1. What is the basis for U.S. Food and Drug Administration (FDA) approval of pharmaceutical products as safe and effective?
A. Economic viability of the product
B. Statements made in the proposed labeling for the product
C. Prescriber willingness to use the product
D. Patient acceptance of the product
2. Under the traditional approach, what is considered to be the foundational information that circumscribes the limits of content for pharmaceutical product promotion?
A. The scientific literature
B. WebMD
C. The United States Pharmacopeia (USP)
D. FDA-approved product labeling
3. Which of the following statements is TRUE with regard to pharmaceutical labeling:
A. It is not intended to be a clinical guideline for health care practice
B. It is necessarily up-to-date
C. All appropriate drug uses are described in the approved labeling
D. Research is not necessary to support a labeling change
4. In what way does labeling facilitate the distinction between drugs and other articles?
A. Labeling shows the intent of the labeler of the article
B. Labeling is printed in a font so small it cannot be read
C. Labeling may be given to patients if requested by them
D. Labeling is actually not useful in making this distinction
5. Which of the following changes to a drug’s labeling would likely cause the drug to be considered a new drug warranting additional FDA review through a supplemental New Drug Application:
A. The addition of a new indication
B. The inclusion of a new route of administration
C. A change in the drug’s dosing schedule
D. All of the above
6. According the to the Food Drug & Cosmetic Act (FDCA), a display of written, printed, or graphic matter upon the immediate container (affixed to the container) would be referred to as which of the following terms:
A. Trade dress
B. Label
C. Labeling
D. Prescribing Information
7. According to the FDCA, written, printed, or graphic matter accompanying a drug would be referred to as which of the following terms:
A. Trade dress
B. Label
C. Labeling
D. Prescribing Information
8. According to the FDCA, there are basically 2 things that cannot be done, in regard to drug use, and activities considered illegal are deemed to be 1 or both of these things. What are the 2 things that cannot be done?
A. Mislabeling and Contamination
B. Misbranding and Contamination
C. Misbranding and Adulteration
D. Mislabeling and Adulteration
9. What is the FDA standard for determining whether a drug is misbranded?
A. False or misleading
B. False and misleading
C. Deceptive or dangerous
D. Deceptive and dangerous
10. The Package Insert (PI) is intended for use by whom?
A. Patients
B. Family caregivers of patients
C. Health care professionals
D. Drug regulatory agencies
11. The Patient Package Insert (PPI) is intended for use by whom?
A. Patients and family caregivers of patients
B. Pharmacy owners
C. Health care professionals
D. Drug regulatory agencies
12. The Medication Guide (MedGuide) is intended for use by whom?
A. Patients and family caregivers of patients
B. Lawyers of patients with malpractice suits
C. Health care professionals
D. Drug regulatory agencies
13. If laboratory tests are required for the appropriate use of a drug, in what section of the PI would that information be listed?
A. “Necessary Labs”
B. “Appropriate Prescribing”
C. “Diagnostic Assistance”
D. “Indications and Usage”
14. In what section of the PI would there be a description of situations in which a drug should not be used because the risk of use clearly outweighs any possible benefit?
A. “Warnings and Precautions”
B. “Risk Management”
C. “Contraindications”
D. “Prohibited Uses”
15. In what section of the PI would the limitations of drug use be listed, such as avoiding certain concomitant therapies?
A. “Warnings and Precautions”
B. “Risk Management”
C. “Contraindications”
D. “Prohibited Uses”
16. What is the FDA’s stated position on the off-label use of a drug?
A. Off-label use is illegal
B. Off-label use violates the FDCA
C. Off-label use does not violate the FDCA
D. Off-label use is encouraged
17. What type of legal proceeding has served as a limiting factor for off-label use?
A. FDA enforcement
B. Malpractice litigation
C. USP standards
D. State licensing agencies
18. What is the purpose of the Risk Evaluation and Mitigation Strategy (REMS) provisions?
A. To restrict the marketing of drugs
B. To remove dangerous drugs from the market
C. To keep drugs on the market and restrict usage only to patients for whom the drug is safe and effective
D. To implement burdensome requirements with no potential benefit
19. Which of the following is the most frequent requirement of a REMS:
A. A patient registry
B. A patient-directed written document
C. A prescriber registry
D. A prescriber exam prior to qualification of the prescriber to authorize use of a drug