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A national guideline for palliative sedation in the Netherlands

A national guideline for palliative sedation in the Netherlands
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  Special Article   A National Guideline for Palliative Sedationin The Netherlands Marian Verkerk, PhD, Eric van Wijlick, MSc, Johan Legemaate, PhD,and Alexander de Graeff, MD, PhD Health Sciences/Medical Ethics (M.V.), University of Groningen/University Medical Center,Groningen; Royal Dutch Medical Association (E.v.W., J.L.), Utrecht; Institute for Social Medicine (J.L.), Vrije Universiteit, Amsterdam; and Division of Medical Oncology (A.d.G.), Department of  Internal Medicine, University Medical Center, Utrecht, The Netherlands   Abstract  The first national guideline on palliative sedation in The Netherlands has been adopted by the General Board of the Royal Dutch Medical Association. By law, the physician is obliged to take this guideline into consideration. In this paper, we present the main principles of the guideline. Palliative sedation is defined as the intentional lowering of consciousness of  a patient in the last phase of his or her life. The aim of palliative sedation is to relieve suffering, and lowering consciousness is a means to achieve this. The indication for  palliative sedation is the presence of one or more refractory symptoms that lead to unbearable suffering for the patient. Palliative sedation is given to improve patient comfort. It is the degree of symptom control, not the level to which consciousness is lowered, which determines the dose and the combinations of the sedatives used and duration of treatment. Palliative sedation is normal medical practice and must be clearly distinguished from the termination of  life. J Pain Symptom Manage 2007;34:666 e 670. Ó 2007 U.S. Cancer Pain Relief  Committee. Published by Elsevier Inc. All rights reserved. Key Words  Palliative sedation, guideline  Introduction  Over the past few years, a great deal of dis-cussion has taken place in The Netherlandsabout ‘‘terminal sedation,’’ also known as palli-ative sedation. The discussion was about thecriteria and the conditions that must be met,and also about the relationship between pallia-tive sedation and euthanasia. In 2003, the for-mer Chief Prosecutor, Joan De Wijkerslooth,suggested that terminal sedation should per-haps be covered by the Euthanasia Act. Minis-ter Piet Hein Donner and Secretary of StateCle´mence Ross-van Dorp responded by in-forming the Lower House that terminal seda-tion was normal medical practice. 1 In the third study of medical decisions inend-of-life care, published in 2003, data ont er-minal sedation appeared for the first time. 2 Inits reaction to this study, the government stressed that it was important for the medicalprofession itself to develop a national Address reprint requests to:  Alexander de Graeff, MD,PhD, Division of Medical Oncology, Department of Internal Medicine, F.02.126, University MedicalCenter, Heidelberglaan 100, 3584 CX Utrecht,The Netherlands. Accepted for publication: January 17, 2007. Ó 2007 U.S. Cancer Pain Relief CommitteePublished by Elsevier Inc. All rights reserved.0885-3924/07/$ e see front matterdoi:10.1016/j.jpainsymman.2007.01.005 666 Journal of Pain and Symptom Management Vol. 34 No. 6 December 2007   guideline with respect to terminal sedation. InSeptember 2004, at the request of the Ministry of Health, Welfare and Sports, the Royal DutchMedical Association (RDMA) appointed a com-mittee that was given the task of drawing upthis guideline. The committee consisted of a medical ethicist (chairperson), two medicaloncologists, two general practitioners, twonursing home physicians, one anesthesiologist,two nurses, a health lawyer, and a health scien-tist. All authors of this paper were members of the RDMA committee that designed theguideline.The committee met 11 times between Octo-ber 2004 and September 2005. A literature re- view was performed. After a consensus wasreached within the committee and a draft guideline was written, comments were givenby several medical, nursing, and pharmacist as-sociations, medical ethicists, and the Ministry of Justice. In November 2005, the final versionof the guideline was adopted by the GeneralBoard of the RDMA. 3 By implication, theguideline is now part of the physician’s profes-sional standard(s). By law, the physician is ob-liged to act according to these standard(s).On December 7, 2005, the guideline was of-fered to the Secretary of State for Health, Wel-fare and Sports.There are a limited number of guidelines orrecommendations for clinical practice. 4 e 14 One of these was recently published as a na-tional guideline, 10 some were developed at an institutional level by a specific taskforce, 5,9,13 and others reflect t he opinionandexperience of the authors. 4,6 e 8,11,12,14 Re-cently, recommendations for standards for pal-liative sedation were published by a task forceof theEuropean Association for PalliativeCare. 15 In this paper, we present the main prin-ciples of the guideline. What Is Palliative Sedation?  The terms palliative sedation, sedation inthe final phase of life, terminal sedation, ordeep sedation may have different meanings,but are often used as synonyms. In the guide-line, the term ‘‘palliative sedation’’ is pre-ferred, as it makes quite clear that thissedation takes place in the framework of palli-ative care. Several definitions have beenproposed in the literature. 15 e 19 The definitionof palliative sedation used in the guideline is asfactual as possible; palliative sedation is ‘‘theintentional lowering of consciousness of a pa-tient in the last phase of his or her life.’’ Theobjective of palliative sedation is to relieve suf-fering (caused by refractory, i.e., untreatable,symptoms), and lowering consciousness isa means to achieve this. It is very important that palliative sedation is given for the right in-dication, proportionally and adequately.Proportionally means that consciousness islowered only to the level necessary and suffi-cient to achieve the desired level of symptomalleviation. 14,15,17,20 The level of reduction of consciousness to achieve this end may vary from superficial to deep. The assessment anddecision-making processes must focus on ade-quate relief of the patient’s suffering, so that a peaceful and acceptable situation is created.Palliative sedation is given in the last phase of life, in the imminently dying patient. According to the guideline, palliative seda-tion may be used in two ways: 1) continuoussedation until death or 2) short-term or inter-mittent sedation. The ethical, legal, social,and political debate that has taken place re-garding ‘‘terminal sedation’’ was mainly about continuous sedation until death. Indication and Conditions   As in all other guidelines, 4 e 15 the indicationfor palliative sedation is formulated as follows:the presence of one or more refractory symp-toms, which leads to unbearable suffering forthe patient. A symptom is or becomes refrac-tory if none of the conventional treatmentsare effective (within a reasonable time frame)and/or these treatments areaccompanied by unacceptable side effects. 6,15 Pain, dyspnea,and delirium are the most common refractory symptoms that in clinicalpractice lead to theuse of palliative sedation. 5,6,15,17  Another condition (which only applies todeep and continuous sedation until death) isthat deathmust be expected within one totwo weeks. 4,18 This condition is also men-tioned in other guidelines. 5,8,10,13 e 15 In theguideline, the assumption is made that if deep and continuous sedation is administered(and the patient is, therefore, unable to take Vol. 34 No. 6 December 2007 667 A National Guideline for Palliative Sedation   fluids him- or herself), artificial hydrat ion willnot contribute to the relief of suffering 4,15,21,22 and may, in fact, have disadvantages, such asthe need for a subcutaneous or intravenouscannula and the possible increase of somesymptoms and signs (e.g., pain, edema, bron-chial secretion, and urinary incontinence). Al-though the decision to discontinue or not tostart artificial h ydration should beseenasasep-arate decision, 15 the guideline recommends ingeneral not to give fluids to a deeply sedatedpatient. It should be noted in this regard that almost all patients for whom deep palliative se-dation is considered have already stopped tak-ing fluids prior to sedation. If life expectancy isless than two weeks, it is assumed that with-drawing artificial hydration will not hastendeath. If life expectation is longer, the situa-tion is different, because in that case, the pa-tient would die sooner due to dehydrationthan would otherwise be the case. Decision Making  In a situation of severe suffering caused by refractory symptoms, palliative sedation may come up for discussion as the result of arequest  d explicitly or implicitly  d from the pa-tient and/or his or her family. Health care pro-fessionals also may take the initiative. In theguideline, it is stated that consideration of pal-liative sedation demands an exploration of thepatient’s situation. Relevant informationshould be obtained from the patient, the fam-ily, and the health care providers involved; thisshould lead to an adequate assessment of thepatient’s condition. Continuity of teamwork,good coordination, exchange of information,and communication between the various careproviders are essential. Lack of any of thesemay lead to inadequate assessment, informa-tion discrepancies, and to unrest. Optimalagreement between all those involved, espe-cially in the home situation, is crucial.Eventually, this should lead to a decision by the physician responsible for the treatment.Palliative sedation is regarded as a normalmedical procedure, although one used rarely and only under exceptional circumstances. El-ements of the decision are the aim and level(superficial or deep) of the sedation, choiceof the correct medication, and dosage. Noteson the decision-making process and theconsiderations playing a role in it are to be re-corded in the patient’s file, including any con-sultation that has taken place with the patient and/or his or her family, between the care pro- viders, and with any specialists involved. Incase of disagreement between the medicalteam and the relatives about what is in the pa-tient’s best interest, the doctor has the final say in the decision making (as is regulated in sec-tion 465 of the Dutch Patients’ Rights Act).In acute life-threatening (e.g., acute suffoca-tion due to tumor growth or bleeding) situa-tions, the treating physician may decide toinitiate palliative sedation without consulta-tion. In these cases, the steps referred to abovemust then be carried out after startingsedation. Consultation   Just as in all other forms of medical treat-ment, there must always be sufficient expertiseon which to base the decision to initiate palli-ative sedation. A doctor who is responsiblebut has insufficient knowledge of the treat-ment of severe symptoms, is uncertain about the correctness of the indication, and/or hasinsufficient knowledge on how to administersedatives should consult an expert, preferably a palliative care specialist. 4,5,7,9 e 11,13 e 15  Administering Sedation  The initiation of palliative sedation is anemotionally charged occasion, especially if it leads to a rapid loss of consciousness so that communication with the patient is lost. Thedoctor should be present when it is initiated,because sometimes intervention is necessary.In the subsequent phase, the administrationof sedation can be left largely to nurses andcarers, if necessary.In the guideline, the administration or doseincreasing of opioids or other nonprimarily sedative medications with the implicit or ex-plicit objective of producing sedation is re-garded as improper use of these medications,as sedation may occur at doses that may be as-sociated with undesirable effects, and evenhigh doses may fail to induce sedation. 4,15,18,22  When palliative sedation is started, usually a stepwise approach is taken. Midazolam isthe drug of first choice. If the response to anoptimal dose of midazolam is inadequate, the 668 Vol. 34 No. 6 December 2007 Verkerk et al.  team should check that the route of adminis-tration and the medication are in order and whether any reversible interfering factors(such as a full bladder or constipation) areplaying a role. Only after excluding these fac-tors should drugs such as levomepromazine,phenobarbital, or propofol be considered. Other Aspects  Good documentation is essential. The rele- vant data about the patient and his or her situ-ation must be recorded in the file: why thedecision was made to initiate palliative seda-tion, how it was administered, an assessment of its effect, and what criteria must be met toadjust the dosage. The treating physicianshould visit the patient at least once a day.Optimal palliative care also includes givingattention, support, and counseling to the pa-tient’s family and close friends. Both duringthe course of events leading up to palliative se-dation and during its administration, they play an important role. They function as carers, ob-servers, informants, and representatives of thepatient, in addition to their role as partner,family member, close friend, or acquaintance.They go through their own process of uncer-tainty, feelings of guilt, fear, sorrow, andmourning. Giving information and explana-tions to the family, working with them, and as-sessing the situation with them are essential fora satisfactory procedure and good parting.There should also be attention for the teammembers involved: care for the carers.Throughout the whole process, care and sup-port should be available for the various careproviders who are involved in the patient’s sit-uation. This requires good communication,reflection, and support for care providers. Palliative Sedation and Euthanasia  In the period preceding the appearance of the guideline, discussion took place about the position of continuous sedation untildeath in comparison to life-terminating treat-ment, in particular, euthanasia. The guidelineexpresses the view that palliative sedation isnormal medical practice and must be clearly distinguished from the termination of life.Palliative sedation is a way to reduce con-scious experience of symptoms and, therefore,of severe suffering. Palliative sedation differsfrom euthanasia in that palliative sedation isnot aimed at the termination of life. There isno evidence that appropriately administeredpalliative sedation shortens life. 23 This meansthat palliative sedation and euthanasia must be clearly distinguished from each other. Palli-ative sedation is for patients who do not want to suffer any more but do not want to end theirlives either. This means that palliative sedationthat is administered for the correct indication,in the correct dose, and in an adequate way isnot a ‘‘shortcut’’ to achieving the same goal aseuthanasia, namely to end life, but more slowly and without observing the requirements andprocedures set for euthanasia. Palliative seda-tion is not ‘‘slow euthanasia.’’ 24 e 26 Conclusion  Initially, palliative sedation had been associ-ated with the termination of life. It shouldnot be. There is no evidence that proportional-ly administered palliative sedation shortenslife. In recent years, it has been stressedmore and more often that palliative sedationis normal medical practice. This view is thepoint of departure in the new guideline issuedby the RDMA. Nevertheless, it is still important to define explicit criteria and conditions forthe use of palliative sedation in order to con-tribute to sound medical practice in this area.It is in this light that the contents of the guide-line should be seen. In this guideline, the com-mittee has gathered current knowledge andexperience based on several previously exist-ing regional guidelines, the national and inter-national literature and the opinions of experts within and outside the committee. Advancinginsights will undoubtedly lead to adjustmentsin the guideline. For the time being, it is im-portant that the debate about palliative seda-tion is stripped of spurious elements and that physicians and other care providers are awareof the standards and points of departure forsound practice. References  1. Sheldon T. ‘‘Terminal sedation’’ different fromeuthanasia, Dutch ministers agree. BMJ 2003;327:465.2. Rietjens JAC, van der Heide A, Vrakking AM,et al. Physicians report of terminal sedation without  Vol. 34 No. 6 December 2007 669 A National Guideline for Palliative Sedation   hydration or nutrition for patients nearing death inthe Netherlands. Ann Intern Med 2000;141:178 e 185.3. Committee on National Guideline for PalliativeSedation, Royal Dutch Medical Association. Guide-line for palliative sedation. Available from Utrecht:KNMG, 2005. ¼  AMGATE_6059_100_TICH_R193567276369746.4. Quill TE, Byock IR. Responding to intractableterminal suffering: the role of terminal sedationand voluntary refusal of food and fluids. Ann InternMed 2000;132:408 e 414.5. Braun TC, Hagen NA, Clark T. Development of a clinical practice guideline for palliative sedation. J Palliat Med 2003;6:345 e 350.6. Cherny NI, Portenoy RK. Sedation in the man-agement of refractory symptoms: guidelines for eval-uation and treatment. J Palliat Care 1994;10:31 e 38.7. Cherny NI. Sedation: Uses, abuses and ethics at the end of life. Jerusalem: Shaare Zedek MedicalCentre, 2003.8. Cowan JD, Palmer TW. Practical guide to pallia-tive sedation. Curr Oncol Rep 2002;4:242 e 249.9. HawryluckLA,HarveyWRC,Lemieux-CharlesL,etal.Consensusguidelinesonanalgesiaandsedationindyingintensivecareunitpatients.BMCMedEthics2002;3:3.10. Morita T, Bito S, Kurihara Y, et al. Development of a clinical guideline for palliative sedation therapy using the Delphi method. J Palliat Med 2005;8:716 e 729.11. Rousseau P, Ross E. Use of palliative sedation.Phoenix, AZ: Carl T. Hayden VA Medical Center,2000.12. Rousseau P. Existential suffering and palliativesedation: a brief commentary with a proposal forclinical guidelines. Am J Hosp Palliat Care 2001;18:151 e 153.13. Schuman ZD, Lynch M, Abrahm JL. Imple-menting institutional change: an institutional casestudy of palliative sedation. J Palliat Med 2005;8:666 e 676.14. Wein S. Sedation in the imminently dying pa-tient. Oncology 2000;14:585 e 591.15. De Graeff A, Dean M. Palliative sedation ther-apy in the last weeks of life: a literature review andrecommendations for standards. J Palliat Med2007;10:67 e 85.16. Beel A, McClement SE, Harlos M. Palliative se-dation therapy: a review of definitions and usage.Int J Palliat Nurs 2002;8:190 e 198.17. Chater S, Viola R, Paterson J, Jarvis V. Sedationfor intractable distress in the dying d a survey of ex-perts. Palliat Med 1998;12:255 e 269.18. Cowan D, Walsh D. Terminal sedation in pallia-tive medicine d definition and review of literature.Support Care Cancer 2001;9:403 e 407.19. Morita T, Tsuneto S, Shima Y. Proposed defini-tions of terminal sedation. Lancet 2001;358:335 e 336.20. Rousseau P. Terminal sedation in the care of dy-ing patients. Arch Intern Med 1996;156:1785 e 1786.21. Fine PG. Total sedation in end-of-life care: clin-ical observations. J Hosp Palliat Nursing 2001;81 e 87.22. Hallenbeck J. Terminal sedation for intractabledistress. West J Med 1999;171:222 e 223.23. Sykes N, Thorns A. The use of opioids and sed-atives at the end of life. Lancet Oncol 2003;4:312 e 318.24. Billings JA, Block SD. Slow euthanasia. J Palliat Care 1996;12:21 e 30.25. Brody H. Commentary on billings and block’s‘‘Slow euthanasia’’. J Palliat Care 1996;12:38 e 41.26. Mount BM. Morphine drips, terminal sedation,and slow euthanasia: definitions and facts, not anec-dotes. J Palliat Care 1996;12:31 e 37. 670 Vol. 34 No. 6 December 2007 Verkerk et al.
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