NAPSRx Study Guide
Pharmaceuticals - ANSMedicines and vaccines for human and animal use. Products may
have a trademark (brand) name or be generic; and they may be prescription or over-the
counter.
Diagnostic - ANSEquipment and supplies used in screening, detecting, and monitoring
disease. Can range from simple home testing kits to sophisticated diagnostic imaging
technologies.
Medical Devices - ANSAdvanced instrumentation and appliances used for medical therapy,
such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug
delivery devices such as syringes, infusion pumps, metered-dose inhalers, and transdermal
patches.
Medical Supplies - ANSCommodity, high-volume supplies such as surgical gowns and
gloves.
Durable Medical Equipment - ANSReusable products for health-related use in the home,
such as walkers, wheelchairs, oxygen equipment, prosthetics and hospital beds.
What countries are pharmaceutical sales the highest? - ANSUnited States, Western Europe,
and Japan.
The U.S. accounts for roughly __________ of the world's pharmaceutical revenues. -
ANS50%
Two factors have significantly contributed to recent growth in the pharmaceutical industry
are? - ANSPopulation growth and increasing life expectancies.
What is the predicted relationship between pharmaceutical companies and genomic
research facilities? - ANSPartnerships between pharmaceutical companies and genomic
research facilities will not prove immediately profitable.
Prescription drug therapy is cost effective for insurance companies and health care
providers. True or False? - ANSTrue
The high price of health care is explained by the high price of medicines. True or False? -
ANSFalse
One of the oldest and least effective pharmaceutical marketing techniques is DTC
(direct-to-consumer) advertising. True or False? - ANSFalse
What influences the number of districts in a region? - ANSThe region's population.
,What is an example of the regionalization of healthcare delivery systems? - ANSCalifornia
and Florida have different prescription reimbursement policies.
What is the heart of a pharmaceutical sales team? - ANSDistrict Manager.
How many territories are in a typical district? - ANS8-12
What is the most effective method for grabbing market share? - ANSComparative selling.
The average review time for a new drug is 18 months, down from almost 3 years in 1996.
True or False? - ANSTrue
What are some questions reps should ask a physician? - ANSWhy do you prefer the
competitor's drug to ours? What do they like and dislike about it? Which patient types is the
drug being used for? What are the results and side effects, if any?
Note: Careful questioning and listening enables reps to craft effective messages based on
each physician's specific needs.
Pharmaceutical reps mainly visit pharmacies. True or False? - ANSFalse. Pharmaceutical
reps mainly visit/target physicians.
It usually takes only 1-2 calls on a physician before he or she prescribes your product. True
or False? - ANSFalse. Your success ultimately depends on your relationship with the
physician. This takes time. Persistence is key.
The pharmacist may dispense a product other than what the physician prescribed. True or
False? - ANSTrue. The pharmacist can either (1) dispense a generic; (2) The pharmacist
calls the doctor and requests permission to dispense a different medication.
According to chapter 2 of your manual which of the following classifies as payers?
(a) employers
(b) patients
(c) pharmacists
(d) physicians - ANS(a) employers
Some third party payers include the insurance company, the employer, managed care
organization, or the U.S. government (Medicare/Medicaid).
What defines ethical pharmaceutical companies? - ANSPharmaceutical companies that
research and develop novel drugs.
Thanks to modern medicine how long are people newly diagnosed with HIV expected to
live? - ANSAnother 50 years.
How much has the average American lifespan increased since 1890? - ANS30 years
What is a treatment group? - ANSA group of patients assigned to receive specific treatment.
, What is the main difference between a blinded and double-blinded study? - ANSIn a double
blinded study, neither the staff nor the study participants know which subjects are in the
experimental group and which subjects are in the control group.
What does asymptomatic mean? - ANSWithout signs or symptoms of disease.
What is an approvable letter? - ANSLetters sent by the FDA to the applicant indicating
whether the new drug application (NDA) or abbreviated new drug application (ANDA) for a
product meets the necessary requirements and whether or not the agency believes that it
can approve the application or abbreviated application if specific additional information or
material is submitted or specific conditions (e.g., certain changes in labeling) are agreed to
by the applicant.
What is a blinded or masked study? - ANSA study in which participants do not know whether
they are in the experimental or control group of a research study. Those in the experimental
group get the medications or treatments being tested, while those in the control group get
standard treatment or no treatment.
What is a control or control group? - ANSThe standard by which experimental observations
are evaluated. In many clinical trials, one group of patients will be given an experimental
drug or treatment, while the control group is given either a standard treatment for the illness
or a placebo.
What is a double-blind or double-masked study? - ANSA study in which neither the
participants nor the study staff know which participants are receiving the experimental
treatment and which patients are in the control group. These studies are performed so
neither the patient nor doctor expectations about the experimental drug can influence the
outcome.
What is edema? - ANSSwelling.
What are fast-track drugs? - ANSFast-track drug approval is provided for drugs that meet
medical needs for patients with serious or life-threatening conditions.
What is indication in terms of drug approval? - ANSThe exact cause or purpose for which the
FDA has approved that a new drug can be prescribed.
What is the institutional review board (IRB)? - ANSA committee of physicians, statisticians,
community advocates, and others which ensures that a clinical trial is ethical and that the
rights of the study participants are protected. All clinical trials in the U.S. must be approved
by the IRB before they begin.
What does the term "off label" mean? - ANSUsage of a medication for purposes other than
the specific ones appearing in the labeling.
Pharmaceuticals - ANSMedicines and vaccines for human and animal use. Products may
have a trademark (brand) name or be generic; and they may be prescription or over-the
counter.
Diagnostic - ANSEquipment and supplies used in screening, detecting, and monitoring
disease. Can range from simple home testing kits to sophisticated diagnostic imaging
technologies.
Medical Devices - ANSAdvanced instrumentation and appliances used for medical therapy,
such as joint replacements, implantable defibrillators, and pacemakers. Also includes drug
delivery devices such as syringes, infusion pumps, metered-dose inhalers, and transdermal
patches.
Medical Supplies - ANSCommodity, high-volume supplies such as surgical gowns and
gloves.
Durable Medical Equipment - ANSReusable products for health-related use in the home,
such as walkers, wheelchairs, oxygen equipment, prosthetics and hospital beds.
What countries are pharmaceutical sales the highest? - ANSUnited States, Western Europe,
and Japan.
The U.S. accounts for roughly __________ of the world's pharmaceutical revenues. -
ANS50%
Two factors have significantly contributed to recent growth in the pharmaceutical industry
are? - ANSPopulation growth and increasing life expectancies.
What is the predicted relationship between pharmaceutical companies and genomic
research facilities? - ANSPartnerships between pharmaceutical companies and genomic
research facilities will not prove immediately profitable.
Prescription drug therapy is cost effective for insurance companies and health care
providers. True or False? - ANSTrue
The high price of health care is explained by the high price of medicines. True or False? -
ANSFalse
One of the oldest and least effective pharmaceutical marketing techniques is DTC
(direct-to-consumer) advertising. True or False? - ANSFalse
What influences the number of districts in a region? - ANSThe region's population.
,What is an example of the regionalization of healthcare delivery systems? - ANSCalifornia
and Florida have different prescription reimbursement policies.
What is the heart of a pharmaceutical sales team? - ANSDistrict Manager.
How many territories are in a typical district? - ANS8-12
What is the most effective method for grabbing market share? - ANSComparative selling.
The average review time for a new drug is 18 months, down from almost 3 years in 1996.
True or False? - ANSTrue
What are some questions reps should ask a physician? - ANSWhy do you prefer the
competitor's drug to ours? What do they like and dislike about it? Which patient types is the
drug being used for? What are the results and side effects, if any?
Note: Careful questioning and listening enables reps to craft effective messages based on
each physician's specific needs.
Pharmaceutical reps mainly visit pharmacies. True or False? - ANSFalse. Pharmaceutical
reps mainly visit/target physicians.
It usually takes only 1-2 calls on a physician before he or she prescribes your product. True
or False? - ANSFalse. Your success ultimately depends on your relationship with the
physician. This takes time. Persistence is key.
The pharmacist may dispense a product other than what the physician prescribed. True or
False? - ANSTrue. The pharmacist can either (1) dispense a generic; (2) The pharmacist
calls the doctor and requests permission to dispense a different medication.
According to chapter 2 of your manual which of the following classifies as payers?
(a) employers
(b) patients
(c) pharmacists
(d) physicians - ANS(a) employers
Some third party payers include the insurance company, the employer, managed care
organization, or the U.S. government (Medicare/Medicaid).
What defines ethical pharmaceutical companies? - ANSPharmaceutical companies that
research and develop novel drugs.
Thanks to modern medicine how long are people newly diagnosed with HIV expected to
live? - ANSAnother 50 years.
How much has the average American lifespan increased since 1890? - ANS30 years
What is a treatment group? - ANSA group of patients assigned to receive specific treatment.
, What is the main difference between a blinded and double-blinded study? - ANSIn a double
blinded study, neither the staff nor the study participants know which subjects are in the
experimental group and which subjects are in the control group.
What does asymptomatic mean? - ANSWithout signs or symptoms of disease.
What is an approvable letter? - ANSLetters sent by the FDA to the applicant indicating
whether the new drug application (NDA) or abbreviated new drug application (ANDA) for a
product meets the necessary requirements and whether or not the agency believes that it
can approve the application or abbreviated application if specific additional information or
material is submitted or specific conditions (e.g., certain changes in labeling) are agreed to
by the applicant.
What is a blinded or masked study? - ANSA study in which participants do not know whether
they are in the experimental or control group of a research study. Those in the experimental
group get the medications or treatments being tested, while those in the control group get
standard treatment or no treatment.
What is a control or control group? - ANSThe standard by which experimental observations
are evaluated. In many clinical trials, one group of patients will be given an experimental
drug or treatment, while the control group is given either a standard treatment for the illness
or a placebo.
What is a double-blind or double-masked study? - ANSA study in which neither the
participants nor the study staff know which participants are receiving the experimental
treatment and which patients are in the control group. These studies are performed so
neither the patient nor doctor expectations about the experimental drug can influence the
outcome.
What is edema? - ANSSwelling.
What are fast-track drugs? - ANSFast-track drug approval is provided for drugs that meet
medical needs for patients with serious or life-threatening conditions.
What is indication in terms of drug approval? - ANSThe exact cause or purpose for which the
FDA has approved that a new drug can be prescribed.
What is the institutional review board (IRB)? - ANSA committee of physicians, statisticians,
community advocates, and others which ensures that a clinical trial is ethical and that the
rights of the study participants are protected. All clinical trials in the U.S. must be approved
by the IRB before they begin.
What does the term "off label" mean? - ANSUsage of a medication for purposes other than
the specific ones appearing in the labeling.
