University Medical Center, Rotterdam, the Netherlands .... The ethical issues that arise are those surrounding the ....
American Journal of Transplantation 2016; 16: 1967–1972 Wiley Periodicals Inc.
© Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons doi: 10.1111/ajt.13746
Special Article
Organ Donation After Euthanasia: A Dutch Practical Manual J. Bollen1,*, W. de Jongh2, J. Hagenaars3, G. van Dijk4, R. ten Hoopen5, D. Ysebaert6, J. Ijzermans7, E. van Heurn8 and W. van Mook9 1
Maastricht University Medical Center, Maastricht, the Netherlands 2 Chair Bureau Donation and Transplantation Coordination, Maastricht University Medical Center, Maastricht, the Netherlands 3 Chair Bureau Donation and Transplantation Coordination, Erasmus University Medical Center, Rotterdam, the Netherlands 4 Department of Medical Ethics and Philosophy of Health Care, Erasmus University Medical Center, Rotterdam, the Netherlands 5 Health Law, Faculty of Law, Maastricht University, Maastricht, the Netherlands 6 Department of Hepatobiliary, Transplantation and Endocrine Surgery, Antwerp University Hospital, Antwerp, Belgium 7 Department of Transplantation Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands 8 Department of Pediatric Surgery, Academic Medical Center, Amsterdam, the Netherlands 9 Maastricht University Medical Center, Maastricht, the Netherlands *Corresponding author: Jan Bollen,
[email protected] Many physicians and patients do not realize that it is legally and medically possible to donate organs after euthanasia. The combination of euthanasia and organ donation is not a common practice, often limited by the patient’s underlying pathology, but nevertheless has been performed >40 times in Belgium and the Netherlands since 2005. In anticipation of patients’ requests for organ donation after euthanasia and contributing to awareness of the possibility of this combination among general practitioners and medical specialists, the Maastricht University Medical Center and the Erasmus University Medical Center Rotterdam have developed a multidisciplinary practical manual in which the organizational steps regarding this combined procedure are described and explained. This practical manual lists the various criteria to fulfill and the rules and regulations the different stakeholders involved need to comply with to meet all due diligence requirements. Although an ethicist was involved in writing this paper, this report is not specifically meant to comprehensively address the
ethical issues surrounding the topic. This paper is focused on the operational aspects of the protocol. Abbreviation: DCD, donation after circulatory death Received 10 May 2015, revised and accepted for publication 24 January 2016
Introduction In September 2013, an article addressing organ donation after active euthanasia was published in the Dutch Journal of Medicine (1). A patient suffering from a progressive neurodegenerative disease was able to donate his liver and both kidneys. Organ donation after euthanasia has been described previously, with excellent transplant outcome (2). Prior to December 2015, organ donation after euthanasia was performed 15 times in the Netherlands and resulted in donation of eight pairs of lungs, 13 livers, 13 pancreases and 29 kidneys. These developments necessitated the creation of a practical manual addressing the combination of both procedures because of the unique and complex legal and ethical issues, together with the appropriate medical care (3). This manual can be used as a framework for hospitals that wish to facilitate such successive procedures. The essential components of the practical manual, developed by the collaborative efforts of the Maastricht University Medical Center and the Erasmus Medical University Medical Center Rotterdam, are discussed below. Although the manual addresses euthanasia and organ donation in the Netherlands, many of the issues raised and discussed may be similar or comparable to those in any country that allows organ donation in the setting of euthanasia. A discussion of ethical considerations is not included in this paper, but this is not intended to dismiss the necessary ethical discussions to be held in this domain.
Legal Issues Regarding Euthanasia and Organ Donation Euthanasia is legally possible in the Netherlands, Belgium, Luxembourg, and Colombia (4). Some other countries
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and states in the United States have legalized assisted suicide. The latter is performed most often by drinking a barbiturate, which causes low blood pressure and oxygen saturation drop with unpredictable duration. Even though this approach has been proposed by others, it is unknown whether organ donation is still medically possible (5). Euthanasia implies the intravenous admission of a coma inducer and a muscle relaxant, causing the patient to die quickly, often without severe ischemia to the organs. If a patient asks to undergo euthanasia and subsequently donate his or her organs, the physician has to investigate whether the due diligence requirements for euthanasia under the Euthanasia Act have been fulfilled before initiating the process of preparation for organ donation. The adult patient needs to request euthanasia voluntarily, and the request must be well considered; the patient must be hopelessly and unbearably suffering and must be well informed; and other reasonable solutions for the patient’s suffering must be unavailable (6,7). This does not mean the patient has to be suffering from a condition that will cause him or her to die within relatively short time frame. Furthermore, a second independent physician has to be consulted, and the euthanasia procedure should be performed according to the latest standard. After the patient has died, the Dutch Burial and Cremation Act requires that the municipal coroner be notified because, from a legal perspective, euthanasia results in a “nonnatural” death. The municipal coroner informs the public prosecutor and the regional euthanasia review committee (8). Because the euthanasia procedure causes the patient to die from cardiac arrest, only donation after circulatory death (DCD) is possible, analogous to Maastricht classification category 3 (9,10).
Ethical Issues Regarding Euthanasia and Organ Donation There are many ethical considerations regarding organ donation after euthanasia but not regarding the donation itself compared with a regular organ donation procedure. The ethical issues that arise are those surrounding the decision to allow euthanasia under these specific circumstances. Even though organ donation after euthanasia has already been performed, the practice remains ethically questionable. Nevertheless, in a recent case in which a patient was denied organ donation after euthanasia by a hospital where he was not under treatment, the strongly voiced public opinion was that the patient’s wish to donate organs
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should have been granted, adding fuel to the debate. This topic was subsequently discussed in the Dutch Parliament, and the parliamentarians asked the Minister of Health to facilitate the process of organ donation after euthanasia. Motivation of the patient The treating physician should investigate whether others, like a person in need of an organ, are persuading the patient to consider euthanasia to make organs available and whether the patient might be requesting euthanasia because he can donate organs. Nevertheless, it is important not to discourage the patient’s altruistic intentions. As long as the patient meets the due diligence criteria for euthanasia, it is ethical to respect the patient’s desire to donate organs. It can be hypothesized that—in the presence of HLA matching or possibly through crossover transplantation— some patients might be motivated or persuaded to undergo euthanasia to donate organs to a specific recipient in need. (11). Although directed donation after death is possible in the United States, allocation in the Netherlands is done by Eurotransplant, using a procedure that does not enable the donor to choose the recipient or recipients (12,13). This approach seemingly contradicts the principle of patient autonomy and could give rise to frustration in the patient as well as the eligible recipient, potentially even causing the patient to abandon the donation procedure. Living donation before euthanasia is a theoretical alternative, even in severely ill patients (14); however, it seems irrational that the only possibility for a patient to choose a recipient is by undergoing surgery before undergoing euthanasia. “Heart-beating” euthanasia Some organ donors expressed the wish to donate all of their organs, including their heart, which is not currently common practice in DCD (15,16). A theoretical possibility would be to perform euthanasia by removing the heart, under general anesthesia (17). The “dead donor rule,” as well as the current Dutch Euthanasia Act, currently does not allow such a “heart-beating” euthanasia–donation procedure (18). Nevertheless, one could question whether this rule needs to be applied to the specific situation of organ donation after euthanasia. In organ donation procedures (without euthanasia), the goal is to protect the donor’s interests by avoiding removal of vital organs from a patient who is not deceased, whereas in organ donation after euthanasia, it is the patient’s strong wish to die, regardless of the donation wish. In addition to this legal threshold, practice has shown that, occasionally, relatives insist on seeing the patient die before being brought to the operating room.
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Is the physician obliged to mention organ donation after euthanasia? What if a physician is confronted with a patient who fulfills all due diligence requirements for euthanasia and lacks contraindications to organ donation but does not raise the issue of organ donation autonomously? By mentioning the possibility of organ donation after euthanasia, the physician appeals to the patient’s right to self-determination and creates awareness and a mindset regarding this perhaps unknown possibility. It could be comforting to the patient to know that he or she is able to help people survive and to improve their quality of life. Alternatively, when a patient is suffering so severely that he or she asks to undergo euthanasia, it may be inappropriate to discuss organ donation. The treating physician, who often has a long-term relationship of trust with the patient, is usually the preferred person to raise the issue of organ donation after euthanasia. If the physician decides to do this, the patient’s previously documented preferences regarding organ donation should be checked in the Dutch Donor Registry, as required by Dutch law. This registration could guide the physician in the dilemma of whether or not to discuss this subject with the patient. The authors are of the opinion that not discussing the option of organ donation only respects the autonomy of those who are well informed. Informing the donor and the recipient In the past, donors have asked who would become the recipients of the different organs. It is not legally allowed to convey this information for reasons of privacy. The answer also might put additional pressure on the donor to continue the process, even if the donor is having thoughts about withdrawal from the donation process. It could also create additional stress if the patient is informed that there is no suitable recipient for an organ. Following Eurotransplant regulations, recipients and their physicians have the opportunity to refuse certain types of donor organs when a patient is placed on the waitlist. These criteria include donor age and type and should also include donor organs from donors after euthanasia (19). As illustrated by the previous sections, many ethical questions arise with the combination of euthanasia and organ donation. In any case, this combination makes it possible for the conscious patient to decide whether, how and when to donate his or her organs, an opportunity that is impossible in all other DCD procedures.
Content of the Practical Manual What practical steps should a general practitioner or medical specialist take when a patient requests euthana-
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sia but also expresses the wish to donate organs, in the absence of contraindications to donation? Euthanasia The patient’s euthanasia request will often result from a process of increasing insight and knowledge during illness and after a constant dialogue between the treating physician and the patient. Different options will be discussed, like palliative sedation, pain relief and going to a hospice. It is possible that the option of organ donation is raised by the patient, even before the issue of euthanasia has been discussed. In this case, the physician should state that the due diligence requirements for euthanasia have to be considered and complied with before the issue of organ donation can be discussed. After the second physician’s consultation, the treating physician can agree with the euthanasia request and then becomes the “performing physician,” which is a pivotal role in the euthanasia procedure. Organ donation If the patient wishes to become an organ donor, the performing physician verifies whether the patient is registered as an organ donor or has the patient sign an advance directive. Transplant coordinator: The physician contacts the transplant coordinator, who reviews the patient’s medical files for contraindications to organ donation. If the patient is a suitable potential donor, a meeting between the patient and the performing physician is arranged during which practical and procedural issues will be clarified (the “house call”). Current practice demonstrates that the presence of a transplant coordinator during the house call is appreciated by all parties. In this meeting, at least two important issues are raised: the necessity of additional diagnostic testing and the need for in-hospital euthanasia (as opposed to a euthanasia procedure at home). Additional diagnostic tests: Even though Dutch law states that diagnostic tests can be performed only when they benefit the patient, the Dutch Organ Donation Act allows the transplant coordinator to perform these tests when it is clear that the patient will die within a limited period of time. Depending on the results, the transplant coordinator, together with the transplant surgeons, decides which organs can be donated. A standard blood and urine sample is collected during the house call (see Appendix). Depending on the organs to be donated, additional tests may be necessary to exclude apparent contraindications (20). These tests can be performed in the hospital before admission or on the
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day of euthanasia, depending on the patient’s wish. Based on the results, Eurotransplant searches for suitable recipients. Nevertheless, it is possible that a contraindication to organ donation could be discovered during surgery. In-hospital procedure: After the euthanasia procedure, the deceased donor is transported to the operating room as fast as possible. This information is important for the relatives; they will not be able to have a quiet, personal moment with the deceased donor because the period of time between death and retrieval of the organs needs to be as short as possible. Every minute of delay causes the quality of the organs to decline, which may even result in impossibility of donation due to ischemia, conflicting with the patient’s explicit wish. The relatives are extensively informed that they need to say goodbye before the euthanasia drugs are administered. This approach has not led to any problems in practice to date. It is imperative to discuss what to do if the patient’s condition deteriorates and the patient becomes unconscious in the days preceding the day of the procedure. If necessary, a new medical evaluation will be performed to determine whether the organs are still eligible for donation. Donation after natural circulatory death is an alternative option for organ donation in this context. Extensive discussion of this procedure is beyond the scope of this article. Preparatory measures: After the house call, the combined euthanasia and organ donation procedure is organized. The patient, the performing physician and the transplant coordinator, in close communication with the medical coordinator of the operating room, will decide on a suitable date. Although several preparatory meetings with all stakeholders to discuss this matter in general will have already been held, any potential moral reservations of the staff involved in the procedure will be respected. For obvious reasons, the hospital will only deploy staff who are willing and able to participate in this procedure. If the performing physician is not an employee of the hospital (e.g. a general practitioner or medical specialist from another institution), the performing physician will need to sign a statement declaring the opinion that the due diligence requirements have been fulfilled and that euthanasia will be performed according to the latest standards; the hospital is formally responsible for the procedure as well (21). The preferred pathway, in view of the fact that euthanasia is a nonnatural death, is that the transplant coordinator preinforms the municipal coroner (forensic physician), who, after examination of the patient’s medical chart, informs the public prosecutor about this procedure and 1970
the scheduled date. The public prosecutor will then be able to grant permission to use the body for organ donation, so that no time is lost after the patient has died (22). This approach optimizes the process of organ donation while respecting the patient’s final wish for organ donation, reducing the period of time between death and organ procurement, and improving the quality of the organs after transplantation. Day of the procedure The patient’s arrival time at the hospital depends on the organs to be donated and when the diagnostic tests will be performed. In case of lung donation, an additional surgical team is required but only if diagnostic tests have ruled out any contraindications and after Eurotransplant has found a recipient. This implies that the patient needs to arrive earlier if the lungs are donated. In the hospital, euthanasia will be performed in a patient room that is located near the operating room, that is spacious enough to allow relatives to be present, and that minimizes interference from other patient care. The euthanasia drugs will be collected from the hospital’s pharmacist by a physician. After all stakeholders have arrived, a nurse inserts an intravenous cannula but is not legally allowed to administer the euthanasia drugs. A Dutch guideline on how to perform euthanasia requires the physician to administer a sedative (the barbiturate thiopental or the hypnotic agent propofol), followed by a muscle relaxant (23). Although a barbiturate is potentially cardiotoxic, propofol is commonly used for general anesthesia and thus does not cause harm to the donated organs. In Belgium, physicians sometimes administer heparin immediately after injection of the euthanasia drugs to improve the quality of the organs. In the Netherlands, this is not done because it is generally felt that donation should not interfere with the euthanasia procedure itself. The patient is not put on a monitor because this could misguide the physician by pulseless electric activity. The Health Council of the Netherlands states that “circulatory death is ascertained by recording the absence of an intra-arterial pressure wave or based on another current method of monitoring circulation. A no-touch period of five minutes is then observed. After this time has elapsed, irreversible circulatory and respiratory arrest exists and death may be declared” (24,25). If the euthanasia procedure were to be performed at home, the performing physician would not have a monitor available to determine death, and death would be based on the absence of respiration and heart rate. After determining death, the performing physician informs the municipal coroner. The patient is transported to the operating room, where the surgical team is on American Journal of Transplantation 2016; 16: 1967–1972
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stand-by. After organ procurement, the organs are transported to the various recipients. Aftercare The nurse and a second transplant coordinator assist the relatives during this process. A private family room is available where the relatives can wait until the procedure has ended. The deceased donor will be laid out in the morgue of the hospital but also can be transported to another morgue or home. Within 2 weeks after the procedure, a debriefing is held to discuss any moral distress that may have arisen among any of the health staff involved and to review all legal, ethical and practical aspects. The regional euthanasia review committee is informed by the municipal coroner and verifies whether the performing physician has complied with the due diligence requirements of performing euthanasia. Should this committee be convinced that not all requirements were fulfilled, it is obliged to inform the Dutch Health Care Inspectorate. This inspectorate can inform the public prosecutor, after which a court could condemn the physician. In the donation-aftereuthanasia procedures performed to date, the Dutch Health Care Inspectorate has ascertained that all requirements were fulfilled. If this had not been the case, it would not necessarily have implied that the organ donation procedure was also unlawful.
Conclusion The Dutch Euthanasia and Organ Donation Acts provide sufficient possibilities for patients to donate their organs after euthanasia. Given the right of self-determination, such a combined procedure may be ethically justifiable, although it should be acknowledged that many ethical issues remain and give rise to ongoing debate. A physician who is confronted with a patient who requests euthanasia may consider raising the possibility of organ donation, if no contraindications are identified. More extensive discussion of ethical issues is necessary but is beyond the scope of this article. The Dutch multidisciplinary practical manual provides a framework for the medical and logistical aspects of donation after euthanasia within the medical, legal and ethical boundaries of Dutch law. As of December 2015, it has been used 11 times. By distributing this information to medical professionals, awareness of this relatively less known possibility for organ donation will increase.
Disclosure The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation. American Journal of Transplantation 2016; 16: 1967–1972
References 1. van Dijk GUF, Hamers R. Orgaandonatie na euthanasie bij een €nt met een neurodegeneratieve aandoening. Dutch J Med patie 2013; 157: A6548. 2. Van Raemdonck D, Verleden GM, Dupont L, et al. Initial experience with transplantation of lungs recovered from donors after euthanasia. Appl Cardiopulm Pathophysiol 2011; 15: 38–48. 3. Cohen J, Van Landeghem P, Carpentier N, Deliens L. Public acceptance of euthanasia in Europe: A survey study in 47 countries. Int J Public Health 2014; 59: 143–156. 4. Resolution regarding the guidelines for the organization and functioning of the Committees to implement the right to die blica De Colombia, with dignity (Colombia), April 20, 2015 [Repu n Social, Resolucio n No mero Ministerio De Salud Y Proteccio 1216 del 20 de abril del 2015 por medio de la cual se da cumplimiento a la orden cuarta de la sentencia T-970 de 2014 de la n con las directrices Honorable Corte Constitucional en relacio n y funcionamiento de los Comite s para hacer para la organizacio efectivo el derecho a morir con dignidad]. BBC News; 2015. 5. Shaw DM. Organ donation after assisted suicide: A potential solution to the organ scarcity problem. Transplantation 2014; 98: 247–251. 6. Euthanasia Act (Netherlands), April 12, 2001, [Wet houdende €indiging op verzoek en hulp bij zelfdoding]. toetsing van levensbee 7. Criminal Code (Netherlands), Article 293, [Wetboek van Strafrecht]. 8. Burial and Cremation Act (Netherlands), Article 7 sub 2, March 7,1991 [Wet op de lijkbezorging]. 9. Organ Donation Act, May 24, 1996, [Wet houdende regelen omtrent het ter beschikking stellen van organen (Wet op de orgaandonatie)]. 10. Kootstra G, Daemen JH, Oomen AP. Categories of non-heartbeating donors. Transpl Proc 1995; 27: 2893–2894. 11. de Klerk M, Ijzermans JN, Kranenburg LW, Hilhorst MT, van Busschbach JJ, Weimar W. Cross-over transplantation; a new national program for living kidney donations. Ned Tijdschr Geneeskd 2004; 148: 420–423. 12. Eurotransplant is a non-profit organization that facilitates patientoriented allocation and cross-border exchange of deceased donor organs. [cited 24 Jan 2016]. Available from: www.eurotransplant.org. 13. Volk ML, Ubel PA. A gift of life: Ethical and practical problems with conditional and directed donation. Transplantation 2008; 85: 1542–1544. 14. Rakke YS, Zuidema WC, Hilhorst MT, et al. Seriously ill patients as living unspecified kidney donors: Rationale and justification. Transplantation 2015; 99: 232–235. 15. Dhital KK, Iyer A, Connellan M, et al. Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: A case series. Lancet 2015; 385: 2585–2591. 16. Gallagher TK, Skaro AI, Abecassis MM. Emerging ethical considerations of donation after circulatory death: Getting to the heart of the matter. Ann Surg 2016; 263: 217–218. 17. Wilkinson D, Savulescu J. Should we allow organ donation euthanasia? Alternatives for maximizing the number and quality of organs for transplantation. Bioethics 2012; 26: 32–48. 18. Bernat JL. Life or death for the dead-donor rule? N Engl J Med 2013; 369: 1289–1291. 19. Eurotransplant, Annual Report 2008, REC01.08 p. 24. 20. Holmes BB, Diamond MI. Amyotrophic lateral sclerosis and organ donation: Is there risk of disease transmission? Ann Neurol 2012; 72: 832–836.
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24. Health Council of the Netherlands. Determining death in postmortal organ donation - Protocols and criteria, including an updated Brain Death Protocol. The Hague: Health Council of the Netherlands, 2015; publication no. 2015/13. ISBN 978-94-6281-040-2. 25. Dhanani S, Hornby L, Ward R, Shemie S. Variability in the determination of death after cardiac arrest: A review of guidelines and statements. J Intensive Care Med 2012; 27: 238–252.
Appendix: Preferred Additional Diagnostic Tests General/kidneys
Liver
Lungs
Pancreas
Blood
Blood group, rhesus factor, hemoglobin, hematocrit, leukocytes, trombocytes, sodium, potassium, urea, creatinine, glucose, fibrinogen, lactate, C-reactive protein, HLA, virology, cross-matching
–
Glucose, amylase, lipase hemoglobin A1c
Urine
Glucose, protein, creatinine, sediment X-thorax, length and weight, ultrasound abdomen (kidneys), complete history Radiologist
Total and direct bilirubin, alanine transaminase, aspartate transaminase, lactate dehydrogenase, c-glutamyl transferase, alkaline phosphatase, total protein, amylase, albumin, fibrinogen, prothrombin time, partial thromboplastin time –
–
–
–
Complete history, computed tomography of lungs
–
–
Pulmonologist
–
Additional
Consultations
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