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.