Balance chronic pain management and responsible opioid prescribing. Michelle Bardack, M.D. Family & Community Medicine April 27, 2011

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1 Balance chronic pain management and responsible opioid prescribing Michelle Bardack, M.D. Family & Community Medicine

2 Overview Frame the dilemma Federation of State Medical Boards Discussion and questions 2

3 United States Statistics million adults have chronic pain % of outpatient visits to primary care clinics 2 Unrelieved pain is a public health epidemic 2003 JAMA published overall costs to society of $61 billion 3, similar to that of cancer and CVD 4 3

4 It s the law! WHO relief of pain is a basic human right 5 JCAHO.Patients have the right to appropriate assessment and management of pain. 6 Pain Relief Act NM January 20, 2003,.every New Mexican shall receive appropriate treatment for pain, further,.health providers have an obligation to treat chronic pain.including the use of controlled substances 7 4

5 Categories of Pain Treatment Psychological approach - CBT, Biofeedback, hypnosis Injection - TPI, ESI, joint Neural blockade - celiac plexus block Implants - intrathecal pump, nerve stimulator Surgical - cordotomy, neurotomy Non-opioid drugs - NSAIDS, acetaminophen Adjuvant analgesics - antidepressants, anticonvulsants Rehabilitative approaches - hot/cold packs, nerve stim, PT/OT CAM - acupuncture, chiropractic, massage Lifestyle changes - Etoh, tobacco, sedentary life, wt loss Opioids - morphine, oxycodone, fentanyl, methadone 5

6 Fear influences us Last week s JAMA: Opioid overdose is now the second leading cause of unintentional death in the USA 8 The 'Oxy Express': Florida's Drug Abuse Epidemic NPR Morning Edition, March 14, "If you're a clinic owner or a doctor or an employee knowingly working at one of these pill mills, we have probably bought dope from you. And we are probably coming to see you soon. 10 6

7 Drug Deaths in New Mexico % Change Total drug overdose deaths Rx drug overdose deaths Illicit drug overdose deaths Morphine/heroin 133 (55%) 121 (44%) -9 Cocaine 94 (39%) 110 (40%) 17 Alcohol 76 (31%) 78 (28%) 3 Methadone 28 (11%) 34 (12%) 21 Oxycodone 14 (6%) 26 (9%) 86 Methamphetamine 11 (5%) 21 (8%) 91 Propoxyphene 10 (4%) 18 (6%) 80 Diazepam 12 (5%) 16 (6%) 33 Hydrocodone 18 (7%) 15 (5%) -17 Amitriptyline 8 (3%) 14 (5%) 75 Fentanyl 2 (1%) 8 (3%) 300 Table 1. The Most Common Drugs Causing Death Among Total Drug Overdose Deaths in New Mexico,

8 DILEMMA How do we responsibly prescribe opioids and balance management of chronic pain? Opiophobia 12 8

9 A New Approach You will no longer cringe, hide head in the sand Rewarding for patient and provider 9

10 Opioid history 1. One of the oldest known drugs - opium 2. Appeared in Europe and US in 1800s, 1890 s 1st Congressional Act--opium taxed 1914 Harrison Tax Act--criminalized non-clinical use 3. Where we are today: Controlled Substances Act 1970 s (CSA) Schedule classification (Class I - V) 10

11 Pharmacology 1. Mechanism of action: mu-opioid receptor Highly variable receptor with a range of responses - producing wide inter-individual variations 2. Types: short, long, rapid-acting 3. Common side effects nausea sedation constipation pruritus 11

12 Which one to choose? An opioid trial is the only way a clinician can determine the efficacy and tolerability of a particular agent in a particular a patient 13 12

13 What are barriers to prescribing? Patient 14 Doctor 14 Regulatory 15 13

14 Patient barriers Barriers Patient: Fear if adverse affects Fear that pain is irreversible and inevitable Fear of addiction Fear of focusing on symptoms and not cause 14

15 Barriers Doctor barriers = opiophobia Lack of education about opioids and current standards Fear of toxicity Fear of addiction Fear of being scammed or had by patient Fear of regulatory scrutiny 15

16 Regulatory Barriers 1. States laws restrict Schedule II prescription quantity or duration prescription validity period 2. Prescription series 3. Triplicates/duplicates 4. Prescription monitoring programs 16

17 Federation of State Medical Boards (FSMB) 2005 Seven Step Process 1. Patient evaluation 2. Treatment plan 3. Informed consent and agreement (contract) 4. Periodic review 5. Consultation 6. Documentation 7. Compliance with controlled substances laws and regulations 17

18 Patient evaluation Step 1 Document H & P Comorbidities - anxiety, depression, cancer History of substance abuse - CAGE, ORT Document the indication for opioid use 18

19 Treatment plan Step 2 Objectives Adjust over time Don t forget other modalities 19

20 Step 3 Informed consent and agreement contract Discuss Document Contract Violation 20

21 Periodic review Step 4 Evaluate progress toward treatment objective FOUR A s - analgesia, activities, adverse effects, aberrant behaviors 16 Satisfactory response Zero pain vs improved quality of life 21

22 Consultation Step 5 Be willing to refer patients at risk Misuse, abuse, or diversion Substance abuse Psychiatric disorder 22

23 Step 6 - Documentation Accurate and complete medical records Treatment objective Discussion of risks and benefits Informed consent Treatments Past tried, why failed; Current; Future ideas Medications: Date, type, dosage, and quantity Instructions and agreements Periodic reviews 23

24 Regulations Step 7 Licensed in the state you are prescribing Federal regulations State regulations

25 Vocabulary Physical Dependence - a state of adaptation that is manifested by drug class-specific signs and symptoms that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of antagonist, physical dependence, by itself, does not equate with addiction 25

26 Pseudoaddiction - iatrogenic syndrome from the misinterpretation of relief seeking behavior as though they are drug -seeking behaviors that are commonly seen in addiction. BUT Vocabulary relief of seeking behavior resolves with the institution of effective analgesia 26

27 Vocabulary Substance Abuse - use of a substance for non therapeutic purposes or use of medication for purposes other than those it was prescribed for Tolerance - a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce a specific effect or a reduced effect is observed with a constant dose over time. Tolerance may or may not be evident during opioid treatment and does not equate with addiction. 27

28 Finally Multiple focus areas for scholarly project/publication National/ International Regulations Public Health Individual Health Government State Public Policy Pharmaceutical Companies 28

29 Websites 2005 National survey on drug use and health University of Wisconsin Pain Policy New England Journal of Medicine Opioid National Alliance Of Advocates - Buprenorphine Treatment 29

30 References 1. Gottlieb S. Speech before the American Pain Foundation. Remarks by the Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration to the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health; December 8, 2005; Washington, DC. 2. Reid MC, Engles-Horton LL, Weber MB, et al. Use of opioid medications for chronic noncancer pain syndromes in primary care. J Gen Intern Med 2002;17: Stewart WF, Ricci JA, Chee E, et al. Lost productive time and cost due to common pain conditions in the US workforce. JAMA 2003;290: International Association for the Study of Pain and European Federation of IASP Chapters. Unrelieved Pain is a Major Global Health Care Problem. November 16, Available at: 5. World Health Assembly, Cancer Prevention and Control, Geneva, Switzerland; 6. Joint Commission on Accreditation of Healthcare Organizations pain management Standards Effective January 1, Volkow Nora D. MD et al, Curtailing Diversion and Abuse of Opioid Analgesics Without Jeopardizing Pain Treatment, JAMA April 6, 2011 vol.305. No Prescription Drug Overdoses: An American Epidemic; Shah, Nina MS, NM Epidemiology Report Volume 2004 number 8, October 1, Forbes, K. Opioids: Beliefs and Myths Journal Pain Palliative Care Pharmacotherapy 2006; 20(3): Opioid Prescribing: Clinical Tools and Risk Management Strategies, Anderson, Alfred V. MD et al, December 31, th Edition 2010 Bonica s Management Of Pain, Chapter 14, Laws And Policies Affecting Pain Management, Aaron M. Gilson 15. Cancer Pain Management Policy Review Group. American Cancer Society Position Statement on Regulatory Barriers to Quality Cancer Pain Management. National Government Relations Department, American Cancer Society; Passik SD, Weinreb HJ. Managing chronic nonmalignant pain: overcoming obstacles to the use of opioids. Adv Ther. 2000; 17(2);

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