Deck 3: Drug Regulation, Development, Names, and Information

Question 1

A nursing student asks a nurse about pharmaceutical research and wants to know the purpose of randomization in drug trials. The nurse explains that randomization is used to do what?

A) To ensure that differences in outcomes are the result of treatment and not differences in subjects
B) To compare the outcome caused by the treatment to the outcome caused by no treatment
C) To make sure that researchers are unaware of which subjects are in which group
D) To prevent subjects from knowing which group they are in and prevent preconception bias

Answer 1

To ensure that differences in outcomes are the result of treatment and not differences in subjects

Question 2

A patient asks a nurse why drugs that have been approved by the FDA still have unknown side effects. What will the nurse tell the patient?

A) Testing for all side effects of a medication would be prohibitively expensive.
B) Patients in drug trials often are biased by their preconceptions of a drug's benefits.
C) Researchers tend to conduct studies that will prove the benefits of their new drugs.
D) Subjects in drug trials do not always represent the full spectrum of possible patients.

Answer 2

Subjects in drug trials do not always represent the full spectrum of possible patients.

Question 3

A nurse educator is conducting a continuing education class on pharmacology. To evaluate the learning of the nurses in the class, the nurse educator asks, "Which drug name gives information about the drug's pharmacologic classification?" Which is the correct response?

A) Amoxicillin
B) Tylenol
C) Cipro
D) Motrin

Answer 3

Amoxicillin

Question 4

A nurse is teaching nursing students about the use of nonproprietary names for drugs. The nurse tells them which fact about nonproprietary names?

A) They are approved by the FDA and are easy to remember.
B) They are assigned by the U.S. Adopted Names Council.
C) They clearly identify the drug's pharmacologic classification.
D) They imply the efficacy of the drug and are less complex.

Question 5

The FDA Amendments Act (FDAAA) was passed in 2007 to address which aspect of drug safety?

A) Allowing pharmaceutical companies to identify off-label uses of medications approved for other uses
B) Evaluating drug safety information that emerges after a drug has been approved and is in use
C) Expediting the approval process of the U.S. Food and Drug Administration (FDA) so that needed drugs can get to market more quickly
D) Requiring manufacturers to notify patients before removing a drug from the market

Question 6

Someone asks a nurse about a new drug that is in preclinical testing and wants to know why it cannot be used to treat a friend's illness. Which statement by the nurse is correct?

A) "A drug at this stage of development can be used only in patients with serious disease."
B) "At this stage of drug development, the safety and usefulness of the medication is unknown."
C) "Clinical trials must be completed to make sure the drug is safe to use in humans."
D) "Until postmarketing surveillance data are available, the drug cannot be used."