Legal And Ethical Issues

Question 1

Before approval for sale ___ ___ reviews drug products to assess what three things?

Answer 1

Health Canada
1. Safety
2. Efficacy
3. Quality

Question 2

Drug products include

Answer 2

-prescription
-nonprescription
-disinfectants/sanitizers

Question 3

In 1953 what act was created?

Answer 3

Canadian Food and Drugs Act

Question 4

In 1996 what act was created

Answer 4

Controlled drugs and substances act

Question 5

What did the controlled drugs and substances act replace and when?

Answer 5

Replaced the: narcotic control act
When: 1961

Question 6

What was the Food and Drugs act and when was it created?

Answer 6

1953
-control of food, drugs, medical devices
-is divided into parts and schedules

Question 7

In 2003 what act was created?

Answer 7

Food and drug regulations
-adjunct to Food and Drugs Act

Question 8

What is the drug product database in the food and drugs act?

Answer 8

Information on drugs approved for use in Canada
-around 15 thousand products

Question 9

Where was prescription drugs found in the Food and Drugs Act

Answer 9

Schedule F (2003)

Question 10

Where are prescription drugs found now (Dec 2013)

Answer 10

In the prescription drug list

Question 11

What drugs are not included in “prescription drugs” under the Food and Drugs Act

Answer 11

Drugs within the Controlled drugs and Substances Act

Question 12

OTC

Answer 12

Non prescription drugs

Question 13

What is the controlled drugs and substances act?

Answer 13

Provides framework for the control of substances that can alter mental processes

Question 14

How are controlled drugs obtained

Answer 14

By prescription from licensed practitioner

Question 15

Are clinically useful drugs apart of the controlled drugs and substances act included on the prescription drug list?

Answer 15

No they are not

Question 16

controlled drugs and substances act: schedule I to V is defined as

Answer 16

Controlled substances

Question 17

controlled drugs and substances act: schedule VI are defined as

Answer 17

Precursors
-precursors required to produced controlled substances

Question 18

controlled drugs and substances act: schedule VII and VII are defined as

Answer 18

These are actually empty
-previously were cannabis and cannabis resin limits

Question 19

controlled drugs and substances act: schedule IX is defined as

Answer 19

Tablet and capsule making devices

Question 20

controlled drugs and substances act: schedule I includes

Answer 20

Most dangerous drugs
-opioids (heroin, morphine), cocaine, amphetamines

Question 21

controlled drugs and substances act: schedule II

Answer 21

Synthetic cannabinols substances

Question 22

controlled drugs and substances act: schedule III examples

Answer 22

LSD

Question 23

controlled drugs and substances act: schedule IV includes

Answer 23

Benzodiazepines, barbiturates

Question 24

controlled drugs and substances act: schedule V includes

Answer 24

Fentanyl precursors

Question 25

controlled drugs and substances act: schedule VI contains

Answer 25

Precursors required to produce controlled substances

Question 26

What are the standards for scheduling of drugs in the controlled drugs and substances act?

Answer 26

-international standards -dependency potential (risk of abuse) -danger to public -usefulness

Question 27

What is the national drug schedule

Answer 27

National drug scheduling model developed by the national association of pharmacy -follows recommendations of NDSAC

Question 28

National drug schedule determines public access to drugs into

Answer 28

3 schedules and 1 unscheduled category

Question 29

Explain the schedules apart of the national drug schedule

Answer 29

S1- requires prescription S2- only at pharmacy, behind desk, but no prescription required S3- in pharmacy but self selection Unscheduled drugs- available for sale in any retail outlet

Question 30

What are the three types of drug names

Answer 30

Chemical name, generic name, trade name

Question 31

Chemical name

Answer 31

Based on chemistry

Question 32

Generic name

Answer 32

Less complex name assigned by drug developer

Question 33

Brand/trade name

Answer 33

The marketing name -Tylenol

Question 34

DIN

Answer 34

Drug identification number assigned after approved for sale

Question 35

Regular acetaminophen tablet contains how many mg of acetaminophen molecules

Answer 35

325 mg

Question 36

Natural Health Products (NHPs)

Answer 36

Vitamins, mineral supplements and herbal products -considered drugs at level of Food and Drugs Act; Natural Health Products

Question 37

Are NHPs considered Drugs under food and drug regulations

Answer 37

No they are not considered drugs