Understanding Drug Therapy, Pharmaceutical Industry, and Drug Development, Assignments of Nursing

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1. Pharmaceuticals are arguably the most socially important healthcare product.
2. Pharmaceutical development is a high-risk undertaking, in which many promising leads prove disappointing.
3. Pharmaceutical sales are highest in which geographic regions?
4. The U.S. accounts for about of the world's pharmaceutical revenues.
5. What event has fueled recent growth in the pharmaceutical industry?
6. According to your manual, what de- scribes the predicted relationship be- tween pharmaceutical companies and genomic research facilities?
7. Prescription drug therapy is not cost-ef- fective for insurance companies and in- surance providers.
8. The high price of healthcare is explained by the high price of medicines.
9. One of the oldest and least effective pharmaceutical marketing techniques is DTC (direct-to-consumer) advertising.
10. What influences the number of districts in a region?
11. What is an example of the regionalization of healthcare delivery systems?

True

True

The U.S., Western Europe, and Japan.

50%

Population growth and in- creased life expectancies.

Partnerships between them will not prove immediately prof- itable.

False

False

False

The regions population

California and Florida have dif- ferent prescription reimburse- ment policies.

12. False

The heart of a pharmaceutical sales team is the Regional Manager.

13. Most District Managers (DMs) did not start as representatives.
14. How many territories are in a typical dis- trict?
15. What is the most effective method for grabbing market share?
16. Pharmaceutical reps mainly visit phar- macies.
17. It usually takes about 1-2 calls to a physi- cian before he/she commits to prescrib- ing your product.
18. The pharmacist may dispense a prod- uct other than what the physician pre- scribed.
19. Which of the following would classify as Payers - Employers, patients, pharma- cists, or physicians?
20. How would you define ethical pharma- ceutical companies?
21. One of the most disappointing results of the pharmaceutical Industry's continued investment in R&D is the few new drugs being approved and in development.
22. Thanks to modern medicines, how long are people newly diagnosed with HIV ex- pected to live?

False

8 to 12

Comparative selling.

False

False

True

Employers.

Ones that research and develop novel drugs.

False

Another 50 years.

23. Almost 30 years

How much has the average American lifespan increased since 1890?

24. What is a treatment group? A group of patients assigned to receive a specified treatment.
25. What is the main difference between a blinded and a double-blinded study?

In a double blind study, neither the study staff nor the study par- ticipants know which subjects are in the experimental group and which are in the control group.

26. What does asymptomatic mean? Not exhibiting signs or symp- toms.
27. What term denotes the study of bodily functions (as opposed to structures)?
28. In its broadest definition, a drug is any substance that produces a physical or psychological change in the body.
29. How does the Federal Food, Drug and Cosmetic Act (FFDCA) define a drug?
30. Most of the body's required vitamins must be taken from outside the body.

Physiology.

True

Any substance intended for use in the diagnosis, cure, mitiga- tion, treatment, or prevention of disease, or a substance other than food intended to affect the structure or function of the body.

True

31. ADME testing measures the rate at which True 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.

32. What field is ADME testing used in pri- marily?
33. Placebo effects can lead to withdrawal symptoms.
34. On average, only about 5 of 4,000 drugs studied in laboratory are eventually stud- ied in people.
35. Sublingual drugs are absorbed directly and almost immediately into the blood- stream.
36. What are 3 of the 7 rights of drug admin- istration?
37. Pro-drugs are administered in active form, which is metabolized into an inac- tive form.
38. The kidney of an 85-year old person ex- cretes drugs only as efficiently as that of a 35-year old person.
39. The normal age-related decrease in kid- ney function can help doctors determine an appropriate dosage based solely on a person's age.
40. What differentiates a caplet from a tablet?

Pharmacokinetics.

True

True

True

The right patient, the right drug, the right dose.

False

Around 50%

True

Caplets are shaped like cap- sules and have film coatings to aid in swallowing.

41. Where will you find the legend, "Caution: On the label of all prescription Federal Law prohibits dispensing with- out a prescription."?

drugs.

42. What happens in slow acetylators? Drugs that are metabolized by N-acetyl transferase tend to

43. About of the people in the U.S. are slow acetylators.
44. Drug-drug interactions are always harm- ful.
45. Smoking decreases the effectiveness of some drugs.
46. Because dietary supplements are not drugs, interactions with drugs are not a concern.
47. Ehrlich stated that an ideal drug (magic bullet) does not exist, would be aimed precisely at a disease site, and would not harm healthy tissues.
48. What is the difference between resis- tance and tolerance?
49. Between 3% and 7% of hospital admis- sions in the U.S. are estimated to be for treatment of adverse drug reactions.
50. There is no universal scale for quantify- ing the severity of an adverse drug reac- tion.
51. Why is noncompliance a serious public health concern?

reach higher blood levels and remain the body longer.

50%

False

True

False

True

Tolerance refers to a person's diminished response to a drug after repeated use, while re- sistance applies to microorgan- ism's or cancer cell's abilities to withstand drug effects.

True

True

It increases the cost of medical care.

52.52.

Name 3 items available for which patent protection is available under U.S. regula- tions.

53. Drugs' trade names are often unrelated to their intended use.
54. Like foods and household products, generic drugs are usually lower quality than the brand name drugs for which they are marketed as equivalents.
55. Legally, bioequivalence of different ver- sions of a drug can vary by up to percent.
56. Biologics do not cause immune respons- es.
57. "Large molecule" products are devel- oped and manufactured by a chemical process.
58. What are the drugs that attract or bind cell receptors in order to mimic or en- hance activities by endogenous chemi- cal messengers?
59. What term denotes how an API works in the body?
60. What cements the active and inert com- ponents together to maintain cohesive portions?

The drug itself, the method of delivering and releasing the drug into the bloodstream, and the way the drug is made.

False

False

False

False

Agonists

Mechanism of action.

Binders.

61. What does the abbreviation BID denote? Twice a day
62. What is the medical abbreviation for 'as needed'?

PRN.

63. Which components might cause pa- tient's different reactions to brand name and generic drugs?

Differences in inactive ingredi- ents.

64. All cells have a nucleus. False
65. Name three things that affect drug re- sponse.
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 reac- tions.
67. What is the typical relationship between a drug's site of administration and site of action?

The patient's genetic makeup, age, body size, and use of other drugs and dietary supplements. The patient's other conditions and diseases. Whether or not the patient takes the drug prop- erly.

False

They are usually somewhat re- moved from one another.

68. What is CMAX? The peak plasma concentration on a measuring curve.
69. Pharmacoprocesses are a main concept of clinical pharmacology.
70. Which is not a route of drug administra- tion - buccal, intramuscular, sublingual, or transfugal?

False

Transfugal

71. How are intradermal drugs delivered? By injection under the skin.
72. An injection of anesthetic directly into the bloodstream is an example of intra- venous drug delivery.

True

73. What are the major organs of the gas- trointestinal system?
74. Who is normally responsible for selling to distributors?
75. How often do secondary drugs whole- sale distributors buy their drugs directly from manufacturers?
76. By FDA law, large chain pharmacies are not allowed to buy directly from drug manufacturers.
77. Only 3 companies account for nearly 90% of all wholesale drug sales.
78. What type of sale bypasses the need for intermediary distributors?
79. What is a group purchasing organization (GPO)?
80. Prescriptions dispensed by mail-order pharmacies are, on average, around than those dispensed by retail pharmacies.
81. Which of the following is NOT a type of non-stock sale - a) brokerage sales b) dock-to-dock sales c) drop shipments d) all of these are types of non-stock sales

The mouth, esophagus, stom- ach, liver, pancreas, gallblad- der, small and large intestines.

NAMs.

Sometimes

False

True

Manufacturer direct sales.

An entity consisting of two or more hospitals or other health care entities that negotiates contracts on behalf of its mem- bers.

3 times larger

D) all of these are types of non-stock sales

82. What is another term for rebates? After market arrangements.
83. The PDMA is the Prescription Drug Man- ufacturers Association.
84. A company that owns and oper- ates three or fewer pharmacies is an .
85. Which section of a drug's package in- sert information covers the usual dosage range?
86. Drug labels must include indications, us- age information, and contraindications.
87. What should be included in the descrip- tion section of a drug's package insert information?

False.

Independent drug store.

Indications and usage.

True

The drug's proprietary name and the established name.

88. Exclusivity gives exclusive , Marketing rights. is granted by the FDA, and can run con- currently with a patent or not.
89. What differentiates exclusivity from a patent?
90. What is required of an invention for it to be worthy of patent protection?

Exclusivity is only granted upon the drug's FDA approval.

It must be novel, useful, and not obvious.

91. A generic drug is to the origina- bioequivalent tor brand-name drug in dosage, strength, safety, and equality.
92. The FDA's Criteria for Equivalency requires the drugs contain identical amounts of the same inactive ingredi- ents.

True

93.93.

What list is generally considered the most reliable source of information on therapeutically equivalent drug prod- ucts?

94. Which of the following is an Orange Book rating a) AZ b) B c) BZ d) CZ
95. What is the term for chemical equivalents which, when administered in the same amounts, will provide the same biologi- cal or physiological availability as mea- sured by blood and urine levels?
96. What term denotes a drug that is iden- tical or bioequivalent to the originator brand-name drug in dosage form, safety, strength, route, quality, performance?
97. What term denotes the dispensing of an unbranded generic product for the prod- uct prescribed?
98. What is the duration of a patent chal- lenge?
99. How is a drug sample closet or cabinet like a grocery store shelf?
100. Pharmaceutical reps do not typically store and secure their own drug sam- ples.

"Approved Drug Products with Therapeutic Equivalence"

b) B

Biologic equivalents.

Generic

Generic substitution.

180 days (6 months)

The more visibility you can give your drug, the more likely it will be prescribed.

False

101. True

Sampling is sometimes the most impor- tant factor in a pharmaceutical rep's suc- cess.

102. The FDA approves storage conditions for drug products.

True

103. Pharmaceutical reps must always record True the amount of drug samples left and ob- tain a signature for that amount.
104. What is prohibited by Section 503 of the Federal Food, Drug, and Cosmetic Act, as amended by the Prescription Drug Mar- keting Act?
105. The federal government does not regu- late the drug sampling for a pharmaceu- tical rep.
106. Section 503 of the Federal Food, Drug, and Cosmetic Act permits hospitals to donate their prescription drug samples to qualified charitable organization.
107. Which entity issues monographs that de- fine how drugs should be stored, and what variance is allowed in their shared contents?
108. Storage conditions for drug products are based on information supplied by the manufacturer.
109. Medications are usually unaffected by changes in temperature, light, humidity, and other environmental factors.
110. In which cases can degraded drugs sometimes still be used?

The sale, purchase, or trade or offer to sell, purchase, or trade prescription drug samples.

True

False

United States Pharmacopoeial Convention.

True

False

When the amount of the re- maining drug has not fallen low-

111. Drug recalls are almost always negotiat- ed with the FDA beforehand.
112. Electronic prescribing systems would improve patients doctor-shopping for controlled substances, pharmacists mis- reading prescriptions, and physicians wasting time calling pharmacies.
113. What should you do if you receive a ship- ment from your employer and you notice that there are twice as many samples as what is posted on the packing slip?
114. Which area of drug R&D has seen the largest cost increases?
115. 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)?
116. Which of the following agencies is indus- try-based (i.e. run mainly by the compa- nies themselves)? a) Drug Enforcement Administration b) European Medicines Agency c) Pharmaceutical Research and Manu- facturers of America (PhRMA) d) the FDA?
117. Growing demand in the medical commu- nity for more complex data about phar- maceuticals has simplified the pharma- ceutical R&D process?

er than 85-90% of that stated on the label.

True

True

Call your Sales Manager and inform him/her of the mistake, and ask for instructions on prop- er procedure.

Clinical trials.

10-15 years

C) PhRMA.

False

118. True

The landmark FDA Modernization Act of 1997 was a major step forward in en- abling safe and effective new drugs and biologics to be made available sooner to patients.

119. Which type system is the best way to deliver healthcare?
120. How would increased pharmaceutical price controls affect the U.S. healthcare system?
121. Which invests a greater percentage of sales in research than the biotech sector a) aerospace b) communications c) electronics d) none of these
122. What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technolo- gy Innovation Act?
123. What did the G10 Medicines Group re- cently report about the pharmaceutical industry in the European Union (EU)?
124. The aim of preclinical pharmacological studies is to obtain data on the safety and effectiveness of the lead compound.
125. Toxicity information in preclinical studies helps provide confidence about a drug's safety.
126. Pharmacological studies using animals are regulated under Good Laboratory Practice.

A market-based system.

Increased price controls would stifle innovation.

d) none of these

To hasten the commercializa- tion of technologies that other- wise might not be used.

There is poor collaboration be- tween publicly- and private- ly-funded research centers.

True

True

True

127. Why do drugs administered to patients only contain APIs?
128. A drug's vesicles affect it's ability to per- meate membranes.
129. Through which barriers can lipid-soluble drugs usually pass?
130. How are weak acid drugs generally ab- sorbed by the stomach?
131. Which route of administration does not completely bypass the liver?
132. Why are intravenous drug dosages eas- ier to control than drugs administered transdermally?
133. A drug's lipid-solubility, polarity, and the of the drug's target tissue affect it's distribution.
134. What medical term means "to apply the drug on the surface of the skin"?
135. Carcinogenicity studies are carried out to identify the tumor-causing potential of a drug.
136. According to NIH ethical guidelines, what is the most important criteria in selecting subjects for clinical studies?
137. The members of the IRB/IEC must be ex- perts in the topic of study.
138. Which phases of clinical studies are open label and which are blinded?

They don't.

True

Cell membranes.

More quickly than weak basic drugs.

Rectal administration.

The entire dose is available in the bloodstream to be distrib- uted to the target site.

vascular nature

Transdermal.

True

Scientific objectives

True

Phase I and IV trials are often open label, but Phase II and III

139. If it is not possible to measure the direct effects of a drug, what is used instead?
140. What is the name of an observational study that first identifies a group of sub- jects with a certain disease and a con- trol group without the disease, and then looks back in time (e.g. via chart reviews) to find exposure to risk factors?
141. Which measure of central tendency is the sum of all observations divided by the number observations?
142. Which measurement describes the num- ber 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)?
143. is used to describe the variability of the population mean.
144. What term denotes the extent to which a test actually measures what it is sup- posed to be measuring, or what we think it is measuring?
145. What are the Kaplan-Meier analysis and Cox proportional hazards analysis?
146. What section of a clinical paper de- scribes subjects' entry and exclusion cri- teria?

are double-blinded or at least blinded.

Surrogate markers such as blood pressure and cholesterol levels.

Case-control study.

Mean.

Incidence.

Standard error of the mean

Validity.

Methods of survival analysis.

Methods.

147. Protocol.

Which document sets out how a trial is to be conducted (i.e. the study's general design and operating features)?

148. When designing and performing clinical trials, several ethical constraints must be considered. Which one of the following is NOT one of these ethical restraints a) geographic variations b) independent review c) scientific validity d) social value?
149. What is one way in which large molecule drugs differ from small molecule drugs?
150. Vaccines are types of small molecule drugs.
151. What is an advantage of attenuated vac- cines over inactivated vaccines?

Geographic variations.

Large molecule drugs are main- ly protein-based drugs that develop in biological systems such as living cells.

False

Attenuated vaccines are less expensive to prepare.

152. How are toxoids derived? From the toxins secreted by a pathogen.
153. What is the estimated annual death toll in Malaria?
154. There are more white blood cells than red blood cells for the same volume in the human body.
155. How was insulin primarily obtained from the 1930s to the 1980s?
156. Which of the following are not types of cytokines a) interferons

1.5 to 3.5 million people.

False

Porcine and bovine extracts.

All of these are types of cy- tokines.

b) interleukins c) monokines d) all of these are types of cytokines

157. Which of the following is not a type of hormones a) amino acid derivatives b) blood glucose c) polypeptides d) steroids?
158. Describe the 'in vitro' gene therapy tech- nique.
159. Pluripotent stem cells can develop into many cell types, but not a new individual.
160. Leukemia is a condition in which the stem cells in the bone marrow malfunc- tion and produce an excessive number of immature white blood cells.

Blood glucose.

Patients' genetically faulted tis- sues are removed, loaded with normal genes in vectors, and returned to the patients' bodies.

True.

True.

161. Retroviruses are types of vectors used in True. gene therapy.
162. Which of the following is not a type of stem cell a) multipotent b) pluripotent c) semipotent d) totipotent
163. Traditional vaccines are prepared in a number of ways. Which of the following is not one of them a) attenuated b) insulin

Semipotent.

Insulin

c) inactivated d) toxoids

164. Effective drug therapy is a cost-effec- tive and highly valuable means of con- trolling total healthcare expenditures and improving quality of life.
165. Drug utilization review (DUR) programs have traditionally been used to ensure the appropriate, safe, and effective use of prescription drugs, but are increasingly shifting their focus to minimize costs.
166. DUR programs involve retrospective monitoring of physicians' prescribing patterns.
167. A formulary is a list of prescription drugs approved by insurance coverage.
168. The history of drug formularies in the U.S. extends back to.
169. Which of these is not a type of formulary a)closed three-tier in which generic drugs are listed on Tier 1 b) five-tier that is supplemented by a step therapy program c) open that replaces few restrictions on coverage or access d) all of these are types of formularies
170. The repeal of Hatch-Waxman is a recent formulary trend.

True

True

True

True

The American Revolution

All of these are types of formu- laries.

False

171. What did the Hatch-Waxman Act do? Make it easier for generic man- ufacturers to compete with R&D companies.

172. What is opportunity cost? The value of a sacrificed alter- native.
173. The three primary entities that fund phar- maceuticals are employers, the govern- ment, and.
174. A company's medical liaison can be a member of a P&T committee.
175. Almost 98% of employed Americans are now covered by a HMO, a preferred provider organization, or a point-of-ser- vice plan.
176. Pharmaceutical companies are more in- terested in acquiring and exploiting an- other's brands than in acquiring anoth- er's R&D and sales marketing assets.
177. Ideally, when should brand strategy de- velopment for a new drug begin?
178. An example of an expressive value is, "I own a BMW because I like feeling the road."
179. Which of the following is not an example of a functional value a) convenience b) efficacy c) safety d) uniqueness
180. It is rare for pharmaceutical companies to explore, develop, and promote ex- pressive value with which patients might identify.

Individuals.

False

False

False

During Phase II clinical trials.

False

Uniqueness

True

181. True

To be competitive, pharmaceutical brands must be distinctive. They must possess defining characteristics that are perceived by customers to be unique, at- tractive, and relevant to their needs.

182. With the global need for new drugs, phar- maceutical brand names are not subject to regulatory approval.
183. Over the last few decades, DTC advertis- ing has become an essential marketing tactic for both large and small brands.
184. Which of the following most strongly in- fluences physicians' prescribing habits a) doctors' personal experiences, and their patients' unique situations, b) DTC advertising c) other types of pharmaceutical market- ing d) patients' opinions about DTC advertis- ing?
185. Pharmaceutical companies spend more on promotional activities than on R&D.

False

True

Doctors' personal experiences, and their patients' unique situa- tions.

False

186. A brand that treats a very common chron- True ic condition would be well-served by mass-market print and TV ads.
187. How do companies use prescriber data? To conduct research.
188. Under PhRMA Code, it is acceptable for modest meals to be provided for staff members attending educational events.
189. Under AMA Guidelines on Gifts to Physi- cians from Industry, it is acceptable to

True

False

only give gifts to doctors with high pre- scribing volumes.

190. According to PhRMA Code, sales reps are allowed to provide modest meals to staff members attending educational events.
191. The PhRMA Code on Interactions with Healthcare Professionals is only volun- tary and not mandatory.
192. Pens and clipboards designed to be used by patients in doctors' offices is consid- ered acceptable under PhRMA Code.
193. Under PhRMA Code, what is one example of an acceptable patient education item?
194. A company is never to provide entertain- ment or recreational activities to health- care practitioners.
195. Under PhRMA Code, may a company sponsor a lunch at a 3-day conference if part of it includes an educational pro- gram for which attendees may choose to receive CME credit?
196. What is the name of the arm of the De- partment of Health and Human Services that investigates regulatory infractions, provides compliance advice, and brings enforcement actions?
197. It is illegal to ask receptionists for per- sonal information about your clients such as home phone numbers, birthdays, or hobbies.

True

True

False

An anatomical model valued under $100.

True

Yes, but only if the lunch is clearly separate from the CME portion of the conference.

Office of Inspector General.

False

198. A primary goal of the P&T committee is to educate sales representatives on legal and ethical guidelines for professional behavior.
199. A major challenge facing family medicine is managed care policies are eroding pa- tient-doctor relationships.
200. Family physicians diagnose and treat ap- proximately what proportion of patients they see (as opposed to referring them to specialists)?
201. Adoption, awareness, and are all steps on the Product Adoption Continuum.
202. would be clas- sified as a type of somatic psychiatric treatment.
203. Why is the last 10 minutes of each hour usually the best time to make office visits to psychiatrists?
204. One of the advantages of selling to residents is that they are often more open-minded.

False

True

95%

Evaluation.

Drug therapy

They often see their patients on the hour for 45 minutes.

True

205. What is drug utilization review (DUR)? An MCO's practice of monitor- ing prescribing patterns.
206. are used in the treatment of manic-depressive illness and schizoaffective disorder.
207. What is the focus of the short call proto- col?

Mood Stabilizers

Beginning with a specific pa- tient type.

208. Who is the Medical Science Liaison (MSL)?
209. What type of education do MSLs typically have?
210. How do companies typically judge the MSL team's contributions?
211. What differentiates push through pro- grams from pull through programs?
212. Adherence/persistency, educational sup- port, and are all types of pull through programs.

Someone employed by a phar- maceutical company who builds relationships with thought lead- ers and acts as an informational resource.

Master's Degrees

Return on education.

Sales reps are more involved in pull through programs.

Therapeutic intervention.

213. Because pharmaceutical sales reps work False. mostly out of their homes, it is not impor- tant that they work well in a team environ- ment.
214. What is a likely reason a doctor would lack interest in one of your clinical stud- ies?
215. Effective methods for reaching the 65+ market are being a Medicare Part D in- formation resource, knowing the physi- cian-payer mix, and taking advantage of .
216. When a physician visits your hospital display, you should begin conversation by asking, "Can I help you?".

He/she does not like the way you are presenting it.

Partnership programs.

False

217. False

One of the rules in making the most out of your sales calls is forcing your agenda, not theirs.

218. Specialty care products are more often prescribed by generalist physicians.
219. Side effects that might be considered merely minor annoyances in acute treat- ment can be a powerful barrier to adop- tion in chronic therapies.
220. Acute medications, such as antibiotics, are used to address short-term illnesses or symptoms.
221. In some medical cases, a therapy may be initiated by a specialist and monitored and maintained by a primary care physi- cian.
222. Blockbuster drug status typically trans- lates into sales of just under $10 million annually.
223. A generic drug manufacturer's greatest challenge is often to replicate drug for- mulation factors that affect the pharma- cokinetic and pharmacodynamic charac- teristics of the original drug.
224. What differentiates an orphan drug from a blockbuster drug?
225. How long are most calls and visits to physicians' offices (excluding waiting and driving time)?
226. Which is not a step in managing rumors a) confirm

False

True

True

True

False

True

Orphan drugs typically treat rare conditions.

Only a few minutes.

Counter attack

b) counter attack c) search d) transition

227. Which of the following is considered go- ing to the next level a) becoming a micro-thinker b) meeting the clients' every need c) minimizing rumors d) staying focused
228. What is one of the primary job responsi- bilities of a retail pharmacist?
229. Pharmaceutical companies and repre- sentatives categorize their customers as 1) acute care vs. chronic care, 2) office-based vs. hospital-based, and 3) vs..

Staying focused

Dispensing pharmaceuticals.

Primary care vs. specialty care