CNPR,NAPSR Exam Test Questions And
Answers Verified 100% Correct
Integrated Delivery Network IDN - ANSWER -a financial management
structure that unites hospitals, physicians ambulatory care site and
managed care plans through ownership or exclusive formal
agreements to provide a system to deliver a continuum of healthcare
services
Mail order pharmacy - ANSWER -a pharmacy that dispenses
prescriptions to patients who submit their prescriptions by mail or fax
manufacturer direct sale - ANSWER -the type of sale that bypasses
the need for any intermediary distributor
mass merchandiser - ANSWER -Department stores with a pharmacy
non-stock sales - ANSWER -brokerage sales, dock to dock sales, drop
shipments, and any form of sale not placed in inventory
out of state wolesaler - ANSWER -a wholesaler that distributes drug
products in a state in which it is not physically located
pharmacy benefit management group - ANSWER -an entity that
administers the prescription drug part of health insurance plans on
behalf of plan sponsors such as self insured employers, insureance
companies, and health maintenance organizations
rebate - ANSWER -the amount that the manufacturer of the drug pays
to an insurer or health plan for each unit of drug dispensed
,self warehousing - ANSWER -a type of distribution system where the
retailer of the institutional dispenser takes on the task of distribution
itself
sell-side margin - ANSWER -wholesaler revenues that are generated
from fees and other charges obtained from dispensers
Upcharge - ANSWER -the percentage fee that is paid by the dispenser
to the wholesaler for the cost of distribution
Orphan Drug (ODE) ` - ANSWER -7 years exclusivity
New Chemical entity - ANSWER -5 years exclusivity
Other Exclusivity - ANSWER -3 years for a change if criteria are met
Pediatric Exclusivity (PED) - ANSWER -6 months added to existing
Patents/exclusivity
Patent Challenge - ANSWER -180 days for ANDAs only
Duration of a patent - ANSWER -20 years
,Package insert - ANSWER -provide practitioners with essential
information they need to prescribe the drug safely and effectively for
the care of patients
Orange Book - ANSWER -list of approved drug products with
therapeutic equivalence
A OBR - ANSWER -products for which there are no known or
suspected bioequivalence problems
AA OBR - ANSWER -products in conventional dosage forms with no
bioequivalence problems
AN OBR - ANSWER -solutions and powders
AO OBR - ANSWER -Injectable oil solutions
AP - ANSWER -injectable aqueous solutions
AT - ANSWER -topical products
B - ANSWER -drug products requiring further FDA investigation and
review to determine equivalence
ANDA - ANSWER -abbreviated new drug application
, How many days does a brand name company have to sue - ANSWER
45
Generic drug first to file exclusivity - ANSWER -the first generic drug
manufacturer to file an ANDA with the FDA on a new off-patent drug
receives a six-month marketing exclusivity
Single-source drug products - ANSWER -there is only one approved
product available for that active ingredient and dosage form
Multi-source drug prodcuts - ANSWER -pharmaceutically equivalent
products are available from more than one manufacturer
Hatch Waxman act - ANSWER -also known as the drug price
competition and patent tem restoration act of 1984 most significant
drug related legislation affecting pharmaceutical and healthcare
industries since 1962
HW Act - ANSWER -made it easier to bring generic drugs to the
market by requiring the FDA to only look at bioavailability studies in
order to approve an ANDA
chemical equivalents - ANSWER -multi-source products which
contain essentially the same amounts of identical active ingredients
in identical dosage forms which meet existing physical chemical
standards
Biological equivalents - ANSWER -chemical equivalents which when
administered in the same amount will provide same biological or
physiological availability as measured by blood and urine levels
Answers Verified 100% Correct
Integrated Delivery Network IDN - ANSWER -a financial management
structure that unites hospitals, physicians ambulatory care site and
managed care plans through ownership or exclusive formal
agreements to provide a system to deliver a continuum of healthcare
services
Mail order pharmacy - ANSWER -a pharmacy that dispenses
prescriptions to patients who submit their prescriptions by mail or fax
manufacturer direct sale - ANSWER -the type of sale that bypasses
the need for any intermediary distributor
mass merchandiser - ANSWER -Department stores with a pharmacy
non-stock sales - ANSWER -brokerage sales, dock to dock sales, drop
shipments, and any form of sale not placed in inventory
out of state wolesaler - ANSWER -a wholesaler that distributes drug
products in a state in which it is not physically located
pharmacy benefit management group - ANSWER -an entity that
administers the prescription drug part of health insurance plans on
behalf of plan sponsors such as self insured employers, insureance
companies, and health maintenance organizations
rebate - ANSWER -the amount that the manufacturer of the drug pays
to an insurer or health plan for each unit of drug dispensed
,self warehousing - ANSWER -a type of distribution system where the
retailer of the institutional dispenser takes on the task of distribution
itself
sell-side margin - ANSWER -wholesaler revenues that are generated
from fees and other charges obtained from dispensers
Upcharge - ANSWER -the percentage fee that is paid by the dispenser
to the wholesaler for the cost of distribution
Orphan Drug (ODE) ` - ANSWER -7 years exclusivity
New Chemical entity - ANSWER -5 years exclusivity
Other Exclusivity - ANSWER -3 years for a change if criteria are met
Pediatric Exclusivity (PED) - ANSWER -6 months added to existing
Patents/exclusivity
Patent Challenge - ANSWER -180 days for ANDAs only
Duration of a patent - ANSWER -20 years
,Package insert - ANSWER -provide practitioners with essential
information they need to prescribe the drug safely and effectively for
the care of patients
Orange Book - ANSWER -list of approved drug products with
therapeutic equivalence
A OBR - ANSWER -products for which there are no known or
suspected bioequivalence problems
AA OBR - ANSWER -products in conventional dosage forms with no
bioequivalence problems
AN OBR - ANSWER -solutions and powders
AO OBR - ANSWER -Injectable oil solutions
AP - ANSWER -injectable aqueous solutions
AT - ANSWER -topical products
B - ANSWER -drug products requiring further FDA investigation and
review to determine equivalence
ANDA - ANSWER -abbreviated new drug application
, How many days does a brand name company have to sue - ANSWER
45
Generic drug first to file exclusivity - ANSWER -the first generic drug
manufacturer to file an ANDA with the FDA on a new off-patent drug
receives a six-month marketing exclusivity
Single-source drug products - ANSWER -there is only one approved
product available for that active ingredient and dosage form
Multi-source drug prodcuts - ANSWER -pharmaceutically equivalent
products are available from more than one manufacturer
Hatch Waxman act - ANSWER -also known as the drug price
competition and patent tem restoration act of 1984 most significant
drug related legislation affecting pharmaceutical and healthcare
industries since 1962
HW Act - ANSWER -made it easier to bring generic drugs to the
market by requiring the FDA to only look at bioavailability studies in
order to approve an ANDA
chemical equivalents - ANSWER -multi-source products which
contain essentially the same amounts of identical active ingredients
in identical dosage forms which meet existing physical chemical
standards
Biological equivalents - ANSWER -chemical equivalents which when
administered in the same amount will provide same biological or
physiological availability as measured by blood and urine levels
