Laws and Legislation

Question 1

the national parliament has the power to “make laws for the peace, order and good governance of Canada” except for __

Answer 1

” subjects assigned exclusively to the legislatures of the provinces”

Question 2

t/f no provincial legislature can take over the powers of Parliament and vice-versa

Answer 2

true

Question 3

what is federal law?

Answer 3

high-level, applies throughout the country, has precedence over provincial

Question 4

what is provincial law?

Answer 4

builds on/supports federal law, or creates within its own authority, may vary by province

Question 5

what type of law regulates the manufacturing, sale, and importation of therapeutic products?

Answer 5

federal

Question 6

what type of law regulates the practice of pharmacy>

Answer 6

provincial

Question 7

___ guides a pharmacist through the grey areas of the law

Answer 7

code of ethics

Question 8

an act is also known as __

Answer 8

enabling legislation

Question 9

an act beh=gins is what form>

Answer 9

draft form (a bill)

Question 10

an act outlines how parliament can delegate __ to other bodies to create regulations

Answer 10

power

Question 11

regulations are also known as

Answer 11

delegate r subordinate legislation

Question 12

___ are not made by parliament, but someone parliament as given authority to

Answer 12

regulations

Question 13

which is easier to change? an act or a regulation?

Answer 13

regulation

Question 14

regulations must be consistent with the __ under which they are made

Answer 14

act

Question 15

a ___ is the operational part of the law, the processes and procedures needed to comply with the law

Answer 15

regulation

Question 16

what is NAPRA

Answer 16

national association of pharmacy regulatory authorities

Question 17

what is the MSOP by NAPRA?

Answer 17

the model standards of practice; the minimum standards of practice a pharmacist must meet and against which their performance will be evaluated

Question 18

what are the 4 domains of the MSOP?

Answer 18

1. expertise in medications
2. collaboration
3. safety and quality
4. professionalism and ethics

Question 19

what body assigns DINs?

Answer 19

therapeutic products directorate of health Canada

Question 20

manufacturers file for patents before/after clinical trial starts?

Answer 20

before

Question 21

what is a patent?

Answer 21

a set of rights granted by a government that gives the holder the exclusive right to make and sell an invention

Question 22

how does the government make sure drugs are safe?

Answer 22

if clinical trial shows potential therapeutic value that outweighs the risks

Question 23

the way a drug works when used in the population is called the ___

Answer 23

effectiveness

Question 24

what is a medication incident?

Answer 24

any preventable event that may cause or lead to inappropriate medication user patient harm while in the control of HCP or consumer

Question 25

what is a hazard?

Answer 25

a setting or technology that has potential to cause harm

Question 26

what are near misses?

Answer 26

events that could have resulted in unwanted consequences, but did not bc of chance (unplanned) or time intervention (planned)

Question 27

what is a no harm event?

Answer 27

mistake reaches patient, but results in no injury

Question 28

all suspected adverse drug reactions should be reported, especially those that are __

Answer 28

1. unexpected, regardless of severity
2. serious, regardless if expected or not
3. reactions to recently marketed products