Legal and Ethical Issues

Question 1

Before approval for sale, Health Canada reviews drug products to assess:

Answer 1

safety, efficacy and quality

Question 2

What year was the Canadian Food and Drugs Act enacted

Answer 2

1953

Question 3

what year was the controlled drug and substances act enacted

Answer 3

1997

Question 4

the CSDA replaced the?

Answer 4

1961 Narcotic control act

Question 5

what year was the food and drug regulations enacted

Answer 5

2003

Question 6

most dangerous drugs including heroin, cocaine and morphine

Answer 6

Schedule I

Question 7

Cannabis and its derivatives

Answer 7

Schedule 2

Question 8

Amphetamines and LSD

Answer 8

Schedule 3

Question 9

Benzodiazepines, barbituates, considered harmful but have therapeutic uses

Answer 9

schedule IV

Question 10

precursors required to produce controlled substances

Answer 10

Schedule VI

Question 11

specifies amounts of cannabis and cannabis resin to charge and sentence

Answer 11

Schedules VII and VIII

Question 12

Schedule IX

Answer 12

regulates devices to make tablets and capsules

Question 13

is the national drug schedule part of legislation?

Answer 13

No

Question 14

National Drug schedule I

Answer 14

requires prescription

Question 15

National drug schedule II

Answer 15

only at pharmacy, behind desk. No prescription required

Question 16

National drug schedule III

Answer 16

In pharmacy, but self-selection

Question 17

National drug schedule: unscheduled drugs

Answer 17

available for sale at any retail outlet

Question 18

Brand name is also called the?

Answer 18

proprietary name

Question 19

problems with brand names and generic names?

Answer 19

1. people can overdose thinking they are 2 different things.
2. Products with the same trade name could also have different active ingredients.
3. Drugs can be reformulated without changing the brand name

Question 20

Phase I clinical trials

Answer 20

use healthy volunteers. Tests metabolism, pharmacokinetics and biologic effects

Question 21

Phase II clinical trials

Answer 21

Uses patients. Tests therapeuticlity and dosagerange

Question 22

Phase III clinical trails

Answer 22

Uses patients. Tests safety and effectiveness.

Question 23

phase IV clinical trials

Answer 23

postmarketing surveillance

Question 24

Drug polymorphism

Answer 24

effect of clients age, sex, and body composition on their ability to absorb and metabolize a drug