Deck 2: Drug Classification, Regulation, and Approval

Question 1

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?

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

Answer 1

Bioavailability

Question 2

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

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

Answer 2

Bioavailability

Question 3

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?

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

Answer 3

The prototype

Question 4

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.

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 5

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?

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.

Question 6

A key responsibility of Health Canada would be:

A) Work independent of provincial and territorial governments
B) Ensure the safety and quality of health products and foods
C) Market a drug for sale to Canadians
D) Set prices for all drugs sold in Canada

Question 7

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

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

Question 8

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

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

Question 9

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:

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

Question 10

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?

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

Question 11

Which type of medication would fall under the Controlled Drugs and Substances Act?

A) ibuprofen
B) morphine
C) amoxicillin
D) acetaminophen

Question 12

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

Question 13

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

Question 14

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

Question 15

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

Question 16

The brand name is usually written in lowercase, whereas the generic name is capitalized.

Question 17

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

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.

Question 19

Drug patent protection in Canada lasts 17 years.

Question 20

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

Question 21

CDSA stands for Controlled Drugs and Supplies Act.

Question 22

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

Question 23

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

Question 24

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