The Oral Maid Option in Canada Part 2: Processes For Providing Review and Recommendations
The Oral Maid Option in Canada Part 2: Processes For Providing Review and Recommendations
1. Executive summary
a. Safe compounding
b. Dispensing
c. Administration
The purpose of this paper is to outline best practices for the safe dispensing,
administration, and evaluation of the plausibility of an oral MAiD provision. Guidance
will be provided for both clinicians and pharmacists in the provision of oral MAiD. The
medications recommended for oral MAiD are covered in Part 1 of this guideline.
11. Immediately prior to the start of the procedure clinicians should obtain final
consent for MAiD, which should include both the oral MAiD procedure as well as
consent for potential IV MAiD supplementation.
12. Clinicians should witness the ingestion of the medication. The patient should
assume a standard Fowler’s position (60 degrees) when consuming the
medication and remaining sitting for at least 20 minutes, even if unconscious,
to optimize absorption and prevent regurgitation.
13. The patient should consume all of the medication within 4 minutes. Use of a
straw should be avoided as its use can slow the rate of consumption. Clear
fluids between swallows are allowed as long as it does not prolong duration of
consumption.
14. After consuming all the medication, the aftertaste can be mitigated by
consumption of a strong liquor (1/4 cup of vodka or whiskey), or a room
temperature non-carbonated beverage (1/2 cup). Creamy and milky liquors or
beverages should be avoided.
15. Any unused medications should be returned to the pharmacy for proper
disposal.
While an oral option has existed in most provinces and territories since Bill C-14
was legislated, almost all provisions in Canada to date have been through the
administration of IV medications. The proportion of those clinicians willing to
complete assessments and to physically provide MAiD versus those only willing to
complete MAiD assessments is probably multifactorial and includes the psychological
burden of being a more active participant in the death as well as a lack of comfort
with vascular access and knowledge of the medications used. With an estimated
0.3-4.6% of all deaths provided by MAiD in countries with a longer history and greater
experience (Health Canada, 2017), we can safely assume that there are currently not
enough practitioners willing to provide MAiD in Canada. Recent polling has suggested
that the introduction of reliable oral medications for the provision of MAiD may
increase access by increasing the comfort for “assessor-only” practitioners to expand
their practice to provisions by mitigating some of the concerns outlined above. This
assumption may be incorrect, at least short term, as prescribing physicians should still
need to be present to obtain final consent and ensure the lethal dose of medication is
delivered securely and successfully. This will also mean that clinicians will still need
to be prepared to obtain vascular access, or otherwise have an IV established before
Clinicians should discuss the approximate time to coma and death with the
patient and family, and should explain to the patient that the oral route has a higher
risk of failure. Clinicians should discuss the time frame for an intravenous (IV)
intervention in the case of a delayed or failed oral provision. The pre-determined
time frame should ideally be established prior to the day of the MAiD provision (for
example, 1 hour or 2 hours as a time frame). An IV may be started prior to the oral
procedure or only after the oral procedure has failed. This decision should be made
taking into account the clinician’s comfort in starting an IV, the predicted ease in
establishing IV access, and the patient’s desire or comfort in having an IV prior to the
start of oral ingestion.
Early communication between the practitioner and the pharmacist about the
anticipated date of the provision is key to success. This allows the pharmacy to have
all the appropriate medications and ingredients available to compound the
prescription and have the agreeable staff available to carry out the compounding.
Formulations that are compounded into suspensions or solutions have a limited expiry
date and should not be prepared until immediately before the scheduled assisted
death. The practitioner and the pharmacist must discuss the appropriate antiemetic
regimen, as well as the need and format of the IV back-up kit. This should be done
prior to writing the MAiD prescription.
Safe Dispensing
There are some general practices of safe dispensing that will be applicable to
all oral preparations. Ideally, formulations should be dispensed in a ready-to-use
format that can be easily consumed by a person in less than 4 minutes. The preferred
format is a suspension or solution of less than 120 mL. This ensures a tight security
chain and minimizes time that is required to store the medication at home. The
disadvantage of this format is that the stability of the medication cannot be
guaranteed beyond a certain period of time. If oral MAiD prescriptions are dispensed in
powder format, there is a need for the person to mix the powder with water and juice
prior to consumption, increasing the risk of complications such as decreased
palatability, failure to consume total dose and failure of completion. In those
situations, it is recommended the compounding of the product should not happen until
immediately prior to the scheduled assisted death.
Dispensing of secobarbital will differ from other agents and practices are
largely based on Dutch experience. The Dutch protocol provides a compounding
procedure for pentobarbital and secobarbital (KNMG/KNMP, 2012) It advises a beyond
use date of 1 month for the unopened bottle if stored at room temperature. This
formulation should NOT be stored in the fridge. Secobarbital solution should NOT be
shaken as the high pH of the solution causes it to form bubbles in a soapy manner.
Therefore, auxiliary labeling should include “lethal dose”, do NOT shake, and do NOT
store in fridge. Keep at room temperature.
The antiemetic agents may be dispensed in tablet format anytime prior to the
scheduled date and consumed as directed. There may be a need to dispense a solution
format, depending on patient specific factors. This requirement can be discussed with
the pharmacist during the planning phase.
In order to maintain the security chain, oral MAiD medications should be passed
from pharmacist to practitioner who provides it to the patient at time of MAiD
provision. This will minimize any concern of the medication being used or
administered by another person, and maximize the effective and timely use of the
medication by the still competent person for whom it was intended. The practitioner
Safe Administration
Safe administration of these medications will optimize absorption, which is
crucial to maximizing the effectiveness of the regime. To optimize absorption,
patients should refrain from eating 6 hours prior to taking the coma-inducing
medication if possible. Clear non-carbonated fluids can be continued. Ensure the anti-
emetic regimen is taken at least 1 hour before consumption of the coma-inducing
agent. Usual medications should be continued right up to the time of the provision,
especially pain and anti-emetic/pro-motility medications. In particular, while the
continuation of some cardiac medications may not seem to be necessary, experiencing
chest pain or shortness of breath prior to the provision will only contribute to
suffering.
Read the directions on the bottle of the coma inducing medication: some
formulations such as suspensions need to be shaken well before administration and
some should NOT be shaken. Patients should remain in a Fowler’s position (60 degrees)
when consuming the medication and for at least 20 minutes after consumption, even if
becoming unconscious, to optimize absorption of the medication and prevent
regurgitation. After that time, they can be lowered to a semi-reclined position.
MAiD medication is often bitter tasting. To help rinse away the bitter aftertaste
and enhance the effect of the medication, ¼ cup of strong liquor such as vodka or
whiskey OR ½ cup of room temperature, non-carbonated beverage can follow the
consumption of the MAiD medication.
On the day of the oral MAiD provision, individuals often spend their final moments
with family and friends. Events may include wishes to consume food, beverages,
alcohol, and/or other substances. As with any MAiD provision (oral and IV routes), any
consumption must be balanced against maintaining capacity for final written and/or
verbal consent to proceed with the planned provision. If an oral route is preferred,
individuals should be informed of enhanced efficacy of medications on an empty
stomach, and as such, should ideally avoid solids and full fluids in the preceding 6
hours. Clear fluids can be continued up to the planned provision. Individuals should
also be informed of the risks of nausea and vomiting associated with these bitter
medications, and if applicable, burning associated with chloral hydrate. Antiemetic
regime adherence is crucial to promoting a successful oral procedure.
Case 5 included as on the day prior to MAID, the patient still expressed strong desire to do oral,
and clinician arrived with that medication, and IV back up kit. The 4 medications were
administered, as for IV-MAID.
A physician was present for all eight cases. All patients were strongly motivated
to not have an IV but consented to having an IV inserted if prolonged death was
observed. The first 3 cases presented did not have any IV intervention. An IV was used
in case 4, 6 and 8, as agonal breathing persisted longer than 60 minutes. 6 of the 7
patients noted bitterness, and 6 of 7 patients successfully took the entire volume
under 4 minutes. The one who was not able to take it in 4 minutes had pre-medicated
with alcohol as part of the event, and continued do take alcohol between sips of the
oral medication. Regurgitation or vomiting were not observed in any of the cases. In
case 2, a trial of Benzocaine spray (Hurricaine ©) was used, but did not seem to
improve the bitterness significantly. There was no loss of bladder or bowel control at
any time for any patient. In all cases, the coma inducing medication was brought by
the attending physician and would not have been able to be picked up by any of the 7
patients themselves because of physical decline.
In this short case series, the patients and families gave positive feedback
regarding the oral experience as a whole. Between the coma and death, the family
discussed suffering, reflected on a life well spent, and shared condolences. The total
time with the patient and family was not significantly longer than IV, but the time was
organized differently.
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