EXAM 1 PHARM (NURS615) STUDY GUIDE | COMPLETE
QUESTIONS & ANSWERS (100% VERIFIED SOLUTIONS)
LATEST UPDATE
1. Identify the stages of drug development and how the drugs are tested at each phase. -
CORRECT ANSWER -ANS:
Phase 1: Testing of a new compound in health subjects, for the purpose of establishing the
tolerance of health human subjects at different doses, defining its pharmacological effects at
anticipated therapeutic levels, and studying its absorption, distribution, metabolism, and
excretion patterns in humans.
Phase 2:Controlled clinical evaluation is done on patients with a specific disease or disorder to
determine the medications possible uses and short term risks. Usually the study is conducted on
only several hundred subjects or less.
Phase 3: Controlled and uncontrolled clinical trials of a drugs safety and efficacy in hospital and
outpatient settings. Gather precise information on drugs efficacy for specific indications to
determine if there is a wider range of adverse effects on those that it did in a small study. They
try to identify what way the drug is best administered (PO, IV, IM...). If the drug is approved this
information forms what goes on the drug label. Phase 3 solidifies phase 2.
Page 33. Pharm 3rd ed.
2. Differentiate between the prescribing of medications by physicians, nurses, and physician's
assistants. - CORRECT ANSWER -ANS:
Physicians-Their focus is related to pharmacology is on the understanding of biochemistry and
prescribing for a given pathophysiology. Their emphasis is on the disease and the drug, with less
emphasis on the impact of the patient.
NPs-nurse practitioners prescribed a drug free given pathophysiology, their nursing background
leads them to place equal emphasis on understanding the impact the drug will have on the
patient. Patient education is a central focus of an NPs practice.
,PAs-The focus of the PA's practice is similar to that of the physician.
p.7-8 Pharm 3rd Ed.
3. What factors are associated with clinical judgment when prescribing medications? - CORRECT
ANSWER -Is there a clear indication for drug therapy? What drugs are effective in treating this
disorder? What is the goal of therapy with this drug? Under what conditions is it determined
that a drug is not meeting the goal in a different therapy or drug should be tried? Are there
unnecessary duplications with other drugs the patient is already taking? Would an over-the-
counter drug be just as useful as a prescription drug? What about the cost? Where is the
information to answer these questions?
P.6 Pharm third edition
4. What is the criteria for choosing an effective drug? - CORRECT ANSWER -1.)
Pharmacodynamic factors of a drug must be specific and selective to the target tissues affected
by the disease to have the greatest therapeutic effect with the least adverse effects. The
relationship between the drugs desired therapeutic effects and it's adverse effects is called it's
therapeutic index. Drugs with the low therapeutic index may require close monitoring for
toxicity and versus facts, where is drugs with a wide therapeutic index are fairly safe and require
less monitoring. Pharmacodynamics means the study of the effects of the drug on the body. 2.)
Pharmacokinetic factors. This is how the body reacts to the drug. It is the study and analysis of
the time course of the drug in the body. How well are the drugs absorbed and eliminated. 3.)
therapeutic factors 4.)safety 5.)Cost 6.) patient factors 7.) adverse drug reactions 8.) Provider
factors
p.25-28 Pharm 3rd edition
5. How does hypoalbuminemia affect the process of prescribing? - CORRECT ANSWER -ANS:
Reduced drug dosages may be indicated in these cases.
http://www.nottingham.ac.uk/nmp/sonet/rlos/bioproc/plasma_proteins/6.html
In a pt with hypoalbuminemia drugs especially antibiotics are unable to bind as needed with
albumin which means there is more of the drug free in the plasma then there would be in a pt
with a normal albumin level.Drug-plasma protein binding forms a "reservoir" of drug, but only
the free (unbound) drug is available to the tissues to exert a therapeutic effect.
, This condition appears to be associated with alterations in the degree of protein binding of
many highly protein-bound antibacterials, which lead to altered pharmacokinetics and
pharmacodynamics, although this topic is infrequently considered in daily clinical practice. The
effects of hypoalbuminaemia on pharmacokinetics are driven by the decrease in the extent of
antibacterial bound to albumin, which increases the unbound fraction of the drug. Unlike the
fraction bound to plasma proteins, the unbound fraction is the only fraction available for
distribution and clearance from the plasma (central compartment). Hence, hypoalbuminaemia
is likely to increase the apparent total volume of distribution (V(d)) and clearance (CL) of a drug,
which would translate to lower antibacterial exposures that might compromise the attainment
of pharmacodynamic targets, especially for time-dependent antibacterials. The effect of
hypoalbuminaemia on unbound concentrations is also likely to have an important impact on
pharmacodynamics, but there is very little information available on this area.
http://www.ncbi.nlm.nih.gov/pubmed/21142293
More Background on hypoalbuminemia:
Albumin comprises 75-80% of normal plasma colloid oncotic pressure and 50% of protein
content. When plasma proteins, especially albumin, no longer sustain sufficient colloid osmotic
6. What is the Prescription Drug Marketing Act? - CORRECT ANSWER -The Prescription Drug
Marketing Act of 1987 (PDMA) was signed into law by the President on April 22, 1988. The
PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and
effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit,
adulterated, misbranded, subpotent, or expired drugs. The legislation was necessary to increase
safeguards in the drug distribution system to prevent the introduction and retail sale of
substandard, ineffective, or counterfeit drugs.
FDA.com
7. How will you stay up to date with medication administration and prescribing? - CORRECT
ANSWER -...
QUESTIONS & ANSWERS (100% VERIFIED SOLUTIONS)
LATEST UPDATE
1. Identify the stages of drug development and how the drugs are tested at each phase. -
CORRECT ANSWER -ANS:
Phase 1: Testing of a new compound in health subjects, for the purpose of establishing the
tolerance of health human subjects at different doses, defining its pharmacological effects at
anticipated therapeutic levels, and studying its absorption, distribution, metabolism, and
excretion patterns in humans.
Phase 2:Controlled clinical evaluation is done on patients with a specific disease or disorder to
determine the medications possible uses and short term risks. Usually the study is conducted on
only several hundred subjects or less.
Phase 3: Controlled and uncontrolled clinical trials of a drugs safety and efficacy in hospital and
outpatient settings. Gather precise information on drugs efficacy for specific indications to
determine if there is a wider range of adverse effects on those that it did in a small study. They
try to identify what way the drug is best administered (PO, IV, IM...). If the drug is approved this
information forms what goes on the drug label. Phase 3 solidifies phase 2.
Page 33. Pharm 3rd ed.
2. Differentiate between the prescribing of medications by physicians, nurses, and physician's
assistants. - CORRECT ANSWER -ANS:
Physicians-Their focus is related to pharmacology is on the understanding of biochemistry and
prescribing for a given pathophysiology. Their emphasis is on the disease and the drug, with less
emphasis on the impact of the patient.
NPs-nurse practitioners prescribed a drug free given pathophysiology, their nursing background
leads them to place equal emphasis on understanding the impact the drug will have on the
patient. Patient education is a central focus of an NPs practice.
,PAs-The focus of the PA's practice is similar to that of the physician.
p.7-8 Pharm 3rd Ed.
3. What factors are associated with clinical judgment when prescribing medications? - CORRECT
ANSWER -Is there a clear indication for drug therapy? What drugs are effective in treating this
disorder? What is the goal of therapy with this drug? Under what conditions is it determined
that a drug is not meeting the goal in a different therapy or drug should be tried? Are there
unnecessary duplications with other drugs the patient is already taking? Would an over-the-
counter drug be just as useful as a prescription drug? What about the cost? Where is the
information to answer these questions?
P.6 Pharm third edition
4. What is the criteria for choosing an effective drug? - CORRECT ANSWER -1.)
Pharmacodynamic factors of a drug must be specific and selective to the target tissues affected
by the disease to have the greatest therapeutic effect with the least adverse effects. The
relationship between the drugs desired therapeutic effects and it's adverse effects is called it's
therapeutic index. Drugs with the low therapeutic index may require close monitoring for
toxicity and versus facts, where is drugs with a wide therapeutic index are fairly safe and require
less monitoring. Pharmacodynamics means the study of the effects of the drug on the body. 2.)
Pharmacokinetic factors. This is how the body reacts to the drug. It is the study and analysis of
the time course of the drug in the body. How well are the drugs absorbed and eliminated. 3.)
therapeutic factors 4.)safety 5.)Cost 6.) patient factors 7.) adverse drug reactions 8.) Provider
factors
p.25-28 Pharm 3rd edition
5. How does hypoalbuminemia affect the process of prescribing? - CORRECT ANSWER -ANS:
Reduced drug dosages may be indicated in these cases.
http://www.nottingham.ac.uk/nmp/sonet/rlos/bioproc/plasma_proteins/6.html
In a pt with hypoalbuminemia drugs especially antibiotics are unable to bind as needed with
albumin which means there is more of the drug free in the plasma then there would be in a pt
with a normal albumin level.Drug-plasma protein binding forms a "reservoir" of drug, but only
the free (unbound) drug is available to the tissues to exert a therapeutic effect.
, This condition appears to be associated with alterations in the degree of protein binding of
many highly protein-bound antibacterials, which lead to altered pharmacokinetics and
pharmacodynamics, although this topic is infrequently considered in daily clinical practice. The
effects of hypoalbuminaemia on pharmacokinetics are driven by the decrease in the extent of
antibacterial bound to albumin, which increases the unbound fraction of the drug. Unlike the
fraction bound to plasma proteins, the unbound fraction is the only fraction available for
distribution and clearance from the plasma (central compartment). Hence, hypoalbuminaemia
is likely to increase the apparent total volume of distribution (V(d)) and clearance (CL) of a drug,
which would translate to lower antibacterial exposures that might compromise the attainment
of pharmacodynamic targets, especially for time-dependent antibacterials. The effect of
hypoalbuminaemia on unbound concentrations is also likely to have an important impact on
pharmacodynamics, but there is very little information available on this area.
http://www.ncbi.nlm.nih.gov/pubmed/21142293
More Background on hypoalbuminemia:
Albumin comprises 75-80% of normal plasma colloid oncotic pressure and 50% of protein
content. When plasma proteins, especially albumin, no longer sustain sufficient colloid osmotic
6. What is the Prescription Drug Marketing Act? - CORRECT ANSWER -The Prescription Drug
Marketing Act of 1987 (PDMA) was signed into law by the President on April 22, 1988. The
PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and
effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit,
adulterated, misbranded, subpotent, or expired drugs. The legislation was necessary to increase
safeguards in the drug distribution system to prevent the introduction and retail sale of
substandard, ineffective, or counterfeit drugs.
FDA.com
7. How will you stay up to date with medication administration and prescribing? - CORRECT
ANSWER -...
