Understanding the Pharmaceutical Industry: Development, Sales, and Regulation, Exams of Nursing

Download Understanding the Pharmaceutical Industry: Development, Sales, and Regulation and more Exams Nursing in PDF only on Docsity! NAPSR- PHARMACEUTICAL SALES TRAINING Spring Revised 472 Out of 472 points 1. ______ are arguably the most socially important healthcare products - answers pharmaceuticals 2. pharmaceutical development - answers is a high risk undertaking, many promising leads prove disappointing 3. pharmaceuticals - answers medicines and vaccines for human and animal use (brand name or generic, prescription or OTC) 4. Diagnostic - answers equipment and supplies used in screening, detecting, and monitoring disease. (ranges from home testing kits to sophisticated diagnostic imaging technologies) 5. medical devices - answers -advanced instrumentation and appliances used for medical therapy (joint replacements, pacemakers, implantable defibrillators) 6. -include drug delivery devices (syringes, infusion pumps, metered-dose inhalers, transdermal patches) 7. medical supplies - answers commodity, high volume supplies such as surgical gowns and gloves 8. durable medical equipment - answers reusable products for health related use in the home 9. (walkers, wheelchairs, oxygen equipment, prosthetics, hospital beds) 10. home-based care - answers -patients/consumers and their friends/family 11. -home health nurses and aides 12. primary care (checkups and general health issues) - answers -OBGYN 13. -family/general practitioners 14. -internists 33. Professional physician promotions - answers sales reps in physicians’ offices, etc. 34. Advertising in medical journals, conferences email, etc. 35. Direct-to-consumer advertising - answers patient directed messages in TV, radio, magazines, etc. 36. newest effective marketing technique 37. Reasons for growth in direct-to-consumer advertising - answers 1. FDA eased regulations 38. 2. patients wanting to be more involved in their decisions thus being more receptive 39. 3. publics increasing health/medical literacy 40. 4. physicians ink in willingness to prescribe patients requests for specific drugs 41. headquarters - answers executive level sales managers & support staff 42. House product managers who are part of companies marketing dept. 43. regions - answers divide country into 4-10 geographic regions 44. Northwest, Midwest, etc. 45. districts - answers each region has several districts that are supervised by district manager 46. territories - answers each district includes 8-12 territories 47. staffed by territory reps 48. What influences the number of districts in a region? - answers regions population 49. What is an example of the regionalization of healthcare delivery systems? - answers California and Florida have different prescription reimbursement policies 50. territory representative (professional sales rep) - answers the heart of pharmaceutical sales team 51. group of reps who interact with customers on a daily basis 52. specialty, hospital, and niche representatives - answers sells exclusively to niche markets 53. district manager - answers territory reps report to them and ensure they are making their sales goals 54. sales reps primary form of contact 55. most DMs start off as reps 56. Regional manager - answers district managers report to them. 57. sets strategy for a region and monitors sales activity in each district 74. specialists - answers researchers are usually found at university and med schools and private practices 75. perform the testing/do research to find new products 76. research & development - answers the "engine of innovation" 77. focused on discovering new chemicals and transforming them into safe/effective pharmaceutical products 78. manufacturing & operations - answers supply, chain, manufacturing trade, distribution 79. produce and package drug and make it available all over the world 80. marketing & sales - answers communicate the benefits of products and create demand 81. responsible for outreach to large corporate accounts and managed care organizations 82. One of the most significant results of the industry’s continued invest in R&D is the - answers large number of new drugs approved and in development 83. new drugs in development - answers - 1 to treat hypospjtasisa 84. -several to treat Lou Gehrig's disease 85. -125 for Alzheimer’s 86. -3070 for cancer 87. -281 for diabetes 88. -185 for HIV/AIDS 89. Thanks to modern medicine, how long are people newly diagnosed with HIV expected to live? - answers another 50 years 90. How much has the average American lifespan increased since 1890? - answers almost 30 years 91. approvable letter - answers letters sent by the FDA to the applicant indicating whether the new drug application for a product meets requirements 92. asymptomatic - answers without signs or symptoms 93. blinded or masked study - answers participants don't know if they are in experimental or control group 94. those in experimental group get medications/treatments being tested 95. control group gets standard or no treatment 96. control group - answers experimental observations are evaluated 97. control group gets standard or no treatment 98. double-blind or double-masked study - answers neither the participants or staff know who is receiving experimental treatment 113. What is the main difference between a blinded and double-blinded study? - answers in a double blinded study neither the staff nor participants know which subjects are in the experimental group and which are in the control 114. anatomy - answers the study of the basic structures of the body 115. physiology - answers the study of how body structures function 116. Clinical Pharmacology - answers the study of the effects and movement of drugs in the human body 117. Pharmacodynamics - answers study of the biochemical and physiological effects of drugs and their mechanisms of action 118. what the drug does to the body 119. Pharmacokinetics - answers study of how a drug is processed by the body with emphasis on the time required for absorptions, duration of action, distribution, and method of excretion 120. how the body affects drugs 121. drug distribution and elimination - answers drug delivery systems, route of administration, modes of excretion 122. chemical name - answers describes the atomic or molecular structure of the drug 123. generic name - answers since chemical name is too complex and official assigns a generic name 124. trade name - answers chosen by pharmaceutical company that manufactures/distributes the drug 125. drug - answers any substance that proceeds a physical or psychological change in the body 126. cell membrane - answers all cells are wrapped in a semi-permeable membrane that protects them from outside elements and distinguishes them from their surround 127. cell membrane receptors - answers specific molecules on the cell membrane surface that produce/block biological activity in the presence3 of specific substances to which they bind 128. the nucleus - answers brain of the cell that regulates all activities 129. some cells don't have one 130. cytoplasm/protoplasm - answers substance inside the outer membrane and outside of the nucleus 131. contains most of the intracellular fluid 132. Extracellular fluid - answers body fluid located between or outside cells. consists of interstitial fluid or 146. broken down into glucose and used for immediate metabolic reactions 147. vitamins - answers substances necessary for growth, development, and normal regulation of metabolic processes 148. taken in from outside body 149. minerals - answers substances necessary for bodily processes such as the balance of body fluids, formation/maintence of bones and teeth, proper functioning of muscles 150. main ones are calcium, potassium, iron, sodium, phosphorus, iodine 151. How does the federal food, drug and cosmetics act (FFDCA) define a drug? - answers any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or a substance other tan food intended to affect the structure or function of the body 152. ADME testing - answers measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into date material and then exerts it from the body 153. ADME testing is primarily used in what field? - answers pharmacokinetics 154. What statement about placebos is correct? - answers placebo effects can lead to withdrawal symptoms 155. on average, only about ____ of 4,000 drugs studied in the lab are studied in people - answers 5 156. Which statement us true about drugs taken sublingually? - answers sublingual drugs are absurd directly and almost immediately into the bloodstream 157. the rights of drug administration - answers the right patient, the right drug, and the right dose, right route, right time 158. pro-drugs - answers admixture in an inactive form, which is metabolized into an active form 159. the resulting metabolites produce the desired therapeutic effects 160. The kidney of an 85-year-old person excretes drugs only _____ as efficiently as that of a 35-year-old person. - answers around 50% 161. the normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person’s age (T/F) - answers TRUE 162. What differentiates a caplet from a tablet? - Answers Caplets are shaped like capsules and have film coatings to aid in swallowing. 163. Where will you find the legend "caution: Federal law prohibits dispensing without a prescription"? - answers on the label of all prescription drugs 178. Which statement is true about the universal scale for quantifying the severity of an adverse drug reaction? - answers none are true because there is no such scale 179. Why is noncompliance a serious public health concern? - answers it increases the cost of medical care 180. Which of the following are eligible for patent protection under US regulations? - answers the drug itself 181. the method of delivering and releasing the drug into the bloodstream 182. the way the drug is made 183. drugs' trade names are often unrelated to their intended use (T/F) - answers TRUE 184. Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents (T/F) - answers FALSE 185. Legally, bioequivalence of different versions of a drug can vary by up to ________. - answers 20% 186. biologics - answers also called "large molecule" drugs 187. derived from living materials 188. vaccines are a type of biologic 189. "large molecule" products are developed and manufactured by a chemical process (T/F) - answers FALSE 190. What are drugs that attract or bind to cell receptors in order to mimic or enhance activities by endogenous chemical messengers? - answers agonists 191. Which term denotes how an API works in the body? - answers mechanism of action 192. What cements the active and inert components together to maintain cohesive portions? - answers binders 193. What does the medical abbreviation "BID" denote? - answers twice a day 194. what is the medical abbreviation for "as needed" - answers PRN 195. Which components might cause patients different reactions to brand name and generic drugs? - answers differences in inactive ingredients 196. What influences drug response? - answers the patents genetic makeup, are, size, use of other drugs/supplements 197. patients other conditions or diseases 198. whether or not the patient takes the drug properly 199. drug reactions are predictable because they do not occur after a person has been previously exposed to the drug one of more times without any allergic reactions (T/F) - answers FALSE 219. How often do secondary drug wholesale distributors buy their drugs directly from manufactures? - answers sometimes 220. By FDA law, large chain pharmacies are not allowed to buy directly from drug manufactures. (T/F) - answers FALSE- they can buy directly from drug manufactures 221. Only 3 companies account for nearly 90% of all drug wholesale sales. - answers TRUE 222. cardinal health, McKesson HBOC, AmerisourceBergen 223. What type of sale bypasses the need for intermediary distributors? - answers manufacturer-direct sales 224. 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 225. Prescriptions dispensed by mail-order pharmacies are, on average, around ____________ than those dispensed by retail pharmacies. - answers 3 times larger 226. types of non-stock sale - answers brokerage sales 227. dock-to-dock sales 228. drop shipments 229. What is another term for rebates? - answers after- market arrangements 230. the PDMA is the prescription drug manufactures associated (T/F) - answers FALSE 231. a company that owns and operates three or fewer pharmacies is an - answers independent drug store 232. Which section of drugs package insert information covers the usual dosage range? - answers indications and usage 233. drug labels must include - answers indications, usage information, and contraindications 234. What should be included in the "description" section of drugs package insert information? - answers the drugs proprietary name and the established name 235. Exclusivity gives exclusive _____, is granted by the FDA, and can run concurrently with a patent or not. - answers marketing rights 236. What differentiates exclusivity from a patent? - answers exclusivity is only granted upon the drug's FDA approval 237. What is required of an invention for it to be worthy of patent protection? - answers it must be novel, useful, and not obvious 238. a generic drug is _____ to the originator brand-name drug in dosage, strength, safety, and quality - answers bioequlivant 251. the FDA approves storage conditions for drug products (t/F) - answers TRUE 252. pharmaceutical reps must always record the amount of drug samples left and obtain a signature for that amount (T/F) - answers TRUE 253. 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 254. the federal government does not regulate the drug sampling for a pharmaceutical rep (t/f) - answers FALSE 255. Which of the following is permitted by section 503 of the federal food, drug, and cosmetic act? - answers none of these 256. 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 257. storage conditions for drug products are based on information supplied by the manufacturer (T/F) - answers TRUE 258. medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors - answers FALSE 259. In which cases can degraded drugs SOMETIMES still be used? - answers when the amount of remaining drug has not fallen lower than 85-90% of that stated on the label 260. drug recalls are almost always negotiated with the FDA beforehand (T/F) - answers TRUE 261. Which problem would NOT be improved by electronic prescribing systems? - answers none of these 262. 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 them of the mistake and ask for instructions on proper procedure 263. Which area of drug R&D has seen the largest cost increases? - answers clinical trials 264. 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 265. Which of the following factories has simplified the pharmaceutical R&D process? - answers none of these 266. The landmark FDA Modernization Act of 1997 was a major step forward in enabling safe and effective new drugs and biologics to be made available sooner to patients. (T/F) - answers TRUE 267. Which of the following regulatory agencies is industry-based (i.e., run mainly by the companies 279. How are weak acid drugs generally absorbed by the stomach? - answers more quickly than weak basic drugs 280. Which of the following routes of administration completely bypass the liver? - answers intravenous administration 281. transdermal administration 282. DOES NOT: rectal administration 283. 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 284. Which of the following affects a drugs distribution to its target tissues? - answers the drugs lipid-solubility 285. the drugs polarity 286. the vascular nature of the drugs target tissue 287. Which of these medical terms means "to apply the drug on the skin surface"? - answers transdermal 288. Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug. (T/F) - answers TRUE 289. According to NIH ethical guidelines, which of the following are the most important criteria in selecting subjects for clinical studies? - answers scientific objectives 290. which statement about the IRB is correct - answers the investigator must inform the IRB/IEC of any changes in the research activity 291. the IRB/IEC acts as a third party to oversee the welfare of the trial subjects 292. the IRB/IEC has the right to stop a trial or require that procedures and methods be changed 293. NOT: 294. the members of the IRB/IEC must be experts in the topic of the study 295. 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 296. 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 297. which of the following is an observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks back in time (e.g., via chart reviews) to find exposure to risk factors? - answers case-control study 298. Which measure of central tendency is the sum of all observations divided by the number of observations? - answers mean may be needed to maximize vaccines' immunological effects 312. vaccine development focuses on how to reduce virulence while retaining the ability to produce immunity 313. vaccines contain antigenic components that are obtained from or derived from the pathogen 314. NOT: 315. vaccines are types of "small molecule" drugs 316. What is an advantage of attenuated vaccines over inactivated vaccines? - answers attenuated vaccines are less expensive to prepare 317. How are toxoids derived? - answers from the toxins secreted by a pathogen 318. What is the estimated annual death toll for malaria? - answers 1.5 to 3.5 million people 319. there are more white blood cells than red blood cells for the same volume in the human body (T/F) - answers FALSE 320. How insulin was primarily obtained from the 1930s to the 1980s? - answers porcine and bovine extracts 321. types of cytokines - answers interferon’s 322. interleukins 323. monotones 324. type of hormones - answers amino acid derivatives 325. polypeptides 326. steroids 327. Which of the following is a basic gene therapy technique? - answers in vitro, in which patients genetically faulted tissues are removed, loaded with normal genes in vectors and returned to the patients bodies 328. Which statement about stem cells is CORRECT? - answers Pluripotent stem cells can develop into many cell types, but not a new individual. 329. leukemia is a condition in which the stem cells in the bone marrow malfunction and produce an excessive number of immature white blood cells (T/F) - answers TRUE 330. Which of the following are types of vectors used in gene therapy? - answers retroviruses 331. types of stem cells - answers multipotent, pluripotent, totipotent 332. Traditional vaccines are prepared in a number of ways. What way is NOT one of them? - answers NOT: insulin 333. attenuated, inactive, toxoids 348. According to your manual, the three primary entities that fund pharmaceuticals are employers, the government (Medicare and Medicaid) and? - answers individuals 349. Which of these individuals would be a member of a P&T committee? - answers an attending physician 350. the physician who heads the surgery department 351. NOT (a company's medical liaison) 352. Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of- service plan. (T/F) - answers FALSE 353. pharmaceutical companies are more interested in acquiring and exploring another brands than in acquiring another R&D and sales and marketing assets (T/F) - answers FALSE 354. Ideally, when should brand strategy development for a new drug begin? - answers during phase II clinical trials 355. Which of the following is an example of an "expressive" value? - answers "I own a BMW because I want people to know that I'm a serious driving enthusiast" 356. According to your manual, which of the following is an example of a "functional" value? - answers convenience 357. efficacy 358. safety 359. NOT: uniqueness 360. It is rare for pharmaceutical companies to explore, develop and promote expressive values with which patients might identify (T/F) - answers TRUE 361. 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. (T/F) - answers TRUE 362. With the global need for new drugs, pharmaceutical brand names are not subject to regulatory approval. (T/F) - answers FALSE 363. 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 364. Which of the following MOST strongly influences physicians' prescribing habits? - answers doctors personal experiences, and their patients unique situation 365. pharmaceutical companies spend more on promotional activities than on R&D. (T/F) - answers FALSE 366. Which of the following would be MOST well-served by mass-market print and TV ads? - answers a brand that treats a very common chronic condition 367. Which of the below is the least commonly analyzed fluid for conducting a medical diagnostic test? - answers saliva 380. Diagnostic tests are done for a variety of reasons, which of the below is NOT a reason to perform a diagnostic test? - answers provide a single purpose for scientific analysis 381. YES: 382. screening, evaluating the severity of a disorder so that treatment can be planned, monitoring the response to treatment 383. many diagnostic tests are considered to be of a general therapeutic area and are not specified (T/F) - answers FALSE 384. 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 (T/F) - answers FALSE 385. Neurodiagnostic tests are done because of a patient’s illness or condition is mostly bead in the central nervous system (brain or spinal cord). Which of the following is NOT a sign of a nervous system disorder? - answers diarrhea 386. YES: 387. chronic headaches, seizures, dizziness 388. the Electroencephalogram (EEG or brain wave test) is a non-invasive procedure used to detect and record brain wave cell activity (T/F) - answers TRUE 389. a coronary angiogram is obtained by injecting an iodine-based dye or other contrast agent into the bloodstream and taking x-rays of the coronary arteries (T/F) - answers TRUE 390. How do companies use prescriber data? - answers conduct research 391. Under Pram Code, which of the following is acceptable? - answers modest meals for staff members attending educational events 392. 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 393. Under Pram code, which of the following actions by sales reps are permitted? - answers providing modest meals to staff members attending educational events 394. The Pram code on interactions with healthcare professionals is only voluntary and not mandatory. (T/F) - answers TRUE 395. Which of the following would NOT be considered acceptable promotional items under Pram code? - answers pens and clipboards designed to be used by patients in doctors’ offices 396. YES: journal subscriptions, medical text books, stethoscopes 397. Under Pram Code, what is one example of an acceptable patient education item? - answers an anatomical model valued under $100 410. Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists? - answers psychiatrist often see patient on the hour for 45 mines 411. What is/are an advantage/s of selling to residents? - answers residents are often more open minded 412. What is drug utilization review (DUR)? - answers an MCO's practice of monitoring prescribing patterns 413. What is the focus of the short call protocol? - answers beginning with a specific patient type 414. Who is the Medical Science Liaison (MSL)? - answers someone employed by a pharmaceutical company who builds relationships with thought leaders and acts as an informational resources 415. What type of education do MSLs typically have? - answers graduate-level science degrees 416. How do companies typically judge the MSL team’s contributions? - answers return on education 417. What differentiates "push through" programs from "pull through" programs? - answers sales reps are more involved in "pull through" programs 418. Which of these is NOT a type of "pull through" program? - answers all of these 419. adherence/persistency, educational support, therapeutic intervention 420. Because pharmaceutical sales reps work mostly out of their home it is not important for a rep to work well in a team environment. (T/F) - answers FALSE 421. 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 422. Which of the following is NOT an effective method for reaching the 65+ market? - answers ALL OF THESE 423. being a Medicare part D information resource, knowing the physician-payer mix, taking advantage of partnership programs 424. When a physician visits your hospital display, you should begin conversation by asking, "Can I help you?" (T/F) - answers FALSE 425. Which of the following is NOT a rule in making the most out of your sales calls? - answers your agenda, not theirs 426. YES: counterpart coordination, no data dumping, reading the environment 427. Specialty care products are often prescribed by generalist physicians. (T/F) - answers FALSE 428. side effects that might be considered merely minor annoyances in acute treatment can be a powerful barrier to adoption in chronic therapies (T/F) - answers TRUE 441. Which of the following are relatively new prescription drug benefits covered under the Medicare prescription drug improvement & modernization act? - answers Medicare part D 442. Which term means "disease producer"? - answers pathogen 443. Which type of blood cell plays the most prominent role in fighting infection and disease? - answers white blood cell 444. 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 445. renal pertains to - answers kidneys 446. What term denotes the practice of locating genes on a chromosome? - answers gene mapping 447. What field is MOST concerned with drug effects due to slight genetic differences? - answers pharmacogenomics 448. Which entity or entities fund/s the National Institutes of Health (NIH)? - answers United States federal government 449. With respect to the material in your manual, what does IDN stand for? - answers integrated delivery network 450. What is SS an abbreviation for? - answers semis 451. What term is used to denote drugs that are non- biological (i.e., chemical) in nature? - answers small molecule 452. When referring to medication dosage, which medical abbreviation denotes "hour"? - answers H 453. Which of the following terms denotes the study of drugs beneficial and toxic effects on living cells, tissues, and organisms? - answers pharmacology 454. What are specialized cells and tissues that work together to perform a specific body function for a common purpose? - answers organs 455. What is the mechanism of action? - answers the method by which a medication produces its therapeutic effects 456. What is plasma? - answers Fluid portion of blood 457. What is anaphylaxis? - answers An extreme sensitivity and reaction to a foreign substance, including medications 458. Which of the following is NOT a way in which CNS agents are used? - answers they are used in all these ways: 459. analgesics, anesthetics, anti-consultants 460. How do cholinergic agonists work? - answers by mimicking the actions of acetylcholine