MCQ Quiz: Prescription vs. OTC Drugs

The distinction between prescription (Rx) and over-the-counter (OTC) drugs is a fundamental concept in pharmacy practice, governed by specific laws and regulations designed to protect public health. PharmD students must have a thorough understanding of how drugs are classified, the legal basis for this classification, and the differing requirements for labeling, dispensing, and patient counseling. This knowledge is crucial for ensuring medications are used safely and appropriately, whether they require the supervision of a healthcare practitioner or are suitable for self-selection by consumers. This quiz will explore key aspects of prescription and OTC drugs, including the Durham-Humphrey Amendment, labeling differences, and principles of generic substitution.

1. Which landmark amendment to the Food, Drug, and Cosmetic Act established the legal distinction between prescription and over-the-counter (OTC) drugs?

a) Kefauver-Harris Amendment
b) Durham-Humphrey Amendment
c) Food, Drug, and Cosmetic Act of 1938
d) Prescription Drug Marketing Act

Answer: b) Durham-Humphrey Amendment

2. A drug is classified as a prescription (legend) drug if it:

a) Is habit-forming, toxic, or has a potential for harmful effect, or its method of use requires practitioner supervision.
b) Can be safely used by a layperson based solely on the labeling.
c) Is a new chemical entity.
d) Is only available in hospitals.

Answer: a) Is habit-forming, toxic, or has a potential for harmful effect, or its method of use requires practitioner supervision.

3. Over-the-counter (OTC) drugs are those that:

a) Require a prescription from a licensed practitioner.
b) Can be safely and effectively used by consumers for self-diagnosed conditions without practitioner supervision, following the label instructions.
c) Are generally more potent than prescription drugs.
d) Are only sold in pharmacies.

Answer: b) Can be safely and effectively used by consumers for self-diagnosed conditions without practitioner supervision, following the label instructions.

4. The label of a prescription drug stock bottle must contain the symbol or statement:

a) “OTC Only”
b) “Rx Only” or a similar legend.
c) “Not for human use”
d) “Dietary Supplement”

Answer: b) “Rx Only” or a similar legend.

5. OTC drug labeling must contain “adequate directions for use.” This means the labeling must be clear enough for:

a) A pharmacist to understand.
b) A physician to understand.
c) A layperson to use the drug safely and effectively for its intended purpose.
d) A pharmacy technician to dispense.

Answer: c) A layperson to use the drug safely and effectively for its intended purpose.

6. Which of the following is a key factor the FDA considers when deciding if a drug can switch from prescription to OTC status?

a) The manufacturer’s desire to increase sales.
b) Whether the condition the drug treats can be self-diagnosed by a layperson.
c) The color and shape of the tablet.
d) The cost of the medication.

Answer: b) Whether the condition the drug treats can be self-diagnosed by a layperson.

7. “Generic substitution” refers to the practice of dispensing:

a) A different brand name drug for the one prescribed.
b) A therapeutically equivalent generic drug in place of a prescribed brand name drug.
c) An OTC drug when a prescription drug was ordered.
d) A different dosage form than what was prescribed.

Answer: b) A therapeutically equivalent generic drug in place of a prescribed brand name drug.

8. For a generic drug to be considered therapeutically equivalent to a brand name drug, it must generally be:

a) Chemically identical and bioequivalent.
b) A different active ingredient but for the same indication.
c) Manufactured by the same company.
d) More potent than the brand name drug.

Answer: a) Chemically identical and bioequivalent.

9. State laws regarding generic substitution typically:

a) Prohibit it entirely.
b) Mandate it in all situations.
c) Permit or mandate it under certain conditions, often allowing prescriber or patient refusal.
d) Only allow it if the generic drug is cheaper by at least 50%.

Answer: c) Permit or mandate it under certain conditions, often allowing prescriber or patient refusal.

10. The FDA publication that contains information on approved drug products with therapeutic equivalence evaluations is commonly known as the:

a) Red Book
b) Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
c) Green Book
d) USP-NF

Answer: b) Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

11. A prescription drug label (the label affixed by the pharmacy to the container dispensed to the patient) must generally include all the following EXCEPT:

a) Name and address of the pharmacy.
b) Name of the patient.
c) Directions for use.
d) The manufacturer’s internal lot number for the stock bottle.

Answer: d) The manufacturer’s internal lot number for the stock bottle.

12. The authority to prescribe medications is determined by:

a) Federal law only.
b) The pharmacist’s discretion.
c) State law, which defines the scope of practice for various healthcare practitioners.
d) Pharmaceutical manufacturers.

Answer: c) State law, which defines the scope of practice for various healthcare practitioners.

13. Can a pharmacist refuse to fill a valid prescription?

a) No, never.
b) Yes, but only if the patient is rude.
c) Yes, under certain circumstances, such as when there is a suspected error, potential harm to the patient, or a legitimate ethical concern.
d) Yes, but only if the medication is out of stock.

Answer: c) Yes, under certain circumstances, such as when there is a suspected error, potential harm to the patient, or a legitimate ethical concern.

14. A prescription for a non-controlled substance is generally valid for how long from the date it was written (unless state law specifies otherwise)?

a) 30 days
b) 6 months
c) 1 year
d) Indefinitely

Answer: c) 1 year

15. What does “PRN” refills on a prescription mean?

a) The prescription cannot be refilled.
b) The prescription can be refilled as needed for up to one year (or the life of the prescription as per state law) for non-controlled substances.
c) The prescription can be refilled only once.
d) The patient determines the number of refills.

Answer: b) The prescription can be refilled as needed for up to one year (or the life of the prescription as per state law) for non-controlled substances.

16. Transferring a prescription for a non-controlled substance between pharmacies:

a) Is illegal.
b) Is generally permissible if allowed by state law and follows specific procedures.
c) Can only be done by the patient.
d) Requires approval from the FDA.

Answer: b) Is generally permissible if allowed by state law and follows specific procedures.

17. Which of the following is a key piece of information that the transferring pharmacist typically provides to the receiving pharmacist during a prescription transfer?

a) The patient’s insurance copay amount.
b) The original prescription information, including date written and number of refills remaining.
c) The wholesale cost of the medication.
d) The patient’s preferred pharmacy hours.

Answer: b) The original prescription information, including date written and number of refills remaining.

18. The primary purpose of the “Drug Facts” label on OTC products is to:

a) Provide marketing information for the manufacturer.
b) Help consumers select and use the product safely and effectively without professional supervision.
c) List all possible off-label uses.
d) Indicate the patent expiration date.

Answer: b) Help consumers select and use the product safely and effectively without professional supervision.

19. If a prescription drug is found to be safe enough for use without a practitioner’s supervision, the FDA may approve it for:

a) Sale only by mail order.
b) OTC status.
c) Use only in hospital settings.
d) A longer patent life.

Answer: b) OTC status.

20. Who is responsible for ensuring that a dispensed prescription is accurate and appropriate for the patient?

a) The pharmacy technician who filled it.
b) The pharmacist who performs the final verification.
c) The patient.
d) The delivery driver.

Answer: b) The pharmacist who performs the final verification.

21. If a prescriber writes “Dispense as Written” (DAW) or “Brand Medically Necessary” on a prescription:

a) The pharmacist must dispense the generic version.
b) The pharmacist should generally dispense the brand name drug as indicated, and generic substitution may be restricted.
c) The pharmacist can ignore this and dispense whatever is cheapest.
d) The prescription is invalid.

Answer: b) The pharmacist should generally dispense the brand name drug as indicated, and generic substitution may be restricted.

22. A key difference in the labeling requirements between a prescription drug dispensed to a patient and an OTC drug is:

a) OTC drugs do not require directions for use.
b) Prescription drug labels are tailored to a specific patient by a pharmacist, based on a practitioner’s order.
c) OTC drugs do not list active ingredients.
d) Prescription drugs do not require the name of the drug on the label.

Answer: b) Prescription drug labels are tailored to a specific patient by a pharmacist, based on a practitioner’s order.

23. Patient counseling by a pharmacist is most comprehensively required for:

a) New OTC drug purchases.
b) New prescription medications and often for refills, depending on state law and professional judgment.
c) Dietary supplements.
d) Medical devices.

Answer: b) New prescription medications and often for refills, depending on state law and professional judgment.

24. The requirement for pharmacists to offer counseling to Medicaid patients was established by:

a) The Durham-Humphrey Amendment.
b) The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90).
c) The Kefauver-Harris Amendment.
d) The Food and Drug Administration Modernization Act (FDAMA).

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

25. An “emergency fill” of a prescription without prescriber authorization:

a) Is never allowed under any circumstances.
b) May be permissible under specific state laws for essential medications to prevent interruption of therapy, with certain quantity limits and documentation requirements.
c) Can be done for any medication at the patient’s request.
d) Only applies to OTC medications.

Answer: b) May be permissible under specific state laws for essential medications to prevent interruption of therapy, with certain quantity limits and documentation requirements.

26. Which of the following formats for a prescription is generally acceptable, assuming it meets all legal requirements?

a) A verbal order from a patient’s friend.
b) A hand-written prescription on a napkin.
c) An electronic prescription (e-prescribing) transmitted directly from the prescriber to the pharmacy.
d) A faxed prescription for a Schedule II controlled substance (in most situations).

Answer: c) An electronic prescription (e-prescribing) transmitted directly from the prescriber to the pharmacy.

27. A pharmacist’s responsibilities with regard to prescriptions include:

a) Verifying the legality and appropriateness of the prescription.
b) Only dispensing what is written without question.
c) Changing the prescribed drug without consulting the prescriber if it’s cheaper.
d) Refusing to fill any prescription from an out-of-state prescriber.

Answer: a) Verifying the legality and appropriateness of the prescription.

28. “Behind-the-counter” (BTC) medications are a class of drugs that:

a) Are the same as traditional OTC drugs.
b) Are kept behind the pharmacy counter and require pharmacist intervention for sale, though a prescription may not be needed.
c) Can only be sold with a prescription.
d) Are only available through mail order.

Answer: b) Are kept behind the pharmacy counter and require pharmacist intervention for sale, though a prescription may not be needed.

29. An example of a BTC medication in many states due to its potential for misuse is:

a) Aspirin
b) Pseudoephedrine-containing products
c) Vitamin C
d) Antacids

Answer: b) Pseudoephedrine-containing products

30. If a pharmacist dispenses an OTC drug based on a prescription, the OTC drug is then typically treated as a:

a) Dietary supplement.
b) Prescription medication for that specific dispensing instance (e.g., regarding labeling and record-keeping).
c) Cosmetic.
d) BTC medication automatically.

Answer: b) Prescription medication for that specific dispensing instance (e.g., regarding labeling and record-keeping).

31. What is the primary purpose of assigning an “A” or “B” therapeutic equivalence code in the Orange Book?

a) “A” rated drugs are considered therapeutically equivalent; “B” rated drugs are not.
b) “A” rated drugs are brand names; “B” rated drugs are generics.
c) “A” rated drugs are for acute conditions; “B” rated drugs are for chronic conditions.
d) “A” rated drugs are more expensive than “B” rated drugs.

Answer: a) “A” rated drugs are considered therapeutically equivalent; “B” rated drugs are not.

32. If a state law and federal law concerning prescription drug dispensing conflict, the pharmacist must:

a) Always follow the federal law.
b) Always follow the state law.
c) Follow the stricter of the two laws.
d) Choose which law is more convenient.

Answer: c) Follow the stricter of the two laws.

33. A prescription written for an “off-label” use (an indication not approved by the FDA):

a) Is illegal for a pharmacist to dispense.
b) May be legally prescribed by a practitioner and dispensed by a pharmacist exercising professional judgment.
c) Automatically converts the drug to OTC status for that patient.
d) Requires the pharmacist to get special FDA permission.

Answer: b) May be legally prescribed by a practitioner and dispensed by a pharmacist exercising professional judgment.

34. Which information is typically NOT required on an OTC drug label (“Drug Facts”)?

a) Active ingredient(s) and purpose.
b) Uses (indications).
c) Specific patient’s name.
d) Warnings and directions.

Answer: c) Specific patient’s name.

35. The process of a drug manufacturer applying to the FDA to change a drug’s status from prescription to OTC is known as:

a) An IND (Investigational New Drug) application.
b) An Rx-to-OTC switch.
c) A REMS (Risk Evaluation and Mitigation Strategy) modification.
d) A compassionate use program.

Answer: b) An Rx-to-OTC switch.

36. When a pharmacist receives a prescription, their first step should generally be to:

a) Immediately fill the prescription.
b) Assess the prescription for completeness, legality, and safety.
c) Call the patient to confirm pickup time.
d) Bill the insurance company.

Answer: b) Assess the prescription for completeness, legality, and safety.

37. Which of the following situations would most likely categorize a drug as needing prescription status?

a) The drug is used for a very common, easily self-diagnosed condition.
b) The drug has a very wide margin of safety and no potential for abuse.
c) The drug requires careful monitoring by a healthcare provider due to its toxicity or method of use.
d) The drug’s labeling can be easily understood by any consumer.

Answer: c) The drug requires careful monitoring by a healthcare provider due to its toxicity or method of use.

38. A “narrow therapeutic index” (NTI) drug is one where:

a) There is a wide range between the effective dose and the toxic dose.
b) Small differences in dose or blood concentration can lead to serious therapeutic failures or adverse drug reactions.
c) It is safe to use in all patient populations.
d) Generic substitution is always preferred.

Answer: b) Small differences in dose or blood concentration can lead to serious therapeutic failures or adverse drug reactions.

39. Pharmacists play a crucial role in OTC medication use by:

a) Discouraging the use of all OTC products.
b) Helping patients select appropriate OTC products, counseling on their safe use, and identifying situations where self-treatment is not appropriate.
c) Selling as many OTC products as possible regardless of need.
d) Referring all patients seeking OTC products to a physician.

Answer: b) Helping patients select appropriate OTC products, counseling on their safe use, and identifying situations where self-treatment is not appropriate.

40. A key element of a valid prescription is:

a) The patient’s preferred pharmacy.
b) The signature of a licensed prescriber.
c) The pharmacy’s hours of operation.
d) The cost of the medication.

Answer: b) The signature of a licensed prescriber.

41. The main difference between a brand name drug and its AB-rated generic equivalent is usually:

a) The active pharmaceutical ingredient.
b) The therapeutic effect.
c) Inactive ingredients, appearance, and price.
d) The approved indications.

Answer: c) Inactive ingredients, appearance, and price.

42. If a prescription is ambiguous or unclear, the pharmacist should:

a) Guess the prescriber’s intent.
b) Dispense the lowest possible dose.
c) Contact the prescriber for clarification before dispensing.
d) Ask the patient what they think the prescriber meant.

Answer: c) Contact the prescriber for clarification before dispensing.

43. The Durham-Humphrey Amendment required that prescription drugs bear the federal legend:

a) “For investigational use only.”
b) “Caution: Federal law prohibits dispensing without prescription.” (or “Rx Only”)
c) “Not to be taken by mouth.”
d) “Shake well before using.”

Answer: b) “Caution: Federal law prohibits dispensing without prescription.” (or “Rx Only”)

44. Which of the following would NOT be a valid reason for a drug to be prescription-only?

a) The drug is intended to treat a condition that requires a medical diagnosis.
b) The drug has a high potential for abuse.
c) The drug is a new flavor of a common OTC medication.
d) The drug can cause serious side effects that require monitoring.

Answer: c) The drug is a new flavor of a common OTC medication.

45. The “practice of pharmacy” typically includes the interpretation, evaluation, and dispensing of prescription orders. This is defined by:

a) Federal law primarily.
b) State law and regulations.
c) The FDA.
d) Pharmaceutical manufacturers’ guidelines.

Answer: b) State law and regulations.

46. When a pharmacist provides an emergency supply of a prescription medication, they must typically:

a) Document the dispensing and make a reasonable effort to notify the prescriber.
b) Charge the patient double the usual price.
c) Provide at least a 30-day supply.
d) Get approval from the state Board of Pharmacy first.

Answer: a) Document the dispensing and make a reasonable effort to notify the prescriber.

47. The primary consideration when deciding whether to recommend an OTC product or refer a patient to a physician is:

a) The profit margin on the OTC product.
b) The patient’s ability to pay for a physician visit.
c) The nature and severity of the patient’s symptoms and whether self-treatment is appropriate and safe.
d) The pharmacy’s current inventory of OTC products.

Answer: c) The nature and severity of the patient’s symptoms and whether self-treatment is appropriate and safe.

48. Can an OTC drug product be legally marketed for an indication not included in its “Drug Facts” label?

a) Yes, if the manufacturer believes it is effective.
b) No, manufacturers can only market OTC drugs for their FDA-approved OTC indications.
c) Yes, if a pharmacist recommends it.
d) Only if it’s a natural product.

Answer: b) No, manufacturers can only market OTC drugs for their FDA-approved OTC indications.

49. A pharmacist filling a prescription must ensure that the medication is not only correct but also:

a) The most expensive option available.
b) Appropriately labeled for the patient with clear directions for use.
c) Packaged in a clear container so the patient can see the contents.
d) Delivered by the pharmacist personally.

Answer: b) Appropriately labeled for the patient with clear directions for use.

50. Understanding the difference between prescription and OTC drugs allows pharmacists to:

a) Only counsel patients on prescription medications.
b) Ensure appropriate access to medications while safeguarding patient health.
c) Charge higher prices for OTC medications.
d) Avoid interacting with patients seeking OTC products.

Answer: b) Ensure appropriate access to medications while safeguarding patient health.

Leave a Comment Cancel reply