The dominant model of the health professional–patient relationship is curative, which is often ­characterized in contradistinction to palliative. The primary focus of the curative model is arriving at a diagnosis and then selecting and implementing an appropriate therapeutic intervention. The primary focus of the palliative model is the relief of pain, suffering, and other forms of ­distress associated with the manifestation of the disease in a particular patient. The patient’s experience of illness is a more important consideration than the label attached to the psychopathophysiological aspects of the disease process. The curative paradigm has shaped the modern medical school curriculum and has been identified as a major barrier to the provision of timely and effective palliative measures (Fox 1997). It is important to avoid simplistic categorizations, for example, that the curative model is only concerned about quantity of life and the avoidance of death while the palliative model is only concerned about the quality of life and the avoidance of pain and suffering at the end of life. Nevertheless, until fairly recently there has been a silo approach to the two models, with exclusively aggressive curative measures pursued until they manifestly fail to achieve their goal, and then their complete abandonment, whereupon there is an abrupt and often untimely shift to entirely palliative measures provided by a completely new cast of professional characters. At about the time of the massive study of intensive care in the United States in the mid-1990s, which revealed a plethora of problems with the palliative aspects of care in this setting (SUPPORT 1995), thought leaders began to call for a transition to what might be characterized as “simultaneous care,” in which curative and palliative measures are routinely provided at the same time rather than a rigid sequence of curative only followed by palliative only (Myers and Linder 2003).

Palliative care and hospice care are related yet distinct concepts and approaches to patient care. Because hospice is provided pursuant to the qualification of the patient for hospice benefits under the Medicare program, requiring certification by a physician that the patient has 6 months or less to live, hospice care is necessarily focused on patients with a terminal condition and the needs of their ­families during the dying and bereavement processes. Palliative care has no such limitations and may be appropriate for any patient experiencing distress arising out of a medical condition. Nevertheless, there is much overlap in the nature of interventions provided in hospice and palliative care settings, and in extreme cases those interventions may include what is the special concern of this chapter – palliative options of last resort.

It is important to note that routine palliative and hospice measures, many of which are covered in great detail in other chapters of this volume, are effective in achieving their objects in the management of the patient in roughly 95% of cases in which it is provided (see also, Section V, this volume). Data continue to show that too many patients who should be receiving and would benefit from quality palliative care do not receive it in a timely way, and sometimes not at all. This, however, is a separate issue from the roughly 5% of patients whose pain, suffering, and distress at the end of life are refractory to the usual and customary palliative measures (IOM 1998). Making palliative options of last resort available to these patients is a clinical and ethical obligation (Pellegrino 1998). Indeed, from a clinical standard of care perspective, some have argued that “a painful death is a presumptively mismanaged death” (Annas 1995).

There is no broad and solid consensus either in the health care professions or in American society concerning what should be considered a palliative option of last resort or when such options are clinically and ethically appropriate. One often-cited article on this topic considered the following measures under this rubric: voluntarily stopping eating and drinking (VSED), terminal sedation (sedation to unconsciousness), physician-assisted suicide (PAS) (lethal dose of medication administered by patient), and voluntary active euthanasia (lethal dose of medication administered by a third person at the patient’s request) (Quill et al. 1997). For reasons that will be discussed in subsequent sections of this chapter, neither the terms “terminal sedation” not “physician-assisted suicide” will be used in this chapter to refer to such practices. VSED is a right which can be asserted by any patient with decisional capacity, and can more aptly be described as a means of controlling the time and manner of one’s own death rather than a form of palliation. Voluntary active euthanasia will be considered only briefly at the end of this chapter because it is not a legal option in any U.S. jurisdiction or in most other countries of the world.

The critical distinction made by most clinicians between palliative measures and euthanasia is that the former are provided with the intent to relieve pain and suffering while the latter are provided with the intent to cause the patient’s death. In the section on lethal prescriptions, we will consider a counter argument that has been offered by some highly respected moral philosophers that in responding to the request for a lethal medication from a dying patient with decisional capacity a clinician may indeed have a palliative rather than homicidal intent. We must now consider how challenging it can be to discern intent solely from actions taken in the context of caring for patients with intractable end-of-life distress.

The Doctrine/Principle/Rule of Double Effect (DDE) is often invoked in the context of discussions about palliative options of last resort and therefore must be briefly reviewed at this point in the discussion. The origins of the doctrine lie in medieval Roman Catholic theology, and credit for its initial formulation is given to Thomas Aquinas in his Summa Theologica. In light of this, it is quite remarkable that DDE is so frequently invoked in contemporary secular discussions of end-of-life care across the domains of medicine, law, and ethics. The widespread references to DDE have tended to convey an impression that its tenets are beyond any reasonable dispute. Both the medical (Quill et al. 1997) and the philosophical (Mcintyre 2004) literatures contain robust critiques of DDE, and debates about its efficacy have been the subject of entire books (Woodward 2001).

The ostensible purpose of the doctrine is to ascertain the conditions under which it is morally acceptable to engage in an action that has both a good and a bad consequence. The doctrine consists of four essential elements:

The doctrine presupposes that those who propose to use it as a heuristic device for morally assessing a particular action will have a consensus view as to such matters as whether the action under review is morally good or morally neutral in and of itself (element 1), and whether the requirement of proportionality between the good and bad effects exists (element 4). In order to appreciate how elusive such a consensus may be, particularly in the care of the dying, consider the concept of a medical fate worse than death. Palliative options of last resort may reasonably be viewed by patients as a means of delivery from such a fate, as may be the withholding or withdrawing of life-sustaining treatment. Frequently cited examples of such fates include: survival in a permanent vegetative state, protracted dying in intractable pain or distress, or being afflicted by the locked-in syndrome (Pearlman et al. 1993). However, other individuals, including some physicians, would dispute that there could be such a thing as a medical fate worse than death because death is the ultimate harm or evil (Nagel 1970).

DDE also appears to take a rather simplistic view of two very complex and nuanced concepts – intent and causation. DDE maintains that there is a distinction with a critical moral difference between that which we intend when we act and that which we merely foresee. It is actually quite remarkable that the U.S. Supreme Court opinions in the PAS cases suggested that such a distinction was consistent with traditional legal distinctions between actions taken because of a given end and actions taken in spite of unintended but foreseen consequences (Glucksberg and Quill 1997). That is because it is a common jury instruction in the criminal law that “a person is presumed to intend the natural and probable consequences of his actions.” The burden of proof in such situations shifts to the defendant to rebut that presumption by competent and credible evidence. This presumption runs directly counter to the second element of DDE.

Those who invoke DDE often assert categorically that one who provides a lethal prescription at the request of a terminally ill patient necessarily intends to bring about the patient’s death, whereas one who disconnects a ventilator from a patient who is dependent upon it may merely intend to respect the patient’s right to refuse life-sustaining treatment, and in such instances neither the clinician nor the patient intend to bring about the patient’s death and that disconnecting the ventilator is not, in fact or in law, the cause of the patient’s death. Rather the underlying medical condition that necessitated ventilator support in the first instance is said to be the cause. Completely lost in the DDE calculus are the vagaries of intent, the interplay between the intent of the clinician and that of the patient, and the inescapable conclusion that but for the withdrawal of ventilator support, the ventilator-dependent patient would not die when and as she does (Miller et al. 2010).

The bottom line is that sound arguments in the philosophical and professional literature can be found supporting the proposition that DDE does not provide a litmus paper test as to whether any act or omission by a health care professional associated with end-of-life decisions is ethically and legally defensible or not. Of particular concern in arriving at such an ethical assessment are such critical considerations as whether accurate information has been conveyed to those involved and whether the patient’s wishes are respected.

Most pain and symptom distress experienced by patients at the end of life can be effectively ­managed utilizing a combination of pharmacological and nonpharmacological measures that constitute the hallmark of quality hospice and palliative care. There are chapters of this volume addressing many types of pain and strategies for the management and treatment of pain across clinical contexts (see also, Section V, this volume). Therefore, this section will only briefly address related ethical and professional issues. On an optimistic note, at long last we may be coming to the end of the life span for the persistent and pernicious myths that appropriately aggressive pain and symptom management carries a high risk of depressing respiration to the point of actually causing or hastening death. Indeed, quite to the contrary, recent data suggest that terminally ill patients who receive hospice care in a timely way actually survive longer and with a better quality of life (Connor et al. 2007).

Prescribing medications as a part of a palliative care plan is always a risk–benefit calculation. Respect for patient autonomy and dignity require that whenever possible the patient’s wishes and values be an important factor in assessing risk and benefit. Some patients wish to prioritize comfort over alertness, while others will bear significant and otherwise relievable distress in order to maintain the ability to interact with family and friends as long as possible. What is critical is that those providing care be competent to utilize available palliative measures consistent with a care plan tailored to the patient’s diagnosis, prognosis, and achievable goals of care.

Such a palliative care plan can be set out in general terms in the advance directive that every adult patient should execute and periodically review and update as appropriate. Upon the diagnosis of a serious or potentially life-threatening condition, the patient’s medical record should reflect more detailed provisions reflecting the patient’s goals and values concerning comfort measures. Does the efficacy of care plans differ across populations? There is some evidence that there are persistent racial/ethnic disparities that persist in advanced care plans? There are definitely values disparities among racial, ethnic, and religious groups, particularly with regard to withholding or withdrawing life-sustaining treatment and utilization of palliative options of last resort. Such disparities make individualized care planning all that much more important so as to insure that the care provided is consistent with patient wishes.

Several legal cases between 1990 and 2005 reveal tragic situations in which elderly cancer patients in the advanced stages of their illness were subjected to days or weeks of unnecessary pain and distress because of the failure or refusal of clinicians to provide adequate analgesia (Estate of Henry James v. Hillhaven Corporation 1991; Bergman v. Chin 2001; Compassion in Dying v. Washington 1994; Tomlinson v. Bayberry Care Center et al. 2002). In each of these cases, clinician ignorance concerning the relative risks and benefits of opioid analgesia in the care of patients with advanced cancer may have resulted in substandard care and legal liability. What can be done to enhance prescribing for pain control in these specific environments? Patients and their family members and/or close friends must be adequately informed about both the benefits and risks of pain and symptom management and empowered to advocate for them (Rich 2010).

For too long a significant number of clinicians have subscribed to myths and misinformation ­suggesting that opioids pose many dangers and offer meager benefits except, perhaps, for patients who are actively dying. Even in the care of patients at or near the end of life, some clinicians and family members view the mere possibility that an escalated dose of morphine might play any causal role in the timing of death as ethically unacceptable and potentially the basis for criminal prosecution. These exaggerated concerns reflect a failure to grasp an essential element of quality palliative care – prioritizing the relief of pain and suffering because death is imminent. When addressing the issue of PAS/aid in dying, the U.S. Supreme Court, through the words of then Justice O’Connor, noted that: “a patient who is suffering from a terminal illness and who is experiencing great pain has no legal barriers to obtaining medication, from qualified physicians, to alleviate that suffering, even to the point of causing unconsciousness and hastening death” (Washington v. Glucksberg 1997). Similarly, a seminal medical journal article by a group of 12 distinguished physicians admonishes that in the care of hopelessly ill patients: “Doses [of analagesics] should be brought promptly to levels that provide a reliable pain-free state … To allow a patient to experience unbearable pain or suffering is unethical medical practice” (Wanzer et al. 1989).

The federal Drug Enforcement Administration and the Federation of State Medical Boards have published formal statements and policies seeking to reassure physicians that they are not at risk of civil or criminal action so long as they prescribe controlled substances for legitimate medical purposes and consistent with recognized clinical practice guidelines (Fishman 2007).

Just before the turn of the twenty-first century, the American Medical Association (AMA), with the support of the Robert Wood Johnson Foundation, initiated the Education for Physicians on ­End-of-Life Care (2010) (EPEC) project. Its goals were to develop – through a series of national “train-the-trainer seminars” – and promulgate a set of core competencies in end-of-life care that should be learned by all physicians (not just hospice and palliative care physicians) who may at some time be involved in the care of the dying. The EPEC program materials include 12 teaching modules on a range of topics including advance care planning, whole patient assessment, pain ­management, goals of care, and managing the last hours of life. The pain management module materials note that the relief of pain is necessary but not sufficient for the relief of suffering (EPEC ­project website). Other measures may well be necessary to adequately address suffering and it is these measures that we consider in subsequent sections of the chapter.

A controversial and problematic term – “slow euthanasia” – has been introduced into the medical and legal setting to characterize the practice involving IV infusion of increasing doses of morphine (Billings and Block 1996).

The suggestion here is that rather than following the standard procedure of titrating the morphine does to effect, the dosage continues to be escalated to the point of somnolence, obtundation, or even obvious respiratory depression. When the article introducing this term appeared, it was accompanied by a series of critical commentaries the analysis of which is beyond the scope of this chapter. However, one very important point to note here is that escalating doses of morphine that may impair the patient’s alertness and/or respiratory drive are not the common and accepted means of providing palliative sedation for many forms of intractable distress. Similarly, the intent of the clinician in aggressively managing pain with opioids or by the administration of palliative sedation is not to cause or hasten the patient’s death but rather to insure comfort. More on this point follows in the next section.

Early discussions of sedation to unconsciousness for intractable distress invoked the term “terminal sedation,” which rapidly became the common characterization of this palliative strategy. Such a characterization is problematic for a number of reasons that warrant discussion at the outset. First, it is unclear to what the word terminal applies. At first glance, it would seem to be to the process of sedation itself. The most commonly used medications are barbiturates such as pentobarbital. However, properly administered and monitored, such drugs neither cause nor hasten death (Cherny and Radbruch 2009).

Upon further reflection, the word terminal does aptly describe the patient’s prognosis, as sedation to unconsciousness with no expectation that the patient will subsequently be brought back to a state of consciousness is only offered to patients in the advanced stages of a terminal illness whose ­distress has proven refractory to standard approaches to relief. Finally, the word “terminal” may be invoked because many, but not all patients who undergo sedation to unconsciousness in the final stages of a terminal condition, do not continue to receive artificial nutrition and hydration. Consequently, some of these patients may die of dehydration before the terminal event(s) of their underlying condition occur. However, the decision whether artificial nutrition and hydration will be provided following sedation to unconsciousness is completely separate and independent from the decision to actually initiate sedation. Not only would it often be quite difficult to accurately determine in such cases whether the primary cause of death was dehydration or complications of the terminal condition, but more importantly the decision not to provide artificial nutrition and hydration can be motivated by reasons other than to hasten the patient’s inevitable death.