Despite substantial advances in the delivery of palliative

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1 Annals of Internal Medicine Perspective Last-Resort Options for Palliative Sedation Timothy E. Quill MD; Bernard Lo, MD; Dan W. Brock, PhD; and Alan Meisel, JD Despite receiving state-of-the-art palliative care, some patients still experience severe suffering toward the end of life. Palliative sedation is a potential way to respond to such suffering, but access is uneven and unpredictable, in part because of confusion about different kinds of sedation. Proportionate palliative sedation (PPS) uses the minimum amount of sedation necessary to relieve refractory physical symptoms at the very end of life. To relieve suffering may require progressive increases in sedation, sometimes to the point of unconsciousness, but consciousness is maintained if possible. Palliative sedation with the intended end point of unconsciousness (PSU) is a more controversial practice that may be considered for much fewer refractory cases. There is more ethical consensus about PPS than PSU. In this article, the authors explore the clinical, ethical, and legal issues associated with these practices. They recommend that palliative care and hospice programs develop clear policies about PPS and PSU, including mechanisms for training and ensuring competency for clinicians, and approaching situations where individuals or institutions may conscientiously object. Ann Intern Med. 2009;151: For author affiliations, see end of text. Despite substantial advances in the delivery of palliative care and hospice (1, 2), some dying patients still experience severe suffering that is refractory to state-of-theart palliative care (3, 4). Some of these patients may not have access to palliative sedation, potentially to the point of unconsciousness, as a last resort to address this difficult circumstance. Consider the following real case. A 50-year-old man had battled lung cancer for several years before transitioning to hospice. He hoped to die comfortably at home with his family, but he feared severe suffering on the basis of experience with other deaths in his family. His palliative care consultant assured him that if his suffering became severe and unacceptable, he could receive total sedation as a last resort. He enrolled in a home hospice program in a small town in an adjacent state, and the local hospice medical director became his treating physician. The patient assumed this option was still open to him if needed. For 2 months, he had good quality of life and many meaningful experiences with his family. But when his dying later became both physically and psychologically unacceptable (intractable nausea, vomiting, weakness, and fear) despite skillful treatment by his hospice team, he asked for total sedation. The hospice team felt uncomfortable about such sedation and refused to provide it. No alternatives other than the status quo were presented. The hospice and its medical director were very uncomfortable with the patient s request, and their organization had no formal policies or guidelines for palliative sedation of any kind. No other hospices were in the city, and the patient was too ill to move to the acute palliative care unit at the site where the original consultant practiced. After extensive discussions with the patient s original palliative care consultant, she arranged for sedating medicines to be delivered from a local pharmacy to the patient and family at home. The patient was disenrolled from the hospice, and the staff was forbidden to see him. The sedating medication was increased in a stepwise manner over hours such that the patient was resting comfortably, which ultimately resulted in his being rendered unconscious. He died peacefully 4 days later. The patient and family were deeply grateful to their original palliative care consultant, but felt abandoned by the local hospice program at their time of greatest need, and the hospice staff caring for the patient felt demoralized and guilty. In this article, we will define 3 distinct but overlapping forms of palliative sedation (5, 6) and discuss ethical and legal issues related to their utilization in a palliative care setting. We provide a comprehensive approach to palliative sedation in patients who experience severe suffering at the end of life to prevent the potential for abandonment in a symptom crisis illustrated in this case. THREE TYPES OF PALLIATIVE SEDATION With ordinary sedation, the goal of treatment is relief of the symptom without reducing the patient s level of consciousness. Anxiety, agitated depression, insomnia, or related disorders can usually be treated in this manner. Decreases in consciousness during waking hours would be side effects that would warrant dose reduction or medication change. Such sedation is used in everyday medical practice both within and outside of palliative care. In proportionate palliative sedation (PPS), sedating medications (usually benzodiazepines) are progressively increased alongside other symptom-relieving measures, resulting in increasing levels of sedation during both waking and sleeping hours to help relieve suffering. It is usually initiated in response to otherwise intractable physical suffering in imminently dying patients, as in the case described, for example, or for agitated terminal delirium. The end point is relief of suffering that is acceptable to the patient by using the minimum amount of sedation needed to achieve this goal. The pace of increasing the sedation depends on the severity of physical symptoms, usually ranging from hourly to daily. Occasionally, PPS requires sedation to unconsciousness, which is considered a foreseen but unintended side effect when lesser degrees of sedation were ineffective. In palliative sedation to unconsciousness (PSU), unconsciousness is the intended goal of the sedation rather than a side effect. It is usually initiated when the imminently dy American College of Physicians 421

2 Perspective Last-Resort Options for Palliative Sedation ing patient finds severe physical symptoms intolerable despite state-of-the-art palliative care, and continuing consciousness under the circumstances is unacceptable. This may occur, for example, in cases of severe refractory bleeding or inability to swallow secretions. More controversially, PSU could also be considered in response to suffering that is predominantly existential or due to the dying patient s need for control. With PSU, sedation is rapidly increased over minutes to a few hours until the patient is unresponsive, and then is left at that level until the patient dies. Except under very unusual circumstances, artificial hydration and nutrition are not provided. Although probably legal, PSU is more ethically controversial than PPS, and there is frequently confusion between the 2 practices (3 5, 7 9). ETHICAL AND LEGAL ISSUES There is broad support for PPS to treat refractory physical suffering in imminently dying patients. In 1997, the U.S. Supreme Court expressed support for the practice of what it called terminal sedation (10), without clearly defining the term (11, 12). In a concurring opinion, Justice O Connor stated: 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, even to the point of causing unconsciousness and hastening death (13). The doctrine of double effect, originating from Catholic theology, provides a potential justification for PPS for some persons who are opponents of physician-assisted death (14). The American Medical Association (15), the American Academy of Hospice and Palliative Medicine (5), the National Hospice and Palliative Care Organization (16), and the Hospice and Palliative Nurses Association (17) have all issued policy statements and recommendations supporting PPS as a last-resort option to treat otherwise intractable physical suffering at the end of life. Critics of PPS and PSU raise several objections. Some fear that access to these practices may become too easy, with patients choosing them when other, less drastic options are still available. In particular, some object that permitting PPS and PSU without clear guidelines might legitimize physicians treating psychological, existential, or spiritual suffering, which in their view is outside the realm of a physician s expertise (7 9, 18). However, physicians already make difficult decisions with similar risks when they use other well-accepted practices, including forgoing life-sustaining therapy. Those with board certification in palliative medicine are trained to address these cases. Risks can be minimized by educating physicians about the proper clinical context for these options, by developing safeguards to guide the practice, and by establishing an internal quality improvement program to review all cases where PPS or PSU is provided, as well as cases where specific requests by patients or surrogates are denied (19). An additional objection to PPS and PSU is that explicit policies might heighten the perception that death is sometimes intentionally hastened within hospice programs. Consequently, some patients would be hesitant to enroll and thereby fail to receive high-quality end-of-life care. This concern should also be addressed by emphasizing that PPS and PSU are restricted to circumstances of unrelieved, severe physical suffering and to patients who are imminently dying (20), and that they will be initiated only with the explicit informed consent of patients or their surrogates. A final concern for some is a slippery slope toward physician-assisted suicide. The adoption of guidelines and policies concerning the use of PPS and PSU will help to assure that they are used only with the intent to relieve suffering and never with the intent to cause death. Palliative sedation to unconsciousness raises more objections than PPS. Although the purpose of PSU is to relieve otherwise intractable suffering, the patient is always rendered unconscious as an end point and therefore cannot take food and fluids by mouth, which may have the unintended effect of hastening a patient s death (14). For some clinicians, the moral ambiguity between what is intended (relief of suffering) and what results (unconsciousness and eventual death) from PSU may be aggravated if the patient explicitly articulates a desire for an earlier death (3, 21). These ethical objections are not unique to the use of PSU; they are also potentially present in decisions to withhold or withdraw life-sustaining therapies. However, no matter what the patient intends, the physician s intent in PSU must be to relieve intractable suffering. Likewise, in stopping artificial nutrition and hydration (should they mutually decide to do so), the physician s intent must be to respect the patient s right to decline treatment (19). The intent present in these situations stands in contrast to euthanasia, where the physician s explicit intent is to relieve suffering by ending the patient s life, which is not permitted by law, by prevailing ethical norms, or by accepted clinical practice. NEED FOR PREDICTABLE, ACCOUNTABLE POLICIES The practices of PPS and PSU currently show striking variation, accounting for 0% to 50% of deaths, depending on definitions and on the values and practice patterns of local hospice and palliative care programs (22, 23). (It is difficult to determine exactly which practice is being measured in these studies.) This wide range suggests that PPS and PSU may be underutilized in some settings and overutilized in others, and also that there may be confusion between the practices. (Proportionate palliative sedation may be relatively common, whereas PSU should be quite rare.) We believe that patients and their families deserve to know the full range of palliative options available to them, especially those who have particular fears and expectations about future treatment options. Such information is needed in advance to make informed decisions about the September 2009 Annals of Internal Medicine Volume 151 Number 6

3 Last-Resort Options for Palliative Sedation Perspective selection of providers and programs, particularly when 1 or both options are not available. To address this problem, we recommend the following: All hospices and palliative care programs should develop explicit policies and guidelines on the use of PPS and PSU for relief of intractable symptoms in terminally ill patients. All national hospice and palliative care organizations should develop model policies that local organizations can adapt to their circumstances. Education about PPS and PSU should be required in palliative care training programs and in the training of all health care professionals who care for seriously ill patients. Model education programs should be developed by national palliative care organizations. Education should include discussions of both the wide consensus about PPS for otherwise unrelievable physical suffering and the controversy about PSU. Individual practitioner knowledge about PPS and PSU (including its controversy) should be tested on certification and recertification examinations for palliative care and hospice clinicians and all others who treat seriously ill patients. As part of its quality improvement and monitoring processes, all institutions that care for seriously ill patients should systematically review cases where PPS or PSU was provided and cases where it was requested and denied. If an organization that provides palliative care has a policy that permits refusals of both PPS and PSU, its policy should include plans for how to inform patients about this limitation at the time of enrollment into the program or initiation of care. If policies allow PPS but permit refusal of PSU, guidelines should be developed for how clinicians should respond to patients who inquire about or request PSU when other palliative treatments including PPS have been tried and have failed. Adopting and publicizing institutional policies and procedures about PPS and PSU will have many salutary effects. First, it will increase transparency and patient and family awareness of these last-resort options. Second, it will help reduce unwarranted variation both inappropriate prohibition and inappropriate provision. Third, requiring that hospice and palliative care programs develop explicit policies and procedures for PPS and PSU could improve the quality of symptom management. Second opinions, mandatory palliative care consultations, and mandatory education about basic palliative care and the management of refractory cases will ensure that more standard palliative care interventions have been fully considered and tried before turning to PPS or PSU. Also, addressing the issue of patient access to these options if a provider or institution chooses not to provide them will help patients obtain the options they desire with reduced interference with their continuity of care. CONSCIENTIOUS OBJECTION Given the existence of national policies and guidelines for the use of PPS, should conscientious objections by local palliative care organizations or individual practitioners be accepted? In our opinion, there is enough ethical and policy consensus on PPS that all hospice and palliative care organizations should offer it as a last-resort option to relieve otherwise refractory physical suffering for their terminally ill patients. If a particular individual or organization is not going to provide PPS under these circumstances, patients and families should be explicitly informed during the referral and intake process. Individual health care workers have a right to conscientious objection, but they should make their objection known in advance, so that the institution providing palliative care can make arrangements for other health care workers to provide this option when appropriate. Although it remains legally permitted, PSU is ethically controversial, and some local palliative care organizations and health care workers have strong objections to it (7 9). When an organization chooses to provide PPS but opt out of PSU, this should be embodied in a written policy that is provided to terminally ill patients or surrogates who ask about the possibility of PSU in the future or request it when other palliative measures have failed to relieve unacceptable suffering. Routinely informing all patients of this limitation would have the benefit of full disclosure, but the risk of frightening patients who have never thought about these issues or are fearful of clinicians hastening death may outweigh this benefit. If the hospice offers PSU but an individual clinician conscientiously objects to it, the clinician or the organization must make arrangements to transfer the patient to a willing provider if needed. However, discussing what relief can be provided through PPS should be initiated before transfer is activated. As illustrated in this case, informing patients that neither option is available at the last minute when their suffering is unrelieved is morally, clinically, and possibly legally unacceptable. At this point, the patient is not in a good position to transfer care to another provider, and even if transfer were feasible, the inevitable delay in addressing the patient s suffering seems inhumane. The wish of individual practitioners and particular palliative care organizations to act on deeply held values deserves respect (7 9), but it must also be balanced against their professional obligations to assure that patients have adequate access to relief of refractory symptoms (24). SUMMARY Despite substantial advances in the delivery of palliative care and hospice, a small percentage of patients still experience severe suffering toward the end of life. Palliative sedation is sometimes considered as a way to respond to such suffering, but there is confusion about exactly what the practice entails, what is permissible, and what is required. Proportionate palliative sedation is intended to relieve refractory physical symptoms at the very end of life by using the minimum amount of sedation necessary to 15 September 2009 Annals of Internal Medicine Volume 151 Number 6 423

4 Perspective Last-Resort Options for Palliative Sedation achieve that end. To relieve suffering may require progressive increases in sedation, sometimes to the point of unconsciousness, but conscious awareness is maintained as much as possible. There is broad ethical consensus about the use of PPS under these circumstances. When other palliative care interventions, including PPS, are insufficient to relieve severe physical suffering, PSU may be needed in a relatively small number of difficult cases. There is less ethical consensus about PSU in these circumstances, and considerable ethical controversy about PSU in situations where the refractory suffering is more existential than physical or when the patient is not already imminently dying. Palliative care and hospice programs and practitioners should have policies about how they approach intractable suffering at the end of life, including their approach to PPS and PSU. If they are not willing to provide PPS or PSU, they should inform all patients of this limitation at the time of enrollment. If they allow PPS but prohibit PSU, their obligation to inform is restricted to when patients or families ask about or need last-resort options. The obligation of clinicians who care for seriously ill patients at the end of life to address intractable suffering requires that they become informed about available options and that they be as responsive as possible without violating fundamental ethical principles. From the Center for Ethics, Humanities and Palliative Care, University of Rochester Medical Center, Rochester, New York; Program in Medical Ethics, University of California, San Francisco, San Francisco, California; Harvard Medical School, Boston, Massachusetts; and Center for Bioethics and Health Law, University of Pittsburgh, Pittsburgh, Pennsylvania. Grant Support: Dr. Lo has received financial support from the National Institutes of Health (grant MH062246) and the Greenwall Foundation. Potential Financial Conflicts of Interest: Royalties: A. Meisel (Aspen [Wolters Kluwer]). Corresponding Author: Timothy E. Quill, MD, Center for Ethics, Humanities and Palliative Care, University of Rochester Medical Center, Box 687, 601 Elmwood Avenue, Rochester, NY Current author addresses are available at References 1. Morrison RS, Meier DE. Clinical practice. Palliative care. N Engl J Med. 2004;350: [PMID: ] 2. Morrison RS, Maroney-Galin C, Kralovec PD, Meier DE. The growth of palliative care programs in United States hospitals. J Palliat Med. 2005;8: [PMID: ] 3. Quill TE, Lo B, Brock DW. Palliative options of last resort: a comparison of voluntarily stopping eating and drinking, terminal sedation, physician-assisted suicide, and voluntary active euthanasia. JAMA. 1997;278: [PMID: ] 4. Quill TE, Byock IR. Responding to intractable terminal suffering: the role of terminal sedation and voluntary refusal of food and fluids. ACP-ASIM End-of- Life Care Consensus Panel. American College of Physicians-American Society of Internal Medicine. Ann Intern Med. 2000;132: [PMID: ] 5. American Academy of Hospice and Palliative Medicine. Position Statements: Statement on Palliative Sedation. Approved by the Board of Directors, 15 September Glenview, IL: American Academy of Hospice and Palliative Medicine; Accessed at on 10 November Chater S, Viola R, Paterson J, Jarvis V. Sedation for intractable distress in the dying a survey of experts. Palliat Med. 1998;12: [PMID: ] 7. Jansen LA, Sulmasy DP. Sedation, alimentation, hydration, and equivocation: careful conversation about care at the end of life. Ann Intern Med. 2002;136: [PMID: ] 8. Curlin FA, Lawrence RE, Chin MH, Lantos JD. Religion, conscience, and controversial clinical practices. N Engl J Med. 2007;356: [PMID: ] 9. Curlin FA, Nwodim C, Vance JL, Chin MH, Lantos JD. To die, to sleep: US physicians religious and other objections to physician-assisted suicide, terminal sedation, and withdrawal of life support. Am J Hosp Palliat Care. 2008;25: [PMID: ] 10. Burt RA. The Supreme Court speaks not assisted suicide but a constitutional right to palliative care. N Engl J Med. 1997;337: [PMID: ] 11. Vacco v. Quill. 117 U.S (1997). 12. Washington v. Glucksberg. 117 U.S (1997). 13. Glucksberg v. Washington. 521 U.S. 702, 737 (1997) (O Connor, J., concurring). 14. Quill TE, Dresser R, Brock DW. The rule of double effect a critique of its role in end-of-life decision making. N Engl J Med. 1997;337: [PMID: ] 15. Sedation to Unconsciousness in End-of-Life Care. Report of the American Medical Association Council on Ethical and Judicial Affairs, Report 5-A-08. Chicago: American Med Assoc; National Hospice and Palliative Care Organization. Total Sedation: A Hospice and Palliative Care Resource Guide. Alexandria, VA: National Hospice and Palliative Care Organization; November Accessed at /public/nhpcototalsedationshort.pdf on 27 July Hospice and Palliative Nurses Association. HPNA Position Statement: Palliative Sedation. Pittsburgh: Hospice and Palliative Nurses Association; April Accessed at Position %20Statements on 27 July Callahan D. The Troubled Dream of Life: In Search of a Peaceful Death. Washington, DC: Georgetown Univ Pr; Lo B, Rubenfeld G. Palliative sedation in dying patients: we turn to it when everything else hasn t worked. JAMA. 2005;294: [PMID: ] 20. Cellarius V. Terminal sedation and the imminence condition. J Med Ethics. 2008;34: [PMID: ] 21. Quill TE. The ambiguity of clinical intentions. N Engl J Med. 1993;329: [PMID: ] 22. Ventafridda V, Ripamonti C, De Conno F, Tamburini M, Cassileth BR. Symptom prevalence and control during cancer patients last days of life. J Palliat Care. 1990;6:7-11. [PMID: ] 23. Claessens P, Menten J, Schotsmans P, Broeckaert B. Palliative sedation: a review of the research literature. J Pain Symptom Manage. 2008;36: [PMID: ] 24. Brock DW. Conscientious refusal by physicians and pharmacists: who is obligated to do what, and why? Theor Med Bioeth. 2008;29: [PMID: ] September 2009 Annals of Internal Medicine Volume 151 Number 6

5 Annals of Internal Medicine Current Author Addresses: Dr. Quill: Center for Ethics, Humanities and Palliative Care, University of Rochester Medical Center, Box 687, 601 Elmwood Avenue, Rochester, NY Dr. Lo: Program in Medical Ethics, University of California at San Francisco, Room C126, 521 Parnassus Avenue, San Francisco, CA Dr. Brock: Division of Medical Ethics, Department of Global Health and Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston MA Dr. Meisel: Center for Bioethics and Health Law, University of Pittsburgh, 3900 Forbes Avenue, Pittsburgh, PA W September 2009 Annals of Internal Medicine Volume 151 Number 6

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