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2/13/2018
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Medical Assistance in Dying - a short
summarypresenter : Dr. Susan Batten
Presenter Disclosure
Rural Generalist with a secondary consulting practise in Palliative Care.
Registered on the Ontario MAiD co‐ordination service
Member of the Canadian Association of MAiD Assessors and Providers (CAMAP)
No relationships with commercial interests
Here to disseminate the information provided from both educational programs and my own experiences over the past year providing MAiD in my rural community IN ONTARIO.
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Expectations of this session on MAiD
Provide an overview of statistics on MAiD Deaths in Canada
Ensure patients are provided access to high‐quality, team‐based palliative care
Understand that MAiD requires a team approach, and participate as a team when providing MAiD
Provide the technical aspects of MAiD
Fulfill legal and regulatory requirements in MAiD
Understand and reflect on the impact of MAiD on yourself (both personal and professional)
Understand the importance to evaluate competency & capacity
The Data
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Who in the World is participating
Five European Countries
The Netherlands
Belgium
Switzerland
Germany
Luxemboug
Six American States
Oregon
Washington
Vermont
Montana
California
Colorado
Columbia
Canada
Total MAiD Deaths in Ontario: 963(from June 2016-Nov. 2017), accounts for 0.9% of deaths in the province
Breakdown of Deaths
9%
13
%
14
%
64
%
0%18%35%53%70%
Other
CVD
Neuro
Cancer
962 clinician administered
1 patient administered
Increase in MAiD
deaths/monthAverage 22%
Cases with <10 waiting period
21%
• 9% loss of capacity imminent
• 3% death imminent
• 9% both
Provider Information (%)
3
3
3
7
10
10
13
51
0 15 30 45 60
Other
Oncology
Surgery
ER
Anesth.
GP
Internal
Family
50
%
50
%
Deaths by
gender
Male
Female
Patient Demographics
AgeYoungest Age to receive MAiD: 22
Average Age to receive MAiD: 73
Oldest age to receive MAiD: 104
Where MAiD occurs
40%
48%
9%3%
Hospital
Home
LTC
Retiremʹt
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MAiD Deaths in Manitoba: (from June 2016-Oct. 2017), accounts for 0.5% of deaths in the province in 2016
Breakdown of Deaths
1%
19
%
13
%
67
%
0%18%35%53%70%88%
Other
CVD
Neuro
Cancer
% with Palliative care support
• 80% on PC prior to request
• 90% on PC after request
• 90% on PC at time of MAiD
37%
63%
Deaths by gender
Male Female
Patient Demographics Where MAiD occurs
55%45%
Hospital
Home
336 people contacted the MAiD Team
• 139 written requests• 81 inquires for information only• 115 died without receiving MAiD• 68 received MAiD• 72 requests denied
• Lacked capacity (19)• Mental Illness only (16)• Natural death not reasonable foreseeable (37)
Health Canada Report of MAiD deaths (July 2016-June 2017)
Breakdown of Deaths
7%
17%
13%
63%
0% 18% 35% 53% 70%
Other
CVD
Neuro
Cancer
53%47%
Deaths by gender
Male Female
Patient Demographics Where MAiD occurs
60%
40%
Hospital
Home
Total Deaths July 2016‐June 2017: 1382
• 875 deaths 2017 (vs 507 in 2016)
• 1 self administered in 2017 (vs 4 in 2016)
• 4.3% administered by a Nurse Practitioner
• 57% urban
• 0.9% of all deaths in 2017 (vs. 0.5% in 2016)
Average Age 73
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Legal, regulatory and liability issues
AKA: what the CMPA wants you to know BEFORE you participate in MAiD (not AFTER)
Summary of Bill C-14
Eligibility:
Eligible for health services in Canada
At least 18 years of age
Voluntary request
Consent
Grievous & irremediable medical condition
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Summary of Bill C-14
Grievous and irremediable medical condition
difficult to apply in ‘real’ life the idea of when natural death becomes reasonably foreseeable
doesn’t mean terminal
doesn’t mean end of life
Isn’t everyone’s life reasonably foreseeable?
Bill C‐14 goes on to state that the criteria requires ‘a temporal but flexible connection’, and to ‘not impose any specific requirements in terms of prognosis or proximity to death.’ In addition ‘the medical condition that is causing the intolerable suffering would NOT need to be the cause…of death’. However, the ‘natural death to be foreseeable in a period of time that is not to remote’.
what this does tell us is that it can be a constellation of medical conditions
Clinical Interpretation of
‘Reasonably Foreseeable’
Clinical Practice Guideline ‐ CAMAP, June 2017
Recommendations
Clinicians should be aware that Bill C‐14 makes MAiD an end‐of‐life regime for individuals whose natural deaths are reasonable foreseeable.
As an aid, clinicians can consider interpreting “reasonably foreseeable” as meaning “reasonably predictable” form the patient’s combination of known medical conditions and potential sequelae, whilst taking other factors including age and frailty into account.
Clinicians should not employ or support rigid timeframes in their assessments of eligibility for MAiD. Bill C‐14 contains no requirement for prognosis having been made as to length of time the patient has remaining.
If a patient’s eligibility remains uncertain, clinicians should seek the advice of a more experienced MAiD provider. Access to such advice might be via personal contacts, local heath authorities or their equivalent in the clinician’s province, organizations such as the provincial college of physicians and surgeons, or national organizations such as CAMAP.
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Summary of Bill C-14
Advanced Directives:
Not appropriate for MAiD
The Patient (and ONLY the Patient) MUST expressly confirm consent immediately before receiving MAiD
However, The CMPA tells us it is important to include MAiD as an option ‐ but not provide an opinion on this choice for the patient.
The request for MAiD can only EVER come from the patient themselves.
Mental Illness : can have a mental illness (ie: depression), but cannot ask for MAiD and state the reason is a mental illness.
Summary of Bill C-14
Step 1:
Patient must request in writing : sign and dated by the patient with two independent witnesses
Independent witness: Must be at least 18y.o. and must not
know or believe that they are a beneficiary under the will of the person making the request
be an owner or operator of the facility where the patient lives or is being treated
directly provide personal care to the patient
Clinician Aid A (IN ONTARIO)
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Summary of Bill C-14
STEP 2 ‐ The First Assessor: (Clinician Aid B in Ontario)
Does the initial assessment to ensure patient qualifies to proceed & is usually the person who administers the medication (but not always).
informed that the patient always and at anytime can withdraw consent for MAiD
10 clear days (ie: 12 days) between request and MAiD ‐ reflection period is to ensure certain intent is sustained.
STEP 3 ‐ The Second Assessor (Clinician Aid C in Ontario)
Written opinion from an independent medical or nurse practitioner confirming eligibility criteria are met
independent means:
not a mentor/supervisor of the first assessor
will not be a beneficiary under this patient’s will
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
Risks associated with MAiD
Criminal:
MAiD is provided to patients who do not meet the eligibility criteria or if safeguards are not met
missing documents or documents destroyed or reporting obligations are not followed
Civil:
no protection against civil claims/complaints or disciplinary actions
CALL CMPA BEFORE if need support/advice, not AFTER
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Conscientious Objection
In weighing competing rights, the courts will typically favour the patient’s right to access
Physicians may object, but they may NOT obstruct ‐ and refusal to refer is considered obstruction.
Call CMPA if have concerns
They want you to call
them…before, not after!
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Exploring an initial inquiry to hasten
deathAKA: talk to your patient, what else has been offered, is this a cry for help, or
for death?
Care of the Dying
Completed requests are not common
Netherlands: 37‐44% of requests were actually completed
Must find out what is behind the desire, the reason, the meaning and the functions of this request.
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Who Receives MAiD?
Those who request MAiD may have ‘death anxiety’, however, those with significant anxiety tent to ask about MAiD but not complete it. For these people MAiD as an option is powerfully therapeutic
Those who receive MAiD tend to be:
Successful, Affluent, Educated, High life satisfaction, Prioritize control, and Not afraid of dying
The Reason, Meaning & Purpose of a request for
MAiD
What are the causes of Suffering for the patient requesting MAiD:
loss of dignity, fear of burden, unrelieved poor symptom control, loss of autonomy, lack of care/support
What are the personal Values that cause the patient to request MAiD: spare others
not have to wait for the end, no value left in living, end severe suffering
What is the Purpose of this request
cry for help, allow person to speak about their death, manipulation
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The question of Suffering
Enduring physical and/or psychological suffering is a Subjective experience ‐ if the patient says it is intolerable, then it is.
Questions to Assess Suffering:
Why are you requesting MAiD
How would you describe your suffering?
Have you considered______________?
Can you help me understand why you’ve decided to refuse ___________?
Do you feel there is anything we can do to help alleviate your suffering?
Desire to Hasten Death categories
Expression of despair
consider emotional distress, fear, loss of control, lack of care/support
Hypothetical exit plan
used as a ‘plan B’, allows for a back‐up plan to prepare in case of suffering
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Desire to Hasten Death categories
Manifestation of letting go
process of disengagement from life, emerges in last weeks of life
Desire for control
strong concept of not wanting to lose control or be a burden.
Responding to the request for MAiD
Acknowledge the request
Sit down, pause, and talk to your patient
expectations, fears, goals, sense of their suffering, meaning and quality of life
rule out depression
rule in capacity
offer options for end of life care
Documentation (Clinician Aid A, B & C and consultant note)
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Treatment options at end of life
Palliative care
The health discipline focused on improving the quality of life of people living with serious life‐threatening illness
relief of suffering
relief of pain and other distressing symptoms
intends neither to hasten or postpone death
using a team approach to address the needs of the patient and the family
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choices that can relieve suffering (at
end of life)…As part of the assessment it must be documented that all options were explored (other then MAiD) for this patient ‐ and indicate why they were unacceptable in the patient’s perspective.
palliative sedation therapy
adequate exploration of options for pain and suffering
withdrawing or withholding treatment
voluntary cessation of eating & drinking
Always, regardless of the patient’s choice, provide good palliative care and support
Assessing Capacity and Obtaining
Consent:AKA: where is a psychiatrist when you
need one?
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Capacity, Voluntariness and Consent in a MAiD
request
Eligibility is assessed by the physician/NP offering MAiD (Clinician Aid B) & one other physician/NP (Clinician Aid C).
Requirements for MAiD:
they are capable of making a decision with respect to their health
they have made a voluntary request
they give informed consent to receive MAiD after they have been informed of other means that are available to relieve their suffering, including palliative care.
What is Capacity?
Ability to communicate a choice
Understanding of the relevant information
Appreciation of the medical consequences of the situation
Ability to reason about treatment or intervention choices
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Capacity and MAiD in Ontario
Patient must be able to:
Understand the information relevant in deciding to consent or not consent to MAiD
Appreciate the reasonably foreseeable consequences of consenting or not consenting to MAiD
Normally a patient is presumed to be capable, however under MAiD legislation a patient must demonstrate capacity on assessment and this assessment needs to be documented.
Questions to Assess Capacity
What is your understanding of your condition?
What is your understanding of MAiD?
Aside from MAiD, what else could we do to help you?
What do you think will happen if you are able to receive MAiD?
What will happen if you don’t receive MAiD?
Why is MAiD the best option for you?
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Assessment tools
If pick up concerns can further help the assessment
Capacity NICE tool
Cognition MMSE/MOCA
Depression Beck Inventory
What is Voluntariness in MAiD
The request for MAiD is made without
Coercion or undue influences from family, friends and authority figures including health care providers
Other external pressures, economic and societal
It is suggested that both the initial request and the final consent discussion should take place in the absence of family or other support persons of the patient.
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Questions to assess Voluntariness
When did you first start thinking about MAiD?
Is anyone encouraging you to ask for MAiD?
Do you feel anyone/anything is influencing your decision to request MAiD?
Who are your supports?
Do you have any financial or other pressure to ask for MAiD?
Have you felt sad or depressed? Have you thought about taking your own life?
Informed consent for MAiD
Patient must have information about:
the nature of the medical condition and the nature of MAiD
the certainty of death upon taking the lethal medication
the potential risks associated with receiving MAiD
alternative courses of action
specifics of MAiD that will be provided (time, place, means of administration, etc.)
right to withdraw or delay their MAiD request without any negative consequences.
Consent must be obtained at the time of assessment and at the time right beforethe provision of MAiD
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Documentation
Provide a written report
Indicate whether you feel that the person has any conditions impairing their judgement regarding the decision to request MAiD
Use direct quotes from the patient (and if applicable the family and/or caregivers)
Document the nature of discussions about MAiD
Include documentation that may be relevant (MoCA, PFT, specialist consultant notes on diagnosis, etc.)
Documentation on Capacity in a MAiD
requestIf possible impairment is detected
state reasoning to determine this outcome
plan (if possible) to eliminate/improve the influence(s) causing impairment
referrals to others to provide clarity and/or interventions
Patient can be re‐assessed after interventions if requested.
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The Netherlands experience
AKA: what we can learn from those who have come before us…
The Netherlands experience
Euthanasia became legal in the NL to protect the physicians that were already practising Physician Assisted Death (PAS), but illegally.
Physicians went to the courts to lobby for legalization ‐ and it was granted.
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The NL experience
less then 4% of all deaths (5516 cases)
5277 doctor administered, 208 patient administered, 31 a combination of both
56 deaths for psychiatric reasons
109 deaths for dementia
each death is investigated by the a Euthanasia board
0.1% (4 cases in 2015) found concerns
3 cases ‐ incorrect medication used
1 case ‐multiple incorrect aspects
The NL experience
85% are patient’s own Family Doctor performs euthanasia or PAD.
72.5% the underlying disease is cancer
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Dutch criteria for eligibility
Voluntary, well‐informed request
must be competent at time of request
Advice directives (not per se)
prefer patient is competent at time of administration of medications but not absolute
Hopeless and unbearable suffering
Consultation with an independent physician (SCEN)
Must use the right medication as per guidelines
Death must be reported to the coroner
Dutch eligibility criteria
In NL they have a 24/7 organization called SCEN
SCEN: Support Consultation Euthanasia Netherlands
provide information about the procedure
available for support
can/will perform the formal consultation
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The NL experience -medications
Oral preparation:
Phenobarbital or secobarbital in a alcohol with solution to help hide the taste.
VERY bitter taste, difficult to drink, many patients can’t complete drinking the full mixture, or vomit.
Thus, NOT recommended ‐ too many issues.
IV agents (see more on this later)
We are almost done…
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Technical aspects of MAiD
AKA: finally, how do we do this the RIGHT way?
Pre-MAiD Checklist
Documentation:
ensure all appropriate documentation is in place ( Clinician Aid A, B & C, both consult notes of eligibility for MAiD, and other relevant medical documents such as other consultant notes, imaging, MoCA, etc)
MAiD prescription with an accepting pharmacy.
EDiTH & DNR‐ C if a home death (Ontario documentation)
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Pre-MAiD checklist
Prescription:
A discussion with the prescriber and the pharmacy to ensure availability of drugs and supplies, back‐up medication, plan for disposal of unused medication, etc.
IV access:
An assessment of the pt’s veins during the MAiD assessment is essential to determine if two peripheral cannulaes can be inserted, or if a PICC line will be necessary
Pre-MAiD Checklist
Implantable Cardio‐defibrillator must be de‐activated prior to MAiD procedure
Funeral Home Arrangements
Where will this happen (home, hospital, LTC, retirement home, hospice, ?hotel?)
Make the date and time, discuss who will be present, cancel cleaning staff and other planed visitors so no unexpected interruptions.
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Event Preparation
Notify pharmacy of date of the expected procedure
If in the home ‐ notify home care services of request to allow them time to prepare
Set a date with family ‐ notify support/spiritual care for support
where they will be (chair, bed), what room, who will be there, is there certain spiritual rituals that they wish to have at this time.
review with the patient (and those who will be present) the procedure, what to expect.
What is YOUR position on photography, children…
Addressing Fears and Concerns
Failure of the drugs to work
drugs themselves are 100% effective if the cannula is correctly sited
there is a full second set of back‐up IV drug supply
Failure of the IV cannula is a possibility
to reduce the risk of failure nursing to place TWO 20G or even an 18G needle the day before with a heparin lock (each at a separate limb)
but no earlier then one day before to reduce the risk of loss of access.
the patient must be informed that if IV access is lost and cannot be regained at home then admission to hospital will be necessary.
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The Day of…
Physician to pick up the double set of medication from the pharmacy ‐ it can be delivered to the home, but I prefer to pick up the medication so I can confirm it is correct.
Confirm patency of the IV access
On this day it is required that consent for MAiD is provided by the patient (and capacity is still intact).
Preparation of the patient and familyOpportunity to rescind the request immediately prior to the procedure taking place.
Give information about the medication and possible problems:
midazolam may cause restlessness, or not cause sedation
the patient may snore briefly after the midazolam is given
propofol injection may cause burning in the vein (which is why we pre inject lidocaine)
respirations may cease during propofol administration
death may result from the propofol injection, but rocuronium is ALWAYS given
Death (cardiac arrest) after rocuronium injection usually occurs within 5min of respirator arrest, but may take as long as 20minutes. Cyanosis may occur
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Do Not Disturb
Any distraction during the preparation or practice of euthanasia is especially unpleasant for the patient and others present, and is challenging for the doctor
It is advisable to turn off any telephones (land lines and cell phones) of all parties present. Inform others that you will not be available for the particular period of time.
See hand-out on the medication of choice
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During the procedure
Physician must be present for the administration of the oral, or must be the person who administers the IV medication
Pre‐medication:
midazolam pre‐administrated to assist with some sedation/anxiety
lidocaine in the IV line to prevent the burn of the propofol
1) Coma Induction
Utmost importance that patient is in a induced coma PRIOR to administration of the neuromuscular blocker.
does not respond to verbal stimuli
slow/weak pulse (may not have one)
slow/shallow breathing (may not be breathing)
no eyelash reflex
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1) Coma induction
Give slowly over about 5 minutes ‐ too fast, patient dies suddenly, too slow, wears off before administration of the neuromuscular blocker
thus, before beginning, warn family/patient that this may occur, but regardless all agents used in MAiD must be completely administered.
2) Neuromuscular blocker
If there is even the slightest doubt regarding whether or not patient is in a coma ‐ a second administration of the coma induction in an alternative IV line must be done.
After completion of the coma‐induction medication the line must be flushed.
The neuromuscular is administered as a bolus, and then the line is flushed again
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Via pre-existing Port-a-Cath
One day in advance confirm port‐a‐cath is still intact
Administration:
Warn the patient and the and other people present that the result can be very rapid
Always give premedication (midazolam) to overcome a sudden death experience
The Challenges
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Institutional Objectors (transfers, patient choice)
Poor Governmental planning (NP payment, no clear billing, lack of training)
Community back‐lash (physician support)
Expiry dates for MAiD once approved ‐ how long is too long to wait to proceed once approved
GREYness (who is eligible, what meds are used, etc)
Up and Coming…
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Federal MAiD Monitoring Regulations ‐Summer 2018
Court challenges and Federal Government review ‐ advanced directives, children, mental health??
Other websites
Canadian Association of MAiD providers and
assessors
CFPC - MAiD policy
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Thank-you…Questions?
References:
Presentation: Medical Assistance in Dying in Ontario, Ministry Update. MOHLTC, November 2, 2017.
Presentation: Medical Assistance in Dying (MAID): From Debate to Implementation. Madeline Li, MD PhD, Psychiatrist, University Health Network, May 10, 2017.
Presentation: Medical Assistance in Dying. Dirk Huyer, MD, Ontario Chief Coroner.
Presentation: Medical Assistance in Dying (MAID) ‐ One Year Later. Manitoba Provincial MAID Clinical Team, October 13, 2017.
Clinical Practice Guideline: The Clinical Interpretation of “Reasonably Foreseeable”. Canadian Association of MAID Assessors and Providers, June 2017.
Advanced Course on End‐of‐Life Care and Medical Assistance in Dying. Canadian Medical Association. Fall 2016 and Fall 2017.
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Suzanne is a 82 y.o. female with a longstanding history of chronic kidney disease. She has a past medical history of DM2, CAD, and previous cardiac bypass.
She recently broke her hip and was hospitalized for three months. Subsequently, she was discharged to a long term care facility. She has been undergoing hemodialysis for 10 years and now wishes to
discontinue treatment.
When assessed, she says that no one has been involved in this decision, but that she would prefer to enjoy her time at the nursing home rather than travel back to the
hospital three times a week.
She has declined peritoneal dialysis stating that it is too complicated.
Capacity, Voluntariness and
Consent
Does she have capacity?
Is this request made voluntarily?
Can she consent?
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Suzanne cont.
What if…
she had a past medical history of Major Depressive Disorder with anxiety?
Is she still capable?
Suzanne cont.
What if…
She has no psychiatric medical history, but she has also been diagnosed with lung cancer. Her prognosis is less than 6 months. She has requested MAiD.
When assessed she says that no one has influenced her decision, but she is tired and not hopeful about the future
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Capacity, Voluntariness and
Consent
Does she have capacity?
Is this request made voluntarily?
Can she consent?
Suzanne cont.
What if…
She does have a past psychiatric history of MDD and anxiety.
When assessed she adds that she feels that her organs are ‘already rotting’ and she is ‘ready to go’
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Assessing Capacity and Obtaining ConsentQuestions to assess Understanding- What is your understanding of your condition?- What are the options for your situation?- What is your understanding of MAiD?- What are the benefits and risks of MAiD?
- What is the likelihood of you having a problem or side effect with this intervention?
Questions to assess Appreciation- Why do you want MAiD?- How long have you been considering this as an option?- Why is MAiD the best option for you?- What do you think will happen to you if you receive MAiD? What will happen if you do not?- What factors/issues are most important to you in considering to have MAiD?- What are you thinking about as you consider this decision?- Can you help me understand why comfort measures are not sufficient currently?
Questions to asses Voluntariness- Are there financial pressures?- Do the feelings of your family and friends influence you?- Is anyone encouraging you to request MAiD?- Is this a request for help and/or better care to relieve suffering or communicate another
concern?- What supports do you have personally and socially?- Is there pressure from society at large influencing your decision?
Questions to assess ability to express Choice- You have been given a lot of information and had much to think about. Have you decided
what is the best option for you right now?
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Canadian Association of MAID Assessors and Providers Clinical Practice Guideline
The Clinical Interpretation of “Reasonably Foreseeable”
Purpose of the Clinical Practice Guideline
To assist assessors and providers in the clinical interpretation of “natural death has become reasonably foreseeable” in Bill C14, in order to provide consistency in interpretation across the country.
Note on terms
Prior to the passing of Bill C-14, medical assistance in dying (MAID) was generally called “physician-assisted dying”. This was the term used by the Supreme Court of Canada in Carter. The Federal Government adopted the term MAID to reflect the decision to allow nurse practitioners as well as physicians to provide the service.
In this document, physicians and nurse practitioners will be jointly referred to as “clinicians” except where the text applies only to one group.
Canadian Association of MAID Assessors and Providers (CAMAP)
CAMAP is a unique association of professionals involved in the assessment and provision of MAID in Canada. Founded in 2016, our mission is to support MAID assessors and providers in their work, educate the public and the health care community about MAID and to provide leadership on determining the highest standards and guidelines of care in MAID provision. CAMAP members strive to achieve the highest level of care for our patients and to model this care for a national and international audience.
We aim to work with governments in Canada at all levels, provincial medical and nursing licensing bodies, national medical colleges, national professional medical groups, medical protective associations, and national advocacy groups.
Key Recommendations
1. Clinicians should be aware that Bill C-14 makes MAID an end-of-life option for individuals whose natural deaths are reasonably foreseeable.
2. As an aid to clarity, clinicians can consider interpreting “reasonably foreseeable” as meaning “reasonably predictable” from the patient’s combination of known medical
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Canadian Association of MAID Assessors and Providers Clinical Practice Guideline
conditions and potential sequelae, whilst taking other factors including age and frailty into account.
3. Clinicians should not employ or support rigid timeframes in their assessments of eligibility for MAID. Bill C-14 contains no requirement for a prognosis having been made as to the length of time the patient has remaining.
Process
This Clinical Practice Guideline (CPG) was drafted by the CAMAP Committee on Standards and Guidelines. Amendments were suggested by the provider members of CAMAP (as those most experienced in MAID assessments) through online discussion. The resultant draft was re-examined by the Committee on Standards and Guidelines and finalized for publication. At the time of publication over 1300 medically assisted deaths have taken place in Canada. A much greater number of patients have been assessed for eligibility. This CPG represents the combined experience of clinicians who have carried out thousands of assessments.
Background
Bill C-14, An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying), received assent on June 17, 2016.
The Act, which is still customarily referred to as Bill C-14, was the Federal Government’s response to the decision of the Supreme Court of Canada (SCC) in Carter v Canada (Attorney General). The nine Supreme Court justices decided unanimously that physician-assisted death should be permitted for a competent adult person who (1) clearly consents to the termination of life and (2) has a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition. No further constraints were imposed by the SCC.
The Federal Government placed additional restrictions within Bill C-14. It sought to strike the most appropriate balance between the autonomy of persons who seek medical assistance in dying on one hand, and the interests of vulnerable persons in need of protection and those of society on the other. It argued that these were necessary to prevent errors and abuse in the provision of medical assistance in dying, to affirm the inherent and equal value of every person’s life, to avoid encouraging negative perceptions of the quality of life of persons who are elderly, ill or disabled, and to avoid undermining efforts at suicide prevention. Bill C-14 also had the stated aim of bringing about a consistent approach to medical assistance in dying across Canada.
This CPG concerns one part of Bill C-14, which requires of the person that their “natural death has become reasonably foreseeable”.
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This CPG does not debate the inclusion of this criterion within Bill C-14. It only examines its meaning, which has caused considerable difficulty to clinicians particularly those carrying out assessments of eligibility for medical assistance in dying (MAID).
In order to discuss the meaning of “reasonably foreseeable” it is necessary to state all the criteria required for a person to be deemed to have a grievous and irremediable condition. Bill C-14 states (emphasis added):
A person has a grievous and irremediable medical condition only ifthey 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 causesthem enduring physical or psychological suffering that is intolerableto them and that cannot be relieved under conditions that theyconsider acceptable; and(d) their natural death has become reasonably foreseeable, takinginto account all of their medical circumstances, without a prognosisnecessarily having been made as to the specific length of time thatthey have remaining.
The term “reasonably foreseeable” is not one used in clinical medical practice. It is a legal term used mainly in civil law (although also found in the criminal law), and there it relates to risk, harm and the law of negligence. It has been defined in the following way:
A consequence is “reasonably foreseeable” if it could have been anticipated by an ordinary person of average intelligence as naturally flowing from his actions
The fact that clinicians have not previously had to consider the meaning of “reasonably foreseeable” in their clinical practice - except in the rather rarified context of wondering whether a court might find a previous action, allegedly negligent and the subject of a legal case, to have been reasonably foreseeable in terms of harm caused - means that it has proved very difficult for them to know how to approach this criterion. Clinicians have discussed this issue amongst themselves and have sought the advice of lawyers engaged by the Canadian Medical Protective Association (CMPA), and have also sought further clarification from the Government. The interpretation of “reasonably foreseeable” as it pertains to MAID has been examined by many different authorities - governmental, legal, and medical.
The intention of the law
The Government published a number of documents to help explain the wording of Bill
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C-14. The Legislative Background document was published prior to the passing of the Bill, in order to inform parliamentarians and the public as to the Government’s intentions in the wording of the Bill. Regarding reasonable foreseeability it stated (emphasis added):
The criterion of reasonable foreseeability of death is intended to require a temporal but flexible connection between the person’s overall medical circumstances and their anticipated death. As some medical conditions may cause individuals to irreversibly decline and suffer for a long period of time before dying, the proposed eligibility criteria would not impose any specific requirements in terms of prognosis or proximity to death (e.g. a six month prognosis as some U.S. states’ medical assistance in dying laws require). The medical condition that is causing the intolerable suffering would not need to be the cause of the reasonably foreseeable death. In other words, eligibility would not be limited to those who are dying from a fatal disease. Eligibility would be assessed on a case-by case basis, with flexibility to reflect the uniqueness of each person’s circumstances, but with limits that require a natural death to be foreseeable in a period of time that is not too remote.
A Glossary was also published. The wording is subtly different from that of the Legislative Background and should therefore be studied for further insights and nuances regarding the intentions of the Government. It states (emphasis added):
“Natural death has become reasonably foreseeable” means thatthere is a real possibility of the patient’s death within a period oftime that is not too remote. In other words, the patient would need toexperience a change in the state of their medical condition so that ithas become fairly clear that they are on an irreversible path towarddeath, even if there is no clear or specific prognosis. Each person’scircumstances are unique, and life expectancy depends on a numberof factors, such as the nature of the illness, and the impacts of othermedical conditions or health-related factors such as age or frailty.Physicians and nurse practitioners have the necessary expertise to evaluate each person’s unique circumstances and can effectively judge when a person is on a trajectory toward death. While medical professionals do not need to be able to clearly predict exactly how or when a person will die, the person’s death would need to be foreseeable in the not too distant future.
The Government also indicated that Kay Carter (of Carter v. Canada) would have qualified for MAID under the legislation – despite the fact that she did not have a terminal illness and, on
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actuarial tables, had years to live – and that others whose factual circumstances are similar to Ms. Carter’s should similarly qualify, clearly indicating that “not too distant future” could include a number of years.
Statements made by Jody Wilson-Raybould, the Minister of Justice, during the debates on Bill C-14 are helpful. In the meeting of the Senate on June 1, 2016 she was asked whether Kay Carter, whose daughter Lee was a plaintiff in the SCC case, would have been eligible under the terms of the Bill. Kay Carter’s grievous and irremediable condition was spinal stenosis, a condition which is not itself terminal. The Minister said:
Unlike some U.S. states that require specific prognosis and fataldisease, Bill C-14 does not require a strict temporal or causalrelationship between any single medical condition and theforeseeability of death. This purposeful flexibility recognizescircumstances such as those of Kay Carter, who was in the finalstages of her natural life even though she did not suffer from anysingle condition that was causing her death.
and later:
I am 100 per cent confident that Kay Carter would be eligible underBill C-14 to access medical assistance in dying. The eligibility criteria and definition around "grievous and irremediable" are meant to be read in their totality, given all of the circumstances of a particular individual. In recognition of Kay Carter: She was 89 years of age, suffering intolerably from spinal stenosis and in a state of irreversible decline. Her death had become reasonably foreseeable by virtue of her age and frailty. The flexibility that we sought to inject in the eligibility criteria was toprovide medical practitioners the ability to assess their patients'circumstances and to provide for that patient to be able to be eligiblefor medical assistance in dying. Kay Carter would have fulfilled thatcriteria.
At the time that the case commenced in the SCC Kay Carter was 87 years old. An average 87 year old Canadian female has a life expectancy greater than 6 years (http://www.statcan.gc.ca/pub/84-537-x/2013005/tbl/tbl1b-eng.htm). Even at the age of 89, (her age when Kay Carter died in Switzerland which was referenced by the Minister), average female life expectancy is greater than 5 years. Whilst Kay Carter was frail, and thus could be expected to have had a life expectancy lower than the average for her age, it is certainly clear that the criterion of "reasonably foreseeable" does not mean 6 months, a year, or any other specified shorter period, which has at times been the interpretation suggested by some legal and medical authorities.
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In July 2016, after Bill C-14 had received assent, an Addendum to the Legislative Background document was posted on the Ministry of Justice website. It tackled the issue of the inclusion of criteria in the Bill that did not appear in the Carter decision, the constitutionality of these criteria, and in particular the issue of reasonable foreseeability. The content of the Addendum led to the CMPA in particular cautioning against confirming eligibility for MAID for people with prognoses longer than 6 to 12 months. This caution is, in the opinion of CAMAP, unwarranted. The wording of the Addendum needs to be examined carefully.
The Addendum noted that there are two categories of legislative regime for assisted dying around the world. The first category restricts MAID to individuals whose natural death is approaching, and most of these regimes limit eligibility to people with terminal diagnoses with a prognosis of 6 months or less. This category of regime exists in the six US jurisdictions that have passed laws permitting MAID (California, Colorado, District of Columbia, Oregon, Vermont and Washington). The second category disregards life expectancy as an issue and is aimed only at relieving unbearable suffering. This category of regime exists in Belgium, the Netherlands, and Luxembourg (the Benelux countries). The key part of the Addendum as far as practicing clinicians are concerned is the following (emphasis added):
The approach taken in Bill C-14 reflects the Government'sassessment, based on the available evidence including internationalexperience and informed opinion, that a broad eligibility model suchas that in the Benelux countries would frustrate the Government'sobjectives, including in relation to the protection and promotion of therights of vulnerable groups. It equally reflects the Government'sassessment that, in view of the nature and seriousness of the risks, aprudent approach is warranted. This means adopting an approachthat is closer to existing end-of-life models than to the Beneluxapproach – a model that restricts eligibility to individuals who aredeclining toward death, allowing them to choose a peaceful death asopposed to a prolonged, painful or difficult one. At the same time,the flexible "reasonably foreseeable death" standard, and theabsence of a specific "time remaining before death"requirement, make Bill C-14 broader than existing end-of-liferegimes.
Some CMPA lawyers’ interpretation
Some lawyers retained for physicians by the CMPA have been advising physicians to adopt a very conservative stance. These lawyers have taken the position that even though the Addendum was published after Bill C-14 was passed, and was thus not available to members of Parliament when they voted, nonetheless it has power as a statement of the Government’s intentions in the
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drafting of Bill C-14 and would be considered in a court of law. Some physicians are advised by counsel that the further a patient’s prognosis extends beyond 6 months, the greater the risk to the physician in any subsequent court case where the physician’s decision that death was “reasonably foreseeable” is challenged. The role of the CMPA is to be risk averse on behalf of physicians, not to provide guidance on best practice. The role of CAMAP is to advise on best practice. In MAID provision, best practice includes not denying MAID to a person who is eligible due to excessive caution on the part of the clinician.
It should be noted that whilst the Legislative Background document and the Addendum make clear that MAID in Canada is an end-of-life issue, the only points at which the period of 6 months is mentioned are to categorize the two types of existing MAID regime (in the Addendum), and to distinguish Bill C-14 from regimes employing rigid time frames by making clear that the law does not impose any specific requirements regarding prognosis. In fact, the only actual declarations regarding prognosis is that it should be “a period of time that is not too remote” and “in the not too distant future”.
Medical health authorities and institutions
Some medical health authorities, particularly those which regulate the provision of MAID within facilities, have adopted time limits to prognosis. For example, some provincial and regional organisations automatically rule ineligible any patient with a prognosis of more than one year.
Clinical interpretation of “reasonably foreseeable”
“Reasonably foreseeable” is a term that can and should be subjected to clinical interpretation in a manner similar to that which occurs in any other clinical assessment. The term “reasonably foreseeable” rarely occurs in medical literature. Its inclusion within the criteria for MAID has therefore perplexed many clinicians and created anxiety given the possible severe consequences of applying an interpretation that a court of law might find erroneous.
However, most clinicians, in particular family physicians, palliative care physicians and others working with patients with terminal illnesses or with the elderly, do in fact already have an understanding of when a natural death is reasonably predictable. If the question “is the patient’s natural death reasonably foreseeable?” is framed in a way that would be asked in other clinical situations, the meaning becomes clearer.
Thus, if asked whether a patient’s death is “reasonably predictable” from the patient’s combination of co-morbidities and age then clinicians would answer more readily. Once the patient’s death and its manner has become reasonably predictable (as far as the factors leading to it are concerned) then it can be said to be reasonably foreseeable. Reasonably predictable does not mean that the clinician is confident that death will definitely ensue in this way, only that
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predicting that it will do so is reasonable.
The explanation within the Glossary (see page 3) is helpful here. It stated that “Natural death has become reasonably foreseeable” means that there is a real possibility of the patient’s death within a period of time that is not too remote” and “it has become fairly clear that they are on an irreversible path toward death, even if there is no clear or specific prognosis”. The use of “possibility” rather than “probability” and the term “fairly clear” shows that the law does not require certainty on the part of the clinician.
Clinicians use their clinical experience to interpret data every day. When uncertain, they turn to other clinicians expert in the relevant field. Although risk is involved in all such decisions, including the risk of making a decision that is later alleged to be negligent, clinicians do not turn to lawyers to help them understand the information on which they make the decision, they turn to other clinicians. Although a new service there is a growing number of clinicians who have become expert in the provision of MAID. The determination of reasonable foreseeability is now firmly within the clinical sphere and actual practice is determining what this term means.
It is clear that it was the intention of the Government to make the issue of whether death is “reasonably foreseeable” a clinical decision when Bill C-14 was drafted. As noted previously the Glossary stated that “Physicians and nurse practitioners have the necessary expertise to evaluate each person’s unique circumstances and can effectively judge when a person is on a trajectory toward death”. Clinicians can use their ordinary clinical experience to determine the meaning of “reasonably foreseeable”, by asking themselves if the natural death of the patient is reasonably predictable because they are on a trajectory toward death.
For example, faced with a 60 year old male with a new diagnosis of multiple sclerosis who has relatively minor symptoms and no significant co-morbidities but who is seeking MAID now on the basis of this diagnosis alone, the average life expectancy of 20 years for a man of his age and the obvious lack of any information regarding his future medical conditions would lead to the conclusion that his natural death is not reasonably predictable whether or not the patient feels that his clinically fairly minor symptoms are intolerable. He would also fail to qualify by not being in an advanced state of irreversible decline.
Conversely, a 95 year old female with pain from osteoarthritis which she finds intolerable, resistant to all medications that do not produce unacceptable side effects, who wishes MAID, should not be found ineligible just because the average life expectancy of a 95 year old Canadian female is over 3 years. It is not likely that the average clinician would regard such a patient’s death as “remote” or as being in the “too distant future”, the terms used in the Government’s explanatory publications. Her death is reasonably predictable.
So is that of a man diagnosed at age 30 with Huntington’s Disease, a relentlessly progressive
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disease (in a manner that multiple sclerosis often is not) leading to a severe movement disorder (chorea) and dementia, and death most commonly from pneumonia, heart disease or suicide. The prognosis at diagnosis is 10-20 years. There is no cure and frequently no effective treatment for the chorea. Once a patient with Huntington’s Disease is suffering intolerably either physically or psychologically or both, and all treatments acceptable to the patient have failed, and they are in an advanced state of irreversible decline, and they request MAID, their reasonably predictable - in fact almost completely predictable - death from their condition should allow consideration of MAID regardless of prognosis. Furthermore, if this patient is suffering intolerably but has not yet lost capacity through cognitive decline then the almost complete predictability of dementia followed by death from his disease should allow for MAID before he loses eligibility due to a loss of capacity, whatever the estimated prognosis.
A clinician should decide:
1. Is it reasonable to predict that death will result from the patient's medical conditions and sequelae, taking into account age and other factors?
2. Is it likely that death will be “remote” or in the “too distant future” in the ordinary sense of these words?
If the answer to the first question is Yes, and the second question is No, then it is CAMAP’s view that the criterion of a reasonably foreseeable natural death is satisfied.
Conclusion
Notwithstanding the fact that no case law regarding MAID in terms of Bill C-14 yet exists, and that little scientific evidence on the application of MAID in Canada has been published, CAMAP takes the view that the interpretation in this CPG of the criterion that “natural death has become reasonably foreseeable” will assist clinicians in determining whether or not a particular patient is eligible for MAID.
CAMAP notes:
1. The intention of Bill C-14 is to provide for an end-of-life MAID regime that balances the autonomy of persons who seek MAID and the interests of vulnerable persons and society.
2. Bill C-14 states clearly that there is no requirement for “a prognosis necessarily having been made as to the specific length of time [the patient] has remaining”.
3. The only time requirement given by the Government in its explanatory publications (but not contained in Bill C-14 itself) is that the reasonably foreseeable natural death is “not too remote”
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and “in the not too distant future”
4. Each application is to be considered on a case-by-case basis.
Recommendations
1. Clinicians should be aware that Bill C-14 makes MAID an end-of-life regime for individuals whose natural deaths are reasonably foreseeable.
2. As an aid to clarity, clinicians can consider interpreting “reasonably foreseeable” as meaning “reasonably predictable” from the patient’s combination of known medical conditions and potential sequelae, whilst taking other factors including age and frailty into account.
3. Clinicians should not employ or support rigid timeframes in their assessments of eligibility for MAID. Bill C-14 contains no requirement for a prognosis having been made as to the length of time the patient has remaining.
4. If a patient’s eligibility remains uncertain, clinicians should seek the advice of a more experienced MAID provider. Access to such advice might be via personal contacts, local health authorities or their equivalent in the clinician’s province, organizations such as the provincial college of physicians and surgeons, or national organizations such as CAMAP. CAMAP has a members-only listserv for providers where advice can be sought.
June 2017
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Resources
Bill C-14 http://www.parl.gc.ca/HousePublications/Publication.aspx? Language=E&Mode=1&DocId=8384014
Glossary http://www.justice.gc.ca/eng/cj-jp/ad-am/glos.html
Legislative Background: Medical Assistance in Dying (Bill C-14) http://www.justice.gc.ca/eng/rp-pr/other-autre/ad-am/p2.html#p2_2
Legislative Background: Medical Assistance in Dying (Bill C-14) - Addendum http://www.justice.gc.ca/eng/rp-pr/other-autre/addend/index.html
Life expectancy table, Canada, females http://www.statcan.gc.ca/pub/84-537-x/2013005/tbl/tbl1b-eng.htm
Life expectancy table, Canada, males http://www.statcan.gc.ca/pub/84-537-x/2013005/tbl/tbl1a-eng.htm
Minister of Justice statements to the Senate, June 1, 2016 https://sencanada.ca/en/Content/Sen/chamber/421/debates/041db_2016-06-01-e
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FORM DR – 14 February 2017 Page 1 of 6 Credit to Albeta Health Services
STANDARDIZED PRESCIPTION PROTOCOL FOR MEDICAL ASSISTANCE IN DYING
Patient Label
Demographic Information
Patient Name: Physician Name:
DOB: CPSO Registration #:
Health Card #: Telephone Number:
Address: Address:
Allergies:
Verification of Request The providing physician shall affirm and initial all of the criteria. Prior to processing the prescription, the pharmacist shall verify with the providing physician that all assessments have been completed and that the patient has been deemed to satisfy all of these criteria.
I have: Dr. Initials Pharm Initials
Affirmed that the patient has been assessed to have a decisional capacity;
Affirmed that the patient has been determined to suffer from a grievous and irremediable medical condition; and
Affirmed that the patient has provided consent for Medical Assistance in Dying
Collaboration
The providing physician and the pharmacist must discuss: Dr. Initials Pharm Initials
Additional or alternative medications required
The scheduled time for the provision of Medical Assistance in Dying
The time required to prepare the medications
How to complete the medication administration record
Procedure for returning unused medications to the pharmacy
In the event of failure to die or an extended dying period, the decision may be made to proceed with the IV protocol. Active consent to proceed to voluntary euthanasia will have to have been obtained at the time of consent being obtained for medical assistance in dying and will be part of the consent for the procedure. Arrangements must be made with pharmacy in advance to ensure the IV protocol is available to the providing physician in the case that conversion is required. Refer to the Protocol Based Drug Information below for detailed instructions on medication prescribing and preparation.
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FORM DR – 14 February 2017 Page 2 of 6 Credit to Albeta Health Services
Physician‐provided Protocol for Euthanasia (initial to indicate medications being ordered)
Pharmacy should supply medications in a ready‐to‐administer format. If not possible, provide vials/ampoules for the physician to prepare at the bedside.
Dr. Initials
1. Anxiolytic Midazolam 2.5 – 10 mg IV over 2 minutes
Dispense: 10 mg
2. Local Anaesthetic (choose either option a or b as appropriate) a. Lidocaine 40 mg IV over 30 seconds
Dispense: 20 mg/mL pre‐filled syringe (1 x 5 mL syringe) OR (if allergic to lidocaine) b. Magnesium sulfate 1000 mg (diluted with normal saline) IV over 5 minutes
Dispense: 1000 mg
3. Normal Saline Flush Flush IV with 10 mL normal saline to prevent any incompatibility with coma‐inducing agent
Dispense: normal saline flush syringe (1 x 10 mL)
4. Coma‐inducing Agent (choose either option a or b as appropriate) Note: if a deep coma cannot be confirmed, an additional dose of the coma‐inducing agent may be required
a. Propofol 1000 mg IV over 5 minutes Dispense: 1000 mg
OR (if allergic /intolerant to propofol) b. pHENobarbital 3000 mg (diluted with normal saline) IV over 5 minutes
Dispense: 3000 mg
5. Normal Saline Flush Flush IV with 10 mL normal saline to prevent incompatibility between coma‐inducing agent and neuromuscular blocker and to ensure full dose is administered
Dispense: normal saline flush syringe (1 x 10 mL)
6. Neuromuscular Blocker (choose either option a or b as appropriate) a. Rocuronium 200 mg by rapid IV injection
Dispense: 200 mg OR (if rocuronium is unavailable) b. Cisatracurium 30 mg by rapid IV injection
Dispense: 30 mg
7. Normal Saline Flush Flush IV with 10 mL normal saline to ensure full dose of neuromuscular blocker is administered
Dispense: normal saline flush syringe (1 x 10 mL)
Consultation between the physician and pharmacist should occur for the following: Opioids: A separate prescription is required if the physician chooses to have an additional opioid on hand. This may be desired for the management of pain, dyspnea, or to prevent withdrawal in the event of a prolonged dying event. Additional Quantities: Physicians should consider whether they wish to prescribe additional quantities of medication(s) to compensate for breakage or the possible need for additional dosing. If additional quantities are requested, they should be prescribed, packaged, and dispensed complementary to, but separate from the prescriptions on this protocol.
Physician Signature Date
Assessing Pharmacist Signature Date
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FORM DR – 14 February 2017 Page 3 of 6 Credit to Albeta Health Services
INTRAVENOUS DRUG PROTOCOL MONOGRAPHS (drugs are listed in order of protocol use)
Patient Label
Please Note: to prevent IV incompatibilities, stop all other infusions and flush the IV line with 10 mL normal saline before proceeding. If this is not feasible, start a second IV line dedicated for MAID administration. 1. Anxiolytic Midazolam Compatible with: Y‐site: atracurium, cisatracurium, fentanyl, haloperidol, HYDROmorphone, insulin, LORazepam, morphine, pancuronium, propofol, remifentanil, SUFentanil, vecuronium MAID Administration Required: midazolam 1 mg/mL (10 mL vial) Directions: withdraw 10 mL into a 20 mL syringe Dose: 2.5 – 10 mg IV over 2 minutes Beyond use date: 24 hours at room temperature in syringe NOTE: Patient may remain awake or may lose consciousness depending on sensitivity to benzodiazepines. 2. Local Anaesthetic (choose either option a or b as appropriate)
2(a) Lidocaine Compatible with: Y‐site: fentanyl, haloperidol, HYDROmorphone, insulin, morphine, SUFentanil MAID Administration Required: lidocaine 20 mg/mL pre‐filled 5 mL syringe Directions: no preparation required Dose: 40 mg (2 mL) IV over 30 seconds Dosing Considerations and Options
Caution: DO NOT administer lidocaine WITH epinephrine IV.
2(b) Magnesium Sulfate (if allergic to lidocaine) Compatible with: Y‐site: fentanyl, midazolam, morphine, pHENorbarbital, SUFentanil MAID Administration Required: magnesium sulfate 200 mg/mL (1 x 10 mL vial) Directions: withdraw 1000 mg (5 mL) into a 20 mL syringe and further dilute with normal saline to a final volume of 10 mL Dose: 1000 mg IV over 5 minutes Beyond use date: 24 hours at room temperature in syringe
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FORM DR – 14 February 2017 Page 4 of 6 Credit to Albeta Health Services
INTRAVENOUS DRUG PROTOCOL MONOGRAPHS (drugs are listed in order of protocol use)
3. IV Line Flush Ten (10) mL of normal saline must be injected prior to the coma‐inducing agent to prevent incompatibility. 4. Coma‐inducing Agent
4(a) Propofol Incompatible with: Y‐site: atracurium, cisatracurium, metoclopramide, morphine sulfate at high concentrations (compatible at 1 mg/mL) Do not mix with other drugs prior to administration. Flush line with 10 mL normal saline to ensure complete dose administered and to prevent precipitation due to incompatibilities. Compatible with: Y‐site: fentanyl, HYDROmorphone, ketamine, lidocaine, midazolam, magnesium sulfate, morphine sulfate at 1 mg/mL, vecuronium MAID Administration Required: propofol 10 mg/mL (100 mL vial) Directions: withdraw 50 mL into a 60 mL syringe. Prepare 2 syringes of 50 mL each. If an additional dose is prescribed, prepare a third syringe. Dose: 1000 mg IV (infuse each syringe over 2.5 minutes). May give additional dose of 500 mg if required. Dosing Considerations and Options
Storage: Store at room temp, protect from light, do not use if there is evidence of separation of phases of emulsion.
Beyond Use Date: 24 hours at room temperature in syringe CAUTION: Loss of consciousness should occur rapidly during the first minute of propofol administration. Propofol may be painful to inject which is the reason for administration of lidocaine prior to the propofol. Cardiovascular and respiratory depression can occur with this dose of propofol. Even if this occurs, proceed with neuromuscular blocker. Coma must be confirmed prior to administration of a neuromuscular blocker. If a deep coma (see Artificial Come Criteria and Richmond Agitation‐Sedation Scale below) cannot be confirmed, then the dose must be increased by adding an additional 500 mg of propofol as required.
Artificial Coma Criteria (adapted from Quebec Protocol)
Physiological Criteria Clinical Signs
Level of consciousness Unable to arouse
No response to verbal commands
No protective reflexes (loss of corneal reflex in particular
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FORM DR – 14 February 2017 Page 5 of 6 Credit to Albeta Health Services
INTRAVENOUS DRUG PROTOCOL MONOGRAPHS (drugs are listed in order of protocol use)
Richmond Agitation‐Sedation Scale (RASS)
Score Term Description
+4 Combative Overtly combative or violent; immediate danger to staff
+3 Very agitated Pulls on or removes tube(s) or catheter(s) or has aggressive behavior towards staff
+2 Agitated Frequent nonpurposeful movement or patient –ventilator dyssynchrony
+1 Restless Anxious or apprehensive but movements not aggressive or vigorous
0 Alert and calm Spontaneously pays attention to caregiver
‐1 Drowsy Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact , to voice
‐2 Light Sedation Briefly (less than 10 seconds) awakens with eye contact to voice
‐3 Moderate sedation Any movement (but no eye contact) to voice
‐4 Deep sedation No response to voice, but any movement to physical stimulation
‐5 Unarousable No response to voice or physical stimulation
. 4(b) pHENobarbital for Injection (if allergic/intolerant to propofol) Compatible with: Y‐site: fentanyl, HYDROmorphone (may be incompatible at high concentrations of both), methadone, morphine, propofol, SUFentanil MAID Administration Required: pHENobarbital 120 mg/mL (25 x 1 mL ampoules) Directions: withdraw 25 mL into a 60 mL syringe. Further dilute with normal saline to total volume of 50 mL. If an additional dose is prescribed, prepare a second syringe. Dose: 3000 mg IV over 5 minutes. May give additional dose of 3000 mg if required. Beyond use date: 24 hours at room temperature in syringe Coma must be confirmed prior to administration of a neuromuscular blocker. If a deep coma (see Artificial Coma Criteria and Richmond Agitation –Sedation Scale above) cannot be confirmed, then the dose must be increased by adding an additional 3000 mg of pHENobarbital are required. 5. IV Line Flush Ten (10) mL of normal saline must be injected between the coma‐inducing agent and the neuromuscular blocker to ensure that the full dose of coma‐inducing agent has been injected into the vein and to prevent a precipitate from forming in the IV tubing. 6. Neuromuscular Blocker (choose either option a or b as appropriate)
6(a) Rocuronium Compatible with: Y‐site: fentanyl, haloperidol, HYDROmorphone, magnesium sulfate, morphine, ondansetron, pHENobarbital, remifentanil, SUFentanil
INTRAVENOUS DRUG PROTOCOL MONOGRAPHS
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FORM DR – 14 February 2017 Page 6 of 6 Credit to Albeta Health Services
(drugs are listed in order of protocol use)
MAID Administration Required: rocuronium 10 mg/mL (4 x 5 mL vials) Directions: withdraw 20 mL into a 30 mL syringe Dose: 200 mg by rapid IV injection Beyond use date: 24 hours at room temperature in syringe 6(b) Cisatracurium (if rocuronium is unavailable) Compatible with: Y‐site: alfentanil, fentanyl, haloperiodol, HYDROmorphone, magnesium sulfate, morphine, ordansetron, remifentanil, SUFentanil. MAID Administration Required: cisatracurium 2 mg/mL (2 x 10 mL vials) Directions: withdraw 15 mL into a 20 mL syringe Dose: 30 mg by rapid IV injection Beyond use date: 24 hours at room temperature in syringe Cautions:
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. 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 may sometimes be a delay of up to 20 minutes between respiratory arrest and cardiac arrest, causing cyanosis.
It is advisable to explain to those present, before starting injections, that death might come relatively quickly and that the heart may keep beating for a long time after breathing has stopped.
7. IV Line Flush Ten (10) mL of normal saline must be injected after the neuromuscular blocker to ensure that the full dose has been injected into the vein.
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