CNPR EXAM 6 KEY CONCEPTS AND
PRACTICE QUESTIONS
◉ Overdosage section of labeling.
Answer: signs, symptoms and treatment of acute overdoses
◉ Types of drug-drug interactions.
Answer: duplication, opposition (antagonism) and alteration
◉ Tolerance vs Resistance.
Answer: tolerance is the diminished response to a drug; resistance is
the cells ability to resist the effects of the drug on them.
◉ Abbreviated New Drug Application (ANDA).
Answer: the process by which applicants must scientifically
demonstrate to the FDA that their generic product is bioequivalent
to or performs in the same way as the innovator drug, no duplicate
testing
◉ Hatch-Waxman Act of 1984.
Answer: A.K.A. Drug Price Competition and Patent Restoration Act;
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; gave protection to the research based manufacturers by
providing a 30-month automatic cooling off period once an ANDA is
challenged for patent infringement.
◉ Four basic transport mechanisms.
Answer: passive diffusion, facilitated diffusion, active transport, and
pinocytosis
◉ Potency vs Efficacy.
Answer: potency: amount of drug necessary to produce desired
effect; efficacy: magnitude of maximal response that can be received
from a drug; efficacy is almost always more important than potency.
◉ Four phases of clinical trials.
Answer: phases I-IV
◉ Key Parts Of A Clinical Paper.
Answer: Abstract, Introduction, methods, results,
discussion/conclusions
◉ Reliability vs Validity.
Answer: reliability = consistency and validity = accuracy
,◉ Sampling error vs Selection bias.
Answer: sampling error is unbiased and is randomly chosen from
the population; selection bias is when the sample was specifically
chosen based on particular characteristics.
◉ Independent vs Dependent variable.
Answer: An independent variable is the one that influences the
variation. A dependent variable is the variable being tested and
measured in a scientific experiment.
◉ Drug Utilization Review (DUR) programs.
Answer: involve retrospective monitoring of physicians' prescribing
patterns; more than 90% of HMOs require DURs; nowadays mostly
monitors cost savings.
◉ Opportunity cost.
Answer: based on the premise that all resources are scarce, and
therefore every time we choose to use a resource it reduces the
possibility of it being used in another way.
◉ DTC advertising in Europe.
Answer: Disease-state or unbranded ads (provides public
information on a disease, not a drug)
, ◉ PhRMA code on meals.
Answer: company reps can only offer occasional meals as long as
they are modest, and only offered in an office/hospital setting in
conjunction with an educational presentation.
◉ FAQ about the PhRMA code.
Answer: p. 268-274
◉ Urology and selling to Urologists.
Answer: p. 300-301
◉ Medical Science Liaison (MLS).
Answer: they serve as educators and field-based medical resources;
they interface between their company and healthcare leaders.
◉ Push through vs Pull through sales strategies.
Answer: push-through refers to the company's overall efforts to
demonstrate clinical efficiency and efficacy and cost effectiveness of
a product.
◉ pull-through.
Answer: generates demand for the product, usually in ways
consistent with the health plans goals and guidelines.
PRACTICE QUESTIONS
◉ Overdosage section of labeling.
Answer: signs, symptoms and treatment of acute overdoses
◉ Types of drug-drug interactions.
Answer: duplication, opposition (antagonism) and alteration
◉ Tolerance vs Resistance.
Answer: tolerance is the diminished response to a drug; resistance is
the cells ability to resist the effects of the drug on them.
◉ Abbreviated New Drug Application (ANDA).
Answer: the process by which applicants must scientifically
demonstrate to the FDA that their generic product is bioequivalent
to or performs in the same way as the innovator drug, no duplicate
testing
◉ Hatch-Waxman Act of 1984.
Answer: A.K.A. Drug Price Competition and Patent Restoration Act;
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; gave protection to the research based manufacturers by
providing a 30-month automatic cooling off period once an ANDA is
challenged for patent infringement.
◉ Four basic transport mechanisms.
Answer: passive diffusion, facilitated diffusion, active transport, and
pinocytosis
◉ Potency vs Efficacy.
Answer: potency: amount of drug necessary to produce desired
effect; efficacy: magnitude of maximal response that can be received
from a drug; efficacy is almost always more important than potency.
◉ Four phases of clinical trials.
Answer: phases I-IV
◉ Key Parts Of A Clinical Paper.
Answer: Abstract, Introduction, methods, results,
discussion/conclusions
◉ Reliability vs Validity.
Answer: reliability = consistency and validity = accuracy
,◉ Sampling error vs Selection bias.
Answer: sampling error is unbiased and is randomly chosen from
the population; selection bias is when the sample was specifically
chosen based on particular characteristics.
◉ Independent vs Dependent variable.
Answer: An independent variable is the one that influences the
variation. A dependent variable is the variable being tested and
measured in a scientific experiment.
◉ Drug Utilization Review (DUR) programs.
Answer: involve retrospective monitoring of physicians' prescribing
patterns; more than 90% of HMOs require DURs; nowadays mostly
monitors cost savings.
◉ Opportunity cost.
Answer: based on the premise that all resources are scarce, and
therefore every time we choose to use a resource it reduces the
possibility of it being used in another way.
◉ DTC advertising in Europe.
Answer: Disease-state or unbranded ads (provides public
information on a disease, not a drug)
, ◉ PhRMA code on meals.
Answer: company reps can only offer occasional meals as long as
they are modest, and only offered in an office/hospital setting in
conjunction with an educational presentation.
◉ FAQ about the PhRMA code.
Answer: p. 268-274
◉ Urology and selling to Urologists.
Answer: p. 300-301
◉ Medical Science Liaison (MLS).
Answer: they serve as educators and field-based medical resources;
they interface between their company and healthcare leaders.
◉ Push through vs Pull through sales strategies.
Answer: push-through refers to the company's overall efforts to
demonstrate clinical efficiency and efficacy and cost effectiveness of
a product.
◉ pull-through.
Answer: generates demand for the product, usually in ways
consistent with the health plans goals and guidelines.
