Chapter 04: Cultural, Legal, and Ethical Considerations

Chapter 04: Cultural, Legal, and Ethical Considerations

 

Complete Chapter Questions With Answers

 

Sample Questions Are Posted Below

 

MULTIPLE CHOICE

 

1. During the development of a new drug, which would be included in the study by the researcher to prevent any bias or unrealistic expectations of the new drug’s usefulness?

a.	A placebo
b.	FDA approval
c.	Informed consent
d.	Safety information

 

 

ANS:  A

To prevent bias that may occur as a result of unrealistic expectations of an investigational new drug, a placebo is incorporated into the study. The other options are incorrect. FDA approval, if given, does not occur until after phase III. Informed consent is required in all drug studies. Safety information is not determined until the study is under way.

 

DIF:    COGNITIVE LEVEL: Understanding (Comprehension)    REF:   p. 55

TOP:   NURSING PROCESS: General

MSC:  NCLEX: Safe and Effective Care Environment: Safety and Infection Control

 

2. A member of an investigational drug study team is working with healthy volunteers whose participation will help to determine the optimal dosage range and pharmacokinetics of the drug. The team member is participating in what type of study?

a.	Phase I
b.	Phase II
c.	Phase III
d.	Phase IV

 

 

ANS:  A

Phase I studies involve small numbers of healthy volunteers to determine optimal dosage range and the pharmacokinetics of the drug. The other phases progressively involve volunteers who have the disease or ailment that the drug is designed to diagnose or treat.

 

DIF:    COGNITIVE LEVEL: Applying (Application)                  REF:   p. 55

TOP:   NURSING PROCESS: General

MSC:  NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

 

3. During discharge patient teaching, the nurse reviews prescriptions with a patient. Which statement is correct about refills for an analgesic that is classified as Schedule C-III?

a.	No prescription refills are permitted.
b.	Refills are allowed only by written prescription.
c.	The patient may have no more than five refills in a 6-month period.
d.	Written prescriptions expire in 12 months.

 

 

ANS:  C

Schedule C-III medications may be refilled no more than five times in a 6-month period. The patient should be informed of this regulation. No prescription refills are permitted for Schedule C-II drugs. Requiring refills by written prescription only applies to Schedule C-II drugs. Schedule C-III prescriptions (written or oral) expire in 6 months.

 

DIF:    COGNITIVE LEVEL: Remembering (Knowledge)           REF:   p. 54

TOP:   NURSING PROCESS: Implementation

MSC:  NCLEX: Physiological Integrity: Pharmacological and Parenteral Therapies

 

4. A patient has been selected as a potential recipient of an experimental drug for heart failure. The nurse knows that when informed consent has been obtained, it indicates which of these?

a.	The patient has been informed of the possible benefits of the new therapy.
b.	The patient will be informed of the details of the study as the research continues.
c.	The patient will receive the actual drug during the experiment.
d.	The patient has had the study’s purpose, procedures, and the risks involved explained to him.

 

 

ANS:  D

Informed consent involves the careful explanation of the purpose of the study, the procedures to be used, and the risks involved. The other options do not describe informed consent.

 

DIF:    COGNITIVE LEVEL: Understanding (Comprehension)    REF:   p. 55

TOP:   NURSING PROCESS: Implementation

MSC:  NCLEX: Safe and Effective Care Environment: Management of Care