Medical Aid in Dying

MEDICAL AID IN DYING

UPDATED 04/2018 PRACTICE AND PHARMACOLOGICAL GUIDELINES Authors Reproduction is authorized for non- commercial purposes only provided the Collège des médecins du Québec source is acknowledged. Ordre des pharmaciens du Québec Ordre des infirmières et infirmiers Legal deposit: 2nd trimester 2018 du Québec Library and Archives Canada Ordre des travailleurs sociaux et des Bibliothèque et Archives nationales thérapeutes conjugaux et familiaux du Québec du Québec ISBN: 978-2-924674-13-0 Barreau du Québec Chambre des notaires du Québec © Collège des médecins du Québec, Ordre des pharmaciens du Québec, The authors would like to thank all their Ordre des infirmières et infirmiers collaborators as well as the organizations du Québec, and people who contributed to the writing Ordre des travailleurs sociaux et des of this document by sharing their skills thérapeutes conjugaux et familiaux and expertise. du Québec, Barreau du Québec, Chambre des notaires du Québec, Publication of the Collège des médecins April 2018 du Québec Note: In this publication, the masculine Collège des médecins du Québec gender is used without prejudice and solely Suite 3500 to facilitate reading. 1250, René-Lévesque Boulevard West Montreal (Quebec) H3B 0G2 Telephone: 514 933-4441 or 1 888 MÉDECIN Website: www.cmq.org Email: [email protected]

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This document advocates professional practice that integrates the latest medical information at the time of publication. However, new scientific knowledge may advance understanding of the medical context described in this document.

This document is valid provided it is not modified or directly or indirectly affected in any way whatsoever by a contrary or incompatible legislative or regulatory provision. It should be noted that Canadian courts are currently dealing with legal challenges regarding the Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) and that the Act respecting end-of-life care is also being contested in court. — Table of contents

06/ 28/ 42/ FOREWORD 3.4.3 Conscientious 5.5.1 Preparation, objection by the physician dispensing and storage 08/ 30/ 44/ 5.5.2 The pharmacist’s INTRODUCTION 3.5 Health insurance personal convictions 11/ 32/ 44/ 5.5.3 Conscientious 1. DEFINITION 4. PROCEDURES objection by the AND DISTINCTIONS 33/ pharmacist 13/ 4.1 Discussions with the interdisciplinary team, the 45/ 2. INDICATIONS patient and his family 6. ADMINISTRATION OF 15/ 34/ MEDICAL AID IN DYING 2.1 Constant and unbearable 4.2 Opinion of a second AND TEAMWORK suffering physician 46/ 1 7/ 37/ 6.1 Explanations to be given 2.2 End of life 4.3 The physician’s to the patient and those conclusion present 19/ 46/ 2.3 Special cases 38/ 4.4 Wait time 6.2 Time and place 21/ 47/ 3. THE DECISION-MAKING 39/ 6.3 Intravenous injection PROCESS AND THE 5. OBTAINING THE 47/ REQUEST FOR MEDICAL MEDICATIONS AND AID IN DYING RELATIONSHIP WITH 6.3.1 Venous access THE PHARMACIST 21/ 47/ 3.1 Capacity to consent 40/ 6.3.1.1 Assessment to care 5.1 Route of administration of venous potential

23/ 40/ 48/ 3.2 Decision-making process 5.2 Dosage 6.3.1.2 Venous line placement 25/ 40/ 49/ 3.3 Request for medical aid 5.3 Systematic process in dying of physician-pharmacist 6.3.2 Prerequisites collaboration 26/ 49/ 3.4 Medical decision 41/ 6.3.3 Anxiolysis 5.4 Prescribing procedure 27/ 50/ 3.4.1 Assessment of 42/ 6.3.4 Artificial coma indications 5.5 Dispensing by the induction pharmacist 27/ 52/ 3.4.2 Medical judgement 6.3.5 Neuromuscular blocker injection — Table of contents

54/ 64/ 94/ 6.4 After death APPENDIX II – EXPLORING APPENDIX X – PSYCHOLOGICAL CONTRAINDICATED 55/ SUFFERING MEDICATIONS AND SUBSTANCES 7. REPORTING 67/ 55/ APPENDIX III – DECISION 95/ 7.1 Record keeping TREE APPENDIX XI – 7-STEP 55/ GUIDE TO SUBMITTING A REPORT FORM 7.2 Attestation of death and 70/ certificate of death APPENDIX IV – 97/ 56/ INTRAVENOUS ADMINISTRATION OF REFERENCES 7.3 Notices MEDICATIONS BASED ON 56/ THE COMA-INDUCING AGENT USED 7.3.1 Notice to be sent to the Commission sur les soins de fin de vie 78/ 57/ APPENDIX V – MEDICAL PRESCRIPTION 7.3.2 Notice to be sent to the CPDP or the CMQ for the purposes 83/ of assessment of the APPENDIX VI – MEDICATION procedure PREPARATION PROTOCOL

58/ 86/ 8. GRIEF COUNSELLING APPENDIX VII AND GRIEVING – MEDICATION ADMINISTRATION RECORD 59/ 9. PRACTICAL TOOLS 91/ APPENDIX VIII – LIST OF 61/ MATERIAL REQUIRED CONCLUSION 93/ 62/ APPENDIX IX – APPENDIX I – TYPES CONTRAINDICATED OF END-OF-LIFE ROUTES OF TRAJECTORIES ADMINISTRATION — List of tables

14/ 52/ 83/ TABLE 1 TABLE 9 TABLE 17 Criteria and conditions Coma induction: Medication preparation prescribed by law phenobarbitol – Medications protocol for injection, in order of 1 7/ administration – 2nd line 8 7/ TABLE 2 53/ TABLE 18 Types of end-of-life MAID medication suffering most frequently TABLE 10 administration record reported to the Collège des Neuromuscular blocker: médecins du Québec and rocuronium – Medications 91/ oversight commissions in for injection, in order of TABLE 19 European countries that have administration List of material required decriminalized euthanasia 54/ 93/ 22/ TABLE 11 TABLE 20 TABLE 3 Neuromuscular blocker: Contraindicated routes Clinical assessment of cisatracurium – Medications of administration capacity to consent to care for injection, in order of and request for MAID administration 94/ 29/ 57/ TABLE 21 Contraindicated medications TABLE 4 TABLE 12 and substances Authorities to be notified in Authorities responsible for the event of conscientious assessing the quality of care objection by the physician 71/ 32/ TABLE 13 TABLE 5 Medications for IV Procedures prescribed by law administration – Propofol 49/ 71/ TABLE 6 TABLE 14 Anxiolysis Material for IV administration of medications – Propofol 50/ 74/ TABLE 7 Artificial coma criteria TABLE 15 Medications for IV 51/ administration – Phenobarbital TABLE 8 Coma induction: propofol – 75/ Medications for injection, in order of administration – TABLE 16 1st line Material for IV administration of medications – Phenobarbital MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 06

FOREWORD

The Act respecting end-of-life care1 sicians and health care organizations (hereafter the ARELC), assented to concerned must follow. The Commis- by the National Assembly of Québec sion sur les soins de fin de vie has the on June 10, 2014 after four years of mandate of overseeing the implemen- debate, came into force on December tation of these special requirements 10, 2015. It establishes rights with re- (s. 42, par. 2). spect to end-of-life care, in particular a person’s right to obtain the end- Supporting people at the end of life of-life care required by their state of by providing them with the best pos- health, including medical aid in dying. sible care has been a part of clinical The ARELC includes special rules practice for many years. The ARELC for the regulation and organization complements what is advocated in of end-of-life care in the health and the Code of ethics of physicians,2 social services network. It sets out namely, that a physician “must, when specific requirements for continuous the death of a patient appears to him palliative sedation and medical aid in to be inevitable, act so that the death dying. The ARELC also establishes the occurs with dignity. He must also Commission sur les soins de fin de vie, ensure that the patient obtains the which is responsible for evaluating appropriate support and relief” (s. 58). its implementation. Lastly, it establishes a regime of advance medical The Act to amend the Criminal Code directives and determines the require- and to make related amendments ments for compliance. to other Acts (medical assistance in dying) was assented to on June 17, With respect to medical aid in dying 2016.3 This federal act amends the specifically, the ARELC establishes Criminal Code to permit the provision very restrictive criteria that a person of medical aid in dying under certain must satisfy to obtain medical aid conditions. in dying in an institution, palliative care hospice or at home as well as a number of procedures that the phy-

1 Act respecting end-of-life care, CQLR, c. S-32.0001. 2 Code of ethics of physicians, CQLR, c. M-9, r. 17. 3 Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying), S.C. 2016, c. 3. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 07

While federal and provincial require- Since medical aid in dying is still ments with respect to medical aid a new practice, the authors of this in dying are largely similar, at times document referred to guidelines and complementary, some of them are current practices in European coun- contradictory. Reconciling them at tries (the Netherlands, Belgium and the patient’s bedside is not simple. Luxembourg) and several states in This is why the Collège des médecins the United States that have legal- du Québec (CMQ), the Ordre des ized euthanasia or assisted suicide pharmaciens du Québec (OPQ) and to prepare this document. In order the Ordre des infirmières et infirmiers to specifically tailor their guidelines du Québec (OIIQ), the authors of the to the provincial context, they also first practice guidelines on medical consulted experts and organizations aid in dying, asked the Ordre des tra- in Quebec’s health and social services vailleurs sociaux et des thérapeutes network and took into consideration conjugaux et familiaux du Québec the numerous testimonies of physi- (OTSTCFQ), the Barreau du Québec cians and other health or social serv- and the Chambre des notaires du ices professionals who care for the Québec to join forces with them to gravely ill. produce this revised version. The CMQ, for its part, has published It is imperative that the legal two other practice guidelines on end- framework be respected while at of-life care for adults: Medical care the same time ensuring that overall in the last days of life and Palliative end-of-life care and clinical practices sedation at the end of life.4 remain coherent and their underlying values and purpose are upheld. To this end, this document aims to clarify certain legal terms and put forward practice standards, describing how these standards can be adapted to specific problems that might arise in clinical situations.

4 These practice guidelines can be accessed on the CMQ’s website at www.cmq.org, Publications section. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 08

INTRODUCTION

This document puts forward stand- MAID, subject to specific legal re- ards to be followed in order to provide quirements (s. 4 of the ARELC and the medical aid in dying (MAID). It is Criminal Code). Nevertheless, the fact intended to serve as a guide for remains that it is never an insignifi- physicians and other health or social cant intervention. It forces physicians services professionals in their prac- and health or social services profes- tice, while ensuring compliance with sionals to assume their professional both the spirit and the letter of the responsibilities, while also bringing law. These practice standards can be each person’s personal convictions used to develop local clinical pro- into play. When considering end- tocols which, while complying with of-life care options in general and the standards (ss. 33 and 35 of the MAID in particular, it is essential to ARELC), take not only constraints respect the diversity of views, those into account, but also culture and of patients as well as those of physi- other characteristics specific to cians and other health or social serv- each institution or practice setting, ices professionals. The latter have a which are obliged to provide end- professional duty to provide the most of-life care and adopt a clear policy appropriate care to patients who give with respect to it (ss. 8 and 9 of the their consent to such care. However, ARELC). and this is one of the few exceptions that prove the rule, under certain Quebec society debated the issue conditions,7 they are not required to of end-life care at length before participate in MAID if it is contrary to allowing MAID, under certain specific their personal convictions. conditions. In 2015, the Supreme Court of Canada decriminalized MAID5 These practice and pharmacological and the Criminal Code6 was amended guidelines are intended for the popu- accordingly. In Quebec, anyone lation of competent adults, the only whose condition requires it is entitled people for whom MAID is authorized to receive end-of-life care, including by law. Standard end-of-life care8

5 Carter v. Canada (Attorney General), [2015] 1 S.C.R. 331. 6 Criminal Code, R.S.C. 1985, c. C-29. 7 The procedures to follow in the event of conscientious objection are described in Subsection 3.4.3 of these guidelines. 8 See, in particular, the practice guidelines Medical care in the last days of life and Palliative sedation at the end of life, published by the CMQ in 2015. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 09

remains the only option for adults ment. While they may be of help in who are incapable of giving consent finding one’s way with respect to all to care and for minors. the administrative or pharmacological procedures, they cannot replace the Above all, this document is intended complete practice and pharmacolo- to be a useful resource for physicians gical guidelines which represent the and interdisciplinary teams involved standards to follow. in caring for end-of-life patients and who may, in exceptional cases, have First, the document defines what to consider MAID for and with a medical aid in dying is and how this patient. It does not claim to answer all practice differs from other types of the questions physicians and interdis- end-of-life care. ciplinary teams ask in each specific clinical situation, which is not the This is followed by a presentation objective of this type of document. of the clinical and legal requirements While broadly covering all the aspects established by the ARELC and the provided for by the legislators, and Criminal Code to prevent unaccept- anticipating the main issues surround- able abuses and which primarily ing the pharmacological procedure, concern the health of the person, it is intended for use in any clinical who must be at the end of life, have a setting and is therefore intentionally serious and incurable illness, be in an general. Each person is invited to advanced state of irreversible decline comply with the standards as closely in capability and experience constant as possible while demonstrating the and unbearable suffering. The guide- clinical judgement required in any lines list the most frequently reported health care situation. However, in cases types of unbearable suffering at the where it would be difficult to apply end of life and describe how they the standards owing to exceptional should be assessed. They define what and justified constraints, caregivers end of life is and how it must be taken are urged to contact their professional into account, along with the diagno- order so that the most appropriate sis of the illness, to allow MAID to be procedure possible can be determined considered as a care option, in com- on a case-by-case basis, taking local pliance with legal requirements, for resources and requirements into patients who cannot or do not want account. to be relieved by more standard care.

The authors of the document cau- The legislation serves as a framework tion physicians and interdisciplinary for the decision-making process and teams regarding summaries and other the request for MAID, which can be memory aids taken from this docu- made only by competent adults. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 10

Physicians and end-of-life patients Lastly, the document provides guid- who are suffering are encouraged to ance for physicians with respect to consider all potentially appropriate medical record keeping, the certifi- health care interventions and therapies cate of death and various notices to so that MAID remains exceptional. be sent to the Commission sur les soins de fin de vie responsible for The guidelines then present the eligi- evaluating compliance with the require- bility requirements for the dying per- ments of the ARELC and to the son’s request for MAID and the crite- authorities responsible for assessing ria that will determine whether or not the quality of care provided. the physician may grant the request. The appendices include a decision The document also describes the tree summarizing the decision-making procedures the physician must follow process to follow with an end-of-life to ensure the decision is made under patient who is experiencing intoler- the best conditions after consulting able suffering and for whom MAID the patient, his family if he so wishes could be considered as an option; the and the interdisciplinary team, as well list of medications that must be used, as a colleague in order to obtain an be it in a health care institution, pal- opinion as to whether or not the deci- liative care hospice or at the patient’s sion meets the legal requirements. home, as well as their dosages; the detailed administration procedure; A large part of the document focuses and techniques that are contraindi- on the medications used to adminis- cated when administering medical aid ter MAID and stresses the collabo- in dying. ration that is necessary between the prescribing physician and the phar- The introduction of the practice of macist. The pharmacological guide- MAID, which is still underway in the lines must be rigorously followed by health system, must be done with- both the physician and the pharmacist. out losing sight of the purpose of the ARELC which is to always better MAID itself is described step by step. ensure that end-of-life patients are While the technical aspects are, of provided with appropriate care that is course, described in some detail, it “respectful of their dignity and their must not be forgotten that MAID is autonomy” while taking each person’s a serious intervention that the phy- roles and responsibilities into account. sician must administer with respect, sensitivity and compassion, as part of supporting the person who is at the end of life. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 11

Chapter 1/ Definition and distinctions

The ARELC defines MAID as “care consisting in the administration by a physician of medications or substances to an end-of-life patient, at the patient’s request, in order to relieve their suffering by hastening death.” (s. 3(6))

By taking this definition, the ARELC is aligned with the definition, which appears broader at first glance, in theCriminal Code, for which medical assistance in dying means:

(a) “the administering by a medical practitioner [...]9 of a substance to a person, at their request, that causes death; or (b) the prescribing or providing by a medical practitioner [...] of a substance to a person, at their request, so that they may self-administer the substance and in doing so cause their own death.” (s. 241.1)

The ARELC strictly limits MAID, very clearly placing it in a context of end-of- life care. Like the Criminal Code, it stipulates that it must be administered by a physician and it states that the autonomy of the person concerned must be respected. It also limits MAID to a single objective: that of putting an end to an end-of-life patient’s suffering by intentionally administering medications that will lead to his death. It should be noted that the route of medication administration, enteral or parenteral, is not specified in the legislation.

›› Thus, MAID must be distinguished from other end-of-life care options, which are certainly likely to shorten life, but whose purpose is not to do so, such as: ›› the administration of treatments to relieve end-of-life symptoms,10 at the risk of shortening life; ›› palliative sedation, i.e., the deliberate lowering of level of consciousness to relieve symptoms;11 ›› the non-initiation or withdrawal of life-sustaining or life-prolonging treatments.

9 See Subsection 3.4.2 regarding nurse practitioners. 10 See, in particular, the practice guidelines Medical care in the last days of life published by the CMQ in 2015 and which can be accessed on its website at www.cmq.org, Publications section. 11 See, in particular, the practice guidelines Palliative sedation at the end of life published by the CMQ in 2015 and which can be accessed on its website at www.cmq.org, Publications section. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 12

The legislation is clear regarding these options and they are increasingly employed in practice. Each is, of course, accompanied by all the necessary appropriate comfort care throughout the process leading to death.

›› MAID within the meaning of the ARELC is also different from assisted suicide (physician assisted or otherwise), defined as “the act of helping a person commit suicide by providing him with the means to do so or information on how to proceed, or both” (Québec, Report of the Select Committee on Dying with Dignity, 2012, p. 18). Assisted suicide should imply that the physician provides the person with the lethal substances which they then self-administer. MAID is clearly distinct from assisted suicide, since it must be administered by a physician and in a context of end-of-life care. The Criminal Code states that under certain conditions, presented further on, assisted suicide is not a criminal offence (ss. 241.1(b) and 241.2), and the Canadian provinces are responsible for establishing the applicable procedures. Following discussions in Quebec society, the option of assisted suicide, physician assisted or otherwise, was rejected, and MAID as defined by the ARELC is considered preferable from an end-of-life care perspective. ›› MAID, of course, still remains different from death caused intentionally outside a health care context.

It should be noted that if the criteria prescribed by law are not met, aid in dying is subject to criminal sanctions.

In this document, the definition of MAID used is the definition set out in the ARELC that applies specifically to Quebec. However, it was felt that some essential aspects needed to be explained, taking the requirements of the Criminal Code into account, and interpreted in medical terms in order to be applied properly in clinical situations (notions of end of life, intolerable suffering, the medications used, etc.). MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 13

Chapter 2/ Indications

End-of-life clinical situations are sometimes difficult. Despite receiving quality care, patients who experience intolerable suffering endure excruciating agony.

The ARELC was created, in particular, to provide an additional option for these end-of-life patients experiencing excessive suffering for whom all curative and palliative therapeutic options have been ruled out, discontinued or in vain, and who would prefer to die rather than to continue suffering.

Patients and their families know that it has been possible to request MAID since the ARELC came into force. But it is not clear whether everyone knows the rules and physicians may have to deal with requests for MAID that do not qualify, for example, a reaction to the development of a recent, easily curable, minor medical condition; or a request from a third party for MAID when the patient himself does not want it, etc. Federal and provincial legislation has established rules so that the request can be responded to as appropriately as possible. Physicians must follow them with common sense and rectitude.

To prevent unacceptable abuses, the legislator has tightly regulated the usual decision-making process by establishing both clinical and legal requirements (ss. 26 and 27 of the ARELC; s. 241.2(1) and (2) of the Criminal Code) as well as procedures that must be rigorously followed by physicians (s. 29 of the ARELC; s. 241.2(3) to (9) of the Criminal Code).

The ARELC and the Criminal Code set out criteria that make MAID a very exceptional practice. Based on practices in European countries that legalized euthanasia and assisted suicide in the 2000s and experiences in Quebec since December 2015, the frequency of MAID is believed to vary with place of practice and medical specialty, but is still minimal. It is all the more important to rigorously comply with the medical directives and legal procedures governing MAID insofar as it is an exceptional, irreversible and distressing intervention.

The ARELC and the Criminal Code set out particularly restrictive criteria with respect to the health of the person who may obtain MAID. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 14

Table 1 Criteria and conditions prescribed by law

QUEBEC CANADA Act respecting end-of-life care – ARELC Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) – Criminal Code

26. Only a patient who meets all of the 241.2 (1) A person may receive medical following criteria may obtain medical aid in assistance in dying only if they meet all of the dying: following criteria:

(1) be an insured person within the meaning (a) they are eligible — or, but for any of the Health Insurance Act (chapter A-29); applicable minimum period of residence or waiting period, would be eligible — for health (2) be of full age and capable of giving services funded by a government in Canada; consent to care; (b) they are at least 18 years of age and capable of making decisions with respect to (3) be at the end of life; their health; (c) they have a grievous and irremediable (4) suffer from a serious and incurable illness; medical condition; (d) they have made a voluntary request for (5) be in an advanced state of irreversible medical assistance in dying that, in particular, decline in capability; and was not made as a result of external pressure; and (6) experience constant and unbearable (e) they give informed consent to receive physical or psychological suffering which medical assistance in dying after having been cannot be relieved in a manner the patient informed of the means that are available to deems tolerable. relieve their suffering, including palliative care. […] 241.2 (2) A person has a grievous and irremediable medical condition only if they meet all of the following criteria:

(a) they have a serious and incurable illness, disease or disability; (b) they are in an advanced state of irreversible decline in capability; (c) that illness, disease or disability or that state of decline causes them enduring physical or psychological suffering that is intolerable to them and that cannot be relieved under conditions that they consider acceptable; and (d) their natural death has become reasonably foreseeable, taking into account all of their medical circumstances, without a prognosis necessarily having been made as to the specific length of time that they have remaining. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 15

2.1 CONSTANT AND UNBEARABLE SUFFERING

It is essential to understand that a person who requests assistance in dying is, above all, expressing that their suffering is such that they would rather die than continue to suffer. The physician and all the health or social services professionals concerned have a duty to hear this expression of suffering and respond appropriately. MAID is one way to do so. Before opting for MAID, it must be determined, with the person and through a well-managed decision-making process, whether it is the most appropriate option for the person requesting it, at the time it is requested.

Under the ARELC, a person who requests MAID must be at the end of life, suffer from a serious and incurable illness, be in an advanced state of irreversible decline in capability, and experience “constant and unbearable physical or psychological suffering which cannot be relieved in a manner the patient deems tolerable” (s. 26(6)).

The Criminal Code takes the same position, for it stipulates that a person may receive MAID only if “that illness, disease or disability or that state of decline causes them enduring physical or psychological suffering that is intolerable to them and that cannot be relieved under conditions that they consider acceptable” (s. 241.2(2)(c)).

Within this legal framework, physicians are not only responsible for confirming the patient’s alleged suffering, but also for determining its nature and ensuring that, to meet the objectives of the legislation, it is coherent with its foundations.12

While the physician can help diagnose the serious and incurable illness and assess its prognosis, the patient, of full age and capable of giving consent, is the best judge of whether or not his suffering is unbearable and how to alleviate it. Assessment scales are available for many symptoms and are especially helpful for caregivers caring for a patient who is suffering. While the physician can use these and can also benefit from the collaboration of the interdisciplinary team caring for the patient, the unbearable nature of suffering is essentially subjective and depends on the patient’s personality and values. However, another person’s suffering can be explored, partially, using an intersubjective approach, even if it is difficult to access suffering objectively.13

12 This refers to the approach to health care that underlies Quebec’s legislation and to the express requirement of the Criminal Code that a causal relationship be established between the person’s illness, disease or disability or the advanced state of irreversible decline in capability and the suffering they are experiencing. 13 For more details on the exploration of another person’s suffering, see Appendix II: Exploring psychological suffering, and Gupta, 2017. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 16

The refractory nature of psychological suffering in particular can be harder to define. Existential suffering, for instance, is not unusual at the end of life. It can turn into real distress, a source of stress for the patient, his family and the members of the interdisciplinary team and, most importantly, requires a specific, multidimensional therapeutic approach and attention (listening, spiritual and religious support, psychotherapy, drug therapy, social intervention, etc.).

The quality of communication between the physician and the patient, who is capable of making his own decisions, is all the more important when assessing the constant and unbearable nature of physical, and a fortiori psychological or existential, suffering. A well-managed decision-making process is of the utmost importance when deciding on the most appropriate care in cases of extreme suffering or distress that are difficult to relieve despite the available therapeutic arsenal.

In the most difficult cases, in addition to consulting the interdisciplinary team, a consultation with a colleague who specializes in the patient’s condition or a palliative care team may be indicated. In addition to determining whether or not the suffering reported by the person seeking medical aid in dying satisfies the criteria prescribed by law, by consulting other health or social services professionals, the approaches used thus far to relieve the patient’s suffering can be reviewed and other options proposed, where appropriate.

By way of indication, in Quebec and in European countries that have decriminalized euthanasia, the types of irremediable physical or psychological suffering most frequently reported at the end of life are listed in Table 2. They often occur concomitantly. The list is not exhaustive. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 17

Table 2 Types of end-of-life suffering most frequently reported to the Collège des médecins du Québec and oversight commissions in European countries that have decriminalized euthanasia*

PSYCHOLOGICAL SUFFERING AT THE END PHYSICAL SUFFERING AT THE END OF LIFE OF LIFE

Cachexia Despair in a hopeless situation

Dysphagia Loss of dignity

Dyspnea Total or almost total dependency

Exhaustion

Gastrointestinal obstruction

Hemorrhage

Pain

Paralysis

Repeated transfusions, punctures and other procedures

Severe wounds

* Specifically, the Commission fédérale de contrôle et d’évaluation de l’euthanasie in Belgium and regional euthanasia review committees in the Netherlands.

2.2 END OF LIFE

The ARELC stipulates that the person must be at the “end of life” (s. 26(3)) for MAID to be considered. The end of life can vary widely in terms of duration or functional impairment, depending on the dying person’s underlying pathology.14 Based on these elements, the Observatoire national de la fin de vie, created in France in 2010, defines it as follows: “The end of life must be seen as a process that varies in length, punctuated by ruptures, during which individuals attempt, more or less easily, to deal with death” [Translated from the French.] (Observa- toire national de la fin de vie, 2011). The Canadian Institute of Health Informa- tion, in its report on health care use at the end of life in the Atlantic provinces,

14 For more details, see Appendix I. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 18

considers end-of-life patients to be those whose “health is declining and who are deemed to be terminal or dying in the foreseeable (near) future” (CIHI, 2011).

The Quebec legislator insisted on this criterion,15 which restricts access to MAID to a certain category of patients, without providing an explicit prognosis, allowing the variability of end-of-life trajectories16 to be taken into account. The “end of life” criterion is therefore not incompatible with the Criminal Code’s criterion whereby “their natural death has become reasonably foreseeable, taking into account all of their medical circumstances, without a prognosis necessarily having been made as to the specific length of time that they have remaining” (s. 241.2(2)(d)).

That said, the prognosis is very important clinically, both for the patient and the physician, in order to decide on appropriate care. Furthermore, while it may be acceptable, under certain conditions, to shorten the agony of an imminently dying person who is experiencing intolerable suffering and is unable to obtain relief, it is entirely different for a person who is not expected to die in the foreseeable future. In this case, it is important to consider not only the entire therapeutic arsenal available to relieve their suffering, but also everything, other than care, that might improve their quality of life.

However, we understand that it is not always easy to define exactly what end of life is or when natural death is “reasonably foreseeable” for a specific individual. This is why the ARELC and the Criminal Code also stipulate that to obtain MAID, a person who is experiencing constant and unbearable suffering at the end of life must “suffer from a serious and incurable illness” (s. 26(4) of the ARELC; s. 241.2(2)(a) of the Criminal Code) and “be in an advanced state of irreversible decline in capability” (s. 26(5) of the ARELC; s. 241.2(2)(b) of the Criminal Code).

These criteria mean that the physician must make an accurate diagnosis and make sure the patient is at the end of life. He must also carefully assess changes in the patient’s capacities, not hesitating to consult specific assessment scales or a specialist in the pathology in question.

In the very exceptional case of a request for MAID being made by an end-of-life patient whose death is not expected to occur in the near future, the physician must exercise caution. For example, the request may be made by a person who has a progressive disease that has led to an advanced state of irreversible decline in capability and who is experiencing constant and unbearable physical

15 It should be noted that this criterion is not stipulated in the legislation of European countries (the Netherlands, Belgium and Luxembourg) that have authorized euthanasia and/or assisted suicide. 16 For an illustration of end-of-life trajectories, see Appendix I. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 19

or psychological suffering that cannot be relieved in a manner the person deems tolerable. It is all the more important that the physician exercise his clinical judgement, make sure the patient is being treated competently, as far as possible by an interdisciplinary team, that he is well informed, and verify that MAID is not being requested for relational, social or economic reasons. He must also take the time to consider the request, verify that the wish to obtain medical aid in dying remains unchanged, and take steps to ensure as correctly as possible, and within a reasonable period of time, that the other criteria set out in the ARELC (s. 29(1)) and in the Criminal Code (s. 242.2(3) to (9)) have been met, before administering MAID, which is still an option.

2.3 SPECIAL CASES

Quebec society did not think it appropriate to mandate physicians to provide aid in dying to people who do not satisfy all the criteria set out in the ARELC.

Thus, and despite the compassion engendered by each of these situations, the administration of MAID is prohibited if requested by a competent person who is experiencing constant and unbearable suffering but is not at the end of life, irrespective of whether he has a severe disability (tetraplegia, for example), or is in the early stages of a degenerative disease, or has a psychiatric illness, or wishes to die but his death is not “reasonably foreseeable”, etc.

Psychiatric disorders17 (including depressive disorders) present particular challenges. Indeed, while they may sometimes compromise a person’s capacity to consent to care, this is not always the case. A specialized consultation is often required to determine whether the psychiatric pathology means that a patient is capable or incapable of making health care decisions and of carefully weigh- ing the consequences.18 Furthermore, it can be difficult to assess the suffering of a patient who has a psychiatric disorder. In cases of genuine extreme and irremediable suffering, it is imperative that the other criteria set out in the ARELC and the Criminal Code, such as capacity to consent to care and being at the end of life, are satisfied, failing which MAID cannot be administered.19

17 It should be noted that delirium, anxiety and depression are not uncommon at the end of life and that a number of therapeutic options are available to reduce their severity, to treat them or to improve the quality of life of those affected (Gupta, 2017). 18 For more information, see Gupta, 2017. 19 Note that in accordance with the requirements of the Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) (s. 9.1(1)), the Council of Canadian Academies formed an expert panel to examine three issues that are particularly complex and beyond the scope of the Act. They include requests for MAID where mental illness is the sole underlying medical condition. The other issues relate to requests by mature minors and advance requests before the person is declared incompetent. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 20

In the case of a person with dementia,20 the challenges are similar. Despite the diagnosis of dementia, the patient may be capable of giving consent to care at the beginning of the illness. However, as cognitive impairment worsens, he loses his capacity to make decisions regarding his care and, deemed to be at the end of life, is often considered incompetent. In addition to the opinion of an independent consultant, that of one or more experts may be indicated to ensure that he is capable of giving consent to care and that the other criteria set out in the ARELC and the Criminal Code are satisfied.

Similarly, MAID is not authorized by the ARELC or the Criminal Code if it is requested by a competent person who, at the end of life, believes that his life is no longer worth living but does not have a serious and incurable illness characterized by an advanced and irreversible decline in his capability and causing constant and unbearable suffering.

Other treatment options are possible in these situations. They must be considered as part of a well-managed decision-making process designed to determine the most appropriate care for each patient at this stage of their life.

20 In March 2017, Quebec’s minister of health and social services announced the formation of an expert panel to reflect on the particular challenges facing people who are incapable of giving consent to care. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 21

Chapter 3/ The decision-making process and the request for medical aid in dying

The decision to provide MAID is an extremely sensitive one given its serious consequences. The process leading to such a decision must therefore be rigorously conducted so that everyone concerned is respected. The interdisciplinary team must be informed, even involved in the decision-making process as much as possible and, if the patient wishes, his family members too.

Appendix III summarizes, in the form of a decision tree, the process for making a decision as to whether or not MAID should be administered in accordance with clinical standards and legal requirements. This process is described in greater detail below.

3.1 CAPACITY TO CONSENT TO CARE

To avoid a situation where a patient who does not want medical aid in dying is forced to undergo it, the legislator stipulates that only a person who is of full age or at least 18 years of age and “capable of making decisions with respect to [their] health” (s. 26(2) of the ARELC; s. 241.2(1)(b) of the Criminal Code) can obtain MAID.

Thus minors, even those who are 14 years of age or older and who are capable of giving consent to standard care for themselves, may not obtain MAID. Nor may people who are incapable of giving consent to care. Nor may MAID be requested in advance medical directives (s. 51 of the ARELC).

A physician may only provide MAID if the patient requested it himself in writing. Proxy consent to MAID is prohibited. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 22

The physician must therefore make sure that the patient is capable of requesting MAID himself and that the request is not being made as a result of undue pressure from a third party.

The physician is responsible for making sure that the patient is capable of giving consent to care.

The interdisciplinary team’s collaboration can be very valuable in this respect.

Very briefly, it must be recalled that a clinical assessment of a person’s capacity to consent to care involves assessing four cognitive skills with respect to this care.

Table 3 Clinical assessment of capacity to consent to care and request for MAID

ASSESSMENT OF FOUR COGNITIVE SKILLS

1. Ability to understand information based on the five Nova Scotia criteria:

A. Does the person understand the nature of the illness for which he is requesting MAID?

B. Does the person understand the nature and purpose of MAID?

C. Does the person understand the benefits and risks of MAID (and of alternative treatments, including not obtaining MAID)?

D. Does the person understand the risks and consequences of not obtaining MAID?

E. Is the person’s ability to understand affected by his illness?

2. Ability to appreciate the significance of the information for his own situation: Is the person able to take the information he has been given about all the options, apply it to himself and show self-criticism?

3. Ability to engage in a process of reasoning with respect to the information: Is the person able to compare the risks and benefits of each of the options discussed, weigh the pros and cons of each and give the reasons for his choice?

4. Ability to express his choice: Is the person able to express a reasoned and consistent choice? MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 23

Suffering, and a fortiori psychological suffering, for example, may lead to cognitive impairment.21 As may some of the treatments the person might be taking. The physician will have to take this into account when he assesses the person’s capacity to consent to care and in particular if he requests MAID. Where applicable, the risk of becoming incompetent could, if all the other eligibility criteria were met and if the treatment were considered appropriate, cause the physician to bring forward the date MAID is administered in accordance with the requirements of the Criminal Code (s. 241.2(3)(g)).22

If the patient is incapable of giving consent to care, other end-of-life care options that are appropriate for his condition must be considered, taking into account any wishes he might have expressed before he became incompetent. Any advance medical directives (AMDs) regarding certain types of care must be respected (s. 58 of the ARELC). If there are no advance medical directives in place, and for types of care other than those provided for in the AMD form, the collaboration of a third party authorized to give consent to care under the provisions of the Civil Code of Québec will be sought and their consent must be obtained (s. 11, par. 2 and s. 15 of the Civil Code of Québec).

3.2 DECISION-MAKING PROCESS

In the event of a fatal prognosis, it is important to give the patient relevant and timely information so that he will have time to reflect on how he would like to end his life and discuss it with his family and the members of the interdisciplinary team who are caring for him. In routine practice, in health care settings, this reflection must be supported by the members of the interdisciplinary team, as part of a decision-making process that respects each person’s roles and responsibilities. The discussion may lead to the institution of a level of medical intervention (LMI) that reflects the end-of-life patient’s wishes.

Accurate and timely information is essential to ensure the patient’s rights are respected. A person at the end of life who is experiencing “constant and unbearable physical or psychological suffering” (s. 26(6) of the ARELC) may have difficulty making considered decisions. It is therefore very important to address these subjects with the person at a fairly early stage, even before their prognosis of survival becomes unfavourable. Furthermore, a request for MAID that is consistent with previous decisions will be more easily understood and accepted by the family and the interdisciplinary team and more easily formalized by the procedures provided for in the ARELC.

21 See Gupta, 2017, in particular Section 3.4: The relationship between suffering and decision-making capacity. 22 Under the procedure prescribed by the Criminal Code, there must be a minimum period of ten days between the day on which the request for MAID was signed and the day on which the medication is administered. This period can be shorter if both physicians who are assessing whether or not the eligibility criteria are met are of the opinion that “the loss of [the person’s] capacity to provide informed consent is imminent” (s. 241.2(3)(g)). See Section 4.4. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 24

While MAID can be requested in Quebec, this does not mean that it is trivial. It calls upon the therapeutic relationship between the physician and the patient. The request must be listened to seriously, with kindness and compassion, by the health or social services professional.

A request for MAID must not go unanswered. Nor must it systematically lead to MAID under the pretext that it is authorized by law, under certain conditions.

Most importantly, the physician and the patient must communicate with one another in order to clearly understand the reasons behind the request and to agree on the decision as to the most appropriate care.

This process requires the physician to provide the patient with adequate information about: ›› his illness; ›› the medical diagnoses; ›› his life expectancy;23 ›› the various possible treatment and intervention options, both curative and palliative, such as palliative care, palliative sedation, withdrawal or refusal of life-sustaining treatments, etc., as well as medical aid in dying.

He must explain the expected benefits but also the risks associated with each of the different options. He must also actively ensure that the patient clearly understands the information.

In addition, the physician must tell the patient immediately whether or not he intends to continue the process with him until the administration of MAID, if any.24

23 In particular, under section 57 of the Code of ethics of physicians: “A physician must inform the patient or, if the latter is unable to act, his legal representative, of a fatal or grave prognosis, unless there is just cause not to do so”. 24 The procedures to follow in the event of conscientious objection are described in Subsection 3.4.3 of this document. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 25

3.3 REQUEST FOR MEDICAL AID IN DYING

To satisfy the requirements of the legislation, the end-of-life patient, of full age and capable of giving consent, who is experiencing constant and intolerable suffering “must request medical aid in dying themselves, in a free and informed manner, by means of the form prescribed by the Minister.25 The form must be dated and signed by the patient” (s. 26, par. 2 of the ARELC).

If the patient “cannot date and sign the form […] because the patient cannot write or is physically incapable of doing so, a third person may do so in the patient’s presence” (s. 27 of the ARELC), “and under the person’s express direction” (s. 242.2(4) of the Criminal Code).

The third party must be of full age and capable of giving consent, may not be a member of the team responsible for caring for the patient (s. 27 of the ARELC), must understand the nature of the request for MAID, must not know or believe that they are a beneficiary under the will of the person making the request, or a recipient, in any other way, of a financial or other material benefit resulting from that person’s death (s. 242.2(4) of the Criminal Code). The reasons the person cannot sign the request himself should be entered in his medical record.

In all cases, the request form must be “signed in the presence of and counter- signed by a health or social services professional”;26 if the professional is not the attending physician, the signed form is to be given by the professional to the attending physician (s. 26, par. 3 of the ARELC). The Criminal Code adds that the form must be signed by the person “before two independent witnesses” who then also signed and dated the request (s. 241.2(3)(c) of the Criminal Code). Under the terms of the Criminal Code (s. 241.2(5)), a witness is not independent if they: ›› know or believe that they are a beneficiary under the will of the person making the request, or a recipient, in any other way, of a financial or other material benefit resulting from that person’s death; ›› are an owner or operator of any health care facility at which the person making the request is being treated or any facility in which that person resides; ›› are directly involved in providing health care services to the person making the request; ›› or directly provide personal care to the person making the request.

25 The MAID request form prescribed by the minister of health and social services (s. 26, par. 2) can be accessed: – in the secure section of the CMQ, OPQ and OIIQ websites; – on the intranet of the health and social services network. 26 A health or social services professional is a member of a professional order. For example, a medical resident, since he is not a member of the Collège des médecins, cannot countersign the request for MAID as a health professional. However, if a resident meets the requirements of the Criminal Code with respect to his independence (s. 241.2(5)), he may sign the request for MAID as an independent witness. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 26

In a health care facility, it is relatively easy to find two people who satisfy these criteria without prejudice to the patient. However, this presents a greater chal- lenge at home. The physician and the interdisciplinary team caring for the patient must ensure his privacy is respected as far as possible and take appropriate confidentiality measures to do so.27

As for any type of care, the patient may withdraw his request for MAID at any time and by any means (s. 28 of the ARELC). He must be duly informed that he may do so (s. 241.2(3)(d) of the Criminal Code).

In addition, the physician must ensure that the patient’s consent is maintained from the time of his initial request until the process is over28 (s. 29(1)(c) of the ARELC and s. 241.2(3)(h) of the Criminal Code).

Any decision to withdraw a request for medical aid in dying or to put off the administration of such aid must also be documented in the patient’s record (s. 32, par. 2 of the ARELC).

3.4 MEDICAL DECISION

To make a decision, especially in an end-of-life care situation, when each option will ultimately lead to the patient’s death, the physician must have a clear understanding of the patient’s personal wishes, carefully assess the indications for each option and use his professional judgement to decide which could best serve this particular patient’s interests.

Medical aid in dying is considered, from both a medical and a legal standpoint, an exceptional measure. It is all the more important for the physician to ensure the intervention is appropriate, since he: ›› will ultimately be held responsible for his decision and will have to be able to justify it; ›› will have to, where applicable, personally administer the medications that will lead to the patient’s death and will be responsible for all the consequences.

27 It is suggested that health or social services professionals or other employees from the local community services centre (CLSC) be called upon if possible: they may be trained and are required to respect clients’ privacy. 28 See Section 4.1 for more details. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 27

3.4.1 ASSESSMENT OF INDICATIONS

Before making his decision, the physician must be satisfied that the person requesting MAID is of full age and capable of giving consent to care, that he is at the end of life, that he has a serious and incurable pathology, that he is in an advanced state of irreversible decline in capability, and that he is experiencing constant and unbearable physical or psychological suffering that cannot be relieved in a manner he deems tolerable. He will have discussed all the therapeutic options with him. He will have reached the conclusion that the person is eligible to receive MAID under the terms of the legislation.

3.4.2 MEDICAL JUDGEMENT

Under section 3(6) of the ARELC, only a physician can administer the medication to provide an end-of-life patient with MAID.

Under section 31(12) of the Medical Act29 and the regulation respecting the activities contemplated therein,30 section 227(1) of the Criminal Code, whereby a nurse practitioner may provide MAID in accordance with the law, does not apply in Quebec.

A physician is someone who is licensed to practice and is entered on the Roll of the Collège des médecins du Québec. Thus, a student, a medical resident or a clinical fellow cannot provide this aid, even under supervision.

In addition to assessing the indications, the physician must use his professional judgement as to the best treatment or intervention options available to relieve a particular patient’s suffering before agreeing to or refusing the patient’s request for MAID.

Thus, while the physician must ensure that all the criteria prescribed by law have been met, he must also assess the relative importance of one versus the other in order to agree with the patient as to the most appropriate treatment.

It should be noted that, in a case of intractable suffering, it is highly likely that a physician will find it even easier to imagine ending a patient’s life if he believes his death is imminent and his suffering is intolerable. In more complex cases, he must take the time to assess every aspect of the clinical picture

29 Medical Act, CQLR, c. M-9, s. 31: “The practice of medicine consists in assessing and diagnosing any health deficiency in a person in interaction with their environment, in preventing and treating illness to maintain or restore health or to provide appropriate symptom relief. The following activities in the practice of medicine are reserved to physicians: […] (12) administering the drug or substance allowing an end-of-life patient to obtain medical aid in dying under the Act respecting end-of-life care (chapter S-32.0001).” 30 Regulation respecting the activities contemplated in section 31 of the Medical Act which may be engaged in by classes of persons other than physicians, CQLR, c. M-9, r. 13. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 28

in order to support his decision, without hesitating to consult colleagues. To agree to administer MAID, the physician should be convinced that it is the best option, not only for the patient requesting it, but also for himself, for he will have to perform the intervention and live with its professional, legal and moral repercussions.

As for any other medical intervention, he should be familiar with the requirements and procedures provided for by law and have a thorough command of the pharmacological, technical and practical aspects of MAID. Needless to say, he should also have soft skills, that is, be able to adapt his behaviour to the gravity of the situation.

A physician who receives a request for MAID must respond with professionalism, irrespective of his personal convictions. However, and this is the exception that confirms the rule, under certain conditions,31 he is not required to participate in MAID if it is contrary to his personal moral or religious convictions. Whatsoever it may be, the physician’s decision must be entered in the patient record.

3.4.3 CONSCIENTIOUS OBJECTION BY THE PHYSICIAN

The Criminal Code stipulates that none of the people who are authorized to provide MAID is compelled to do so (s. 241.2(9) of the Criminal Code). In addition, the Code of ethics of physicians (s. 24)32 states that a physician may refuse to prescribe or provide professional services that may be appropriate for a patient because of his personal moral or religious convictions. He must then offer to help the patient find another physician. In keeping with theCode of ethics of physicians, the ARELC reiterates that, for the same reasons, a physician may refuse to administer MAID but must ensure continuity of care for the patient (s. 50). The ARELC provides for certain mechanisms to help him do so. He must immediately notify the competent authorities who will then take the necessary steps to find another physician willing to accommodate the request in accordance with the procedures provided for in the ARELC (s. 31). The authorities to be notified vary depending on the physician’s place of practice, as shown in Table 4, and not depending on where the patient consults him.

31 See Subsection 3.4.3. 32 Section 24 of the Code of ethics of physicians: “A physician must, where his personal convictions prevent him from prescribing or providing professional services that may be appropriate, acquaint his patient with such convictions; he must also advise him of the possible consequences of not receiving such professional services. The physician must then offer to help the patient find another physician.” MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 29

Table 4 Authorities to be notified in the event of conscientious objection by the physician

PLACE OF PRACTICE AUTHORITIES

Centre operated by an President and CEO of the CISSS, CIUSSS, UHC or university institution institute, or any other person designated by the president and CEO

Private health facility President and CEO of the CISSS or CIUSSS that serves the territory in which the patient resides, or the person designated by the president and CEO

If no CISSS or CIUSSS serves the territory in which the patient resides, the president and CEO of the institution operating a CLSC in the territory or the person designated by the president and CEO

CEO: Chief executive officer CISSS: Centre intégré de santé et de services sociaux [Integrated health and social services centre] CIUSSS: Centre intégré universitaire de santé et de services sociaux [Integrated university health and social services centre] UHC: University hospital centre CLSC: Centre local de services communautaires [Local community services centre]

All information and documents in connection with the request for medical aid in dying, including the form used to request such aid and the reasons for the physician’s decision, whatsoever it may be, must be recorded or filed in the patient’s record (s. 32, par. 1 of the ARELC).

For many physicians, providing MAID outside a meaningful therapeutic relationship may seem extremely difficult. It is also likely that for a dying person, receiving MAID from an unfamiliar physician, assigned to his bedside by an administrative body, will increase his suffering. Thus, in order to improve access to MAID for an end-of-life patient who is suffering from a serious and incurable illness and who is experiencing unbearable suffering, it is recommended that a physician who cannot provide MAID because of his personal convictions inform the patient sufficiently early on that he will not be able to do so. At the same time, he must tell him about the range of available medical options and, by notifying the authorities, help him find a colleague who is willing to provide such aid provided the legal and medical requirements are met.

A physician who has a conscientious objection to providing MAID must not abandon a patient who requests it. He must continue to provide him with all the other care that is appropriate for his condition in collaboration with the interdisciplinary team. It is entirely acceptable that a physician who has MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 30

developed a therapeutic relationship with a patient and who has a conscientious objection to his request for MAID agree to his request that he remain at his bedside while his request is being evaluated and until MAID is administered by a willing colleague. Nonetheless, it is recommended that he not provide the second physician’s opinion.33

Claiming a conscientious objection in order to refuse to assess suffering or do a clinical assessment of capacity to consent to care or give an opinion on the prognosis of a person requesting MAID cannot be justified. It is certainly understandable that some physicians would be reluctant to give an opinion that might confirm that one or other of the legal criteria authorizing MAID has been met, for fear that all the criteria would be met and that two colleagues would consider MAID acceptable. However, doing these assessments before deciding what the most appropriate care for the patient is (MAID and/or other types of care) means not participating in the recommendation or the administration of this care. Not doing so, just in case, would discriminate against people whose suffering is such that they request assistance in dying and who might then be deprived of the best possible care.

Irrespective of any possible conscientious objections, the ARELC stipulates that “palliative care hospices determine the end-of-life care provided in their premises” (s. 13, par. 1), unlike institutions in the health and social services network which are obliged to offer the full range of end-of-life care (s. 7). It should be noted that an institution in the network which “only offers palliative care may continue to offer that care exclusively” (s. 72, par. 1). This type of institution and palliative care hospices must clearly inform persons whether or not they offer MAID in accordance with the requirements before admitting them (s. 13, par. 2 and s. 72, par. 2). They should also provide for measures to ensure that requests for MAID are responded to in a way that ensures everyone’s rights are respected.

3.5 HEALTH INSURANCE

To qualify for MAID, a person must be “insured within the meaning of the Health Insurance Act”34 (s. 26(1) of the ARELC). This means that he is a resident or temporary resident of Quebec who is duly registered with the Board. He may be a Canadian citizen; a permanent resident within the meaning of the Immi- gration and Refugee Protection Act; an Indian who is registered as an Indian pursuant to the Indian Act; a person having been granted refugee status, within the meaning of the Geneva Convention, by a competent authority; or a person belonging to any other class of persons determined by regulation.

33 See Section 4.2. 34 Health Insurance Act, CQLR, c. A-29. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 31

This fundamental requirement has its advantages. Universal access to quality care and health insurance are safeguards against concerns about abuse of MAID: it is imperative that other end-of-life care be considered before MAID. The costs associated with MAID are then covered, ensuring access for all insured persons who request it and who satisfy the requirements, irrespective of their ability to pay. This provision is also intended to prevent end-of-life patients from other Canadian provinces or other countries from coming to Quebec to obtain MAID, including those who would be willing to cover the cost of the procedure themselves. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 32

Chapter 4/ Procedures

Before providing MAID, the physician must, as required under section 29 of the ARELC, “be of the opinion that the patient meets all the criteria of section 26”, listed previously. With some exceptions, these criteria are similar or consistent with the eligibility criteria for MAID set out in the Criminal Code.

Table 5 Procedures prescribed by law

QUEBEC CANADA Act respecting end-of-life care – ARELC Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) – Criminal Code

Section 29 241.2 (3) Before a medical practitioner [...] provides a person with medical assistance in “Before administering medical aid in dying, dying, the medical practitioner […] must: the physician must: (a) be of the opinion that the person meets (1) be of the opinion that the patient meets all of the criteria set out in subsection (1); all the criteria of section 26, after, among (b) ensure that the person’s request for other things: medical assistance in dying was: (i) made in writing and signed and dated (a) making sure that the request is being by the person or by another person under made freely, in particular by ascertaining that subsection (4), and it is not being made as a result of external (ii) signed and dated after the person was pressure; informed by a medical practitioner [...] that the person has a grievous and irremediable (b) making sure that the request is an medical condition; informed one, in particular by informing the (c) be satisfied that the request was signed patient of the prognosis for the illness and and dated by the person — or by another of other therapeutic possibilities and their person under subsection (4) — before two consequences; independent witnesses who then also signed and dated the request; (c) verifying the persistence of suffering and (d) ensure that the person has been informed that the wish to obtain medical aid in dying that they may, at any time and in any manner, remains unchanged, by talking with the withdraw their request; patient at reasonably spaced intervals given the progress of the patient’s condition; MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 33

QUEBEC CANADA Act respecting end-of-life care – ARELC Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) – Criminal Code

(d) discussing the patient’s request with any (e) ensure that another medical practitioner members of the care team who are in regular [...] has provided a written opinion confirming contact with the patient; and that the person meets all of the criteria set out in subsection (1); (e) discussing the patient’s request with the (f) be satisfied that they and the other patient’s close relations, if the patient so medical practitioner [...] referred to in wishes; paragraph (e) are independent; (g) ensure that there are at least 10 clear days (2) make sure that the patient has had the between the day on which the request was opportunity to discuss the request with the signed by or on behalf of the person and the persons they wished to contact; and day on which the medical assistance in dying is provided or — if they and the other medical (3) obtain the opinion of a second physician practitioner [...] referred to in paragraph (e) confirming that the criteria set out in section are both of the opinion that the person’s 26 have been met. death, or the loss of their capacity to provide informed consent, is imminent — any shorter The physician consulted must be period that the first medical practitioner [...] independent of both the patient requesting considers appropriate in the circumstances; medical aid in dying and the physician (h) immediately before providing the medical seeking the second medical opinion. The assistance in dying, give the person an physician consulted must consult the opportunity to withdraw their request and patient’s record, examine the patient and ensure that the person gives express consent provide the opinion in writing.” to receive medical assistance in dying; and (i) if the person has difficulty communicating, take all necessary measures to provide a reliable means by which the person may understand the information that is provided to them and communicate their decision.

4.1 DISCUSSIONS WITH THE INTERDISCIPLINARY TEAM, THE PATIENT AND HIS FAMILY

A patient who has a “serious and incurable illness” is usually treated not by a single physician, but by an interdisciplinary team. Each physician and health or social services professional has a special relationship with the patient and often with his family. They must work closely together when caring for the patient in the final stages of his life. The physician must discuss the patient’s request “with any members of the care team who are in regular contact with the patient” (s. 29(1)(d) of the ARELC). As far as possible, the physician and the interdisciplinary team must seek consensus, but, ultimately, the physician is the only person responsible for deciding whether or not MAID will be administered and, where applicable, must administer such aid personally. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 34

If, and only if, the patient so wishes and authorizes him to do so, the physician must also discuss the request with the patient’s family.

With the patient, he must: ›› make sure “that the request is being made freely, in particular by ascertaining that it is not being made as a result of external pressure” (s. 29(1)(a) of the ARELC); this pressure may be relational, psychosocial or financial. To make sure his request has been made voluntarily, the physician must also diligently verify that the patient is capable of making a free and informed decision; ›› make sure “that the request is an informed one, in particular by informing the patient of the prognosis for the illness and of other therapeutic possibilities and their consequences” (s. 29(1)(b) of the ARELC); ›› and verify “the persistence of suffering and that the wish to obtain medical aid in dying remains unchanged, by talking with the patient at reasonably spaced intervals given the progress of the patient’s condition” (s. 29(1)(c) of the ARELC).

Both physician and patient must be convinced that no other reasonable solution is acceptable before considering the option of MAID.

The physician must also make sure “that the patient has had the opportunity to discuss the request with the persons they wished to contact” (s. 29(2) of the ARELC). The interdisciplinary team’s collaboration can be valuable in this respect. This measure is important for the dying person but also for those who will survive him and will have to cope with bereavement. Family members may not, however, contest the patient’s decision.

4.2 OPINION OF A SECOND PHYSICIAN

In addition, the physician must obtain the opinion of a second physician confirming that the criteria set out in section 26 of the ARELC and in section 241.2(1) of the Criminal Code have been met. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 35

Both the physician who is willing to administer MAID and the physician who is consulted to give this opinion must be independent of one another as well as of the person requesting MAID (s. 29(3) of the ARELC; s. 242.2 (3)(e) and (f) of the Criminal Code). Situations that could influence and bias their professional judgement must be avoided.

The Code of ethics of physicians requires a physician to safeguard his professional independence and “avoid any situation in which he would be in conflict of interest, in particular when the interests in question are such that he might tend to favour certain of them over those of his patient or where his integrity and loyalty toward the latter might be affected” (s. 63).

The Criminal Code states that, in the context of a request for MAID, the physician who administers MAID or the physician who provides his opinion are independent “if they:

a) are not a mentor to the other practitioner or responsible for supervising their work;

b) do not know or believe that they are a beneficiary under the will of the person making the request, or a recipient, in any other way, of a financial or other material benefit resulting from that person’s death, other than standard compensation for their services relating to the request;

c) do not know or believe that they are connected to the other practitioner or to the person making the request in any other way that would affect their objectivity.” (s. 241.2(6) of the Criminal Code)

Therefore, the physician must avoid putting himself in a position where his professional independence is compromised. If he finds himself in a situation where it may be called into question, he must refrain from practicing or be able to demonstrate his independence if necessary.

The physician who is consulted to give his opinion regarding compliance with the legal criteria must, of course, be qualified to assess the criteria relative to the sick person’s health. For the most complex cases and in accordance with proper medical practice, it may be appropriate to seek the opinion of a physician with relevant expertise (in the pathology, end-of-life care or psychiatry, for example).

It should be noted that the second physician’s opinion must be objective and impartial. It must not be influenced by his personal convictions. A physician who refuses to participate in MAID because of his personal moral or religious convictions should not participate in this second consultation. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 36

The patient’s attending physician may agree to his request for MAID but prefer not to administer the medication himself for reasons other than his personal convictions. A colleague who does not know the patient may agree to do so. The latter will then be responsible for conducting the decision-making process with the patient, taking his request for MAID into consideration, assessing the indications, exercising his professional judgement, complying with the procedure prescribed by law, administering MAID and notifying the authorities responsible for assessing the quality of the procedure or compliance with the law. For his part, the attending physician must be able to continue his therapeutic relationship with the patient and provide him with the care he requires. He knows the patient well, has sometimes known him for months or even years. Unless he does not feel sufficiently objective or competent, it must be possible to consult him so that he can provide the second physician’s opinion regarding compliance with the criteria set out in section 26 of the ARELC and section 241.2(1) of the Criminal Code.

Local interdisciplinary support groups (ISGs) have been created in institutions in the health and social services network across Quebec to provide support for physicians and health or social services professionals who participate in medical aid in dying. They can help find a physician who may be willing to give an opinion or administer MAID.

The patient must be capable of giving consent to the consultation of a second physician prescribed by law.

The second physician “must consult the patient’s record, examine the patient and provide the opinion in writing” (s. 29(3) of the ARELC) and his report, duly dated, must be entered in the record (s. 32, par. 1 of the ARELC). He can use the form “Opinion of second physician consulted regarding the fulfillment of criteria for obtaining medical aid in dying”35 proposed by the MSSS. He is not required to send the form to the authorities responsible for assessing the quality of the procedure or its compliance with the law unless specifically asked to do so.

If the physician consulted is unable to confirm that all the criteria have been met, MAID cannot be administered. It can be assumed that differences of opinion will be more likely to concern the criteria regarding the patient’s suffering and the assessment of his prognosis of survival, possibly his ability to consent to care, than the other, purely administrative, criteria. Where applicable, and as stipulated in the ARELC, the patient will be able to make another request and

35 The form “Opinion of second physician consulted regarding the fulfillment of criteria for obtaining medical aid in dying” can be accessed: – in the secure section of the CMQ, OPQ and OIIQ websites; – on the intranet of the health and social services network. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 37

the procedures will be repeated. The institution’s ISG’s support may be of benefit to both the patient and the interdisciplinary team that is caring for him.

The opinion of the physician consulted (not the form) must be systematically reported by the physician who will be administering MAID in his report to the council of physicians, dentists and pharmacists of which he is a member or to the Collège des médecins du Québec if he is practicing in a private health facility, as well as to the Commission sur les soins de fin de vie when notice of MAID is given.36

The physician who receives the request for MAID and who would be willing to administer it must inform the patient about the report written by the physician consulted. He must explain the findings in the report clearly and discuss them with the patient. Note that the patient has right of access to his complete medical record.37 Any physician who is consulted must bear this in mind when writing his report.

4.3 THE PHYSICIAN’S CONCLUSION

“If a physician determines, subsequent to the application of section 29, that medical aid in dying may be administered to a patient requesting it, the physician must administer such aid personally and take care of and stay with the patient until death ensues” (s. 30, par. 1 of the ARELC).

As for any other medical intervention, a physician who agrees to administer MAID must not only be familiar with the requirements and procedures prescribed by law but must also have a thorough command of the pharmacological, technical and practical aspects in order to ensure a respectful death, quick and free of suffering.

“If the physician determines that medical aid in dying cannot be administered, the physician must inform the patient of the reasons for that decision” (s. 30, par. 2 of the ARELC). Furthermore, all information and documents in connection with a request for medical aid in dying, regardless of whether the physician administers it or not, including the form used to request such aid and the reasons for the physician’s decision, must be recorded or filed in the patient’s record (s. 32, par. 1 of the ARELC).

36 For more information about reporting, see Chapter 7 of these guidelines. 37 Act respecting health services and social services, CQLR, c.S-4-2, s. 17. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 38

4.4 WAIT TIME

It should be noted that a patient who requests MAID is usually ready to receive such aid. However, the physician, a fortiori if he has only known the patient for a short while, must also work toward a joint decision, without rushing, despite a possible feeling of urgency to relieve the person’s suffering. Furthermore, the time required to follow the procedures prescribed by the ARELC may seem, more to the patient than the physician, excessive. Being aware of and understanding the time involved, and talking about it, can certainly help make it easier to accept. However, the physician must be diligent: it would be unacceptable were an overlong wait time to be used as a pretext for refusing a request for MAID.

The Criminal Code requires a wait time of “at least ten clear days” between the day on which the request form for MAID was signed and the day on which it is provided (s. 241.2(3)(g)). This period can be shorter, in full compliance with the law, if both physicians are of the opinion that the person’s death, or the loss of their capacity to provide informed consent, is “imminent”. It is understood that at the very end of life and/or under the effects of the treatments provided to relieve unbearable suffering, either one or both of these risks is extremely common. Where applicable, the physicians’ opinion must be entered in the patient’s medical record. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 39

Chapter 5/ Obtaining the medications and relationship with the pharmacist

In principle, if MAID is correctly administered, it should not cause the patient any additional suffering and should lead to death within a short time. Anxiolysis is followed by the induction of a deep coma and, lastly, definitive respiratory arrest is triggered.

While knowledge of toxicology allows the lethal dose of each pharmacological agent to be determined, few agents can guarantee total effectiveness, the absence of suffering and unrestricted access.

The doses, dosage regimens, methods of administration, special instructions or particular aspects to monitor or, conversely, that do not require monitoring mentioned throughout this document are applicable to the specific context of medical aid in dying at the end of life.

In most instances, the information presented is different from that provided in other situations or clinical protocols and, consequently, cannot be transposed to these other contexts.

The Collège des médecins du Québec, the Ordre des pharmaciens du Québec, the Ordre des infirmières et infirmiers du Québec and the experts consulted provide this information as clinical standards. They made sure the information in this document was accurate at the time of publication. However, the physician is responsible for verifying that the information is adapted to the clinical situation in question and is not out of date.

The following guidelines were drawn up in collaboration with expert physicians and pharmacists from Quebec. They are largely based on the joint recommen- dations made by the Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie (KNMP)38 and the Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG)39 in 2012. They were revised in April 2017

38 KNMP is the Royal Dutch Pharmacists Association. 39 KNMG is the Royal Dutch Medical Association. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 40

based on available scientific evidence and experiences in Quebec since the coming into force of the ARELC.

It should be noted that there is limited medical and scientific literature on the subject and that the need to evaluate practices and carry out research in this area remains critical.

The Collège des médecins du Québec is committed, with its partners, to updating this document regularly.

5.1 ROUTE OF ADMINISTRATION

Only the intravenous administration of medications is addressed here.

Indeed, given the disadvantages of per os administration, such as variable effectiveness, the risk of prolonging the procedure unduly, the side effects of the medications, etc., the use of this route to provide MAID is prohibited by professional orders in Quebec. For more information about contraindicated routes of administration, see Appendix IX.

5.2 DOSAGE

The administration protocol for MAID provides for a single dosage for each medication used.

5.3 SYSTEMATIC PROCESS OF PHYSICIAN-PHARMACIST COLLABORATION

Since medical aid in dying is an exceptional measure and since it requires deep respect on the part of each of the care providers concerned, the physician and the pharmacist are encouraged to work together closely throughout the procedure.

The physician must, without fail, notify the pharmacist in a health care institution or a community pharmacy in a timely manner that he will be receiving a prescription for MAID and discuss it with him in person. They must identify themselves, showing photo identification where necessary.

Given the type of medications used for MAID, a certain interval between the time the pharmacist receives the medication order from the physician and the delivery of the medications is to be expected. The physician and the pharmacist must agree on how long this interval of time will be. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 41

To provide quality, safe pharmaceutical service that respects the patient’s autonomy, the pharmacist must have all the necessary information. Thus, the patient or, at the very least, his medication profile, must be known to him. In addition, if the patient gives his consent,40 the physician should provide the pharmacist with a duly signed copy of his request form for MAID.

The physician and the pharmacist must discuss: ›› the patient’s medical and medication history; ›› the protocol selected in accordance with the guidelines; ›› the scheduled time for the administration of MAID; ›› the time required to prepare the medications; ›› how to complete the medication administration record; and ›› the procedures for returning unused products to the pharmacy and for their destruction.

As far as possible, the patient, especially if he is being cared for at home, should be able to choose the pharmacist who will participate in medical aid in dying.

5.4 PRESCRIBING PROCEDURE

The physician must determine with the pharmacist which medications are most appropriate for a particular patient. He must know the characteristics of each of the medications available, listed in Chapter 6 of this document. He must also know which medications or substances must not be used to provide MAID. For more details, see Appendix X.

The prescription must be written in the patient’s name and clearly state that it has been written for the purposes of providing medical aid in dying.

The physician must ensure that he prescribes a sufficient quantity of each product.

Given the special context surrounding MAID and the need to standardize the steps involved as much as possible in order to minimize the risk of incidents and accidents, physicians are encouraged to use the preprinted prescription41 and to give it to the pharmacist in person with, if the patient gives his consent, a copy of his duly signed request form for MAID.

40 The MAID request form prescribed by the minister includes a section where the patient may give consent to a copy of his request being sent to the pharmacist who will be providing the medications. 41 The preprinted prescription is available online on the CMQ and OPQ websites. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 42

5.5 DISPENSING BY THE PHARMACIST

5.5.1 PREPARATION, DISPENSING AND STORAGE

The pharmacist is responsible for preparing the products and labelling the containers (syringes, etc.). Each medication must be prepared in accordance with Norme 2014.01 - Préparation de produits stériles non dangereux en pharmacie [Standard 2014.01 - Preparation of non-hazardous sterile products in pharmacies] produced by the Ordre des pharmaciens du Québec in 2014.

Several syringes are required. They must be labelled in accordance with the Regulation respecting the labelling of medications and poisons.42 In addition, they must: ›› be identified with the patient’s name and health insurance number; ›› indicate the name and dose of the product they contain; ›› be ready to use and numbered in the order of administration of the medication they contain.

They must be presented in a sealed kit. The contents of the kit must be listed on the medication administration record designed for this purpose by the pharmacist and which must be included with the kits. A sample record is provided in Appendix VII.

A second kit containing a duplicate set of the products and injection material must be systematically prepared, sealed and made available at the site of the procedure. It may be useful for adjusting the dosage of a medication and in the event of damage or improper handling.

Experience shows that the second kit is necessary. Therefore, it is mandatory.

42 Regulation respecting the labelling of medications and poisons, CQLR, c. P-10, r. 15. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 43

Example of a sealed kit:43

If the physician is administering MAID in a centre operated by an institution, he must pick up the medications at the institution’s pharmacy himself, in a place that is quiet and away from curious onlookers. If MAID is provided in the patient’s home or in a palliative care hospice, the physician and the pharmacist must meet. If they have not seen each other before, they must identify themselves and show photo identification.

As far as possible, a nurse would benefit from being present too. This could greatly facilitate her collaboration in the later stages of the procedure.

The pharmacist must give the physician the two kits with the medications and injection material in person along with appropriate instructions for storing the medications until they are used. Together, they must check the contents of each kit, initial the medication administration record and seal the kits.

Once medical aid in dying has been administered, the physician must always return any unused products and material to the pharmacist along with the two kits and the medication administration record that he duly completed while he was administering MAID or just after doing so.

The pharmacist and the physician must inventory the empty syringes and any partially used or unused medications and reconcile the inventory with the medication administration record, including the section for the second kit even if it was not used.

The medications must then be destroyed immediately in accordance with the policies and procedures in effect in the institution. After doing so, the professionals (physicians or pharmacists) must sign the medication administration record again.

Soiled injection material should be put in a container provided for this purpose that should be supplied with the kits and that should be destroyed when they are returned to the pharmacy in accordance with the policies in effect in the institution. Only clean, unused material may be recycled.

43 The appearance of the kits should be sufficiently neutral to allow them to be transported and handled as discreetly as possible. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 44

The patient’s medication record must include: ›› the physician’s prescription; ›› if the patient gives his consent, a copy of the patient’s duly signed request form for MAID; ›› the medication administration record.

The pharmacist must also enter in the medication record: ›› the date and time the physician gave him the prescription; ›› the main points discussed with the physician; ›› the patient’s date of death.

5.5.2 THE PHARMACIST’S PERSONAL CONVICTIONS

A pharmacist who is given a medication order must dispense it with professionalism, irrespective of his personal convictions, by preparing and providing the required medications and the necessary information for their proper use in accordance with the law and professional standards governing the practice of pharmacists.

However, under the ARELC, he is not obliged to participate in administering MAID within the limits of his professional role, namely, prepare and provide the prescribing physician with the required medications, if it is contrary to his personal convictions (s. 50 of the ARELC). Where applicable, he must maintain a professional relationship with the person who requests MAID and answer his questions.

5.5.3 CONSCIENTIOUS OBJECTION BY THE PHARMACIST

As for physicians, the ARELC provides for the conscientious objection of any health professional (s. 50). It stipulates that a professional who refuses to participate in administering MAID because of his personal convictions must ensure continuity of care is provided to the patient, in accordance with his code of ethics. Thus, in such a situation, a pharmacist must inform the patient of this, if they know one another, as well as the prescribing physician and offer to help the latter find another pharmacist. To comply with theCode of ethics of pharmacists (s. 26),44 the pharmacist could immediately notify the competent authorities or support organizations, such as an institution’s ISG, which could find a pharmacy that is able to accommodate the request. The competent authorities and support organizations vary depending on the pharmacy’s practice conditions.

44 Code of ethics of pharmacists, CQLR, c.P-10, r. 7, s. 26: “Pharmacists must, where their personal convictions may prevent them from recommending or providing pharmaceutical services that may be appropriate, so inform their patients and explain the possible consequences of not receiving the services. Pharmacists must then offer to help the patients find another pharmacist.” MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 45

Chapter 6/ Administration of medical aid in dying and teamwork

Under the terms of the ARELC, the physician is the only person authorized to administer medical aid in dying. However, the importance of nurses’ and other interdisciplinary team members’ contribution to this intervention cannot be overstated. These health or social services professionals usually play a key role, not only by providing the patient with care, support and comfort, but also by assisting his family members in their process. They also support the physician, for instance by contributing to the decision-making process to some extent.

Nurses also continuously assess the patient’s clinical condition and provide pharmacological or other types of relief for pain and symptoms as well as the necessary clinical monitoring. Thus they actively participate in a number of technical interventions, such as venous line placement or the preparation of injection material for medications, always with the objective of meeting the patient’s needs as best they can.

By way of example, a number of technical and pharmacological aspects that must be considered before and during medication administration are presented in Appendix IV.

Once again, it should be noted that the ARELC provides for the conscientious objection of any health professional. Thus, in accordance with the ARELC (s. 50) and the Code of ethics of nurses (s. 44),45 a nurse who refuses to participate in administering MAID for moral or religious reasons must immediately notify the competent authorities, such as the institution’s director of nursing, who will then take the necessary steps to find a nurse who is able to provide appropriate care and support for the patient and his family.

45 Code of ethics of nurses, CQLR, c. I-8, r. 9, s. 44: “A nurse shall not be negligent in the care and treatment provided to the client or to the research subject. In particular, a nurse shall: (1) perform the assessment required by the client’s state of health; (2) intervene promptly when the client’s state of health so requires; (3) ensure the clinical monitoring and follow-up required by the client’s state of health; (4) take reasonable action to ensure continuity of care and treatment.” MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 46

6.1 EXPLANATIONS TO BE GIVEN TO THE PATIENT AND THOSE PRESENT

Once the joint decision to administer MAID has been made, it is important to explain to the patient once again how MAID will be administered: first the patient will be helped to relax, then he will be put in a deep sleep and he will not feel anything when he stops breathing. It may be appropriate to explain what to expect (immediate effect, time to death, etc.), the associated risks, as well as the procedure after providing MAID.

The patient can change his mind up until the very last moment. The physician must allow him to do so and systematically verify that his wish to obtain medical aid in dying remains unchanged at each step of the process and until it is time to administer MAID (s. 28 of the ARELC and s. 241.2(3)(d) and (h) of the Criminal Code).

Depending on the patient, and the meaning he gives it, MAID can be administered with only the patient and the physician present46 or it can be a shared event: if the patient wishes, and if they wish to be there, family members can be present when MAID is administered. Similarly, again in accordance with the patient’s wishes, a nurse and other members of the interdisciplinary team, even another physician, may be present. The physician must inform those present, as far as possible before the day of the procedure, and support them with tact and compassion, so that MAID, beyond its technical and legal aspects, is a gesture of solidarity, full of humanity. By his attitude, the physician must minimize the “technical” aspects of the intervention as far as possible. “Touching the dying person with emotion is more important than counting his breaths” [Translated from the French.] (ADMD-L, 2012).

6.2 TIME AND PLACE

If a specific time has been agreed upon, it is important to respect it: each person concerned uses it to mark the time left and say their goodbyes.

MAID should be marked by a profound solemnity that holds the protagonists’ undivided attention. It is important for the physician, the patient and anyone else present that there be no disturbances during the preparation and administration of MAID.

46 Note that section 54 of the Code of ethics of physicians does not apply in the context of MAID. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 47

The physician must be completely available to administer MAID, from start to finish. He must not choose a time when he is on call, for example. Pagers and cellphones should be switched off and everyone present should be asked to do likewise. Colleagues and the other members of the interdisciplinary team must be informed that the physician cannot be reached during this time.

For the same reasons, MAID will be administered in a quiet and appropriate place. Thus, in a health care institution, the patient must be given a private room, as provided for in section 12 of the ARELC for all end-of-life care, for the final few days preceding death.

The physician must administer MAID personally and take care of and stay with the patient until death ensues (s. 30, par. 1). The procedure may take 20 to 30 minutes.

6.3 INTRAVENOUS INJECTION

MAID is a three-step process. It starts with anxiolysis, followed by induction of an artificial coma and, lastly, the administration of a neuromuscular blocker that causes respiratory arrest, cardiac arrest and death.

Note that the intravenous route is the only acceptable route of administration for MAID and that good venous access is an absolute prerequisite. In other words:

Precarious venous access is an absolute contraindication to the administration of MAID.

If peripheral venous access is impossible, a central line will have to be planned.

6.3.1 VENOUS ACCESS

6.3.1.1 ASSESSMENT OF VENOUS POTENTIAL

It is recommended that the nurse or physician assess venous potential within 24 hours prior to the administration of MAID.

Loss of venous access during coma induction is a possible complication and must be given serious thought. Systematic “preventive” placement of two peripheral venous lines or a central line (including a PICC line) for each patient is not indicated; it may not only be difficult but also painful and excessive. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 48

However, a second potential site, either peripheral or central, depending on the patient’s venous capital, must be identified in advance and, where applicable, provision made for the necessary material and a nurse’s or anesthesiologist’s assistance. Needless to say, central line placement, which cannot be performed in the patient’s home,47 would require hospitalization.

Once venous access has been restored, it is still necessary to induce a deep coma, administering a coma-inducing agent again, where appropriate, and carefully check that coma is confirmed before injecting the neuromuscular blocker.

6.3.1.2 VENOUS LINE PLACEMENT

Within 4 hours prior to the administration of MAID, a nurse or physician inserts a venous line (intermittent venous access device [saline lock] or KVO infusion). A 20 G catheter is preferred to better ensure the medications are injected in the time allocated by preventing loss of venous access. An 18 to 22 G catheter could be used depending on the patient’s venous capital, but the rate of medication administration would then have to be controlled: the smaller the catheter gauge, the slower the flow rate. Antireflux tubing is indicated if the patient has small veins to minimize the risk of retrograde infusion.

The catheter must always be checked to make sure it is correctly placed and patent48 in order to prevent unnecessary pain and avoid compromising the effectiveness of the medications injected.

Note that catheter placement and connection (if necessary) to an administration device (infusion bag) can be done in advance by a health professional who has the necessary expertise and is authorized to do so. However, the remainder of the procedure, that is, the intravenous administration of each medication, must be done by the physician himself.

47 Placement of a femoral vein catheter is an option to consider, in particular in the patient’s home. 48 By injecting saline to assess for signs of obstruction or infiltration of the vein (swelling). MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 49

6.3.2 PREREQUISITES

Since none of the medications used for MAID have a significant analgesic effect, analgesia must be continued until MAID is administered. However, analgesic medication should not be administered at the same time as MAID.

Oxygen therapy should be discontinued as soon as MAID is initiated to avoid prolonging the period of apnea and delaying cardiac arrest by hypoxia.

It may also be appropriate, if it has not already been done, to deactivate an implantable cardioverter defibrillator before administering MAID.

6.3.3 ANXIOLYSIS

Anxiolysis by slow direct intravenous injection of midazolam is indicated before coma induction.

Table 6 Anxiolysis

DOSAGE BASED ON ROUTE AND ONSET OF ACTION PATIENT STATUS DURATION OF ADMINISTRATION

Midazolam 5 to 10 mg Direct IV injection, 3 to 5 minutes 1 mg/ml (5 to 10 mL) over 2 minutes to be titrated based on patient response

IV: intravenous.

Paradoxical agitation may occur in some patients. Coma should then be induced without delay and without giving any further doses of midazolam.

6.3.4 ARTIFICIAL COMA INDUCTION

An artificial coma that is deep enough to prevent the patient from feeling the effects of the neuromuscular blocker must be induced. With the products and dosages recommended in this protocol, the risk of loss of consciousness being inadequate or too brief is very low. However, the medications may be less effective if the intravenous catheter is not inserted correctly. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 50

It is necessary to carefully check that coma is confirmed before administering the neuromuscular blocker.

Table 7 Artificial coma criteria

PHYSIOLOGICAL CRITERIA CLINICAL SIGNS

Level of consciousness Unable to rouse, no response to verbal commands, no protective reflexes (loss of ciliary reflex in particular)

Cardiovascular function Compromised

Respiratory function Spontaneous breathing inadequate

The medications used to induce an artificial coma are either a general anesthetic such as propofol or a barbiturate such as phenobarbital.

If there is a severe allergy to one of the medications (note that propofol contains egg and soy in its excipients), it is best to use the other one, unless contraindicated.

Intravenous injection of these medications is often painful and an injection of parenteral lidocaine without epinephrine or, if there is a known allergy to lidocaine, an injection of magnesium sulfate, must be given first. Note also that the injection is less painful if it is given in an antebrachial vein, in the elbow crease, or a large diameter vein (including those in the lower limbs if no other site is available). An analgesic must always be injected, irrespective of whether the coma-inducing agent is injected by a central or peripheral venous line.

Both propofol and phenobarbital must be injected directly and slowly, over 5 minutes. Administering an injection too quickly, as a bolus, may result in loss of venous access, while an injection that is too slow could reduce the effectiveness of the medication and compromise the development of a sufficiently deep coma.

At the dosages recommended for MAID, cardiopulmonary arrest can occur rapidly during coma. Those present should be advised of this. The full dose of the coma-inducing agent must nonetheless be administered. It should be noted that rapid cardiopulmonary arrest is less common when medication is administered gradually. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 51

Even when cardiopulmonary arrest occurs during coma induction, the neuromuscular blocker must always be injected to prevent any doubt as to the patient’s death.

Table 8 Coma induction: propofol – Medications for injection, in order of administration – 1st line

MEDICATION DOSAGE ROUTE OF DURATION OF EXPECTED ADVERSE ADMINISTRATION ADMINISTRATION EFFECT EFFECT

Parenteral 40 mg Direct IV 30 seconds Local lidocaine (2 mL) injection analgesia 2% without epinephrine

Or, if allergy to lidocaine:

Magnesium 1000 mg Slow direct IV 5 minutes Local sulfate (2 mL) injection analgesia 500 mg/mL (complete ad 10 mL with NaCl 0.9%)

Propofol 1000 mg Slow direct IV 5 minutes Cardio- Pain on 10 mg/mL (2 x 50 mL) injection (2.5 minutes vascular and injection At the per syringe) respiratory slightest depression doubt, continue coma induction by increasing the dose of the medication

IV: intravenous. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 52

OR, if there is a known allergy to propofol or if propofol is not available:

Table 9 Coma induction: phenobarbital – Medications for injection, in order of administration – 2nd line

MEDICATION DOSAGE ROUTE OF DURATION OF EXPECTED ADVERSE ADMINISTRATION ADMINISTRATION EFFECT EFFECT

Parenteral 40 mg Direct IV 30 seconds Local lidocaine (2 mL) injection analgesia 2% without epinephrine

Or, if allergy to lidocaine:

Magnesium 1000 mg Slow direct IV 5 minutes Local sulfate (2 mL) injection analgesia 500 mg/mL (complete ad 10 mL with NaCl 0.9%)

Phenobarbital 3000 mg Slow direct IV 5 minutes Deep coma Pain on 120 mg/mL (25 mL) injection injection (complete ad 50 mL with NaCl 0.9%) At the slightest doubt, continue coma induction by increasing the dose of the medication

IV: intravenous.

6.3.5 NEUROMUSCULAR BLOCKER INJECTION

Intravenous injection of a sufficient dose of neuromuscular blocker causes paralysis of the striate muscles (except the myocardium) within minutes. The resulting respiratory arrest leads to death by anoxia.

Needless to say, the neuromuscular blocker cannot be injected until the artificial coma is confirmed. At the slightest doubt, coma induction must be continued by increasing the dose of the medication. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 53

Ten (10) mL of NaCl 0.9% must be injected between the coma-inducing agent and the neuromuscular blocker to ensure that the full dose of coma-inducing agent has been administered and to prevent the barbiturate and neuromuscular blocker from forming a precipitate in the syringe or tubing.

It is equally essential to inject 10 mL of NaCl 0.9% after the neuromuscular blocker to ensure that the full dose has been administered and to prevent any residual amount from contaminating a third person.

Death can come very quickly once the neuromuscular blocker has been injected, if it did not already occur during coma induction. Respiratory arrest occurs before cardiac arrest. There is usually a delay of 5 minutes between respiratory arrest and cardiac arrest, but delays of up to 20 minutes may occur, causing cyanosis.

It is advisable to explain to those present, before starting the injections, that death might come relatively quickly, that respiratory arrest may be preceded by snoring sounds for a short time and that the heart may keep beating for a long time after breathing has stopped.

Table 10 Neuromuscular blocker: rocuronium – Medications for injection, in order of administration

MEDICATION DOSAGE ROUTE OF DURATION OF EXPECTED EFFECT ADMINISTRATION ADMINISTRATION

NaCl 0.9% 10 mL Direct IV injection Instantaneous Flushing of the syringe and/or tubing

Rocuronium 200 mg Rapid direct IV Respiratory arrest, fol- bromide (20 mL) injection lowed by cardiac arrest 10 mg/mL and death

NaCl 0.9% 10 mL Direct IV injection Instantaneous Flushing of the syringe and/or tubing to ensure that the full dose of rocuronium has been injected into the vein

IV: intravenous. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 54

Table 11 Neuromuscular blocker: cisatracurium – Medications for injection, in order of administration

MEDICATION DOSAGE ROUTE OF DURATION OF EXPECTED EFFECT ADMINISTRATION ADMINISTRATION

NaCl 0.9% 10 mL Direct IV injection Instantaneous Flushing of the syringe and/or tubing

Cisatracurium 30 mg Rapid direct IV Respiratory arrest, besylate (15 mL) injection followed by cardiac arrest 2 mg/mL and death

NaCl 0.9% 10 mL Direct IV injection Instantaneous Flushing of the syringe and/or tubing to ensure that the full dose of cisatracurium has been injected into the vein

IV: intravenous.

The Collège des médecins, the Ordre des pharmaciens and the Ordre des infirmières et infirmiers du Québec require any deviation from the recommended protocol to be explicitly justified and documented. The three- step process, namely, anxiolysis, coma induction and injection of a neuromuscular blocker, must be completed in every case.

6.4 AFTER DEATH

The moment of death is charged with emotion for everyone present. The physician must stay in the room to provide support to the interdisciplinary team and the family. It is helpful to note these elements in the medical record.

Any unused medications and material, packaging and empty syringes as well as the second kit must be returned to the pharmacist by the physician in person. This allows any partially used or unused products to be destroyed, including any controlled drugs and targeted substances, in accordance with the prin- ciples of federal and provincial regulatory policy. The procedure can also be reviewed and unexpected problems that arose discussed. These can be taken into account when other requests for MAID are made. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 55

Chapter 7/ Reporting

7.1 RECORD KEEPING

All information and documents in connection with a request for medical aid in dying, regardless of whether the physician administers it or not, including the form used to request such aid, the reasons for the physician’s decision whatsoever it may be and, where applicable, the opinion of the physician consulted, must be recorded or filed in the patient’s record (s. 32, par. 1 of the ARELC).

Before administering MAID, the physician must discuss the request for MAID “with any members of the care team who are in regular contact with the patient” (s. 29(1)(d) of the ARELC) and “with the patient’s close relations, if the patient so wishes” (s. 29(1)(e) of the ARELC). He should note the dates of meet- ings and the nature of the discussions (possible disagreements, approval of decisions, cooperation, etc.) in the record.

A decision to withdraw a request for medical aid in dying or to put off the administration of such aid must also be recorded in the patient’s record (s. 32, par. 2 of the ARELC).

7.2 ATTESTATION OF DEATH AND CERTIFICATE OF DEATH

At the point of care, the physician must draw up the attestation of death49 (DEC-101 form, one copy of which is to be sent to the registrar of civil status and the other to the person who is required to declare the death) and complete the certificate of death (SP-3 form, which states the cause of death) intended for the minister of health and social services, the Institut de la statistique du Québec (ISQ) (Public Health Act, s. 46), the medical record or coroner’s record and, lastly, the funeral director. The physician must enter the disease or mor- bid condition that warranted MAID and led to death as the immediate cause of death. This is not the manner of death (cardiac arrest) but the disease, injury or complication that caused death. The term medical aid in dying should not appear on the certificate of death. Indeed, if this information were disclosed to family members who had not been informed, it could, on the one hand, go

49 Civil Code of Québec, CQLR, c. CCQ-1991, s. 122: “The physician who establishes that a death has occurred draws up an attestation of death. He transmits a copy of the attestation to the person who is required to declare the death. Another copy is sent without delay to the registrar of civil status by the physician or by the funeral director who takes charge of the body of the deceased, together with the declaration of death, unless it cannot be transmitted immediately.” MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 56

against the patient’s wishes to keep the information confidential and, on the other hand, cause them harm.50 It should be noted that the DEC-101 and SP-3 forms come together in a single booklet.

The Commission sur les soins de fin de vie, not the ISQ, is responsible for the compilation of statistics on the number of times MAID is administered based on the notices it receives from physicians who administer MAID, as provided for in the ARELC.

7.3 NOTICES

The notices sent to the Commission sur les soins de fin de vie and other competent authorities can be used to profile and track developments in various end-of-life practices (continuous palliative sedation and medical aid in dying) and to provide the oversight prescribed by law.51

We cannot overstate the need to strictly follow the procedures provided for in the ARELC, to complete52 the medical aid in dying administration report form53 made available by the minister of health and social services in full and to send it to the competent authorities within the prescribed timeframe.

7.3.1 NOTICE TO BE SENT TO THE COMMISSION SUR LES SOINS DE FIN DE VIE

A physician who administers MAID must personally notify54 the Commission sur les soins de fin de vie within the next 10 days and send the Commission the information prescribed by government regulation.55 This information is confidential and may not be disclosed to any other person, except to the extent that is necessary for the Commission’s assessment of compliance with section 29 (ss. 46 and 47 of the ARELC).

The Commission is responsible for assessing compliance with the procedures set out in section 29 of the ARELC and which every physician must follow. Its assessment is based on the notices received from physicians and, if necessary, the Commission may complete its assessment by having a discussion with either physician or with any other person. On completion of the assessment, if two

50 Note that under section 49 of the Act respecting end-of-life care, “The decision of a patient […] to request […] medical aid in dying may not be invoked as a reason to refuse to pay a benefit or any other sum due under a contract.” 51 To find out more about the role of each of the authorities, consult the documentDéclaration de l’administration d’une aide médicale à mourir: Pourquoi, comment et après ?, published by the Collège des médecins du Québec in March 2017 [Reporting the administration of medical aid in dying: Why, how and after?; available in French only]. 52 Only the physician who administers MAID is authorized to complete the MAID administration report form. 53 The MAID administration report form made available by the minister of health and social services can be accessed: – in the secure section of the CMQ, OPQ and OIIQ websites; – on the intranet of the health and social services network. 54 See the 7-step guide to submitting a report form, Appendix XI. 55 Regulation respecting the procedure followed by the Commission sur les soins de fin de vie to assess compliance with the criteria for the administration of medical aid in dying and the information to be sent to the Commission for that purpose, CQLR, c. S-32.0001, r. 1. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 57

thirds or more of the members of the Commission are of the opinion that the required procedures were not complied with in a particular case, the Commission sends a summary of its conclusions to the Collège des médecins du Québec and, where applicable, to the institution where the physician in question practices so that “they can take appropriate measures” (s. 47, par. 2 of the ARELC).

Any person who notes that a physician has contravened section 46 by failing to report the administration of MAID to the Commission “must bring the breach to the attention of the Collège des médecins du Québec so that it can take appropriate measures” (s. 46, par. 2 of the ARELC).

7.3.2 NOTICE TO BE SENT TO THE CPDP OR THE CMQ FOR THE PURPOSES OF ASSESSMENT OF THE PROCEDURE

If a physician practices his profession in a centre operated by an institution, he must, within 10 days of administering MAID, inform56 the council of physicians, dentists and pharmacists (CPDP) of which he is a member or, if no CPDP is established for the institution, the head of medical services or the physician responsible for medical care in the institution. If he practices in a private health facility, he must inform the Collège des médecins du Québec.

These authorities, or their competent committee, assess the quality of the care provided, particularly with respect to the applicable clinical protocols (ss. 34, 35 and 36 of the ARELC). They also ensure the improvement of certain aspects of the practice of MAID and the development of clinical guidelines.

Table 12 Authorities responsible for assessing the quality of care

PLACE OF PRACTICE AUTHORITIES

Centre operated by an CPDP of which the physician is a member, whether MAID is institution administered in the facilities of an institution, in the premises of a palliative care hospice or in the patient’s home

If no CPDP is established for the institution, inform the head of medical services or the physician responsible for medical care in the institution

Private health facility CMQ, whether MAID is administered in the premises of a palliative care hospice or in the patient’s home

CPDP: Council of physicians, dentists and pharmacists CMQ: Collège des médecins du Québec

56 See the 7-step guide to submitting a report form, Appendix XI. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 58

Chapter 8/ Grief counselling and grieving

During the patient’s illness and until his death, the interdisciplinary team provides support to family members. After the death of the person who requested MAID, the team must be able to continue to provide support during the grieving period or refer family members to another resource such as their local community services centre (CLSC) or a community group that offers grief counselling.

Members of the interdisciplinary team who had a relationship with the deceased person and/or his family will also have some grieving to do. They must at least be able to talk about the process that led to MAID, the procedure itself and the grief they are experiencing together during a team meeting or in a support group, for example, or during an individual consultation with a psychologist, social worker or marriage and family therapist. Their institution’s Employee Assistance Program (EAP) could be a valuable resource, where applicable.

The physician(s) who cared for the person who requested MAID will also experience grief. Some physicians will need support. They should be able to turn to their colleagues and/or various resources, such as a support group in an institution or the Québec Physicians’ Health Program (QPHP).

The ISG that has been set up in the institution and is active on its territory should be able to help family members, caregivers and other interdisciplinary team members as well as physicians working both in institutions and in patients’ homes find the most appropriate resources to help them deal with their grief. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 59

Chapter 9/ Practical tools

The appendices to this document contain a number of tools that may be helpful for practitioners involved in caring for a patient who requests MAID.

DECISION-MAKING PROCESS

Appendix I presents the different types of end-of-life trajectories based on the underlying pathology. Exploring psychological suffering in the context of a request for medical aid in dying includes specific clinical considerations that are summarized in Appendix II. The process for making a decision as to whether or not to administer MAID, in keeping with clinical standards and legal requirements, is summarized in a decision tree in Appendix III.

ADMINISTRATION OF MAID

Appendix IV describes how to administer the medications depending on the coma-inducing agent used: the medications, material, precautions to take and administration procedure. A sample preprinted prescription and supplementary information (generic and brand names of the medications) are presented in Appendix V. The medication preparation protocol to be used in the pharmacy is provided in Appendix VI. Appendix VII contains a sample medication administration record. The material required to administer MAID is listed in Appendix VIII.

The other routes of medication administration and some substances must not be used to provide medical aid in dying. They are described briefly in Appen- dices IX and X for information.

The preprinted prescription and the medication administration record can be accessed in the secure section of the CMQ and OPQ websites. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 60

FORMS

The forms “Request for medical aid in dying”, “Declaration of administration of medical aid in dying” and “Opinion of second physician consulted regarding the fulfillment of criteria for obtaining medical aid in dying” can be accessed: ›› in the secure section of the CMQ, OPQ and OIIQ websites; ›› on the intranet of the health and social services network.

The seven steps to follow to submit the MAID administration report form are described in Appendix XI. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 61

CONCLUSION

After debating the issue of end-of-life of experiences in Quebec since the care for several years, Quebec society coming into force of the ARELC and declared itself in favour of medical across Canada since the adoption of aid in dying under certain conditions the Criminal Code, to strengthen the and created a legal framework for foundation established in 2015. the practice. The Act to amend the Criminal Code and to make related The clinical standards will need to be amendments to other Acts (medical adapted again and will have to change assistance in dying) amends the over time. Criminal Code to allow medical aid in dying under certain conditions, To improve practices, it is imperative compatible to some extent with those that the physicians and other health prescribed by Quebec law. or social services professionals concerned continue to follow these The Act respecting end-of-life care standards rigorously and that they stipulates that the clinical standards share their experiences, in particular developed by professional orders by means of the notices provided for must be respected. This is why by law. the CMQ, the OPQ, the OIIQ, the OTSTCFQ, the Barreau du Québec and Once again, the CMQ is committed, the Chambre des notaires du Québec with its partners, to updating these worked closely together to define and practice and pharmacological clarify them. guidelines regularly based on the information that will be collected with They consulted the people and other the collaboration of health or social organizations concerned to produce services professionals. and revise this document. It is largely based on European experiences which they adapted to Quebec’s context: to its legislation, its health and social services system and the medications available in the province. It is also based on the first months MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 62

— Appendices

APPENDIX I – TYPES OF END-OF-LIFE TRAJECTORIES

Authors have studied end-of-life trajectories in cohorts of people followed for several years and classified them into four theoretical trajectories based on the evolution of functional impairment over time. Their main objective was to try to optimize care planning and organization (and palliative care in particular) based on the needs of end-of-life patients. In addition to the sudden acciden- tal death trajectory, they described three types of end-of-life trajectories: one of these mainly concerns people with incurable cancer. The disease can progress over a few years, but the terminal phase of the trajectory is usually fairly predictable and lasts a few months. Another type of trajectory, often seen in people with fatal chronic circulatory and respiratory diseases, is characterized by a gradual decline, over 2 to 5 years, punctuated by episodes of acute dete- rioration and some recovery, with sudden and unexpected death sometimes. The last type of trajectory, typical of frail elderly people or people with dementia, is characterized by a gradual, prolonged decline that is quite variable, up to 6 to 8 years (Lunney, 2003; Murray, 2005; INSPQ, 2006). MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 63

APPENDIX I – TYPES OF END-OF-LIFE TRAJECTORIES (CONT.)

SHORT PERIOD OF EVIDENT DECLINE

HIGH

Mostly cancer FUNCTION Death

LOW Onset of incurable cancer Often a few years, but decline usually over a few months TIME •

LONG-TERM LIMITATIONS WITH INTERMITTENT SERIOUS EPISODES

HIGH

Mostly heart and lung failure FUNCTION Death

LOW Sometimes emergency hospital admissions 2-5 years, but death usually seems “sudden” TIME •

PROLONGED DWINDLING

HIGH

Mostly frail elderly people and people FUNCTION with dementia Death

LOW Onset could be deficits in functional Quite variable – up to 6-8 years capacity, speech, cognition TIME •

Source: INSPQ, 2006, adapted from Murray, 2005. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 64

— Appendices

APPENDIX II – EXPLORING PSYCHOLOGICAL SUFFERING 57

Suffering results from the meaning a person gives his experience of a particular situation depending on his values, roles, relationships and life course. Can it be evaluated and characterized? Where appropriate, why and how should we explore the suffering of a person requesting medical aid in dying (MAID)?

1. CAN WE EXPLORE ANOTHER PERSON’S SUFFERING?

By definition, suffering is comprehensive, multidimensional and indivisible. It is essentially subjective without being entirely private. Other people can have partial access to it using an intersubjective approach. Indeed, we are generally aware that a person is suffering when we have a relationship with them, even if they do not say so explicitly. Nevertheless, it is difficult to access suffering objectively: one person’s suffering is not the same as that of another person who has the same condition; and the perception of another person’s suffering can vary depending on the observer. Thus the physician’s task is better understood as an exploration of the person’s suffering, rather than an evaluation.

That said, why and, most importantly, how should we explore the suffering of a person requesting MAID?

2. WHY SHOULD WE EXPLORE THE SUFFERING OF A PERSON REQUESTING MAID?

A. TO RECOGNIZE AND RELIEVE IT

While the majority of people with a terminal disease will face the end of life without support, others will experience temporary moments of distress, in particular during the transition from curative treatment to palliative care, or persistent psychological suffering, even psychiatric symptoms or disorders such as delirium (80%), anxiety (10 to 30%) or depression (5 to 26% of people at the end of life, 8 to 47% of patients suffering from a serious and incurable illness who wish to see their death hastened). Persistent psychological suffering may be psychological, social, existential or spiritual. Existential distress is not fre- quent. It can be associated with poor quality of life, depression or anxiety, as well as a wish for a hastened death.

A request for MAID can be distinguished clinically from suicidal ideation, although sometimes a patient may present with both. Suicidal ideation can be expressed as a request for MAID in a patient who has a mental illness. The level

57 This appendix was taken from the document written by Dr. Mona Gupta et al., 2017, Exploring the psychological suffering of a person requesting medical assistance in dying. The reader is strongly encouraged to consult it. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 65

APPENDIX II – EXPLORING PSYCHOLOGICAL SUFFERING (CONT.) of risk must be rigorously evaluated and protective measures put in place if necessary. Suicidal ideation or threats can also be a means to negotiate with the health care team. Suicidal ideation can also be an indication of the considered desire to die of a person who is ineligible for MAID.

The physician must be attentive to all these types of distress, whether the person is at the end of life and/or seeking aid in dying. The physician, in collaboration with the interdisciplinary team, should offer the patient any therapeutic, pharmacological, psychosocial and/or spiritual interventions likely to reduce or ease his suffering or treat any psychiatric disorders, whether the patient per- sists in his request for MAID or not.

B. BECAUSE IT IS REQUIRED BY LAW

The law requires that two independent physicians determine whether a person requesting MAID fulfils the criteria, including the requirement that the person has to experience constant and unbearable physical or psychological suffering that cannot be relieved in a manner the person deems tolerable. Physicians are not only responsible for confirming the patient’s alleged suffering, but also for determining its nature and ensuring that, to meet the objectives of the legislation, it is coherent with its foundations.58

3. HOW SHOULD WE EXPLORE THE PSYCHOLOGICAL SUFFERING OF A PERSON REQUESTING MAID?

The physician must always take the time to carry out a complete assessment of the clinical situation of the person requesting MAID, in collaboration with the interdisciplinary team, if possible, and without getting carried away by a feeling of urgency that is quite understandable but possibly harmful.

A physician who is aware of his own values and attitudes with respect to suffering, end of life and death is less likely to be influenced by his assumptions and to project his preferences onto a patient’s experience.

First and foremost, exploring a person’s psychological suffering requires active listening and a knowledge of his history. Talking with a patient at the end of life about his preferences or his understanding of death does not usually increase his distress, quite the opposite. The perceptions of loved ones and members of the interdisciplinary team can also be valuable.

58 This refers to the approach to health care that underlies Quebec’s legislation and to the express requirement of the Criminal Code that a causal relationship be established between the person’s illness, disease or disability or the advanced state of irreversible decline in capability and the suffering they are experiencing. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 66

APPENDIX II – EXPLORING PSYCHOLOGICAL SUFFERING (CONT.)

In the presence of a person who is experiencing psychological suffering, the physician should: ›› Take the time to carry out a complete assessment of his mental state. ›› Explore the reasons behind his request, his values, preferences, end-of-life care options and his psychosocial or spiritual needs. ›› Review what has been tried to alleviate his suffering and offer untried interventions, including interventions provided by another physician or health professional or by psychosocial and spiritual services. ›› Evaluate whether suffering affects his capacity to consent to care.

In certain complex situations or ones that require more in-depth assessment, the physician may consult a psychiatrist in order to: ›› Ensure that the patient is capable of consenting to care and to MAID in particular. ›› Evaluate the patient’s mental state and/or advise the health care team on certain types of interventions to offer. ›› Assess the suicide risk and the need for protective measures. ›› Assist, in collaboration with the health care team, in resolving an impasse in the relationship between the patient, his family and his health care providers.

In conclusion, exploring the suffering of a person requesting MAID requires both particular expertise and the time to do it properly. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 67

— Appendices

APPENDIX III – DECISION TREE

CAPACITY TO CONSENT TO CARE IN A PERSON OF FULL AGE WHO REQUESTS MEDICAL AID IN DYING

Clinical assessment of incapacity Capable of consenting to No care? Possible consultation with other professionals

Medical aid in dying Yes (MAID) is NOT an option

Advance medical directives?

Yes

Proxy Patient’s consent decision

MAID may be an option

Reassess care

Next page MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 68

APPENDIX III – DECISION TREE (CONT.)

CLINICAL INDICATIONS FOR MAID FOR A PERSON OF FULL AGE WHO IS CAPABLE OF GIVING CONSENT TO CARE

Assess suffering

Constant and unbearable No Possible consultation with suffering?* other professionals

Yes Assess the prognosis of survival

Patient at the No end of life?* Possible consultation with other professionals

Yes Establish a diagnosis

Serious, incurable illness and advanced state of No Possible consultation with irreversible decline in other professionals capability?*

Yes

MAID is NOT an option Discussion about all end-of-life care options

MAID is still Reassess care an option

*No order of priority. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 69

APPENDIX III – DECISION TREE (CONT.)

FOLLOW-UP OF A REQUEST FOR MAID DEEMED ELIGIBLE

Request for MAID deemed eligible

No Conscientious Discussion with the patient objection by the physician?

Discussion with the family, if the patient so wishes

Yes Discussion with the The request is interdisciplinary team made in a free and Notify the competent informed manner?* authorities

Seek consensus The physician is ultimately the only person responsible Yes for the decision Other willing physician

Opinion of a second Persistence independent physician of suffering?* No

Review of the record, patient examination Yes

MAID is not an option No No Wish to obtain Confirmation MAID remains that the criteria have unchanged?* been met? Decision NOT to ADMINISTER MAID

Yes Yes

MAID is still an option

Decision to ADMINISTER MAID

*No order of priority. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 70

— Appendices

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED

INTRODUCTORY NOTE

In most instances, the information presented is different from that provided in other situations or clinical protocols and, consequently, cannot be transposed to these other contexts.

The Collège des médecins du Québec, the Ordre des pharmaciens du Québec, the Ordre des infirmières et infirmiers du Québec and the experts consulted provide this information as clinical standards. They made sure the information in the document was accurate at the time of publication. However, the physician is responsible for verifying that the information is adapted to the clinical situation in question and is not out of date.

The following indications are provided as an example based on the coma- inducing agent used and with a neuromuscular blocker (in this case, rocuronium), one of the two recommended in these guidelines. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 71

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

1. COMA-INDUCING AGENT = PROPOFOL

A. MEDICATIONS

Table 13 Medications for IV administration – Propofol

ROUTE AND DURATION MEDICATION DOSAGE OF ADMINISTRATION

Midazolam 5 to 10 mg to be titrated Slow direct IV injection, over 2 minutes 1 mg/mL based on patient response (10 mL)

Parenteral lidocaine 2% 40 mg Direct IV injection, over 30 seconds without epinephrine (2 mL) 20 mg/mL

Propofol 1000 mg Slow direct IV injection, over 5 minutes 10 mg/mL (2 x 50 mL)

NaCl 0.9% 4 x 10 mL Direct IV injection, to flush the syringe and/or tubing

Rocuronium bromide 200 mg Rapid direct IV injection, over 30 10 mg/mL (20 mL) seconds

IV: intravenous.

B. MATERIAL

Table 14 Material for IV administration of medications – Propofol

QUANTITY MATERIAL INDICATION

1 20 G infusion catheter Venous line placement

1 Short extension If using an intermittent venous access device

2 10 x 10 cm gauze pads Venous line placement

Sterile transparent occlusive Venous line placement 2 dressings

1 Transparent adhesive tape Venous line placement

3 Antiseptic swabs Venous line placement MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 72

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

C. SECOND KIT

The second kit, which may be useful in the event of damage or improper handling, must be systematically prepared and sealed by the pharmacist and given to the physician. It must contain the same set of medications and material prescribed by the physician as the original kit.

D. SPECIAL PRECAUTIONS

(1) Storage Propofol is an oil-in-water emulsion, a medium that can be conducive to microbial growth. The product’s organoleptic properties (colour, consist- ency, no agglomerates or undissolved emulsion in the container) should be inspected before handling, and the vial or syringe shaken before use. Propofol can be stored in a syringe at room temperature for 24 hours. It should not be refrigerated. Rocuronium can be stored in a syringe at room temperature for 48 hours.

(2) Adverse effects (a) Pain Injection with propofol is painful for most people. It is advisable to inform the patient and anyone present of this when MAID is administered. Pain can be reduced by giving the injection in an antebrachial vein, in the elbow crease, or a large vein (including the veins in the lower limbs) and by the pre-administration of 2 mL of parenteral lidocaine 2% without epinephrine. (b) Allergy While the risk of allergy to propofol must be taken into consideration in a preoperative anesthetic assessment, it is not indicated for the administration of medical aid in dying. However, if there is a known allergy to propofol, a different medication, such as phenobarbital, will have to be used to induce coma. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 73

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

(3) Loss of venous access Loss of venous access is a possible complication and must be given serious thought: a second potential site, either peripheral or central, depending on the patient’s venous capital, must be identified in advance and, where applicable, provision made for the necessary material and a nurse’s or anesthesiologist’s assistance.

E. ADMINISTRATION PROCEDURE

(1) The day before Check in advance (within 24 hours) that venous access is possible and insert a venous line within 4 hours (maximum) prior to administration of MAID.

(2) Check each kit Each kit must contain: ›› 1 syringe of midazolam; ›› 1 syringe of parenteral lidocaine without epinephrine; ›› 2 x 2 syringes of propofol;59 ›› 4 syringes containing 10 mL of NaCl 0.9% that will be used to assess catheter patency and to flush the needle and tubing after injecting the propofol, then after injecting the rocuronium; ›› 1 syringe of rocuronium.

(3) Administration ›› Inform the patient and anyone present that the injection might be painful and that there is a risk of losing venous access; ›› Inject 10 mL of NaCl 0.9% and make sure the catheter is inserted correctly and is patent; ›› Inject 5 mg (5 mL) of midazolam over 2 minutes to obtain anxiolysis; titrate up to 10 mg (10 mL) based on patient response;

59 The protocol provides for the injection of 100 mL of propofol (2 x 50 mL syringes). However, if this is not enough to induce a deep coma, the dose must be increased. Hence the need for 4 x 50 mL syringes per kit. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 74

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

›› Inject 2 mL of parenteral lidocaine without epinephrine over 30 seconds; ›› Inject the propofol over 5 minutes (2.5 minutes per syringe); ›› Flush the injection device with 10 mL of NaCl 0.9%; ›› Carefully check that coma is confirmed; at the slightest doubt, continue coma induction by increasing the dose of propofol; ›› Where appropriate, flush the injection device again with 10 mL of NaCl 0.9%; ›› Then inject a bolus of rocuronium immediately, over 30 seconds; ›› Flush the injection device with 10 mL of NaCl 0.9%.

2. COMA-INDUCING AGENT = PHENOBARBITAL

A. MEDICATIONS

Table 15 Medications for IV administration – Phenobarbital

ROUTE AND DURATION MEDICATION DOSAGE OF ADMINISTRATION

Midazolam 5 to 10 mg to be titrated Slow direct IV injection, 1 mg/mL based on patient response over 2 minutes (10 mL)

Parenteral lidocaine 2% 40 mg Direct IV injection, without epinephrine (2 mL) over 30 seconds 20 mg/mL

Phenobarbital 3000 mg Slow direct IV injection, 120 mg/mL (25 mL) over 5 minutes (complete ad 50 mL with NaCl 0.9%)

NaCl 0.9% 4 x 10 mL Direct IV injection, to flush the syringe and/or tubing

Rocuronium bromide 200 mg Rapid direct IV injection, 10 mg/mL (20 mL) over 30 seconds

IV: intravenous. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 75

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

B. MATERIAL

Table 16 Material for IV administration of medications – Phenobarbital

QUANTITY MATERIAL INDICATION

1 20 G infusion catheter Venous line placement 1 Short extension If using an intermittent venous access device

2 10 x 10 cm gauze pads Venous line placement 2 Sterile transparent occlusive Venous line placement dressings

1 Transparent adhesive tape Venous line placement 3 Antiseptic swabs Venous line placement

C. SECOND KIT

The second kit, which may be useful in the event of damage or improper handling, must be systematically prepared and sealed by the pharmacist and given to the physician. It must contain the same set of medications and material prescribed by the physician as the original kit.

D. SPECIAL PRECAUTIONS

(1) Storage The phenobarbital solution can be stored in a syringe at room temperature for 24 hours. Rocuronium can be stored in a syringe at room temperature for 48 hours. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 76

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

(2) Adverse effects Injection with phenobarbital is painful. It is advisable to inform the patient and anyone present of this when MAID is administered. Pain can be reduced by giving the injection in an antebrachial vein, in the elbow crease, or a large vein (including the veins in the lower limbs) and by the pre-administration of 2 mL of parenteral lidocaine 2% without epinephrine.

(3) Risk of precipitation The infusion catheter must be flushed with 10 mL of NaCl 0.9% after injecting the phenobarbital to prevent it from forming a precipitate with the rocuronium.

(4) Loss of venous access Loss of venous access is a possible complication and must be given serious thought: a second potential site, either peripheral or central, depending on the patient’s venous capital, must be identified in advance and, where applicable, provision made for the necessary material and a nurse’s or anesthesiologist’s assistance.

E. ADMINISTRATION PROCEDURE

(1) The day before Check in advance (within 24 hours) that venous access is possible and insert a venous line within 4 hours (maximum) prior to administration of MAID.

(2) Check each kit Each kit must contain: ›› 1 syringe of midazolam; ›› 1 syringe of parenteral lidocaine without epinephrine; ›› 2 x 1 syringe of phenobarbital;60

60 The protocol provides for the injection of 25 mL of phenobarbital (1 x 50 mL syringe of phenobarbital and NaCl 0.9%). However, if this is not enough to induce a deep coma, the dose must be increased. Hence the need for 2 x 50 mL syringes per kit. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 77

APPENDIX IV – INTRAVENOUS ADMINISTRATION OF MEDICATIONS BASED ON THE COMA-INDUCING AGENT USED (CONT.)

›› 4 syringes containing 10 mL of NaCl 0.9% that will be used to assess catheter patency and to flush the needle and tubing after injecting the phenobarbital, then after injecting the rocuronium; ›› 1 syringe of rocuronium.

(3) Administration ›› Inform the patient and anyone present that the injection might be painful; ›› Inject 10 mL of NaCl 0.9% and make sure the catheter is inserted correctly and is patent; ›› Inject 5 mg (5 mL) of midazolam over 2 minutes to obtain anxiolysis; titrate up to 10 mg (10 mL) based on patient response; ›› Inject 2 mL of parenteral lidocaine without epinephrine over 30 seconds; ›› Inject the phenobarbital slowly, over 5 minutes; ›› Flush the injection device with 10 mL of NaCl 0.9%; ›› Carefully check that coma is confirmed. Note that the onset of action of IV phenobarbital is 5 minutes and that the peak action in the central nerv- ous system occurs 15 to 20 minutes after the peak plasma concentration (which occurs after 30 minutes); at the slightest doubt, continue coma induction by increasing the dose of phenobarbital; ›› Where appropriate, flush the injection device again with 10 mL of NaCl 0.9%; ›› Then inject a bolus of rocuronium immediately, over 30 seconds; ›› Flush the injection device with 10 mL of NaCl 0.9%. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 78

— Appendices

APPENDIX V – MEDICAL PRESCRIPTION

The dynamic version of the preprinted prescription can be accessed in the secure section of the CMQ and OPQ websites.

MEDICAL PRESCRIPTION - MEDICAL AID IN DYING

Scheduled date and time Name: of administration: RAMQ no.: Record no.: Telephone: Adress: Note: Medications must be ready to use Known severe allergies: without any further handling. They must be placed in 2 identical kits.

ANXIOLYSISEXAMPLE

Benzodiazepine Total quantity Dosage Notes Physician’s (to be divided initials between 2 kits)

Midazolam 2 x 10 mg 5 to 10 mg (5 to 10 mL) To be titrated 1 mg/mL (10 mL) IV over 2 minutes based on pain a syringe tient response

COMA INDUCTION

Select ONE local anesthetic:

Local Total quantity Dosage Notes Physician’s anesthetic (to be divided initials between 2 kits)

Lidocaine 2 x 40 mg 40 mg (2 mL) 1st line without (2 mL) IV over 30 seconds epinephrine in a syringe 20 mg/mL

Magnesium 2 x 1000 mg 1000 mg (2 mL) 2nd line, sulfate (2 mL) (complete ad 10 mL if allergy to 500 mg/mL in a syringe with NaCl 0.9%) by lidocaine slow IV injection (5 minutes) MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 79

APPENDIX V – MEDICAL PRESCRIPTION (CONT.)

Select ONE coma-inducing agent:

Coma- Total quantity Dosage Notes Physician’s inducing (to be divided initials agent between 2 kits)

Propofol 2 x 4 x 500 mg 1000 mg (100 mL) 1st line 10 mg/mL (50 mL) by slow IV injection in a syringe (5 minutes) Shake before use Use 2 syringes contain- Do not ing 500 mg (50 mL) refrigerate

If any doubt about Second dose in coma induction, in- each kit, if any crease the dose doubt about coma induction

Phenobarbital 2 x 2 x 3000 mg 3000 mg (25 mL) 2nd line 120 mg/mL (25 mL) (complete ad 50 mL (25 x 1 mL) EXAMPLEin a syringe with NaCl 0.9%) by Second dose in slow IV injection over each kit, if any 5 minutes doubt about coma induction If any doubt about coma induction, increase the dose

NEUROMUSCULAR BLOCKER INJECTION

Select ONE neuromuscular blocker:

Neuromuscular Total quantity Dosage Notes Physician’s blocker (to be divided initials between 2 kits)

Cisatracurium 2 x 30 mg 30 mg (15 mL) Physician’s besylate (15 mL) by rapid IV choice 2 mg/mL in a syringe

Rocuronium 2 x 200 mg 200 mg (20 mL) Physician’s bromide (20 mL) by rapid IV choice 10 mg/mL in a syringe MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 80

APPENDIX V – MEDICAL PRESCRIPTION (CONT.)

FLUSH THE INJECTION DEVICE before starting the protocol, after administering the coma-inducing agent and after injecting the neuromuscular blocker

Saline Total quantity Dosage Notes Physician’s solution (to be divided initials between 2 kits)

NaCl 0.9% 2 x 4 x 10 mL 1 x 10 mL IV to assess in a syringe catheter patency

2 x 10 mL IV after injecting the coma- inducing agent

1 x 10 mL IV after injecting the neuromuscular blocker

VENOUS LINE PLACEMENT

As needed, selectEXAMPLE the required material:

Total quantity Material Indication Physician’s (to be divided initials between 2 kits) 2 x 3 Antiseptic swabs Skin disinfection 2 x 2 10 x 10 cm gauze pads 2 x 1 18 G short catheter 2 x 2 20 G short catheters 2 x 1 22 G short catheter If difficulty in- serting a larger gauge catheter 2 x 1 Short extension If using an intermittent venous access device 2 x 2 Intermittent venous access devices 2 x 2 Sterile transparent occlusive dressings 2 x 1 Adhesive tape 2 x 15 Syringes with 1-inch 18 G needles MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 81

APPENDIX V – MEDICAL PRESCRIPTION (CONT.)

The medications and material61 must be provided in two identical sealed kits. The material must be compatible with the material used in the patient’s health care setting.

Each medication must be prepared in accordance with Norme 2014.01 – Prépara- tion de produits stériles non dangereux en pharmacie [Standard 2014.01 – Prepa- ration of non-hazardous sterile products in pharmacies] and each syringe must be labelled in accordance with the Regulation respecting the labelling of medications and poisons. Each syringe must also be identified with the patient’s name and health insurance number (RAMQ number); it must be ready to use and numbered in the prescribed order of administration.

Physician’s name: Permit no.: Place of practice: Mailing address: Telephone no.:EXAMPLE Signature: Date:

NOTE FOR THE PHYSICIAN: If the patient gives his consent, attach a copy of the signed medical aid in dying request form. Complete the medical aid in dying medication administration record with the pharmacist. Return any unused medication or material as well as any packaging and empty syringes to the pharmacy once the medications have been administered.

61 See the list of material required in Appendix VIII. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 82

— Appendices

APPENDIX TO THE PRESCRIPTION – GENERIC AND BRAND NAMES OF MEDICATIONS – FOR INFORMATION

GENERIC NAME BRAND NAME*

Benzodiazepine

Midazolam Midazolam® SDZ, Midazolam PPC

General anesthetic

Propofol Diprivan®, PMS-Propofol

Barbiturate

Phenobarbital Phenobarbital sodium injection Sandoz

Neuromuscular blockers

Cisatracurium (besylate) Cisatracurium Omega, Cisatracurium Mylan, Nimbex®

Rocuronium (bromide) Rocuronium bromide Hospira or Omega, Rocuronium injection Sandoz, Zemuron®

Other

Lidocaine without epinephrine Xylocaine® 2% without epinephrine polyamp (AstraZeneca)

Magnesium sulfate Magnesium sulfate vial 500 mg/mL (Fresenius Kabi formerly PPC)

*This list of brand names may not be exhaustive. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 83

— Appendices

APPENDIX VI – MEDICATION PREPARATION PROTOCOL

Table 17 Medication preparation protocol

MEDICATION MATERIAL PREPARATION QUANTITY PHYSICAL AND COMMENTS Final concentration REQUIRED PROTOCOL FOR FOR 2 KITS CHEMICAL EACH KIT STABILITY AT ROOM TEMPERATURE62

Midazolam 2 vials of Withdraw 10 mL 2 syringes 4 weeks 10 mg/10 mL midazolam (10 mg) of containing protected from In a 10 mL 1 mg/mL, 10 mL midazolam 10 mL each light syringe 1 mg/mL Polypropylene (1 syringe per IV syringes kit)

Injectable Injectable lido- Withdraw 2 syringes 90 days lidocaine caine 2% 2 mL (40 mg) containing 2% without without of lidocaine 2 mL each epinephrine epinephrine 2% without 40 mg/2 mL epinephrine (1 syringe per In a 3 mL Differents sizes kit) syringe available

IV Polypropylene over syringes 30 seconds

Magnesium 1 vial of Withdraw 2 mL 2 syringes 48 hours In the absence sulfate magnesium (1000 mg) of containing (extrapolated of data, empir- 1000 mg/10 mL 500 mg/mL, magnesium sul- 10 mL each value) ical stability In a 10 mL 10 mL, fate 500 mg/mL of 48 hours at syringe NaCl 0.9% and complete (1 syringe per room temper- ad 10 mL with kit) ature is pro- IV NaCl 0.9% posed.63

62 Exceptionally, given the special context of MAID and the intended use of the preparations, the expiry date (microbiological stability) is not a consideration. 63 Taken from stability data for magnesium 1000 mg/2 mL in a syringe mixed with another medication (e.g., metoclopramide) at room temperature. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 84

APPENDIX VI – MEDICATION PREPARATION PROTOCOL (CONT.)

MEDICATION MATERIAL PREPARATION QUANTITY PHYSICAL AND COMMENTS Final concentration REQUIRED PROTOCOL FOR FOR 2 KITS CHEMICAL EACH KIT STABILITY AT ROOM TEMPERATURE62

Propofol 4 vials of Withdraw 50 mL 8 syringes 24 hours IMPORTANT 1000 mg/100 mL propofol (500 mg) containing (extrapolated Oil-in-water In a 60 mL 10 mg/mL, of propofol 50 mL each value) emulsion pro- syringe 100 mL 10 mg/mL motes rapid (4 syringes per microbial IV over 5 minutes Polypropylene kit) growth (within syringes hours).

The duration of stability may be longer depending on the formula- tion used.64

Phenobarbital 100 ampoules Withdraw 25 mL 4 syringes 24 hours Empirical sta- 3000 mg/50 mL of (3000 mg) of containing (extrapolated bility of 48 In a 60 mL phenobarbital phenobarbital 50 mL each value) hours at room syringe 120 mg/mL, 120 mg/mL and temperature 1 mL complete ad (2 syringes per is proposed IV over 5 NaCl 0.9% 50 mL with NaCl kit) based on minutes 0.9% stability data for syringes and infusions in sometimes unspecified conditions (references dating from the 1960s).

Cisatracurium 3 vials of Withdraw 15 mL 2 syringes 30 days Similar stability besylate cisatracurium (30 mg) of containing 15 if protected 30 mg/15 mL besylate cisatracurium mL each from light or In a 20 mL 2 mg/mL, 10 mL besylate exposed to syringe (1 syringe per fluorescent Plastic syringes kit) light. Rapid IV

64 In particular depending on the antioxidant (EDTA or sodium metabisulfite). MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 85

APPENDIX VI – MEDICATION PREPARATION PROTOCOL (CONT.)

MEDICATION MATERIAL PREPARATION QUANTITY PHYSICAL AND COMMENTS Final concentration REQUIRED PROTOCOL FOR FOR 2 KITS CHEMICAL EACH KIT STABILITY AT ROOM TEMPERATURE62

Rocuronium 8 vials of Withdraw 2 syringes 48 hours In the absence bromide rocuronium 20 mL (200 mg) containing (extrapolated of data, empir- 200 mg/20 mL bromide of rocuronium 20 mL each value) ical stability In a 20 mL 10 mg/mL, bromide of 48 hours at syringe 5 mL (1 syringe per room temper- kit) ature is pro- Rapid IV posed.

NaCl 0.9% 8 commercially 8 syringes Manufacturer’s Where pos- available containing expiry date sible, use syringes 10 mL each commercially containing available pre- 10 mL of (4 syringes per filled syringes. NaCl 0.9% kit) MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 86

— Appendices

APPENDIX VII – MEDICATION ADMINISTRATION RECORD

The dynamic version of the preprinted record can be accessed in the secure section of the CMQ and OPQ websites.

Using the physician’s prescription, the pharmacist prepares the MAID medication administration record. Therefore, it is specific to each patient. It is included with both kits. It must be systematically initialed: ›› by both when the pharmacist gives the kits to the physician and after they have checked the contents together; ›› by the physician when he administers medical aid in dying, or just after doing so; ›› by the physician and the pharmacist when unused medications are returned to the pharmacy; ›› and, lastly, by the professionals (physicians or pharmacists depending on the policies and procedures in effect in the institution) once any partially used or unused products have been destroyed.

The medication administration record must be entered in the patient’s medication record65 once the procedure has been completed.

The information entered in the boxes in Table 18 is provided as an example.

65 The medication administration record does not have to be entered in the patient’s medical record. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 87

APPENDIX VII – MEDICATION ADMINISTRATION RECORD (CONT.)

Table 18 MAID medication administration record

Patient Physician Pharmacist Name: Name: Name: RAMQ no.: Permit no.: Permit no.: Record no.: Contact information: Contact information: Date of death:

KIT NO. 1 – Medications Prescription Kit (seal no.) Medication Dosage Given to the physician Injected Returned to the pharmacy Destroyed no. Date: Date: Date: Date: Date: Name Strength Total vol. MD* Phm.* Vol. MD* Vol. MD* Phm.* Vol. MD/Phm.* Phm.*

KIT NO. 1 Anxiolysis - Benzodiazepine 5 to 10 mg 111-221 32485 Midazolam 1 mg/mL 10 mL 5 mL 5 mL 5 mL to be titrated Local anesthetic (1/kit)EXAMPLE Lidocaine 2% 111-225 32485 (without 20 mg/mL 40 mg 2 mL 2 mL 0 0 epinephrine) Magnesium 500 mg/ 1000 mg 10 mL sulfate diluted mL

Coma-inducing agent (1/kit) 111-224 32485 Propofol 10 mg/mL 4 x 500 mg 4 x 50 mL 2 x 50 mL 2 x 50 mL 2 x 50 mL Phenobarbital 120 mg/mL 2 x 3000 mg 2 x 50 mL diluted

Neuromuscular blocker (1/kit) Cisatracurium 2 mg/mL 30 mg 15 mL 111-222 32485 Rocuronium 10 mg/mL 200 mg 20 mL 20 mL 0 0

To flush the syringe 111-223 32485 NaCl 0.9% 4 x 10 mL 4 x 10 mL 4 x 10 mL 0 0

* Initials. Vol.: volume (mL).

Document must be entered in the medication record. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 88

APPENDIX VII – MEDICATION ADMINISTRATION RECORD (CONT.)

Patient Physician Pharmacist Name: Name: Name: RAMQ no.: Permit no.: Permit no.: Record no.: Contact information: Contact information: Date of death:

KIT NO. 1 - Material

Prescription no. Kit (seal no.) Material Given to the physician Returned to the pharmacy Destroyed**

Date: Date: Date:

KIT NO. 1 Qty MD* Phm.* Qty MD* Phm.* Qty MD/Phm.* Phm.*

111-226 32485 Swabs for skin disinfection 3

111-227 32485 20 G short catheters 2

111-228 32485 22 G short catheter 1

111-229 32485 Short extension 1

111-230 32485 Intermittent venous access devices 2 111-231 32485 EXAMPLESterile transparent occlusive dressings 2 111-232 32485 Adhesive tape 1

111-233 32485 10 x 10 cm gauze pads 2

* Initials. ** Unused material can be recycled. Qty: quantity.

Document must be entered in the medication record. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 89

APPENDIX VII – MEDICATION ADMINISTRATION RECORD (CONT.)

Patient Physician Pharmacist Name: Name: Name: RAMQ no.: Permit no.: Permit no.: Record no.: Contact information: Contact information: Date of death:

KIT NO. 2 - Medications Prescription Kit (seal no.) Medication Dosage Given to the physician Injected Returned to the pharmacy Destroyed no. Date: Date: Date: Date: Date: Name Strength Total vol. MD* Phm.* Vol. MD* Vol. MD* Phm.* Vol. MD/Phm.* Phm.*

KIT NO. 2 Anxiolysis - Benzodiazepine 5 to 10 mg 111-221 32486 Midazolam 1 mg/mL 10 mL 0 10 mL 10 mL to be titrated

Local anesthetic (1/kit) Lidocaine 2% 111-225 32486 (without 20 mg/mL 40 mg 2 mL 0 2 mL 2 mL epinephrine)EXAMPLE Magnesium 500 mg/ 1000 mg 10 mL sulfate diluted mL

Coma-inducing agent (1/kit) 111-224 32486 Propofol 10 mg/mL 4 x 500 mg 4 x 50 mL 0 4 x 50 mL 4 x 50 mL Phenobarbital 120 mg/mL 2 x 3000 mg 2 x 50 mL diluted

Neuromuscular blocker (1/kit) Cisatracurium 2 mg/mL 30 mg 15 mL 111-222 32486 Rocuronium 10 mg/mL 200 mg 20 mL 0 20 mL 20 mL

To flush the syringe 111-223 32486 NaCl 0.9% 4 x 10 mL 4 x 10 mL 0 4 x 10 mL 4 x 10 mL

* Initials. Vol.: volume (mL).

Document must be entered in the medication record. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 90

APPENDIX VII – MEDICATION ADMINISTRATION RECORD (CONT.)

Patient Physician Pharmacist Name: Name: Name: RAMQ no.: Permit no.: Permit no.: Record no.: Contact information: Contact information: Date of death:

KIT NO. 2 - Material

Prescription no. Kit (seal no.) Material Given to the physician Returned to the pharmacy Destroyed**

Date: Date: Date:

KIT NO. 2 Qty MD* Phm.* Qty MD* Phm.* Qty MD/Phm.* Pharm.*

111-226 32486 Swabs for skin disinfection 3

111-227 32486 20 G short catheters 2

111-228 32486 22 G short catheter 1

111-229 32486 Short extension 1

111-230 32486 Intermittent venous access devices 2 111-231 32486 EXAMPLESterile transparent occlusive dressings 2 111-232 32486 Adhesive tape 1

111-233 32486 10 x 10 cm gauze pads 2

* Initials. ** Unused material can be recycled. Qty: quantity.

Document must be entered in the medication record. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 91

— Appendices

APPENDIX VIII – LIST OF MATERIAL REQUIRED

Table 19 List of material required

VENOUS LINE PLACEMENT PRIOR TO ADMINISTRATION OF MEDICAL AID IN DYING – MATERIAL NOT SUPPLIED – ENSURE MATERIAL IS COMPATIBLE WITH THE MATERIAL SUPPLIED IN THE KITS

Quantity Material Indication

Swabs for skin 3 disinfection

10 x 10 cm 2 gauze pads

20 G short catheters (18 to 22 G depending 4 on the patient’s venous potential) 1 Short extension

Intermittent venous 2 access devices

Bottle or vial of To flush the vein to assess competence 1 NaCl 0.9% and patency

Syringe To flush the vein by preinjecting with NaCl 1 0.9% to assess competence and patency

Sterile transparent 2 occlusive dressings 1 Adhesive tape

ADMINISTRATION OF MEDICAL AID IN DYING – MATERIAL SYSTEMATICALLY SUPPLIED IN THE KITS

Quantity Material Indication 2 x 10 Needles or needle-free To connect the prepared syringe to the connectors (e.g., Blunt, patient’s administration device to 15 MicroClave) 2 x 1 Short extension If using an intermittent venous access device; promotes comfort; allows more freedom of movement; facilitates injection by the physician MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 92

APPENDIX VIII – LIST OF MATERIAL REQUIRED (CONT.)

ADMINISTRATION OF MEDICAL AID IN DYING – MATERIAL SYSTEMATICALLY SUPPLIED IN THE KITS

2 x 1 10 mL syringe For benzodiazepine: midazolam 2 x 1 3 mL syringe For 2 mL of parenteral lidocaine 2% without epinephrine IV

or or or

2 x 1 10 mL syringe For 2 mL of magnesium sulfate 500 mg/mL (1000 mg) diluted ad 10 mL with NaCl 0.9% IV 2 x 4 60 mL syringes For 100 mL of propofol 10 mg/mL (1000 mg) IV

or or or

2 x 2 60 mL syringes For 25 mL of phenobarbital 120 mg/mL (3000 mg) diluted ad 50 mL with NaCl 0.9% IV 2 x 1 20 mL syringe For 15 mL of cisatracurium besylate (30 mg) IV

20 mL of rocuronium bromide (200 mg) IV 2 x 4 10 mL syringes For 4 x 10 mL of NaCl 0.9% IV MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 93

— Appendices

APPENDIX IX – CONTRAINDICATED ROUTES OF ADMINISTRATION

Table 20 Contraindicated routes of administration

MEDICATION CONTRAINDICATED ROUTES OF ADMINISTRATION

Oral Intrarectal Intramuscular Subcutaneous

Barbiturate: Variable effective- Variable Painful Painful phenobarbital ness, risk of slow effectiveness, onset and unpre- uncomfortable Variable Variable dictable duration (rectal irritation, effectiveness effectiveness of action, distress- diarrhea), ing side effects unacceptable in (vomiting, etc.) the context

Anesthetic: N/A Variable Insufficient data Insufficient data propofol effectiveness, uncomfortable, unacceptable

Neuromuscular Ineffective Ineffective Contraindicated Contraindicated blocker

Source: Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG) and Koninklijke Neder- landse Maatschappij ter bevordering der Pharmacie (KNMP), 2012.

The intravenous route is the only acceptable route of administration for MAID. If peripheral venous access is impossible, a central line must be inserted. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 94

— Appendices

APPENDIX X – CONTRAINDICATED MEDICATIONS AND SUBSTANCES

Table 21 Contraindicated medications and substances

SUBSTANCE REASONS FOR CONTRAINDICATIONS

Benzodiazepines The induction of coma by the IV administration of a benzodiazepine is too unreliable, even in high doses.

Midazolam can, however, be used as pretreatment, for anxiolysis.

Opioids If the patient has been given opioids previously, their administration, even in high doses, may not cause death.

If a patient has not been given opioids previously, a high dose can cause respiratory depression and death.

Their effect is therefore unpredictable and their use is not recommended for MAID.

Insulin The induction of a hypoglycemic coma by the IV administration of insulin is very unreliable and lengthy. The coma is agi- tated and accompanied by muscle cramps. Insulin should be avoided.

Potassium Cardiac arrest can be triggered with high doses of IV potas- chloride sium chloride (KCl), but the injection is very painful and KCl causes muscle contractions, even after the administration of a neuromuscular blocker. The administration of KCl should be avoided.

Source: Koninklijke Nederlandsche Maatschappij tot bevordering der Geneeskunst (KNMG) and Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie (KNMP), 2012. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 95

— Appendices

APPENDIX XI – 7-STEP GUIDE TO SUBMITTING A REPORT FORM

1/ Complete all three parts of the form “Declaration of administration of medical aid in dying” carefully,66 answering all the questions and using clinical arguments and recognized eligibility criteria. Note that the Commission sur les soins de fin de vie does not and must not have access to the medical record, in whole or in part. 2/ File the original copy of the form in the medical record of the person who received medical aid in dying (MAID). 3/ Remove any identifying information from the copies of the form that will be sent to the authorities by striking through or cutting out any references to the person (patient label at the top right) in all three parts. If cutting out, make sure the relevant information on the back of the patient label is kept. 4/ Put the copies of Part 3 that will be sent to the authorities in a sealed envelope. This envelope will only be opened if needed, if one of the authorities considers it necessary to contact the physician(s) concerned. 5/ Within 10 days of administering MAID, mail a legible copy of Parts 1 and 3 to the Commission sur les soins de fin de vie:

Commission sur les soins de fin de vie 2535, Laurier Boulevard, 5th Floor Quebec QC G1V 4M3

6/ Within 10 days of administering MAID, mail a legible copy of Parts 1, 2 and 3 of the form to either: ›› the institution’s council of physicians, dentists and pharmacists if the physician who administered MAID practices his profession in a centre operated by an institution; or ›› the Collège des médecins du Québec if the physician who administered MAID practices his profession in a private health facility:

For the attention of the Secretary of the Collège des médecins du Québec and Chair of the Committee on End-of-Life Care Suite 3500 1250, René-Lévesque Boulevard West Montreal QC H3B 0G2

66 The MAID administration report form made available by the minister of health and social services can be accessed: – in the secure section of the CMQ, OPQ and OIIQ websites; – on the intranet of the health and social services network. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 96

APPENDIX XI – 7-STEP GUIDE TO SUBMITTING A REPORT FORM (CONT.)

7/ Where applicable, conscientiously respond to any requests for additional information or clarifications from the Commission sur les soins de fin de vie. If a reply is not received within 10 days, the file is systematically sent to the Collège des médecins du Québec and the institution concerned as required. MAID PRACTICE AND PHARMACOLOGICAL GUIDELINES 97

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