MCQ Quiz: Advertising by Manufacturers and Pharmacies

Pharmaceutical advertising is a powerful and highly regulated industry in the United States, overseen by both the FDA and FTC. Pharmacists, as trusted medication experts, must be able to critically evaluate the claims made in drug advertisements and understand the legal framework that governs them, a key topic in the Principles of Pharmacy Law and Ethics course “. This quiz will test your knowledge of the regulations for prescription and OTC advertising, the pharmacist’s role in combating misinformation, and the rules governing pharmacy-specific promotion.

1. The advertising of prescription drugs to the general public is regulated by which federal agency?

• a. The Federal Trade Commission (FTC)
• b. The Drug Enforcement Administration (DEA)
• c. The Food and Drug Administration (FDA)
• d. The Centers for Medicare & Medicaid Services (CMS)

Answer: c. The Food and Drug Administration (FDA)

2. The advertising of over-the-counter (OTC) drugs and dietary supplements is regulated by which federal agency?

• a. The Federal Trade Commission (FTC)
• b. The Drug Enforcement Administration (DEA)
• c. The Food and Drug Administration (FDA)
• d. The Centers for Medicare & Medicaid Services (CMS)

Answer: a. The Federal Trade Commission (FTC)

3. Direct-to-Consumer (DTC) prescription drug ads that mention the drug’s name and its indication must present a “fair balance” of:

• a. The cost versus the benefit.
• b. The risks versus the benefits.
• c. The brand name versus the generic name.
• d. The opinions of doctors versus patients.

Answer: b. The risks versus the benefits.

4. A television commercial for a prescription drug includes a long list of potential side effects read very quickly. This part of the ad is known as the:

• a. Indication Statement
• b. Major Statement
• c. Reminder Statement
• d. Final Statement

Answer: b. Major Statement

5. A print ad for a prescription drug that shows the brand name but not the indication (e.g., “Ask your doctor about Lipitor”) is called a(n):

• a. Product claim ad
• b. Help-seeking ad
• c. Reminder ad
• d. Unapproved ad

Answer: c. Reminder ad

6. A pharmaceutical company sponsors a speaker to talk to physicians about an unapproved, “off-label” use for their medication. This is an example of:

• a. An appropriate educational activity.
• b. A legal marketing strategy.
• c. Illegal off-label promotion.
• d. A Phase 4 clinical trial.

Answer: c. Illegal off-label promotion.

7. A drug that is marketed by its manufacturer for an unapproved indication is legally considered:

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

Answer: d. Misbranded

8. While off-label promotion by manufacturers is illegal, off-label prescribing by a physician is:

• a. Also illegal.
• b. A legal and common practice based on professional judgment.
• c. Only legal in a hospital setting.
• d. Only legal for non-controlled substances.

Answer: b. A legal and common practice based on professional judgment.

9. The FDA’s “Bad Ad” program is a resource for:

• a. Patients to get drug coupons.
• b. Healthcare professionals to report misleading or illegal drug promotion.
• c. Companies to submit their ads for pre-approval.
• d. Pharmacists to advertise their services.

Answer: b. Healthcare professionals to report misleading or illegal drug promotion.

10. The advertising of pharmacy services and prescription prices is primarily regulated by:

• a. The FDA
• b. The FTC
• c. State Boards of Pharmacy
• d. The DEA

Answer: c. State Boards of Pharmacy

11. The principles of critically appraising literature are essential for evaluating advertising claims.

• a. True
• b. False

Answer: a. True

12. A “help-seeking ad” by a manufacturer will:

• a. Mention the drug’s name and its indication.
• b. Describe a disease or condition but will not mention a specific drug name.
• c. Only show the drug’s name.
• d. Make a direct comparison to a competitor’s drug.

Answer: b. Describe a disease or condition but will not mention a specific drug name.

13. The main legal standard the FTC uses to evaluate OTC drug advertising is preventing:

• a. Unfair or deceptive practices.
• b. Off-label use.
• c. Drug interactions.
• d. High prices.

Answer: a. Unfair or deceptive practices.

14. A pharmacist’s professional role in regard to drug advertising is to:

• a. Act as an evidence-based resource to help patients interpret marketing claims.
• b. Recommend products based on which one has the best commercial.
• c. Provide samples of advertised drugs.
• d. Design advertisements for their pharmacy.

Answer: a. Act as an evidence-based resource to help patients interpret marketing claims.

15. The federal regulations for dietary supplements are covered in the Patient Care I course.

• a. True
• b. False

Answer: a. True

16. Which of the following would be an example of a permissible “structure/function” claim for a dietary supplement?

• a. “Cures osteoporosis.”
• b. “Prevents bone fractures.”
• c. “Helps support strong bones.”
• d. “Reverses bone loss.”

Answer: c. “Helps support strong bones.”

17. The new drug approval process is a topic in the Medicinal Chemistry and Pharmacology I course.

• a. True
• b. False

Answer: a. True

18. If a manufacturer wants to advertise a new indication for their approved drug, they must first:

• a. Create a new television commercial.
• b. Submit a Supplemental New Drug Application (sNDA) and get FDA approval for that indication.
• c. Conduct a survey of physicians.
• d. Inform their sales representatives.

Answer: b. Submit a Supplemental New Drug Application (sNDA) and get FDA approval for that indication.

19. A key skill for a pharmacist is to be able to differentiate between marketing and:

• a. Evidence-based clinical information.
• b. A good business practice.
• c. A patient’s preference.
• d. A legal requirement.

Answer: a. Evidence-based information.

20. A pharmacy advertises “We have the lowest prices in the state” but consistently does not. This would be a violation of:

• a. FDA regulations.
• b. State laws against false or misleading advertising.
• c. DEA regulations.
• d. HIPAA.

Answer: b. State laws against false or misleading advertising.

21. A “product claim” advertisement must include all of the following EXCEPT:

• a. The name of the drug (brand and generic).
• b. At least one FDA-approved use for the drug.
• a. A fair balance of risk and benefit information.
• d. The cost of the medication.

Answer: d. The cost of the medication.

22. It is legal for a pharmaceutical sales representative to give a pharmacist a peer-reviewed journal article about an off-label use of their drug if:

• a. The pharmacist makes a specific, unsolicited request for that information.
• b. The article has a lot of colorful graphs.
• c. The sales representative brings food to the pharmacy.
• d. It is never legal.

Answer: a. The pharmacist makes a specific, unsolicited request for that information.

23. The Principles of Pharmacy Law and Ethics course is a core part of the curriculum.

• a. True
• b. False

Answer: a. True

24. The main reason for the strict regulation of prescription drug advertising is:

• a. To make drugs more expensive.
• b. To protect the public health from misleading information about potent medications.
• c. To limit the profits of pharmaceutical companies.
• d. To ensure advertisements are entertaining.

Answer: b. To protect the public health from misleading information about potent medications.

25. A pharmacist providing a patient with a “Medication Guide” is often fulfilling a requirement of a(n):

• a. Advertising campaign
• b. FDA-mandated REMS program
• c. Compounding regulation
• d. Inventory audit

Answer: b. FDA-mandated REMS program

26. The FDA has the authority to require a company to run corrective advertising if their initial ads were found to be misleading.

• a. True
• b. False

Answer: a. True

27. A pharmacy can legally advertise prices for which of the following?

• a. Compounded prescriptions
• b. Controlled substances
• c. Prescription drugs, as long as it is done in a non-misleading way and complies with state law.
• d. It is illegal to advertise the price of any prescription drug.

Answer: c. Prescription drugs, as long as it is done in a non-misleading way and complies with state law.

28. An ad that shows happy, active people while a voiceover rapidly lists serious side effects is attempting to:

• a. Fulfill the “fair balance” requirement.
• b. Minimize the perception of risk while meeting the legal obligation to state it.
• c. Both a and b.
• d. Neither a nor b.

Answer: c. Both a and b.

29. The concept of misbranding is directly related to:

• a. The drug’s chemical purity.
• b. The drug’s labeling and promotion.
• c. The drug’s packaging.
• d. The drug’s cost.

Answer: b. The drug’s labeling and promotion.

30. The “Medication Safety” module in Patient Care 5 would cover risks associated with inappropriate drug promotion.

• a. True
• b. False

Answer: a. True

31. When a patient asks about a new drug they saw advertised on TV, the pharmacist’s best action is to:

• a. Agree that the drug is a miracle cure as seen on TV.
• b. Refuse to discuss any advertised drug.
• c. Provide patient-specific, evidence-based information about the drug’s risks, benefits, and place in therapy.
• d. Tell them to ask their doctor.

Answer: c. Provide patient-specific, evidence-based information about the drug’s risks, benefits, and place in therapy.

32. A “teaser ad” for a prescription drug might:

• a. State the name of the drug and its full list of risks.
• b. State the indication but not the drug name.
• c. State the drug name but not its indication, thus avoiding the need to list risks.
• d. Make a direct comparison to another drug.

Answer: c. State the drug name but not its indication, thus avoiding the need to list risks.

33. The FDA does not typically review and approve prescription drug ads before they are aired.

• a. True
• b. False

Answer: a. True

34. The pharmacist’s role as a public health promoter is covered in the CIPPE course.

• a. True
• b. False

Answer: a. True

35. A key skill for a pharmacist is to be able to evaluate if an advertisement’s claims are consistent with:

• a. The FDA-approved package insert and scientific evidence.
• b. The patient’s opinion.
• c. The price of the drug.
• d. The popularity of the drug.

Answer: a. The FDA-approved package insert and scientific evidence.

36. A pharmacy advertising a “free” blood glucose meter with the purchase of 100 test strips must:

• a. Clearly and conspicuously disclose all terms and conditions.
• b. Ensure the offer is not misleading.
• c. Comply with state and federal anti-kickback statutes.
• d. All of the above.

Answer: d. All of the above.

37. It is illegal for a pharmacist to promote a drug for an off-label use.

• a. True
• b. False

Answer: a. True

38. The FDA’s authority to regulate drug advertising stems from which act?

• a. The Controlled Substances Act
• b. The Food, Drug, and Cosmetic Act
• c. The Affordable Care Act
• d. The HIPAA Act

Answer: b. The Food, Drug, and Cosmetic Act

39. A pharmacist’s professional ethics require them to provide truthful information, even if it contradicts a drug advertisement.

• a. True
• b. False

Answer: a. True

40. A DTC ad must provide “adequate provision” for disseminating the product’s labeling. This can be achieved through:

• a. A website address.
• b. A toll-free phone number.
• c. A reference to a healthcare provider.
• d. All of the above.

Answer: d. All of the above.

41. The primary difference in regulation between prescription and OTC drug advertising is the:

• a. Regulating federal agency (FDA vs. FTC).
• b. Need for fair balance in prescription ads.
• c. Both a and b.
• d. There are no differences.

Answer: c. Both a and b.

42. A pharmacy that advertises compounding services must not:

• a. List the types of compounds they can make.
• b. Make therapeutic claims for compounded products that are not supported by evidence.
• c. Advertise their location and hours.
• d. List the credentials of their pharmacists.

Answer: b. Make therapeutic claims for compounded products that are not supported by evidence.

43. A key principle taught in the EBP course is to appraise the evidence behind a therapeutic claim.

• a. True
• b. False

Answer: a. True

44. A pharmacist who receives a request for an off-label use should base their recommendation on:

• a. The manufacturer’s promotional material.
• b. The available scientific literature and clinical evidence.
• c. Personal experience only.
• d. A desire to make a sale.

Answer: b. The available scientific literature and clinical evidence.

45. The overall goal of regulating drug advertising is to:

• a. Ensure healthcare professionals and consumers receive truthful and non-misleading information.
• b. Stifle communication about new drugs.
• c. Make healthcare more confusing.
• d. Increase drug costs.

Answer: a. Ensure healthcare professionals and consumers receive truthful and non-misleading information.

46. If a pharmacist is concerned about a local pharmacy’s advertising practices, they can report it to:

• a. The FDA
• b. The FTC
• c. Their State Board of Pharmacy
• d. The DEA

Answer: c. Their State Board of Pharmacy

47. Understanding the legal and ethical aspects of pharmacy practice is a foundational component of the PharmD curriculum.

• a. True
• b. False

Answer: a. True

48. An advertisement that compares the efficacy of two prescription drugs must be supported by:

• a. At least two head-to-head clinical trials.
• b. Anecdotal evidence.
• c. Patient testimonials.
• d. A survey of doctors.

Answer: a. At least two head-to-head clinical trials.

49. The management of drug information, including that from advertising, is a key professional competency.

• a. True
• b. False

Answer: a. True

50. The ultimate reason a pharmacist needs to understand the regulation of advertising is to:

• a. Protect the public and their patients from misinformation.
• b. Be able to create their own advertisements.
• c. Pass the MPJE.
• d. Both a and c.

Answer: d. Both a and c.