An Approach to An Approach to Intractable Suffering: Intractable Suffering: Palliative SedationPalliative Sedation

Lauren Michalakes, MDLauren Michalakes, MDPalliative Care ProgramPalliative Care ProgramMaine Medical CenterMaine Medical Center

June 10, 2009June 10, 2009

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Case: M.L.Case: M.L. What is the nature of this patient’s What is the nature of this patient’s

suffering? suffering? How do we know it was managed How do we know it was managed

appropriately?appropriately? How was the course affected by the family’s How was the course affected by the family’s

suffering?suffering? Was this a “good death?”Was this a “good death?” Would we have viewed it differently if he Would we have viewed it differently if he

had died shortly after the first dose of had died shortly after the first dose of phenobarb?phenobarb?

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

Isaac AsimovIsaac Asimov

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

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Goals todayGoals today What is suffering?What is suffering? What are our professional, ethical and What are our professional, ethical and

moral obligations to treat suffering?moral obligations to treat suffering? Palliative sedation: One of the palliative Palliative sedation: One of the palliative

treatments of last resorttreatments of last resort Guiding ethical principalsGuiding ethical principals Recommendations of the Council on Recommendations of the Council on

Ethical and Judicial AffairsEthical and Judicial Affairs

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Euthanasia….Euthanasia…. Greek: eu-thanatos, “Good death”Greek: eu-thanatos, “Good death” Practice of ending of a life in a painless Practice of ending of a life in a painless

mannermanner Voluntary versus involuntaryVoluntary versus involuntary Passively, non-actively and activelyPassively, non-actively and actively Passive Euthanasia Passive Euthanasia

Withholding treatmentsWithholding treatments Administering medications for pain that sedate: Administering medications for pain that sedate:

PSPS

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1995….1995….

Term “palliative sedation” did not existTerm “palliative sedation” did not exist Palliative Medicine was evolvingPalliative Medicine was evolving Practices were outside of mainstream, not Practices were outside of mainstream, not

evidence based, rooted in hospice culture evidence based, rooted in hospice culture and traditionand tradition

In isolation, at the bedside, one moment at In isolation, at the bedside, one moment at a timea time

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1995-2008……1995-2008…… Academy of Hospice Physicians became the American Academy of Hospice Physicians became the American

Academy of Hospice and Palliative Medicine: 1996Academy of Hospice and Palliative Medicine: 1996 American Board of Hospice and Palliative Medicine American Board of Hospice and Palliative Medicine

organizes and initiates the certification of diplomats: organizes and initiates the certification of diplomats: 19961996

Oregon passes Death with Dignity, legalizing PAS: 1997Oregon passes Death with Dignity, legalizing PAS: 1997 Supreme Court rulings regarding PAS: 1997Supreme Court rulings regarding PAS: 1997 Jack Kevorkian goes to jail 1999Jack Kevorkian goes to jail 1999 Hospice and palliative care initiatives flourish in Hospice and palliative care initiatives flourish in

community, institutional and academic settingscommunity, institutional and academic settings American Board of Medical Specialties awards Hospice American Board of Medical Specialties awards Hospice

and Palliative Medicine sub-specialty status: 2006and Palliative Medicine sub-specialty status: 2006

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AAHPM published its AAHPM published its Position Statement on Palliative Position Statement on Palliative SedationSedation

ABMS reported a total of 1,271 physicians who ABMS reported a total of 1,271 physicians who successfully received subspecialty certification in successfully received subspecialty certification in hospice and palliative medicine from one of the 10 co-hospice and palliative medicine from one of the 10 co-sponsoring boards following the 2008 examsponsoring boards following the 2008 exam

American Medical Association accepted a Report from American Medical Association accepted a Report from its Council on Ethical and Judicial Affairs on Palliative its Council on Ethical and Judicial Affairs on Palliative Sedation, such that ethical guidelines are included in the Sedation, such that ethical guidelines are included in the AMA’s AMA’s Code of Medical Ethics: Code of Medical Ethics: 20082008

An intervention that has moved from something poorly An intervention that has moved from something poorly understood, not well defined, (feared) to a therapeutic understood, not well defined, (feared) to a therapeutic practice with legitimate foundations in clinical, practice with legitimate foundations in clinical, institutional and academic medicineinstitutional and academic medicine

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

AAHPM Policy StatementAAHPM Policy Statement September 2006 September 2006

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Ethical, professional, personal challenges….Ethical, professional, personal challenges….

What is intractable suffering?What is intractable suffering? What is the difference between managing a difficult What is the difference between managing a difficult

symptom that results in sedation and the act of palliative symptom that results in sedation and the act of palliative sedationsedation

What is the difference between palliative sedation and What is the difference between palliative sedation and euthanasia?euthanasia?

Just because I know what I’m doing doesn’t mean Just because I know what I’m doing doesn’t mean everyone else knows what I’m doing.everyone else knows what I’m doing.

Thin line between expected and intended death: “When Thin line between expected and intended death: “When is this gonna be over?”is this gonna be over?”

An ugly death lives forever.An ugly death lives forever.

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What is suffering?What is suffering?

Physical painPhysical pain Other symptoms: dyspnea, nausea, Other symptoms: dyspnea, nausea,

vomiting, delirium vomiting, delirium Emotional, social, spiritualEmotional, social, spiritual Hurting bodies, minds, hearts, soulsHurting bodies, minds, hearts, souls

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Physical suffering…..Physical suffering…..(100 patients admitted (100 patients admitted to a PCU, all with prognosis less than 6 months, 60% died within 1 to a PCU, all with prognosis less than 6 months, 60% died within 1 week)week)

Moderate to Severe Pain: 50-80%Moderate to Severe Pain: 50-80% Severe dyspnea: 50%Severe dyspnea: 50% Depression/anxiety: 37%Depression/anxiety: 37% Confusion: 37%Confusion: 37% Nausea/vomiting: 30%Nausea/vomiting: 30% Constipation: 35%Constipation: 35% Anorexia: 70%Anorexia: 70% Fatigue: 81% Fatigue: 81%

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Physical suffering….Physical suffering…. Some studies report that as many as 50% Some studies report that as many as 50%

patients in palliative care programs still patients in palliative care programs still report pain one week before deathreport pain one week before death

Most common symptoms: dyspnea, pain, Most common symptoms: dyspnea, pain, delirium, vomitingdelirium, vomiting

54% have more than one uncontrollable 54% have more than one uncontrollable symptomsymptom

Refractory symptoms 16-52%Refractory symptoms 16-52%

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Existential suffering…..Existential suffering….. Anguish that results with awareness that Anguish that results with awareness that

death is inevitabledeath is inevitable Descent into nothingness Descent into nothingness Solitary journeySolitary journey Overcome by constructing meaning out of Overcome by constructing meaning out of

nothingnessnothingness

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Bodies do not suffer....Bodies do not suffer.... Pain is not synonymous with sufferingPain is not synonymous with suffering Persons suffer….Persons suffer….Eric Cassell 1991 Eric Cassell 1991 The Nature of The Nature of

Suffering and the Goals of MedicineSuffering and the Goals of Medicine Suffering: Disintegration of personSuffering: Disintegration of person

o Personal matterPersonal mattero Loss of controlLoss of controlo Meaning of pain: dire, catastrophic, without Meaning of pain: dire, catastrophic, without

endendo Threat to existenceThreat to existence

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Traditional healing approach….Traditional healing approach…. Biomedical modelBiomedical model Body and disease-basedBody and disease-based Goals are curative and life prolongationGoals are curative and life prolongation Death as medical failureDeath as medical failure Lacks intuitive connection to the care of Lacks intuitive connection to the care of

the dyingthe dying Death often medicalized, painful, lonelyDeath often medicalized, painful, lonely

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Broader model of healing…Broader model of healing… Death as a natural end to the life cycleDeath as a natural end to the life cycle Opportunity for growth and closureOpportunity for growth and closure Maintaining integration of person: avoiding Maintaining integration of person: avoiding

disintegrationdisintegration Opportunity to finding meaning Opportunity to finding meaning Maintaining connection: obligation of a Maintaining connection: obligation of a

compassionate health care systemcompassionate health care system

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Palliative Care Values……Palliative Care Values…… Comprehensive Comprehensive interdisciplinaryinterdisciplinary plan of plan of

carecare Patient and family centeredPatient and family centered Relief of Relief of sufferingsuffering Intensive treatment of pain and other Intensive treatment of pain and other

symptomssymptoms Psychosocial, existential, spiritualPsychosocial, existential, spiritual Partnership and Partnership and nonabandonmentnonabandonment

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Occasionally…..Occasionally….. In spite of comprehensive interdisciplinary In spite of comprehensive interdisciplinary

attention to all domains of human suffering attention to all domains of human suffering related to terminal illness, anguish and related to terminal illness, anguish and pain continue, and suffering is deemed pain continue, and suffering is deemed “refractory.”“refractory.”

Nonabandonment, and our obligation to Nonabandonment, and our obligation to continue care, in spite of the refractory continue care, in spite of the refractory nature, requires we continue “do nature, requires we continue “do something.”something.”

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Terminal Sedation…Terminal Sedation… Practice first described by Robert Enck, Practice first described by Robert Enck,

Medical Care of the Dying,Medical Care of the Dying, early 1990s; early 1990s; Proponents: humane and efficient Proponents: humane and efficient Relief!Relief! Others: “slow euthanasia”; not done well, Others: “slow euthanasia”; not done well,

over protracted period of time, allowing over protracted period of time, allowing suffering to lingersuffering to linger

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Terminal sedation….literatureTerminal sedation….literature Utilization prevalence 2-52Utilization prevalence 2-52%% Reported that more than 50% of cancer Reported that more than 50% of cancer

patients dying at home with physical patients dying at home with physical suffering only controllable by sedationsuffering only controllable by sedation

Lack of universal language, definitionsLack of universal language, definitions Terminal, total, controlled, respite, Terminal, total, controlled, respite,

sedation in imminently dying patientssedation in imminently dying patients

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Terminal Sedation….. Is legalTerminal Sedation….. Is legal

Fundamentally sanctioned by the US Fundamentally sanctioned by the US Supreme Court in its opposition to a Supreme Court in its opposition to a constitutional right to PAS (1997 Vacco v constitutional right to PAS (1997 Vacco v Quill, Washington v Glucksberg)Quill, Washington v Glucksberg)

“…“…terminal patients should be treated terminal patients should be treated even to the point of rendering the patient even to the point of rendering the patient unconscious, or of hastening death”unconscious, or of hastening death”

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Palliative Sedation…..Palliative Sedation….. Semantic response to clarify intent, Semantic response to clarify intent,

although fundamentally, the practice might although fundamentally, the practice might be the same. be the same.

Hopefully lacks the moral ambiguity that Hopefully lacks the moral ambiguity that the term “terminal sedation” might hold to the term “terminal sedation” might hold to outsidersoutsiders

Clarity of language, intent, purpose, Clarity of language, intent, purpose, thoughtthought

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Ethical principles..Ethical principles.. Beneficence: work to relieve sufferingBeneficence: work to relieve suffering Non-maleficence: Cause no harm, Non-maleficence: Cause no harm,

Hastening death most obvious Hastening death most obvious Doctrine of the Double EffectDoctrine of the Double Effect ProportionalityProportionality AutonomyAutonomy

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Doctrine of the Double Effect……Doctrine of the Double Effect…… Intentions and consequencesIntentions and consequences Developed by Roman Catholic Church Developed by Roman Catholic Church

theologians during the middle ages in theologians during the middle ages in response to situations where one cannot response to situations where one cannot possibly avoid all harmful actionspossibly avoid all harmful actions

An action with two possible effects, one good An action with two possible effects, one good and one bad, is morally permitted if certain and one bad, is morally permitted if certain conditions are metconditions are met

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The action is allowed if it…The action is allowed if it… is not in itself immoralis not in itself immoral is undertaken only with the intention of is undertaken only with the intention of

achieving the possible good effect, achieving the possible good effect, without intending the possible bad effect, without intending the possible bad effect, although it may be foreseenalthough it may be foreseen

does not bring about the possible good does not bring about the possible good effect by means of the possible bad effect by means of the possible bad effect, andeffect, and

Proportionality favors the good. Good Proportionality favors the good. Good effect must outweigh the badeffect must outweigh the bad

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In palliative sedation…..In palliative sedation….. The act: administering pain medications or The act: administering pain medications or

sedativessedatives The intention of the act: is to the relief of pain or The intention of the act: is to the relief of pain or

suffering, although death is expected suffering, although death is expected Death should not be intended as a means to Death should not be intended as a means to

relieve sufferingrelieve suffering The relief of suffering must outweigh or balance The relief of suffering must outweigh or balance

the risk of the expected deaththe risk of the expected death

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Autonomy…Autonomy… As in withholding and withdrawing life-sustaining As in withholding and withdrawing life-sustaining

treatments, where physicians are obligated to respect treatments, where physicians are obligated to respect patients wishes, autonomous decision-making dictates patients wishes, autonomous decision-making dictates that a fully informed patient should be able to choose that a fully informed patient should be able to choose palliative sedationpalliative sedation

When refractory suffering occurs, it is necessary to fully When refractory suffering occurs, it is necessary to fully inform competent patients, or their surrogates about the inform competent patients, or their surrogates about the possibility of sedation, and whether it seems like an possibility of sedation, and whether it seems like an appropriate optionappropriate option

Informed consent is critical Informed consent is critical

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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

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Outcome: DeathOutcome: Death ““Expected" but not "intended”Expected" but not "intended” Sedation given while not administering hydration Sedation given while not administering hydration

or nutrition ensures death. How does it remain or nutrition ensures death. How does it remain unintended?unintended?

Intention is always locked within the mind of the Intention is always locked within the mind of the clinician. How can we be sure?clinician. How can we be sure?

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Potential last resort options…..Potential last resort options….. Accelerating opioids to sedation for painAccelerating opioids to sedation for pain Stopping life-sustaining therapyStopping life-sustaining therapy

Voluntary stopping eating and drinkingVoluntary stopping eating and drinking Palliative sedationPalliative sedation

Physician-assisted suicidePhysician-assisted suicide Voluntary active euthanasiaVoluntary active euthanasia

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So….So…. If a clinician believes that euthanasia is If a clinician believes that euthanasia is

never morally permissible, the never morally permissible, the Doctrine of Doctrine of the Double Effectthe Double Effect allows that clinician to allows that clinician to treat pain and suffering at the end of life treat pain and suffering at the end of life with a clear conscience. with a clear conscience.

Although both interventions could be Although both interventions could be exactly the same. exactly the same.

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Realities at the bedside…….Realities at the bedside……. All of our patients are dying…All of our patients are dying… All have metabolic and hemodynamic conditions All have metabolic and hemodynamic conditions

that alter wakefulness and mental clarity.that alter wakefulness and mental clarity. Low oxygen, high carbon dioxide, high acid Low oxygen, high carbon dioxide, high acid

levels, low kidney functions, with high creatinine, levels, low kidney functions, with high creatinine, high blood urea levels, high calcium, high high blood urea levels, high calcium, high sodium, low free water, diminished liver function, sodium, low free water, diminished liver function, high ammonia levels…..etc. high ammonia levels…..etc.

Nobody dies when they’re fully awakeNobody dies when they’re fully awake Or metabolically intactOr metabolically intact

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Almost all medications we use to treat symptoms Almost all medications we use to treat symptoms cause sedation and/or mental clouding, and cause sedation and/or mental clouding, and have active or toxic metabolites that are less have active or toxic metabolites that are less efficiently cleared by the bodyefficiently cleared by the body

Pain is a stimulant; causing “fight or flight” in the Pain is a stimulant; causing “fight or flight” in the body. Raging catecholamines!body. Raging catecholamines!

Relief of pain can shut off those raging catechols Relief of pain can shut off those raging catechols and, all by itself, be sedating. Or liberating. and, all by itself, be sedating. Or liberating. Patients do “let go.”Patients do “let go.”

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Result….Result…. Patients come to us with incurable diseases, a Patients come to us with incurable diseases, a

myriad of physical and emotional experiences, myriad of physical and emotional experiences, declining organ systems, multiple metabolic declining organ systems, multiple metabolic abnormalities, with at least 4 sedating or mind-abnormalities, with at least 4 sedating or mind-altering medications on board, and poorly altering medications on board, and poorly cleared metabolites…along a continuum of gray, cleared metabolites…along a continuum of gray, where only the outcome is definite. where only the outcome is definite.

The background is fear, grief, anxiety, anger, The background is fear, grief, anxiety, anger, non-acceptance….lack of preparedness, lack of non-acceptance….lack of preparedness, lack of truth-telling. Lack of readinesstruth-telling. Lack of readiness..

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Our job…Our job… Provide excellent and expert pain and symptom Provide excellent and expert pain and symptom

management for our patients, before and at the management for our patients, before and at the moment of deathmoment of death

Create moments of gratitude, and some sense Create moments of gratitude, and some sense of acceptance for the caregivers at the bedside. of acceptance for the caregivers at the bedside. Create a moment they can continue to live with.Create a moment they can continue to live with.

Don’t violate any of the principles of sound Don’t violate any of the principles of sound ethical and moral behavior.ethical and moral behavior.

Stay within the scope of our practice.Stay within the scope of our practice. Don’t break the law. Don’t break the law.

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Back to definitions….AAHPMBack to definitions….AAHPM

Ordinary sedationOrdinary sedation: ordinary use of sedative for : ordinary use of sedative for appropriate indications: anxiety, agitated appropriate indications: anxiety, agitated depression. Goal is the relief of symptom depression. Goal is the relief of symptom without reducing level of consciousness (most without reducing level of consciousness (most frequent)frequent)

Palliative sedationPalliative sedation: use of sedative to, in part, : use of sedative to, in part, reduce the patients awareness of a distressing reduce the patients awareness of a distressing symptom. Level of sedation is proportionate to symptom. Level of sedation is proportionate to level of distress. Alertness is preserved as level of distress. Alertness is preserved as much as possible (very frequentmuch as possible (very frequent))

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Palliative Sedation…….Palliative Sedation……. to unconsciousness to unconsciousness

Administration of sedative to the point of Administration of sedative to the point of unconsciousnessunconsciousness, when less extreme , when less extreme sedation has not achieved sufficient relief sedation has not achieved sufficient relief of distressing symptom (rare)of distressing symptom (rare)

Intractable or Intractable or refractory sufferingrefractory suffering This practice is used only This practice is used only at the very end at the very end

of lifeof life

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Intervention: Morphine for pain or dyspnea Intervention: Morphine for pain or dyspnea

Morphine will relieve pain and air hunger, Morphine will relieve pain and air hunger, or suppress respirations and cause deathor suppress respirations and cause death

Intent: To relieve pain and air hunger: Intent: To relieve pain and air hunger: GoodGood

Intent: The only way to relieve pain and air Intent: The only way to relieve pain and air hunger is to “get this over with”: Badhunger is to “get this over with”: Bad

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Intervention: Midazolam for sedation Intervention: Midazolam for sedation

Midazolam: short acting, easy to titrate, Midazolam: short acting, easy to titrate, CNS depressant, sedates to either a state CNS depressant, sedates to either a state of unconsciousness or deathof unconsciousness or death

Intent: to induce calm sleep-like state, Intent: to induce calm sleep-like state, allowing the family to finally get close, stay allowing the family to finally get close, stay connected, provide hands-on care in the connected, provide hands-on care in the remaining hours to days with their loved remaining hours to days with their loved one: Goodone: Good

Intent: To get it over with: BadIntent: To get it over with: Bad

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Report of the AMA Council on Ethical and Judicial Report of the AMA Council on Ethical and Judicial Affairs: Affairs: Sedation to Unconsciousness in End-of-Life Care Sedation to Unconsciousness in End-of-Life Care

In June 2008 AMA House of Delegates accepted a In June 2008 AMA House of Delegates accepted a report from its CEJA supporting the use of palliative report from its CEJA supporting the use of palliative sedation for refractory pain and suffering at the end of sedation for refractory pain and suffering at the end of lifelife

Built upon the levels of sedation defined by the AAHPM Built upon the levels of sedation defined by the AAHPM Position Statement from 2006Position Statement from 2006

Added discussion of clinical and ethical issuesAdded discussion of clinical and ethical issues Provided a set of recommendations regarding patient Provided a set of recommendations regarding patient

selection, consenting and monitoring.selection, consenting and monitoring.

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Overall Discussion…Overall Discussion…

Affirms the duty to relieve pain and suffering as central to Affirms the duty to relieve pain and suffering as central to the physicians role as healer and an obligation the physicians role as healer and an obligation physicians have to their patientsphysicians have to their patients

Recognizes Palliative Care as a universally accepted Recognizes Palliative Care as a universally accepted approach to prevent and relieve suffering of patients with approach to prevent and relieve suffering of patients with life-limiting illnesslife-limiting illness

Supports palliative sedation as an important technique Supports palliative sedation as an important technique for combating extreme sufferingfor combating extreme suffering

Recognizes the possibility for moral debate because of Recognizes the possibility for moral debate because of its potential to be misconstrued as active euthanasiaits potential to be misconstrued as active euthanasia

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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

Discussion: Palliative Sedation Ethics

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But wait, there’s more…Rule of Double Effect

JustificationThe 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.

Discussion: Palliative Sedation Ethics

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When Applied to Palliative Sedation JustificationThe level of sedation must be justified by the severity of thepatient’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

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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

Discussion: Final CEJA Report

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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

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“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

“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