Understanding State Board Regulations: Providing Compassionate Care While Avoiding Common Mistakes

1. Understanding State Board Regulations: Providing Compassionate Care While Avoiding Common Mistakes Joe Y. Kim, MD Water’s Edge: Memorial’s Pain Relief Institute

2. Washington State • Follows Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain • Federation of State Medical Boards • July 2013 (1997, 2003)

3. Washington State • Since 2004 • 1 in 4 in primary care settings, pain limits ADL’s • Undertreatment of pain is serious public health problem

4. Inappropriate Management • Inadequate initial assessment for clinical indication • Inadequate monitoring • Inadequate attention to patient education/consent • Unjustified dose escalation: risks? alternatives?

5. Discipline • “Physicians should not fear disciplinary action from the Board for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice, when currentbest clinical practices are met.”

6. Discipline • “The Board will not take discplinary action against a physician for deviating from this Model Policy when contemporaneous medical records show reasonable cause for such a deviation.” • “The board will judge the validity of the physician’s treatment of a patient on the basis of available documentation, rather than solely on the quantity and duration of medication administered”.

7. Guidelines • Understanding Pain: • Patient Evaluation and Risk Stratification • Development of a Treatment Plan/Goals • Informed Consent/Treatment Agreement

8. Guidelines • Initiating an Opioid Trial • Ongoing Monitoring and Adapting the Treatment Plan • Periodic Drug Testing • Consultation and Referral

9. Guidelines • Discontinuing Opioid Therapy • Medical Records • Compliance with Controlled Substance Laws and Regulations

10. Methadone • Increased rate of methadone related deaths • QTc: pre, 3days, annual • 450-500 ms discuss (debate) • “No evidence has been found to support the use of the EKG for preventing cardiac arrhythmias in methadone-treated opioid dependents” Cochrane investigators

11. Methadone • Follow up sooner after: • Initiation or increase • Pharmacodynamics/kinetics • Analgesic action 6 hrs (morphine is opposite) • Full analgesic effects • Morphine conversion median 5 days (range 4-13) • May be 1-2 weeks • Long half-lfe/accumulation ==> delayed toxicity

12. Methadone • Equianalgesic for repetitive dosing smaller than single-dose • 65 y/o decreased clearance • No liver adjustments • Metabolites do not accumulate with renal failure

13. Methadone • Increased rate of methadone related deaths

14. What is the ideal opioid? • half-life, side effects, metabolites, etc…

15. What is the ideal opioid? Oxycodone No ceiling dose Minimal side effects Absence/minimal activce metabolite Easy titration Rapid onset Short half-life Long duration Predictable pharmacokinetics

16. Random Considerations • T3/T4: ceiling effect 60mg/dose, max 360mg/day • Hyrdocodone: maximal daily 60mg/day? • Morphine: renal failure (M6G); rectal? • Oxymorphone: hepatic impairment

17. Random Considerations • Tapentadol (Nucynta): seizures, ICP, asthma • inhibit serotonin/NE reuptake • Tramadol: 5HT, cardiovascular, seizures, addiction • TCA/MSO4: synergistic CNS/respiratory depression

18. Guidelines • Patient Evaluation and Risk Stratification • Indication/Evaluation • Assessment • Nature, intensity, treatments, comorbidities, function. • ROS, SH, FH (abuse), PE, labs?, SOAPP-R, ORT • All patients should be screened for depression/mental health

19. Guidelines • Assessment • History of substance abuse: failure/harm • If possible, consult before therapy initiated. • Current abuse • Established in treatment/recovery program • Co-managed with addictions specialist

20. Terms • Tolerance • Dependence • Abuse • Addiction

21. Guidelines • Assessment • Brings in own pile of records • ask for records directly • PMP

22. Guidelines • Development of a treatment plan/goals • Goals • Improvement of pain and function • Improvement of pain associated symptoms • Avoidance of unnecessary/excessive use of meds • Revisited regularly

23. Guidelines • Development of a treatment plan/goals • Individualized • Supports selection of treatment • Objectives to evaluate progress • pain relief • physical/psychosocial function

24. Guidelines • Informed consent • Risks/benefits • Why change • Treatment agreement • Goals • Patient’s/physician’s responsibilities

25. Guidelines • Informed consent/Treatment agreement • Shared decision • Store/disposal

26. Guidelines • Initiating an Opioid Trial • Present as a trial (e.g. 90 days) • Evaluate benefit (pain/fxn/QOL) vs. harm • Lowest possible start dose • Short acting

27. Guidelines • Ongoing Monitoring and Adapting the Treatment Plan • Collateral information: family, close contacts, PMP • More frequently at first • Five A’s: Analgesia, Activity, Adverse Effects, Aberrancy, Affect/mood

28. Guidelines • Ongoing Monitoring and Adapting the Treatment Plan • Continue? • Progress towards goals (pain, fxn, QOL) • Absence of risks/adverse events

29. More meds • Psychotherapy • Rehabilitative • Injection • Surgery • Medications

30. More meds • Anti-inflammatory • Antidepressants • Membrane stabilizers • Muscle relaxants • Opioids

31. Escalations • Can be a sign of use disorder/diversion • Good time to get UDS • “halftime” rule

32. High doses • 200mg (MED) in 2010, lower now • Concerns • Hyperalgesia • Neuroendocrine • Immunosuppression

33. Guidelines • Periodic Drug Testing/Screening • Clinical judgement > recommendations • Discuss in supportive fashion • Pill count “useful” • PMP “highly recommended”

34. Opioid Rotation • Intolerable side effects • Inadequate benefit • 25-50% reduction

35. Rotation • Total 24-hour dose • Calculate new dose • 50-65% got incomplete cross-tolerance • Consider rescue

36. Rotation • Fentanyl 50% decrease in 17 hours • Calculate new dose • 50-65% got incomplete cross-tolerance • Consider rescue

37. Guidelines • Periodic Drug Testing/Screening • Unsatisfactory progress • Intervention needed: • early refill • multiple lost/stolen rx • physician shopping • intoxication/impairment • pressuring/threatening behavior • illicit/unprescribed drugs

38. Guidelines • Periodic Drug Testing/Screening • Intervention needed: • Behavior suggesting RECURRING misuse • self-increase dose • deteriorating function • failure to comply to the treatment plan

39. Guidelines • Periodic Drug Testing • “Firm response” • Forgery • Obvious impairment • abusive/assaultive behavior

40. Transit times (inexact) • Rapid: • EtOH 7-12 hrs • Pentobarbitol (24h) • Propoxyphene 6-48 hrs

41. Transit times • Fast: • (Meth) Amphetamine 48 hrs • Codeine 48 hrs • Heroine 48 hrs • Cocaine metabolites 2-4 days • Hydromorphone 2-4 days • Methadone 3 days • Short-acting BZ’s 3days • Long-term/heavy 30 d

42. Transit times • Long • PCP 8 days • Phenobarbital 3 wks • Long-acting BZ’s 30 days

43. Guidelines • Consultation and Referral • Pain, psychiatry, addiction, or mental health specialist “if needed” • History of substance abuse • Co-occuring mental health disorder • Know treatment options in treatment programs for addictions

44. Guidelines • Discontinuing Opioid Therapy • Regularly weigh benefits/risks • Discontinue • resolution • intolerable side effects • inadequate analgesia • failure to improve QOL • significant aberrancy

45. Guidelines • Discontinuing Opioid Therapy • Structured tapering regimen • Withdrawal • Addiction specialist or physician • Not the end (direct care or referral)

46. Weaning off • Repeated aberrant drug-related behaviors • Diversion • Intolerable side effects • No progress towards goals

47. “More Serious” • Repeatedly non adherent • Cocaine • Unprescribed opioids • Doctor Shopping • Unprescribed opioids • Morphine example

48. “Non-serious” • 1-2 unauthorized dose escalations • Alcohol

49. Wean off • Rehabilitation setting ideal • Addiction • Addiction treatment made available • Follow-up • Non-opioid pain management

50. Wean off • Slow: 10%/ week • Rapid: 25-50% every few days • At higher doses, can be more rapid • When get to lower doses, slow down