Week 3 Pre Reading

Question 1

Additions to the food and drug act

Answer 1

Schedules C and D
Prescription drug list
Part G
Narcotic drugs and preparations
Part J
Benzodiazepines and other targeted substances regulations

Question 2

Schedules C and D

Answer 2

Drugs in these schedule must list where the drug was made and manufacturing conditions

Question 3

Prescription drug list

Answer 3

Replaces schedule F
List of ingredients in a drug that requires prescription
(Excluding drugs in controlled drug and substances act)

Question 4

Part G (3)

Answer 4

Controlled drugs (affect CNS)
- labeled with a C

Three parts of categorization

1 - drugs with misuse potential that are used for designated conditions (in food and drug act)

2 - sedatives

3 - controlled drugs with misuse potential like steroids or weight reduction drugs

Question 5

Narcotic drugs and preparations

Answer 5

Drugs with high misuse potential

• codeine, fent etc

Question 6

Part J

Answer 6

Drugs with dangerous physiological and psychological effects with NO RECOGNIZED MEDICAL USE

Eg. LSD, psilocybin

Question 7

Canadian food and drug act

Answer 7

Primary part of legislation governing food drugs cosmetics and medical devices in Canada

Has schedule A which lists diseases for which treatments aren’t available to the public

Question 8

CSD label

Answer 8

Canadian standard drug

Says that the drug meets all standards

Question 9

Schedule C

Answer 9

Radiopharmaceuticals

Question 10

Schedule D

Answer 10

Allergenic substances, vaccines, insulin, blood derivatives

Question 11

Controlled drug and substances act

Answer 11

Provides requirements for control and sale of narcotics, controlled drugs

Question 12

Schedule I

Answer 12

Contains most dangerous drugs
Heroin, cocaine, etc

Question 13

How many schedules contained in the controlled drug and substances act

Answer 13

8

Question 14

Benzodiazepines and other targeted substances regulations

Answer 14

Specify restrictions in benzodiazepines

Question 15

Precursor control regulations

Answer 15

Address the need for control of essential chemicals used to make meth and ecstasy

Question 16

Priority review of drug submissions process

Answer 16

Fast track approval for life saving therapies

180 days down for 300

Question 17

Drug approval process phase 1

Answer 17

Phase 1
- healthy people
- determine potential adverse affects, optimal dosage, pharmacokinetics

Question 18

Drug approval process phase 2

Answer 18

Involve larger numbers of people who have the disease that the drug is designed for
- doses are refined

Question 19

Drug approval process phase 3

Answer 19

More people
- idea is to find out rare adverse effects
- uses placebo to see if the drug is actually helpful
- tests with a control group

Question 20

Drug approval process phase 4

Answer 20

Aftermarket monitoring

Question 21

IND

Answer 21

Investigational new drug

Question 22

Classes of drug recall from health Canada

Answer 22

1 2 and 3

1: most severe (can cause bad affects or death)

2: may result in temporary of medically reversible side effects

3: use of the drug is not likely to cause any major helath issues

Question 23

Special access programme

Answer 23

Allows HCPs assess to drugs that aren’t for sale in Canada

Limited to serious or life threatening cases

Question 24

Legal nursing considerations

Answer 24

Scope of practice
Nursing roles
Educational requirements
Standard of care
Safe practice
Differences in practice

Question 25

Areas of liability for nurses

Answer 25

Faultier to ensure safety Medication errors Failure to assess or evaluate

Question 26

PIPEDA

Answer 26

Personal information protection and electronic documents act Protects people

Question 27

Polymorphism

Answer 27

Effect of a patients age, gender, size, race, etc has on pharmacokinetics of drugs

Question 28

P450 enzyme

Answer 28

Control a stage of hepatic metabolism Different levels mean you can metabolize drugs at different speeds or dosages