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An Approach to Intractable Suffering: Palliative Sedation

An Approach to Intractable Suffering: Palliative Sedation. Lauren Michalakes, MD Palliative Care Program Maine Medical Center June 10, 2009. Case: M.L. What is the nature of this patient’s suffering? How do we know it was managed appropriately?

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An Approach to Intractable Suffering: Palliative Sedation

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  1. An Approach to Intractable Suffering: Palliative Sedation Lauren Michalakes, MD Palliative Care Program Maine Medical Center June 10, 2009

  2. Case: M.L. What is the nature of this patient’s suffering? How do we know it was managed appropriately? How was the course affected by the family’s suffering? Was this a “good death?” Would we have viewed it differently if he had died shortly after the first dose of phenobarb?

  3. “Life is pleasant. Death is peaceful. It’s the transition that’s troublesome.”Isaac Asimov

  4. “It’s not that I’m afraid to die, I just don’t want to be there when it happens.” Woody Allen

  5. Goals today What is suffering? What are our professional, ethical and moral obligations to treat suffering? Palliative sedation: One of the palliative treatments of last resort Guiding ethical principals Recommendations of the Council on Ethical and Judicial Affairs

  6. Euthanasia…. • Greek: eu-thanatos, “Good death” • Practice of ending of a life in a painless manner • Voluntary versus involuntary • Passively, non-actively and actively • Passive Euthanasia • Withholding treatments • Administering medications for pain that sedate: PS

  7. 1995…. Term “palliative sedation” did not exist Palliative Medicine was evolving Practices were outside of mainstream, not evidence based, rooted in hospice culture and tradition In isolation, at the bedside, one moment at a time

  8. 1995-2008…… Academy of Hospice Physicians became the American Academy of Hospice and Palliative Medicine: 1996 American Board of Hospice and Palliative Medicine organizes and initiates the certification of diplomats: 1996 Oregon passes Death with Dignity, legalizing PAS: 1997 Supreme Court rulings regarding PAS: 1997 Jack Kevorkian goes to jail 1999 Hospice and palliative care initiatives flourish in community, institutional and academic settings American Board of Medical Specialties awards Hospice and Palliative Medicine sub-specialty status: 2006

  9. AAHPM published its Position Statement on Palliative Sedation ABMS reported a total of 1,271 physicians who successfully received subspecialty certification in hospice and palliative medicine from one of the 10 co-sponsoring boards following the 2008 exam American Medical Association accepted a Report from its Council on Ethical and Judicial Affairs on Palliative Sedation, such that ethical guidelines are included in the AMA’s Code of Medical Ethics: 2008 An intervention that has moved from something poorly understood, not well defined, (feared) to a therapeutic practice with legitimate foundations in clinical, institutional and academic medicine

  10. “The administration of sedatives to the point of unconsciousness, when less extreme sedation has not achieved sufficient relief of distressing symptoms. This practice is used only for the most severe, intractable suffering at the very end of life.”AAHPM Policy Statement September 2006

  11. Ethical, professional, personal challenges…. What is intractable suffering? What is the difference between managing a difficult symptom that results in sedation and the act of palliative sedation What is the difference between palliative sedation and euthanasia? Just because I know what I’m doing doesn’t mean everyone else knows what I’m doing. Thin line between expected and intended death: “When is this gonna be over?” An ugly death lives forever.

  12. What is suffering? • Physical pain • Other symptoms: dyspnea, nausea, vomiting, delirium • Emotional, social, spiritual • Hurting bodies, minds, hearts, souls

  13. Physical suffering…..(100 patients admitted to a PCU, all with prognosis less than 6 months, 60% died within 1 week) • Moderate to Severe Pain: 50-80% • Severe dyspnea: 50% • Depression/anxiety: 37% • Confusion: 37% • Nausea/vomiting: 30% • Constipation: 35% • Anorexia: 70% • Fatigue: 81%

  14. Physical suffering…. Some studies report that as many as 50% patients in palliative care programs still report pain one week before death Most common symptoms: dyspnea, pain, delirium, vomiting 54% have more than one uncontrollable symptom Refractory symptoms 16-52%

  15. Existential suffering….. Anguish that results with awareness that death is inevitable Descent into nothingness Solitary journey Overcome by constructing meaning out of nothingness

  16. Bodies do not suffer.... • Pain is not synonymous with suffering • Persons suffer….Eric Cassell 1991 The Nature of Suffering and the Goals of Medicine • Suffering: Disintegration of person • Personal matter • Loss of control • Meaning of pain: dire, catastrophic, without end • Threat to existence

  17. Traditional healing approach…. Biomedical model Body and disease-based Goals are curative and life prolongation Death as medical failure Lacks intuitive connection to the care of the dying Death often medicalized, painful, lonely

  18. Broader model of healing… Death as a natural end to the life cycle Opportunity for growth and closure Maintaining integration of person: avoiding disintegration Opportunity to finding meaning Maintaining connection: obligation of a compassionate health care system

  19. Palliative Care Values…… Comprehensive interdisciplinary plan of care Patient and family centered Relief of suffering Intensive treatment of pain and other symptoms Psychosocial, existential, spiritual Partnership and nonabandonment

  20. Occasionally….. In spite of comprehensive interdisciplinary attention to all domains of human suffering related to terminal illness, anguish and pain continue, and suffering is deemed “refractory.” Nonabandonment, and our obligation to continue care, in spite of the refractory nature, requires we continue “do something.”

  21. Terminal Sedation… Practice first described by Robert Enck, Medical Care of the Dying, early 1990s; Proponents: humane and efficient Relief! Others: “slow euthanasia”; not done well, over protracted period of time, allowing suffering to linger

  22. Terminal sedation….literature Utilization prevalence 2-52% Reported that more than 50% of cancer patients dying at home with physical suffering only controllable by sedation Lack of universal language, definitions Terminal, total, controlled, respite, sedation in imminently dying patients

  23. Terminal Sedation….. Is legal Fundamentally sanctioned by the US Supreme Court in its opposition to a constitutional right to PAS (1997 Vacco v Quill, Washington v Glucksberg) “…terminal patients should be treated even to the point of rendering the patient unconscious, or of hastening death”

  24. Palliative Sedation….. Semantic response to clarify intent, although fundamentally, the practice might be the same. Hopefully lacks the moral ambiguity that the term “terminal sedation” might hold to outsiders Clarity of language, intent, purpose, thought

  25. Ethical principles.. • Beneficence: work to relieve suffering • Non-maleficence: Cause no harm, Hastening death most obvious • Doctrine of the Double Effect • Proportionality • Autonomy

  26. Doctrine of the Double Effect…… Intentions and consequences Developed by Roman Catholic Church theologians during the middle ages in response to situations where one cannot possibly avoid all harmful actions An action with two possible effects, one good and one bad, is morally permitted if certain conditions are met

  27. The action is allowed if it… is not in itself immoral is undertaken only with the intention of achieving the possible good effect, without intending the possible bad effect, although it may be foreseen does not bring about the possible good effect by means of the possible bad effect, and Proportionality favors the good. Good effect must outweigh the bad

  28. In palliative sedation….. The act: administering pain medications or sedatives The intention of the act: is to the relief of pain or suffering, although death is expected Death should not be intended as a means to relieve suffering The relief of suffering must outweigh or balance the risk of the expected death

  29. Autonomy… As in withholding and withdrawing life-sustaining treatments, where physicians are obligated to respect patients wishes, autonomous decision-making dictates that a fully informed patient should be able to choose palliative sedation When refractory suffering occurs, it is necessary to fully inform competent patients, or their surrogates about the possibility of sedation, and whether it seems like an appropriate option Informed consent is critical

  30. Assumptions: • Death is always bad • Living in an unconscious yet actively dying state is better than death • Informed consent is valid in the face of unrelenting suffering. Moments of desperation play no role. • Proxies always act in ways consistent with the patient, putting aside their own emotional issues, beliefs and values • No one ever changes their mind

  31. Outcome: Death “Expected" but not "intended” Sedation given while not administering hydration or nutrition ensures death. How does it remain unintended? Intention is always locked within the mind of the clinician. How can we be sure?

  32. Potential last resort options….. • Accelerating opioids to sedation for pain • Stopping life-sustaining therapy • Voluntary stopping eating and drinking • Palliative sedation • Physician-assisted suicide • Voluntary active euthanasia 32

  33. So…. • If a clinician believes that euthanasia is never morally permissible, the Doctrine of the Double Effect allows that clinician to treat pain and suffering at the end of life with a clear conscience. • Although both interventions could be exactly the same.

  34. Realities at the bedside……. All of our patients are dying… All have metabolic and hemodynamic conditions that alter wakefulness and mental clarity. Low oxygen, high carbon dioxide, high acid levels, low kidney functions, with high creatinine, high blood urea levels, high calcium, high sodium, low free water, diminished liver function, high ammonia levels…..etc. Nobody dies when they’re fully awake Or metabolically intact

  35. Almost all medications we use to treat symptoms cause sedation and/or mental clouding, and have active or toxic metabolites that are less efficiently cleared by the body Pain is a stimulant; causing “fight or flight” in the body. Raging catecholamines! Relief of pain can shut off those raging catechols and, all by itself, be sedating. Or liberating. Patients do “let go.”

  36. Result…. Patients come to us with incurable diseases, a myriad of physical and emotional experiences, declining organ systems, multiple metabolic abnormalities, with at least 4 sedating or mind-altering medications on board, and poorly cleared metabolites…along a continuum of gray, where only the outcome is definite. The background is fear, grief, anxiety, anger, non-acceptance….lack of preparedness, lack of truth-telling. Lack of readiness.

  37. Our job… Provide excellent and expert pain and symptom management for our patients, before and at the moment of death Create moments of gratitude, and some sense of acceptance for the caregivers at the bedside. Create a moment they can continue to live with. Don’t violate any of the principles of sound ethical and moral behavior. Stay within the scope of our practice. Don’t break the law.

  38. Back to definitions….AAHPM Ordinary sedation: ordinary use of sedative for appropriate indications: anxiety, agitated depression. Goal is the relief of symptom without reducing level of consciousness (most frequent) Palliative sedation: use of sedative to, in part, reduce the patients awareness of a distressing symptom. Level of sedation is proportionate to level of distress. Alertness is preserved as much as possible (very frequent)

  39. Palliative Sedation……. to unconsciousness Administration of sedative to the point of unconsciousness, when less extreme sedation has not achieved sufficient relief of distressing symptom (rare) Intractable or refractory suffering This practice is used only at the very end of life

  40. Intervention: Morphine for pain or dyspnea Morphine will relieve pain and air hunger, or suppress respirations and cause death Intent: To relieve pain and air hunger: Good Intent: The only way to relieve pain and air hunger is to “get this over with”: Bad

  41. Intervention: Midazolam for sedation Midazolam: short acting, easy to titrate, CNS depressant, sedates to either a state of unconsciousness or death Intent: to induce calm sleep-like state, allowing the family to finally get close, stay connected, provide hands-on care in the remaining hours to days with their loved one: Good Intent: To get it over with: Bad

  42. Report of the AMA Council on Ethical and Judicial Affairs: Sedation to Unconsciousness in End-of-Life Care In June 2008 AMA House of Delegates accepted a report from its CEJA supporting the use of palliative sedation for refractory pain and suffering at the end of life Built upon the levels of sedation defined by the AAHPM Position Statement from 2006 Added discussion of clinical and ethical issues Provided a set of recommendations regarding patient selection, consenting and monitoring.

  43. Overall Discussion… Affirms the duty to relieve pain and suffering as central to the physicians role as healer and an obligation physicians have to their patients Recognizes Palliative Care as a universally accepted approach to prevent and relieve suffering of patients with life-limiting illness Supports palliative sedation as an important technique for combating extreme suffering Recognizes the possibility for moral debate because of its potential to be misconstrued as active euthanasia

  44. Discussion: Palliative Sedation Ethics The Rule of Double Effect This rule provides the main ethical basis for providing palliative sedation; generally, it states: An action with both good and bad effects is ethically permissible if: 1. The action itself is good or neutral (but not bad). 2. The good effect is the intended effect. 3. A bad action is not used to achieve a good effect. 4. The good effect outweighs the risk of the bad effect

  45. Discussion: Palliative Sedation Ethics But wait, there’s more…Rule of Double Effect Justification The benefits of exposing someone to a potentially harmful action must be justified by the seriousness of the situation: Diligence (Avoidance of Recklessness) When acting in such a situation, one must exercise appropriate caution to minimize the risk of the negative effect of an action with potentially mixed (good and bad) effects.

  46. When Applied to Palliative Sedation Justification The level of sedation must be justified by the severity of the patient’s suffering; deeper sedation brings greater risk of death. The terminal condition justifies the intervention. Diligence (Avoidance of Recklessness) One must exercise sufficient caution to minimize the risk of the negative effect of an action with both good and bad effects: • Start with safe amounts of medication • Increase incrementally, stopping at the lowest effective dose • Observe effects and reassess/re-adjust accordingly

  47. Discussion: Final CEJA Report Palliative Sedation to Unconsciousness is ethically permissible when: •It is intended to reduce refractory suffering at end-of-life, • All other palliative measures have failed. Regarding Palliative Sedation to Unconsciousness, CEJA Recommends: • Document the terminal condition and reason for using palliative sedation to unconsciousness (such as refractory suffering failing aggressive palliation) • Document informed consent

  48. Regarding Palliative Sedation to unconsciousness, CEJA Recommends (continued): • Palliative care consultation • Discuss the intended goal or length/depth of sedation • Monitor the patient’s status to assure achieving goals and maintaining proper diligence • Do not use for cases involving existential suffering solely (reflects controversies in the field) • Never intentionally use it to cause a patient’s death

  49. “The duty to relieve pain and suffering is central to the physician’s role as healer and is an obligation physicians have to their patients.” CEJA 2008

  50. “Palliative sedation to unconsciousness is an important tool in the armamentarium of palliative medicine…... It is medically and ethically acceptable under specific, relatively rare circumstances. It should be used only as a therapy of last resort for relief of severe, unrelenting clinical symptoms after the failure of other aggressive interventions, including psycho-social support. It is important to ensure that patients are indeed at the end stage of a terminal illness and that other forms of symptom-specific treatment are not effective. It is most appropriate as part of a multi-disciplinary mode of palliative care that addresses the whole patient in the context of that patient’s family system, spiritual beliefs and values…. It is not appropriate for suffering that is mainly existential….” CEJA 2008

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