MCQ Quiz: Generic Substitution

MCQ Quiz: Generic Substitution

Generic substitution is a cornerstone of modern pharmacy practice, aimed at providing cost-effective medication alternatives while maintaining therapeutic efficacy and safety. For PharmD students and practicing pharmacists, a comprehensive understanding of the principles, laws, and clinical considerations surrounding generic substitution is essential. This includes familiarity with concepts like bioequivalence, therapeutic equivalence, the FDA’s Orange Book, and state-specific regulations. Navigating prescriber intent (Dispense as Written – DAW), patient preferences, and ensuring optimal patient outcomes are all critical aspects of responsibly implementing generic substitution. This quiz will test your knowledge on the key facets of generic drug dispensing.

1. Generic substitution in pharmacy practice is best defined as the process of dispensing:

• a) A different brand name drug for the one prescribed if it’s cheaper.
• b) A therapeutically equivalent generic drug in place of a prescribed brand name drug.
• c) An over-the-counter (OTC) medication when a similar prescription drug was ordered.
• d) A medication with a completely different active ingredient but for the same condition.

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

2. The primary purpose of allowing generic substitution is to:

• a) Increase profits for pharmaceutical manufacturers.
• b) Reduce healthcare costs for patients and third-party payers by providing less expensive, equivalent alternatives.
• c) Limit the number of brand name drugs on the market.
• d) Make it easier for pharmacists to manage inventory.

Answer: b) Reduce healthcare costs for patients and third-party payers by providing less expensive, equivalent alternatives.

3. For a generic drug to be considered for substitution, it must be proven to be ________ to the brand name drug.

• a) Chemically dissimilar but clinically superior
• b) Bioequivalent and thus therapeutically equivalent
• c) Manufactured in the same country
• d) Less potent

Answer: b) Bioequivalent and thus therapeutically equivalent

4. Bioequivalence means that the generic drug:

• a) Looks and tastes identical to the brand name drug.
• b) Has the same inactive ingredients as the brand name drug.
• c) Exhibits comparable bioavailability (rate and extent of absorption of the active ingredient) when studied under similar conditions.
• d) Is always 50% cheaper than the brand name drug.

Answer: c) Exhibits comparable bioavailability (rate and extent of absorption of the active ingredient) when studied under similar conditions.

5. The FDA publication that provides information on approved drug products and their therapeutic equivalence evaluations is commonly known as the:

• a) Red Book
• b) Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
• c) United States Pharmacopeia (USP)
• d) Physician’s Desk Reference (PDR)

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

6. In the FDA’s Orange Book, an “A” therapeutic equivalence rating (e.g., AB) indicates that the generic drug is considered:

• a) Not therapeutically equivalent to the reference listed drug.
• b) Therapeutically equivalent to the reference listed drug.
• c) Still under investigation for equivalence.
• d) Approved only for hospital use.

Answer: b) Therapeutically equivalent to the reference listed drug.

7. A “B” therapeutic equivalence rating in the Orange Book generally means that:

• a) The drug is a brand name product.
• b) The FDA has determined there are actual or potential bioequivalence problems that have not been resolved.
• c) The drug is a new formulation.
• d) The drug is an OTC product.

Answer: b) The FDA has determined there are actual or potential bioequivalence problems that have not been resolved.

8. State laws regarding generic substitution typically:

• a) Prohibit it completely to protect brand name manufacturers.
• b) Mandate it in every situation, regardless of prescriber or patient wishes.
• c) Permit or, in some cases, mandate substitution under specific conditions, while allowing for prescriber and patient choice.
• d) Only apply to controlled substances.

Answer: c) Permit or, in some cases, mandate substitution under specific conditions, while allowing for prescriber and patient choice.

9. If a prescriber writes “Dispense as Written” (DAW), “Brand Medically Necessary,” or a similar notation on a prescription, the pharmacist should generally:

• a) Ignore the notation and dispense the cheapest generic available.
• b) Dispense the brand name drug as prescribed, as generic substitution may be restricted.
• c) Call the patient to ask if they prefer the generic.
• d) Dispense the generic but label it as the brand name.

Answer: b) Dispense the brand name drug as prescribed, as generic substitution may be restricted.

10. “Formulary” in the context of insurance plans refers to:

• a) A list of all pharmacies participating in the network.
• b) A list of medications, both brand and generic, that are covered by the insurance plan, often with preferred options.
• c) The maximum daily dose for a medication.
• d) A guide for compounding medications.

Answer: b) A list of medications, both brand and generic, that are covered by the insurance plan, often with preferred options.

11. The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) significantly impacted generic drugs by:

• a) Making it much harder for generic drugs to gain FDA approval.
• b) Streamlining the approval process for generic drugs through the Abbreviated New Drug Application (ANDA).
• c) Eliminating patents for brand name drugs.
• d) Requiring generic drugs to undergo full new clinical trials.

Answer: b) Streamlining the approval process for generic drugs through the Abbreviated New Drug Application (ANDA).

12. Can a patient refuse generic substitution even if the prescriber has allowed it?

• a) No, the pharmacist must dispense the generic if allowed by the prescriber and state law.
• b) Yes, in most states, patients have the right to request the brand name drug, though they may have to pay a higher copay.
• c) Only if they have a documented allergy to an inactive ingredient in the generic.
• d) Only if the brand name drug is cheaper.

Answer: b) Yes, in most states, patients have the right to request the brand name drug, though they may have to pay a higher copay.

13. The active pharmaceutical ingredient (API) in an AB-rated generic drug is:

• a) Different from the brand name drug but provides a similar effect.
• b) The same as the API in the brand name drug.
• c) A less potent version of the API in the brand name drug.
• d) A more potent version of the API in the brand name drug.

Answer: b) The same as the API in the brand name drug.

14. While the active ingredient is the same, generic drugs may differ from their brand name counterparts in:

• a) Therapeutic effect.
• b) Bioavailability.
• c) Inactive ingredients (e.g., fillers, binders, colors).
• d) Approved indications for use.

Answer: c) Inactive ingredients (e.g., fillers, binders, colors).

15. “Narrow Therapeutic Index” (NTI) drugs are those for which:

• a) Generic substitution is always mandatory.
• b) Small changes in dosage or blood concentration can lead to serious therapeutic failures or toxicity.
• c) There is a very wide margin of safety.
• d) Bioequivalence is not a concern.

Answer: b) Small changes in dosage or blood concentration can lead to serious therapeutic failures or toxicity.

16. When considering generic substitution for an NTI drug, pharmacists should:

• a) Always substitute without consulting anyone.
• b) Exercise caution, adhere strictly to state laws, and sometimes consult the prescriber or patient, even if substitution is generally permitted.
• c) Refuse to dispense NTI drugs.
• d) Only dispense the brand name NTI drug if it is on sale.

Answer: b) Exercise caution, adhere strictly to state laws, and sometimes consult the prescriber or patient, even if substitution is generally permitted.

17. If a state has a “permissive” generic substitution law, it means that pharmacists:

• a) Must substitute with a generic if one is available.
• b) May substitute a generic drug for a brand name drug if certain conditions are met (e.g., prescriber allows, patient consents).
• c) Are not allowed to substitute generics under any circumstances.
• d) Can only substitute generics for patients with state-funded insurance.

Answer: b) May substitute a generic drug for a brand name drug if certain conditions are met (e.g., prescriber allows, patient consents).

18. If a state has a “mandatory” generic substitution law, it typically requires pharmacists to substitute with a generic unless:

• a) The patient prefers the color of the brand name drug.
• b) The prescriber has indicated “Dispense as Written” or the patient requests the brand.
• c) The generic drug is more expensive.
• d) The pharmacy is out of stock of the generic.

Answer: b) The prescriber has indicated “Dispense as Written” or the patient requests the brand.

19. Which of the following is a common misconception about generic drugs?

• a) They contain the same active ingredient as the brand name drug.
• b) They are less effective or lower quality than brand name drugs.
• c) They must meet the same FDA standards for manufacturing as brand name drugs.
• d) They are typically less expensive than brand name drugs.

Answer: b) They are less effective or lower quality than brand name drugs.

20. The pharmacist’s professional judgment in generic substitution involves:

• a) Choosing the generic with the highest profit margin for the pharmacy.
• b) Ensuring the selected generic product is therapeutically equivalent and appropriate for the patient.
• c) Overriding a “Dispense as Written” order if the generic is much cheaper.
• d) Only substituting if the patient explicitly asks for the generic.

Answer: b) Ensuring the selected generic product is therapeutically equivalent and appropriate for the patient.

21. What does an “AB1” rating compared to an “AB2” rating in the Orange Book signify for different generic versions of the same reference drug?

• a) AB1 is more potent than AB2.
• b) They are considered bioequivalent to the reference drug but may not be bioequivalent to each other if they are in different equivalency subgroups.
• c) AB1 is for oral use and AB2 is for topical use.
• d) AB2 is a newer version than AB1.

Answer: b) They are considered bioequivalent to the reference drug but may not be bioequivalent to each other if they are in different equivalency subgroups.

22. “Pharmaceutical alternatives” are drug products that:

• a) Contain the identical active ingredient, dosage form, and route of administration.
• b) Contain the same therapeutic moiety but may differ in salt, ester, dosage form, or strength.
• c) Are from completely different therapeutic classes but treat the same condition.
• d) Are always interchangeable.

Answer: b) Contain the same therapeutic moiety but may differ in salt, ester, dosage form, or strength.

23. “Therapeutic substitution” (dispensing a different chemical entity within the same therapeutic class) is different from generic substitution and generally requires:

• a) Only patient consent.
• b) Prescriber authorization, often through a formulary or collaborative practice agreement.
• c) No special authorization.
• d) An Orange Book “A” rating.

Answer: b) Prescriber authorization, often through a formulary or collaborative practice agreement.

24. If a new generic product becomes available for a brand name drug a patient has been taking, the pharmacist should ideally:

• a) Automatically switch without informing the patient to save them money.
• b) Inform the patient of the substitution (if permissible by law and prescriber), explain its equivalence, and address any concerns.
• c) Refuse to dispense the new generic until it has been on the market for a year.
• d) Tell the patient the generic is not as good as the brand.

Answer: b) Inform the patient of the substitution (if permissible by law and prescriber), explain its equivalence, and address any concerns.

25. The appearance (e.g., color, shape) of a generic drug may differ from the brand name drug because:

• a) It indicates a difference in the active ingredient.
• b) Trademark laws prevent generic drugs from looking identical to brand name drugs.
• c) It signifies a lower quality.
• d) The FDA mandates different appearances for generics.

Answer: b) Trademark laws prevent generic drugs from looking identical to brand name drugs.

26. When a patent for a brand name drug expires:

• a) The brand name drug is immediately removed from the market.
• b) Other manufacturers can apply to produce and sell generic versions, pending FDA approval.
• c) The price of the brand name drug automatically decreases by 50%.
• d) No further research is allowed on that active ingredient.

Answer: b) Other manufacturers can apply to produce and sell generic versions, pending FDA approval.

27. A “Reference Listed Drug” (RLD) in the Orange Book is typically:

• a) The generic version of a medication.
• b) The innovator or brand name drug product that was the subject of a full New Drug Application (NDA) and to which generics are compared.
• c) A drug that has been recalled.
• d) An OTC medication.

Answer: b) The innovator or brand name drug product that was the subject of a full New Drug Application (NDA) and to which generics are compared.

28. The main financial benefit of generic substitution accrues to:

• a) Only the pharmaceutical company that makes the brand name drug.
• b) Patients, insurance companies, and the healthcare system as a whole through cost savings.
• c) Only the pharmacy.
• d) Only the FDA.

Answer: b) Patients, insurance companies, and the healthcare system as a whole through cost savings.

29. If a patient experiences an unexpected side effect after switching from a brand name drug to a generic, the pharmacist should:

• a) Dismiss the patient’s concern as it’s likely psychological.
• b) Document the event, counsel the patient, and consider reporting it as an adverse drug event; consultation with the prescriber may be warranted.
• c) Immediately switch the patient back to the brand without further investigation.
• d) Tell the patient to stop taking all medications.

Answer: b) Document the event, counsel the patient, and consider reporting it as an adverse drug event; consultation with the prescriber may be warranted.

30. “Authorized generics” are brand name drugs that are marketed as generics by:

• a) A completely unrelated generic company.
• b) The brand name drug company itself or with its permission, and are identical to the brand product except for the label or packaging.
• c) A company that has violated patent laws.
• d) Only foreign manufacturers.

Answer: b) The brand name drug company itself or with its permission, and are identical to the brand product except for the label or packaging.

31. Can a hospital formulary system mandate generic substitution within the institution?

• a) No, hospital policies cannot override prescriber preference.
• b) Yes, hospitals often have policies that promote or mandate generic substitution, sometimes as part of a therapeutic interchange program, with mechanisms for exceptions.
• c) Only for non-critical medications.
• d) Only if the patient does not have insurance.

Answer: b) Yes, hospitals often have policies that promote or mandate generic substitution, sometimes as part of a therapeutic interchange program, with mechanisms for exceptions.

32. The responsibility for ensuring a generic drug is bioequivalent to the brand name drug lies with the:

• a) Prescribing physician.
• b) Dispensing pharmacist.
• c) Generic drug manufacturer (through studies submitted to the FDA).
• d) Patient.

Answer: c) Generic drug manufacturer (through studies submitted to the FDA).

33. Pharmacists must be knowledgeable about generic substitution laws in:

• a) Only the state where they attended pharmacy school.
• b) All 50 states, regardless of where they practice.
• c) The specific state(s) in which they are licensed and practicing.
• d) Only federal laws, as state laws are not important.

Answer: c) The specific state(s) in which they are licensed and practicing.

34. If a prescriber verbally indicates “brand necessary” over the phone but does not write it on the subsequent hard copy or electronic prescription, the pharmacist should:

• a) Dispense the brand based on the verbal instruction.
• b) Dispense the generic as there’s no written DAW.
• c) Document the verbal instruction and, if state law allows or requires, clarify the prescriber’s intent regarding dispensing the brand.
• d) Refuse to fill the prescription.

Answer: c) Document the verbal instruction and, if state law allows or requires, clarify the prescriber’s intent regarding dispensing the brand.

35. Patient education about generic substitution should include reassurance that generics:

• a) Are weaker versions of brand name drugs.
• b) Have the same active ingredient and are expected to have the same therapeutic effect as the brand name drug.
• c) Are not tested by the FDA.
• d) Will always look identical to the brand name drug.

Answer: b) Have the same active ingredient and are expected to have the same therapeutic effect as the brand name drug.

36. Why might a patient express concern about switching to a generic drug?

• a) Belief that “newer is always better.”
• b) Previous negative experience or perception that generics are less effective or safe.
• c) Preference for a specific color or shape of the brand name pill.
• d) All of the above.

Answer: d) All of the above.

37. A “biological product” or “biologic” is typically a large, complex molecule. Substitution with a “biosimilar” product:

• a) Is identical to generic substitution for small-molecule drugs and follows the same Orange Book ratings.
• b) Involves products that are highly similar to an FDA-approved biologic (reference product) with no clinically meaningful differences in safety, purity, and potency, but has its own specific regulatory pathway.
• c) Is not allowed in the United States.
• d) Means the biosimilar is chemically identical to the reference biologic.

Answer: b) Involves products that are highly similar to an FDA-approved biologic (reference product) with no clinically meaningful differences in safety, purity, and potency, but has its own specific regulatory pathway.

38. The FDA’s list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations is known as the:

• a) Orange Book
• b) Purple Book
• c) Green Book
• d) Yellow Book

Answer: b) Purple Book

39. An “interchangeable biosimilar” is one that:

• a) Is only approved for investigational use.
• b) Is expected to produce the same clinical result as the reference product in any given patient and, for products administered more than once, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biosimilar and the reference product is not greater than the risk of using the reference product without such alternation or switch. It may be substituted by a pharmacist without prescriber intervention (subject to state laws).
• c) Is significantly cheaper but less effective.
• d) Has a different mechanism of action.

Answer: b) Is expected to produce the same clinical result as the reference product in any given patient and, for products administered more than once, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biosimilar and the reference product is not greater than the risk of using the reference product without such alternation or switch. It may be substituted by a pharmacist without prescriber intervention (subject to state laws).

40. The primary factor that allows generic drugs to be less expensive than brand name drugs is:

• a) They use lower quality active ingredients.
• b) Generic manufacturers typically do not have to repeat the extensive (and expensive) clinical trials for safety and efficacy that were required for the original brand name drug approval.
• c) They are only sold in large quantities.
• d) They are not subject to FDA inspection.

Answer: b) Generic manufacturers typically do not have to repeat the extensive (and expensive) clinical trials for safety and efficacy that were required for the original brand name drug approval.

41. If a patient reports an allergy to an inactive ingredient (excipient) present in a specific generic formulation but not in the brand or another generic, this is:

• a) Impossible, as all generics are identical to the brand.
• b) A valid concern that may necessitate dispensing the brand or a different generic formulation.
• c) A sign the patient is non-compliant.
• d) Not the pharmacist’s responsibility to address.

Answer: b) A valid concern that may necessitate dispensing the brand or a different generic formulation.

42. Does the FDA require generic drug manufacturing plants to meet the same quality standards (CGMP) as those for brand name drugs?

• a) No, standards are lower for generics.
• b) Yes, all drug manufacturing plants, whether for brand or generic drugs, must comply with Current Good Manufacturing Practices (CGMP).
• c) Only if the generic is manufactured in the USA.
• d) CGMP standards are voluntary.

Answer: b) Yes, all drug manufacturing plants, whether for brand or generic drugs, must comply with Current Good Manufacturing Practices (CGMP).

43. A “pharmaceutical equivalent” contains the same active ingredient(s), dosage form, route of administration, and strength. To be a “therapeutic equivalent,” it must also be:

• a) More palatable.
• b) Bioequivalent and have the same clinical effect and safety profile when administered as specified in the labeling.
• c) Available in more dosage strengths.
• d) Approved for more indications.

Answer: b) Bioequivalent and have the same clinical effect and safety profile when administered as specified in the labeling.

44. In some states, pharmacists are required to inform the patient when generic substitution occurs and/or indicate the substitution on the prescription label. This is to promote:

• a) Confusion for the patient.
• b) Transparency and patient awareness.
• c) Increased pharmacy workload.
• d) Higher drug costs.

Answer: b) Transparency and patient awareness.

45. The term “Reference Standard” in the context of generic drug approval often refers to:

• a) The most recently approved generic product.
• b) The specific lot of the Reference Listed Drug (RLD) used in bioequivalence studies.
• c) A quality standard set by a professional organization.
• d) The cheapest available product.

Answer: b) The specific lot of the Reference Listed Drug (RLD) used in bioequivalence studies.

46. If a brand name drug is discontinued by the manufacturer, can its AB-rated generics still be legally dispensed?

• a) No, generics can only be dispensed if the brand is actively marketed.
• b) Yes, as long as the generic products themselves are FDA-approved and not discontinued.
• c) Only for 30 days after the brand is discontinued.
• d) Only if the prescriber specifically requests it.

Answer: b) Yes, as long as the generic products themselves are FDA-approved and not discontinued.

47. What is the pharmacist’s role if a patient insists on a brand name drug for which a generic is available, and the prescriber has permitted substitution, but the patient’s insurance will only cover the generic or charge a much higher copay for the brand?

• a) Refuse to dispense any medication.
• b) Dispense the generic without further discussion.
• c) Explain the insurance coverage and cost difference to the patient, allowing them to make an informed decision about whether to pay out-of-pocket for the brand or accept the generic.
• d) Bill the insurance for the brand but dispense the generic.

Answer: c) Explain the insurance coverage and cost difference to the patient, allowing them to make an informed decision about whether to pay out-of-pocket for the brand or accept the generic.

48. Generic substitution practices are ultimately in place to balance which two main considerations?

• a) Manufacturer profits and pharmacy convenience.
• b) Patient access to affordable medications and assurance of therapeutic equivalence.
• c) Innovation of new drugs and speed of dispensing.
• d) Marketing of brand drugs and ease of prescription writing.

Answer: b) Patient access to affordable medications and assurance of therapeutic equivalence.

49. When a pharmacist substitutes a generic drug, they are generally attesting that, in their professional judgment and according to applicable laws, the generic is:

• a) Identical in appearance to the brand.
• b) Therapeutically equivalent and appropriate for the patient.
• c) The only option available.
• d) Preferred by the prescriber.

Answer: b) Therapeutically equivalent and appropriate for the patient.

50. Continuous education for pharmacists on generic and biosimilar products is important because:

• a) The laws never change.
• b) New products, guidelines, and scientific understanding evolve, impacting substitution practices.
• c) Patients rarely have questions about these products.
• d) Generic drugs are always problematic.

Answer: b) New products, guidelines, and scientific understanding evolve, impacting substitution practices.