AnswersVA_Pharmacology_AHow Drugs Work

How Drugs Work Answers

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1
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What protects a drug developer’s rights to sell and manufacture a new, brand-name drug?

A
the Orange Book
B
the drug vehicle
C
a patent
D
the FDA
2
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3

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4

What is the best description of a pharmaceutical alternative?

A
a drug not yet approved for prescription use
B
a drug similar to another, but that does not require a prescription
C
a drug with the same clinical and safety profile as another
D
a drug similar to another drug, and that may be used to treat the same condition
5

What are the FDA criteria for therapeutic equivalence? Check all that apply.clinical indicationsafety profileprice differencedosage formpill shaperoute of administrationdrug color

A
clinical indication
B
safety profile
C
price difference
D
dosage form
E
pill shape
F
route of administration
G
drug color
6

When a drug company wants to get a drug approved, what must it demonstrate about the drug?The drug is effective at treating the indicated condition.The drug is the most effective at treating the indicated condition.The drug can be manufactured by generic drug companies.The drug can be manufactured consistently.The drug is safe for patients to take as part of their treatments.

A
The drug is effective at treating the indicated condition.
B
The drug is the most effective at treating the indicated condition.
C
The drug can be manufactured by generic drug companies.
D
The drug can be manufactured consistently.
E
The drug is safe for patients to take as part of their treatments.
7

Read this prescription and complete the following sentences. Click here to see a full list of prescription abbreviations. This prescription should be. Thehas the authority to make substitutions to the prescription.

Answers:
Selection 1:dispensed as written
Selection 2:physician
8

A pharmacy technician is filling a prescription for which there are several generic options available. How should the pharmacy technician decide which substitution to make?

A
Check the patent information in the Orange Book.
B
Select the least-expensive version of the drug.
C
Ask the pharmacist to make that professional judgment.
D
Do not make a substitution without physician permission.
9

A drug company is performing tests of its generic drug to determine the rate and extent of the action of a compound in the body. The company wants to compare this drug to a brand-name drug. What will these experiments tell them?

A
if the two drugs are bioequivalent
B
if the brand-name drug is under patent
C
if the drugs are pharmaceutical alternatives
D
if the drugs are approved by the FDA
10

Generic drugs are. set(s) the criteria for therapeutic equivalence The Drug Price Competition and Patent Term Restoration Act is a law that encouragesgeneric drugs.

Answers:
Selection 1:therapeutic equivalents
Selection 2:The FDA
Selection 3:development of
11

What information is contained in the Orange Book? Check all that apply.

A
patent information on approved drugs
B
state laws on prescription substitution
C
therapeutic equivalence (TE) codes
D
descriptions of FDA approved drugs
E
insurance coverage information
12

Why are generic drugs less expensive than brand-name drugs? Check all that apply.

A
They are less effective at treating patients.
B
They can be manufactured less expensively.
C
They do not have to be advertised.
D
The FDA approval process is shorter.
E
They are not regulated by the FDA.
13

What factors prevent prescription substitution? Check all that apply.The brand name drug is available.There are no appropriate "A" code drugs.The drug company prefers to sell the brand-name drug.The prescription states DAW.The patient wants to save money.

A
The brand name drug is available.
B
There are no appropriate "A" code drugs.
C
The drug company prefers to sell the brand-name drug.
D
The prescription states DAW.
E
The patient wants to save money.
14

Lopressor® and metoprolol have the same active ingredient at the same concentration. Both are given as pills, and have the same side effects. Both are used to treat high blood pressure.What are these two examples of?

A
pharmaceutical alternatives
B
therapeutic equivalents
C
prescription substitutions
D
bioequivalents
15

What might be affected by changes to a drug vehicle? Check all that apply. dosage formindications for useroute of administrationTE codepatent

A
dosage form
B
indications for use
C
route of administration
D
TE code
E
patent
16

Vicodin® (acetaminophen plus hydrocodone) and Percocet® (acetaminophen plus oxycodone) are both synthetic opioid analgesic drugs. Both are given as oral pills.What term best describes the relationship between Vicodin® and Percocet®?

A
bioequivalents
B
therapeutic equivalents
C
pharmaceutical alternatives
D
unrelated medicines
17

How does the Hatch-Waxman Amendment encourage the generic drug market?

A
by creating a streamlined process for the approval of therapeutic equivalents
B
by displaying patent information on drugs in the FDA’s Orange Book
C
by limiting the price of generic drugs to only 80 percent of brand-name drugs
D
by forcing pharmacists to substitute prescriptions for generic when possible
18

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