Drugs 101

Question 1

Define pharmacology

Answer 1

the science of drug action

Question 2

Define clinical pharmacology

Answer 2

the drug therapy of and for individual diseases

Question 3

Define pharmacy

Answer 3

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

Question 4

List the 6 determinants of drug response

Answer 4

What patient was told (placebo)
Adherence of patient
Social environment
Pharmokinetics
Route of administration
Interactions with other drugs on board

Question 5

What are the 3 purposes of drugs

Answer 5

Cure, Prevent, Suppress

Question 6

List the 3 ways to reduce risk of drugs

Answer 6

Site specific effect (decrease side effects)
Site specific delivery
Better prescribing

Question 7

What are the two criticisms of modern drug therapy?

Answer 7

cost (only 10 years to make up cost of production)

DTC advertising (1/3 of cost)

Question 8

What is homeopathy?

Answer 8

“like cures like” take a small amount of the problem chemical and dilute it, shake it, and inject to patient

Question 9

What is a CAM?

Answer 9

complementary alternative medicine, nutritional and herbals, unit of measure is serving size (not dose), NOT FDA tested or approved

Question 10

Why are CAM popular?

Answer 10

patient autonomy

Question 11

What drugs that are OTC used to be RX?

Answer 11

GI antacids, allergy meds

Question 12

Define formularies

Answer 12

preferred drugs, who the hospital has contracts with

Question 13

what makes a preferred agent preferred?

Answer 13

contracts

Question 14

What is prior authorization?

Answer 14

before insurance pays the provider must contact someone else

Question 15

Before ______ it was against the law to tell patients what drug is and counsel them

Answer 15

1950s

Question 16

What is an orphan drug

Answer 16

for rare/obscure disease, only produced when needed

Question 17

What does the FDA ask about a drug?

Answer 17

1. Does it work
2. Is it safe?
3. What dose?

Question 18

List the phases of a drug production

Answer 18

Pre-clinical studies
Phase 0
Phase I
Phase II
Phase III
Phase IV

Question 19

Describe pre-clinical studies

Answer 19

in vitro

preliminary efficacy, toxicity, and ADME info

Question 20

Describe Phase 0 studies

Answer 20

Microdosing trials to speed process for promising drugs

single subtheraputic dose to small groups 15-20

pharmacokinetic and dynamics data only

Question 21

Describe Phase 1 studies

Answer 21

n=20-100 of HEALTHY volunteers

safety, tolerability, ADME, dose escalation

Question 22

Describe Phase 2 studies

Answer 22

n=20-300 or SICK volunteers

dosing requirements and overall efficacy

Question 23

Describe Phase 3 studies

Answer 23

Gold Standard
randomized control trial (placebo or drug)
n=300-3,000

Question 24

Describe Phase 4 studies

Answer 24

post marketing surveillance
large n, power ramifications (type II error B)
side effects

Question 25

What name do we use??

Answer 25

Generic name

Question 26

New label says what regarding pregnancy

Answer 26

1) effect on pregnancy, labor, delivery
2) effect on lactation
3) effect on men/women reproductive potential

Question 27

What is a side effect?

Answer 27

predictable and dose related effect of drug

Question 28

What is an adverse effect?

Answer 28

harmful, seriously unpleasant side effect

Question 29

What is the black box warning?

Answer 29

medical studies indicate drug carries significant adverse effect.

Question 30

What is an anaphalactic reaction?

Answer 30

2 or more severe reactions at once, antigen and antibody interact on 2nd exposure after antibodies have been formed.

Question 31

T or F

All substances should b considered equally antigenic

Answer 31

TRUE

Question 32

T or F

Prolonged primary exposure can cause an allergic reaction

Answer 32

TRUE

Question 33

What is cross sensitivity? give example

Answer 33

change of being allergic to both,

PCN and cephalosporins

Question 34

Give three examples of ergogenic drugs

Answer 34

GHB
Erythropoietin
Anabolic steroids