ANSWER KEY FOR 16TH EDITION CNPR PHARMACEUTICAL
SALES REPS EXAM QUESTIONS AND ANSWERS
what accurately differentiates resistance from tolerance - ANSWER-
tolerance refers to a persons diminished response to a drug after repeated use,
while resistance applies to microorganisms
between 3%-7% of hospital admissions in the US are estimated to be treatment for
adverse drug reactions. true or false - ANSWER- true
why is noncompliance a serious public health concern - ANSWER- it
increases the cost of medical care
which of the following is not eligible for patent protection under u.s. regulations -
ANSWER- companies would be granted patents for all of these
things..
1. drug itself
2. delivery method & release drug into bloodstream
3. the way the drug is made
drug trade names are often unrelated to their intended use. true or false -
ANSWER- true
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? - CORRECT
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 - CORRECT
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
what is prohibited by section 503 of the federal food and drug and cosmetic act as
amended by the prescription drug marketing act - ANSWER- the sale,
purchase, or trade, or offer to sell, purchase, or trade prescription drug sales
the federal government does not regulate the drug sampling for a pharm rep. true or
false - ANSWER- false
SALES REPS EXAM QUESTIONS AND ANSWERS
what accurately differentiates resistance from tolerance - ANSWER-
tolerance refers to a persons diminished response to a drug after repeated use,
while resistance applies to microorganisms
between 3%-7% of hospital admissions in the US are estimated to be treatment for
adverse drug reactions. true or false - ANSWER- true
why is noncompliance a serious public health concern - ANSWER- it
increases the cost of medical care
which of the following is not eligible for patent protection under u.s. regulations -
ANSWER- companies would be granted patents for all of these
things..
1. drug itself
2. delivery method & release drug into bloodstream
3. the way the drug is made
drug trade names are often unrelated to their intended use. true or false -
ANSWER- true
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? - CORRECT
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 - CORRECT
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
what is prohibited by section 503 of the federal food and drug and cosmetic act as
amended by the prescription drug marketing act - ANSWER- the sale,
purchase, or trade, or offer to sell, purchase, or trade prescription drug sales
the federal government does not regulate the drug sampling for a pharm rep. true or
false - ANSWER- false
