Drug Regulation And Control Flashcards

1
Q

Which is an example of a medication that is part of a class 2 recall

A

A contaminated medication that could cause temporary, reversible adverse effects

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2
Q

Exenatide and Iiraglutide are both in region memetics used to treat diabetes. Exenatide and Iiraglutide are

A

Therapeutic alternatives

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3
Q

In 2004, the prescription Vioxx was removed from pharmacy shelves permanently due to the reports of increased heart problems. This is an example of a:

A

Market withdrawl

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4
Q

When a generic medication is identical in active ingredients, strength, dosage form, and route of administration as the brand name product it’s considered a(n)

A

Pharmaceutical equivalent

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5
Q

Which DAW code means the brand name product is dispensed as generic?

A

DAW 5

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6
Q

Mylan’s clonazepam 1mg is AB-rated to Klonopin 1mg. This means:

A

Clonazepam is the therapeutic equivalent to Klonopin

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7
Q

What is a manufacturer allowed to change when creating an equivalent generic medication

A

Fillers

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8
Q

Which committee approves patient consent forms and protects the welfare of drug research volunteers

A

IRB

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9
Q

For an involuntary recall, who requires the recalled drug to be removed from pharmacy shelves

A

FDA

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10
Q

Which phase of testing involves introducing a drug for the first time in humans

A

Phase 1 Testing

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11
Q

After which phase of the drug approval process, does the drug company file a New Drug Application (NDA) to then sell the drug on the market?

A

Phase 3 testing

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12
Q

A drug that contains a different active ingredient, but is the same drug class and works similarly to another medication is considered a

A

Therapeutic alternative

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13
Q

FDA approved an ANDA. This means a manufacturer can

A

Bring a generic medication to market

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14
Q

A brand name patent gives a drug company exclusive rights to the compound for a ___________ time

A

Limited

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15
Q

An injectable med with pieces of glass in the medication is an example of which type of recall

A

Class I

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16
Q

A drug that contains the same ingredient, but is a different strength is considered a

A

Pharmacological alternative

17
Q

What does DAW 0 mean?

A

No product substitution is indicated, substitution is allowed

18
Q

A collaborative agreement is a system that allows pharmacists to automatically substitute

A

Pharmacological and therapeutic alternatives

19
Q

What does DAW 2 mean

A

Patient requests name brand

20
Q

Investigational drug returns can be performed by the

A

IDs technician

21
Q

FDA may approve a Biological License Application is the biological proves to be

A

Safe and effective

22
Q

What is an investigational drug

A

A drug compound undergoing clinical testing in humans

23
Q

Which type of recall involves products that are unlikely to cause adverse effects

A

Class III

24
Q

What does DAW 3 mean?

A

Pharmacist determines brand should be dispensed

25
Q

Which resource contains TE codes to help guide generic substitution

A

Orange book

26
Q

Which DAW code means the substitution is not allowed by the prescriber

A

DAW 1

27
Q

What does DAW 6 mean

A

An override is required

28
Q

What does DAW 7 mean

A

Substitution is not allowed since the brand name is mandated by law

29
Q

Paxil is an immediate release paroxetine tablet. Paxil CR is a controlled release paroxetine tablet. Both medications are used to treat the same condition. These medications are pharmacologic alternatives because?

A

They contain the same active ingredient, but are different dosage forms