Chapter 21 - Legal and Ethical Issues Flashcards
What level of government has jurisdiction over food and drugs, including health products?
Federal government.
What level of government is responsible for delivery of health care?
Provincial.
What level of government is responsible for legislation with respect to health care professionals?
Provincial.
What is post-marketing surveillance for?
Looking for long term safety and rare side effects.
What is the primary reason to regulate NHPs?
Safety
The government has historically regarded most NHPs as…
inherently safe.
What would be the downside to asking NHPs to be tested to the same rigor as pharmaceuticals?
It would cost more and take more time.
Why is labelling on NHPs important?
Consumers deserve relavent information about products available for purchase.
What types of research should be acceptable regarding the efficacy of NHPs and their interactions with conventional medicine?
At the least, good quality RCTs.
Regulation of CAM practitioners are needed to protect the public from…
incompetent and unethical individuals
Regulation of CAM practitioners allows the public to determine if they are dealing with a ___ practioners.
qualified
3 forms of regulation
- Statutory
- Through Common Law
- Self-regulation
Statues
Laws passed by parliament or provincial legislature that addresses specific issues.
What method is usually used to regulate OM professionals?
Statues
3 methods of statutory regulation in Canada
- Exclusive scope of practice
- Controlled Acts
- Title Protection
Exclusive scope of practice
Only registered members of a particular profession can provide the services that have been established as within their exclusive scope of practice.
What do Controlled Acts do?
Create a list of controlled acts.
If a health service is not listed in the list of controlled acts then ___ may provide it.
anyone
Title Protection
Only registered members of a health profession may use a particular title.
How does title protection help consumers?
Consumers will know that individuals with certain titles are regulated and have met certain standards of relevant competency.
Statutory regulation clarifies what ___ will be required before a practitioner can be registered as a member of a profession or discipline.
training
Regulated practitioners are usually required to carry ___ insurance.
malpractice
Common Law
Law developed by judges through decisions of courts rather than through legislative statues.
Common law is based on…
precedents
What is the highest level of court?
Supreme Court of Canada
Four elements of informed consent
- Capacity
- Informed Consent
- Voluntariness
- Deferability
Deferability
If a patient cannot consent, the decision can be left alone until later, or a decision can be made by a surrogate.
Capacity
The capacity of adults to make decisions for themselves.
What must physicians discuss with a patient in terms of what a reasonable person in the patient’s circumstances would want to know?
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.
Should OM physicians have an obligation to refer patients to CAM practitioners?
No, this is not necessary if the alternative would be of no benefit to the individual.
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?
- If a reasonable physician should know of these alternatives.
- If evidence exists to establish the efficacy and safety of the alternative.
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?
Yes.
What is the main reason insurance companies provide coverage for CAM?
There is demand for it, not because of any evidence of efficacy.
What is an underlying theme to legal considerations regarding CAM?
There is a lack of evidence to support the claims of efficacy and safety of most CAM.
What is the current discussion regarding legal considerations of CAM being driven by?
Marketing pressure and consumer demand.
4 key Ethical Principles in health?
- Autonomy
- Beneficence
- Non-malfeasance
- Justice
Autonomy
An individual being able to make choices for themselves based on their own values.
Beneficence
The ideal of helping those who have come for care whenever possible.
Non-malfeasance
Practitioners should not cause their patient’s harm.
Justice
Distributing resources in an equitable way.
