Lecture 2 Flashcards
_____ has a database of drug shortages
FDA
When a drug is in shortage, how does this affect insurance?
they may replace that drug in shortage with an alternative for their formulary – so ppl can still get their needed medication
explain the controversy of determining if a product is FDA approved and 3 resources to go to
Drug vs product – the INGREDIENT in a product may be approved, but the product itself may not be.
3 resources: drugs@FDA, purple/orange book and national drug code
according to Nayak, is there a foolproof way of looking at a bottle and saying definitively if it’s FDA approved?
no
a “TE code” for generics is based on what 2 things?
bioavailability and bioequivalence
in the orange book, there is an additional column called “application number”
what is this number?
NDA#
true or false
the FDA has zero concerns of the brand therapeutic equivalence if a generic has an “A” rating
true
can a B rated generic become A rated?
yes – with more info
can pharmacists substitute a brand for a B rated generic?
no law prohibiting it, but it is a risk for the pharmacist. done a lot if there are shortage issues
are B rated generics FDA approved
yes
what does NDC stand for
national drug code
___ has a database of NDC’s
the FDA
How many digits are there in an NDC?
usually 10, but newer drugs may have 11
name the 3 parts of an NDC
- labeler
- product code
- package code
“product ID”
NDC
