Deck 7: Pharmacoepidemiology

Question 1

What is the purpose of a drug effectiveness study?

A) To determine the benefit of a drug when it is used in real-world settings.
B) To determine whether a drug is safe for specific populations to use.
C) To determine whether a drug is beneficial for conditions other than the one it was approved to treat.
D) To determine the ideal dosage level of a drug.

Answer 1

To determine the benefit of a drug when it is used in real-world settings.

Question 2

Much of pharmacoepidemiology focuses on what happens after a drug has been approved, on what the real-world effects of a drug are in populations.

Answer 2

True

Question 3

If the Food and Drug Administration FDA) requires a Phase IV or post-marketing drug study, the drug cannot be made available to the general public for use until the study is completed and it demonstrates that the drug is safe for general use.

Answer 3

False

Question 4

If a researcher wanted to quantify the use of a particular drug over time, across geographic regions, or within specific populations, what type of study would he conduct?

A) Preclinical study
B) Comparative effectiveness study
C) Comparative safety study
D) Drug utilization study

Question 5

During which phase of the drug approval process in the U.S. is the safety of a drug tested in people without the disease or symptom the drug is designed to treat?

A) Preclinical
B) Clinical: Phase I
C) Clinical: Phase II
D) Clinical: Phase III

Question 6

At what point in the drug approval process was it discovered that the pain medication Vioxx® increased the risk of cardiac events?

A) During preclinical animal studies.
B) During Phase I studies in healthy volunteers.
C) During Phase III studies with a large number of individuals with the symptom of interest pain).
D) During the post-marketing period when the manufacturer was attempting to show the superiority of the drug over its competitors.

Question 7

All three phases of clinical testing of a drug on healthy volunteers, a small number of people with the disease of interest, and a larger number of people with the disease of interest) are considered premarketing studies.

Question 8

Which of the following is a problem with the premarketing studies done as part of the U.S. drug approval process?

A) The studies are only done on animals and data must be extrapolated to humans.
B) The sample sizes are so large that too many negative effects are statistically significant.
C) The study participants tend to be taking many other medications and have many other health conditions so it is difficult to control for confounding.
D) The study participants are more middle-aged, healthy, and compliant than the general population so the real-world effects and side effects are not clear.

Question 9

Which of the following statements is true about premarketing and postmarketing drug studies?

A) Both premarketing and post-marketing studies are nearly always randomized trials.
B) Premarketing studies are typically randomized trials and post-marketing studies can be randomized trials or observational studies.
C) Premarketing studies are typically observational studies and post-marketing studies can be randomized trials or observational studies.
D) Both premarketing and post-marketing studies are nearly always observational studies.

Question 10

What did the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act do?

A) Created the Food and Drug Administration FDA)
B) Required that certain drugs be made available over-the-counter.
C) Strengthened requirements for safety and efficacy studies before drugs were approved.
D) Created the first registry of adverse drug events.

Question 11

During which phase of the drug approval process in the U.S. is the safety and efficacy of a drug established, usually in laboratory animals?

A) Preclinical
B) Clinical: Phase I
C) Clinical: Phase II
D) Clinical: Phase III

Question 12

A spontaneous reporting system - a passive surveillance system in which health care providers report adverse drug events to the FDA - is part of the drug safety surveillance system in the United States.

Question 13

Pharmacoepidemiology is the application of epidemiological reasoning, methods, and knowledge to the study of the uses and effects of drugs in human populations

Question 14

In pharmacoepidemiology, the term effectiveness is used to describe the real-world effect of a drug while efficacy is used to describe the effect of the drug under ideal or tightly controlled clinical conditions.

Question 15

Assessing exposure in post-marketing Phase IV) drug studies is simple because each drug has a unique National Drug Code and there is a centralized system for tracking prescriptions in the United States that provides all the information a researcher needs about dosage, prescription dates, and the reason a person is prescribed a medication

Question 16

Part of the reason one may see an increase in adverse drug events is improved surveillance for drug safety.

Question 17

Which of the following drugs caused severe physical abnormalities in children born to women took it during pregnancy and was a leading cause for drug regulations increasing worldwide?

A) Digoxin
B) Thalidomide
C) Vioxx®
D) Antibiotics

Question 18

In comparative effectiveness research, a drug is compared to a placebo inactive substance) to determine the benefit of the drug compared to no drug.

Question 19

Pharmaceutical drugs have been carefully controlled and regulated since the 1800s in the United States; regulation actually has decreased over time.

Question 20

Which of the following accurately describes the problem of confounding by severity in a drug safety study?

A) The more severe side effects of drugs cause people to stop taking the drug and the drug appears less harmful than it really is.
B) When health care providers prescribe one drug more commonly than others for patients with a more severe form of disease, the drug will look more harmful than it really is.
C) When patients have previously experienced severe side effects from a similar type of drug, they will not be put on a drug, thus making it look less harmful than it really is.
D) When there are severe side effects from a drug, people over-report them, making a drug look more harmful than it really is.