PTU Study Deck Pt. 1

Question 1

The Pure Food and Drug Act

Answer 1

• first law to regulate medications
• misbranding
• adulteration

Question 2

Food, Drug, and Cosmetic Act

Answer 2

• requires pharmaceutical manufacturers to prove a drug’s purity, strength, and safety before it is sold

Question 3

Durham-Humphrey Amendment 1951

Answer 3

• created 2 classes of medications: Rx and OTC
• OTC must contain active and inactive ingredients, purposes or uses, etc.

Question 4

Schedule II Rx must be:

Answer 4

written or faxed

Question 5

How many refills can a Schedule III and IV may have?

Answer 5

5 refills within 6 months

Question 6

What program is used for someone taking isotretinoin?

Answer 6

iPLEDGE

Question 7

What are the key aspects of prescribing isotretionin?

Answer 7

• can not have refills
• no more than a 30 days supply
• do not dispense date is 7 days after preg. test and 30 days after office visit

Question 8

What program is used to track the dispensing of immediate-release fentanyl products?

Answer 8

TIRF Program

Question 9

What is the LOTRONEX REMS Program?

Answer 9

• pertains to lotronex which is used for women with severe IBS
• severe GI effects from it

Question 10

Explain the Clozapine REMS Program

Answer 10

• ANC lab work must be complete before dispensing clozaril medications

Question 11

What is listed in the highlights section of a PI?

Answer 11

• contains the most important about benefits and risks of using the drug
• contains boxed warnings

Question 12

Where in the PI will you find the lists of conditions the medication is approved to treat?

Answer 12

Indications and Usage

Question 13

What is within the Nonclinical Toxicology section of a PI?

Answer 13

• lists any cancer and fertility risks from medication

Question 14

Where in the PI does it list the medication’s dosage forms, color, markings, and special storage/handling instr. ?

Answer 14

How Supplied

Question 15

What is the Orange Book?

Answer 15

• informs which generics are equivalent to which brand drugs

Question 16

The definition of a product being therapeutically equivalent.

Answer 16

generic products must be identical in active ingredients, strength, and dosage form to the brand name; must absorb and release identically in the body

Question 17

What does A stand for as a TE code?

Answer 17

product has therapeutic equivalence

Question 18

What does B stand for TE code?

Answer 18

product does not have ther. equi.

Question 19

What are pharmacological alternatives?

Answer 19

same active ingredient; different dosage form or strength

Question 20

What are therapeutic alternatives?

Answer 20

differenct active ingredient; used to treat the same condition

Question 21

What act issued child-resistant containers?

Answer 21

Poison Prevention Act of 1970

Question 22

Explain the Hatch-Waxman Act

Answer 22

• Drug Price Competition and Patent Term Restoration
• regulated generic drugs

Question 23

What act requires pharmacists to counsel patients?

Answer 23

OBRA ‘90