Pearson Drugs

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Unit One

THE PAST HISTORY,PRESENT USES, ANDFUTURE OF DRUGS

Chapter 1

Introduction to Pharmacology and the History of Drugs

Chapter 2

Drug Design, Testing, Manufacturing, and Marketing

Chapter 3

Drug Forms

Chapter 4

Routes of Administration and the Drug Cycle

Chapter 5

Using Drugs Therapeutically

Chapter 6The Prescription

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Understanding Pharmacology for Health Professionals, Fourth Edition, by Susan M. Turley, MA (Educ), BSN, RN, RHIT, CMT. Published by Prentice Hall.Copyright 2010 by Pearson Education, Inc.


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Introduction to Pharmacologyand the History of Drugs

CHAPTER CONTENTS

Origins of Pharmacology WordsMedical Uses for Drugs

Drugs in Ancient Times

Modern Drugs Derived from NaturalSources

Drugs in the 1800s and 1900s

Pharmaceutical Timeline

Mislabeled and Dangerous Drugs

Drug Legislation and Drug AgenciesPrescription and Over-the-CounterDrugs

Schedule Drugs

Orphan Drugs

Quiz Yourself

Clinical Applications

Multimedia Extension Exercises

Learning Objectives

After you study this chapter, you should be able to

1. Describe the origin of the wordspharmacology, drug, medicine, and other wordsrelated to specialty fields within pharmacology.

2. Describe the three general medical uses for drugs.

3. Give the origin and meaning of the symbol Rx.

4. Name at least five drugs historically derived from plant, animal, or mineralsources that are still in use today.

5. Describe the process of the preparation of drugs in the 1800s to early 1900s.

6. Name 10 major pharmaceutical milestones that have occurred since the 1800s.

7. Describe the use of mislabeled and dangerous drugs and the problem theypresented in the past for consumer safety.

8. Describe the origin and content of the various drug laws.

9. Describe the function of the Food and Drug Administration (FDA) with respectto approving or removing drugs from the market.

10. Differentiate between prescription and over-the-counter (OTC) drugs.

11. Define schedule drugs and describe the five categories of controlled substances.

12. Define orphan drugs.

CHAPTER

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Understanding Pharmacology for Health Professionals, Fourth Edition, by Susan M. Turley, MA (Educ), BSN, RN, RHIT, CMT. Published by Prentice HalCopyright 2010 by Pearson Education, Inc


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CHAPTER 1 INTRODUCTION TO PHARMACOLOGY AND THE HISTORY OF DRUGS 3

Pharmacology is a fascinating and multifaceted discipline that impacts not onlyour chosen career in health care, but also our personal lives. From our role asmembers of the healthcare team to that of consumers, pharmacology plays a partin our lives.

The study of pharmacology covers a broad spectrum of diverse, yet interrelated,

topics: botany, molecular chemistry, research, toxicology, legislation, and patienteducation.

There is an excitement inherent in the study of pharmacology. The field of pharma-cology is amazing in its scope, ranging from the historical and present day uses of herbsand plant extracts to day-to-day painstaking research that produces unusable productsas well as life-saving drugs to the future with genetic manipulation, molecular pharma-cology, adult stem cell therapy, and a seemingly limitless potential for discovery.

Origins of Pharmacology Words

Pharmacology

Pharmacology is the study of drugs and their interactions with living organisms. The wordpharmacology comes from the Greek wordpharmakon, which means medicine or drug, and the

suffix -logy, which means the study of. Pharmacology is concerned with the nature of drugs, their

effects in the body, drug doses, side effects, and so forth.

Pharmacology is a general word. Other more specific words related to specialty fields within

the field of pharmacology include the following:

molecular pharmacology the study of the chemical structures of drugs and the effects of drugs at

the molecular level within cells

pharmacodynamics the mechanisms of action by which drugs produce their effects (desired or

undesired) based on time and dose

pharmacogenetics how the genetic makeup of different people affects their responses to certain

drugs

pharmacogenomics using genome technology to discover new drugs

pharmacokinetics how drugs move through the body in the processes of absorption, distribution,

metabolism, and excretion

pharmacotherapy using drugs to affect the body therapeutically.

Drugs and Medicines

The word drug is derived from the Dutch word droog, which means dry, and refers to the use of

dried herbs and plants as the first medicines. The Latin word for drug is medicina, from which we

derive the words medicine and medication. A drug or a medicine can be thought of as any nonfood

chemical substance that affects the mind or the body. The word medicine refers to a drug that is

deliberately administered for its medicinal value as a preventive, diagnostic, or therapeutic agent(see FIGURE 11). The word drug can be used interchangeably with the word medicine, but

drug can also refer specifically to chemical substances that do not have a preventive, diagnostic, or

therapeutic use (e.g., illicit or street drugs).

Medical Uses for Drugs

Drugs have three medical uses. They are used to prevent disease, to diagnose disease, and to treat

symptoms, signs, conditions, and diseases. The study of these uses is known as pharmacotherapy.

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4 UNIT ONE THE PAST HISTORY, PRESENT USES, AND FUTURE OF DRUGS

1. Preventive use. Drugs are used to prevent the occurrence of diseases or conditions. The

administration of a preventive drug is known asprophylaxis. Prophylaxis is from a Greek

word meaning to keep guard before. Examples of the preventive uses of drugs include the

following: Drugs taken prior to traveling to prevent motion sickness (see FIGURE 12) Contraceptive drugs taken to prevent pregnancy Vaccinations given to immunize children or adults against certain diseases, such as polio,

diphtheria, or influenza.

2. Diagnostic use. Drugs are used by themselves or in conjunction with radiologic procedures

and other types of medical tests to provide evidence of a disease process. Examples of the

diagnostic uses of drugs include the following:

Radiopaque contrast dyes used during x-ray procedures Drugs that mimic the cardiac effect of exercise in patients who cannot undergo regular

cardiac exercise stress testing.

FIGURE 11 Medications.Medications or medicines are drugs that are

used to prevent, diagnose, or treat

symptoms, signs, conditions, and diseases.

FIGURE 12 Preventive use of drugs.Dramamine is an over-the-counter drug that is taken to prevent

motion sickness and vomiting. The word vomiting does not

appear on the drug package, but the word antiemetic, which

meanspertaining to against vomiting, appears at the top right.



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3. Therapeutic use. The majority of drugs are used to control, improve, or cure symptoms,

signs, conditions, or diseases of a physiologic or psychological nature. Examples of the thera-

peutic uses of drugs include the following: Antibiotic drugs to kill bacteria and cure an infection Analgesic drugs to control the pain and inflammation of arthritis Insulin to treat diabetes mellitus.

Drugs in Ancient Times

Pharmacology is one of the oldest branches of medicine. Ancient peoples such as the Sumerians and

Egyptians recorded the use of drugs on clay tablets, on wall paintings in tombs, and on papyrus as

early as 2000 B.C. The Egyptians treated diseases with substances such as frogs bile, sour milk,

lizards blood, pigs teeth, sugar cakes, dirt, spiders webs, hippopotamus oil, and toads eyelids.

The Egyptians applied moldy bread to abrasions, a practice that actually had some therapeutic basis

as, many centuries later, penicillin was extracted from a mold. An Egyptian medicinal scroll, theEbers Papyrus from 1500 B.C. (discovered in the early 1800s), contained the names of 800 different

herbal formulations and prescriptions. The Egyptians also extracted the oil from various plants

known for their healing properties. In 1922 when King Tutankhamuns tomb was opened, archeolo-

gists discovered 350 alabaster jars of plant oils in it.

The ancient Chinese practiced healing arts that emphasized the use of herbs and some minerals,

but few animal products (see FIGURE 13). Herbal preparations were used in conjunction with

acupuncture, massage, and exercise. Shen Nong completed the first Chinese book on herbal medi-

cine in 3494 B.C. It included 365 different herbal remedies.

Clinical ApplicationsThe American Academy of Pediatrics issues an annual immunization schedule for preventing

childhood diseases. All children must receive certain immunizations before they are permitted

to enroll in school. Exceptions are granted for religious reasons or when immunizations are

medically inadvisable.

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Many other cultures around the world furthered the use of drugs within their own cultures,

including the Native Americans of North America. The Aztec Indians of Mexico grew many

herbs with medicinal properties. Aztec King Montezuma maintained royal gardens of medici-

nal plants.

The Greeks and Romans furthered the study of medicine through an understanding of anatomy

and physiology, which was an important first step toward understanding how drugs exert their

effects in the body.

Ancient drugs were prepared according to standard recipes that involved drying, crushing, and

combining a variety of plants, substances from animals, or minerals. The symbol Rx, which comesfrom the Latin word recipe, meaning take, indicates a prescription, the combining of ingredients to

form a drug. The use of some ingredients was based on medical lore and superstition. Some ingre-

dients had therapeutic value, but others were worthless or actually harmful.

Medieval physicians prescribed a broad range of drugs from herbs to metals (e.g., powdered

gold) to addictive substances (e.g., opium). In the 1600s, patients were advised to eat soap to cure

blood in the urine and put mercury in beer to cure intestinal worms. Because little was known about

even the most fundamental physical and chemical processes of the body, the therapeutic use of

drugs was not an exact science.

Modern Drugs Derived from Natural Sources

Amazingly, there are a number of drugs, based on old prescriptions, that are still in use today. These

include drugs derived from plants, animals, and minerals.

Drugs Derived from Plants

The medicinal use of the foxglove plant was noted in 13th-century writings (see FIGURE 14).

A derivative of this plant is used to make the drug digoxin (Lanoxin), which is still used today to

treat congestive heart failure.

FIGURE 13 Chinese herbal medicines.This Chinese pharmacist prepares herbal medicines in much the

same way that his ancestors did, by using dried herbs which are

then crushed into powder. He is making four batches of the same

medicine, each of which contains the same mixture of herbs. The

wall behind him holds drawers of many different types of dried

herbs. In 1970, the Chinese Academy of Medical Science compiled

a collection of traditional herbal remedies. American pharmacists

evaluated those remedies and found that 45 percent of them were

therapeutic, according to Western standards of medicine.



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The belladonna plant was the original source of two drugs that are still in use todayatropine

and scopolamine. Belladonna means beautiful lady in Italian. Sixteenth century Italian women ...

squeezed the juice of the berries of these plants into their eyes to widen and brighten them.

(Michael C. Gerald, Pharmacology: An Introduction to Drugs, 2nd ed. Englewood Cliffs, NJ:

Prentice Hall, 1981, p. 149, out of print.) Atropine is still used to dilate the pupil in patients with

inflammatory conditions of the iris. Scopolamine is used to treat motion sickness.

The opium poppy has been used for centuries as a painkiller and also as a recreational drug to induce

euphoria and a trance-like state. The sap from the seedheads of the poppy flower Papaver somniferum

contain opium, a substance that is the source of the illegal street drug heroin, which has no medical use,as well as the prescription drug morphine, which is a potent analgesic drug used to treat severe pain.

Colchicine, a drug still used to treat gout, was used for that same purpose in the sixth century.

It was originally derived from the autumn crocus known as Colchicum autumnale.

Ephedrine is present in the leaves of a bushy shrub (species name, Ephedra). The leaves were

burned and used by the ancient Chinese to treat respiratory ailments. Today, ephedrine is present in

over-the-counter bronchodilator drugs.

FIGURE 14 Foxglove plant.This beautiful wild flowering plant is commonly known as foxglove, but

its scientific name isDigitalis lanata. The drug digitalis (which is no

longer in use) came from this plant, as does the modern drug digoxin

(Lanoxin), which is used to treat congestive heart failure.

Did You Know?

Herbs have been a part of all cultures for centuries and have been mentioned frequently in liter-ature. Henbane, a very toxic herb, was supposed to have been the poison that Claudius used to

kill his brother, Hamlets father. Henbane should not be confused with wolfsbane. Students of

literature know wolfsbane to be useful as a vampire repellant (Dracula, 1897); however, we

should point out that double-blind studies demonstrating the effectiveness of this plant have

not as yet been conducted. (Michael C. Gerald, Pharmacology: An Introduction to Drugs,

2nd ed. Englewood Cliffs, NJ: Prentice Hall, 1981, p. 149, out of print.)

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TABLE 11 Other plant sources of some modern drugs

Plant Sources Modern Drug

black cohosh Remifemin (used to treat menopause hot flashes)

cinchona bark quinine (used to treat malaria)

cocoa butter binder or filler ingredient

hot pepper plant capsaicin (topical pain relief)

mold penicillin (antibiotic drug)

statin drugs (used to treat high cholesterol)periwinkle (vinca) vincristine (used to treat cancer)

rose hips vitamin C (see FIGURE 15)

snakeroot reserpine (used to treat hypertension)

willow bark aspirin (used to treat pain)


FIGURE 15 Rose hips.Hips are the botanical name for the rounded fruit of a rose.

Powdered rose hips are still the source of natural vitamin C in

some over-the-counter vitamin C dietary supplements. Other

products use synthetic vitamin C.

Some estrogen hormone replacement therapy drugs are derived from yams. The drug galanta-

mine (Razadyne), which is used to treat Alzheimers disease, is derived from daffodil bulbs. In addi-

tion, many of the gums, oils, and bases in which drugs are dissolved come from plant sources. Many

drugs contain soybean oil, sesame seed oil, or olive oil.

Other plants have also become the sources of some modern drugs (see TABLE 11).



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Drugs Derived from Animals

Thyroid supplement drugs are composed of dried (desiccated) thyroid gland tissue taken from ani-

mals. Thyroid supplement drugs are used to treat patients with hypothyroidism.

The drug Premarin, a female hormone replacement drug used to relieve the symptoms of

menopause, is derived from pregnant mares urine, and the trade name is formed from selected let-

ters taken from that phrase.

Lanolin, a common ingredient of topical skin drugs, is obtained from the purified fat of

processed sheeps wool.

In the past, the only source of insulin used to treat diabetes mellitus was from ground-up animal

pancreas (see FIGURE 16). This type of insulin is still available.

FIGURE 16 NPH Iletin II insulin.The drug label clearly shows that the source of this insulin is from

pork (in vertical capital letters).

Drugs Derived from Minerals

Minerals, such as calcium and iron, are available as individual dietary supplements, and trace

minerals, such as copper, magnesium, selenium, and zinc, are included in many multivitamin

supplements. Centrum multivitamins use the advertising slogan From A to Zinc, to show thatthey contain vitamins and minerals alphabetically from vitamin A through zinc.

Potassium, in the form of potassium chloride, is given in conjunction with diuretic drugs

because diuretic drugs cause increased excretion of potassium (and water).

The cardiac drug quinapril (Accupril) contains red iron oxide as an inert ingredient in its brown

tablets.

Drugs in the 1800s and 1900s

It was not until the 1800s that chemists developed techniques to extract and isolate pure substances

from crude drug preparations. The isolation of morphine in 1803 by a German pharmacist marked

the beginning of modern drug therapy using chemically pure ingredients.

In the early 1900s, the extraction and preparation of drugs was still a time-consuming processthat utilized test tubes, filters, and Bunsen burners. Pharmacists at that time actually prepared the

drugs they dispensed. Daily, they made milk of magnesia, paregoric, and syrup bases for liquid

medicines. In addition, they hand-rolled cocoa butter suppositories. They measured out drugs in

minims, drams, ounces, grains, and scruples (the apothecary system of measurement).

Much has changed since then. Many drugs are now completely synthetic rather than derived

from natural sources. Other natural drugs have undergone chemical modification and molecular

restructuring to create new drugs that possess superior pharmacologic action. In addition, the phar-

macist no longer prepares drugs, but dispenses them and provides patient information and education.

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Pharmaceutical Timeline

The following list briefly notes some major pharmaceutical milestones dating from the 1800s to the

present time (see TABLE 12).

(continued)

TABLE 12 Major pharmaceutical milestones of the 1800s to the present

Year Major Pharmaceutical Milestone

1803 Morphine isolated from crude opium

1827 Merck & Company, a German drug company, begins the first commercialproduction of morphine

1843 Dr. Alexander Wood of Scotland creates the syringe and injects patients withmorphine

1899 Aspirin introduced

1908 Sulfanilamide introduced (first anti-infective drug)

1912 Phenobarbital introduced for epilepsy (first antiepileptic drug)

1913 Vitamins A and B discovered

1922 Insulin introduced (first drug for diabetes mellitus)

1938 Dilantin introduced for epilepsy

1941 Penicillin introduced (first antibiotic drug)

1945 Benadryl introduced (first antihistamine drug)

1948 Cortisone introduced (first corticosteroid drug)

1952 Thorazine introduced for psychosis (first antipsychotic drug)

1952 Hydrocortisone introduced (first topical corticosteroid drug)

1957 Librium introduced for neurosis (first antianxiety drug)

1958 Haldol introduced for psychosis

1966 Clotting factors introduced for hemophilia

1967 Inderal introduced for hypertension (first beta-blocker drug)

1970 Levodopa introduced for Parkinsons disease

1972 Researchers discover a receptor in the brain that responds to drugs derivedfrom opium

1977 Tagamet introduced for peptic ulcers (first H2 blocker drug)

1978 First portable insulin pump introduced1981 Verapamil introduced for heart arrhythmia (first calcium channel blocker drug)

1982 Humulin (human insulin) introduced (first drug made by recombinant DNAtechnology)



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TABLE 12 Major pharmaceutical milestones of the 1800s to the present

Year Major Pharmaceutical Milestone

1983 Topical prescription drug hydrocortisone approved for over-the-counter sales

1985 ACE inhibitor drugs introduced for hypertension1986 Orthoclone OKT3 introduced (first monoclonal antibody drug)

1987 Mevacor introduced (first statin drug for high cholesterol)

1987 Alteplase (Activase) introduced for dissolving blood clots (first tissueplasminogen activator drug)

1987 AZT (zidovudine, Retrovir) introduced (first drug for HIV)

1992 Proscar introduced for benign prostatic hypertrophy (first nonsurgical treatment)

1993 Cognex introduced (first drug for Alzheimers disease)

1994 Combination drug therapy introduced for peptic ulcers caused by Helicobacterpylori

1995 Cozaar introduced for hypertension (first angiotensin II receptor blocker drug)

1996 Invirase introduced for HIV (first protease inhibitor drug)

1996 Fosamax introduced for osteoporosis (first nonhormonal drug treatment)

1996 Nicoderm introduced (first prescription-strength, over-the-counter drug forstopping smoking)

1997 Plavix introduced for the treatment of acute coronary syndrome

1998 Viagra introduced (first oral drug for erectile dysfunction in men)

1999 Celebrex introduced for arthritis (first COX-2 inhibitor drug)

2000 Deciphering of the human genome opens the field of gene therapy inpharmacology

2001 Anthrax attack on the United States creates high demand for the antibioticdrugs ciprofloxin and doxycycline

2002 Botox introduced for the treatment of facial wrinkles

2003 Fuzeon introduced (first fusion inhibitor drug for HIV)

2004 Lunesta introduced for the long-term treatment of chronic insomnia

2005 Requip introduced (first drug for restless legs syndrome)

2006 Gardasil introduced (first vaccine against cervical cancer caused by HPV)

2007 Exelon introduced (first transdermal drug patch for Alzheimers disease)

2007 Zyrtek is the first drug to have the same dose strength for both its prescription

and over-the-counter forms2007 Isentress introduced (first integrase inhibitor drug for HIV)

2008 Xenazine introduced (first FDA-approved drug for Huntingtons disease)

(continued)

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FIGURE 17 Cocaine in a common drug.This 1885 advertisement was for the drug Cocaine Toothache Drops.

It was not known at that time that cocaine was a highly addictive drug.

Children as well as adults became addicted to this drug.

Mislabeled and Dangerous Drugs

From the early history of pharmacology, most physicians attempted to treat patients based on what

little scientific knowledge was available to them. As early as 2100 B.C., the Code of Hammurabi

gave severe penalties for malpractice.

However, throughout medical history many ineffective, mislabeled, and even dangerous drugshave been manufactured, advertised, and prescribed. In 1680, English apothecary (pharmacist)

Thomas Sydenham created the drug Sydenhams Laudanum, which contained powdered opium,

wine, and herbs. During the 1700s and 1800s, drugs with names such as Warners Safe Cure for

Diabetes, Dr. Shreves Anti-Gallstone Remedy, and Anti-Morbific Great Liver and Kidney

Medicine were commonly sold without regulation and were accompanied by extravagant claims of

cures. Drugs often contained one of the addicting ingredients of opium, morphine, or cocaine

without its presence being listed on the label. Ayers Cherry Pectoral, advertised for respiratory

ailments, contained cherry flavoring and heroin. Even when a drug included the name of the addic-

tive ingredient in its title or on its label (see FIGURE 17), consumers were often not aware of

its addictive qualities. One drug prescribed for respiratory ailments, hydrocyanic acid, caused

many deaths. (This poison, which as a gas contains cyanide, is used for legal executions.)

It is estimated that in the early 1900s one out of every 200 Americans was addicted, most of

them middle-class women who used these drugs for themselves and their children.

Consumer warnings against the misuse of drugs, the possibility of addiction, or dangerous drugside effects did not exist. At that time, the prevailing dictum was Let the buyer beware.

Drug Legislation and Drug Agencies

Laws were passed in the 1900s to protect the public from unscrupulous drug sellers, as well as from

worthless, mislabeled, and dangerous drugs that were then on the market. The drug manufacturers

strongly opposed drug laws, but public outrage resulted in the passage of The Food and Drugs Act

of 1906, the first federal drug law. A 1912 amendment to this act required the accurate labeling of

drugs to prevent substitution or mislabeling of ingredients. It also stated that only drugs listed in the



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United States Pharmacopeia or National Formulary could be prescribed. Nevertheless, many

worthless drugs remained on the market because the burden of proof lay with the government to

show fraud on the part of the seller.

It took a national tragedy to force a much-needed update of The Food and Drugs Act of 1906.

Sulfonamide, an early anti-infective drug, was widely used in the United States in 1937. After an

extensive advertising campaign aimed at physicians, a Tennessee company marketed this drug in araspberry-flavored base and called it Elixir of Sulfonamide. This base had been tested by the man-

ufacturer for flavor and fragrance but not for safety. Elixirs are made from a sweetened alcohol base,

but this drug base was an industrial-strength liquid solvent. A number of children died after taking

less than one ounce of this drug, and over 350 individuals were poisoned. At that time, a drug man-

ufacturer did not need FDA approval before marketing a drug. Because of this tragedy, Congress

passed The Food, Drug, and Cosmetic Act of 1938 that previously had lacked the support it

needed to pass. As a result, the government no longer needed proof of fraud to stop the sale of a

drug. It could seize any drug suspected of being toxic. Secondly, the burden of proof was shifted to

the drug manufacturers, who were required to provide data based on scientific experiments to show

that their product was safe before they were allowed to market it. It became the job of the Food and

Drug Administration (FDA) to review these data and evaluate the safety of drugs.

In 1951, the Durham-Humphrey Amendment to The Food, Drug, and Cosmetic Act definedprescription drugs as those drugs that could only be given to patients under the care of a physician.

In the late 1950s, the drug thalidomide was developed in West Germany and was used exten-

sively during early pregnancy to treat morning sickness in women. The FDA refused to approve its

use in the United States without further studies. Before these additional studies could be completed

by the manufacturer, evidence against the safety of the drug began to accumulate. Over 8,000 babies

in Europe were born with deformed limbs (seal limbs, or phocomelia). This tragedy resulted in

the passage of the 1962 Kefauver-Harris Amendment to The Food, Drug, and Cosmetic Act,

which tightened control on existing prescription drugs and new drugs. It required that drugs be

shown to be both safe and effective before being marketed. It also required manufacturers to report

adverse side effects from new drugs. Since that time, many drugs have been kept from the market or

have been removed from the market because of a lack of safety.

Historical Notes

Because of its devastating adverse effects in unborn children, thalidomide would have been

relegated to an obscure footnote in medical history, but in 1997 it was discovered to be a

useful drug in treating cancer, AIDS, and leprosy. The potential adverse effects of this drug

are so great that it is only considered as a viable treatment option for these life-threatening

diseases. The FDA regulates the use of thalidomide in two ways: (1) by limiting the number

of physicians who can prescribe it and (2) by requiring women taking the drug not to have

sexual intercourse or to use two forms of birth control (so that there is virtually no risk of

them giving birth to a child with phocomelia). Thalidomide is now an official prescription

drug used to treat multiple myeloma, leprosy, graft-versus-host disease, and several types of

cancers. It is also officially recognized as an orphan drug that is used to treat wasting syn-

drome from HIV, as well as Crohns disease.

For each new drug, the FDA must weigh the inherent risks of the drug against its potential ben-

efits. To do this thoroughly, the FDA must take the time to complete its review process before it

issues a final approval (or rejection) of a new drug. In 1988, the Food and Drug Administration was

moved under the federal Department of Health and Human Services.

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In 1994, the Dietary Supplements and Health and Education Act was passed. This legislationallowed the FDA to set up guidelines for the manufacturers of herbal products and dietary supple-

ments (see FIGURE 18). Although the FDA could not regulate these products and the products

were still available without a prescription, the drug manufacturers were now liable for any claims

against their products in accordance with the FDA guidelines.

In the early 1990s, FDA approval of a new drug took an average of 34 months. However, for

certain critical drugs the process could be much shorter. The first drug effective against HIV was

approved by the FDA in 1987 in just 107 days. Despite the rapid handling of many critical drugs,

critics still pointed to a time lag in the approval of other new drugs. They argued that some drugs

were available in other countries for quite some time before they received approval by the FDA

for use in the United States. For example, Inderal, a widely used drug for hypertension and

arrhythmias, was available in Europe for nearly 10 years before it was finally approved for use in

the United States in 1967. In response to this criticism, the FDA made a concerted effort tostreamline the approval process, particularly with respect to drugs used to treat life-threatening

diseases. In 1996, indinavir (Crixivan), a protease inhibitor drug used to treat HIV, was approved

by the FDA in record time, just 42 days after the new drug application was submitted. In 1997,

then-President Clinton signed the Food and Drug Administration (FDA) Modernization Act.

It gave the FDA the authority to accelerate the approval process for certain types of drugs. By

2000, the average review time for new drugs had fallen to less than 15 months. Critically needed

drugs (as well as those for whom the drug manufacturer pays a special fee) can be approved in as

little as 6 months.

In addition, the FDA allows physicians to prescribe some investigational drugs even before

they are officially approved for marketing. These drugs are for life-threatening diseases for which

no other alternative therapy exists. In order to prescribe such a drug, the FDA requires an

Emergency Treatment Investigational New Drug (IND) application to be filed. This is alsoknown as a Compassionate Use IND application. In the 1970s, long before the cardiac drug amio-

darone (Cordarone) was on the market (final approval, 1985), cardiologists prescribed it as an inves-

tigational new drug to treat patients with life-threatening cardiac arrhythmias that did not respond to

other antiarrhythmic drugs. Similarly, the first drug for HIV was prescribed for patients before its

approval in 1987. This was done under a Compassionate Use IND application.

Under the federal regulations of HIPAA (pronounced hip-ah), the Health Insurance

Portability and Accountability Act of 1996, all healthcare settings must provide patients with a

statement that verifies that their health record information, including all drug information, is kept

FIGURE 18 Dietary supplements.Dietary supplements, such as vitamins, minerals, and herbs,

are manufactured in tablets and capsules that resemble

prescription and over-the-counter drugs. However, the bottle

label clearly states Dietary Supplement, and the reverse side

of the bottle provides information under the heading of

Supplement Facts.



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TABLE 13 Some prescription drugs that are also OTC drugs

Generic NamePrescription TradeName OTC Trade Name Therapeutic Use

butenafine Mentax Lotrimin Ultra skin fungal infection

butoconazole Gynazole-1 Mycelex-3 vaginal yeast infection

cetirizine Zyrtec Zyrtec nasal allergies

cimetidine Tagamet Tagamet HB 200 heartburn/ulcer

cromolyn Intal Nasalcrom nasal allergies

famotidine Pepcid Pepcid AC heartburn/ulcer

hydrocortisone Hycort Cortizone-5 skin inflammation

ibuprofen Motrin Advil, Motrin IB painnaproxen Naprosyn Aleve pain

nicotine Nicotrol Inhaler Nicoderm CQ quit smoking

nizatidine Axid Axid AR heartburn/ulcer

omeprazole Prilosec Prilosec OTC heartburn/ulcer

ranitidine Zantac Zantac 75 heartburn/ulcer

secure and is only released to authorized inquiries from other healthcare providers, insurance com-

panies, or healthcare quality monitoring organizations.

Prescription and Over-the-Counter Drugs

The Food and Drug Administration (FDA) regulates prescription drugs and over-the-counter

drugs. Prescription drugs are defined as those drugs that are not safe to use except under profes-

sional medical supervision. Prescription drugs can only be obtained with a written prescription or

verbal order from a physician, dentist, nurse practitioner, or other healthcare provider whose

license permits this. Prescription drugs are also known as legend drugs because the drug manufac-

turer and pharmacist add one of these two legends (inscriptions) to the drug package and to the

filled prescription bottle: Caution: Federal law prohibits dispensing without a prescription or

Rx only.

In addition to prescription drugs, the FDA also regulates over-the-counter (OTC) drugs. An

OTC drug is defined as one that can be purchased without a prescription and is generally considered

safe for consumers to use if the labels directions and warnings are followed carefully. OTC drugs

comprise more than half of all the drugs used in the United States.

For many years, there was a clear distinction between prescription drugs and OTC drugs. Then,

in 1983, the topical prescription drug hydrocortisone was approved for over-the-counter sales and

many other drugs followed. The OTC drug is the same as the original prescription drug, but the rec-

ommended dose is usually just a fraction (often half) of the dose of the prescription drug. An excep-

tion to this is cetirizine (Zyrtec), a prescription antihistamine drug whose over-the-counter dose, as

approved by the FDA, is the same as its prescription dose.

In 1992, the OTC Drugs Advisory Committee was created to assist the FDA in reviewing drugs

and determining which ones were safe and appropriate for over-the-counter use (see TABLE 13).

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This committee consists of physicians and pharmacists, as well as one nonvoting member from the

drug/cosmetics industry. The FDA approves a prescription drug being reclassified as an OTC drug

if the following criteria are met: (1) the indication for the drugs OTC use is similar to its use as a

prescription drug, (2) the patient can easily diagnose and monitor his or her own condition when

using the OTC drug, (3) the OTC drug has a low rate of side effects/toxicity and a low potential for

abuse, and (4) use of the OTC drug does not require the patient to have any special monitoring ortesting.

Schedule Drugs

Drugs with the potential for abuse and dependence were first regulated by The Harrison Narcotics

Act of 1914. This act established the legal framework for controlling these drugs and introduced the

word narcotic. This act was replaced in 1970 by The Comprehensive Drug Abuse Prevention

and Control Act. Title II of this act, The Controlled Substances Act, established the Drug

Enforcement Administration (DEA) in 1973 to regulate the manufacturing and dispensing of

these drugs. The act also divided potentially addictive drugs into five categories or schedules based

on their potential for physical or psychological dependence. These drugs are known as schedule

drugs orcontrolled substances. The labeling and packaging for a controlled substance and all of itsadvertisements must clearly show the drugs assigned schedule (see FIGURE 19). The manu-

facturing, storage, dispensing, and disposal of controlled substances are strictly regulated by both

federal and state laws.

FIGURE 19 Controlled substance symbol.The capital Cstands for controlled substance. The number written inside

(always a Roman numeral) indicates the assigned schedule. It is important

to remember that a Cwith the Roman numeral IV inside it does notmean

that the drug is to be given by the intravenous (I.V.) route; it means that

the drug is a Schedule IV controlled substance.

Supporters of the reclassification of some prescription drugs to an OTC status claim that this

will lower drug prices and allow better access to treatment and fewer visits to the doctor.

Opponents to reclassification have these arguments: (1) consumers may actually pay more

because health insurance plans will not reimburse for OTC drug purchases, (2) excessive use

of OTC drugs may increase the number of adverse drugdrug interactions, and (3) con-

sumers may try to self-medicate serious illnesses instead of visiting their physicians for appro-

priate treatment.

Focus on Healthcare Issues

Schedule I

Extremely high potential for abuse and addiction

No currently accepted medical use

Not available under any circumstances, even with a prescription

Examples: heroin, LSD, marijuana, methaqualone, peyote, psilocybin



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Schedule II (see FIGURE 110)

High potential for abuse and addiction

Currently accepted medical uses

Requires an official prescription form

Severe physical and psychological dependence may result

Examples: cocaine, codeine, Demerol, Dilaudid, methadone, morphine, OxyContin,

Percodan, Ritalin

Schedule III

Less potential for abuse and addiction than Schedule II drugs


Moderate physical and psychological dependence may result

Examples: anabolic steroid drugs, dronabinol (Marinol), Hycodan, paregoric, phenobar-

bital, testosterone, Tylenol w/ Codeine, Vicodin

Schedule IV

Less potential for abuse and addiction than Schedule III drugs


Limited-to-moderate physical and psychological dependence may result

Examples: Ambien, Darvon, Librium, Meridia, Sonata, Valium, Xanax

Schedule V

Limited potential for abuse


Some physical and psychological dependence may result

Examples: cough syrups with codeine, Lomotil

FIGURE 110 Schedule II drug.OxyContin is a prescription drug that is used to treat severe pain.

It is also a popular drug of abuse. Because it is a Schedule II

drugsee the symbol on the labelit has a high potential for

addiction. The drug bottle is sitting on a blue pill-counting tray in

the pharmacy. This tray helps the pharmacist accurately count out

the exact number of tablets specified in the patients prescription.

The logo in the center of the tray reminds the pharmacist to

Check, Counsel, Communicate.

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Physicians, dentists, podiatrists, nurse practitioners, and other healthcare providers whose

state licenses allow them to may prescribe controlled substances. First, however, they must regis-

ter with the federal Drug Enforcement Agency and be issued a DEA certificate and number to pre-

scribe or dispense a schedule drug (controlled substance). The providers DEA number must be

clearly written on any prescription for a schedule drug. In addition, some states require the health-

care provider to register with the state agency that controls schedule drugs and be issued a state

certificate and number in order to prescribe or dispense schedule drugs in that state.

Orphan DrugsIn 1983, The Orphan Drug Act was passed. Its purpose was to facilitate the development of new

drugs to treat rare diseases. Normally, drug companies are reluctant to spend large amounts of time

and money to research and test a drug if it will have a limited market. In the past that meant that

drugs for rare diseases that only affected a few patients were not being developed. The Orphan Drug

Act provided special incentives to a drug company, including grants to offset drug development

costs, a tax credit that allowed the drug company to deduct up to 75 percent of the cost of clinical

trials, a streamlined process for obtaining FDA approval, and exclusive marketing rights for seven

years. This encouraged the development of orphan drugs to treat rare diseases, and now there are

more than 1,000 orphan drugs.

Chapter Review

Quiz Yourself

1. Describe the linguistic origin/etiology of the following words.

a. pharmacology

b. medicine

c. drug

There has been a longstanding debate over whether marijuana (a Schedule I drug) should be

legally available to treat patients with certain medical conditions. In 1996, voters in California

passed Proposition 215 to allow seriously ill patients to use marijuana if approved by their

primary care physician. Eight other states passed similar laws.However, the federal law that prohibits the manufacturing and distribution of marijuana

supersedes individual state laws. In November 2000, the U.S. Supreme Court agreed to hear

a case that sought an exemption from the federal law for cases of medical necessity. The

American Medical Association (AMA) advised that marijuana did provide medical benefit to

patients with certain conditions, and many other groups supported the legalization of mari-

juana to varying degrees. In May 2001, however, the Supreme Court issued a decision that

federal drug laws that ban the manufacture and distribution of marijuana allow for no

exceptions, even for medical necessity.

Despite this ruling, many patients do use the marijuana plant to treat themselves. Of note

is that the main active ingredient in marijuana is available as the prescription drug dronabinol

(Marinol). It is a Schedule III drug and is used to treat nausea and vomiting caused bychemotherapy and to stimulate the appetite in patients with HIV.

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2. How are the definitions of drug and medicine the same? How are they different?

3. Describe the three medical uses for drugs and give examples.

4. Give the meaning of and describe the linguistic origin of the symbolRx.

5. Give the name of a drug in current usage that originated from the natural sources listed

below.

Natural Source Druga. foxglove plant ________________

b. sheeps wool ________________

c. rose hips ________________

d. poppy ________________

e. mold ________________

f. periwinkle ________________

6. In what decade was each of the following drugs first introduced?

Circle the correct answer.

a. insulin 1890s 1900s 1910s 1920s 1930s 1940s

b. penicillin 1890s 1900s 1910s 1920s 1930s 1940s

c. aspirin 1890s 1900s 1910s 1920s 1930s 1940s

d. cortisone 1890s 1900s 1910s 1920s 1930s 1940se. vitamin A 1890s 1900s 1910s 1920s 1930s 1940s

f. phenobarbital 1890s 1900s 1910s 1920s 1930s 1940s

g. Viagra 1950s 1960s 1970s 1980s 1990s 2000s

h. Tagamet 1950s 1960s 1970s 1980s 1990s 2000s

i. Librium 1950s 1960s 1970s 1980s 1990s 2000s

j. 1st recombinant DNA drug 1950s 1960s 1970s 1980s 1990s 2000s

k. Thorazine 1950s 1960s 1970s 1980s 1990s 2000s

l. Gardisil 1950s 1960s 1970s 1980s 1990s 2000s

m. Inderal 1950s 1960s 1970s 1980s 1990s 2000s

n. H2 blocker drugs 1950s 1960s 1970s 1980s 1990s 2000s

o. Nicoderm 1950s 1960s 1970s 1980s 1990s 2000s

p. First drug for HIV 1950s 1960s 1970s 1980s 1990s 2000sq. Botox 1950s 1960s 1970s 1980s 1990s 2000s

7. Name three ancient medicines that seem silly or outrageous to us today.

8. Is it possible that some of the medicines you named for Question 7 could be found to have

some therapeutic value in the future? State the reason for your answer.

9. In the 1700s and 1800s, drugs frequently contained addictive ingredients not listed on the

label. Name two such ingredients.

10. Describe the social and consumer safety circumstances that led to the passage of each of these

drug laws.

a. The Food and Drugs Act of 1906

b. The Food, Drug, and Cosmetic Act of 1938

c. Kefauver-Harris Amendment of 1962

d. FDA Modernization Act of 198711. What federal agency is empowered to review data on a drugs safety and clinical effectiveness

and approve drugs for marketing?

12. What is a Compassionate Use IND application?

13. Define the following phrases:prescription drug, over-the-counter drug.

14. Describe how The Controlled Substances Act categorized drugs of potential abuse.

15. What is the purpose of the 1983 Orphan Drug Act? What three incentives does it offer to drug

companies to develop orphan drugs?

16. What part of the wording of a drug label tells you that it is a prescription drug?

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17. Why was the drug thalidomide, which caused severe birth defects in thousands of babies,

allowed on the market again?

18. What is the meaning of this symbol?

Clinical Applications

1. In 2001, the manufacturer of lovastatin (Mevacor) asked the FDA to allow this prescription

drug to switch from being a prescription drug to being an OTC drug. The FDA did not

approve this change. Describe the four criteria mentioned in this chapter for prescription-to-

OTC approval. Explain why you think the FDA OTC Drugs Advisory Committee ruledagainst this request? If you had been on the committee, would you have voted for or against

approving this drug for OTC use? (Hint: Look up lovastatin in Appendix D of this textbook

and see what category of drugs it belongs to; then look up that category of drugs in Chapter 11

and read about it.)

2. You are caring for a patient who is extremely ill but might be able to be helped if he could get

access to a drug that is already approved in Europe. Write a paragraph criticizing the time lag

in the United States for the approval of new drugs that are already in clinical use in other

countries. Give a drug example to support your position.

3. You read in the newspaper about an FDA-approved drug that has now suddenly been with-

drawn from the market because of causing serious adverse reactions and several deaths. Write

a paragraph defending the time needed to investigate drugs before approving them. Give a

drug example to support your position.4. Look at this drug label and answer the following questions.

a. What is the name of this drug?

b. To what schedule does this drug belong?

c. Is this a prescription drug or an over-the-counter drug? How can you tell?

Multimedia Extension Exercises Go to www.pearsonhighered.com/turley and click on the photo of the cover of Understanding

Pharmacology for Health Professionals to access the interactive Companion Website created

for this textbook.


Documents

Pearson Drugs