Download NAPSR/CNPR Exam latest with complete answers 100% correct /verified/24/25 and more Exams Nursing in PDF only on Docsity! NAPSR/CNPR Exam latest with complete answers 100% correct /verified/24/25 1. Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness 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 discovering or inventing promising new product.: Research & Development 5.This includes supply chain, manufacturing, trade, and distribution functions of the business.: Manufacturing & Operations 6. In 2012, FDA regulators approved 39 new drugs for use in the U.S.: True 7.3,070 new meds are in development for cancer.: True 8.Define Off-label: Usage of a medication for purposes other than the specific ones appearing on the label 9.Toxicity: The extent, quality, or degree to which a substance is poisonous or harmful to the body 10.Institutional review Board (IRB): A committee of physicians, staticians, com- munity advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before 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 effects and movement of drugs in the human body 15.Anatomy: The study of basic structures of the body 16.Physiology: The study of how those body structures function 17.Basic clinical pharmacology involves 3 main concepts: Pharmacodynam- ics, Pharmacokinetics, drug distribution and elimination. 18.Pharmacodynamics: Study of the biochemical and physiological effects of drugs and their mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeutic effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of action. 19.Pharmacokinetics: Study of how a drug is processed by the body, with empha- sis on the time required for absorption, duration of action, distribution, and method of excretion. The study of how the body affects drugs. 20.Drug distribution & elimination: Drug delivery systems, route of administration , modes of excretion. 46.BID: twice a day 47.Cmax: Peak plasma concentration on a measuring curve 48.Half-life: Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly 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 plasma protein. 53.TID: three times a day 54.Titration: the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects 55.Tmax: Time of peak plasma concentration on a measuring curve 56.STAT: Immediately 57.Primary wholesale distributors: Buy most of their drugs directly from manufac- turers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers 58.Secondary wholesale distributors: Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA 59.Distribution Terminology: Pg 60-61 60.Average wholesale price (AWP): Published wholesale price of list price sug- gested by the manufacturer. 61.Chain drug store: Company that owns and operates four or more pharmacies 62.Drop shipment: Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler 63.Group purchasing organization (GPO): An entity consisting of two or more hospitals or other healthcare entities that is formed to offer its members access to purchasing contracts for health supplies 64.Upcharge: Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution 65.Package Insert Info: Pg 63 66.Drug Patents: Pg 65 Terms pg 67 67.Orange Book ratings: A AA AN AO AP AT B 68.Hatch-Waxman Act: aka Drug Price Competition and Patent Term Restoration Act of 1984. Considered the most significant drug-related legislation affecting phar- ma and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to only look at bioavailability studies in order to approve. Also gave protection to the research based manu's by providing a 30 months automatic cooling off period 69.It is important not to change the order of a sample closet: True 70.Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples: True 71.Meticulous records must be kept of sample inventories and reps are re- quired to account for their samples periodically.: True 72.Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination: True 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.: True 74.In some situations, a physician may sign the paperwork before the number of samples has been recorded: True 101. Peptide Vaccines: Chemically synthesized and normally consist of 8-24 amino acids 102. Adjuvants: pg 110 103. Cytokines are produced mainly by the leukocytes (white blood cells): True 104. Hormones are intercellular messengers.: True 105. Retrovirus: Integrates genes to hose chromosomes, change of long term stability. 106. Adendovirus: This vector has a large capacity for foreign genes. 107. Liposomes: Vector does not have viral genes so they do not cause disease. 108. Naked DNA: they do not have viral genes and do not cause disease 109. Gene Therapy types: Retrovirus, adenovirus, adeno-associated virus, lipo- somes, naked DNA 110. Stem Cells: Pg 114 111. Managed Care: Pg 117 112. Formulary: List of prescription drugs approved by insurance coverage pg 118 113. Opportunity cost: pg 124 114. Branding: pg 113 115. Values: Function, Expressive, Central 116. Functional Values: Efficacy, safety, convenience, cost-effectiveness 117. 6 stages of brand strategy: Brand positioning, brand personality, brand val- ues, unique values of the brand that support the values, how the brand appears to its audience, internal commitment 118. Pharmetrics: impact, pronunciation, scriptability, confusion, symbolism and communication, fit, appeal pg 144 119. Brands should be:: Easy to pronounce, easy to write and read, memorable, distinctive and different 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: True 126. Individual gifts of minimal value (Under $100) are permissible as long as the gifts are related to the work: True 127. Subsidies should not be accepted to pay for the costs of travel, lodging, or other personal expenses. Paying for a modest meal is OK: True 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 extra mile, be a resource, be creative, invest in yourself, authentic and real, love what they do, focus on service, cultivate support, believe, focus, macro-thinking, KIT, ask, keep accurate records 135. Glossary: 271 136. Exclusivity is granted for an orphan drug for : 7 years 137. Patents are applied for with, and granted by the FDA.: False 138. Patents expire after how many years from the date of filing?: 20 years 139. Generic drugs are not regulated by the Food & Drug Administration.: - False 140. The most reliable source of information for determining therapeutically equivalent drug products are: ORange Book granted by the FDA, and can run concurrently with a patent or not.: marketing rights 153. Exclusivity is granted for an orphan drug for years.: 7 154. A generic drug is to the originator brand-name drug in dosage, strength, safety, and quality.: bioevuivalent 155. Generic drugs are not regulated by the FDA.: False 156. The Orange Book is considered the most authoritative manual on thera- peutic .: equivalence 157. The Hatch-Waxman Act is considered the most significant drug-related affecting the pharmaceutical industry since 1962.: legislation 158. First pass metabolism occurs when a drug administered orally is metab- olized in the .: Liver 159. Pharmacological studies using animals are regulated under Good Labo- ratory Practice.: True 160. M onoclonal antibodies are created in laboratories to target the of patients to kill cancer.: Cancer cells 161. The best way to deliver health care is through a system.: market based 162. The costs for all phases of R&D for drug companies are rising, with the increase particularly acute for .: clinical trials 163. The agency which regulates the distribution and use of narcotics and other controlled substances is .: DEA 164. The FDA approves storage conditions for drug products.: True 165. The most important benefit of electronic prescribing is related to patient .: safety 166. Patients with leukemia have a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells, which interfere with normal blood cell production.: true 167. There are more white blood cells than red blood cells for the same volume in the human body.: false 168. Unlike the small molecule drugs (pharmaceuticals) described, large mol- ecule drugs (biopharmaceuticals) are mainly protein-based.: true 169. The duration for Phase III of the clinical trial can typically last 3-5 years.- : true 170. The aim of the Phase IV clinical trial is to examine the safety and effec- tiveness of the drug in the targeted disease group.: false 171. Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.: true 172. Which one of the below terms is not a route for excreting a drug from the body?: heart 173. Which of the below terms means "to apply the drug on the skin surface"?- stract 191. Pharmaceutical reps should thoroughly read sections of clinical studies when results are released.: all 192. The three major areas in which biologics are used are prophylactic, , and replacement therapy.: therapeutic 193. A formulary is a list of prescription drugs approved by insurance cover- age.: true 194. Three primary entities fund pharmaceuticals: employer, government (Medicare and Medicaid), and .: individuals 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.: true 196. T he key areas in hospitals that require special selling tactics are , formulary committee, and the medical education department.: pharmacy de- partment 197. Opportunity Cost refers to the value of a sacrificed alternative, when making a choice using resources.: true 198. One of the oldest and least effective pharmaceutical marketing tech- niques is the direct-to-consumer advertising.: false 199. Typically it only takes 1-2 calls to an individual physician before you can successfully get a physician to commit to prescribing your drug or product.- : false 200. One of the most disappointing results of the pharmaceutical industry's continued investment in R & D is the few number of new drugs being approved and in development.: false 201. The extent, quality, or degree to which a substance is poisonous or harmful to the body.: toxicity 202. The US accounts for about of all the world's pharmaceutical rev- enues.: 1/2 203. The most effective method for grabbing market share is:: comparative selling 204. Most visits by pharmaceutical reps are to pharmacies.: false 205. A mong the biotechnology medications under development, about target cancer.: 50% 206. A is an inactive medication with no treatment value, used in exper- imental studies.: placebo 207. The heart of a pharmaceutical sales team is the Regional Manager.: false 208. The Hatch-Waxman Act made it more difficult for generic manufacturers to manufacture and distribute off-patent drugs and compete with R & D companies: false 209. It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify: true cell 231. SS: Used when referring to medication 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:: declining 233. The substances comprising all active and inert pharmaceutical ingredi- ents, including fillers, colors, and other excipients used to prepare dosage forms:: 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 therapeutic drugs.: US federal govt 237. Oral Glaucoma Therapy is classified as:: ophthalmology therapy 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 medical reimburse- ment.: coding system 243. A term used to refer to drugs that are non-biological (that is, chemical) in nature:: small molecule 244. The origin, or cause, of a disease or a patient's symptoms:: Etiology 245. Used when referring to medication dosage, means "as needed":: PRN 246. Where the tolerance of one medication may result in increased tolerance of another medication?: cross tolerance 247. The study of the effects, both beneficial and toxic, of drugs and chemicals on living cells, tissues, organisms:: pharmacology 248. A substance that enhances the action of a drug or antigen:: adjuvant 249. A site in the body which generally resides on a cell surface or within the cytoplasm. When stimulated or occupied, a biological change/activity takes place:: 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 system