STAT order a drug needed immediately and given only once
Overdosage section of labeling signs, symptoms and treatment of acute overdoses
Types of drug-drug interactions duplication, opposition (antagonism) and alteration
Tolerance vs Resistance 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) 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
Hatch-Waxman Act of 1984 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.
Four basic transport mechanisms passive diffusion, facilitated diffusion, active transport, and pinocytosis
Potency vs Efficacy 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 than potency.
Four phases of clinical trials phases I-IV
Key Parts Of A Clinical Paper Abstract, Introduction, methods, results, discussion/conclusions
Reliability vs Validity reliability = consistency and validity = accuracy
Sampling error vs Selection bias sampling error is unbiased and is randomly chosen from the population; selection
bias is when the sample was specifically chosen based on particular
characteristics.
Independent vs Dependent variable An independent variable is the one that influences the variation. A dependent
variable is the variable being tested and measured in a scientific experiment.
Drug Utilization Review (DUR) programs involve retrospective monitoring of physicians' prescribing patterns; more than
90% of HMOs require DURs; nowadays mostly monitors cost savings.
Opportunity cost 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.
, NAPSRx CNPR Exam Key Concepts and Questions
DTC advertising in Europe Disease-state or unbranded ads (provides public information on a disease, not a
drug)
PhRMA code on meals 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.
FAQ about the PhRMA code p. 268-274
Urology and selling to Urologists p. 300-301
Medical Science Liaison (MLS) they serve as educators and field-based medical resources; they interface
between their company and healthcare leaders.
Push through vs Pull through sales strategies push-through refers to the company's overall efforts to demonstrate clinical
efficiency and efficacy and cost effectiveness of a product.
pull-through generates demand for the product, usually in ways consistent with the health
plans goals and guidelines.
predictive validity the ability of an indicator to correctly predict an outcome.
criteria for mass advertising in pharmaceutical marketing *the size of the target patient population, the chronicity of the disease state, the
relevance of that disease state to its sufferers, the avg value of a patient taking
medication.
AMA guidelines on subsidies conference sponsors should accept subsidies for continuing medical education
conferences.
decision maker in pharmaceutical sales the physician.
fast track drugs drugs approved for serious or life-threatening conditions.
rebate the amount that the manufacturer of a drug pays to an insurer or health plan for
each unit of drug dispensed.
generic drug a drug identical to a brand-name drug in various aspects.
e-prescribing can prevent abuse of controlled substances by cross-checking regional e-
prescriptions.
phase III trials cost increased cost and complexity is due to patient recruitment.
, NAPSRx CNPR Exam Key Concepts and Questions
loading dose purpose to reach equilibrium quickly.
methods section of a clinical paper provides patient characteristics and demographics.
disadvantage of attenuated vaccines limited shelf life.
HMO trends HMOs declined in the early 2000s but rose again later due to decreasing
Medicare enrollment.
common joint for arthrocentesis knee.
brand-name drug pricing factor the primary factor affecting the price during exclusive rights period is competition
from generic drugs.
PhRMA interactions pharmaceutical sales representatives should inform healthcare professionals
about products.
Product Adoption Continuum a framework for understanding how physicians (consumers) adopt new products.
thought-provoking questions in sales should be asked at the beginning of a call.
successful speaker program set the mood by introducing the speaker and allowing for a question-and-answer
format.
leveraging clinical evidence pharmaceutical sales representatives can address rumors by presenting current
clinical studies that address concerns.
pharmaceutical industry's growth driver heavy investment in R&D.
anaphylaxis severe allergic reaction.
mail-order pharmacy the pharmacy's submission of prescriptions by mail or fax, with the pharmacy
mailing the filled prescription.
sorting drugs into therapeutic groups drugs are sorted first by the conditions that they are used to treat, and then by
their mechanisms of action.
bone marrow transplants require that the patient first undergo chemotherapy or radiation to kill the
diseased stem cells and promote white blood cell production.