Lecture 1

Question 1

Central Concept of Pharmacology

Answer 1

Active drug must reach drug target (receptor) at sufficient levels and for sufficient duration to therapeutically modify biological response

Question 2

Pharmacology

Answer 2

The study of substances that interact with living systems through
chemical processes, especially by binding to regulatory molecules and activating or
inhibiting normal body processes

Question 3

Drug

Answer 3

A substance that affects a change in biologic function

Question 4

Hormone

Answer 4

Bioactive substance synthesized within the body (endogenous)

Question 5

Xenobiotic

Answer 5

Bioactive substance not synthesized in the body (exogenous). May be
beneficial (medication) or harmful (toxin)

Question 6

Toxin/Poison

Answer 6

Substance with almost exclusively harmful effects.

Question 7

Pharmacokinetics (PK)

Answer 7

Process by which bioactive substance is absorbed,

distributed, metabolized and eliminated by the body

Question 8

Pharmacodynamics (PD)

Answer 8

The action or effects of bioactive substances on living organisms

Question 9

The Harris-Kefauver Amendments

Answer 9

-Require sufficient pharmacological
and toxicological research in animals before a drug can be tested in human beings.
-The data from such studies must be submitted to the FDA in the form of an application for an investigational new drug (IND) before clinical studies can begin.
-Three phases of clinical testing are required to support a New Drug Application (NDA).
-Proof of efficacy and relative safety in terms of the risk-to-benefit ratio for the disease to be treated are required.

Question 10

Phase 1 Drug Development

Answer 10

Initial safety and tolerability, determine safe dose range and side effects, <50 patients

Question 11

Phase 2 Drug Development

Answer 11

Effectiveness (exploratory), dose response, safety evaluation, <100 patients

Question 12

Phase 3 Drug Development

Answer 12

Effectiveness, side effects, compare to standard of care, safety evaluations, 100s-1000s patients

Question 13

Phase 4 Drug Development

Answer 13

Post-marketing (therapeutic use), effectiveness in general population, optimization of drug use

Question 14

Types of Controlled Studies (4)

Answer 14

1. Randomized
2. Double-blind
3. Placebo controlled
4. Comparison to standard of care

Not all studies can be conducted using randomized, double-blind, placebo methods due to ethical reasons of not treating ½ the patients (placebo) or due to small population size with certain disease.

Question 15

Randomized Study

Answer 15

Patient population is equally divided in a random manner.

Question 16

Double-Blind Study

Answer 16

Neither the patient nor health care provider know whether the patient is receiving the experimental drug or a placebo.

Question 17

Placebo Controlled Study

Answer 17

Placebo should be used that cannot be differentiated from the experimental drug (size, color, taste etc.)

Question 18

Comparison to Standard of Care Studies

Answer 18

Validates efficacy

Question 19

Drug Regulation Points

Answer 19

• Tension between time to drug approval (3-10 years) and needs of patient populations and pharmaceutical companies.
• Streamlining and expedited reviews in 1980s in response to AIDS.
• Once a drug is marketed, the physician is allowed to determine use.
• All marketed drugs must include an insert with basic pharmacological information, as well as essential clinical information in regard to approved indications, contraindications, precautions, warnings, adverse reactions, usual dosage, and available preparations.

Question 20

Non-prescription Drugs

Answer 20

Over-the-Counter (OTC) which are judged safe

for use without medical supervision

Question 21

Prescription Drugs

Answer 21

Considered to be unsafe for use except under

supervision and must be dispensed only by the order of practitioners licensed by law to administer them.

Question 22

Controlled Substances

Answer 22

Prescription drugs with the potential for
abuse. Schedules I, II, III, IV, V. Prescribers must provide a DEA number and the pharmacist must keep precise records of these transactions.

Question 23

CI

Answer 23

• High potential for abuse, physical and psychological dependence
• No accepted medical use
• Examples: Heroin, LSD

Question 24

CII

Answer 24

• High potential for abuse, physical and psychological dependence
• Accepted for medical use
• Examples: Morphine, Vicodin

Question 25

CIII

Answer 25

• Lower potential of abuse than CII
• Moderate to low risk of dependence
• Accepted for medical use
• Examples: Tylenol with Codeine

Question 26

CIV

Answer 26

• Lower potential of abuse than CIII
• May lead to limited dependence
• Accepted for medical use
• Example: Stadol

Question 27

CV

Answer 27

• Lower potential of abuse than CIV
• May lead to limited dependence
• Accepted for medical use
• Small amounts are available as OTCs
• Example: codeine in certain cough preparations

Question 28

a.c.

Answer 28

Before meals

Question 29

ad lib

Answer 29

As needed

Question 30

b.i.d.

Answer 30

Twice a day

Question 31

c

Answer 31

With

Question 32

h.s.

Answer 32

At bedtime (hour of sleep)

Question 33

n.p.o. (NPO)

Answer 33

Nothing by mouth

Question 34

p.c.

Answer 34

After meals

Question 35

p.r.n.

Answer 35

As needed

Question 36

q.d.

Answer 36

Every day

Question 37

q.h.

Answer 37

Every hour

Question 38

q.h.s.

Answer 38

At bedtime (hour of sleep)

Question 39

q.i.d.

Answer 39

Four times a day

Question 40

q.o.d.

Answer 40

Every other day

Question 41

s

Answer 41

Without

Question 42

t.i.d.

Answer 42

Three times a day