National Ethics Teleconference

National Ethics Committee Report: The Ethics of Palliative Sedation as a
Therapy of Last Resort

## July 26, 2006

# 

# INTRODUCTION

**Dr. Berkowitz:**

Good day everyone. This is Ken Berkowitz. I am the Chief of the Ethics
Consultation Service at the VHA National Center for Ethics in Health
Care and a physician at the VA NY Harbor Healthcare System. I am very
pleased to welcome you all to today\'s National Ethics Teleconference.
By sponsoring this series of calls, the Center provides an opportunity
for regular education and open discussion of ethical concerns relevant
to VHA. Each call features an educational presentation on an interesting
ethics topic followed by an open, moderated discussion of that topic.
After the discussion, we reserve the last few minutes of each call for
our \'from the field section\'. This will be your opportunity to speak
up and let us know what is on your mind regarding ethics related topics
other than the focus of today\'s call.

# PRESENTATION

**Dr. Berkowitz**:

Today's presentation will focus on the ethics of using palliative
sedation as a therapy of last resort. Our discussion today will include
defining palliative sedation and identifying ethical concerns about the
practice of palliative sedation as a therapy of last resort. We will
also review emerging professional consensus regarding the use of
palliative sedation for managing severe, refractory systems at the end
of life.

Joining me on today's call is:

**James Hallenbeck MD -- Dr. Hallenbeck** is the Director of Palliative
Care Services at the VA Palo Alto Health Care System and an Assistant
Professor of Medicine at Standford University School of Medicine. He is
also the hub-site director for the VA Interprofessional Palliative Care
Fellowship Program.

**Mary Beth Foglia, RN, PhC, MN, MA** -- Ethics Consultant and
Evaluation Specialist, National Center for Ethics

Thank you all for being on the call today.

Jim, can you begin by giving us a brief overview of palliative sedation.

**Dr. Hallenbeck:**

Sure Ken. For most patients nearing the end of life, the goals of care
shift from an emphasis on prolonging life and optimizing function to
maximizing the quality of remaining life, and promoting comfort.
Palliative care becomes the priority. We also know that for some
patients, even expert symptom management can fail to provide relief. For
patients suffering from severe pain, dyspnea, vomiting, or other
symptoms that prove refractory to treatment, there is consensus that
palliative sedation is an appropriate intervention of last resort.
Specifically, the National Hospice and Palliative Care Organization and
the American Academy of Hospice and Palliative Medicine both support the
use of sedation to treat otherwise intractable and severe suffering at
the end of life. The practice has also been endorsed by the End-of-Life
Care Consensus Panel of the American College of Physicians, American
Society of Internal Medicine, and the American Medical Association.

**Dr. Berkowitz:**

So then, what do we mean by 'palliative sedation'?

**Dr. Hallenbeck:**

In the broadest terms, palliative sedation means sedating a patient to
the point of unconsciousness to relieve one or more symptoms that are
intractable and maintaining that level of sedation until the patient
dies. The intent of the clinician is to provide symptom relief for a
dying patient when all other efforts have failed.

It is important to note that palliative sedation is distinct from
sedation that normally accompanies therapeutic interventions, such as
intubation or treatment of severe burns, where recovery is expected or
likely to occur. Lesser degrees of sedation may also be appropriate at
the end-of-life for agitation, delirium and distress and such sedation
is "palliative" in its intent and use. However, this lighter sedation is
not usually called palliative sedation. This term is usually restricted
to deep sedation to the point of unconsciousness. Sedating the patient
as a palliative intervention is also distinct from the unintended and
variable sedative side-effects of medications.

Many practitioners also distinguish between palliative sedation and
'respite palliative sedation or simply respite sedation. Unlike
palliative sedation which continues until the patient dies, respite
sedation is provided as a time-limited therapy (e.g., 24-48 hours),
offered in the hope that temporary sedation will break the dying
patient's cycle of pain, anxiety, and distress. It has been argued that
temporarily lightening sedation also enables practitioners to check-in
with the patient to determine how effective they have been in
alleviating suffering associated, for example, with pain.

**Dr. Berkowitz:**

In this report, how does the National Ethics Committee define palliative
sedation?

**Dr. Hallenbeck:**

The National Ethics Committee defines palliative sedation as "the
administration of nonopioid drugs to sedate a terminally ill patient to
unconsciousness as an intervention of last resort to treat severe,
refractory pain or other clinical symptoms that have not been relieved
by aggressive, symptom-specific palliation."

**Dr. Berkowitz:**

So we know that there is broad professional agreement that palliative
sedation is a clinically and ethically appropriate response when
patients who are near death suffer unremitting symptoms but how do we
determine that a symptom is truly refractory?

**Dr. Hallenbeck:**

To help clinicians determine when a symptom is truly refractory, the
report suggests that clinicians consider the following questions: 1) are
further interventions capable of providing relief; 2) is the anticipated
acute or chronic morbidity of the intervention tolerable to the patient,
and; 3) are the interventions likely to provide relief within a
tolerable time frame? If the answer to any of these three questions is
no, then these are refractory symptoms for which palliative sedation may
be considered.

**Ms. Foglia:**

And I'd like to add that palliative sedation has been provided for a
wide range of symptoms experienced by patients at the end of life. For
example, studies have found that the primary indications for this
intervention include pain, nausea, and vomiting, shortness of breath,
and agitated delirium. Other indications noted in the literature include
urinary retention due to clot formation, gastrointestinal pain and
uncontrolled bleeding, and myoclonus. In addition palliative sedation
has been used to relieve severe and refractory psychological distress --
with the important caveat that potentially treatable mental health
conditions have been ruled out.

**Dr. Berkowitz**

Now let's turn our discussion to ethical concerns about palliative
sedation. The ethical debate about palliative sedation has been framed
largely in terms of five key questions: 1) is palliative sedation
ethically different from physician-assisted suicide and euthanasia?, 2)
is palliative sedation ever ethically appropriate for patients who are
not imminently dying?, 3) should willingness to forgo life-sustaining
treatment be a condition for administering/receiving palliative
sedation?, 4) is palliative sedation an ethically appropriate response
to "existential" suffering?, and; 5) may palliative sedation be provided
to patients who lack decision-making capacity?

Mary Beth, can you begin by discussing whether palliative sedation is
ethically different than physician assisted suicide or euthanasia?

**Ms. Foglia**

Sure Ken. It is fair to say that the general public and many clinicians
remain uncertain or confused about the ethical differences between
palliative sedation and physician-assisted suicide and euthanasia.
Although the ten year old debate continues with some vigor, the dominant
view among professional organizations and the bioethics community is
that palliative sedation is ethically different from physician-assisted
suicide or euthanasia.

Let me clarify. Clinicians are often faced with decisions that cannot be
avoided and that will have both desirable and undesirable effects. One
of these effects is intended by the clinician and is ethically
permissible and the other effect is not intended by the clinician and is
ethically undesirable. It has been argued that palliative sedation
involves just such a trade-off. What is desired through sedation is
relief of severe, intractable suffering, a good thing. However, some
have been concerned that in pursuit of this goal through palliative
sedation, death might be hastened, as an unintended (and ethically
undesirable) consequence. While this is a legitimate ethical concern,
there is no evidence that palliative sedation, applied selectively and
appropriately, results in hastened death. This stands in sharp contrast
to both physician-assisted suicide and euthanasia.

**Dr. Hallenbeck**

Palliative sedation also differs from physician assisted suicide and
euthanasia in terms of clinician intent. In physician-assisted suicide
and euthanasia, the clinician's intent is to cause or hasten the
patient's death, with the patient's suffering ending as a result. In
contrast, in palliative sedation, the clinician's intent is to relieve
the patient's suffering. One way that clinicians can demonstrate this
intent -- is to give just enough medication to control symptoms -- and
to titrate those medications to objective criteria. For example, in
ordering sedating medication for agitated terminal delirium, the orders
might explicitly set parameters for dose increases based on distress, as
evidenced by moaning, grimacing or calling out. Once the targeted
behavior is controlled, no further dose increase should occur.

A second but related difference is that in physician assisted suicide or
euthanasia, a lethal dose of medicine is prescribed or administered to
the patient. Conversely, in palliative sedation the patient is
administered only enough medicine to control their symptoms and lessen
suffering.

**Ms. Foglia**

Proportionality is a second ethical principle that helps us distinguish
between palliative sedation and physician-assisted suicide or
euthanasia. The principle of proportionality has long been a tenet of
medicine and basically states that the risk of causing harm must be
weighed against the expected benefit. In other words, clinicians are
permitted to perform, and patients to undergo, treatments and procedures
that carry serious or grave risks when there are commensurate benefits
to be gained.

**Dr. Hallenbeck**

Right. Think of the example of surgery for a patient who is seriously
injured in a car accident. Administering general anesthesia carries a
foreseeable risk of death. Yet the good intended -- for example, saving
the patient's leg or minimizing brain damage -- is usually held to be
significant enough to justify taking a substantial risk to obtain it. In
palliative sedation, although the means -- deep, continuous sedation for
a dying patient -- are grave, they are proportional to the goal to be
achieved which is relieving severe, unremitting suffering when all other
interventions acceptable to the patient have failed.

**Dr. Berkowitz:**

I'd also like to note that the distinction between palliative sedation
and either physician-assisted suicide or euthanasia recognized in the
emerging medical and ethical consensus is also supported in case law. In
the 1997 decisions in Vacco v. Quill and Washington v. Glucksberg, both
cases dealing with physician-assisted suicide, the U.S. Supreme Court
seemed to distinguish palliative sedation from assisted suicide as
legally acceptable practice. The Court did not explicitly address
palliative sedation as such, but did indicate strong support for
aggressive symptom relief for dying patients, even to the point of
rendering the patient unconscious.

**Ms. Foglia**:

And these rulings were likely influenced by the AMA's friend of the
court brief that took the position that "the pain of most terminally ill
patients can be controlled throughout the dying process without heavy
sedation or anesthesia but for a few patients sedation to a sleep like
state in the last days or weeks of life is necessary to prevent the
patient from experiencing severe pain."

**Dr. Berkowitz:**

Mary Beth, what about the second question -- is palliative sedation ever
ethically appropriate for patients who are not imminently dying?

**Ms. Foglia:**

Well Ken, the professional community remains divided about whether
palliative sedation is ethically appropriate for a patient who
experiences intolerable, intractable suffering but who is not imminently
dying.

Those in favor of expanding the application of palliative sedation to
terminally ill patients who are not imminently dying make the following
argument. If palliative sedation is an ethically appropriate response to
severe, intractable suffering, then why should it only be available to
patients who are hours or days from death? To withhold palliative
sedation from patients whose symptoms are severe and refractory solely
because they are not expected to die within hours or days imposes an
artificial and arbitrary constraint. And worse still, condemns these
individuals to endure unrelieved suffering for a potentially long period
of time.

**Dr. Berkowtiz:**

The National Ethics Committee recognized the ethical salience of this
position. However there are other compelling concerns raised by the
prospect of permitting palliative sedation for terminally ill patients
who are expected to survive for weeks or months.

**Ms. Foglia**

Right Ken. The committee report argues that allowing palliative sedation
when the patient can reasonably be expected to live for weeks or months
risks eroding the very important ethical distinction between palliative
sedation and physician-assisted suicide or euthanasia. For example,
sedating a terminally ill patient for weeks or months in order to
relieve suffering while respecting his or her right to forgo
artificially administered nutrition and hydration or other
life-sustaining treatment will directly and predictably shorten the
patient's life, a result clearly contrary to the goal of palliative
sedation.

**Dr. Berkowitz:**

And providing palliative sedation to patients who are not imminently
dying also raises slippery slope concerns. Palliative sedation is
generally considered appropriate only for patients who are imminently
terminally ill. At what other point in the trajectory of terminal
illness can we draw a line to distinguish when palliative sedation is
and when it is not ethically permissible?

**Ms. Foglia:**

The committee argues that by accepting "terminal illness" alone as a
sufficient criterion for palliative sedation, instead of the more
restrictive "imminently dying" we may increase the risk that the
practice would someday extend to individuals who are chronically but not
terminally ill.

**Dr. Hallenbeck:**

I would like to add here that it is important to remember that we are
not very accurate in predicting with a high degree of certainty how long
a patient will live. Patients with terminal cancer may follow a
relatively predictable course to death, but even for those patients,
physicians' predictions about the timing of death are not very accurate.
For patients with other types of life-limiting illness -- e.g. end-stage
kidney, lung or heart disease -- prognostication is even more
challenging. Ultimately, the determination that a patient has entered
the final phase of dying rests not on precise predictions of survival,
but on well-considered, informed professional judgment, which argues, by
the way, for the involvement of practitioners with appropriate
expertise, including palliative care specialists, in decision making
about palliative sedation.

While it is difficult at times to state with absolute certainty that a
patient is "imminently dying," proximity to death is generally
considered important in determining the appropriateness of palliative
sedation, based on the aforementioned principle of proportionality. The
closer the patient to death, the more reasonable and appropriate
sedation is thought to be.

Another concern, originally raised in reference to physician-assisted
suicide, may also be cogent with respect to palliative sedation for
patients who are not imminently dying. That is, deep sedation will come
to be seen as an alternative to providing high quality palliative care.
High quality palliative care is an essential pre-condition for any
consideration of palliative sedation and in fact, all palliative
therapies must be exhausted, including treatment for pain, depression,
delirium and anxiety prior to using palliative sedation

**Dr. Berkowitz:**

Let's turn to our third question -- should willingness to forgo
life-sustaining treatment be a condition for administering/receiving
palliative sedation?

**Dr. Hallenbeck:**

Professional consensus regarding best practice for palliative sedation
clearly establishes that patients who do not have a do-not-resuscitate
(DNR) order should not be considered appropriate candidates for
palliative sedation.

The National Ethics Committee believes that this is an appropriate
standard consistent with the overall goals of palliative sedation.

However, the debate continues about whether it is ethically appropriate
to provide other life-sustaining interventions, such as ventilator
support, dialysis, or artificially administered nutrition and hydration
to patients who receive palliative sedation.

Significantly, for the majority of imminently dying ill patients who are
appropriate candidates for palliative sedation, the question of
life-sustaining treatment is not likely to arise.

**Dr. Berkowitz:**

True enough but some dying patients who are appropriate candidates for
palliative sedation will want both palliative sedation and
life-sustaining treatment. What is the goal of care in a situation like
this?

**Dr. Hallenbeck:**

The goal of care would be twofold: to relieve suffering and to prolong
life consistent to the degree possible with the patient's goals.

**Ms. Foglia**

It is important to remind ourselves that the goal of palliative sedation
and the intention of clinicians who provide it is to relieve severe,
refractory suffering -- not hasten death. If patients with severe,
refractory suffering are excluded because they wish to continue life
sustaining treatments such as artificial hydration or nutrition, then
the intention is both to hasten death and relieve suffering -- blurring,
if not breaking down the distinction between physician assisted suicide,
euthanasia and palliative sedation.

**Dr. Hallenbeck:**

Right, the bottom line is that we find no compelling argument to limit
other concurrent life-sustaining interventions for patients who receive
palliative sedation, so long as those interventions are clinically
indicated.

**Dr. Berkowitz:**

Is palliative sedation ethically appropriate when suffering is
'existential'?

**Ms. Foglia:**

This remains one of the most deeply contested questions about palliative
sedation, that is, whether the practice is ethically appropriate as a
response to 'existential suffering' as distinct from pain or other
clinically defined physical or psychiatric symptoms. The three basic
concerns are: 1) the difficulty of defining existential suffering and of
distinguishing it clinically from treatable psychiatric conditions, 2)
whether the relief of existential suffering represents a 'proportionate'
goal, and 3) whether relief of existential suffering as such is within
the goals of medicine, and thus whether providing a pharmacological
intervention for such suffering is appropriate for health care
professionals.

But despite these concerns, there is some degree of support for
palliative sedation in response to existential suffering within the
professional hospice and palliative care community in the US -- and if
not palliative sedation then respite sedation to try and interrupt and
ameliorate the suffering.

**Dr. Berkowitz:**

As I understand it, the Committee members found these are challenging
issues and did not share a uniform perspective. This lack of consensus
within the Committee itself lead to the report taking a conservative
stance with respect to palliative sedation for existential suffering.

**Ms. Foglia:**

That's correct.

**Dr. Berkowitz:**

Let's address the last question which is, may palliative sedation be
provided to patients who lack decision-making capacity?

**Ms. Foglia:**

Because the decision to sedate a patient to unconsciousness and maintain
that state until he or she dies is a serious one, some might argue that
palliative sedation should be considered only for patients who can
consent to it themselves. However, confining palliative sedation to
patients who have decision-making capacity risks excluding many patients
whose suffering cannot be relieved by other means and for whom
surrogates are already empowered to make all other treatment decisions.
Surrogates have the right within VHA to make all treatment decisions for
patients who lack capacity and there are not strong arguments for why
palliative sedation should be viewed differently.

**Dr. Berkowitz:**

Thank you Mary Beth and Jim.

During our discussion today we have noted the important role in
palliative sedation of professional input from multiple disciplines. We
have also stressed that providing high quality palliative care is an
absolute prerequisite to decisions about palliative sedation. These
fundamental conditions for ethically appropriate practice of palliative
sedation are well recognized in the professional community. Consultation
with practitioners who are experts in pain and symptom management is
essential to assure that a patient's symptoms truly are refractory
before palliative sedation is considered and to initiate and monitor
sedation. Likewise patients must be assured access to expert
psychological and spiritual assessment and support prior to palliative
sedation.

The decision to sedate a dying patient to unconsciousness for the
duration of his or her life is a very serious one and should be made
only after careful clinical evaluation and thoughtful deliberations, and
must be implemented with appropriate monitoring and supervision.

Jim can you tell us what the National Ethics Committee recommends for VA
policy?

**Dr. Hallenbeck:**

Sure Ken. The National Ethics Committee recommends that VA policy permit
the

administration of palliative sedation to patients who have entered the
final stages of the dying process as a therapy of last resort when
severe pain or other clinical symptoms are not ameliorated by aggressive
symptom-specific interventions that are tolerable to the patient. The
patient should have a DNR order.

Further, signature consent of the patient, or surrogate when the patient
lacks capacity, is required by VA policy and the consent conversation
should be documented in the health record.

The committee also recommends that a series of safeguards be established
to protect patients' interests and assure consistent, high quality
palliative care. For example, palliative care experts should be
consulted with as needed during the decision making process. Further,
the plan of care needs to be clarified with the patient and/or surrogate
and should explicitly address whether the patient desires concurrent
life sustaining treatment.

Palliative sedation should only be administered by a health care
professional with appropriate expertise and the effects of the sedation
should be closely monitored to assure adequate and continuous
unconsciousness while avoiding untoward or unnecessary drug effects.
Patients should continue to receive all appropriate care and hygiene.

Finally, clear procedures for resolving disagreements about treatment
plans or specific treatment decisions should be established and ethics
consultation should be requested when indicated.

**CONCLUSION**

**Dr. Berkowitz:**

Well, as usual, we did not expect to conclude this discussion in the
time allotted, and unfortunately we are out of time for today\'s
discussion. We will post on our Web site a very detailed summary of each
National Ethics Teleconference. So please visit our Web site to review
today\'s discussion. We will be sending a follow up email for this call
that will include the call summary and the CME credits.

We would like to thank everyone who has worked hard on the development,
planning, and implementation of this call. It is never a trivial task
and I appreciate everyone\'s efforts, especially, Mary Beth Foglia,
James Hallenbeck, Nichelle Cherry, and other members of the Ethics
Center and EES staff who support these calls.

-   Let me remind you that there will be no scheduled call in August.
    Our next NET call will be on Tuesday September 26^th^ from 12-1:00
    PM ET. Please look to the Web site at vaww.va.gov/vhaethics and your
    Outlook e-mail for details and announcements.

```{=html}
<!-- -->
```
-   I will be sending out a follow-up e-mail for this call with the
    summary of this call and the instructions for obtaining CME credits.

-   Please let us know if you or someone you know should be receiving
    the announcements for these calls and didn\'t.

```{=html}
<!-- -->
```
-   Please let us know if you have suggestions for topics for future
    calls.

```{=html}
<!-- -->
```
-   Again, our e-mail address is: vhaethics@.va.gov.

Thank you and have a great day!