Chapter 1

Question 1

adverse effects

Answer 1

drug effects that are not the desired therapeutic effects; may be unpleasant or even dangerous

Question 2

brand name

Answer 2

trade name of approved drug; name given to a drug by pharmaceutical company that developed it

Question 3

drugs

Answer 3

chemicals that are introduced into the body to bring about some sort of change

Question 4

FDA

Answer 4

federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies

Question 5

generic name

Answer 5

the original designation that a drug is given when the drug company that developed it applies for the approval process

Question 6

genetic engineering

Answer 6

process of altering DNA, usually bacteria, to produce a chemical to be used as a drug

Question 7

orphan drugs

Answer 7

drugs that have been discovered but would not be profitable for a drug company to develop; usually drugs that would treat only a small number of people

Question 8

OTC

Answer 8

deemed to be safe when used as directed; drugs are available w/o a prescription for self-treatment of a variety of complaints

Question 9

pharmacology

Answer 9

the study of biological effects of chemicals

Question 10

pharmacotherapeutics

Answer 10

clinical pharmacology–the branch of pharmacology that deals w/ drugs; chemicals that are used in medicine for the Tx, prevention, and Dx of disease in humans

Question 11

phase I study

Answer 11

a pilot study of a potential drug done w/ a small number of selected, healthy human volunteers. most are done on men.

Question 12

phase II study

Answer 12

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat; patients must provide informed consent

Question 13

phase III study

Answer 13

use of proposed drug on a wide scale in the clinical setting w/ patients who have the disease the drug is thought to treat. patients are asked to keep a journal so prescribers can determine if the reported effects are from the disease or the drug

Question 14

phase IV study

Answer 14

continual evaluation of a drug after it has been released for marketing. sometimes the effects are therapeutic and new discoveries are made.

Question 15

preclinical trials

Answer 15

initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects. Done to determine if the chemicals have the presumed effects in living tissue, and evaluate adverse effects.

Question 16

teratogenic

Answer 16

having adverse effects on the fetus (one reason some chemicals are discarded after preclinical trial)

Question 17

Which branch of pharmacology uses drugs to treat, prevent, and diagnose diseases?

Answer 17

Pharmacotherapeutics

Question 18

What is another name for pharmacotherapeutics?

Answer 18

Clinical pharmacology

Question 19

What is the concern of clinical pharmacology?

Answer 19

The drug’s effects on the body and the body’s response to the drug.

Question 20

What are the two different effects of drugs?

Answer 20

therapeutic and adverse

Question 21

Why are animal products being used less often to replace human chemicals?

Answer 21

genetic engineering, synthetic preparations, are safer.

Question 22

What is a nurse’s position regarding drug therapy?

Answer 22

ADMINISTERING drugs, ASSESSING the effects, INTERVENING to make the regimen more tolerable, provident patient TEACHING, and MONITORING the overall care plan to prevent medication errors. (All of this enhances the effectiveness of drug therapy.)

Question 23

How do the changes in chemical structure benefit the drugs?

Answer 23

They are more potent, stable and less toxic. Genetic engineering alters bacteria to produce chemicals that are therapeutic and effective.

Question 24

What is the synthetic version of the active ingredient in marijuana called?

Answer 24

Marinol. Helps prevent N&V in cancer patients w/o the adverse effects of smoking the leaves.

Question 25

Prototype Drugs

Answer 25

the original drug in a class of drugs, that has emerged as the most effective. Other drugs are derived from that basis w/ slightly different properties.

Question 26

Why are most drugs tested on men, and not women?

Answer 26

The chemicals may exert unknown and harmful effects on a woman’s ova, the risk of destroying some are too high. Women are born with a certain amount of ova,and can’t make new ones after birth.

Question 27

What are reasons a drug tested in Phase II may not be further investigated for use?

Answer 27

Less effective than anticipated, too toxic w/ patients, unacceptable adverse effects, low benefit-to-risk ratio, no more effective than other drugs already on the market

Question 28

What are reasons a drug tested in Phase I may not be further investigated for use?

Answer 28

lack therapeutic effect in humans, unacceptable adverse effects, teratogenic, too toxic

Question 29

What does it take for a drug to be marketed?

Answer 29

Must pass phase III, and be approved by the FDA.

Question 30

What does drug lag mean?

Answer 30

a drug that is available in another country may not be available in the US due to the 5-6 years approval process by the FDA.

Question 31

What law prevented the marketing of adulterated drugs; required labeling to eliminate false/misleading claims?

Answer 31

Pure Food and Drug Act in 1906

Question 32

Which law mandated tests for drug toxicity and provided means for recall of drugs; established procedures for introducing new
drugs; gave Food and Drug Administration
(FDA) the power of enforcement?

Answer 32

Federal Food, Drug and Cosmetic Act of 1938

Question 33

Which law tightened control of certain drugs; specified drugs to be labeled “may not
be distributed without a prescription”?

Answer 33

Durham-Humphrey Amendment of 1951

Question 34

Which drug tightened control over the quality of drugs; gave FDA regulatory power over the procedure of drug investigations; stated that efficacy as well as safety of drugs had to be established?

Answer 34

Kefauver-Harris Act of 1962

Question 35

Which law defined drug abuse and classified drugs as to their potential for abuse; provided
strict controls over the distribution, storage,
and use of these drugs?

Answer 35

Controlled Substances Act of 1970

Question 36

Which law provided incentives for the
development of orphan drugs for treatment of
rare diseases?

Answer 36

Orphan Drug Act of 1983

Question 37

Which FDA pregnancy category is never to be used and why?

Answer 37

Category X b/c the risks outweigh the benefits

Question 38

Which FDA pregnancy category should not be used, but may be acceptable and why?

Answer 38

Category D b/c there is evidence of fetus risk but the potential benefits in pregnant women may be acceptable despite the risks.

Question 39

Which FDA pregnancy category of drugs has shown no risks to pregnant women in 1st trimester, and no evidence of risk in later terms?

Answer 39

Category A

Question 40

Which FDA pregnancy category of drugs has shown no risks in animal studies, but there hasn’t been adequate studies in pregnant women?

Answer 40

Category B

Question 41

Which FDA pregnancy category of drugs has shown adverse effects in animal studies, but adequate studies in pregnancy women have known shown risks to first trimester or following terms?

Answer 41

Category B

Question 42

Which FDA pregnancy category of drugs has shown risk to the fetus in animal studies, but haven’t had adequate studies in humans?

Answer 42

Category C

Question 43

When might a brand name drug be used over a generic drug?

Answer 43

When the drugs have narrow safety margins. This ensures quality control and the action/effect expected w/ the drug. Some generic drugs have binders that differ from the brand drug and so the way the body breaks it down and uses it may differ.

Question 44

What are 3 concerns w/ OTC drugs?

Answer 44

they can mask the S&S of underlying disease, drug interactions w/ prescription drugs, overdose w/ prescription drugs