To Help and Not to Harm; A Dialogue on Everyday Ethical Issues in the Management of Pain

1. To Help and Not to Harm; A Dialogue on Everyday Ethical Issues in the Management of Pain Palliative Care Symposium June 15, 2010 George Dreher

3. “Failure to treat pain has an impact on the deepest (ethical) roots of the medical profession.”Clark, PA Health Progress 2002 ‘People are dying on the streets from the drugs doctors are prescribing’Comment at Maine hearing on Overdose Deaths

4. Case DiscussionMr. Smith“Ethical and Clinical Choices in Pain Management”

5. Mr. Smith: Chronic Back Pain ID: The patient is a 61-year-old married man, father of three, working as an electrician with a CC of “need my back pain prescriptions refilled, and they’re not working as well any more.”

6. Mr. Smith HPI: Low back pain off and on for the past 3 years, chronic in nature for past 4 months, mild radiation from the R L/S region to the right upper thigh, worsened by lifting and bending, interfering with ability to work.

7. Mr. Smith HPI: L/S MRI from 2 years ago showed mild degenerative changes. Orthopedic evaluation at the time indicated no intervention indicated. Tried physical therapy on 2 occasions without improvement. Recent increasing problems with feeling depressed and eating less with 8# weight loss, difficulty with urination, fatigue, and constipation. He has a history of misuse of his opioids in the past year with occasional over-use and on one occasion reported his medication stolen.

8. Mr. Smith Clinical Decision Point: Is this patient a good candidate for long-term opioid analgesics? • If “YES”, then why? • If “NO”, then why not? • If “I don’t know”, what further information would you need?

9. Mr. Smith What areas of ethical concern are contained within this decision making process ?

10. Mr. SmithPotential Ethical Concerns • Patient barriers to adequate pain control • Complexity of care • Known Vs. unknowable treatment risks for the patient • Opioids • Where does cannabis fit in? • Conflicts within the care provider • Risks Vs. benefits for the community • Just distribution of resources

11. Professionalism in Pain Care I ‘Promote the good and avoid harm’ Respect the autonomy of the patient Requires careful listening and discussion Balance of compassion and caution Benefit vs. risk balance Competing Harms / Double Effect Consideration of impact on family / caregivers

12. Doctrine of Double Effect A person may licitly perform an action that he foresees will produce a good effect and a bad effect provided that four conditions are verified at one and the same time: that the action in itself from its very object be good or at least indifferent; that the good effect and not the evil effect be intended; that the good effect be not produced by means of the evil effect; that there be a proportionately grave reason for permitting the evil effect” (Joseph Mangan 1949, p. 43).

13. Professionalism in Pain Care II • Evidence informed care and treatment • Both competence & Art of Medicine • Free / distanced from ulterior motives • Trustworthy practice • Focus not on regulatory or other fears • Self-awareness of inner struggles

14. Ethics Zone #1 Patient Barriers to Adequate Pain Control What are our obligations to reduce / remove them? What are our limits in this role?

15. Patient -related barriers to adequate pain control Reluctance to report pain because of: Desire to be a “good” patient Fear of distracting physician from detecting and treating life threatening aspects of disease Belief in pain as part of life / religious beliefs Increasing limits to communication with dementia / delirium

16. Patient -related barriers to adequate pain control Fear of using prescribed Rx due to: Desire to use holistic, non-pharmacological approaches Costs Fear of being seen as “drug seeker” Concerns about re-addiction in recovering addicts Misconceptions re: addiction liability of opioids, meaning of tolerance, side effects, fear of injections

17. Ethics Zone #2Complexity of Care Duty to keep multiple possibilities in mind

18. Chronic pain patient clinical problems Complex patients with multi-system disease Providing care seems to conflict with monitoring / “police” approach Medical preference for clear-cut choices Vs. multi-layered with much unknowing Heterogeneous pain response between patients Heterogeneous response to opioids Pathway into problematic use may be subtle Urine drug testing complex / incomplete / “beatable”

19. Pain’s impact on patient’s quality of life Depression often co-existent with pain (30 – 87% of patients) Suicidal ideation twice as likely (40%) in those depressed with pain as those without (20%) Functional impairment highly correlated with depression and pain intensity Patients with chronic pain more likely to be unemployed & have fewer social supports

20. Differential Dx of Addiction Misunderstanding instructions Inadequate analgesia – “Pseudoaddiction”1 Disease progression Opioid resistant pain2 Withdrawal mediated pain Opioid analgesic tolerance3 Opioid-induced hyperalgesia3 Addiction / seeking euphoria or reward Self-medicating other symptoms (mood / sleep / disturbing memories /…) Criminal intent – diversion 1 Weissman DE, Haddox JD. 1989; 2 Evers GC. 1997; 3 Chang C et al 2007

21. Pain Vs Suffering Pain without meaning / loss of self => suffering Physical pain Emotional pain Spiritual pain Social pain Existential pain Poor pain control / avoidance of pain Rx may reflect unstated component Families pain may be projected onto the patient

22. Clinical Problems Adequate communication / understanding The most difficult to treat patients often are on opioids Most pain patients are genuine and those with episodic yellow / red flag pattern easily missed in busy setting Use of opioids has way outpaced prior training / our actual knowledge base Lack of training in constructive confrontation skills

23. Ethics Zone # 3Known vs. unknown treatment risks with Opioids Harm reduction / Competing Harms

24. Opioid Benefits • Less frequent / severe medical side-effects compared to NSAIDs / acetaminophen / aspirin … • Quick action • Many varieties / dosing forms available • Heterogeneous receptor actions provides range of options / partial cross-tolerance • Stigma of use lessening

25. Irrationality abounds in opioid use Fear of addiction Fear of side-effects Social / personal stigma of opioid use “Difficult patient” = ? Inadequate education of anyone involved

26. Opioid Limitations • Opioids impact on pain minimal in up to 40% of patients • In those that respond, opioids typically relieve 30% of patient’s pain • Opioid responsiveness varies • Acute > Chronic • Nociceptive > Neuropathic • The vast majority of patients discontinue opioid use on their own in a short time

27. Opioid Limitations Immediate side-effects Constipation (never clears) Respiratory depression Nausea / vomiting Pruritis Long term use side-effects: Gonadal axis dysfunction Adrenal axis dysfunction Decreased immune function (pain also contributes) Emerging concern of opioid hyperalgesia

29. Cannabis enters … • Maine Medical Marijuana Act passed 11/09 • Certification of patients has begun • Full system to be in place in the next few months (dispensary sites being selected)

30. Cannabis allowed for: • 8 listed conditions: cancer, Hep. C, ALS, DAT, HIV/AIDS, Crohn’s, nail-patella syndrome or glaucoma • “condition or treatment that produces intractable pain” • for any “chronic or debilitating disease or medical conditions or its treatment that produces one or more of the following: • Cachexia • Sever nausea • Seizures • Severe or persistent muscle spasms • Any other medical condition or its treatment approved by DHHS

31. Cannabis: Physician role • Provides “written certification” to a “qualifying patient” • Must be in the course of bona fide physician –patient relationship • Must comply with Board of Medicine Chapter 11 / 21 rules • NOT a prescription

32. Cannabis: quandaries • Not FDA approved • Still DEA level I drug (experimentation only) • Little adequate research • Variation between sources / growers • Varying strength • Impurities • Adequacy of training for physicians / numbers of physicians willing to certify • Not in PMP • No requirement for employer accommodation / health insurance coverage

33. Ethics Zone #4Conflicts within the care provider Thanks to Lesley M. Fernow, MD, FACP

34. Counter transference in Patients With Pain Puritanism is the lurking fear that someone, somewhere, is happy. H.L. Mencken Calvinism is the belief that suffering is good for the soul, and no degree of suffering can not be made worse..

35. Health care provider barriers to pain management: underlying themes People who get AIDS/cancer/COPD/ deserve it => suffering is the punishment for acquisition of disease Partially treating pain insures we won’t overly gratify patients / promote addiction Fear of regulatory scrutiny of prescribing patterns

36. Health care provider barriers to pain management: inadequate knowledge pharmacology /pharmacokinetics of analgesics understanding effective analgesic use inattention to behavioral, social, spiritual and psychological aspects of pain difficulty assessing pain inadequate knowledge base of specific pain syndromes in cancer, HIV/AIDS, others

37. Health care provider barriers to pain management: Inner struggles • Others unrealistic expectations of medical system • Trained to cure vs. acceptance of limits • Exposure to others suffering creates ones own pain and suffering • Moral distress in being part of team making difficult choices • Overwork => under-empathic • Ones own fears of illness and death

38. Ethics Zone #5Risks to the community Were does our concern for others over-ride our care of the patient?

39. Demographics of Substance Abuse 8% of Americans aged 12 or older used an illicit substance in the past monthSAMSHA 2007 Substance use disorders are more common in hospitalized patients 19 to 26% of all patientsBrems et al 2002 40 to 60 % of trauma patientsHeinemann et al 1998, Norman et al 2007 Increased risk in patients with mood or anxiety disorder / some personality disorders / under severe social stress …

40. Maine Admissions 2003

41. Maine Admissions 2008

42. Methadone Related Deaths 2005Larger Circle indicate higher rates NYT 8.17.08

43. Where Pain Relievers Were ObtainedNon-medical Use among Past Year Users Aged 12 or Older 2006 Source Where Respondent Obtained Bought on Internet0.1% Drug Dealer/Stranger3.9% Other 14.9% Source Where Friend/Relative Obtained More than One Doctor 1.6% More than One Doctor3.3% Free from Friend/Relative7.3% Free from Friend/Relative55.7% One Doctor 19.1% Bought/Took fromFriend/Relative4.9% OneDoctor 80.7% Bought/Took from Friend/Relative14.8% Drug Dealer/Stranger1.6% Other 12.2% 1 The Other category includes the sources: “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.”

44. Ethics Zone # 6Justice Limitations on resources due to managed care / state budgets / costs to patient / pharmacy practices

45. Case Discussion:Mr. SmithBalancing risks in treatment

46. Mr. Smith • On exam he has no abnormal neurologic findings, a somewhat distended bladder and enlarged prostate. • His PSA level is 28 • A repeat pelvic x-ray shows several areas of reduced bone density in the sacrum and pelvis • A repeat MRI confirms these, a very enlarged prostate, and narrowing of the colon.

47. Mr. Smith • A referral to an oncologist confirms prostate cancer and treatments are begun. • Mr. Smith has escalating pain as these events unfold and is diagnosed with depression and anxiety which are being treated.

48. Mr. Smith Clinical Decision Point: • How does this change your perceptions of the Mr. Smith? • Adequate pain control with concerns about prior Rx mis-use? • Autonomy meets paternalism ? • Individual Vs Community ?

49. Differential Dx of Intolerable Suffering • Under treated Pain of any sort • Unacknowledged fears • Loneliness • Loss of hope • Demoralization • Other … ?

50. Doctrine of Double Effect and Terminal Sedation • A person may licitly perform an action that he foresees will produce a good effect and a bad effect provided that four conditions are verified at one and the same time: • that the action in itself from its very object be good or at least indifferent; • that the good effect and not the evil effect be intended; • that the good effect be not produced by means of the evil effect; • that there be a proportionately grave reason for permitting the evil effect” • (Joseph Mangan 1949, p. 43).