Week 1

Question 1

What is the perfect drug? 6

Answer 1

Effectively treats
Rapid response
Produce no adverse effects
Infrequently
Inexpensive
Not interact with other meds

Question 2

What are the common medication errors?
That will make pt harm

Answer 2

Wrong drug
Overdosage
Wrong Route
Monitoring Error

Question 3

Source of drug
Plant
a) Willow tress
b) Ephedra sinica
c) Opium Poppy

Answer 3

Most drugs come from plants

a) Aspirin
b) ephedrine, ephedra5
c) laudanum, opium 1%

Question 4

Source of drug
Animal
a) cows and pigs
b) horses
c) cow stomach
d) anchovies, sardines
e) diphtheria, tetanus

Answer 4

Insulin
Conjugated estrogens
Pepsin
Fish oil
Antitoxin sera

Question 5

Source of drug
Microbes
a) Penicillium molds
b) lactobacillus family

Answer 5

Penicillin
Dextran

Question 6

Source of drug
Synthetic

Answer 6

Naturally available

Aspirin
Antihistamines
Anesthetics
Fentanyl

Question 7

Source of drug
Semi-Synthetic
a) Hydromorphone and Heroin from?
b) Ampicillin from?

Answer 7

taken from something and changed to get fewer side effects or to get the desired effect
a) Morphine
b) Penicillin

Question 8

Source of drug
Biosynthetic
a) From yeast?
b) From bacteria?

Answer 8

a) Hepatitis B vaccine
b) Recombinant insulin

Question 9

What is tertiary Literature?

Answer 9

Summarized
Evaluates or interprets primary sources

Question 10

What is Secondary Literature?

Answer 10

Databases use to search for primary literature

Question 11

What is Primary Literature?

Answer 11

Clinical research studies
Provide the most recent information
Require longer time commitment

Question 12

Drug laws
Pure food and drug act 1906

Answer 12

Protect the public from mislabeled drugs and food
Required to list if 1 of 11 dangerous and or addicting drugs

Question 13

Drug laws
Food drug and cosmetic act 1938

Answer 13

Test for harmful effects
Drag labels must be accurate and complete

Question 14

Durham-Humphrey Amendment (1952)

Answer 14

Specified how prescription drugs can be ordered and dispensed

Question 15

Drug laws
Kefauver-Harris Amendment (1962)

Answer 15

Required proof of both safety and efficacy prior to approve
Permitted generic versions of drugs initially marketed from 1938-1962

Question 16

Drug approve process
Phase 1

Answer 16

Initial pharmacologic evaluation
Small # of normal /healthy/unafflicted volunteers
1.5 years

Question 17

Drug approve process
Phase 2

Answer 17

Limited controlled evaluation
(tested on patients with disease)
Determines clinical effectiveness, drug safety, and establishes the safe/effective dose

2 years

Question 18

Drug approve process
Phase 3

Answer 18

Extended clinical evaluation
Determination of Clinical effectiveness
and safe/effective dose
3.5 years

Question 19

Generic drug approval
Same active ingredients, dosage, form, strength and route

Answer 19

Pharmaceutical Equivalence

Question 20

Generic drug approval
Rate and extent of absorption
What factors and must lie within?

Answer 20

Bioequivalence
AUC
C max
T max
Must lie within 80 to 125%(-20 to +25%)

Question 21

Texas Controlled Substances Act
Classifies controlled substances according to?

Answer 21

Their abuse potentials

Question 22

Prescriptions are electronically transmitted to?

Answer 22

DPS
Texas Department of Public Safety

Identify prescribers who may be inappropriately
prescribing controlled substances
Identify potential abusers
Identify diversion

Question 23

Schedule 1 medication

Answer 23

High abuse potential
No accepted medical use
May lead to sever dependance
Heroin
Marijuana
LSD

Question 24

Schedule 2 medication

Answer 24

Accepted medical use
High abuse potential
May lead to sever dependance
Must be written on an official prescription form
No refills

Oxycodone
Cocaine
Morphine

Question 25

Schedule 3 medication

Answer 25

Accepted medical use
low/moderate physical dependance
Written or oral prescription
High psychological dependance
6 months of refills

Acetaminophen
Steroid

Question 26

Schedule 4 medication

Answer 26

Accepted medical use
Written or oral prescription
6 months of refills

Question 27

Schedule 5 medication

Answer 27

Accepted medical use
May or may not require prescription

Question 28

Where drugs do come from?

Answer 28

Plants
Animals
Microbes
Synthetic
Semi-Synthetic
Biosynthetic

Question 29

What are
a) C max
b) T max
c) AUC

Answer 29

a) The amount of drugs that get into the bloodstream
b) How long it take for drug to take effect
c) Result of time and concentration, used to determine equivalence

Question 30

Differentiate between t generic and trade name?

Answer 30

brand name drug refers to the name giving by the producing company
generic drug refers to a drug produced after the active ingredient of the brand name drug

Question 31

Drug laws
Drug Price Competition and Patent Term Restoration Act(1984)

Answer 31

Established the approval pathway for generic drug products

Question 32

What is an ANDA?

Answer 32

After 5 years generic companies can submit an ANDA to get their generic drug approved
Drug must be able to display pharmaceutical equivalence and bioequivalence

Question 33

What is an NDA?

Answer 33

New Drug Application (NDA)
Must go through the FDA drug approval process (3 phases) then submit an NDA drug application to the FDA

Question 34

Chemical name of drug?

Answer 34

Expresses the chemical makeup of the drug
Ex: N-(4 hydroxyphenyl) acetamide

Question 35

Generic name of drug?

Answer 35

Actual name of the drug (common name)
Each drug has 1 generic name
Tells us the drug category
Ex: acetaminophen, ibuprofen

Question 36

Trade name/Brand name of drug?

Answer 36

Name the drug is marketed under (several names)
Each drug can have multiple names
Has the “R” symbol behind name

Question 37

What are the advantages and disadvantages of the drug information references?
Package insert/drug label

Answer 37

Advantages:
FDA required and approved
Great for warnings, contraindications, side effects

Disadvantages:
Not good for indications
(since almost all drugs have more than one use other than what the FDA approves the drug for)