Exam 1: Intro to Pharm + Gov regulations

Question 1

Pharmacology can be described as

Answer 1

Study of drugs/chemicals that alter functions in living organisms

Question 2

Drugs are chemicals that are introduced into the body to effect physiological processes by

Answer 2

replacing
increasing
depressing
interfering

Question 3

How do drugs replace

Answer 3

Replace or act as a substitute for missing chemicals

Question 4

How do drugs increase a physiological process

Answer 4

Increase or stimulate cellular activity

Question 5

How do drugs depress physiological process

Answer 5

Depress or slow cellular activity

Question 6

How do drugs interfere with physiological processes?

Answer 6

Interfere with the function of foreign cells

Question 7

Properties of an ideal drug

Answer 7

Efficacy
Safety
Selectivity

Question 8

An effective drug is a drug that

Answer 8

does something useful

Question 9

A safe drug is one that

Answer 9

Does no produce harmful effects

Question 10

Is there such thing as an absolute safe drug?

Answer 10

NO, there is not such thing because all drugs have the potential to cause injury

Question 11

How can the relative safety of a drug be increased?

Answer 11

By proper drug selection, dosage, and monitoring

Question 12

A truly selective drug is

Answer 12

one that elicits only the desired response and not undesired or adverse effects

Question 13

Is there such thing as a truly selective drug?

Answer 13

No there is no such thing as a truly selective drug because all drugs cause effects other than the intended therapeutic effect

Question 14

Principle 1 of drug action

Answer 14

Drugs modify existing functions within the body, they do not create new functions

Question 15

Principle 2 of drug action

Answer 15

No drug has a single action

Question 16

Principle 3 of drug action

Answer 16

Drug effects are determined by the drugs interaction with the body

Question 17

1906 pure food and drug act

Answer 17

Required listing of ingredients to prevent the marketing of adulterated drugs

Question 18

1938 federal pure food, drug, and cosmetic act

Answer 18

-Mandated testing for drug toxicity
-provided means to recall drugs
Established procedures for introduction of new drugs, FDA enforced

Question 19

1951 Durham-Humphrey Amendement

Answer 19

Defined two categories of medications (prescription and over-the-counter)

Question 20

Criteria for a drug to be OTC

Answer 20

• Acceptable margin of safety (therapeutic index)
• Little potential for abuse
• recognized and treated with minimal or no intervention by HCP
• Benefits>risks
• Deemed safe and effective without a prescription

Question 21

Problems with OTC medications

Answer 21

• May mask signs and symptoms of other disease
• may interact with prescription drugs
• may be taken in greater than the recommended dose—> Toxicity
• may not report use of OTC

Question 22

OTC drugs account for

Answer 22

60% of all doses; 40% of Americans take at least 1 OTC drug every 2 days

Question 23

1962 Harris-Kefauver Amendments

Answer 23

-Tightened control over quality of drugs
-Efficacy and safety required to be established
Required that all drugs between 1932-1962 undergo testing for effectiveness

Question 24

Harris - Kefauver Amendments (1962) was in response to

Answer 24

Thalidomide tragedy

Question 25

Preclinical trials

Answer 25

- chemicals tested on laboratory animals - Determine valur on living tissues - Evaluate adverse effects - ----Toxicity - ----Teratogenicity - ----Safety margins - ---- has to have LD50 to get accepted

Question 26

Reasons medications are discarded at the end of preclinical trials

Answer 26

- Lack of therapeutic activity - Toxicity to living animals creating too high a risk for drug development - High incidence of teratogenic effects - Safety margins too small for use in clinical setting

Question 27

1970 controlled substance act

Answer 27

-Controlled substances were divided into five classes on basis of their therapeutic use, safety, and potential for abuse

Question 28

Class 1 drug schedule

Answer 28

Abuse potential - Highest Physical dependency- High Psychologic dependency- High

Question 29

Examples of class 1 drug

Answer 29

Heroin, LSD, marijuana

Question 30

Class 2 drug schedule

Answer 30

Abuse potential - high Physical dependency - high Psychologic dependency - high

Question 31

Examples of class 2 drugs

Answer 31

Morphine, cocaine, methamphetamine

Question 32

Class 3 drug schedule

Answer 32

Abuse potential - Moderate Physical dependency - moderate Psychologic dependency - High

Question 33

Examples of class 3 drug schedule

Answer 33

Codeine, hydrocodone with aspirin or Tylenol, some barbiturates

Question 34

Class 4 drug schedule

Answer 34

Abuse potential - lower Physical Dependency - lower Psychologic dependency - lower

Question 35

Examples of class 4 drug schedule

Answer 35

Dextropropoxyphene, pentazocine, diazepam, alprazolam

Question 36

Class 5 drug schedule

Answer 36

Abuse potential - lowest Physical Dependency - lowest Psychologic dependency - lowest

Question 37

Examples of class 5 drugs

Answer 37

OTC cough medicines with codeine, diphenoxylate

Question 38

1983 orphan drug act

Answer 38

law passed to facilitate the development of drugs for rare diseases, orphan drugs

Question 39

A rare disease is defined as

Answer 39

one that affects fewer than 200,000 people in the US

Question 40

Examples of rare diseases

Answer 40

Huntington's disease Amyotrophic Lateral Sclerosis (ALS) Tourette syndrome Muscular dystrophy

Question 41

Teratogenesis

Answer 41

Induction of developmental defects in the somatic tissues of a fetus

Question 42

Mutagenesis

Answer 42

induction of changes in genetic material

Question 43

what category is usually given to pregnant women

Answer 43

Category A-C

Question 44

Pregnancy and lactation labeling rule

Answer 44

- PLR format - help assess benefit vs. risk - remove pregnancy letter - label be updated

Question 45

Drugs interact with intended site and

Answer 45

affect ALL cellular receptors with which they are compatible

Question 46

Adverse drug reactions

Answer 46

response to a medicine that is noxious, unintended, and undesired side effect that occurs at normal frug doses

Question 47

patients older than 60 account for nearly

Answer 47

50% of all ADRs

Question 48

fetal ADR % is

Answer 48

5%

Question 49

Black box warnings

Answer 49

Strongest warning FDA can place on drug label

Question 50

Drug interaction

Answer 50

altered or modified effect of drugs as a result of interaction with - 2 or more drugs - nutrients - herbal preparations

Question 51

Drug interactions can be

Answer 51

intended & desired | Unintended & undesired

Question 52

effect can vary by

Answer 52

- Intensification of effects - reduction of effects - creation of unique response

Question 53

Generic drugs

Answer 53

Name of medication containing chemical

Question 54

Off label use of a drug

Answer 54

use of a drug for an indication that is unapproved by the FDA