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
what is a pricing benchmark
AWP
how do you find AWP?
redbook
for claims processing and product identification, what do you need?
awp AND NDC
What is the “starting point price” when pharmacies are buying drugs
AWP
who helps pharmacies negotiate better prices than AWP?
GPO – group purchasing organization
AWP-X%
x% is discount % when purchasing drugs. GPOs work to make that x a large percentage discount
besides drugs, what else does medwatch monitor?
products that are considered food (ie: nutraceuticals and supplements) and cosmetics
biologics, medical devices, etc
who can report a problem on medwatch?
ANYONE
who works with PBMs ? what do they do
PSAOs – “pharmacy services administration organization”
they perform collective negotiation of contract terms with PBMs
