PTU Study Deck Pt. 1 Flashcards
The Pure Food and Drug Act
- first law to regulate medications
- misbranding
- adulteration
Food, Drug, and Cosmetic Act
- requires pharmaceutical manufacturers to prove a drug’s purity, strength, and safety before it is sold
Durham-Humphrey Amendment 1951
- created 2 classes of medications: Rx and OTC
- OTC must contain active and inactive ingredients, purposes or uses, etc.
Schedule II Rx must be:
written or faxed
How many refills can a Schedule III and IV may have?
5 refills within 6 months
What program is used for someone taking isotretinoin?
iPLEDGE
What are the key aspects of prescribing isotretionin?
- 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
What program is used to track the dispensing of immediate-release fentanyl products?
TIRF Program
What is the LOTRONEX REMS Program?
- pertains to lotronex which is used for women with severe IBS
- severe GI effects from it
Explain the Clozapine REMS Program
- ANC lab work must be complete before dispensing clozaril medications
What is listed in the highlights section of a PI?
- contains the most important about benefits and risks of using the drug
- contains boxed warnings
Where in the PI will you find the lists of conditions the medication is approved to treat?
Indications and Usage
What is within the Nonclinical Toxicology section of a PI?
- lists any cancer and fertility risks from medication
Where in the PI does it list the medication’s dosage forms, color, markings, and special storage/handling instr. ?
How Supplied
What is the Orange Book?
- informs which generics are equivalent to which brand drugs
The definition of a product being therapeutically equivalent.
generic products must be identical in active ingredients, strength, and dosage form to the brand name; must absorb and release identically in the body
What does A stand for as a TE code?
product has therapeutic equivalence
What does B stand for TE code?
product does not have ther. equi.
What are pharmacological alternatives?
same active ingredient; different dosage form or strength
What are therapeutic alternatives?
differenct active ingredient; used to treat the same condition
What act issued child-resistant containers?
Poison Prevention Act of 1970
Explain the Hatch-Waxman Act
- Drug Price Competition and Patent Term Restoration
- regulated generic drugs
What act requires pharmacists to counsel patients?
OBRA ‘90
