Drug Utilization Review (DUR) programs Right Ans - -involve retrospective
monitoring of physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
Opportunity cost Right 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.
What type of DTC advertising is the only legal form in Europe? Right Ans -
Disease-state or unbranded ads (provides public information on a disease, not
a drug)
(p. 223)
Can pharm sales reps offer doctors meals? (PhRMA code) Right 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)
What does a STAT order mean? Right Ans - a drug needed immediately and
given only once
What information does the overdosage section of the labeling provide?
Right Ans - signs, symptoms and treatment of acute overdoses
Types of drug-drug interactions: Right Ans - duplication, opposition
(antagonism) and alteration (p.51)
Tolerance vs resistance Right Ans - tolerance is the diminished response to
a drug; resistance is the cells ability to resist the effects of the drug on them.
abbreviated new drug application (ANDA) Right 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)
, The Hatch-Waxman Act of 1984 Right Ans - -A.K.A. Drug Price Competition
and Patent Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to
only look at bioavailability studies in order to approve an ANDA.
-gave protection to the research based manufacturers by providing a 30-
month automatic cooling off period once an ANDA is challenged for patent
infringement (p. 75)
Four basic transport mechanisms Right Ans - passive diffusion, facilitated
diffusion, active transport, and pinocytosis (p. 95)
Potency vs efficacy Right 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)
The four phases of clinical trials Right Ans - phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) Right Ans - Abstract, Introduction,
methods, results, discussion/conclusions (p. 128-129)
Reliability vs validity Right Ans - reliability = consistency and validity =
accuracy
(p. 138; 143)
Sampling error vs selection bias Right Ans - sampling error is unbiased and
is randomly chosen from the population.
selection bias is when the sample was specifically chosen based on particular
characteristics (p.142-143)
Independent vs dependent variable Right 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).
FAQ about the PhRMA code Right Ans - p. 268-274
Urology and selling to Urologists Right Ans - p. 300-301
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