1. Drug Development and Ethics

Question 1

3 core ethical principles

Answer 1

• respect for persons
• beneficence
• justice

Question 2

the right to be informed and the right to voluntary participation

Answer 2

informed consent

Question 3

Who is responsible for obtaining informed consent, providing education, expectations, and answering the pts questions

Answer 3

the health care provider

Question 4

What is the nurse’s role in informed consent?

Answer 4

• serve as advocate

- be knowledgeable about the drug or health care procedure

Question 5

testing drug compounds in animals and tissues (about 3.5 years)

Answer 5

drug discovery

Question 6

test drug for safety in 20-80 healthy people (about 1 year)

Answer 6

phase 1 trial

Question 7

test effectiveness in 100-300 real patients (about 2 years)

Answer 7

phase 2 trial

Question 8

confirm safety and effectiveness of drug in 1,000+ patients (about 3 years)

Answer 8

phase 3 trial

Question 9

submitting data to FDA for review (about 2.5 years)

Answer 9

FDA applications

Question 10

test for long-term effects, optimal and additional uses

Answer 10

phase 4 trial

Question 11

published annually with high standard for therapeutic use, pt safety, quality, purity, strength, packaging, and dosage form

Answer 11

US Pharmacopeia

Question 12

What does USP mean behind a drug name?

Answer 12

means the drug has met the standards of the US Pharmacopeia

Question 13

Food and Drug Act of 1906

Answer 13

first law to regulate drugs, prohibit sale of misbranded and adulterated drugs; does not address effectiveness and safety

Question 14

1912 Sherley Amendement

Answer 14

prohibits false therapeutic claims on drug labels

Question 15

1938 Federal Food, Drug, and Cosmetic Act

Answer 15

FDA ensure drugs are safe prior to marketing and require labeling with adverse side effects (ASE)

Question 16

1970 Comprehensive Drug Abuse Prevention and Control Act

Answer 16

created the scheduling of controlled substances

Question 17

substances have no current accepted medical use in the US, lack of accepted safety for use under medical supervision and a high potential for abuse

Answer 17

schedule 1 drugs

Question 18

substances have a high potential for abuse and may lead to severe psychological or physical dependence

Answer 18

schedule 2 drugs

Question 19

substances have a potential for abuse less than 1 or 2 and abuse may lead to moderate or low physical dependence or high psychological dependence

Answer 19

schedule 3 drugs

Question 20

substances have low potential for abuse relative to schedule 3

Answer 20

schedule 4 drugs

Question 21

substances have a low potential for abuse relative to schedule 4 and consist primarily of preparations containing limited quantities of certain narcotics

Answer 21

schedule 5 drugs

Question 22

T/F: nurses can be prosecuted for giving wrong dosage, omitting a drug dose, or giving a drug by the wrong route

Answer 22

True

Question 23

official name for a drug; not owned by any drug company and is universally accepted

Answer 23

generic name

Question 24

name chosen by the drug company and usually includes a registered trademark

Answer 24

brand (trade) name

Question 25

6 things that should be labeled on OTC drugs

Answer 25

• active ingredients
• purpose
• use
• specific warnings
• dosage
• inactive ingredients

Question 26

all possible consequences of a clinical study must be analyzed and balanced against the inherent risks and the anticipated benefits

Answer 26

risk-benefit ratio

Question 27

The ANA Code of Ethics has how many provisions?

Answer 27

9

Question 28

What is the purpose of state nurse practice acts?

Answer 28

provide guidance and govern nursing practice, including drug administration by nurses (generally can’t be done without a provider’s orders)

Question 29

What are 3 references for drugs?

Answer 29

• textbook/drug handbook
• MicroMedEx
• Medline Plus