Chapter 9
Principles of
Pharmacology
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9-1
Objectives
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Pharmacology
• Pharmacology
– The study of drugs or
medications and their
effect on living systems
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Pharmacology
• Pharmacodynamics
– The study of the effects of drugs and
their mechanisms of action at target
sites in the body
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Drug Legislation in the United States
9-5
Drug Legislation
• Protects the public from contaminated or
mislabeled drugs
• 1848 – Drug Importation Act
– Required U.S. Customs Service inspectors
to stop entry of contaminated drugs from
overseas
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Drug Legislation
• 1902 – Biologics Control Act
– Passed to ensure purity and safety of
serums, vaccines, and similar
products used to prevent or treat
diseases in humans
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Drug Legislation
• 1906 – Pure Food and Drug Act
• Prohibited interstate commerce in misbranded
and impure foods, drinks, and drugs
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Drug Legislation
• 1912
• Shirley Amendment
• Prohibited labeling medicines with false
therapeutic claims intended to defraud the
purchaser
9-9
Drug Legislation
• 1914 – Harrison Narcotic Act
– Established the word “narcotic”
– Required prescriptions for products
exceeding the allowable limit of narcotics
– Required increased recordkeeping for
physicians and pharmacists who
dispense narcotics
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Drug Legislation
• 1937
• Elixir of Sulfanilamide kills 107 persons, many of
whom were children
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Drug Legislation
• 1938 – Federal Food, Drug, and Cosmetic
Act of 1938
– Required that new drugs be shown to be
safe before marketing
– Established the FDA’s responsibility for
supervising and regulating drug safety
– Authorized factory inspections
– Required that drugs contain a label listing
all of the ingredients and directions for use
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Drug Legislation
• 1951 – Durham-Humphrey Amendment
• Required that prescription drugs (also called
legend drugs) must carry the following label:
“Caution: Federal law prohibits dispensing
without a prescription.”
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Drug Legislation
• 1962 – Kefauver-Harris Drug Amendments
– Passed to ensure drug effectiveness and
greater drug safety
– Drug manufacturers required to prove to
FDA the effectiveness of their products
before marketing them
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Drug Legislation
• 1970 – Controlled Substances Act
– Established five schedules
(classifications) of drugs based on their
accepted medical use in the United States,
abuse potential, and potential for addiction
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Drug Legislation
• 1983 – Orphan Drug Act
– Enabled FDA to promote research and
marketing of drugs needed for treating
rare diseases
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Drug Legislation
• 1988 – Food and Drug Administration Act
– Officially established FDA as an agency
of the Department of Health and Human
Services
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Drug Legislation
• 1990 – Anabolic Steroid Act
– Identified anabolic steroids as a class of
drugs and specified over two dozen items
as controlled substances
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Federal Regulatory
Agencies and Services
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Federal Regulatory Agencies
• Drug Enforcement Agency (DEA)
– Division of the Justice Department
– Became the sole legal drug
enforcement agency in July 1973
• Food and Drug Administration (FDA)
– Enforces Federal Food, Drug, and
Cosmetic Act
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Drug Sources
• Plants
• Minerals or mineral products
• Animals and humans
• Synthetic, semi-synthetic drugs
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Drug Names
• Chemical name
• Generic name
• Trade name
Generic Name
albuterol
ibuprofen
sildenafil
citrate
Trade Name
Chemical Name
Proventil, Ventolin alpha1[(tert-Butylamino)methyl]-4hydroxy-m-xylene-alpha, alpha´-diol
sulfate
Motrin, Advil,
(±)-2-(p-isobutylphenyl) propionic acid
Midol
Viagra, Revatio
1-[[3-(6,7-dihydro-1-methyl-7-oxo-3propyl-1H-pyrazolo[4,3-d]pyrimidin- 5yl)-4-ethoxyphenyl]sulfonyl]-4methylpiperazine citrate
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Sources of Drug Information
• United States Pharmacopeia (USP)
• American Hospital Formulary Service (AHFS)
• Physician’s Desk Reference (PDR)
• Patient package inserts
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Drug Forms
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Drug Effects
• Local effects
• Systemic effects
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Drug Forms
• Gas
– Breathed in and absorbed through the
respiratory tract
– Example
• Oxygen
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Drug Forms
• Liquid
– Contain medication that is ground into a
powder and mixed with a substance, such
as water
– Examples
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•
•
•
•
Elixir
Emulsion
Gel
Lotion
Suspension
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Drug Forms
• Solid
– A drug that is in solid form is usually
swallowed
– Requires a responsive patient who is
cooperative and has an intact gag reflex
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Drug Profile
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Drug Profile
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•
•
•
•
•
•
•
Generic and trade names of the drug
Mechanism of action
Indications
Dose
Route of administration
Contraindications
Adverse effects
Special considerations
9-30
Questions?
9-31