Question 1

Explain how the CDSA is organized into schedules, which schedule is the strictest, and give an example of a drug within that schedule.

Accepted Answer

The CDSA is organized into 8 schedules with Schedule 1 having the strictest regulations and the most penalty. Examples of drugs within Schedule 1 would be heroin, morphine, and codeine

Question 2

The symbol Pr means the drug can only be dispensed with a prescription.

Accepted Answer

A) True 
 B)False  True

Question 3

A pharmacy technician is discussing generic and trade drugs with a patient. The patient wants to know why it takes so long for trade drugs to become available in the generic form, which are generally cheaper. What is the pharmacy technicians' best response?

Accepted Answer

A)   It takes 20 years for all pharmaceutical companies to develop a generic version of the drug.
B)   It will take 20 years of clinical trials to approve the drug.
C)   Sole ownership of a drug allows the pharmaceutical company to earn back the money spent to develop the drug.
D)   Animal testing must continue for 10 years, then 10 years of human clinical trials, for a drug to be approved. C

Question 4

The pharmacy technician teaches a patient that some drugs are frequently abused, and cause an overwhelming feeling that drives someone to use the drug repeatedly. What topic is the pharmacy technician teaching to this client?

Accepted Answer

A)   Addiction
B)   Psychological dependence
C)   Physical dependence
D)   Dependence

Question 5

Controlled drugs would include narcotics, such as morphine, controlled drugs, such as methylphenidate, and targeted products, such as diazepam.

Accepted Answer

A) True 
 B)False

Question 6

The purpose of this phase of testing during the drug approval process is to check the effectiveness of the product within large populations of patients. This phase is called:

Accepted Answer

A)   Preclinical investigation
B)   Post-marketing surveillance
C)   Clinical investigation
D)   Health Canada Review

Question 7

Which statements regarding prototype drugs are not accurate? (Select all that apply.) Note: Credit will be given only if all correct choices and no incorrect choices are selected.

Accepted Answer

A)   A pharmacy technician can apply understanding of the effects of a prototype drug to other drugs in the same class.
B)   Understanding the effects of the prototype drug does not help the pharmacy technician to understand the effects of other drugs in the same class.
C)   The mechanism of action is different for the prototype drug than for other drugs in the same class.
D)   The most commonly used drug in a specific class is always the most widely prescribed drug.
E)   Prototype drugs rarely cause drug resistance.

Question 8

Drug patent protection in Canada lasts 17 years.

Accepted Answer

A) True 
 B)False

Question 9

A generic drug takes 60 minutes to produce a therapeutic effect; the brand name drug takes the same amount of time to produce the same effect. This phenomenon is an example of which pharmacological concept?

Accepted Answer

A)   Bioavailability
B)   Efficacy
C)   Therapeutic effect
D)   Adverse effect

Question 10

What is the difference between the generic name of a drug and a generic drug.

Accepted Answer

The answer of What is the difference between the generic...

Question 11

The physiologic ability of the drug to reach its target cells and produce its effect is known as which pharmacological concept?

Accepted Answer

A)   Efficacy
B)   Bioavailability
C)   Therapeutic effect
D)   Adverse effect

Question 12

Describe the harmonized drug schedules and give examples of medications found within each schedule.

Accepted Answer

The answer of Describe the harmonized drug schedules and give...

Question 13

The mechanism of action of a drug is how the medication produces its effects within the body.

Accepted Answer

A) True 
 B)False

Question 14

A scientist is performing research on cellular cultures for a new drug product. At which stage of development is this new drug product?

Accepted Answer

A)   Pre-clinical investigation
B)   Clinical investigation
C)   Submission of New Drug Application
D)   Post marketing surveillance

Question 15

There are usually many generic names for the same brand name product.

Accepted Answer

A) True 
 B)False

Question 16

A pharmacy technician instructor is teaching fundamental pharmacological content. In helping the students become comfortable with this material, what should the instructor suggest that the student focus on initially?

Accepted Answer

A)   The prototype
B)   The generic names
C)   The trade names
D)   The adverse effects

Question 17

This division of Health Canada authorizes the marketing of pharmaceutical drugs or medical devices after safety, efficacy and quality data is collected from manufacturers:

Accepted Answer

A)   The Biologics and Genetic Therapies Directorate
B)   The Therapeutic Products Directorate
C)   The Natural Health Products Directorate
D)   The Health Products Directorate

Question 18

Health Canada works in partnership with the provincial and territorial governments to maintain and improve the health of Canadians and to ensure medications are safe to use.

Accepted Answer

A) True 
 B)False

Question 19

A prototype drug is always the most prescribed type of drug within that drug class.

Accepted Answer

A) True 
 B)False

Question 20

When drugs are grouped together on the basis of how they work within the body pharmacologically, this is referred to as a therapeutic classification.

Accepted Answer

A) True 
 B)False

Exam 2: Drug Classification, Regulation, and Approval

Explain how the CDSA is organized into schedules, which schedule is the strictest, and give an example of a drug within that schedule.

The symbol Pr means the drug can only be dispensed with a prescription.

A pharmacy technician is discussing generic and trade drugs with a patient. The patient wants to know why it takes so long for trade drugs to become available in the generic form, which are generally cheaper. What is the pharmacy technicians' best response?

The pharmacy technician teaches a patient that some drugs are frequently abused, and cause an overwhelming feeling that drives someone to use the drug repeatedly. What topic is the pharmacy technician teaching to this client?

Controlled drugs would include narcotics, such as morphine, controlled drugs, such as methylphenidate, and targeted products, such as diazepam.

The purpose of this phase of testing during the drug approval process is to check the effectiveness of the product within large populations of patients. This phase is called:

Which statements regarding prototype drugs are not accurate? (Select all that apply.) Note: Credit will be given only if all correct choices and no incorrect choices are selected.

Drug patent protection in Canada lasts 17 years.

A generic drug takes 60 minutes to produce a therapeutic effect; the brand name drug takes the same amount of time to produce the same effect. This phenomenon is an example of which pharmacological concept?

What is the difference between the generic name of a drug and a generic drug.

The physiologic ability of the drug to reach its target cells and produce its effect is known as which pharmacological concept?

Describe the harmonized drug schedules and give examples of medications found within each schedule.

The mechanism of action of a drug is how the medication produces its effects within the body.

A scientist is performing research on cellular cultures for a new drug product. At which stage of development is this new drug product?

There are usually many generic names for the same brand name product.

A pharmacy technician instructor is teaching fundamental pharmacological content. In helping the students become comfortable with this material, what should the instructor suggest that the student focus on initially?

This division of Health Canada authorizes the marketing of pharmaceutical drugs or medical devices after safety, efficacy and quality data is collected from manufacturers:

Health Canada works in partnership with the provincial and territorial governments to maintain and improve the health of Canadians and to ensure medications are safe to use.

A prototype drug is always the most prescribed type of drug within that drug class.

When drugs are grouped together on the basis of how they work within the body pharmacologically, this is referred to as a therapeutic classification.