MCQ Quiz: Prescription Drug Labelling

Prescription drug labeling is a critical component of medication safety, governed by a complex framework of federal and state regulations. From interpreting the detailed manufacturer’s package insert to creating a clear and accurate label for the patient’s vial, pharmacists are the key guardians of this information. This skill draws on foundational knowledge from the Principles of Pharmacy Law and Ethics course and is applied daily to ensure safe medication use, as emphasized in medication safety modules. This quiz will test your knowledge on the required elements of all types of prescription labeling and the pharmacist’s role in ensuring their accuracy.

1. The official, FDA-approved labeling for a prescription drug, intended for healthcare professionals, is most commonly known as the:

• a. Patient leaflet
• b. Medication Guide
• c. Package Insert (PI) or Prescribing Information
• d. Orange Book

Answer: c. Package Insert (PI) or Prescribing Information

2. The FDA’s strongest warning that can be required on a drug’s label is the:

• a. Contraindication section
• b. Adverse Reactions section
• c. Black Box Warning
• d. Dosage and Administration section

Answer: c. Black Box Warning

3. The requirements for what must appear on a pharmacy-dispensed prescription label are primarily determined by:

• a. The FDA only
• b. The DEA only
• c. The individual pharmacist’s preference
• d. Each state’s Board of Pharmacy, with some federal requirements.

Answer: d. Each state’s Board of Pharmacy, with some federal requirements.

4. The section of the package insert that lists situations in which a drug should not be used because the risk outweighs any potential benefit is the:

• a. Indications and Usage
• b. Warnings and Precautions
• c. Contraindications
• d. Adverse Reactions

Answer: c. Contraindications

5. A pharmacist dispenses a prescription but omits the patient’s name from the label. Under the Food, Drug, and Cosmetic Act, this drug is considered:

• a. Adulterated
• b. Counterfeit
• c. Misbranded
• d. A controlled substance

Answer: c. Misbranded

6. The “Principles of Pharmacy Law and Ethics” is a core course in the curriculum.

• a. True
• b. False

Answer: a. True

7. “Take with food” and “May cause drowsiness” are examples of what type of labels applied to a prescription vial?

• a. Primary labels
• b. Auxiliary labels
• c. Manufacturer’s labels
• d. System labels

Answer: b. Auxiliary labels

8. The new Pregnancy and Lactation Labeling Rule (PLLR) replaced the old letter categories with:

• a. A simple “safe” or “unsafe” rating.
• b. A narrative summary of risks and clinical considerations.
• c. A numerical score.
• d. A color-coded system.

Answer: b. A narrative summary of risks and clinical considerations.

9. A Medication Guide (MedGuide) is an FDA-required patient handout that must be dispensed with certain drugs that have:

• a. A low risk of side effects.
• b. A generic version available.
• c. Serious and significant public health concerns.
• d. A simple dosing schedule.

Answer: c. Serious and significant public health concerns.

10. Which federal law mandated that pharmacists must offer to counsel Medicaid patients, a requirement now adopted by most states for all patients?

• a. The Kefauver-Harris Amendment of 1962
• b. The Controlled Substances Act of 1970
• c. The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)
• d. The Drug Quality and Security Act of 2013

Answer: c. The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)

11. The “Medication Safety” module is part of the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

12. The “Indications and Usage” section of a package insert lists:

• a. All known side effects of the drug.
• b. The drug’s chemical structure.
• c. The FDA-approved uses for the medication.
• d. All possible off-label uses.

Answer: c. The FDA-approved uses for the medication.

13. A prescription for a C-II controlled substance requires which specific cautionary statement on the label?

• a. “May cause drowsiness”
• b. “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
• c. “Shake well before use”
• d. “For external use only”

Answer: b. “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

14. A pharmacist’s role includes translating the prescriber’s directions (the “Sig”) into clear, patient-friendly language on the prescription label.

• a. True
• b. False

Answer: a. True

15. A pharmacist is using a package insert to answer a drug information question. The package insert is considered what type of literature?

• a. Primary
• b. Secondary
• c. Tertiary
• d. It is not a form of literature.

Answer: c. Tertiary

16. The “Highlights of Prescribing Information” section of a package insert is intended to be:

• a. A complete, detailed monograph of the drug.
• b. A concise summary of the most important information, with references to the full prescribing information.
• c. A marketing tool for the manufacturer.
• d. A guide for patients.

Answer: b. A concise summary of the most important information, with references to the full prescribing information.

17. The “Drug Approval Process” is a topic in the Medicinal Chemistry and Pharmacology I course.

• a. True
• b. False

Answer: a. True

18. A “tall man” lettering scheme (e.g., hydrOXYzine vs. hydrALAZINE) is a safety strategy that can be used on:

• a. Pharmacy shelf labels
• b. Computer screen displays
• c. Prescription labels
• d. All of the above

Answer: d. All of the above.

19. Which of the following is NOT typically required on a pharmacy-dispensed prescription label?

• a. The patient’s name.
• b. The prescription number.
• c. The name of the pharmacy technician who filled the prescription.
• d. The name and strength of the drug.

Answer: c. The name of the pharmacy technician who filled the prescription.

20. A key professional responsibility of the pharmacist is to ensure that the prescription label is accurate before the medication is dispensed.

• a. True
• b. False

Answer: a. True

21. The “Adverse Reactions” section of a package insert contains:

• a. A list of all contraindications.
• b. A list of undesirable effects observed in clinical trials of the drug.
• c. The drug’s mechanism of action.
• d. The results of the pivotal efficacy trials.

Answer: b. A list of undesirable effects observed in clinical trials of the drug.

22. An “off-label” use is a use that is not listed in which section of the package insert?

• a. Adverse Reactions
• b. Warnings and Precautions
• c. Indications and Usage
• d. Drug Interactions

Answer: c. Indications and Usage

23. The principles of EBP are crucial for interpreting the data found in a package insert.

• a. True
• b. False

Answer: a. True

24. An auxiliary label stating “Do not take with grapefruit juice” would be appropriate for a drug that is a substrate of:

• a. CYP2D6
• b. CYP1A2
• c. CYP3A4
• d. UGT1A1

Answer: c. CYP3A4

25. A pharmacist’s final verification of a prescription is a critical safety check to ensure the dispensed medication matches the label and the original prescription.

• a. True
• b. False

Answer: a. True

26. The “Dosage and Administration” section of the package insert provides information on:

• a. Recommended doses for approved indications.
• b. How to prepare and administer the drug.
• c. Dose adjustments for specific populations (e.g., renal or hepatic impairment).
• d. All of the above.

Answer: d. All of the above.

27. A prescription label with the wrong patient’s name on it is a form of:

• a. Adulteration
• b. Misbranding
• c. A controlled substance violation
• d. It is not an error if the correct drug is in the bottle.

Answer: b. Misbranding

28. An active learning session on medication safety, including labeling, is part of the Patient Care 5 course.

• a. True
• b. False

Answer: a. True

29. The expiration date on a manufacturer’s stock bottle is different from the ______ date that is placed on a dispensed prescription vial.

• a. “do not use before”
• b. “beyond-use”
• c. “best-by”
• d. “compounding”

Answer: b. “beyond-use”

30. The “How Supplied/Storage and Handling” section of a package insert provides information on:

• a. The drug’s available dosage forms and strengths.
• b. The proper storage conditions for the drug.
• c. The appearance of the drug.
• d. All of the above.

Answer: d. All of the above.

31. Patient-friendly labeling uses:

• a. As much medical jargon as possible.
• b. Simple, clear language and avoids confusing abbreviations.
• c. A very small font size to save space.
• d. The color red exclusively.

Answer: b. Simple, clear language and avoids confusing abbreviations.

32. The pharmacist must use their professional judgment to decide which auxiliary labels are most important for a given prescription.

• a. True
• b. False

Answer: a. True

33. The section of the PI that describes a drug’s mechanism of action, pharmacodynamics, and pharmacokinetics is:

• a. Clinical Trials
• b. Clinical Pharmacology
• c. Nonclinical Toxicology
• d. Indications and Usage

Answer: b. Clinical Pharmacology

34. A REMS (Risk Evaluation and Mitigation Strategy) might require specific labeling, such as:

• a. A different colored bottle.
• b. The mandatory dispensing of a Medication Guide.
• c. A larger font size.
• d. The pharmacist’s signature.

Answer: b. The mandatory dispensing of a Medication Guide.

35. A prescription label reading “Take as directed” is generally considered:

• a. The best way to write directions.
• b. Unacceptable as it is ambiguous and can lead to patient confusion and errors.
• c. Acceptable for all medications.
• d. A legal requirement.

Answer: b. Unacceptable as it is ambiguous and can lead to patient confusion and errors.

36. The “Use in Specific Populations” section of the PLLR includes information on all of the following EXCEPT:

• a. Pregnancy
• b. Lactation
• c. Geriatric Use
• d. Females and Males of Reproductive Potential

Answer: c. Geriatric Use

37. Verifying that the NDC number on the stock bottle matches the one selected in the computer system is a safety check to prevent:

• a. Billing errors
• b. Dispensing the wrong drug, strength, or formulation.
• c. A HIPAA violation
• d. A drug interaction

Answer: b. Dispensing the wrong drug, strength, or formulation.

38. The pharmacy law course provides the foundation for understanding labeling requirements.

• a. True
• b. False

Answer: a. True

39. An auxiliary label stating “May cause sun sensitivity” would be appropriate for which drug?

• a. Penicillin
• b. Metformin
• c. Doxycycline
• d. Acetaminophen

Answer: c. Doxycycline

40. The patient’s address is required on a prescription label for which type of medication?

• a. All prescriptions
• b. Only medications for hypertension
• c. Controlled substances
• d. Only medications for geriatric patients

Answer: c. Controlled substances

41. The information in a drug’s package insert is primarily based on:

• a. Anecdotal reports
• b. The pre-market clinical trials conducted for FDA approval.
• c. Post-marketing case reports only.
• d. The manufacturer’s marketing goals.

Answer: b. The pre-market clinical trials conducted for FDA approval.

42. Which of the following is a key patient safety consideration for prescription labels?

• a. Readability (font size, clarity)
• b. Use of plain language
• c. Avoiding confusing abbreviations
• d. All of the above

Answer: d. All of the above

43. A pharmacist’s counseling should reinforce and clarify the information provided on the prescription label.

• a. True
• b. False

Answer: a. True

44. A label stating “Warfarin 5 mg” but containing Warfarin 10 mg tablets is an example of:

• a. Adulteration
• b. Misbranding
• c. A controlled substance violation
• d. An acceptable practice

Answer: b. Misbranding

45. The pharmacist is the final healthcare professional to check a prescription before it reaches the patient, making the final label verification a critical step.

• a. True
• b. False

Answer: a. True

46. A “black box warning” is so named because:

• a. It warns about the risk of “blacking out.”
• b. The text in the package insert is enclosed in a black border to draw attention to it.
• c. It is only for drugs that are black in color.
• d. It is a secret warning only for pharmacists.

Answer: b. The text in the package insert is enclosed in a black border to draw attention to it.

47. The “Medication Safety” module in the curriculum emphasizes the importance of clear communication, including labeling.

• a. True
• b. False

Answer: a. True

48. An auxiliary label stating “Take with plenty of water” is important for:

• a. A topical cream.
• b. An eye drop.
• c. Drugs that can cause crystalluria (e.g., sulfamethoxazole) or esophageal irritation (e.g., bisphosphonates).
• d. All injectable medications.

Answer: c. Drugs that can cause crystalluria (e.g., sulfamethoxazole) or esophageal irritation (e.g., bisphosphonates).

49. The overall goal of prescription drug labeling is to:

• a. Fulfill a legal requirement.
• b. Communicate essential information to promote the safe and effective use of the medication.
• c. Make the prescription bottle look official.
• d. Justify the cost of the medication.

Answer: b. Communicate essential information to promote the safe and effective use of the medication.

50. The ultimate reason a pharmacist must master the details of drug labeling is to:

• a. Pass the pharmacy law exam (MPJE).
• b. Prevent medication errors and ensure patient safety.
• c. Both a and b.
• d. Neither a nor b.

Answer: c. Both a and b.