Chapter 21 - Legal and Ethical Issues

Question 1

What level of government has jurisdiction over food and drugs, including health products?

Answer 1

Federal government.

Question 2

What level of government is responsible for delivery of health care?

Answer 2

Provincial.

Question 3

What level of government is responsible for legislation with respect to health care professionals?

Answer 3

Provincial.

Question 4

What is post-marketing surveillance for?

Answer 4

Looking for long term safety and rare side effects.

Question 5

What is the primary reason to regulate NHPs?

Answer 5

Safety

Question 6

The government has historically regarded most NHPs as…

Answer 6

inherently safe.

Question 7

What would be the downside to asking NHPs to be tested to the same rigor as pharmaceuticals?

Answer 7

It would cost more and take more time.

Question 8

Why is labelling on NHPs important?

Answer 8

Consumers deserve relavent information about products available for purchase.

Question 9

What types of research should be acceptable regarding the efficacy of NHPs and their interactions with conventional medicine?

Answer 9

At the least, good quality RCTs.

Question 10

Regulation of CAM practitioners are needed to protect the public from…

Answer 10

incompetent and unethical individuals

Question 11

Regulation of CAM practitioners allows the public to determine if they are dealing with a ___ practioners.

Answer 11

qualified

Question 12

3 forms of regulation

Answer 12

1. Statutory
2. Through Common Law
3. Self-regulation

Question 13

Statues

Answer 13

Laws passed by parliament or provincial legislature that addresses specific issues.

Question 14

What method is usually used to regulate OM professionals?

Answer 14

Statues

Question 15

3 methods of statutory regulation in Canada

Answer 15

1. Exclusive scope of practice
2. Controlled Acts
3. Title Protection

Question 16

Exclusive scope of practice

Answer 16

Only registered members of a particular profession can provide the services that have been established as within their exclusive scope of practice.

Question 17

What do Controlled Acts do?

Answer 17

Create a list of controlled acts.

Question 18

If a health service is not listed in the list of controlled acts then ___ may provide it.

Answer 18

anyone

Question 19

Title Protection

Answer 19

Only registered members of a health profession may use a particular title.

Question 20

How does title protection help consumers?

Answer 20

Consumers will know that individuals with certain titles are regulated and have met certain standards of relevant competency.

Question 21

Statutory regulation clarifies what ___ will be required before a practitioner can be registered as a member of a profession or discipline.

Answer 21

training

Question 22

Regulated practitioners are usually required to carry ___ insurance.

Answer 22

malpractice

Question 23

Common Law

Answer 23

Law developed by judges through decisions of courts rather than through legislative statues.

Question 24

Common law is based on…

Answer 24

precedents

Question 25

What is the highest level of court?

Answer 25

Supreme Court of Canada

Question 26

Four elements of informed consent

Answer 26

1. Capacity 2. Informed Consent 3. Voluntariness 4. Deferability

Question 27

Deferability

Answer 27

If a patient cannot consent, the decision can be left alone until later, or a decision can be made by a surrogate.

Question 28

Capacity

Answer 28

The capacity of adults to make decisions for themselves.

Question 29

What must physicians discuss with a patient in terms of what a reasonable person in the patient's circumstances would want to know?

Answer 29

Patient's diagnosis. Nature and purpose of proposed treatment. Any material risks. Possible outcomes if treatment is taken or refused. Reasonable alternatives. Conflicts of interest. And any other relevant information.

Question 30

Should OM physicians have an obligation to refer patients to CAM practitioners?

Answer 30

No, this is not necessary if the alternative would be of no benefit to the individual.

Question 31

Extending case law of conventional medicine, when could it be argued that a physician has the duty to inform a patient about a CAM treatment?

Answer 31

1. If a reasonable physician should know of these alternatives. 2. If evidence exists to establish the efficacy and safety of the alternative.

Question 32

Is there an obligation on the part of the health care professional to inquire as to a patient's use of other therapies or products, including NHPs?

Answer 32

Yes.

Question 33

What is the main reason insurance companies provide coverage for CAM?

Answer 33

There is demand for it, not because of any evidence of efficacy.

Question 34

What is an underlying theme to legal considerations regarding CAM?

Answer 34

There is a lack of evidence to support the claims of efficacy and safety of most CAM.

Question 35

What is the current discussion regarding legal considerations of CAM being driven by?

Answer 35

Marketing pressure and consumer demand.

Question 36

4 key Ethical Principles in health?

Answer 36

1. Autonomy 2. Beneficence 3. Non-malfeasance 4. Justice

Question 37

Autonomy

Answer 37

An individual being able to make choices for themselves based on their own values.

Question 38

Beneficence

Answer 38

The ideal of helping those who have come for care whenever possible.

Question 39

Non-malfeasance

Answer 39

Practitioners should not cause their patient's harm.

Question 40

Justice

Answer 40

Distributing resources in an equitable way.