Dangerous Liaisons. Overdose, Diversion & Deception

Transcription

1 Dangerous Liaisons Overdose, Diversion & Deception David A. Frenz, M.D. Diplomate, American Board of Addiction Medicine Diplomate, American Board of Family Medicine Minnesota Academy of Family Physicians Summer Destination CME 19 August 2017

2 Disclosures I m a physician in private practice I was previously employed by HealthEast Care System (medical director) North Memorial Health Care (vice president) I m on faculty at the University of Minnesota Evidence-based medicine

3 Disclosures I don t have any financial relationships with the pharmaceutical or medical device industries But I m a paid consultant for Venebio, the company that received a grant to develop the overdose calculator that I ll be presenting I don t intend to discuss investigational drugs or the off label use of medications

4 Lecture Outline Overdose Diversion Deception

5 Overdose

6 JAMA 2016;315:1624

7 JAMA 2016;315:1624

8 Biggest Game Changer Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to 50 morphine milligram equivalents (MME) or more per day, and should avoid increasing dosage to 90 MME or more per day or carefully justify a decision to titrate dosage to 90 MME or more per day. JAMA 2016;315:1624

9 MME Opioid CF mg/d Morphine Hydrocodone Hydromorphone Oxycodone Oxymorphone mcg/h Fentanyl TD JAMA 2016;315:1624 CF = Conversion Factor

10 J Pain 2015;16:318

11 Pain Med 2017 Apr 13 [Epub ahead of print]

12 Venebio Group, LLC

13 Odds Ratio OR = 1 No change in event rate Generally the reference group/anchor OR < 1 Reduced event rate OR > 1 Increased event rate

14 Demographic Risk Factors Variable Odds Ratio* Residence in the Midwest 1.22 Age 65 years 1.21 Male 1.10 * 95% confidence interval (CI) does not include 1 Pain Med 2017 Apr 13 [Epub ahead of print]

15 Clinical Risk Factors Variable Odds Ratio* Myocardial infarction 2.39 Cerebrovascular disease 2.35 Chronic kidney disease 1.93 Heart failure 1.92 Chronic pulmonary disease 1.33 Diabetes without complications 1.22 Systemic hypertension 1.20 * 95% confidence interval (CI) does not include 1 Pain Med 2017 Apr 13 [Epub ahead of print]

16 Mental Health & Addiction Risk Factors Variable Odds Ratio* Substance use disorder Depression 3.12 Bipolar disorder 2.18 Schizophrenia 2.06 Tobacco use disorder 1.69 Anxiety disorder 1.64 * 95% confidence interval (CI) does not include 1 Pain Med 2017 Apr 13 [Epub ahead of print]

17 Pain-Related Risk Factors Variable Odds Ratio* Recurrent headache 1.48 Low back disorders 1.42 * 95% confidence interval (CI) does not include 1 Pain Med 2017 Apr 13 [Epub ahead of print]

18 Opioid-Related Risk Factors Variable Odds Ratio* Fentanyl 2.83 Morphine 2.44 Methadone 2.35 Oxycodone 1.32 ER/LA formulation 1.48 MED = mg/d 1.35 MED 100 mg/d 2.31 * 95% confidence interval (CI) does not include 1 Pain Med 2017 Apr 13 [Epub ahead of print]

19 Medication-Related Risk Factors Variable Odds Ratio* Benzodiazepines 1.77 Muscle relaxants 1.40 Other sedatives 1.34 Antidepressants 1.33 Antipsychotics 1.19 * 95% confidence interval (CI) does not include 1 Pain Med 2017 Apr 13 [Epub ahead of print]

20 American Academy of Pain Medicine 2015 Annual Meeting Poster #LB010

21 Example Patient Clinical Feature Points COPD 5 ER/LA opioid 5 Fluoxetine 8 Total Points 18 Risk Class 5 Risk of Overdose 30% American Academy of Pain Medicine 2015 Annual Meeting Poster #LB010

22 Risk Management Hedges Better informed consent Patient-specific risk factors Naloxone intranasal

23 Diversion

24 Definition In this section, diversion means the transfer of a controlled substance from a lawful to an unlawful channel of distribution or use Model Controlled Substances Act (1994)

25 Clin J Pain 2016;32:279

26 Not Concerned Although many respondents expressed concern regarding opioid diversion, approximately 1 in 4 reported being not at all or only slightly concerned about this phenomenon, despite its ubiquity and the important role it plays in overall opioid-related morbidity and mortality Clin J Pain 2016;32:279

27 Friendly Sources Although 4 in 5 physicians believed that rogue prescribers and pill mills contribute some or a lot to opioid abuse, these are not the ultimate sources of many prescription opioids used for nonmedical purposes Clin J Pain 2016;32:279

28 Substance Abuse and Mental Health Services Administration Source for Diverted Opioids

29 J Pain Res 2015;8:361

30 Study Design Primary objective Assess a new pain medication (morphine + naltrexone) Secondary objective Assess patient risk for misuse, abuse and diversion: physician rated vs patient reported

31 Study Design 157 centers in 35 states 687 patients were consented 682 patients were assessed by clinicians for risk of diversion 587 patients completed a anonymous survey about their history of diversion

32 J Pain Res 2015;8:361

33 J Pain Res 2015;8:361

34 SR-MAD Self-Reported Misuse, Abuse and Diversion 18 items/questions covering 3 domains Anonymous Not designed for in-clinic use J Pain Res 2015;8:361

35 Q11 Have you ever had to visit more than 1 doctor at the same time to get enough of your opioid medication? 100% 80% 60% 40% YES NO 20% 0% Q11 J Pain Res 2015;8:361

36 Q13 Have you ever helped someone else who was sick or in pain by giving them some of your opioid medication? 100% 80% 60% 40% YES NO 20% 0% Q13 J Pain Res 2015;8:361

37 Q15 Have you ever had to get your opioid medication from someone who was not a doctor because you didn t have enough? 100% 80% 60% 40% YES NO 20% 0% Q15 J Pain Res 2015;8:361

38 Q17 Have you ever suspected that someone else may be taking your medication without asking you? 100% 80% 60% 40% YES NO 20% 0% Q17 J Pain Res 2015;8:361

39 Drugs (Abingdon Engl) 2012;19:144

40 Study Design Eligibility At least 18 years of age Sold at least 100 pills of prescription controlled substances in the past month Data acquisition 50 drug sellers were interviewed per a semi-structured interview guide Interviews were recorded, transcribed and themed Drugs (Abingdon Engl) 2012;19:144

41 Drugs (Abingdon Engl) 2012;19:144

42 Sellers Reporting 60% 50% 40% 30% 20% 10% 0% Doctor shopping Sponsorship Buying prescriptions Connections Drugs (Abingdon Engl) 2012;19:144

43 Buying Prescriptions Dealers tended to seek out individuals with reliable monthly prescriptions for medications, and who had low or no income, and/or sizable drug habits. Those who most commonly sold their medications to dealers were veterans, Medicaid/Medicare recipients, crack and heroin addicts, and HIV/AIDS patients. Drugs (Abingdon Engl) 2012;19:144

44 Connections By far, the most commonly utilized connect was a pharmacy technician who was willing to provide the dealer with prescription drugs via their access as an employee This was usually accomplished by systematically shorting or undercounting dispensed medications at pharmacies Drugs (Abingdon Engl) 2012;19:144

45 Connections Pharmacy technicians also assisted dealers by not calling in or verifying forged prescriptions, and by providing dealers with inside information such as when shipments of medications were scheduled to come in or details on how to break into the pharmacy undetected The dealer would typically compensate the connect in cash, illicit drugs or sometimes sexual favours Drugs (Abingdon Engl) 2012;19:144

46 Universal Precautions No clinical features are sufficiently sensitive/specific to establish/exclude the possibility of diversion Constant vigilance per a uniform approach

47 Risk Management Hedges Primary source verification Obtain medical records directly from prior providers/facilities

48 Risk Management Hedges Minnesota Prescription Monitoring Program Doctor shopping Dispensing intervals

49 Risk Management Hedges Urine toxicology Random = better Absence of illicit substances and non-medical medications Presence of prescribed medications

50 Risk Management Hedges Managing quantity and access Minimum effective dose Serial prescriptions with do not dispense dates for higher risk patients or those on greater-than-average medication doses

51 Risk Management Hedges Pills counts Random = better In your office or a pharmacy

52 Deception

53 He could be faking it Vedder Reminiscence

54 Spine J 2005;5:404

55 Disability Ultimately, the relevant question to both clinical practitioners and the justice system is not only how much pain is this person experiencing but to what degree is this person disabled by their pain? Spine J 2005;5:404

56 Pain-Related Disability PRD refers to the altered capacity to care for oneself or others, or altered capacity to work that results from the physical, emotional, behavioral, and/or cognitive symptoms that arise from or are described in terms of tissue damage. Spine J 2005;5:404

57 Malingered Pain-Related Disability We formally define Malingered Pain-Related Disability (MPRD) as the intentional exaggeration or fabrication of cognitive, emotional, behavioral, or physical dysfunction attributed to pain for the purposes of obtaining financial gain, to avoid work, or to obtain drugs (incentive). Spine J 2005;5:404

58 Spine J 2005;5:404

59 Big Picture A. Evidence of significant external incentive B. Evidence from physical examination C. Evidence from neuropsychological testing D. Evidence from self-report Spine J 2005;5:404

60 Spine J 2005;5:404 Scoring

61 Risk Management Hedges Zero in on external incentives Look for inconsistencies and discrepancies Involve your consultants in very intentional ways Is this typical/usual?

62 Contact Information 825 Nicollet Mall Suite #1451 Minneapolis, MN Medical Arts Building