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Understanding Pharmacology
for Health Professionals
FIFTH EDITION
CHAPTER
1
Introduction to
Pharmacology and the
History of Drugs
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Learning Objectives
1. Describe the origin and meaning of the
words pharmacology, drug, medicine, and
Rx.
2. Describe the three general medical uses for
drugs.
3. Name several drugs derived from plant,
animal, or mineral sources that are still in
use today.
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Learning Objectives
4. Describe what types of drugs were used in
the past.
5. Name 10 major pharmaceutical milestones
that have occurred since the 1800s.
6. Describe the use of mislabeled and
dangerous drugs and the problem they
presented in the past for consumer safety.
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Learning Objectives
7. Describe the origin and content of the
various drug laws.
8. Describe the function of the Food and Drug
Administration (FDA).
9. Differentiate between prescription and overthe-counter (OTC) drugs.
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Learning Objectives
10.Describe the five categories of controlled
substances and give examples.
11.Describe designer drugs and orphan drugs
and their uses.
12.Define the Key Words and Phrases for this
chapter.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Introduction to Pharmacology
• Pharmacology
 Fascinating and multifaceted discipline
 Impacts
• Chosen career in health care
• Personal lives
• Healthcare team members
• Consumers
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Introduction to Pharmacology
• Study of pharmacology covers a broad
spectrum of diverse, yet interrelated,
topics.






Botany
Molecular chemistry
Research
Toxicology
Legislation
Patient education
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Introduction to Pharmacology
• Pharmacology is amazing in its scope.
 Historical and present day uses of herbs
and plant extracts
 Day-to-day painstaking research
• Produces unusable products
• Produces life-saving drugs
• Genetic manipulation
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Introduction to Pharmacology
• Pharmacology is amazing in its scope.
 Day-to-day painstaking research
• Molecular pharmacology
• Adult stem cell therapy
• Seemingly limitless potential for
discovery
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Introduction to Pharmacology
• The study of pharmacology covers:






botany
molecular chemistry
research
toxicology
legislation
patient education
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Origins of Pharmacology Words
• Pharmacology
 The study of drugs and their
interactions with living organisms
 Derived from:
• The Greek word pharmakon (meaning
medicine or drug)
• Suffix –logy (means the study of)
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Origins of Pharmacology Words
• Pharmacology
 Pharmac/ology
• Pharmac-(pharmakon [medicine or
drug])
• -ology (the study of)
• Lit. "the study of medicine or drug"
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
All Rights Reserved
Origins of Pharmacology Words
• Drug
 Dutch word droog (means dry)
 Refers to the use of dried herbs and
plants as the first medicines
 Latin word for drug is medicina.
• Derives the words medicine and
medication
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Origins of Pharmacology Words
• Drug
 A drug deliberately administered for its
medicinal value as a:
• Preventive agent
• Diagnostic agent
• Therapeutic agent
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Origins of Pharmacology Words
• Medicine
 Can be used interchangeably with the
word medication
 Can refer to chemical substances that
do not have:
• Preventative use
• Diagnostic use
• Therapeutic use
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Origins of Pharmacology Words
• A drug or a medicine is:
 Nonfood chemical substance
 Affects the mind or the body
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Figure 1–1 Medicines. Medications or medicines are drugs that are used to prevent,
diagnose, or treat symptoms, signs, conditions, and diseases. Source: Inna
Astakhova/Fotolia
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Medical Uses For Drugs
• Drugs have three medical uses.
 Prevent disease
 Diagnose disease
 Treat symptoms, signs, conditions,
diseases
• The study of these uses is known as
pharmacotherapy.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Medical Uses For Drugs
• Preventive use
 Prevent the occurrence of diseases or
conditions
 Prophylaxis
• Greek origin: to keep guard before
 Examples
• Prevent motion sickness prior to traveling
• Prevent pregnancy
• Vaccinations
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Medical Uses For Drugs
• Diagnostic use
 By themselves
 In conjunction with procedures/tests
 Examples
• Radiopaque contrast dye
• Cardiac stress test
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Figure 1–2 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 means pertaining to against vomiting,
appears at the top right.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Figure 1–3 Immunization. This newborn infant is receiving an intramuscular injection
of a vaccine. Intramuscular injections are given in a large muscle that is not near a large
artery, vein, or nerve. In newborns, the only suitable site for an intramuscular injection
is in the lateral aspect of the upper thigh, in the largest muscle in the body.
Source: Dmitry Lobanov/Fotolia
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Focus on Health Care
• The American Academy of Pediatrics
issues an annual immunization
schedule to prevent childhood diseases.
• All children must receive certain
immunizations before they are
permitted to enroll in school.
• Exceptions are granted for religious
reasons or when immunization are
medically inadvisable.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Medical Use for Drugs
• Therapeutic use
 To control, improve, or cure symptoms,
conditions, or diseases
 Examples
• Antibiotic drugs
• Analgesic drugs
• Insulin
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Figure 1–4 Therapeutic drug use. Humulin insulin is used to treat patients with type
1 diabetes mellitus. This drug must be injected subcutaneously (under the skin) one or
more times each day.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Egyptians
 Treated diseases with:
•
•
•
•
•
•
•
Frogs' bile
Sour milk
Lizards blood
Pigs' teeth
Sugar cakes
Dirt
Spiders' webs
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Egyptians
 Treated diseases with:
• Hippopotamus' oil
• Toads' eyelids
 Applied moldy bread to abrasions
• Some therapeutic basis
• Penicillin was extracted from a mold.
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Egyptians
 Ebers Papyrus (1500 B.C.) contained the
names of 800 different herbal
formulations and prescriptions.
 Extracted the oil from plants known for
healing properties
 King Tutankhamum's tomb had 350
alabaster jars of plant oils in it.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Drugs in Ancient Times
• Chinese
 Practiced healing arts
 Emphasized use of herbs and some
minerals
• Herbal preparations were used in
conjunction with:
• Acupuncture
• Massage
• Exercise
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Drugs in Ancient Times
• Chinese
 Few animal products
 Shen Nong
• Wrote first Chinese book on herbal
medicine
• Contained 365 different herbal remedies
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Figure 1–5 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. The shop walls are filled with labeled jars 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% of them were therapeutic, according to Western standards of
medicine. Source: Maron/Fotolia
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Other Cultures
 Native Americans of North America
 Aztec Indians of Mexico
• Grew herbs with medicinal properties
• Montezuma maintained royal gardens of
medicinal plants.
 Greeks and Romans
• Furthered the study of medicine
• Important first steps
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Ancient drugs were prepared according
to standard recipes.
 Drying, crushing, and combining a
variety of:
• Plants
• Substances from animals
• Minerals
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• The symbol Rx
 Latin word for recipe, meaning take
 Indicates a prescription
• The combining of ingredients to form a
drug
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Drugs in Ancient Times
• Because little was known, it was a
matter of guessing.
• Drug ingredients
 Based on medical lore and superstition
 Some had therapeutic value.
• Others were worthless or harmful.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Medieval physicians
 Prescribed a broad range of drugs
• Herbs
• Metals (e.g., powered gold)
• Addictive substances (e.g., opium)
 1600s, patients advised to:
• Eat soap to cure blood in the urine
• Put mercury in beer to cure intestinal
worms
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
by Pearson Education, Inc.
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Drugs in Ancient Times
• Apothecary
 Greek word meaning storehouse (of
dried plants and herbs)
 Person in charge of the storehouse
 First U.S. apothecary shop in 1729
 System for measuring precise amounts
of small quantities of drugs and herbs
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Drugs in Ancient Times
• Pharmacopeia
 From Greek pharmakon, meaning
medicine or drug and poiein, meaning to
make
 List of all drugs used in apothecary,
individual ingredients, strengths and
purity, and how to prepare them
 United States Pharmacopeia first
published in 1820
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Figure 1–6 Foxglove plant. This beautiful wild flowering plant is commonly known as
foxglove, but its scientific name is Digitalis lanata because its flowers were thought to
resemble fingerlike digits. The drug digitalis (which came from the dried leaves of this
plant but is no longer in use) was discovered in 1741 by Dr. William Withering, an
English physician, and used as a treatment for congestive heart failure. The drug digoxin
(Lanoxin) is derived from foxglove and is still used today.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from plants
 foxglove plant
• derivative, drug digoxin (Lanoxin) for
congestive heart failure
 belladonna plant
• original source of two drugs
• atropine
• scopolamine
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from plants
 Opium poppy
• Used as a painkiller
• Recreational drug
• Sap from the seedheads contain opium.
• Source of illegal street drug heroin
• Source of the prescription drug morphine
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Figure 1–7 Opium poppy. Sap from the blue-green seed heads of the large, wavy
pink or purple flower of the opium poppy was first used in 1806 to produce morphine, a
narcotic drug used to treat severe pain. It was also used to produce heroin, an illegal,
recreational drug. Source: Pics-xl/Shutterstock
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from plants
 Colchicine
• Used to treat gout
• Derived from autumn crocus known as
Colchicum autumnale
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from plants
 Ephedrine
• Present in the leaves of a bushy shrub
• Chinese burned leaves to treat
respiratory ailments
• Ephedrine present in over-the-counter
bronchodilators
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from plants
 Yams
• Estrogen hormone replacement therapy
drugs
 Daffodil bulbs
• The Alzheimer disease drug galantamine
(Razadyne)
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from plants
 Drugs dissolved into plant sources
• Gums
• Oils
• Many drugs contain a type of oil.
• Bases
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Did You Know?
• Herbs have been a part of all cultures
for centuries and have been mentioned
frequently in literature.
• Henbane, a very toxic herb, was
supposed to have been the poison that
Claudius used to kill his brother,
Hamlet's father.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Table 1—1
Other plant sources of some
modern drugs
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Figure 1–8 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
dietary supplements. Other products use synthetic vitamin C. Source: Neirfy/Fotolia
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from animals
 Thyroid supplement drugs
• Composed of dried (desiccated) animal
thyroid gland tissue
• Used to treat hypothyroidism
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Drugs derived from animals
 Pregnant mares' urine
• Drug Premarin, a female hormone
replacement
• Pregnant Mare's Urine
• Used to relieve the symptoms of
menopause
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Modern Drugs Derived from
Natural Sources
• Drugs derived from animals
 Lanolin
• Common ingredient of topical skin drugs
• Obtained from the purified fat of sheeps
wool
 Insulin
• In the past, only source from ground-up
animal pancreas
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
Copyright © 2016, 2010, 2003
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Figure 1–9 Gila monster. This large, poisonous, orange-and-black lizard lies in the
southwestern United States and Mexico. Its saliva is the source of the drug Byetta, which
is used to treat type 2 diabetes mellitus. Source: Fivespots/Fotolia
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Modern Drugs Derived from
Natural Sources
• Minerals
 Individual dietary supplements
 Potassium chloride
• Trace minerals
 Included in many multivitamin
supplements
 Quinapril (Accupril) contains red iron
oxide as an inert ingredient.
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Drugs in the 1800s and 1900s
• Pharmacists prepared the drugs they
dispensed.
 Made daily:
• Milk of magnesia
• Paregoric
• Syrup bases for liquid medicines
 Hand-rolled cocoa butter suppositories
Understanding Pharmacology for Health Professionals, 5th Ed.
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Drugs in the 1800s and 1900s
• Pharmacists prepared the drugs they
dispensed.
 Measured out drugs
• Apothecary system of measurement
•
•
•
•
•
Minims
Drams
Ounces
Grains
Scruples
Understanding Pharmacology for Health Professionals, 5th Ed.
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Drugs in the 1800s and 1900s
• Much has changed since then.
 Many now completely synthetic
 Other natural drugs, to create new
drugs, have undergone:
• Chemical modifications
• Molecular restructuring
continued on next slide
Understanding Pharmacology for Health Professionals, 5th Ed.
Susan M. Turley
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Drugs in the 1800s and 1900s
• Much has changed since then.
 Pharmacist no longer prepares
medications.
• Dispenses them
• Provides patient information and
education
Understanding Pharmacology for Health Professionals, 5th Ed.
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Major Pharmaceutical Milestone
• 1806
 Morphine isolated from crude opium
• 1853
 Dr. Alexander Wood of Scotland creates
the syringe and injects patients with
morphine.
• 1899
 Aspirin introduced by German company,
Bayer
continued on next slide
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Major Pharmaceutical Milestone
• 1908
 Sulfanilamide introduced
• First anti-infective drug
• 1912
 Phenobarbital introduced for epilepsy
• First antiepileptic drug
• 1913
 Vitamins A and B discovered
continued on next slide
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Major Pharmaceutical Milestone
• 1922
 Insulin introduced
• First drug for diabetes mellitus
• 1941
 Penicillin introduced
• First antibiotic drug
• 1945
 Benadryl introduced
• First antihistamine drug
Understanding Pharmacology for Health Professionals, 5th Ed.
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continued on next slide
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Major Pharmaceutical Milestone
• 1948
 Cortisone introduced
• First corticosteroid drug
• 1952
 Thorazine introduced for psychosis
• First antipsychotic drug
• 1952
 Hydrocortisone introduced
• First topical corticosteroid drug
continued on next slide
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Major Pharmaceutical Milestone
• 1957
 First drug for anxiety/neurosis
• 1966
 Clotting factors introduced for
hemophilia
• 1967
 Inderal introduced for hypertension
• First beta-blocker drug
continued on next slide
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Major Pharmaceutical Milestone
• 1970
 Levodopa introduced for Parkinson
disease
• 1972
 Researchers discover opioid receptor in
brain
• 1977
 Tagamet introduced for peptic ulcers
• First H2 blocker drug
Understanding Pharmacology for Health Professionals, 5th Ed.
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continued on next slide
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Major Pharmaceutical Milestone
• 1978
 First portable insulin pump introduced
• 1981
 Verapamil introduced for heart
arrhythmia
• First calcium channel blocker drug
continued on next slide
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Major Pharmaceutical Milestone
• 1982
 Humulin (human insulin)
• First drug made using recombinant DNA
technology
• 1983
 Topical prescription drug hydrocortisone
approved for over-the-counter sales
continued on next slide
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Major Pharmaceutical Milestone
• 1985
 ACE inhibitor drugs introduced for
hypertension
• 1986
 Orthoclone OKT3 introduced
• First monoclonal antibody
continued on next slide
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Major Pharmaceutical Milestone
• 1987
 Mevacor introduced
• First statin drug for high cholesterol
 Alteplase (Activase) introduced for
dissolving blood clots
• First tissue plasminogen activator drug
• 1987
 AZT (zidovudine, Retrovir) introduced
• First drug for HIV
continued on next slide
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Major Pharmaceutical Milestone
• 1992
 Proscar introduced for benign prostatic
hypertrophy
• 1993
 Cognex introduced
• First drug for Alzheimer disease
continued on next slide
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Major Pharmaceutical Milestone
• 1994
 Combination drug therapy introduced
for peptic ulcers caused by Helicobacter
pylori
• 1995
 Cozaar introduced for hypertension
• First angiotension II receptor blocker
drug
continued on next slide
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Major Pharmaceutical Milestone
• 1996
 Fosamax introduced for osteoporosis
• First nonhormonal drug treatment
• 1996
 Nicoderm introduced
• First prescription-strength drug for
stopping smoking
continued on next slide
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Major Pharmaceutical Milestone
• 1998
 Viagra introduced
• First oral drug for erectile dysfunction in
men
• 1999
 Celebrex introduced for arthritis
• First COX-2 inhibitor drug
continued on next slide
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Major Pharmaceutical Milestone
• 2000
 Deciphering of the human genome
opens the field of gene therapy in
pharmacology
• 2002
 Botox introduced for the treatment of
facial wrinkles
continued on next slide
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Major Pharmaceutical Milestone
• 2005
 Requip introduced
• First drug for restless legs syndrome
• 2006
 Gardasil introduced
• First vaccine against cervical cancer
caused by HPV
continued on next slide
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Major Pharmaceutical Milestone
• 2007
 Exelon introduced
• First transdermal drug patch for
Alzheimer disease
• 2007
 Zyrtec is the first drug to have the same
dosage strength for both its prescription
and over-the-counter forms
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Mislabeled and Dangerous Drugs
• Most physicians through history
attempted to treat patients accurately.
 based on what knowledge was available
 2100 B.C., the Code of Hammurabi gave
severe penalties for malpractice
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Mislabeled and Dangerous Drugs
• During the 1700s and 1800s
 Commonly sold without regulation
 Accompanied by extravagant claims of
cures
 Often contained addicting ingredients
without its presence being listed
• Opium
• Morphine
• Cocaine
continued on next slide
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Mislabeled and Dangerous Drugs
• During the 1700s and 1800s
 Even when included in title or on label,
consumers were often not aware of
cocaine's addictive qualities.
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Mislabeled and Dangerous Drugs
• Consumer warnings did not exist.




Misuse of drugs
Possibility of addiction
Dangerous drug side effects
Prevailing dictum was "Let the buyer
beware."
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Drug Legislation and Drug
Agencies
• Laws were passed in the 1900s to
protect the public from:
 Unscrupulous drug sellers
 Worthless, or mislabeled, dangerous
medicines
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Drug Legislation and Drug
Agencies
• Passage of The Food and Drugs Act of
1906, the first federal drug law
 1912 amendment required accurate
labeling.
 Only drugs listed in the United States
Pharmacopeia or National Formulary
could be prescribed.
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Drug Legislation and Drug
Agencies
• Sulfonamide national tragedy
 Forced update of The Food and Drug Act
of 1906
 Widely used anti-infective drug
 Elixirs made from a sweetened alcohol
base
continued on next slide
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Drug Legislation and Drug
Agencies
• Sulfonamide national tragedy
 Drug base was an industrial-strength
liquid solvent.
 Large number of children died.
 Drug manufacturer did not need FDA
approval.
• The Food, Drug, and Cosmetic Act of
1938
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Drug Legislation and Drug
Agencies
• 1951 Durham-Humphrey Amendment
 Defined prescription drugs
• Thalidomide
 FDA refused to approve U.S. use.
 Evidence against the safety began to
accumulate.
• 8,000 babies born with deformed limbs
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Drug Legislation and Drug
Agencies
• 1962 Kefauver-Harris Amendment
 Required that:
• Drugs show that they are safe and
effective before being marketed
• Manufacturers report adverse side effects
 Since that time, many drugs have been
kept from the market or removed.
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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.
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Historical Notes
• 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.
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Historical Notes
• The FDA regulates the use of
thalidomide in two ways:
1. By limiting the number of physicians
who can prescribe it
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)
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Historical Notes
• Only in 2013 was Diclegis approved by
the FDA for the treatment of nausea
and vomiting in early pregnancy.
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Drug Legislation and Drug
Agencies
• FDA (Food and Drug Administration)
 Weighs the inherent risks against its
benefits
 Completes review process before it
issues a final approval (or rejection)
• 1994 Dietary Supplements and Health
and Education Act
 FDA guidelines for herbal products and
dietary supplements
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Figure 1–10 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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Drug Legislation and Drug
Agencies
• Early 1990s
 34 month average for FDA approval of a
new drug
 For certain critical drugs, the process
could be much shorter.
• In 1987, the first drug effective against
HIV was approved in just 107 days.
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Drug Legislation and Drug
Agencies
• Critics still pointed to a time lag.
 Some drugs were available in other
countries before FDA approved for use
in United States.
 Took time before approved by the FDA
for U.S. use
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Drug Legislation and Drug
Agencies
• In 1996, indinavir (Crixivan) was
approved by the FDA in a record 42
days.
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Drug Legislation and Drug
Agencies
• 1997 Food and Drug Administration
(FDA) Modernization Act
 Gave authority to accelerate approval
process for certain types of drugs
 In 2000, average review time less than
15 months
 Critically needed drugs in as little as 6
months
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Drug Legislation and Drug
Agencies
• FDA allows physicians to prescribe
some investigational drugs.
 Life-threatening diseases, no other
alternative therapy
• Requires an Emergency Treatment
Investigational New Drug (IND)
application
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Drug Legislation and Drug
Agencies
• HIPAA (Health Insurance Portability and
Accountability Act of 1996)
 Verifies that health information,
including all drug information, is kept
secure
 Information only released to authorized
inquiries
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Drug Legislation and Drug
Agencies
• Medicare Prescription Drug,
Improvement, and Modernization Act of
2006
 Medicare part D to reduce cost of
prescription drugs for senior citizens
• FDA Safety and Administration Act of
2012
 "Breakthrough therapy"
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Drug Legislation and Drug
Agencies
• The Joint Commission
 "Do Not Use" list for acceptable and
unacceptable medical and drug
abbreviations
• State licensing boards
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Prescription and Over-the-Counter
(OTC) Drugs
• The FDA regulates prescription drugs
and OTC drugs.
• "Rx only" drugs
 Defined as those drugs that are not safe
to use except under professional
medical supervision
 Can only be obtained with a prescription
by a healthcare provider whose license
permits it
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Prescription and Over-the-Counter
(OTC) Drugs
• For many years, distinction was clear
between prescription and OTC drugs.
• Over-the-counter (OTC) drugs
 Can be purchased without a prescription
 Generally considered safe for consumers
to use if:
• Label directions and warnings are
followed
• Warnings are heeded
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Prescription and Over-the-Counter
(OTC) Drugs
• Over-the-counter (OTC) drugs
 OTC drug often the same as prescription
drug
 1992, the OTC Drugs Advisory
Committee was created.
• Assists the FDA in reviewing drugs
• Determines which ones were safe and
appropriate for OTC use
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Table 1–2 Prescription drugs that
became FDA-Approved OTC drugs
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Prescription and Over-the-Counter
(OTC) Drugs
• FDA approves a prescription drug
being reclassified as an OTC drug if the
following criteria are met:
 The indication for the drug's OTC use is
similar to its use as a prescription drug.
 The patient can easily diagnose and
monitor his or her own condition when
using the OTC drug.
continued on next slide
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Prescription and Over-the-Counter
(OTC) Drugs
• FDA approves a prescription drug
being reclassified as an OTC drug if the
following criteria are met:
 The OTC drug has a low rate of side
effects/toxicity and a low potential for
abuse.
 The use of the OTC drug does not
require the patient to have any special
monitoring or ongoing test.
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Drug Controversy
• 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.
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Drug Controversy
• Opponents to reclassification argue:
 Consumers may actually pay more
because health insurance plans will not
reimburse for OTC drug purchases.
 Excessive use of OTC drugs may
increase the number of adverse drugdrug interactions.
 Consumers may try to self-medicate
serious illnesses instead of visiting their
physician for appropriate treatment.
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Schedule Drugs
• Harrison Narcotics Act of 1914
 Drugs with the potential for abuse and
dependence were first regulated
 Established the legal framework for
controlling these drugs
 Introduced the word narcotic
 Act was replaced in 1970 by The
Comprehensive Drug Abuse Prevention
and Control Act
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Schedule Drugs
• The Controlled Substances Act
 Title II of this Act established the Drug
Enforcement Administration (DEA) in
1973 to regulate the manufacturing and
dispensing of these drugs.
continued on next slide
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Schedule Drugs
• The Controlled Substances Act
 Divided potentially addictive drugs into
five categories or schedules
• Based on their potential for physical or
psychological dependence
• Known as schedule drugs or controlled
substances
continued on next slide
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Schedule Drugs
• The Controlled Substances Act
 Divided potentially addictive drugs into
five categories or schedules
• Labeling and packaging for a controlled
substance and all of its advertisements
must clearly show the drug's assigned
schedule.
continued on next slide
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Schedule Drugs
• The Controlled Substances Act
 Divided potentially addictive drugs into
five categories or schedules
• Manufacturing, storage, dispensing, and
disposal of controlled substances are
strictly regulated by both federal and
state laws.
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Figure 1–11 Controlled substance symbol. The capital C stands for controlled
substance. The number written inside (always a Roman numeral) indicates the assigned
schedule. It is important to remember that a C with the Roman numeral IV inside it does
not mean that the drug is to be given by the intravenous (I.V.) route; it means that the
drug is a Schedule IV controlled substance.
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Schedule Drugs
• Schedule I
 Extremely high potential for abuse and
addiction
 No currently accepted medical use
 Not available under any circumstances,
even with a prescription
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Schedule Drugs
• Schedule II




High potential for abuse and addiction
Currently accepted medical uses
Requires an official prescription form
Severe physical and psychological
dependence may result.
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Schedule Drugs
• Schedule III
 Less potential for abuse and addiction
than Schedule II drugs
 Currently accepted medical uses
 Moderate physical and psychological
dependence may result.
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Figure 1–12 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 drug—see the
symbol on the label—it has a high potential for addiction. Source: Darren
McCollester/Staff/Getty Images, Inc.
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Schedule Drugs
• Schedule IV
 Less potential for abuse and addiction
than Schedule III drugs
 Currently accepted medical uses
 Limited-to-moderate physical or
psychological dependence may result.
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Schedule Drugs
• Schedule V
 Limited potential for abuse
 Currently accepted medical uses
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Drug Controversy
• There has been a longstanding debate
over whether marijuana (a Schedule I
drug) should be legally available to
treat patients with certain medical
conditions.
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Drug Controversy
• In 1996, voters in California passed
Proposition 215 to allow seriously ill
patients to use marijuana if approved
by their primary care physician.
 Twenty other states passed similar laws.
 Colorado and Washington allow the sale
of marijuana for recreational uses.
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Drug Controversy
• However, the federal law that prohibits
the manufacturing and distribution of
marijuana supersedes individual state
laws.
• In 2001, the U.S. Supreme Court
agreed to hear a case that sought an
exemption from the federal law for
cases of medical necessity.
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Drug Controversy
• 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
marijuana to varying degrees.
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Drug Controversy
• 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.
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Schedule Drugs
• To prescribe or dispense scheduled
drugs healthcare providers must:
 Register with the federal Drug
Enforcement Agency
 Be issued a DEA certificate and number
 Have DEA number clearly written on any
prescription for a schedule drug
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Schedule Drugs
• Some states require the healthcare
provider to also register with the state
agency.
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Designer Drugs
• Created by molecular modification of an
existing illegal Schedule I or II drug
• Federal Analogue Act of 1986
 Any substance similar to a Schedule I or
II drug could be treated as though it
were a schedule drug.
• Some state level analog drug laws
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Orphan Drugs
• In 1983, The Orphan Drug Act was
passed.
• Purpose to facilitate the development of
new drugs to treat rare diseases
• Drug companies are reluctant to spend
large amounts of time and money:
 To research and test a drug
 Especially if it will have a limited market
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Orphan Drugs
• Drugs for rare diseases were not being
developed.
• The Orphan Drug Act provides special
incentives including:
 Grants to offset drug development costs
 A tax credit that allows up to 75%
deduction of the cost of clinical trials
continued on next slide
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Orphan Drugs
• The Orphan Drug Act provides special
incentives including:
 Streamlined process for obtaining FDA
approval
 Exclusive marketing rights for seven
years
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