Test Bank For Core Concepts in Pharmacology 3rd Edition Holland Adams
Test Bank For Core Concepts in Pharmacology 3rd Edition Holland Adams
Test Bank For Core Concepts in Pharmacology 3rd Edition Holland Adams
8. MC Drugs that demonstrate wide margins of safety and are used over long periods
of time are often switched from:
A.* Prescription-only to over-the-counter (OTC) drug.
B. Traditional drug therapy classification to biologics classification.
C. One classification to a lower, less restrictive one.
D. Therapeutic to effective.
10. MC Reasons why a client might prefer to take an OTC drug are numerous. Which
of the following statements is a potential advantage of OTC drugs versus prescription
drugs?
A.* A client can obtain OTC drugs more easily than prescription drugs.
B. Choosing the proper medication for a specific problem can be
challenging.
C. Self-treatment is sometimes ineffective.
D. OTC drugs can react with foods, herbal products, and prescriptions, or
with other OTC drugs.
12. MC A client expresses concerns about his newly prescribed medication. The nurse
explains that the safety and effectiveness of the medication have been proven,
according to the statutes of which law?
A. Public Health Service Act
B. FDA Modernization Act
C. Pure Food and Drug Act
D.* Food, Drug, and Cosmetic Act
13. MC A client asks the nurse whether the claims made regarding a new medication
are true or false. The nurse tells the client the following act or amendment was passed
in 1912 to prevent the sale of drugs with false therapeutic claims that were intended to
cheat the consumer:
A. Food, Drug, and Cosmetic Act.
B. Pure Food and Drug Act.
C. FDA Modernization Act.
D.* The Sherley Amendment.
14. MC If the FDA discovers a serious problem with a medication that has been
approved, the FDA will:
A.* Require that the drug be withdrawn from the market and its use
discontinued.
B. Issue a warning to practitioners to watch for side effects in clients taking
the drug.
C. Require the medication to have additional clinical trials conducted.
D. Continue to monitor the medication in post-marketing studies.
16. MC A client asks the nurse if all herbal supplements undergo the same testing that
prescription drugs undergo. Which of the following statements would be the best
response by the nurse?
A. "The Center for Food Safety and Applied Nutrition (CFSAN) regulates
use of herbal supplements, which means the medication must be safe."
B. "All medications and herbal supplements undergo the same testing
before being made available for purchase."
C.* "Herbal products and dietary supplements are regulated by the Dietary
Supplement Health and Education Act of 1994. This act does not require the same
research for herbal or dietary supplements."
D. "Herbal and dietary supplements may not be marketed without prior
approval from the FDA."
17. MC Which government agency has control over which prescription or OTC drugs
may be used for therapy?
A. The Center for Biologics Evaluation and Research (CBER)
B. The National Institutes of Health (NIH)
C. The Center for Food Safety and Applied Nutrition (CFSAN)
D.* The Center for Drug Evaluation and Research (CDER)
18. MC Which branch of the FDA is responsible for the use of biologics, including
serums, vaccines, and products found in the bloodstream?
A. The Center for Drug Evaluation and Research (CDER)
B. The Center for Food Safety and Applied Nutrition (CFSAN)
C.* The Center for Biologics Evaluation and Research (CBER)
D. The FDA does not have a branch responsible for the use of biologics.
21. MC Which of the following lists the stages of approval for therapeutic and biologic
drugs in the correct order?
A.* Preclinical investigation, clinical investigation, NDA submission with
review, and post-marketing studies
B. NDA submission with review, preclinical investigation, clinical
investigation, and post-marketing studies
C. NDA submission with review, clinical investigation, preclinical
investigation, and post-marketing studies
D. Preclinical investigation, NDA submission with review, clinical
investigation, and post-marketing studies
22. MC The nurse is aware of the increased potential for adverse drug-drug and drug-
herbal interactions, and explains this to the client in the following statement:
A.* "Drugs are being developed at a faster rate than their risk can be
assessed."
B. "The restrictions placed by the FDA are stricter."
C. "Managed care has made a greater number of drugs available to
consumers."
D. "People are using more herbs, so the risk for interaction is greater."
23. MC Which division of Health Canada is responsible for ensuring that health
products and foods approved for sale to Canadians are safe and of high quality?
A. Natural Health Products Directorate (NHPD)
B. Biologics and Genetic Therapies Directorate (BGTD)
C.* Health Products and Food Branch (HPFB)
D. Therapeutic Products Directorate (TPD)
24. MC A client asks the nurse about the safety of medications from Canadian
pharmacies. The nurse responds that drugs sold in Canada:
A.* Must be marketed with an NOC and DIN.
B. Are not safe.
C. Are not the same as those sold in the United States.
D. Are not governed by Canada.