NRSG540 Module 1 Quiz

Pharmacotherapeutics is best defined as:

• The study of drug metabolism and excretion

• The branch of pharmacology that uses drugs to treat, prevent, and diagnose disease

• The study of the biological effects of chemical

• The regulation of drugs by the FDA

A patient asks why they must use the generic drug instead of the brand name. The nurse’s best response is:

• “Brand name drugs are always safer.”

• “Generic drugs are less effective but cheaper.”

• “Generic drugs are bioequivalent, equally safe, and more cost-effective.”

• “You may experience completely different therapeutic effects.”

Answer explanation

Generics are bioequivalent and safe, with identical therapeutic use, though inert ingredients may vary.

A nurse is reviewing drug names with a student. Which example represents a trade name?

• ibuprofen

• 8-chloro-1-methyl-6-phenyl-4H-5-triazolo-benzodiazepine

• Advil

• acetaminophen

Answer explanation

Trade (brand) names are capitalized and given by the manufacturer (e.g., Advil). Generic names are lowercase (ibuprofen, acetaminophen). Chemical names are rarely used clinically.

A patient asks why some drugs require a prescription while others are OTC. The nurse’s best teaching point is:

• Prescription drugs are always more effective.

• OTC drugs are safe for self-diagnosis and low risk for misuse.

• OTC drugs never cause side effects.

• Prescription drugs are cheaper and more accessible.

Answer explanation

OTC drugs can be used safely without provider oversight, are low risk for abuse, and appropriate for self-diagnosed conditions.

Which law classifies controlled substances and established schedules for their use?

• Controlled Substance Act of 1970

• Orphan Drug Act of 1983

• Food, Drug, and Cosmetic Act of 1938

• Pure Food and Drug Act of 1906

Answer explanation

The Controlled Substance Act (1970) established drug schedules and regulation of narcotics.

A patient prescribed a new medication for hypertension asks about “off-label use.” The nurse explains:

• “It means the drug is unsafe.”

• “It means the drug is counterfeit.”

• “It means you are in a clinical trial.”

• “It means the provider is prescribing the drug for a use not approved by the FDA.”

Answer explanation

Off-label use occurs when an FDA-approved drug is prescribed for a condition not in its official approval.

A nurse is teaching a patient about biologics. Which statement indicates understanding?

• “They are always synthetic chemicals.”

• “They are available only as OTC products.”

• “They include antibodies, hormones, and vaccines.”

• “They are identical to CAM therapies.”

Answer explanation

Biologics include vaccines, hormones, monoclonal antibodies, and similar biologically derived products.

A patient asks, “Why are some drugs pulled from the market after FDA approval?” The nurse’s best answer is:

• “The FDA only tests drugs in animals.”

• “Sometimes long-term adverse effects are discovered during post-marketing surveillance.”

• “Sometimes the government changes its mind about certain drugs.”

• “Patients don’t like the side effects.”

Answer explanation

Phase IV post-marketing studies monitor for long-term or rare adverse effects; drugs may be withdrawn if significant harm emerges.

A drug is being tested on 1,000 patients with the target disease to compare its efficacy and adverse effects against current standard treatments. This describes clinical phase ______ of the FDA approval process.

Which responsibilities does the FDA hold in the drug approval and regulation process? Select all that apply.

• Ensuring drugs are safe and effective before marketing

• Regulating clinical trial phases

• Monitoring long-term adverse effects in Phase IV

• Requiring boxed (black box) warnings when needed

• Assigning and enforcing controlled-substance schedules