Off-Label Use Disclosure o Off-label use of a drug and/or product will NOT be addressed in this presentation. 2

3 Planning Committee, Disclosures AAAP aims to provide educational information that is balanced, independent, objective and free of bias and based on evidence. In order to resolve any identified Conflicts of Interest, disclosure information from all planners, faculty and anyone in the position to control content is provided during the planning process to ensure resolution of any identified conflicts. This disclosure information is listed below: The following developers and planning committee members have reported that they have no commercial relationships relevant to the content of this webinar to disclose: AAAP CME/CPD Committee Members Dean Krahn, MD, Kevin Sevarino, MD, PhD, Tim Fong, MD, Robert Milin, MD, Tom Kosten, MD, Joji Suzuki, MD; and AAAP Staff Kathryn Cates-Wessel, Miriam Giles and Justina Andonian. All faculty have been advised that any recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in the presentation must conform to the generally accepted standards of experimental design, data collection, and analysis. Speakers must inform the learners if their presentation will include discussion of unlabeled/investigational use of commercial products. 3

4 Target Audience The overarching goal of PCSS-O is to offer evidence-based trainings on the safe and effective prescribing of opioid medications in the treatment of pain and/or opioid addiction. Our focus is to reach providers and/or providers-intraining from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators. 4

5 Educational Objectives At the conclusion of this activity participants should be able to: o State the true percentage of addiction/aberrant behavior with opioid use o List the high rates of co-morbidity between pain and mental illness o State the legal issues involved in opioid prescribing 5

6 OPIOIDS FOR PAIN 6

7 Whatever they re called, do they work? In a large epidemiologic study in Denmark, chronic pain patients using opioids had worse pain, higher health care utilization and lower activity levels than matched chronic pain patients not using opioids. 1 Opioid use may go against important principles of chronic pain management including increased self-efficacy, reduced reliance on the health care system, reinforcement of pain behavior, and passivity and loss of autonomy by externalization of the locus of control. 2 1 Eriksen J, Sjogren P, Bruera E, et al. Critical issues on opioids in chronic non-cancer pain: an epidemiological study. Pain 2006;125: Large RG, Schug Sa. Opioids for chronic pain of non-malignant origin- caring or crippling? Health Care Anal 1995;3:

8 But A systematic review of randomized trials for multiple opioids utilized for managing various chronic pain conditions, showed fair evidence for tramadol in managing osteoarthritis. For all other conditions and all other drugs excluding tramadol, the evidence was poor based on either weak positive evidence or indeterminate or negative evidence. Manchikanti L, Ailinani H, Koyyalagunta D, et al. A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain. Pain Phys 2011;14:

9 Myths and Facts ( Myth: Chronic opioid therapy is supported by strong evidence Physical dependence only occurs with high doses over months High dose ( 120 mg of morphine/day) therapy is supported by strong evidence Fact: Evidence of long-term efficacy is limited and of low quality With daily use, dependence can occur in days or weeks No randomized trials show long-term effectiveness in chronic non-cancer pain (CNCP) 9

10 Psychological Considerations 10

11 Co-morbidity Prevalence of chronic pain ranges from 30-60% in depressed patients. Depression (57%) is twice as common as anxiety (23%) in chronic pain. 1 1 Wong WS, Chen PP, Yap J, et al. Chronic pain and psychiatric morbidity: a comparison between patients attending specialist orthopedics clinic and multidisciplinary pain clinic. Pain Med 2011;12:

12 Co-morbidity ~50% of patients with chronic pain have PTSD vs. 8% of the general population % of patients with PTSD have chronic pain 5,6 1 Amir M, Kaplan Z, Neumann L, et al. Posttraumatic stress disorder, tenderness and fibromyalgia. J Psychosom Res 1997;42: Asmundson GJ, Norton GR, Allerdings MD, et al. Posttraumatic stress disorder and work-related injury. J Anxiety Disord 198;12: Benedikt RA, Kolb LC. Preliminary findings on chronic pain and posttraumatic stress disorder. Am J Psychiatry 1986;143: Engel Jr CC, Lie X, McCarthy BD, et al. Relationship of physical symptoms to posttraumatic stress disorder among veterans seeking care for gulf war related health concerns. Psychosom Med 2000;62: Beckham JC, Braxton LE, Kudler HS, et al. Minnesota multiphasic personality inventory profiles of Vietnam combat veterans with posttraumatic stress disorder and their children. J Clin Psychol 1997;53: Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance. Clin Psychol Rev 2001;12:

13 Co-morbidity There is some evidence that patients with depression, regardless of pain condition, do not respond as well to opioid therapy as nondepressed patients. Middleton P, Pollard H. Are chronic low back pain outcomes improved with co-management of concurrent depression? Chiropr Osteopat 2005;13(1):8. 13

14 Suicidality ~4% of the US general population reports SI in the past year and 0.5% attempt suicide 1 50% of CNCP have had serious thoughts about committing suicide 2 Smith et al, 2004: 153 adults with CNCP, clinical interview and depression inventory 3 19% had current passive SI 13% had current active SI 5% had current plan (75% overdose) 1 Substance Abuse and Mental Health Services Administration, Office of Applied Sciences. (September 17, 2009). The NSDUH Report: Suicidal Thoughts and Behaviors among Adults. Rockville, MD. 2 Hitchcock LS, Ferrell BR, McCaffery M. The experience of chronic nonmalignant pain. J Pain Symptom Manage 1994;9(5): Smith MT, Edwards RR, Robinson RC, et al. Suicidal ideation, plans, and attempts in chronic pain patients: factors associated with increased risk. Pain 2004;111(1-2);

15 Substance Abuse ~6% of adults have a substance use disorder. 1 ~18% with mental illness ~46% of patient with CNCP have history of illicit drug use and 8-23% are current users, 12% are actively abusing opioids. 2,3 1 Substance Abuse and Mental Health Services Administration, Results from the 2011 National Survey on Drug Use and Health: Mental Health Findings, NSDUH Series H-45, HHS Publication No. (SMA) Rockville, MD: Substance Abuse and Mental Health Services Administration, Manchikanti L, Cash KA, Malla Y, et al. A prospective evaluation of psychotherapeutic and illicit drug use in patients presenting with chronic pain at the time of initial evaluation. Pain Phys 2013;16:E Manchikanti L, Damron KS, McManus CD, et al. Patterns of illicit drug use and opioid abuse in patients with chronic pain at initial evaluation: a prospective, observational study. Pain Phys 2004;7:

16 Addiction In CNCP, rates were believed to be 2-18%. July 2011 study assessed rates of opioid abuse/dependence using both DSM-IV and proposed DSM-V criteria in CNCP: 35% Boscarino JA, Rukstalis MR, Hoffman SN. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. Jour of Add Dis 2011;30:

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18 Intrathecal Pumps (ITP) and Addiction Literature review One article from 1997 use of intrathecal opioid therapy for pain in individuals with histories of addiction is highly controversial. 1 There is no evidence or literature regarding de novo addiction, etc. Informed consent for possibility of addiction and continued adherence/compliance monitoring (UDS) 2 Minimizing dose escalation may be prudent 1 Portenoy RK, Savage SR. Clinical realities and economic considerations: special therapeutic issues in intrathecal therapy tolerance and addiction. J Pain Symptom Manage 1997;14:S Fishbain DA, Lewis JE, Gao J. Medical malpractice allegations of iatrogenic addiction in chronic opioid analgesic therapy: forensic case reports. Pain Med 2010;11(10):

19 Medico-legal Issues 2013 population-based study with ~550,000 adults examined opioid use and MVA in real life driving conditions. Daily use of > 20 morphine equivalents (MEQ) was associated with a 21-42% increased odds of MVA in a largely dose dependent fashion. 1 1 Gomes T, Redelmeier DA, Juurlink DN, et al. Opioid dose and risk of road trauma in Canada. JAMA Intern Med 2013;173(3):

20 What do State Medical Board members believe? 2004 survey 1 57 yo, member for 5 years, ~73% were physicians, 20% were public o 41% considered opioid dosages greater than those recommended in the PDR as probably excessive and cause for concern. MS Contin, Oxycontin, Percocet individualize dose Vicodin: Adjust dose according to severity of pain and response o 28% would doubt the legitimacy of a physician issuing more than one opioid for a single patient. 1 Gilson AM, Maurer MA, Joranson DE. State medical board members beliefs about pain, addiction, and diversion and abuse: a changing regulatory environment. J Pain 2007;8(9):

21 State Medical Board Members Only 28% believe physicians knowledge of pain management is adequate. Only 43% knew that federal law does not limit the amount of a Schedule II substance that can be prescribed at one time. 21

22 In Conclusion High rates of co-morbid depression, anxiety, PTSD and substance abuse o High risk of suicide with access to potentially easily lethal medications (opioid, benzos, TCAs). ITP therapy is not the solution for addiction o Addiction requires active management and altering the opioid delivery system alone can not treat the biopsychosocial and spiritual aspects of the disease. A contentious medico-legal atmosphere with uncertain future 22

23 References Amir M, Kaplan Z, Neumann L, et al. Posttraumatic stress disorder, tenderness and fibromyalgia. J Psychosom Res 1997;42: Asmundson GJ, Norton GR, Allerdings MD, et al. Posttraumatic stress disorder and work-related injury. J Anxiety Disord 198;12: Beckham JC, Braxton LE, Kudler HS, et al. Minnesota multiphasic personality inventory profiles of Vietnam combat veterans with posttraumatic stress disorder and their children. J Clin Psychol 1997;53: Benedikt RA, Kolb LC. Preliminary findings on chronic pain and posttraumatic stress disorder. Am J Psychiatry 1986;143: Boscarino JA, Rukstalis MR, Hoffman SN. Prevalence of prescription opioiduse disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. Jour of Add Dis 2011;30:

24 References Engel Jr CC, Lie X, McCarthy BD, et al. Relationship of physical symptoms to posttraumatic stress disorder among veterans seeking care for gulf war related health concerns. Psychosom Med 2000;62: Eriksen J, Sjogren P, Bruera E, et al. Critical issues on opioids in chronic noncancer pain: an epidemiological study. Pain 2006;125: Fishbain DA, Lewis JE, Gao J. Medical malpractice allegations of iatrogenic addiction in chronic opioid analgesic therapy: forensic case reports. Pain Med 2010;11(10): Gilson AM, Maurer MA, Joranson DE. State medical board members beliefs about pain, addiction, and diversion and abuse: a changing regulatory environment. J Pain 2007;8(9): Gomes T, Redelmeier DA, Juurlink DN, et al. Opioid dose and risk of road trauma in Canada. JAMA Intern Med 2013;173(3):

25 References Hitchcock LS, Ferrell BR, McCaffery M. The experience of chronic nonmalignant pain. J Pain Symptom Manage 1994;9(5): Large RG, Schug Sa. Opioids for chronic pain of non-malignant origin- caring or crippling? Health Care Anal 1995;3:5-11. Manchikanti L, Ailinani H, Koyyalagunta D, et al. A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain. Pain Phys 2011;14: Manchikanti L, Cash KA, Malla Y, et al. A prospective evaluation of psychotherapeutic and illicit drug use in patients presenting with chronic pain at the time of initial evaluation. Pain Phys 2013;16:E1-13. Manchikanti L, Damron KS, McManus CD, et al. Patterns of illicit drug use and opioid abuse in patients with chronic pain at initial evaluation: a prospective, observational study. Pain Phys 2004;7:

26 References Middleton P, Pollard H. Are chronic low back pain outcomes improved with comanagement of concurrent depression? Chiropr Osteopat 2005;13(1):8. Portenoy RK, Savage SR. Clinical realities and economic considerations: special therapeutic issues in intrathecal therapy tolerance and addiction. J Pain Symptom Manage 1997;14:S Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance. Clin Psychol Rev 2001;12: Smith MT, Edwards RR, Robinson RC, et al. Suicidal ideation, plans, and attempts in chronic pain patients: factors associated with increased risk. Pain 2004;111(1-2); Substance Abuse and Mental Health Services Administration, Office of Applied Sciences. (September 17, 2009). The NSDUH Report: Suicidal Thoughts and Behaviors among Adults. Rockville, MD. 26

27 References Substance Abuse and Mental Health Services Administration, Results from the 2011 National Survey on Drug Use and Health: Mental Health Findings, NSDUH Series H-45, HHS Publication No. (SMA) Rockville, MD: Substance Abuse and Mental Health Services Administration, Wong WS, Chen PP, Yap J, et al. Chronic pain and psychiatric morbidity: a comparison between patients attending specialist orthopedics clinic and multidisciplinary pain clinic. Pain Med 2011;12:

28 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN),and International Nurses Society on Addictions (IntNSA). For more information visit: For questions pcss-o@aaap.org Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. H79TI023439) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by 28 the U.S. Government.