1. Introduction to Pharmacology: Drug Regulation and Approval Chapter 1
John Paul Joson MSN CNS

2. OBJECTIVES What is it? History
Classification of Therapeutic Agents as :
Drugs
Biologics
Complementary and Alternative therapies
Therapeutic and Pharmacologic Class
Chemical vs Generic vs Trade Names
Prescription vs OTC

3. What is it? . . . Pharmacology
Pharmakon = ____________________
Logos = ________________________
Application of products to relieve human suffering
Focus on patient and to improve quality of life
History of pharmacology –oldest form of health care is herbal medicine, plants
Modern pharmacology began in 1800’s, chemist testing drugs on animals and selves.

4. Pharmacology The study of medicine Drug vs. Medicine
Therapeutic
Adverse
Factors Affecting Medication Doses & Responses
Age (Peds, Adults, Geriatrics)
Sex
Body mass
Health status
Genetics
Expansive subject –how drugs administered, where administered, where in body do drugs travel, response produced
Need a good foundation in A&P, chemistry, micro, and patho.
Drug –chemical agent capable of producing biologic response in body
After drug administered it is called a medicine because it is treating something.
Desirable/Undesirable

5. Drug Regulations and Standards
1820
Group of MDs established U.S. Pharmacopeia (drug recipes)
1852
American Pharmaceutical Association, established National Formulary pharmaceutical ingredients
1862
Federal Bureau of Chemistry →Food and Drug Administration Act (FDA)
1902
Biologics Control Act –quality of serums and other blood related products
1906
Pure Food and Drug Act –labeling of medicines, followed in 1912 ensure no false labels
1938
Food, Drug, and Cosmetic Act –drugs must be tested via submission of New Drug Application to FDA prior to marketing
1986
Childhood Vaccine Act
1988
FDA →U.S. Department of Health and Human Services
1994
Dietary Supplement Health and Education Act
Few standards or guidelines in place to protect public from misuse of drugs until 19th century.
U.S. Pharmacopeia –drug purity, strength, directions for synthesis

6. Pharmacology Classification of Therapeutics
Drug =
Desirable vs Undesirable
Medication =
Biologics
Complementary & Alternatives
Drug= chemical agent capable of producing biologic responses
Desirable =Therapeutics –prevention of disease and treatment of suffering
Undesirable = adverse
Biologics –agents naturally produced in animal cells, microorganisms, or by body itself
Complementary–natural plant extracts, herbs, vitamins, minerals, dietary supplements (can also include accupuncture, hypnosis)

7. Therapeutic vs Pharmacological Class
Therapeutic = What is used for ?
Anticoagulant
Antihyperlipidemic
Antihypertensive
Antidysrhythmic
Antianginal
Pharmacological = What does it do to the body?
Diuretic
Calcium channel blocker
Angiotensin converting enzyme
Vasodilator

8. Chemical vs Generic vs Trade Name
Chemical Name = International Union of Pure and Applied
ChemistryN-acetyl-p-aminophenol
2-(4-isobutylphenyl) propanoic acid
Generic Name = U.S. Adopted Name Council = usually only one name
Acetaminophen
Ibuprofen
Trade = What everybody knows it as = many names
Tylenol, A-mol, Acimol, Activate
Advil, Motrin, arthrofen

9. Pharmacology Prescription Over the counter (OTC)
Received written order from person with legal authority to write such a prescription
Over the counter (OTC)
Do not require physician’s order
Legal drugs obtained either by prescription or OTC
Advantages and disadvantages to prescription vs. OTC
Get thorough assessment from MD and determine specific dx, ordering the proper dose amount, frequency of drug to be dispensed to maximize therapy
OTC –if patient does not follow directions of drug can have adverse effect, although OTC are easily obtainable, less expensive, save time with having to make MD appointment, but how do you choose the right one.