Drugs 101

Question 1

Define pharmacology

Answer 1

The science of drug action

Question 2

Define clinical pharmacology

Answer 2

Drug therapy of and for individual diseases

Question 3

Define pharmacy

Answer 3

Science of the proper preparation, dispensing, and utilization of drug products

Question 4

List the four categories of pharmacokinetics

Answer 4

A: Absorption
D: Distribution
M: Metabolism (liver and kidney)
E: Excretion

Question 5

Differentiate between primary and secondary prevention (vaccinations).

Answer 5

1: prevent you from getting sick the first time
2: you get sick, we’re trying to keep you from getting sick again

Question 6

List three ways drugs can do harm and give an example of each.

Answer 6

1. Insufficiently selective (TCAs) –> many side effects
2. Too selective for function (ASA)
3. Prolonged modification of cell function (chemo)

Question 7

What are two reason drug costs are high?

Answer 7

1. Many failed drugs tested to get right one.

2. 1/3 of drug company budgets in marketing

Question 8

List 2 criteria for medications to be listed as OTC.

Answer 8

1. Relief of symptoms where Dx may not be necessary.

2. Uncomplicated cases of some chronic or recurrent disease.

Question 9

Define a behind the counter medication and give an example.

Answer 9

Px not needed but must get the medication from the pharmacist –> sudafed

Question 10

When a company develops a new drug, for how long do they maintain the patent?

Answer 10

10 years

Question 11

What must a generic drug maker prove to FDA in order to sell their version of the drug?

Answer 11

Must prove bioavailability is within 80% of original brand name drug.

Question 12

When must a pharmacist dispense the generic version of a drug?

Answer 12

Always unless the prescriber specifies brand name medically necessary.

Question 13

What is a formulary and why are the beneficial?

Answer 13

List of medications providers within a health system may prescribe. Beneficial because it saves money and prevents resistance (Abx)

Question 14

List and describe 6 phases of clinical drug trials.

Answer 14

Pre-clin: efficacy, toxicity, and pharmacokinetics

0: Single subtherapeutic doses to small groups (15-20) for kinetics and dynamics - no safety/efficacy
1: Given to mall group (20-100) of healthy volunteers to determine ADME
2. Given to large group (20-300) with disease to determine dose and overall efficacy
3. Large (300-3000) RCT against standard of care
4. Post marketing surveillance in general pop –> side effects may not show earlier b/c of low power

Question 15

What are three names given to each drug?

Answer 15

Chemical –> given by the chemist
Generic –> given by a governing body
Trade –> given by a drug company

Question 16

Differentiate between a reaction and an allergy.

Answer 16

Rxn: predictable and usually dose related, may be harmful or unpleasant
Allergy: Interaction between drug and patient on subsequent exposure –> antigen and antibody

Question 17

What is an anaphylactoid reaction?

Answer 17

Allergy on 1st exposure caused by drug directly with no antibodies –> morphine causes itching

Question 18

Describe a FDA black box warning.

Answer 18

Highest level warning FDA can issue and still approve medication. Studies show risk of serious or life threatening adverse effect.

Question 19

Define cross sensitivity.

Answer 19

2 drugs interact that are chemically related

Question 20

Describe the five old school pregnancy categories.

Answer 20

A: Trials show no evidence of risk to fetus
B: No risk in animal studies, but no human studies done -or- animal studies show risk while human studies don’t
C: Animal studies show risk to fetus, no human studies done, and potential benefit exists
D: Human studies show harm but benefit might outweigh risk in some circumstances
X: Benefit will never outweigh risk

Question 21

Describe new school pregnancy labeling.

Answer 21

Provides info on risk to mother in pregnancy, fetus, during lactation, and harm to reproductive potential.

Question 22

List and describe 2 ways KY tracks drugs of abuse.

Answer 22

KASPER: Tracks pharmacy, Pt, and prescriber any time a controlled substance is dispensed.
MethCheck: tracks purchasing of sudafed.

Question 23

What are ergogenic drugs?

Answer 23

PEDs –> GHB, EPO, steroids (testosterone), etc

Question 24

What is doping?

Answer 24

Using drugs to enhance athletic performance.