NAPSRx CNPR exam (Revised 18th Edition) Questions and Answers

NAPSRx CNPR exam (Revised 18th Edition) what does a STAT order mean? - Answer-a drug needed immediately and given only once what information does the overdosage section of the labeling provide? - Answer-signs, symptoms and treatment of acute overdoses types of drug-drug interactions: - Answer-duplication, opposition (antagonism) and alteration (p.51) tolerance vs resistance - Answer-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) - Answer-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 - Answer--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 - Answer-passive diffusion, facilitated diffusion, active transport, and pinocytosis (p. 95) potency vs efficacy - Answer-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 - Answer-phases I-IV (P. 124-126) Key Parts Of A Clinical Paper (5) - Answer-Abstract, Introduction, methods, results, discussion/conclusions (p. 128-129) reliability vs validity - Answer-reliability = consistency and validity = accuracy (p. 138; 143) sampling error vs selection bias - Answer-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 - Answer-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). Drug Utilization Review (DUR) programs - Answer--involve retrospective monitoring of physicians' prescribing patterns -more than 90% of HMOs require DURs -nowadays mostly monitors cost savings (p. 181) opportunity cost - Answer-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? - Answer-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) - Answer-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) FAQ about the PhRMA code - Answer-p. 268-274 Urology and selling to Urologists - Answer-p. 300-301 what is a Medical Science Liaison (MLS)? - Answer-they serve as educators and field-based medical resources. they interface between their company and healthcare leaders. push through vs pull through sales strategies - Answer-- 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. (p. 311) drug labeling requirements FDA - Answer- What is predictive validity? - Answer-the ability of an indicator to correctly predict an outcome. what are some of the criteria that influence the decision to use mass advertising in pharmaceutical marketing? - Answer-*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 according to the AMA guidelines, who should accept subsidies for continuing medical education conferences? - Answer-conference sponsors who is the decision maker in pharmaceutical sales? - Answer-the physician "fast track drugs" refer to - Answer-drugs approved for serious or life-threatening conditions rebate definition - Answer-the amount that the manufacturer of a drug pays to an insurer or health plan for each unit of drug dispensed. generic drug definition - Answer-a drug identical to a brand-name drug in various aspects