Week 3

Question 1

What are the three core ethical principles for drug research?

Answer 1

• Respect for persons
• Beneficence
• Justice

Question 2

What are the two main aspects of the ethical principle “Respect for Persons”

Answer 2

• Autonomy

- Informed consent

Question 3

What is Autonomy?

Answer 3

The right for self-determination

Question 4

What is informed consent?

Answer 4

The patient should only consent if they have been completely informed of the risks and benefits.

• Provider Explains
• RN is advocate

Question 5

What is Beneficence?

Answer 5

• Protecting the patient from harm

- Assessing the potential risks and making sure they are outweighed by the benefits

Question 6

The Ethical principle of justice ensures that ____

Answer 6

the selection of participants in a drug study are selected in a fair manner

Question 7

What is the purpose of pre-clinical trials?

Answer 7

To determine a drugs toxic and pharmacological effects

Question 8

How many phases of Human Clinical drug experimentation are there?

Answer 8

4

Question 9

What occurs during a phase 1 drug trial?

Answer 9

-New drug tested on small number to evaluate safety and determine safe dose range and side effects

Question 10

What occurs during phase 2 drug trials

Answer 10

-Larger group to test effectiveness and eval safety

Question 11

What occurs during phase 3 drug trials?

Answer 11

-Larger group to compare drug to other treatments and to continue to assess for safety, effectivness, and side effects

Question 12

What occurs during phase 4 drug trials?

Answer 12

-occurs after drug is on market. Assesses long term use

Question 13

According to the ADA code of ethics, what is the nurses responsibility during drug research?

Answer 13

They are responsible for the safety of the patient and integrity of the research protocol

Question 14

For a drug to be included in the US pharmacopoeia they must meet _____

Answer 14

Standards set by the FDA

Question 15

What categories of standards do drugs need to meet in order to be included in the national formulary?
7

Answer 15

• Therapeutic use
• Patient safety
• Quality
• Purity
• Strength
• Packaging safety
• Dosage form

Question 16

What is the primary purpose of federal legislation in regard to drug approval

Answer 16

The ensure safety

-Protects from impure, toxic, ineffective, or untested drugs.

Question 17

The nurse practice act states that

Answer 17

Nurses generally can not prescribe or administer drugs without a HCP’s order

Question 18

What are the most common counterfeit drugs?

Answer 18

• HTN
• Antibiotics
• Chemo
• HIV/AIDs
• ED

Question 19

What is the nurses role in protecting patients from counterfeit drugs?

Answer 19

To educate a patient to recognize and report differences in taste/apperance/packaging

Educate patient to pay attention to labels and to buy med’s from legitimate agencies

Question 20

What are the three types of drug names?

Answer 20

• Chemical
• Generic
• Trade/Brand

Question 21

What is a chemical drug name?

Answer 21

The actual chemical structure of the drug

Question 22

What is a generic drug name?

Answer 22

The official name that is not owned by the drug company

Question 23

What is a trade/brand drug name?

Answer 23

A name chosen by the drug company that is a registered trademark

Question 24

Generic drugs are required to?

3 things

Answer 24

• Be approved by the FDA
• Be equivalent to the brand name
• Contain the same active ingredients as brand name

Question 25

Does a generic drug need to have identical effectiveness to the brand name drug to be considered equivalent?

Answer 25

no. They are allowed a 20% variance in pharmacokinetic effects