1. Identify the stages of drug development and how the drugs are tested at each phase. - 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 therape...
Exam 1 Pharm (NURS615) Study
Guide 2024
1. Identify the stages of drug development and how the drugs are tested at each phase.
- 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. - 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? - 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? - 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? - 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? - 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
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