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Ethics - Notes (2023-03-28)

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261 views

Ethics - Notes (2023-03-28)

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© © All Rights Reserved
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3)

ETHICS

07
:6
MCQ Exam Preparatory Course

(ID
ya
di
va
Ke

1
sh
iyu
li P

TABLE OF CONTENTS
ija

• Legend • Paternalism: The Opposite of


Br

• 6 Bioethical Principals Autonomy


• How to use the principles: The • Capacity Vs. Competence
to

PharmAchieve Ethical Decision- • Informed Consent


Making Framework
ed

• Ethics Boards
• Principles and Cases: • Other Ethical Topics
ns

• Autonomy • Appendix
• Non-Maleficence
ce

• Ethics of Relationship
• Beneficence • Ethics of Prescribing
Li

• Justice
• Fidelity
• Veracity

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Private & Confidential 1
DEFINITIONS

MORALS: beliefs distinguishing between what is right and wrong

ETHICS: The science of distinguishing between right and wrong in human conduct

3)
CONSENT: A patient’s permission to undergo a treatment or research, or to collect, store or

07
disclose, or use information

:6
RESEARCH: Collection of patient data, through interventions that go beyond those
necessary for the individual’s immediate well-being

(ID
ya
di
va
Ke
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SOME ORIGINS OF BIO-ETHICAL PRINCIPLES


ija
Br
to
ed
ns

Time
ce

Nuremberg Code (NC) ~1945 Beauchamp and


Hippocrates 460 BC Immanuel Kant (1724-1804) Childress (1978)
Li

Declaration of Helsinki (DOC)


Non-Maleficence Autonomy (1975) Autonomy
Beneficence Beneficence
Fidelity Human experiments must be for Non-Maleficence
greater good (NC. DOH) Fidelity
Voluntary participation (NC, DOH) Veracity
Informed decisions (DOH) Justice
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Private & Confidential 2
6 BIOETHICAL PRINCIPLES ! No principle routinely trumps the others!

BENEFICENCE: Being of benefit to the patient by (promoting the patient’s best interest and
well-being)

NONMALEFICENCE (3 duties):

3)
(1) “do no needless harm” by refraining from actions (or inactions) that may harm patients
(2) prevent harm; and

07
(3) remove harm

:6
JUSTICE: Equity and fairness in the distribution of resources, treatments and harms

AUTONOMY: Respecting the patient’s free will and decisions to choose/refuse treatment

(ID
HONESTY/VERACITY: Telling the truth without deception or an intent to mislead

ya
FIDELITY: Loyalty and keeping our promises to the patient. This forms the ethical basis of
the practice of confidentiality (the act of keeping a patient’s information private) and
keeping yourself free of conflicts of interest,.

di
va
Don’t participate in a cover-up! If you have good reason to suspect something illegal or unethical is
going on, let the authorities know.
Ke
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WHAT IS A MORAL DILEMMA?


ija
Br

• A situation in which you must choose between 2 or more alternative actions.

• Each action based on different moral principles such that it is impossible to act in such a
to

way and follow all the moral principles.


ed

• No matter what you do at least one principle will be violated.


ns
ce

Principle 1 You Principle 2


Li

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Private & Confidential 3
PHARMACHIEVE’S ETHICAL DECISION MAKING FRAMEWORK

When >1 principle applies to a situation which one wins?

• No principle routinely wins against the others so judgement


is required based on specifics of each case

3)
What is the situation?

07
:6
Does a law, regulation, or YES Follow the law, regulation,
standard of practice apply? or standard of practice

(ID
NO

If principles in conflict, Act according to the

ya
Identify which ethical
decide which principle principle that has
principles are involved
takes precedence precedence

di
va
Ke
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AUTONOMY Patients’ right to make their own decisions


ija

If a patient has the capacity to make decisions, you should defer to the patient’s wishes
Br

Exceptions: patients who lack capacity and emergencies (e.g. when patient is unconscious
and you cannot get patient’s consent).
to
ed

Example of upholding autonomy: Example of violating autonomy:


You follow the informed consent protocol You choose a treatment for the patient
ns

by explaining in detail the treatment when there are many options without
alternatives, the relative benefits and risks explaining the alternatives because
ce

of each treatment, while also providing the “you know what’s best”
patient the choice of choosing among the
Li

options

Common Dilemmas:
• Beneficence vs. Autonomy

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Private & Confidential 4
NOT an ethical principle; it is opposite of autonomy and occurs when a
PATERNALISM healthcare professional thinks their will should override the patient’s

Occurs because the healthcare professional (i) believes that they know the patient’s best
interests better than the patient and (ii) acts on this belief in a way that diminishes patient
autonomy. Often beneficence and non-maleficence are used by healthcare professionals to
justify paternalism.

3)
Examples:

07
1. A pharmacist does not disclose the side effects of a drug that the
patient needs for their care because she thinks the patient will not take

:6
the needed drug if the patient knows what the side effects.
2. When a patient asks how to treat a condition, a pharmacist only

(ID
discusses the one treatment she thinks is best. She does not counsel on
the risks and benefits of that treatment, or the risks and benefits of the
alternatives.

ya
3. A patient refuses a blood transfusion on religious grounds, but a
healthcare professional knowingly transfuses blood anyway with the

di
reason that “it will save the patient’s life.”
va
Ke
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NONMALEFICENCE 1. Do no needless harm (physical, emotional, psychological)


through your actions/inactions;
ija

2. Prevent harm
3. Remove harm.
Br

Examples of upholding nonmaleficence: Example of harm from actions:


1. You recommend against an addictive pain 4. You make an error while dispensing
to

killer because an alternative non- 5. You recommend a non-evidence-based


addictive pain killer with fewer side treatment
ed

effects exist (thus preventing harm)


6. You prescribe a potentially addictive pain
2. You institute TALLman lettering to medication when a just-as-effective non-
ns

prevent similar sounding medications addictive one exists.


from mistakenly being interchanged (thus
ce

Example of harm from inactions:


preventing harm).
7. Forgetting to counsel a patient about how to
3. You do not recommend treatments where
Li

avoid the side effects of a drug (e.g. rinse


the risks outweigh the benefits (thus
mouth after using corticosteroid spray) that
doing no harm)
leads to patient developing thrush
4. You discontinue unneeded medications Common Dilemmas:
(thus removing harm)
• Beneficence vs. Non-maleficence
• Balancing benefits and risks of treatment
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Private & Confidential 5
BENEFICENCE Being of benefit to the patient. Doing what is best for the patient

Examples:
• Providing vaccinations for the general population
• Encouraging a patient to quit smoking and start an exercise program

3)
• Talking to the community about STD prevention.

07
• Recommending therapeutic options to a patient
• Dispensing a medication

:6
• Counselling a patient
• Administering a medication

(ID
Common Dilemmas:

ya
• Beneficence vs. Non-Maleficence
• Beneficence vs. Autonomy

di
• Patient’s autonomous decision conflicts with the pharmacist’s duty to look out
va
for the patient’s best interest
Ke
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NONMALEFICENCE CASE
ija

You are a manager of a pharmacy with only 1 other pharmacist and no other staff. You are certain
Br

that only you and your pharmacist colleague are the ONLY ones with access to narcotics but a
large volume of narcotics has repeatedly and persistently gone missing and you have nothing to
do with it. What should you do?
to

a) Talk to the colleague about the situation


ed

b) Install a video camera


c) Report your suspicions to your pharmacy regulatory authority
ns
ce
Li

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Private & Confidential 6
Equity and fairness in the distribution of benefits, harms, and resources and
JUSTICE decisions about treatment
How do you know what’s equitable? John Rawls suggests you imagine yourself behind
a veil of ignorance where you don’t know who you are, where you were born, your natural
abilities, your position in society, wealth, sex, race, nationality, or individual tastes, etc. so you
don’t know who your decision will benefit, including you. How would you organize society?
Examples whose analysis require considering the principle of justice:

3)
1. For a clinical trial of a drug, you recruit people of low income because it is easier to recruit

07
them than wealthy people.
• Is this just? How can this study be made more just?

:6
• Would your answer change if the study caused benefit vs. harm?
2. An expensive drug is only made available to the rich people who can afford it.

(ID
• How can justice be brought to this situation?
• Which principle did you violate?
3. You are interviewing someone for a pharmacy technician job. What questions can you ask

ya
during the interview? (a) religion (b) age (c) criminal record (d) ethnicity.
4. In the midst of the COVID-19 outbreak you hear that Remdesivir might help infected people

di
fight the disease. The drug is in short supply, but you stockpile the drug “in case your family
va
needs it,” even though your friends and family aren’t at high risk or infected.
Ke
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FIDELITY Loyalty and honouring one’s commitments to the patient


ija

• This duty of loyalty is the basis of trust in the healthcare provider


Br

• One way we remain loyal is by avoiding conflicts of interest and keeping our promises
and keeping patient information confidential. This duty is not only an ethical one but is
also required by law
to

Examples:
ed

You promised to meet a patient (P1) at the time of discharge to go over their medications.
But another patient (P2) was just admitted who also requires your urgent attention. You
ns

cannot make both appointments at the same time. You decide to deal with the admission
for P2 because the discharge for P1 can be delayed. What principle was upheld, which was
ce

violated and to whom?


A mother asks you to identify a pill she found in her daughter’s bedroom and to tell her
Li

what it’s for. It is a birth control pill. What should you do?
You work in a pharmacy near an STD clinic. A patient’s sibling asks if her brother is a
patient? What do you tell her?

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Private & Confidential 7
FIDELITY Continued

A pharmacist is on the Medical Advisory Committee (MAC) deciding on what drugs to include in
the hospital formulary. The drug being discussed is a drug the pharmacists was paid by a drug
company to provide talk about at a conference. What should the pharmacist do?

3)
Implied Consent:
• Sometimes a patient does not have to give you permission to reveal confidential information.

07
Examples include sharing health information with other healthcare providers in the circle of
care and responding to emergencies

:6
(ID
A patient receives an A1C test at a pharmacy that is unusually high. Can the pharmacist inform
the patient’s family physician?

ya
A pharmacist adjusts the dose of a medication. Can the family physician be informed?

di
It is permissible to break confidentiality if you believe the person will harm a person or a group
va
of persons. This includes the person possibly harming themselves (e.g. suicide).
Ke
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VERACITY Duty to tell the whole truth and not mislead


ija
Br

Examples:
to

• You use placebos for addiction withdrawal without telling the patient because your research
indicated this was the best way to taper the patient off the drug. What principle upheld?
Which was violated?
ed
ns

• A physician asks you to not tell a patient about the side-effects of a drug that she believes
could significantly help the patient. The physician fears that if you tell the patient about the
possible side effects, the patient might not accept the medication. What principal was
ce

upheld? What principle was violated?


Li

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Private & Confidential 8
ETHICAL DILEMMAS Practice Cases

1. You are about to close the pharmacy and a customer arrives at the last minute looking to refill
a prescription for acute gout pain. If you refuse to dispense what principle is violated?

2. You were very busy in the pharmacy and forgot to counsel a patient on a new prescription.

3)
a) What ethical principle was breached?
b) What if the patient experiences a side effect that your counselling could have prevented?

07
3. A pharmacy owner has decided to stop selling subcutaneous syringes to reduce customer

:6
traffic of suspected drug addicts at night. What ethical principle is breached?

(ID
4. You are concerned about the OTC sales of several products containing pseudoephedrine and
dimenhydrinate. As a pharmacy owner, you decide to keep these products behind the counter
so that you can counsel and/or restrict access.

ya
a) Which ethical principle(s) are involved?
b) Which principle may be violated depending on how the pharmacist interacts with a

di
patient?
va
Ke
Copyright © 2023 PharmAchieve Corporation Ltd. Private & Confidential. Adapted from: Alberta College of Pharmacists Code of Ethics

17
sh
iyu
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There is a trend in society and the courts towards


CAPACITY VS. COMPETENCE autonomy for patients that have the capacity to
make decisions
ija
Br

Capacity Competence
Type of concept Ethical Legal
to

Health Care Professionals treating


Who makes the assessment? Judge
the patient (pharmacist, MD, etc.)
ed

How long does it take for a Time consuming


Immediate/brief
determination to be made? legal process
ns

Very clear. A person either


Often unclear. Has to be estimated
How clear is its existence? has competence or they do
by the Health Care Professionals
ce

not.
Is it temporary or permanent? Is permanent (until changed
Li

Can temporarily fluctuate and is


Does it apply to some by a court) and applies to
decision/task specific
decisions or all decisions? all decisions in most cases
If it doesn’t exist,
who makes the decision in See chart on next slide Court appointed Guardian
place of the patient?
Copyright © 2023 PharmAchieve Corporation Ltd. Private & Confidential. Source: Adapted from Phil Lawson MD, Ethical Challenges in Medical Decision Making, 2012

18

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Private & Confidential 9
It depends. Assume patient
WHO MAKES A HEALTHCARE DECISION? has capacity. But adjust your
assessment accordingly
Legal Hierarchy for SDM (varies by province/territory)
• Spouse Red Flags:
• Child • Significant mental illness
• Brother/Sister

3)
• Disability affecting
• Relative Red flags trigger understanding/decision making abilities
Patient

07
assessment that patient
• Dementia/delirium
Power of lacks capacity
• Either end of age spectrum

:6
Attorney for
Health If no power of • Polypharmacy (linked to cognitive

(ID
attorney impairment in the elderly)
Substitute Decision • Making choices inconsistent with prior
Maker (SDM) values/choices

ya
If no SDM • Making a choice with high risk / low
benefit

di
Court Appointed
Guardian • Refusing treatment highly likely to
va benefit with low risk of harm
• Severe depression
Ke
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CONSENT AND CAPACITY In order to be able to give consent a person


needs the capacity to make decisions
ija

In the previous slide we discussed WHO makes a healthcare decision. In this slide we discuss
Br

HOW these people can make a healthcare decision for a patient who loses capacity. There are
generally 3 approaches. They are ordered from most desirable to least desirable to maximize
to

patient autonomy:

1. Living Will (also known as advance directives): Written document stating the patient’s
ed

wishes to healthcare professionals in case they lose the capacity to make decisions.
ns

2. Substituted Judgement: If no living will exists, or if the living will does not cover the
ce

situation at hand, the “Substituted Judgement Approach” is generally used. Under this
approach surrogates, usually family members try to determine what the patient would
Li

have decided if they still had the capacity to make decisions.

3. Best Interests: If the patient left little or no indication on what they would have decided,
the surrogate decide based on what would be good for the patient. The moral principle
underlying this approach is beneficence.

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Private & Confidential 10
INFORMED CONSENT

“[The] process by which the treating health care provider discloses appropriate
information to a competent patient so that the patient may make a voluntary choice
to accept or refuse treatment” (Appelbaum, 2007)

3)
07
Informed consent recognizes that patients can’t make informed decisions without being
given the necessary facts. If you don’t fully inform the patient, you violate their autonomy.

:6
Informed consent requires the patient to know:

(ID
✓ The nature of the decision/ procedure
✓ Reasonable alternatives to the proposed intervention

ya
✓ Relevant risks, benefits and uncertainties related to each alternative
✓ Assessment of patient understanding

di
✓ Acceptance of the intervention by the patient
va
Ke
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INFORMED CONSENT Practice Cases


ija
Br

1. There are a number of possible treatment options for a patient, each with its own
significant pros and cons, but you only tell the patient about one treatment you prefer and
to

do not tell them that alternatives exist.


ed

• Does this provide the patient the opportunity to give informed consent?
• Can the patient exercise autonomy without knowing the alternatives?
ns

2. You get a verbal prescription for dabigatran. You are told by the physician to ensure that
ce

no print-out is given about the drug to the patient because the bleeding risk may frighten
the patient from taking the medication.
Li

• What ethical principles are involved?


• What principle is breached by the physician and yourself carrying out the plan?

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Private & Confidential 11
ETHICS BOARDS

• Generally, research involving human subjects requires prior approval by a research ethics
board (REB).
• REB usually consists of clinicians (doctors, nurses, pharmacists), a legal member, and ≥1

3)
member(s) of the public (to reflect the interests of the sick)

07
• Research proposals need to be reviewed to make sure they are consistent with ethical
principles. Some of the things REBs consider when reviewing a proposal:

:6
✓ Respect for human dignity
✓ Informed consent

(ID
✓ Privacy and confidentiality
✓ Justice

ya
✓ Balancing harms and benefits

di
va
Ke
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ija
Br
to
ed
ns
ce
Li

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Private & Confidential 12
REFUSAL TO FILL For moral or religious reasons

A pharmacist is permitted to decline providing certain services/products but must ensure an


alternate source to obtain services/products is arranged. When doing so you should avoid
sharing your moral objections, and should arrange the alternative care in a way that minimizes
the suffering of the patient.

3)
ETHICS OF PRESCRIBING Self and Family Member Prescribing

07
A personal, non-professional relationship makes it inappropriate to “treat” an individual with

:6
objectivity (includes ordering and performing tests, making/communicating a diagnosis, and
prescribing)

(ID
• Pharmacists and physicians should NOT treat either themselves or family members except:
• For “minor conditions” and “emergency situations” where no other qualified health care

ya
provider is readily available
• If care is provided, then this should be transferred to another qualified healthcare

di
professional as soon as possible
va
Ke
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ETHICS OF PRESCRIBING Self and Family Member Prescribing


ija

• Physicians should never prescribe narcotics, controlled drugs, psychotropic drugs or any drugs
Br

with addictive properties for either themselves or family members


• Non-compliance with the above can be subject to allegations of professional misconduct
to

• Prescribing for family members is not banned by law but it is banned in some but not all
ed

provinces through their respective code of ethics (e.g. for pharmacists, physicians, dentists,
etc.) so it is not illegal but it can be unethical
ns

• Regardless, a pharmacist can refuse to dispense if they think abuse is occurring


ce

Case: You are pharmacist at a community hospital in a province where pharmacists can prescribe a certain
Li

medication. You notice a colleague consistently prescribing for self and family members. What should you
do?
a) Talk to the colleague about the situation
b) Tell the family members they should get their prescriptions from someone else.
c) Report the activity to the College

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Private & Confidential 13
CASE 1

You work at an STD clinic. You call a patient’s home phone to confirm an appointment
but someone else answers the phone. You leave a message.

3)
What principle was violated?

07
:6
(ID
ya
di
va
Ke
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sh
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CASE 2
ija
Br

A hypertensive patient arrives at your pharmacy to ask about the side effects of
pseudoephedrine because they have nasal congestion that affects their quality of life.
You tell them that pseudoephedrine can increase blood pressure and that they should
to

discontinue the medication, but you do not recommend an alternative therapy.


ed

What principle was upheld and which was violated?


ns
ce
Li

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Private & Confidential 14
CASE 3

A physician prescribes a non-evidence-based treatment (an antibiotic) at the patient’s


request for an antibiotic to treat influenza virus.

3)
What principal has been upheld and which has been violated?

07
:6
(ID
ya
di
va
Ke
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CASE 4
ija

A patient asks you to fill a prescription for Mifegymiso® (Mifepristone/Misoprostol)


Br

indicated for medical abortion.


to

If you are not feeling comfortable, can you refuse to fill this prescription?
ed
ns
ce
Li

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Private & Confidential 15
Appendix

3)
07
:6
(ID
ya
di
va
31
Ke

31
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ETHICS OF RELATIONSHIPS Pharmacists and Pharmaceutical Industry


ija

Guidelines have been developed by a number of associations with common elements:


Br

• Patients should be the pharmacist’s primary concern in all aspects of pharmacy practice,
including interactions with industry
to

• Pharmacists should not solicit or accept gifts from industry that might influence or appear to
influence objectivity, independence, or fairness in clinical and professional judgment (but
gifts of minimal value (<$100) e.g. pens are acceptable)
ed

• Pharmacists should disclose financial, consulting, or other relationships that are or appear to
ns

constitute conflicts of interest


• Pharmacists who make decisions regarding the purchase, prescribing, or use of drugs or
ce

devices by others through formulary committee deliberations, clinical practice guideline


development, or administrative responsibilities should avoid financial, consulting, or other
Li

relationships with industry that are or appear to constitute conflicts of interest


• Pharmacists who are members of an ethics review board should avoid any real, potential, or
perceived conflicts of interest that could occur in connection with matters before the board
• Pharmacists who participate in industry associated research should only do so if that research
meets accepted ethical, regulatory, and scientific standards
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PHARMACIST CODE OF ETHICS

• A pharmacist should use their knowledge, skills and resources to:


✓ Provide care to patients

3)
✓ Contribute to societal needs
✓ Act as ambassadors (or stewards) for their profession

07
• This means that the pharmacist needs to :

:6
✓ Maintain professional competence
✓ Develop professional knowledge & skills through life-long learning

(ID
✓ Maintain good relationship with others (respect others)
✓ Make patient care their 1st concern
Exercise professional judgment in the interest of patients & public

ya

✓ Take responsibility for their work & practices

di
✓ Encourage patients to participate in decisions about their care
va
Ke
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REFERENCES
ija

1. Alberta College of Pharmacists. Code of Ethics. 2015. Available at: https://pharmacists.ab.ca/nPharmacistResources/CodeofEthics.aspx.


Br

2. College of Pharmacists of British Columbia. Code of Ethics. 2011. Available at: http://library.bcpharmacists.org/D-Legislation_Standards/D-
2_Provincial_Legislation/5019-Code_of_Ethics_Detailed.pdf.
3. College of Physicians & Surgeons of Ontario. College of Physicians & Surgeons of Ontario Policy Statement #7-06: Treating Self & Family Members.
to

2011. Available at: http://www.cpso.on.ca/uploadedFiles/policies/policies/policyitems/treating_self.pdf.


4. Ethics. 1st ed. Toronto: College of Nurses of Ontario; 2016:1-24. Available at: http://www.cno.org/globalassets/docs/prac/41034_ethics.pdf.
ed

5. Lawson P. Ethical Challenges in Medical Decision Making. 2012.


6. Oxford Dictionaries. Oxford Dictionaries. 2016. Available at: http://www.oxforddictionaries.com/.
7. Pharmacists.ca. Canadian Pharmacists Association - CPhA. 2016. Available at: http://www.pharmacists.ca/.
ns

8. University of Ottawa. Basic Concepts in Medical Ethics. Available at: http://www.med.uottawa.ca/sim/data/Ethics_e.htm.


9. Walker R, Logan T, Clark J, Leukefeld C. Informed consent to undergo treatment for substance abuse: a recommended approach. Journal of Substance
Abuse Treatment. 2005;29(4):241-251. doi:10.1016/j.jsat.2005.08.001.
ce

10. Beauchamp and Childress, Principles of Biomedical Ethics, 7th Edition, 2012
Li

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Private & Confidential 17
MEDICAL ASSISTANCE IN DYING (MAID)
Who can provide MAID? Who can assist the providers and assessors?
Both physicians and nurse practitioners are able to provide MAID.
Other health providers who assist with the process of assessing eligibility or administering MAID are also protected from liability. These practitioners include, but
are not limited to, pharmacists, social workers, psychologists, therapists, hospital lawyers and nurses.

3)
What types of MAID are permitted in Canada?
In Canada, two types of MAID are allowed:
A physician or nurse practitioner can directly administer a substance that causes the death of the person who has requested i t, and

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A physician or nurse practitioner can give or prescribe to a patient a substance that they can self-administer to cause their own death.

Who is eligible for MAID under Canadian law?


Under Bill C-14, two independent health care professionals need to evaluate an individual in order to determine whether he/she qualifies for MAID. To qualify for

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MAID, a person must satisfy all of the following criteria. They must:
Be eligible for government-funded health insurance in Canada;
Be 18 years of age or older;
Have a grievous and irremediable condition, as defined by Section 241.2, para. 2 of the Criminal Code;

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Have made a voluntary request for MAID that was not made as a result of external pressure;
Give informed consent to receive MAID after having been informed of the means that are available to relieve their suffering, including palliative care.

In order to have a “grievous and irremediable medical condition,” as defined by Bill C-14, a person must satisfy all of the following requirements:
Have a serious and incurable illness, disease, or disability;

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Be in an advanced state of irreversible decline in capability;
Endure physical and psychological suffering that is intolerable to them; and
Their natural death has become reasonably foreseeable.

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Patients must also be capable of providing informed consent at the time that MAID is provided.

Does someone have to have a terminal illness in order to qualify for medical assistance in dying? va
No. Unlike assisted dying laws in some other jurisdictions, Bill C-14 does not put a specific timeline on who is eligible for assistance in dying.
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August 5, 2022
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Copyright © 2023 PharmAchieve Corporation Ltd. Private & Confidential.

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Copyright © 2023 PharmAchieve Corporation Ltd.


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