QUESTIONS AND ANSWERS VERIFIED 100%
CORRECT
Like foods and household products, generic drugs are usually lower
quality than the brand name drugs for which they are marketed as
equivalents. true or false - ANSWER -false
Legally, bioequivalence of different versions of a drug can vary by up
to ________. - ANSWER -20%
what is incorrect about biologics - ANSWER -they do not cause
immune responses
"large molecule" products are developed and manufactured by a
chemical process. true or false - ANSWER -false
what are drugs that attract or bind to cell receptors in order to mimic
or enhance activities by endogenous chemicals - ANSWER -agonists
Who is normally responsible for selling to distributors? - ANSWER -
NAMs
How often do secondary drug wholesale distributors buy their drugs
directly from manufactures? - ANSWER -sometimes
By FDA law, large chain pharmacies are not allowed to buy directly
from drug manufactures. true or false - ANSWER -false
Only 3 companies account for nearly 90% of all drug wholesale sales.
,true or false - ANSWER -true
What type of sale bypasses the need for intermediary distributors? -
ANSWER -manufacturer- direct- sales
what is a group purchasing organization (gpo) - ANSWER -an entity
consisting of two or more hospitals or other health care entities that
negotiates contracts on behalf of its members
Prescriptions dispensed by mail-order pharmacies are, on average,
around ____________ than those dispensed by retail pharmacies. -
ANSWER -3 times longer
what is not a stock sale ..
- brokerage sales
- docl-to-dock sales
-drop shipments - ANSWER -they all are
what is another term for rebates - ANSWER -after market
arrangements
the PDMA is the prescription drug manufacture organization. true or
false - ANSWER -false
A company that owns and operates three or fewer pharmacies is an
____________. - ANSWER -independant drug store
,Drug labels must include indications and usage information, as well
as contraindications. true or false - ANSWER -true
what should be included in the description section of a drugs package
insert information - ANSWER -the drugs proprietary name and
established name
Exclusivity gives exclusive ______, which is granted by the FDA, and
can run concurrently with a patent or not. - ANSWER -marketing
rights
what differentiates exclusively from a patent - ANSWER -exclusively is
only granted upon the drugs FDA approval
what is required of an invention for it to be worthy of patient
protection - ANSWER -it must be novel, useful, not obvious A generic
drug is ______ to the originator brand-name drug in dosage, strength,
safety, and quality. - ANSWER -bioequivalent
what is not required by FDA's criteria for equivalency - ANSWER --
what is generally considered the most reliable source of information
on therapeutically equivalent drug protects - ANSWER -approval drug
products with therapeutic equivalence
what is an orange book rating - ANSWER --
what is the term for chemical equivalents which are administered in
the same amounts will provide the same biological or physiological
, availability as measured by blood and urine levels - ANSWER
biological equivalents
what term denotes a drug that is identical or bioequivalent to the
originator brand name in dosage form, safety, strength, route, quality,
performance, characteristics, intended use - ANSWER -generic
what term denotes the dispensing of an unbranded generic product
for the product prescribed - ANSWER -generic substitution
what is the duration of a patent challenge - ANSWER -180 days
How is a drug sample closet or cabinet like a grocery store shelf? -
ANSWER -the more visibility you can give your drug, the more likely it
will be prescribed
pharm reps do not typically store and secure their own drug samples.
true or false - ANSWER -false
Sampling is sometimes the most important factor in a pharmaceutical
rep's success. true or false - ANSWER -true
the FDA approves storage conditions for drug products. true or false -
ANSWER -true
pharmaceutical reps must always record the amount of drug samples
left and obtain a signature for that amount. true or false - ANSWER true