Pharmacology General Principles

Question 1

What is Pharmacology?

Answer 1

The study of substances that interact with biological system through chemical processes

Question 2

What are drugs?

Answer 2

substances (but not foods) that affect biologic function through chemical actions

Question 3

Pharmacology is a_____ and ____ science

Answer 3

basic and clinical

Question 4

What are the subdivisions of Pharmacology?

Answer 4

1) Pharmacotherapeutics
2) Pharmacokinetics
3) Pharmacodynamics
4) Toxicology
5) Pharmacogenomics

Question 5

Define Pharmacotherapeutics

Answer 5

The diagnosis, treatment, and prevention of disease through the use of drugs

Question 6

Define Pharmacokinetics

Answer 6

The qualitative and quantitative description of what happens to a drug in the body over time
“body affecting drug”

Question 7

Define pharmacodynamics

Answer 7

The site and mechanism of action of the drug affecting the body

Question 8

Define Toxicology

Answer 8

Adverse effects of drugs and environmental chemicals

Question 9

Define Pharmacogenomics

Answer 9

The study of genetic variations that cause differences in drug response

Question 10

Define Summation

Answer 10

The combination of two drugs with similar actions that produces an additive effect

Question 11

Define Synergism

Answer 11

The presence of one drug enhancing the effects of another to produce effects greater than that of simple summation

Question 12

Define Antagonism

Answer 12

The presence of a drug that block or reverses the effects of another

Question 13

Define Latency

Answer 13

The delayed onset of therapeutic effects

Question 14

Define Tolerance

Answer 14

Acquired insensitivity (requires at least one exposure

Question 15

What are the two types of tolerance?

Answer 15

Tachyphylaxis (rapid) and slow

Question 16

Define Drug resistance

Answer 16

lack of responsiveness to drugs

Question 17

What cells often show drug resistance?

Answer 17

bacterial or cancer cells

Question 18

Define drug sensitivity

Answer 18

Exaggerated response to a drug (genetic)

Question 19

What are the 3 most important properties of an ideal drug?

Answer 19

Efficacy**
Safety
Selectivity

Question 20

All drugs produce side effects and thus are not completely ________

Answer 20

selective

Question 21

Define efficacy in relation to drugs

Answer 21

The ability to produce a specified reaction

Question 22

Define safety in relation to drugs

Answer 22

A drug with minimal potential to cause injury even at high doses or when taken for an extended period of time

Question 23

Define selectivity in relation to drugs

Answer 23

a drug which produces only the responses for which it is given; receptors are responsible for this

Question 24

What happens in the 0-4 years of preclinical drug testing?

Answer 24

Drugs are identifies, tested in vitro and tested in animals

Question 25

What portion of drug testing does the drug metabolism and safety assessment occur during?

Answer 25

animal testing, phase 1,2,and 3

Question 26

What happens during phase 1 of drug testing?

Answer 26

• Identification of pharmacokinetic parameters (how does the body affect the drug? Is it safe?)
• 20-100 subjects

Question 27

What happens during phase 2 of drug testing (~ 1 year)?

Answer 27

• It is given to people who have the disease to test for EFFICACY
• 100-200 patients

Question 28

What happens during phase 3 of drug testing (~1 year)?

Answer 28

• multicenter
• 1000-6000 patients–> trying to catch a rare toxicity
• double blind to test the placebo effect

Question 29

What happens during phase 4 of drug testing(~2 years)?

Answer 29

It is the postmarketing surveillance that may show toxicities or other effects of the drug once it is being prescribed.

Question 30

When do you have to fill out the New Drug Application and get FDA approval?

Answer 30

between phase 3 and 4

Question 31

What was the purpose of the Federal Pure Food and Drug Act of 1906?

Answer 31

It was a labeling law that prohibited misbranding and adulteration of foods and drugs

Question 32

What is the purpose of the Food, Drug and Cosmetic Act of 1938?

Answer 32

It required that new drugs be “safe” but did NOT require proof of efficacy

Question 33

What was the purpose of the Harris-Kefauver Amendment of 1962?

Answer 33

It required proof of efficacy

Question 34

What is a category D drug for pregnancy risk?

Answer 34

There is evidence of human fetal risk, but potential benefits may outweigh risks

Question 35

What is a category X drug for pregnancy risk?

Answer 35

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk and the risks outweigh potential benefits

Question 36

What is bioavailability?

Answer 36

The amount of drug reaching the blood in relation to how much is taken
1= all of the drug absorbed

Question 37

What are the physiologic variable that affect drug responses?

Answer 37

body weight and size
age
gender

Question 38

What are the pathologic variables that affect drug responses?

Answer 38

renal insufficiency
hepatic disease
acid/base imbalance
altered electrolyte status

Question 39

What are the genetic variables that affect drug response?

Answer 39

variations in biotransformation
variations in functional proteins and enzymes
variation in receptor proteins

Question 40

How does a drug become antigenic?

Answer 40

It must be covalently linked to a macromolecule (usually a hapten-protein complex)

Question 41

T/F allergic reactions to drugs are unrelated to its pharmacological effect

Answer 41

True