NAPSRX EXAM STUDY GUIDE
QUESTIONS AND ANSWERS.
What is the placebo effect? - Answer-The effect produced by a placebo due to the
expectations of the patient. The effect in placebo-controlled clinical trials is generally
measured by comparing the effect observed in patients receiving the placebo
treatment to the effect observed in patients receiving the active treatment.
What is study protocol? - Answer-The general design and operating features of a
trial. It is distinguished from the study manual operations by its generality and
absence of specific details needed for day-to-day execution of the trial.
Define toxicity. - Answer-The extent, quality, or degree to which a substance is
poisonous or harmful to the body.
Define "anatomy" - Answer-The study of the basic structures of the body.
Define "physiology" - Answer-The study of how those body structures function
Define "clinical pharmacology" - Answer-The study of the effects and movements of
drugs in the human body.
Define "pharmacodynamics" - Answer-Study of biochemical and physiological effects
of drugs and their mechanisms of action, i.e., the study of what a drug does to the
body. Drug dynamics (pharmacodynamics) describes the therapeutic effects of drugs
(e.g., pain relief, blood pressure reduction), their side effects, their sites of action
(i.e., which tissues they act on), and their mechanisms of action (i.e., how they act on
those tissues). A drug's effects on the body may be influenced by many factors, such
as a person's age and genetic makeup and disorders the person has other than the
one being treated.
Define "pharmacokinetics" - Answer-Study of how a drug is processed by the body,
with emphasis on the time required for absorption, duration of action, distribution,
and method of excretion, i.e., the study of how the body affects drugs.
Drug distribution and elimination - Answer-Drug delivery systems, route of
administration, modes of excretion (passing from the body).
About __ people in the U.S are slow acetylators?
(a) 1%
(b) 5%
(c) 25%
(d) 50% - Answer-50% of people are slow acetylators. Where is this in the book?
Which statements are/is INCORRECT about an ideal drug or magic bullet as Ehrlich
phrased it?
(a) it does not exist
(b) it would be aimed precisely at the disease site
,(c) it would not harm healthy tissues
(d) All of these statements are correct - Answer-(d) All of these statements are
correct
Which term denotes the study of bodily functions? - Answer-Physiology
What is a blinded or masked study? - Answer-A 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? - Answer-The 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? - Answer-A 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? - Answer-Swelling.
What are fast-track drugs? - Answer-Fast-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? - Answer-The exact cause or purpose
for which the FDA has approved that a new drug can be prescribed.
What is the institutional review board (IRB)? - Answer-A 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? - Answer-Usage of a medication for purposes
other than the specific ones appearing in the labeling.
What is a placebo? - Answer-A placebo is an inactive pill, liquid, or powder that has
no treatment value. In clinical trials, experimental treatments are often compared
with placebos to assess the treatment's effectiveness
What is the broadest definition of a drug? - Answer-Any substance that produces a
physical or psychological change in the body.
How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug? -
Answer-Any substance intended for use in the diagnosis, cure, mitigation, treatment
or prevention of a disease or a substance other than food intended to affect structure
of function of the body.
, What is true about vitamins? - Answer-Most of the body's required vitamins must be
taken in from outside the body.
What does ADME testing measure? - Answer-The rate at which the body absorbs
the drug, distributes it to the organs necessary to produce the desired effect,
metabolizes it into waste material and then excretes it from the body.
ADME testing is primarily used in what field? - Answer-Pharmacokinetics
What is true about placebos? - Answer-Effects can lead to withdrawal symptoms.
On average, what percent of drugs are studied in the lab are eventually studied in
people? - Answer-5 of 4000
What is true about drugs taken sublingually? - Answer-Are absorbed directly and
almost immediately into the bloodstream.
What are 3 of the 7 rights of the drug administration? - Answer-The right patient, the
right drug, and the right dose.
Pro-drugs are administered in the active for, which is metabolized into an active
form. - Answer-False
The kidney of an 85 year old person excretes drugs only _____________ as
efficiently as that of a 35 year old person. - Answer-Around 50%
The normal age related disease in kidney function can help doctors determine an
appropriate dosage based solely on a person age. - Answer-True
What differentiates a caplet from a tablet? - Answer-Caplets are shaped like
capsules and have film coatings to aid in swallowing.
Where will you find the legend "federal law prohibits dispensing without a
prescription"? - Answer-On the label of all prescription drugs.
What happens in slow acetylators? - Answer-Drugs that are metabolized by N-acetyl
transferase tend to reach higher blood levels and remain in the body longer.
About _________ of the people in the Unites States are slow acetylators. - Answer-
50%
Smoking decreases the effectiveness of some drugs. - Answer-True
What about drug-drug interaction is not correct? - Answer-Drug interaction are
always harmful.
What about dietary supplements is incorrect? - Answer-Because dietary
supplements are not drugs, interacting with drugs is not a concern.
QUESTIONS AND ANSWERS.
What is the placebo effect? - Answer-The effect produced by a placebo due to the
expectations of the patient. The effect in placebo-controlled clinical trials is generally
measured by comparing the effect observed in patients receiving the placebo
treatment to the effect observed in patients receiving the active treatment.
What is study protocol? - Answer-The general design and operating features of a
trial. It is distinguished from the study manual operations by its generality and
absence of specific details needed for day-to-day execution of the trial.
Define toxicity. - Answer-The extent, quality, or degree to which a substance is
poisonous or harmful to the body.
Define "anatomy" - Answer-The study of the basic structures of the body.
Define "physiology" - Answer-The study of how those body structures function
Define "clinical pharmacology" - Answer-The study of the effects and movements of
drugs in the human body.
Define "pharmacodynamics" - Answer-Study of biochemical and physiological effects
of drugs and their mechanisms of action, i.e., the study of what a drug does to the
body. Drug dynamics (pharmacodynamics) describes the therapeutic effects of drugs
(e.g., pain relief, blood pressure reduction), their side effects, their sites of action
(i.e., which tissues they act on), and their mechanisms of action (i.e., how they act on
those tissues). A drug's effects on the body may be influenced by many factors, such
as a person's age and genetic makeup and disorders the person has other than the
one being treated.
Define "pharmacokinetics" - Answer-Study of how a drug is processed by the body,
with emphasis on the time required for absorption, duration of action, distribution,
and method of excretion, i.e., the study of how the body affects drugs.
Drug distribution and elimination - Answer-Drug delivery systems, route of
administration, modes of excretion (passing from the body).
About __ people in the U.S are slow acetylators?
(a) 1%
(b) 5%
(c) 25%
(d) 50% - Answer-50% of people are slow acetylators. Where is this in the book?
Which statements are/is INCORRECT about an ideal drug or magic bullet as Ehrlich
phrased it?
(a) it does not exist
(b) it would be aimed precisely at the disease site
,(c) it would not harm healthy tissues
(d) All of these statements are correct - Answer-(d) All of these statements are
correct
Which term denotes the study of bodily functions? - Answer-Physiology
What is a blinded or masked study? - Answer-A 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? - Answer-The 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? - Answer-A 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? - Answer-Swelling.
What are fast-track drugs? - Answer-Fast-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? - Answer-The exact cause or purpose
for which the FDA has approved that a new drug can be prescribed.
What is the institutional review board (IRB)? - Answer-A 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? - Answer-Usage of a medication for purposes
other than the specific ones appearing in the labeling.
What is a placebo? - Answer-A placebo is an inactive pill, liquid, or powder that has
no treatment value. In clinical trials, experimental treatments are often compared
with placebos to assess the treatment's effectiveness
What is the broadest definition of a drug? - Answer-Any substance that produces a
physical or psychological change in the body.
How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug? -
Answer-Any substance intended for use in the diagnosis, cure, mitigation, treatment
or prevention of a disease or a substance other than food intended to affect structure
of function of the body.
, What is true about vitamins? - Answer-Most of the body's required vitamins must be
taken in from outside the body.
What does ADME testing measure? - Answer-The rate at which the body absorbs
the drug, distributes it to the organs necessary to produce the desired effect,
metabolizes it into waste material and then excretes it from the body.
ADME testing is primarily used in what field? - Answer-Pharmacokinetics
What is true about placebos? - Answer-Effects can lead to withdrawal symptoms.
On average, what percent of drugs are studied in the lab are eventually studied in
people? - Answer-5 of 4000
What is true about drugs taken sublingually? - Answer-Are absorbed directly and
almost immediately into the bloodstream.
What are 3 of the 7 rights of the drug administration? - Answer-The right patient, the
right drug, and the right dose.
Pro-drugs are administered in the active for, which is metabolized into an active
form. - Answer-False
The kidney of an 85 year old person excretes drugs only _____________ as
efficiently as that of a 35 year old person. - Answer-Around 50%
The normal age related disease in kidney function can help doctors determine an
appropriate dosage based solely on a person age. - Answer-True
What differentiates a caplet from a tablet? - Answer-Caplets are shaped like
capsules and have film coatings to aid in swallowing.
Where will you find the legend "federal law prohibits dispensing without a
prescription"? - Answer-On the label of all prescription drugs.
What happens in slow acetylators? - Answer-Drugs that are metabolized by N-acetyl
transferase tend to reach higher blood levels and remain in the body longer.
About _________ of the people in the Unites States are slow acetylators. - Answer-
50%
Smoking decreases the effectiveness of some drugs. - Answer-True
What about drug-drug interaction is not correct? - Answer-Drug interaction are
always harmful.
What about dietary supplements is incorrect? - Answer-Because dietary
supplements are not drugs, interacting with drugs is not a concern.