Ch 2 Nclex-Drug Approval Process

Question 1

1. The nurse is having a health teaching session with a patient who has many questions about the history of drug labels. What is the nurse’s best legislation reference for drug labels and increased control on drug safety?
   a. Kefauver-Harris Amendment to the 1938 Act
   b. Controlled Substances Act
   c. Food, Drug, and Cosmetic Act
   d. Durham-Humphrey Amendment to the 1938 Act

Answer 1

A

Question 2

2.The nurse is reviewing a patient’s list of medications and notes that several have the highest abuse potential. According to U.S. standards, the highest potential for abuse of drugs with accepted medical use is found in drugs included in which schedule?
a.II
b.III
c.IV
D. V

Answer 2

A

Question 3

3. The nurse is reviewing the drug-approval process in the United States and learns that the Food and Drug Administration Modernization Act of 1997 contains which provisions? (Select all that apply.)
   a. Review of new drugs is accelerated.
   b. Drug companies must provide information on “off-label” drugs.
   c. Privacy of individually identifiable health information must be protected.
   d. Drug companies must offer advanced notice of plans to discontinue drugs.
   e. Drug labels must describe side effects and adverse effects.

Answer 3

A, b, d

Question 4

4. The patient has questions about counterfeit drugs. Which factors alert the patient or nurse that a drug is counterfeit or adulterated? (Select all that apply.)
   a. Variations in packaging
   b. Unexpected side effects
   c. Different taste
   d. Different chemical components
   e. Different odor

Answer 4

A, b, c

Question 5

5. The nurse must be knowledgeable about the Nurse Practice Act. In the event the nurse gives the correct drug via the wrong route, resulting in the death of the patient, what may the nurse be charged with in a civil court?
   a. Misfeasance
   b. Nonfeasance
   c. Malfeasance
   d. Negligence

Answer 5

C

Question 6

6. The nurse knows the importance of administering the right medication to the patient and that drugs have many names. It is therefore most important that drugs be ordered by which name?
   a. Generic
   b. Brand
   c. Trade
   d. Chemical

Answer 6

A

Question 7

7. A drug label has “t/c” on it. The nurse knows that which statement is true about this designation? (Select all that apply.)
   a. It is on all schedule F prescription drugs.
   b. It is on targeted substances, such as benzodiazepines.
   c. It is a designation of the Canadian Controlled Drugs and Substances Act.
   d. It is on all narcotics.
   e. It is on over-the-counter drugs.

Answer 7

b, c

Question 8

8. What provisions from the Controlled Substances Act of 1970 were designed to remedy drug abuse?
   a. The act established treatment and rehabilitation facilities.
   b. The act tightened controls on experimental drugs.
   c. The act required clinical trial data on drugs.
   d. The act required drug companies to give information on off-label drugs.

Answer 8

A