Pharmaceutical Industry: Understanding Drugs, Regulations, and Pharmacology, Exams of Nursing

Download Pharmaceutical Industry: Understanding Drugs, Regulations, and Pharmacology and more Exams Nursing in PDF only on Docsity! Solutions NAPSRX Exam Spring 2024 Revised Attempt Questions with Answers 1. Pharmaceuticals are arguably the most socially important healthcare product - answers>true 2. Pharmaceutical development is a big-risk undertaking, in which many promising leads prove disappointing - answers>true 3. Pharmaceutical sales are highest in which geographical regions - answers>The U.S., Western Europe, and Japan 4. The U.S. accounts for about ____ of the world's pharmaceutical revenues - answers>50% 5. Which off the following has fueled recent growth in the pharmaceutical industry - answers>population growth and increased life expectancies 6. According to your manual, which statement accurately describes the predicted relationship between pharmaceutical companies and genomic research facilities - answers>partnerships between pharmaceutical companies and genomic companies will not prove immediately profitable 7. prescription drug therapy is not cost-effective for insurance companies and healthcare providers - answers>false 8. the high price of healthcare is explained by the high price of medicines - answers>false 9. one of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising - answers>false 10. what influences the number of districts in a region - answers>the region's population 11. what is an example of the regionalization off healthcare delivery systems - answers>California and Florida have different prescription reimbursement policies 12. the heart of pharmaceutical sales is the regional manager - answers>false 13. most DMs did not start as representatives - answers>false 14. how many territories are in a typical district - answers>8 to 12 a substance other than food intended to affect the structure or function of the body 30. which statement about vitamins is correct - answers>most of the body’s required vitamins must be taken in from outside the body 31. ADME testing measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material and then excretes it from the body. - answers>true 32. ADME testing is primarily used in what field - answers>Pharmacokinetics 33. which statement about placebos is correct - answers>Placebo effects can lead to withdrawal symptoms. 34. on average, only about 5 off 4,000 drugs studied in the laboratory are eventually studied in people - answers>true 35. which statement is true about drugs taken sublingually - answers>sublingual drugs are absorbed directly and almost immediately into the bloodstream 36. what are 3 off the 7 rights of drug administration - answers>the right patient, right drug, and right dose 37. pro-drugs are administered in an active form, which is metabolized into an inactive form - answers>false 38. the kidney of an 85-year-old person excretes drugs only ____ as efficiently as that of a 35-year-old person - answers>around 50% 39. the normal age-related decrease in kidney function came help doctors determine an appropriate dosage based solely on a person's age - answers>true 40. what differentiates a caplet from a tablet - answers>caplets are shaped like capsules and have film coatings to aid in swallowing 41. what will you find the legend "Caution: federal law prohibits dispensing without a prescription - answers>on the label of all prescription drugs 42. what happens to slow acetylators - answers>Drugs that are metabolized by N-acetyl transferase tend to reach higher blood levels and remain in the body longer. 43. About ___ of the people in the U.S. are "slow acetylators" - answers>50% 44. which of the following statements about drug-drug interactions is incorrect - answers>drug-drug interactions are always harmful 45. Smoking decreases the effectiveness of some drugs - answers>true 46. which of the following statements about dietary supplements is incorrect - answers>because dietary supplements are not drugs, interactions with drugs are not a concern 47. which statement/s is/are incorrect about an ideal drug, or "magic bullet" as Ehrlich phrased it - answers>it does not exist, it would be aimed precisely at a disease site, it would not harm healthy tissues 48. which statement accurately differentiates resistance from tolerance - answers>tolerance refers to a person's diminished response to a drug after repeated use, while resistance applies to microorganisms' or "cancel" cells' abilities to withstand drug effects 64. all cells have a nucleus - answers>false 65. which of the following does not affect drag response - answers>the patients' genetic makeup, age, body size, and use of other drugs and dietary supplements, the patient's other conditions or diseases, whether or not the patient takes the drug properly 66. drug reactions are predictable because they do not occur after a person has been previously exposed to the drug one or more times without any allergic reactions - answers>false 67. what is the typical relationship between a drug's site of administration and site of action - answers>they are usually somewhat removed from each other 68. what is CMAX - answers>Peak plasma concentration on a measuring curve 69. which of the following is not a main concept in clinical pharmacology - answers>pharmacoprocesses 70. which of the following is not a route of drug administration - answers>trans fugal 71. How are intradermal drugs delivered? - answers>by injection under the skin 72. what is an example of intravenous drug delivery - answers>an injection of anesthetic directly into the bloodstream 73. what are the major organs of the gastrointestinal system - answers>the mouth, esophagus, stomach, liver, pancreas, gallbladder, small intestine, large intestine 74. who is normally responsible for selling to distributors - answers>NAMs 75. How often do secondary drug wholesale distributors buy their drugs directly from manufactures? - answers>sometimes 76. By FDA law, large chain pharmacies are not allowed to buy directly from drug manufactures. - answers>false 77. Only 3 companies account for nearly 90% of all drug wholesale sales. - answers>true 78. what type of sale bypasses the need for intermediary distributors - answers>manufacturer- direct sales 79. what is a group purchasing organization (GPO) - answers>an entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its members 80. Prescriptions dispensed by mail-order pharmacies are, on average, around ____________ than those dispensed by retail pharmacies. - answers>3 times larger 81. which of the following is not a type of non-stock sale - answers>brokerage sales, dock-to-dock sales, drop shipments 82. what is another term for rebates - answers>after-market arrangements 83. the PDMA is the prescription drug manufacturers association - answers>false 84. a company that owns and operates three or fewer pharmacies is an - answers>independent drug store 85. which section of a drug's package insert information covers the usual dosage range - answers>indications and usage 100. How is a drug sample closet or cabinet like a grocery store shelf? - answers>the more visibility you can give your drug, the more likely that it will be prescribed 101. pharmaceutical representatives do not typically store and secure their own drug samples - answers>false 102. Sampling is sometimes the most important factor in a pharmaceutical rep's success. - answers>true 103. the FDA approves storage conditions for drug products - answers>true 104. pharmaceutical representatives must always record the amount of drug samples left and obtain a signature for that amount - answers>true 105. what is prohibited by Section 503 of the federal food, drug, and cosmetic act, as amended by the prescription drug marketing act - answers>the sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples 106. the federal government does not regulate the drug sampling for a pharmaceutical representative - answers>false 107. which of the following is permitted by Section 503 of the federal food, drug and cosmetic act - answers>cannot donate or sell prescription drug samples 108. which entity issues monographs that define how drugs should be stored, and what variance is allowed in their stated contents - answers>United States Pharmacopoeia Convention 109. Storage conditions for drug products are based on information supplied by the manufacturer - answers>true 110. medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors - answers>false 111. In which cases can degraded drugs SOMETIMES still be used? - answers>when the amount off remaining drug has not fallen lower than 85-90% of that stated on the label 112. Drug recalls are almost always negotiated with the FDA beforehand. - answers>true 113. Which problem would NOT be improved by electronic prescribing systems? - answers>none: patients "doctor-shopping" for controlled substances, pharmacists misreading prescriptions, physicians wasting time calling pharmacies 114. what should you do if you receive a shipment from your employer and you notice that there are twice as many samples as what is posted on the packing slip - answers>call your sales manager to inform him/ her of the mistake and ask for instructions posted on the packing slip 115. which area of drugs R&D has seen the largest cost increases - answers>clinical trials 116. on average, how long does it take for a new drug to be developed (I.e., from the discovery of the initial compound to FDA approval) - answers>10-15 years 117. which of the following regulatory agencies is industry- based (Inc., run mainly by the companies themselves) - answers>Pharmaceutical research and manufactures of America (Pram) 118. which of the following factors has simplified the pharmaceutical R&D process - answers>none: an intensive regulatory process, growing demand in the medical community for more complex data about pharmaceuticals, and the increasing number of procedures in Phase III trials 133. Why are intravenous drug dosages easier to control than drugs administered transdermal? - answers>the entire dose is available in the bloodstream to be distributed to the target site 134. which of the following does not affect a drug's distribution to its target tissues - answers>the drug's lipid-solubility, the drug's polarity, the vascular nature of the drug's target tissue- all these facts affect a drug's distribution to its target tissues 135. which of these medical terms means "to apply the drug on the skin surface" - answers>transdermal 136. Carcinogenicity studies are carried out to identify the tumor- causing potential of a drug. - answers>true 137. According to NIH ethical guidelines, which of the following is the most important criteria in selecting subjects for clinical studies? - answers>scientific objectives 138. which statement about the IRB in incorrect - answers>the members of the IRB/IEC must be experts in the topic of study 139. Which phases of clinical studies are open label and which are blinded? - answers>phase I and IV trials are often open label, but phase II and III are double blinded or at least blinded 140. If it is not possible to measure the direct effects of a drug, what is used instead? - answers>surrogate markers such as blood pressure and cholesterol levels 141. which of the following is an observational study that first identifies a group of subject with a certain disease and a control group without the disease, and then looks to back in time (e.g. via chart reviews) to find exposure to risk factors - answers>case- control study 142. which measure of central tendency is the sum of all observations divided by the number of observations - answers>mean 143. which measurement describes the number of new events that occur during a specified period of time in a population at risk for the event (e.g. lung infections per year) - answers>incidence 144. which of the following measures is used to describe the variability of the population mean - answers>standard error of the mean 145. which of the following terms denotes the extent to which a test actually measures what it is supposed to be measuring, or what we think it is measuring - answers>validity 146. What are the Kaplan-Meier analysis and Cox proportional hazards analysis? - answers>methods of survival analysis 147. what section of a clinical paper describes subjects' entry and exclusion criteria - answers>methods 148. which document sets out how a trial is to be conducted (I.e. the study's general design and operating features) - answers>inclusion criteria 149. When designing and performing clinical trials, several ethical constraints must be considered. which of the following is NOT one of these ethical constraints - answers>geographic variations 150. what is one way in which "large molecule" drugs DIFFER from "small molecule" drugs - answers>large molecule drugs are mainly protein-based drugs that develop in biological systems such as living cells 151. which of the following statements about vaccines is incorrect - answers>vaccines are types of "small molecule drugs" 166. Drug Utilization Review (DUR) programs - answers>have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimizing costs. 167. DUR programs involve retrospective monitoring of physicians' prescribing patterns. - answers>true 168. A formulary is a list of prescription drugs approved by insurance coverage. - answers>true 169. The history of drug formularies in the U.S. extends back to... - answers>the American revolution 170. which of these is not a type of formulary - answers>All of these are types of formularies: A. a closed three-tier formulary in which generic drugs are listed on Tier 1 B. a five-tier formulary that is supplemented by a step therapy program C. an open formulary that places few restrictions on coverage or access 171. which of the following is not a recent formulary trend - answers>the repeal of hatch-Waxman 172. What did the Hatch-Waxman Act do? - answers>make it easier for generic manufacturers to compete with R&D companies 173. What is opportunity cost? - answers>the values of a sacrificed alternative 174. according to your manual, the three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid) and - answers>individuals 175. which of these individuals would not be a member of a P&T committee - answers>a company's medical liaison 176. Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-service plan. - answers>false 177. pharmaceutical companies are more interested in acquiring and exploiting another's brand than in acquiring another's R&D and sales and marketing assets - answers>false 178. ideally, when should brand strategy development for a new drug begin - answers>during phase II clinical trials 179. which of the following is an example of a "expressive" value - answers>"I own a BMW because I want people to know that I'm a serious driving enthusiast 180. according to you manual, which of the following is not an example of a "functional" value - answers>uniqueness 181. It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify - answers>true 182. To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, attractive and relevant to their needs. - answers>true 183. With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. - answers>false 184. How has DTC advertising changed over the last few decades? - answers>DTC advertising has become an essential marketing tactic for both large and small brands 185. which of the following most strongly influences physicians' prescribing habits - answers>doctors' personal experiences, and their patients' unique situations 198. many diagnostic tests are considered to be of a general therapeutic are and are not specified - answers>false 199. the most sensitive screening tool to detect osteoporosis- a disorder characterized by fragile, weak bones due to a drop in bone mass and increased risk of fracture is the arthrocentesis diagnostic test - answers>false 200. Neurodiagnostic tests are done because of patient’s illness or condition is mostly based in the central nervous system (brain or spinal cord). which of the below is not a sign of a nervous system disorder - answers>diarrhea 201. the electroencephalogram (EEG or brain wave test) is a non- invasive procedure used to detect and record brain wave activity - answers>true 202. a coronary angiogram is obtained by injecting an iodine- based dye or other contrast agent into the bloodstream and takin x-rays of the coronary arteries - answers>true 203. how do companies use prescriber data - answers>to conduct research 204. Under PhRMA Code, what of the following is acceptable - answers>modest meals for staff members attending educational events 205. Under the AMA Guidelines on Gifts to Physicians from Industry, which gifts are NOT permitted? - answers>gifts that are only given to doctors with high prescribing volumes 206. under PhRMA code, which of the following actions by sales reps are permitted - answers>providing modest meals to staff members attending educational events 207. the PhRMA Code on interactions with healthcare professional is only voluntary and not mandatory - answers>true 208. which of the following would not be considered acceptable promotional items under PhRMA Code - answers>pens and clipboards designed to be used by patients in doctors' offices 209. Under PhRMA Code, what is one example of an acceptable patient education item? - answers>an anatomical model valued under $100 210. under what circumstances does PhRMA code permit a company to provide entertainment or recreational activities to healthcare practitioners - answers>none of these: when the activity is intended to facilitate informational exchange, when the practitioner is acting as a bone fide advisory board consultant, when the practitioner is providing a legitimate service to the company 211. Under PhRMA Code, may a company sponsor a lunch at a 3- day conference if part of it includes an educational program for which attendees may choose to receive CME credit? - answers>yes, but only if the lunch is clearly separate from the CME portion of the conference 212. which of the following is an arm of the department of health and human services that investigates regulatory infarctions, provides compliance advice, and brings enforcement actions - answers>office of inspector general 213. It is illegal to ask receptionists for personal information about your clients such as home phone numbers, birthdays, or hobbies. A. TRUE 214. B. FALSE - answers>false 215. which of the following is not a primary goal or function of the P&T committee - answers>to educate sales representatives on legal and ethical guidelines for professional behavior 230. what is the most likely reason that a doctor would lack interest in one of your clinical studies - answers>the doctor does not like the way you are presenting it 231. which of the following are an effective method for researching the 65+ market - answers>all: being a Medicare part d information resource, knowing the physician-payer mix, taking advantage of partnership programs 232. when a physician visits your hospital display, you should begin the conversation by asking "can I help you" - answers>false 233. which of the following is not a rule in making the most out of your sales calls - answers>your agenda, not theirs 234. Specialty care products are often prescribed by generalist physicians. - answers>false 235. side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies - answers>true 236. Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms. - answers>true 237. in some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physician - answers>true 238. Blockbuster drug status typically translates into sales of just under $10 million annually. - answers>false 239. A generic drug manufacturer's greatest challenge is often to replicate drug formulation factors that affect the pharmacokinetic and pharmacodynamic characteristics of the original drug. - answers>true 240. what differentiates an "orphan" drug from a "blockbuster" drug - answers>orphan drugs typically treat rare conditions 241. How long are most calls and visits to physicians' offices (excluding waiting and driving time)? - answers>only a few minutes 242. which of the following is not a step in managing rumors - answers>counter attack 243. according to the text, which of the following is considered "going to the next level" - answers>staying focused 244. what is one of the primary job responsibilities of a retail pharmacist - answers>dispensing pharmaceuticals 245. what is not one of the ways in pharmaceutical companies and representatives categorize their customers - answers>companies and agents categorize their patients in all of these ways 246. which of the following are relatively new prescription drug benefits covered under the Medicare prescription improvement & modernization act - answers>Medicare part D 247. which term means "disease producer" - answers>pathogen 248. which type of blood cell plays the most prominent role in fighting infection and disease - answers>white blood cell 249. which of the following generally resides on a cell surface (or in the cytoplasm) and causes a biological change or activity when stimulated - answers>receptor 250. renal pertains to - answers>kidneys