An Approach to Intractable Suffering Palliative Sedation

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					   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
 How do we know it was managed
 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
“Life is pleasant. Death is peaceful. It’s the
transition that’s troublesome.”

                                Isaac Asimov

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

                                   Woody Allen

               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

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

 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:
 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

   AAHPM published its Position Statement on Palliative
   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

“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

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
   What is the difference between palliative sedation and
   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.

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

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%
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
 Refractory symptoms 16-52%

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

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

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

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

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

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

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

Terminal sedation….literature
 Utilizationprevalence 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

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”

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
 Clarity of language, intent, purpose,

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

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

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

   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

 •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

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

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

 Ifa 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.

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

 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.”

 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.
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.

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
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)
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

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

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

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
   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.

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

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

Discussion: Palliative Sedation Ethics
But wait, there’s more…Rule of Double Effect
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.

When Applied to Palliative Sedation

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
 • Start with safe amounts of medication
• Increase incrementally, stopping at the lowest effective dose
• Observe effects and reassess/re-adjust accordingly

    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

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

“The duty to relieve pain and suffering is
central to the physician’s role as healer and
is an obligation physicians have to their
                          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

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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