Drug Regulation And Control Flashcards
Which is an example of a medication that is part of a class 2 recall
A contaminated medication that could cause temporary, reversible adverse effects
Exenatide and Iiraglutide are both in region memetics used to treat diabetes. Exenatide and Iiraglutide are
Therapeutic alternatives
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:
Market withdrawl
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)
Pharmaceutical equivalent
Which DAW code means the brand name product is dispensed as generic?
DAW 5
Mylan’s clonazepam 1mg is AB-rated to Klonopin 1mg. This means:
Clonazepam is the therapeutic equivalent to Klonopin
What is a manufacturer allowed to change when creating an equivalent generic medication
Fillers
Which committee approves patient consent forms and protects the welfare of drug research volunteers
IRB
For an involuntary recall, who requires the recalled drug to be removed from pharmacy shelves
FDA
Which phase of testing involves introducing a drug for the first time in humans
Phase 1 Testing
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?
Phase 3 testing
A drug that contains a different active ingredient, but is the same drug class and works similarly to another medication is considered a
Therapeutic alternative
FDA approved an ANDA. This means a manufacturer can
Bring a generic medication to market
A brand name patent gives a drug company exclusive rights to the compound for a ___________ time
Limited
An injectable med with pieces of glass in the medication is an example of which type of recall
Class I
A drug that contains the same ingredient, but is a different strength is considered a
Pharmacological alternative
What does DAW 0 mean?
No product substitution is indicated, substitution is allowed
A collaborative agreement is a system that allows pharmacists to automatically substitute
Pharmacological and therapeutic alternatives
What does DAW 2 mean
Patient requests name brand
Investigational drug returns can be performed by the
IDs technician
FDA may approve a Biological License Application is the biological proves to be
Safe and effective
What is an investigational drug
A drug compound undergoing clinical testing in humans
Which type of recall involves products that are unlikely to cause adverse effects
Class III
What does DAW 3 mean?
Pharmacist determines brand should be dispensed
Which resource contains TE codes to help guide generic substitution
Orange book
Which DAW code means the substitution is not allowed by the prescriber
DAW 1
What does DAW 6 mean
An override is required
What does DAW 7 mean
Substitution is not allowed since the brand name is mandated by law
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?
They contain the same active ingredient, but are different dosage forms
