NAPSRx CNPR exam (Revised 18th Edition)
"fast track drugs" refer to - ANS - drugs approved for serious or life-threatening conditions
\abbreviated new drug application (ANDA) - ANS - 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 (p. 75)
\according to the AMA guidelines, who should accept subsidies for continuing medical education
conferences? - ANS - conference sponsors
\can pharma sales reps offer doctors meals? (PhRMA code) - ANS - 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. (p. 228)
\drug labeling requirements FDA - ANS -
https://www.fda.gov/about-fda/oncology-center-excellence/how-do-i-use-prescription-drug-labeli
ng#Section-10
\Drug Utilization Review (DUR) programs - ANS - -involve retrospective monitoring of
physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
\FAQ about the PhRMA code - ANS - p. 268-274
\four basic transport mechanisms - ANS - passive diffusion, facilitated diffusion, active transport,
and pinocytosis (p. 95)
\generic drug definition - ANS - a drug identical to a brand-name drug in various aspects
\how can e-prescribing prevent abuse of controlled substances? - ANS - by cross-checking
regional e-prescriptions
\how can pharmaceutical sales representatives leverage clinical evidence to address rumors? -
ANS - present current clinical studies that address concerns
\how can you set the mood for a successful speaker program during the event? - ANS -
Introduce the speaker and allow for a question-and-answer format
\in the methods section of a clinical paper, what info is provided? - ANS - patient characteristics
and demographics
\independent vs dependent variable - ANS - An independent variable is the one that influences
the variation. A dependent variable is the variable being tested and measured in a scientific
experiment (the result of applying the independent variable).
\Key Parts Of A Clinical Paper (5) - ANS - Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
\opportunity cost - ANS - 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.
\potency vs efficacy - ANS - 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 that potency* (p. 106)
"fast track drugs" refer to - ANS - drugs approved for serious or life-threatening conditions
\abbreviated new drug application (ANDA) - ANS - 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 (p. 75)
\according to the AMA guidelines, who should accept subsidies for continuing medical education
conferences? - ANS - conference sponsors
\can pharma sales reps offer doctors meals? (PhRMA code) - ANS - 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. (p. 228)
\drug labeling requirements FDA - ANS -
https://www.fda.gov/about-fda/oncology-center-excellence/how-do-i-use-prescription-drug-labeli
ng#Section-10
\Drug Utilization Review (DUR) programs - ANS - -involve retrospective monitoring of
physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
\FAQ about the PhRMA code - ANS - p. 268-274
\four basic transport mechanisms - ANS - passive diffusion, facilitated diffusion, active transport,
and pinocytosis (p. 95)
\generic drug definition - ANS - a drug identical to a brand-name drug in various aspects
\how can e-prescribing prevent abuse of controlled substances? - ANS - by cross-checking
regional e-prescriptions
\how can pharmaceutical sales representatives leverage clinical evidence to address rumors? -
ANS - present current clinical studies that address concerns
\how can you set the mood for a successful speaker program during the event? - ANS -
Introduce the speaker and allow for a question-and-answer format
\in the methods section of a clinical paper, what info is provided? - ANS - patient characteristics
and demographics
\independent vs dependent variable - ANS - An independent variable is the one that influences
the variation. A dependent variable is the variable being tested and measured in a scientific
experiment (the result of applying the independent variable).
\Key Parts Of A Clinical Paper (5) - ANS - Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
\opportunity cost - ANS - 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.
\potency vs efficacy - ANS - 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 that potency* (p. 106)
