Download NAPSR-CNPR Exam Questions and Answers and more Exams Nursing in PDF only on Docsity! NAPSR/CNPR Exam 1 / 26 1. Pharma companies must submit extensive data to the FDA demonstrating the safety and effective- ness of new drugs before receiving approval for sale. True 2. Average review time for a new drug 18 months 3. Sales Team Pg 7 4. The "engine of innovation," focused on discover- ing or inventing promising new product. 5. This includes supply chain, manufacturing, trade, and distribution functions of the business. 6. In 2012, FDA regulators approved 39 new drugs for use in the U.S. Research & Devel- opment Manufacturing & Op- erations True 7. 3,070 new meds are in development for cancer. True 8. Define Off-label Usage of a med- ication for purposes other than the specif- ic ones appearing on the label 9. Toxicity The extent, quality, or degree to which a substance is poi- sonous or harmful to the body 10. Institutional review Board (IRB) A committee of physicians, stati- cians, community advocated, and oth- ers which ensure that a clinical trial is ethical and that the rights of the study NAPSR/CNPR Exam 2 / 26 participants are pro- tected. All clinical trials must be ap- proved by an IRB be- fore they begin. 11. Placebo Inactive pill, liquid, or powder that has no treatment value aka sugar pill 12. Edema Swelling 13. Asymptomatic Without signs or symptoms 14. Clinical Pharmacology The study of the ef- fects and movement of drugs in the hu- man body 15. Anatomy The study of ba- sic structures of the body 16. Physiology The study of how those body struc- tures function 17. Basic clinical pharmacology involves 3 main con- cepts Pharmacodynam- ics, Pharmacokinetics, drug distribution and elimination. 18. Pharmacodynamics Study of the bio- chemical and phys- iological effects of drugs and their mechanisms of ac- NAPSR/CNPR Exam 5 / 26 nervous, musculoskeletal, reproductive, immune 31. Absorption How the drug pass- es from its side of ad- ministration into the bloodstream 32. Distribution How the drug is dis- persed among the organs after absorp- tion into the blood 33. Metabolism How the active part of a drug is metab- olized into a more water-soluble com- pound that can be readily excreted by the kidneys 34. Excretion How the drug is elim- inated from the body. Usually drugs are eliminated via urine. They can also be ex- creted through the lungs, skin, or breast milk. 35. It takes about 10 years for a drug to hit the market True 36. Routes of drug administration Pg 26-29 37. Seven rights of drug administration pg 30 38. Bioavailability how quickly and how much of a drug NAPSR/CNPR Exam 6 / 26 reaches its intended target site of action 39. Bioequivalent when they contain the same active in- gredients and pro- ceed virtually the same blood levels over time. 40. Therapeutic equivalence Production of the same medicinal ef- fect 41. Drug elimination and Excretion pg 34 42. Drug Forms Pg 35-38 43. Patent last 20 years True 44. Inactive ingredients Added to pro- vide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body 45. Pharmaceutical Ingredients Pg 54 46. BID twice a day 47. Cmax Peak plasma con- centration on a mea- suring curve 48. Half-life Period of time it takes for a specif- ic amount of drug in the body to be re- duced, through the excretion or elimina- NAPSR/CNPR Exam 7 / 26 tion process, to ex- actly one-half that original amount 49. PRN As needed 50. QD Once a day 51. QID Four times a day 52. Protein binding the ability of certain drugs to bind to plas- ma protein. 53. TID three times a day 54. Titration the process of ad- justing drug doses to achieve the max positive therapeutic effects while mini- mizing adverse or side affects 55. Tmax Time of peak plas- ma concentration on a measuring curve 56. STAT Immediately 57. Primary wholesale distributors Buy most of their drugs directly from manufacturers. Legally considered authorized distribu- tors within the mean- ing of the PDMA be- cause they usually have ongoing rela- NAPSR/CNPR Exam 10 / 26 69. It is important not to change the order of a sample closet 70. Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples 71. Meticulous records must be kept of sample inven- tories and reps are required to account for their samples periodically. 72. Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be sub- jected to extremes of temperature, moisture, and contamination 73. A sample closet or cabinet is essentially similar to a grocery store shelf. The more visibility you can give your drug, the more likely it will be used. 74. In some situations, a physician may sign the pa- perwork before the number of samples has been recorded manu's by providing a 30 months auto- matic cooling off pe- riod True True True True True True 75. Section 503 Prohibits sale, pur- chase, or trade of drug samples 76. E-sampling Pg 72 77. Many pharmaceutical manufacturers set expiration True dates every six months (June, December) 78. True NAPSR/CNPR Exam 11 / 26 NAPSR/CNPR Exam DEA regulates the distribution and use of narcotics and other controlled substances 79. FTC Regulates general business practices to protect con- sumers against mis- leading claims and anticompetitive be- havior 80. AMA provides ethical guidelines to physi- cians about appro- priate interactions with pharmaceutical companies 81. Benefits of Government-Industry Partnerhsips Pg 79 82. Preclinical studies pg 81 83. Pinocytosis Involves the engulf- ing of fluids by a cell. 84. Transport Mechanisms Passive diffusion, facilitated diffusion, active transport, pinocytosis 85. Absorption methods Oral, Buccal, sublin- gual, rectal, subcuta- neous, intramuscu- lar, transdermal, top- ical, inhalation, intra- venous 86. The liver is the major organ for metabolizing drugs. True Secondary is kidney NAPSR/CNPR Exam 12 / 26 NAPSR/CNPR Exam 87. CL= rate of drug elimination/drug concentration in blood True 88. In vitro assays are increasingly being see because True they are usually less expensive, offer more rapid results, and are not as prone to negative publicity. 89. Clinical Trials pg 89 90. Subjects should be informed about the aims, meth- ods, risks, and benefits of the trial True 91. Four phases of clinical trials Pg 90 92. Regulatory Requirement terms Pg 92 93. Investigator The person who con- ducts the trial. This person is normal- ly an expert in the field. They should not be employed by the sponsor 94. Sponsor The organization or individual that initi- ates the trial and fi- nances the study, 95. Protocol This document sets out how a trial is to be conducted 96. Epidemiology The study of how factors influence dis- ease and health in human populations. 97. Therapeutic Antibodies 15 / 26 appears to its audi- ence, internal com- mitment 118. Pharmetrics impact, pronunci- ation, scriptability, confusion, symbol- ism and communica- tion, fit, appeal pg 144 119. Brands should be: Easy to pronounce, easy to write and read, memorable, distinctive and differ- ent from competition 120. Direct-to-consumer (DTC) pg 152 121. Factors that influence DTC pg 153 122. Gifts Pg 162 123. PhRMA Code Now prohibits pens, mugs, objects with company logo 124. AMA Gift guidelines Pg 165 125. Any gifts accepted by physicians individually should entail a benefit to the patient and not be of substantial value 126. Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work 127. Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expens- es. Paying for a modest meal is OK True True True , 16 / 26 128. PhRMA Code on relationships Pg 167 129. PhRMA FAQ Pg 174 130. Nursing Structures Pg 200 131. Sales techniques pg 207 132. Medicare part D pg 225 133. Organizing your day Pg 239 134. Traits of Pharma sales Rep Passion, Go the ex- tra mile, be a re- source, be creative, invest in yourself, au- thentic and real, love what they do, focus on service, cultivate support, believe, fo- cus, macro-thinking, KIT, ask, keep accu- rate records 135. Glossary 271 136. Exclusivity is granted for an orphan drug for 137. Patents are applied for with, and granted by the FDA. 138. Patents expire after how many years from the date of filing? 7 years False 20 years 139. Generic drugs are not regulated by the Food & Drug False Administration. 140. The most reliable source of information for de- termining therapeutically equivalent drug products are ORange Book , 17 / 26 141. Pharmaceutical representatives will typically store True and secure their own drug samples 142. Pharmaceutical representatives must always record the amount of drug samples left and obtain signature for that amount. 143. The federal government does not regulate the drug sampling for a pharmaceutical representative 144. Storage conditions for drug products are based on data and information supplied by the manufacturer 145. Drug recalls are almost always negotiated with the FDA beforehand. 146. The PDMA is the Prescription Drug Manufacturers Association. 147. Primary wholesale distributors buy most of their drugs directly from 148. The AWP is a published price, suggested by drug manufacturers. 149. Rebates are also referred to as after-market arrangements. 150. Drug labels must include indications and usage information, as well as contraindications. 151. A patent owner has the right to exclude others from making, using, selling or importing into the US the it describes. 152. Exclusivity gives exclusive , which is grant- ed by the FDA, and can run concurrently with a patent or not. True False True True False manufacturers wholesale true true invention marketing rights NAPSR/CNPR Exam 20 / 26 Toxicity information in preclinical studies provides confidence about a drugs safety aspect. 177. The aim of pharmacological studies is to obtain data on the safety and effectiveness of the lead compound. 178. Effective drug therapy typically is a cost-effec- tive and highly valuable means of controlling total healthcare expenditures and improving quality of life. 179. Almost 98% of employed Americans are now cov- ered by a HMO, a preferred provider organization, or a point-of-service plan. 180. DUR programs involve retrospective monitoring of physicians' prescribing patterns. 181. The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distrib- ute off-patent drugs and compete with R & D com- panies. 182. PBM's tend to serve a local market through a net- work of pharmacies. 183. The chief motivating force in mergers and acqui- sitions within the pharmaceutical industry is the desire of one company to acquire and exploit more successfully the brands of another. true true false true false false false 184. It is rare for pharmaceutical companies to explore, true develop and promote expressive values with which patients might identify. 185. To be competitive, pharmaceutical brands must be distinctive. They must possess defining character- istics that are perceived by customers to be unique, attractive and relevant to their needs. true NAPSR/CNPR Exam 21 / 26 186. With the global need for new drugs, pharmaceu- tical brand names are not subject to regulatory approval. 187. DTC advertising has become a required tactical consideration for most pharmaceutical brands in the U.S.. 188. Subjects for clinical trials are selected on the basis of false true scientific objectives 189. The pivotal trial is Phase of the clinical trial. 3 190. The "road map" for a clinical research paper is called the . 191. Pharmaceutical reps should thoroughly read sections of clinical studies when results are released. 192. The three major areas in which biologics are used are prophylactic, , and replacement thera- py. 193. A formulary is a list of prescription drugs approved by insurance coverage. 194. Three primary entities fund pharmaceuticals: em- ployer, government (Medicare and Medicaid), and . 195. The more a patient is asked to pay for his/her medication, the greater likelihood that he/she will refuse to fill the prescription, pr will not take the medication properly. 196. The key areas in hospitals that require special sell- ing tactics are , formulary committee, and the medical education department. abstract all therapeutic true individuals true pharmacy depart- ment NAPSR/CNPR Exam 22 / 26 197. Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources. 198. One of the oldest and least effective pharmaceuti- cal marketing techniques is the direct-to-consumer advertising. 199. Typically it only takes 1-2 calls to an individual physician before you can successfully get a physi- cian to commit to prescribing your drug or product. 200. One of the most disappointing results of the phar- maceutical industry's continued investment in R & D is the few number of new drugs being approved and in development. 201. The extent, quality, or degree to which a substance is poisonous or harmful to the body. 202. The US accounts for about of all the world's pharmaceutical revenues. 203. The most effective method for grabbing market share is: 204. Most visits by pharmaceutical reps are to pharma- cies. 205. Among the biotechnology medications under de- velopment, about target cancer. 206. A is an inactive medication with no treatment value, used in experimental studies. 207. The heart of a pharmaceutical sales team is the Regional Manager. 208. The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distrib- true false false false toxicity 1/2 comparative selling false 50% placebo false false NAPSR/CNPR Exam 25 / 26 230. A type of blood cell that helps the body fight infec- tion and disease: white blood cell 231. SS Used when refer- ring to medica- tion dosage, means "one-half": 232. Dividing a group of physicians and other potential prescribers for a certain category of drugs based on anticipated prescription volume: 233. The substances comprising all active and inert pharmaceutical ingredients, including fillers, col- ors, and other excipients used to prepare dosage forms: declining formulation 234. A low supply of oxygen due to low blood flow is: ischemia 235. The acronym for pharmacokinetics is: PK 236. According to the text, there are classes of ther- apeutic drugs. US federal govt 237. Oral Glaucoma Therapy is classified as: ophthalmology ther- apy 238. internist is a physician that practices internal medicine 239. IDN integrated delivery network 240. Another name for biologic compound is: large molecule 241. SS is an abbreviation for: semis 242. The is used to determine appropriate coding system medical reimbursement. NAPSR/CNPR Exam 26 / 26 243. A term used to refer to drugs that are non-biologi- cal (that is, chemical) in nature: 244. The origin, or cause, of a disease or a patient's symptoms: 245. Used when referring to medication dosage, means "as needed": 246. Where the tolerance of one medication may result in increased tolerance of another medication? 247. The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms: 248. A substance that enhances the action of a drug or antigen: 249. A site in the body which generally resides on a cell surface or within the cytoplasm. When stimulat- ed or occupied, a biological change/activity takes place: small molecule Etiology PRN cross tolerance pharmacology adjuvant receptor 250. Refers to medication dosage, means "hour": h 251. Outside a living body: ex vivo 252. The meaning of subcutaneous is: beneath outer skin 253. The acronym for effective dose is: ed 254. ML stands for: milliliter 255. According to the text, depression is a disease that attacks the: central nervous sys- tem