Deck 13: Food and Drugs As Public Health Issues

Question 1

The primary goal of FDA phases 2 and 3 is to:

A) demonstrate that the drug is free of side effects.
B) demonstrate that the drug has effectiveness.
C) demonstrate that the drug has efficacy.
D) None of these is correct.

Answer 1

C

Question 2

FDA approval of a drug has all of the following implications, except:

A) the drug may be advertised and marketed for the approved indication.
B) the drug may be prescribed for the approved indication on populations other than the one on which it was investigated.
C) the drug may be prescribed for other indications.
D) the drug is free of life-threatening side effects.

Answer 2

D

Question 3

All of the following are limitations of randomized controlled trials for the investigation of safety, except:

A) sample size limits the ability of randomized controlled trials to observe rare, but serious, side effects.
B) short duration of most randomized controlled trials limits the ability to observe long-term side effects.
C) serious side effects are often overlooked due to infrequent observation.
D) patients in randomized controlled trials often have less-complex clinical presentations than those in practice.

Answer 3

C

Question 4

FDA requirements for efficacy need to be established based upon randomized controlled trials for all of the following types of products, except:

A) prescription drugs.
B) vaccines.
C) dietary supplements.
D) None of these is correct.

Question 5

Which type of adverse effect is most likely to be reported as part of the spontaneous reporting system?

A) Dramatic conditions occurring soon after the drug's administration that rarely occur in clinical practice in the absence of the drug
B) Conditions that mimic those caused by the disease itself
C) Conditions that are self-limited or mild
D) Conditions that occur long after the administration of the drug began

Question 6

Which of the following is not true of the FDA use of animal testing of drugs?

A) Animal testing is generally conducted on at least two species.
B) Animal testing aims to evaluate the potential for carcinogenicity by testing animals at doses well above those expected to be used in human beings.
C) Animal testing for teratogenic effects is a standard part of the animal testing process.
D) Absence of toxicity in animal testing has been shown to correlate very closely with the absence of toxicity in human studies.

Question 7

Which of the following is the first step in an outbreak investigation?

A) Defining and finding cases
B) Detecting a possible outbreak
C) Generating hypotheses about likely sources
D) Testing the hypothesis

Question 8

Which of the following is the last step in an outbreak investigation?

A) Controlling the outbreak
B) Finding the point of contamination and the source of the outbreak
C) Deciding that an outbreak is over
D) Testing the hypothesis

Question 9

Which of the following organizations is not a regulatory agency, but establishes policy and makes recommendations for the United States?

A) Food and Agriculture Organization (FAO)
B) World Health Organization (WHO)
C) United States Department of Agriculture (USDA)
D) United States Food and Drug Administration (FDA)
E) Centers for Disease Control and Prevention (CDC)

Question 10

Which of the following is not a regulatory agency, but establishes policy and makes recommendations globally?

A) Food and Agriculture Organization (FAO)
B) World Health Organization (WHO)
C) United States Department of Agriculture (USDA)
D) United States Food and Drug Administration (FDA)
E) Centers for Disease Control and Prevention (CDC)