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2
Drug Design, Testing, Manufacturing,
and Marketing
LEARNING OBJECTIVES
After the student studies this chapter, the student should be able to
1.
2.
3.
4.
5.
6.
7.
8.
9.
Name several ways in which drugs are discovered or created.
Describe how computers facilitate drug design.
Differentiate between the chemical, generic, and trade/brand names of a drug.
List at least five things that the trade names of drugs might tell you about those drugs.
Describe the three phases of the human testing of new drugs.
Define the phrases in vitro, in vivo, clinical trials, control group, drug patent, isomer, and placebo.
Describe how inert ingredients might affect the bioavailability of a drug.
Describe how direct marketing of prescription drugs has affected consumers and drug costs.
Give four reasons why a drug might be withdrawn from the market or recalled.
TEACHING STRATEGIES
For Chapter 2, you will want to stress these broad concepts at the beginning of the lecture or distancelearning presentation.
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The six ways in which drugs are created or discovered
The chemical, generic, and trade names of a drug and how they are selected
What the trade name of a drug can reveal about that drug
The process of animal and human testing before a drug is approved
Drug marketing and the benefits and drawbacks of direct-to-consumer drug advertising
Drug patents, drug withdrawls, and drug recalls
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Test the Chapter 2 material in some or all of these ways:
•
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Chapter test
Spelling test
Pronunciation test
Student activity assignments
Chapter Test
Construct a chapter test by selecting chapter test questions from the Test Bank. Test each chapter
separately or test two or three chapters at the same time with a combined chapter test. The Test Bank
is located on the Web at www.pearsonhighered.com/turley. It is also in Word format and in the
Test Gen on the Instructor’s Resource CD-ROM.
Tear-Out Worksheets
There are tear-out Worksheets in each chapter of the Instructor’s Resource Manual that contain
the Chapter Spelling List, Chapter Pronunciation List, and student activities. Photocopy these
Worksheets for each student. Alternatively, use the Worksheets for each chapter that are available on the Instructor’s Resource CD-ROM. Cut and paste the materials from the CD-ROM
into your course management software or into an e-mail to send to your regular classroom or
distance-learning students. Note: The Answer Key for these Worksheets is located at the end of
the chapter.
Spelling Test
Tell students to study the Chapter Spelling List. The words in this list have been carefully selected
to include common but challenging drug categories, drug names, or drug words. Before administering the spelling test, use the Chapter Spelling Test (see below) to verify your pronunciation of
each drug name on the list. To administer the spelling test, pronounce each drug name or drug word
and have students write it. Instruct students to lowercase generic drugs, capitalize trade name
drugs, and include internal capitalization, if present, in the trade name drug. Alternatively, both
regular students and distance-learning students can take the Chapter Spelling Test on the textbook Website. They will be able to submit their results via e-mail.
To assist you in administering the Chapter Spelling Test, the Chapter Spelling List words
have been duplicated here, accompanied by their pronunciations, for your convenience.
CHAPTER SPELLING LIST
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
bioavailability [BY-oh-ah-VAIL-ah-BIL-ih-tee]
gene [JEEN]
generic [jeh-NAIR-ik]
genetic [jeh-NET-ik]
human genome [HYOO-man JEE-nohm]
isomer [EYE-soh-mer]
patent [PAT-ent]
placebo [plah-SEE-boh]
recombinant [ree-KAWM-bih-nant]
therapeutic index [THAIR-ah-PYOO-tik IN-deks]
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Pronunciation Test
Tell students to study the Chapter Pronunciation List. The words on this list have been carefully
selected to include common but challenging drug categories, drug names, or drug words. To
administer the pronunciation test in class, have each student come into a separate room and pronounce each of the words on the list in front of you or into a tape recorder. This can be done while
students are taking a chapter test. Alternatively, tell regular or distance-learning students to call
your answering machine, give their name, and pronounce each of the words on the list.
Student Activity Assignments
Have students complete the Chapter Word Search puzzle and/or other Chapter Exercises and turn
them in either to count toward their grade or for extra credit points.
INTRODUCTION TO THE CHAPTER
Read aloud the chapter contents and the learning objectives (or instruct distance-learning students
to read them themselves). If you plan to administer a chapter test after students study this chapter, specifically state this as you introduce the chapter. If you plan to administer a chapter spelling
test and/or chapter pronunciation test, specifically state this and photocopy these tear-out Worksheets ahead of time for students (or post these lists on your distance-learning site).
LEARNING ENRICHMENT
Include this additional information in your lecture or on your distance-learning site for learning
enrichment that goes beyond what is presented in the textbook chapter.
Drug Discovery and Creation
William Fenical, Director of the Center for Marine Biotechnology and Biomedicine at the Scripps
Institution of Oceanography, has found over 5,000 new microorganisms never before known to exist
in samples of deep ocean mud. Many of these microorganisms are showing the potential for becoming antibiotic, antifungal, or chemotherapy drugs. He notes that 70 percent of the earth’s surface
is made up of oceans, and so the potential for the discovery of new drugs seems almost limitless.
“Drugs from the Deep.” Sciencentral.com Website, November 30, 2005.
The DNA molecule is in the shape of a double helix, two chains wound around each other to form
a spiral structure. In 1962, Watson and Crick received the Nobel Prize for identifying the doublehelix structure of DNA in the nucleus of the cell. In 2000, all 3.2 billion parts of the human genome
with all of its genes and DNA had been mapped through the Human Genome Project.
Also, there are approximately 300 micro RNAs in the human genome that control different groups
of genes and their activities. Researchers have already designed chemicals known as antagomirs that
bind to specific micro RNAs and completely shut down their activity. Experiments have shown that
the micro RNA that controls the production of cholesterol in mice can be shut down by a customdesigned antagomir given to mice as a drug. Further research into the function of all of the different
types of micro RNAs will provide opportunities to develop targeted drugs for humans.
Although mapping of the human genome has been a recent accomplishment, attention has now
turned to a more specific area of research: the proteome. All of the proteins that make up the human
genome are known as the proteome. Drug design is now focusing on the proteins, as well as on the
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sugars, that coat cell membranes to determine how a new drug that is just a protein molecule or a
sugar molecule would interact with the cell membrane.
In 2007, a synthetic drug based on the venom of a yellow scorpion was undergoing clinical trials
to treat a glioma, a type of brain tumor that is usually fatal within 2 years of diagnosis. The drug
is currently undergoing clinical trials.
“Cancer Curing Creature.” Reader’s Digest, July 2007, p. 112.
[From the textbook] The technique of gene cloning allows the production of a large supply of a
DNA segment. The DNA segments are then spliced together (recombined) with the DNA in a bacterial cell. As the bacterium multiplies, it carries the new DNA within it as part of the genetic
makeup of all subsequent generations of bacteria, which are now preprogrammed to make supplies of that particular substance that can be used as a drug. In huge vats, these bacteria can produce unlimited quantities of the drug. [As described in the Reader’s Digest article] A single
bacterium can become two, then four, then eight, then a billion in less than a day. All that’s needed
is enough food—a standard microbiological medium—for the whole multiplying clan to eat Á
Then they mass-produce perfect copies of themselves, Á continually pumping out the desired
drug without error.”
Doug Stewart, “These Germs Work Wonders.” Reader’s Digest, January 1991, p. 83.
The heart on the computer screen is pounding erratically—severe arrhythmia. But with a few
keystrokes, researcher Raimond Winslow adjusts the ion channels and within moments the
heart—a three-dimensional model that exists only within the computer—is again beating normally. Winslow, an associate professor of biomedical engineering at The Johns Hopkins University, is developing a detailed computer model that mimics the way the heart works—down to the
subcellular level—in order to study serious cardiac arrhythmias and mathematically test the
drugs that might cure them. He said, “There is just an explosion of cellular and molecular data
on the properties of heart tissue. By using computer models of the heart, pharmaceutical companies will be able to dramatically narrow their searches for life-saving medicines, as well as save
millions of dollars now spent on conventional trial-and-error methods. If you can tell a company
to search for a drug that has a specific effect on a particular ion channel, that is important because
once these companies know what kind of drug to look for, they have the technology to screen more
than 10,000 compounds a day in an effort to find such a drug.”
Laurie Palmer, “Plugged In: Computer Modeling Improves Cardiac Care.”
Journal of the American Health Information Management Association, October 1997:68, p. 13.
Stem cell research was originally done on human embryo cells, some of which were unused
following assisted reproduction procedures in which ovulation-stimulating drugs produced
multiple ova. These ova were then harvested, mixed with sperm, and fertilized in vitro (in a
test tube). The best of these fertilized ova (but not all) were then implanted into the woman’s
uterus. Now human embryos are not needed for stem cell research, as stem cells can be
obtained from the patient. Baby magazines contain full-page advertisements for companies that
will save the umbilical cord of a newborn after birth (with all of its stem cells)—for a fee. This
source of stem cells is then available if the baby ever needs stem cell therapy (as a child or as
an adult). It can also be used if a sibling needs stem cell therapy. It was reported on the news
that one family with a child with leukemia had another child to obtain the stem cells from a
genetically related donor.
Drug Names
Share this in-depth and interesting information about drug names.
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According to a study by the United States Pharmacopeia, nearly 1,500 commonly used drugs have
names so similar to another drug that they have already caused mix-ups. The U.S. Pharmacopeia
has developed a Website where doctors can check to see if they are prescribing any of these errorprone drugs. The Food and Drug Administration rejects more than a third of proposed names for
new drugs because they are too similar to drug names already on the market. The FDA estimates
that 1.5 million Americans are harmed each year by a drug error, and mixed-up drug names
account for 25% of these errors.
Lauran Neergaard, “Beware of Drug Names that Look, Sound Alike.” Associated Press, 2008.
Tip 11 in the chapter mentions Tylenol w/ Codeine No. 2 and Tylenol w/ Codeine No. 3. Note that
these contain 15 mg of codeine and 30 mg of codeine. There is also a Tylenol w/ Codeine No. 4 that
contains 60 mg of codeine. Interestingly, however, there is no Tylenol w/ Codeine No. 1, but there is
just plain Tylenol w/ Codeine that contains 12 mg of codeine.
The following is an excerpt from “Pharmaceutical Nomenclature: The Lawless Language,” by
John H. Dirckx, M.D., Perspectives on the Medical Transcription Profession (spring/summer 1991), pp. 9–15,
and is reprinted here with the permission of the publisher, Health Professions Institute, Modesto, CA.
A trademark is a distinctive word, name, symbol, or device used by manufacturers or sellers to
identify their goods and distinguish them from the goods of others. Once registered with the
United States Patent Office, a trademark becomes the exclusive property of the registrant.
Unauthorized use by others constitutes infringement and is grounds for legal action. Generally,
a firm registers its business name (e.g., Hoechst-Roussel Pharmaceuticals), any logo or device
with which it marks its products or goods, and the names of such of those products that are
sufficiently distinctive to deserve names of their own, particularly if a manufacturer holds
patents on them. A patent continues in effect for only a limited period (usually 17 years), after
which other firms are permitted to manufacture and market the patented product. Any trade
name, however, remains the exclusive property of the registrant. A firm marketing a product
on which the patent has expired can register its own brand name for the productÁ . Pharmaceutical manufacturers may register symbols, monograms, and even the shapes of tabletsÁ . A
firm may own brand names not only for the individual pharmaceuticals it manufactures (such
as Demerol, Motrin, and Tylenol) but also for distinctive or exclusive dosage forms or packaging or delivery systems (such as Gelcap and Spansule).
The trade name or brand name [or proprietary name] of a new drug is devised by the firm
that develops, manufactures, or markets it. Every brand name must be approved by the Food and
Drug Administration, which tries to promote simplicity of naming and to avoid names that may
easily be confused with other names or that may give misleading information about the nature
or purpose of a drugÁ .
Although a drug may be marketed under various brand names by various manufacturers or
suppliers, all of these will also identify it by its generic name. A generic name is a nonproprietary name
that identifies the chemical or pharmaceutical nature of a drug irrespective of who manufactures or
sells itÁ . A generic name is ordinarily proposed by the firm that develops the drug and plans to
patent and market it. In the U.S., generic names must be approved by the United States Adopted
Names (USAN) Council, formed in 1964 under the joint sponsorship of the American Medical Association, the American Pharmaceutical Association, and the United States Pharmacopeial Convention,
Inc., which publishes the United States Pharmacopeia. The USAN Council was created to provide a set
of standards for generic names. These standards, incorporating guidelines set by the Food and Drug
Administration, call for simplicity on the one hand and consistency on the otherÁ .
Once a brand name has achieved a favorable reputation among prescribing physicians, the
manufacturer cannot change it without risking severe financial loss.
The brand names [of drugs] are difficult and unpredictable partly because manufacturers,
who are not held to any particular standards of linguistic decorum, deliberately vary the
spelling of words Á to make it more phonetic (Example: Azmacort, a drug for asthma).
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Testing of New Drugs
If you want to be a human guinea pig, there’s a job for you. Advertisements seeking healthy medical research volunteers appear in local newspapers, on fliers in college dormitories, and on
Websites. Many volunteers sign up for altruistic reasons, but a study done by Johns Hopkins
researchers suggests that the lure of substantial payment is particularly strong for the poor and
uneducated. Low-income people were more likely to sign up for multiple experiments and volunteer for riskier studies. Nearly a third of those studied had joined 10 or more clinical trials.
Doctors don’t know much about the long-term health effects of repeatedly volunteering for
these studies.
Chris Emery, “Medical testing of volunteers questioned.”
The Baltimore Sun, April 14, 2007, p. A1.
Many drug company clinical trials are not listed in the clinical trials database from the National
Institutes of Health. This is because the drug company would have to disclose information about
a drug’s development that could be used by competitors.
According to an African-American professor of medicine at Johns Hopkins, many African-American
patients refuse to join clinical trials of drugs for fear they will be lied to and harmed by researchers
who view them as human guinea pigs. A study he conducted found that “blacks were also more
distrustful of doctors than whites, and 58 percent of black patients felt their physicians would
willingly give them experimental drugs without their consent compared with 28 percent of whites.”
Clinical trials of drugs often fail to enroll enough black participants, and this means that those
studies can’t uncover important biological differences in how people of different races respond to
a new drug. Harriet Washington, author of the 2007 book Medical Apartheid, a history of medical
experimentation on African-Americans, said, “ Á in the 1800s sick black slaves were sold to doctors for medical experiments, doctors sterilized blacks without their consent after the Civil War,
and African-American patients were subjected to deadly, experimental doses of radiation in the
1950sÁ . There is a long, unhappy and unfortunately consistent history of exploitation of blacks
by the medical system.” Many African-Americans still remember the Tuskegee study, which ran
from 1932 to 1972, in which white doctors allowed 400 black men, most of whom were illiterate,
to suffer the long-term effects of syphilis without being treated.
Chris Emery and David Kohn, “Many blacks remain wary of clinical trials.”
The Baltimore Sun, January 15, 2008, p. 2A.
This interview originally appeared on the television news program Frontline in 2003. During the
interview, this question was asked of an FDA official and another drug expert:
Q: Should the public be alarmed at the number of drugs that have recently been taken off the
market?
A: Although it may appear that the rate at which drugs have been removed from the market is higher, it is because there have been a series of high-profile drugs removed and the
reality is that very few drugs get removed from the market. This rate hasn’t changed over
time.
2003 acting director of the FDA’s Center for Drug Evaluation and Research.
A: We have had more drug safety-related problems recently than really almost any comparable
period of time. The sad thing is these were preventable. In most cases, if not all of the cases,
there were strong danger signals even before the drug came on the market that there was a
problem. In all cases, there was a dangerous and reckless slowness to respond to the signals
that came after marketing.
A drug expert.
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Drug Manufacturing
According to a news report, 80 percent of all individual drug ingredients (active drug, buffers,
fillers, etc.) used in the United States are produced/manufactured in China. A number of deaths
were caused by a cheaper-but-deadly ingredient substituted by a Chinese drug manufacturer.
The substituted ingredient became part of the liquid drug heparin, which was distributed in the
United States by Baxter Corporation. This heparin was given to a mother and her adult son, both
of whom were on dialysis, and both died. The FDA announced plans to open a branch office in
China to oversee Chinese drug companies making products for the U.S. market.
ABC Evening News, April 29, 2008.
Half of the 2004–2005 flu vaccine supply had to be taken off the market because it was contaminated
during the manufacturing process and was unusuable.
Jerry Avorn, M.D., “A Prescription for Trouble.” AARP, March/April 2006.
The drug company that makes the cardiac drug digoxin (Digitek) had to recall all the drug tablets
in April 2008 because the tablets contained twice the amount of drug that they should have.
Because digoxin has a low therapeutic index, even a small increase in the dose can cause symptoms of toxicity, such as nausea and vomiting, low blood pressure, decreased heart rate, and
even death.
The childproof safety cap for prescription bottles was invented in 1984.
Drug Marketing
An internist notes that 94 percent of doctors take gifts from drug companies, even though research
has shown that these gifts bias their clinical decision making. The so-called medication samples
of the newest and most expensive drugs may not be the best or the safest.
“41 Things Doctors Never Tell You.” Reader’s Digest, July 2008, p. 124.
In the past, drug companies provided doctors with free concert tickets, restaurant dinners, oil
changes for their cars, or payment for attending continuing education medical courses. The drug
companies themselves stopped this practice in 2002, but still continued to give free lunches, pens,
clocks, and notepads. Under pressure from Congress and consumer groups, Pharmaceutical
Research and Manufacturers of America, the industry organization for drug companies,
announced that it was revising its voluntary marketing guidelines to recommend against all of
those practices. These recommendations will go into effect on January 1, 2009.
Jonathan D. Rockoff, “Doctors’ gifts cut.” The Baltimore Sun, July 11, 2008, p. 3A.
Some doctors actually have a sign posted at their reception desk that drug company representatives
can only be seen during certain hours or not at all.
Some drug television advertisements state the drug’s name but not what it is actually used for.
Sometimes the advertisement ends with “It’s time to see your doctor,” as did a Claritin ad.
After seeing this advertisement, patients call their doctors and ask “What is Claritin? What is
it used for?” Some patients even call their gynecologists and ask if they are candidates for
taking Claritin, because they don’t know Claritin is for seasonal allergies! Why all the secrecy?
Because by stating just the drug’s name but not what it is used for, the ads are exempt from a
Food and Drug Administration regulation that generally requires prescription drug advertisements to disclose the risks of the drug as well as its benefits. From the drug company’s perspective, it may be impractical to include the detailed risk information in a 30- or 60-second
TV advertisement.
Tamar Nordenberg, “Direct to You: TV Drug Ads That Make Sense.”
FDA Website, www.fda.gov, 1998.
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The Annals of Family Medicine reported on a study funded by the National Cancer Institute that
assessed the educational value of 38 direct-to-consumer television advertisements. The study
found that 80 percent of the advertisements did make some factual claims and had rational arguments for use of the drugs, but only 25 percent described symptoms and causes of illness, associated risk factors, or how common or rare the diseases were. The study found that the advertisements
portrayed people taking control of their lives because they took the drug, gaining social approval
because they took the drug, or implied that the drug was a medical breakthrough.
Dominick L. Frosch, Ph.D.; Patrick M Krueger, Ph.D.; Robert C Hornik, Ph.D.;
Peter F. Cronholm, M.D.; and Frances K Barg, Ph.D., “Creating Demand for Prescription
Drugs: A Content Analysis of Television Direct-to-Consumer Advertising.”
Annals of Family Medicine 5:6-13 (2007). As reported on medicalnewstoday.com.
In a New England Journal of Medicine article about drug advertising, Sidney Wolfe of the Public
Citizen Health Research Group said, “There is evidence that many drug advertisements are not
balanced or accurate.” Alan Holmer of the Pharmaceutical Research and Manufacturers of America
said that drug advertising does not replace the physician-patient relationship; its purpose is
rather to encourage an informal discussion between patient and physician.
“Drug Advertising Skyrockets.” CBS Evening News, February 13, 2002.
Because of constant advertisements, drugs have become media stars. Their nicknames, such as
“the purple pill” (Nexium), have become household words and many of these drugs have their
own Websites. Alli is the first FDA-approved, over-the-counter weight loss aid, and it has the
full spectrum of advertising gimmicks. Its name is a play on words (pronounced AL-lie) to suggest to the patient that the drug will act as a friend and ally in weight loss efforts. Even the catchy
product and Website slogans suggest the same: “If you have the will, we have the power” and
“www.myalli.com.”
In 2004, Pfizer drug company paid a $430 million fine for illegally marketing their drug Neurontin
to treat diseases for which it had never received FDA approval.
Julie Schmidt, “Drugmaker admits fraud, but sales flourish.”
USA Today, August 17, 2004, p. A1.
Most doctors get their information about new drugs from representatives of the drug companies.
Some patient advocates worry that the information is one-sided and that the small gifts and free
lunches offered by the drug reps may influence doctors. A bill has been introduced into the Senate
that would use federal money to train health professionals to give drug information to physicians
and to give universities grants to develop unbiased, standardized informational packets on drugs.
The Pharmaceutical Research and Manufacturers of America says that this is unnecessary, and that
drug company reps make sure that the information they provide is accurate and consistent with
FDA-approved labeling.
“How MDs Learn About Drugs.” Parade, August 24, 2008, p. 6.
Drug Marketing
TV advertisements, particularly during evening news broadcasts, are heavily weighted toward
prescription drugs. The consumer is inundated with TV ads for prescription drugs, mainly for
drugs for chronic conditions that require long-term treatment. Insurance companies complain that
the billions of dollars spent on drug advertising have prompted consumers to demand new, more
expensive drugs in place of older, less expensive, but equally effective drugs.
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At the present time, the United States is one of the few countries that allows direct-to-consumer
advertising of prescription drugs in newspapers, magazines, and television. A 2007 study published
in the medical journal Annals of Family Medicine found that Americans watch up to 16 hours of television advertisements for prescription drugs each week, that 95 percent of these advertisements use
emotion to influence viewers, and that only 18 percent suggest making lifestyle changes instead of
taking a drug.
Prescription drugs advertised directly to consumers in 2007 had a more than 40 percent growth
in annual sales, while other prescription drugs not advertised in this way had a growth in sales of
only 13 percent. Prescription drugs that have recently had the greatest television marketing campaigns to consumers include Claritin (an antihistamine drug), Nasonex (for nasal allergies), Mucinex
(for chest congestion), Amitiza (for constipation), Chantix (to stop smoking), Vytorin (for high cholesterol), Caduet (for hypertension and high cholesterol), and Boniva (to prevent osteoporosis). By
law, a prescription drug ad must include a “brief summary” of the indications, side effects, and
risks of the drug. In print advertisements, this information is quite lengthy and often fills an entire
magazine page. However, in television ads, this information is abbreviated and usually presented
verbally by a pleasant, fast-talking voice.
The Health Care Financing Administration (HCFA) has noted that the cost of prescription
drugs, which increased 79 percent from 1993 to 1999, has been a major factor in rising healthcare
costs. During 2000, many of the largest health insurance companies increased their insurance
premiums by 10–20 percent, and they attributed these increases primarily to high prescription
drug prices. According to Fortune magazine, drug companies as a whole enjoyed an 18.6 percent
profit margin in 1999, which was greater than that of banks, insurance companies, and telecommunications companies. Drug companies claim that this figure is inaccurate because it does not
take into account the high expense involved in the research and development of drugs. The
American Association for Retired Persons (AARP) disagrees. Both seniors and baby boomers
taking care of their senior relatives are complaining to their congressional representatives about
the high cost of prescription drugs.
According to the New England Journal of Medicine, drug companies spent $11 billion on all
forms of drug advertising in 1981. In 1996, that rose to almost $30 billion. Direct-to-consumer
advertising during that time increased by 330 percent.
SUGGESTIONS FOR STUDENT ACTIVITIES
Assign some or all of these activities, as time permits.
1. Complete the Quiz Yourself and Clinical Applications questions at the end of the chapter.
2. Complete some or all of the activities on the Tear-Out Worksheets.
3. Read through Appendix A, Sound-Alike Drug Names, at the end of the textbook. Select four
pairs of sound-alike drugs. Look up each drug name in Appendix D and write what the drug
is used for after its drug name.
4. Look in your newspaper for advertisements for clinical trials needing volunteers or do a Google
search on “volunteer for a clinical trial” and select and report on one of the sites that comes up.
What is the clinical trial drug used to treat? How long is the clinical trial? Do volunteers get
paid and, if so, how much?
5. Ask your physician if he/she accepts any small gifts from drug company representatives.
6. Explore the Companion Website. Directions on how to gain access are located in the Multimedia Extension Exercises section at the end of the textbook chapter.
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CHAPTER 2
Drug Design, Testing, Manufacturing, and Marketing
Worksheet 1
Word Search
Locate and circle the pharmacology words hidden horizontally, vertically, or diagonally, forward
or backward, in this puzzle. In the word list, a number in parentheses indicates how many times
the word can be found in the puzzle.
cell
computer
design
DNA
drug
gene
genetic
inert
in vivo
isomer
molecule
name (2)
NDC
patent
placebo
recombinant
soil
trade name
T R A D E N A M E M
N G I S E D J S P O
A P E W O B A N D L
N Q L N P I K A O E
I
D S A E A L M V C
B S C G C T T E I U
M L O N E E I E V L
O P A M S N B C N E
C M B J E G E O I T
E G U R D R L L E C
R E T U P M O C W S
Chapter Spelling List
1. bioavailability
2. gene
3. generic
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4. genetic
5. human genome
6. isomer
7. patent
8. placebo
9. recombinant
10. therapeutic index
Chapter Pronunciation List
1. bioavailability [BY-oh-ah-VAIL-ah-BIL-ih-tee]
2. frequency distribution [FREE-kwen-see DIS-trih-BYOO-shun]
3. generic name [jeh-NAIR-ik NAYM]
4. human genome [HYOO-man JEE-nohm]
5. isomer [EYE-soh-mer]
6. in vitro [in VEE-troh]
7. median effective dose [MEE-dee-an ee-FEK-tiv DOHS]
8. placebo [plah-SEE-boh]
9. recombinant DNA technology [ree-KAWM-bih-nant D-N-A tek-NAWL-oh-jee]
10. therapeutic index [THAIR-ah-PYOO-tik IN-deks]
[The accuracy of the student’s pronunciation to be evaluated by the instructor.]
Exercise 1
Sequence these steps in order, beginning with the one that occurs first.
Clinical trials on 50 to 500 patients with actual disease
Generic name selected
Animal testing
Double-blind studies with the drug and a control group given a placebo
Design or discovery of a new drug
Clinical trials on 10 to 100 healthy volunteers
FDA approval
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Exercise 2
Given the definition of a word, give that word and correctly spell it.
1. Drug name picked by the drug company and the United States Adopted Names Council:
_______________
2. All 3.2 billion parts where deciphered as of June 2000: _______________ _______________
3. Drug testing done in test tubes: _______________ _______________
4. Relative margin of safety between dose that produces the desired effect and dose that produces
a toxic effect: _______________ _______________
5. Drug that the control group receives: _______________
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CHAPTER 2
Drug Design, Testing, Manufacturing, and Marketing
Worksheet 2
True or False
_______ 1. A totally new chemical can be discovered in the environment or derived from the
molecular manipulation of an existing drug in order to create a new drug.
_______ 2. In the 1990s, Seldane was removed from the market because of adverse effects;
however, the drug was chemically modified and is now sold as Sudafed.
_______ 3. Computer-aided design (CAD) has yet to be proven successful in the creation of
new drugs.
_______ 4. Only healthy volunteers are used in phase I of clinical trials.
_______ 5. Only about one out of five new drug applications (NDA) filed with the FDA ever
receives final FDA approval.
_______ 6. Inert ingredients (fillers, binders) used to manufacture generic drugs never change
the therapeutic effect of a drug.
_______
7. Even though direct-to-consumer marketing has become common, direct-to-physician
marketing is still the most prevalent form of marketing prescription drugs.
_______ 8. Due to the use of computers and sophisticated technology to develop new drugs,
the cost of prescription drugs has significantly decreased in the last 20 years.
_______
9. Because of post-marketing surveillance, there is no guarantee that all drugs
approved by the FDA will remain on the market indefinitely.
_______ 10. In print advertisements, prescription drug information is usually quite lengthy, as
opposed to television advertisements, which present an abbreviated version.
Multiple Choice
11. Which of the following drugs was named purposefully to indicate the disease or symptom it
is used to treat?
A. Azmacort
B. penicillin
C. Kay Ciel
D. Premarin
E. Bactrim DS
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12. Which of the following drugs was named purposefully to indicate which part of the body is
being treated?
A. Haldol
B. Rythmol
C. Dermatop
D. Nitro-Bid
E. Tylenol w/ Codeine No. 3
13. Which of the following drugs was named purposefully to indicate the duration of the drug’s
action?
A. Lipitor
B. Cortizone-5
C. Transderm-Scop
D. Cardizem LA
E. Humulin
14. Which of the following drugs was named purposefully to indicate the ingredients or source
of the drug?
A. Premarin
B. Nasalcrom
C. Sudafed
D. Pepcid
E. Restoril
15. Which of the following drugs was advertised during the TV broadcasts of the 2004 Super
Bowl because of the large number of males watching the show?
A. Nexium
B. Cialis
C. Lunesta
D. Boniva
E. Rogaine
16. Each prescription drug has a National Drug Code which identifies all of the following EXCEPT
the _______________.
A. drug manufacturer
B. drug strength
C. drug dose
D. package size/type
E. route of administration
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17. Which of the following is not a reason for a drug withdrawl or drug recall?
A. Unexpected adverse effects of the drug.
B. The drug does not contain the correct amount of active ingredient.
C. The drug does not remain stable until its expiration date.
D. The post-marketing research found that the drug was not popular with physicians.
E. The drug is contaminated from the manufacturing process.
18. What is the length of time for a standard patent for new drugs?
A. 5 years
B. 10 years
C. 17 years
D. 25 years
E. 27 years
19. Which of the following has responsibility for assigning a generic name to a new drug?
A. Food and Drug Administration
B. United States Adopted Names Council
C. International Union of Pure and Applied Chemistry
D. Drug Enforcement Administration
E. Recombinant DNA Advisory Committee
20. Which of the following is an example of an inert ingredient that could be included in a drug?
A. cocoa butter
B. dessicant
C. potassium chloride
D. penicillin
E. hydrocortisone
Fill in the Blank
21. Recombinant DNA technology is also known as gene splicing or ____________________________.
22. Every drug has three names—its chemical name, its trade (or brand) name, and its
____________________________ name.
23. The time required for drug levels in the serum to decrease from 100 percent to 50 percent is
called the ____________________________.
24. The relative margin of safety between the dose that produces a therapeutic effect and the
dose that produces toxicity is called the ____________________________.
25. There are ____________________________ phases of human testing, which are known as
clinical trials.
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26. A ____________________________ is a drug form that exerts no pharmacologic effect, no therapeutic effect, and has no side effects when administered.
27. The advertising of prescription drugs is regulated by the ____________________________
based on the Federal Food, Drug, and Cosmetic Act.
28. In 1984, a law was passed that allowed drugs companies to recover up to _______________________
years of patent protection that were used up during the drug approval process.
29. Nitro-Bid indicates that the drug should be taken ____________________________ a day.
30. Chemical analysis of a drug done in a laboratory using test tubes is known as
____________________________ testing.
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CHAPTER 2
Answer Key for the Chapter Review
Quiz Yourself
1. Chemical name, generic name, and trade
or brand name.
2. True.
3. [Only need to name six.] Trade names are
chosen (1) to indicate the disease process
being treated, (2) to indicate what part of
the body is being treated, (3) to simplify the
generic name while still retaining its phonetic sound, (4) to indicate the drug’s ingredients, (5) to indicate the action of the drug,
(6) to indicate how often the drug is to be
taken, (7) to indicate the duration of the
drug’s action, (8) to indicate the strength of
the drug, (9) to indicate the route of administration, and (10) to indicate the amount
of a particular ingredient, (11) to indicate
the drug manufacturer.
4. [Only need to name four.] New drugs may
be discovered or created (1) from ancient
sources in use for many years, (2) from a
totally new chemical discovered in the
environment (plants, animals, ocean, soil),
(3) from molecular manipulation of a drug
already in use, (4) from genetic manipulation and recombinant DNA technology,
(5) from stem cell therapy, (6) from gene
therapy.
5. Recombinant DNA technology (rDNA)
involves using enzymes in a test tube to cut
apart a segment of a DNA molecule from a
human cell. Gene cloning allows the production of a large supply of this DNA segment. The DNA segments are then spliced
together (recombined) with the DNA in a
bacterial cell. As the bacterium multiplies,
it carries the new DNA within it as part of
the genetic makeup of all subsequent generations of bacteria. In huge vats, these bacteria can produce unlimited quantities of
the drug.
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6. Tests performed in vitro are done in a test
tube; tests performed in vivo are carried out
in animals or humans.
7. There are three phases of human testing of a
drug. During phase I, about 10 to 100 healthy
volunteers are used to study a safe dose
range, evaluate side effects, and establish a
final, correct dose and study the pharmacokinetics of the drug (movement of the drug
through the body via the processes of
absorption, distribution, metabolism, and
excretion). In phase II, the drug is given to
about 50 to 500 patients who actually have
the disease that the drug is intended to treat
to determine its therapeutic effect. During
phase III, the drug is administered to several
hundred or several thousand ill patients in
exactly the way (dose, route of administration, frequency, etc.) in which it will be used
once it is on the market. The performance of
the drug is compared with that of other
drugs currently being used to treat the same
disease in order to evaluate its relative effectiveness. In addition, double-blind studies
with the drug and a placebo are performed,
in which neither the patients nor the
physician-investigators know which patients
are receiving the drug and which patients
(the control group) are receiving the placebo.
8. A computer can display the molecular
structure of any drug from a listing of
thousands contained in its database. With
only very slight molecular changes, the
original drug may be significantly changed
in a variety of ways that influence the
absorption, metabolism, half-life, therapeutic effect, or side effects. The computer
can also identify those chemicals that
would probably not be successful in treating a particular disease before time and
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money are invested in extensive testing.
With computers, researchers can study
any molecule, rotating it in three dimensions on the computer screen. By analyzing the molecules, researchers can tell if
that particular arrangement of atoms is the
“key” that will open the “lock“—that is,
activate a particular receptor on the cell
membrane. When a researcher wants to
know why different-looking drugs seem
to produce a similar effect on the same
receptor, he/she can have the computer
superimpose all of the drugs on the screen
to see how their atoms match up.
9. The inert ingredients in a drug can affect
the disintegration, absorption, metabolism,
and excretion of a drug, and this affects the
bioavailability of the drug.
10. Numerous television ads for prescription drugs have prompted consumers to
demand new drugs in place of older, less
expensive, but equally effective drugs. In
television advertisements, the indications,
side effects, and risks of the drug are usually abbreviated.
11. A drug can be withdrawn from the market because of adverse drug effects, especially those that involve deaths. A drug can
be recalled because (1) it does not contain
the correct amount of active ingredient,
(2) it does not remain stable until its expiration date, and (3) it is contaminated with
particulate matter from the manufacturing
process.
Clinical Applications Questions
1. a. Toprol XL
b. 100 mg
c. AstraZeneca Pharmaceutic
d. 00186
e. 1092
f. 30 (tabs)
2. This drug is created by recombinant DNA
technology. The label says “rDNA origin.”
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Worksheet Answer Keys
CHAPTER 2:
Drug Design, Testing, Manufacturing, and Marketing
Worksheet 1
Word Search
T R A D E N A M E M
N G I S E D J S P O
A P E W O B A N D L
N Q L N P I K A O E
I
D S A E A L M V C
B S C G C T T E I U
M L O N E E I E V L
O P A M S N B C N E
C M B J E G E O I T
E G U R D R L L E C
R E T U P M O C W S
Exercise 1
Design or discovery of a new drug, generic name selected, animal testing, clinical trials on 10 to
100 healthy volunteers, clinical trials on 50 to 500 patients with actual disease, double-blind studies with the drug and a control group given a placebo, FDA approval
Exercise 2
1. generic
2. human genome
3. in vitro
4. therapeutic index
5. placebo
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Worksheet 2
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
T
F
F
T
T
F
T
F
T
T
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
A
C
D
A
B
E
D
C
B
A
38 Understanding Pharmacology for Health Professionals
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
genetic engineering
generic
half-life
therapeutic index
3
placebo
FDA
5
twice
in vitro
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