MCQ Quiz: Federal and State Laws regarding Counseling

Patient counseling is not just a professional best practice but a legal requirement governed by a framework of federal and state laws. The landmark Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) established the federal foundation for counseling, which has since been expanded upon by nearly every state. This topic is a cornerstone of the Principles of Pharmacy Law and Ethics course and a fundamental skill practiced throughout the PharmD curriculum. This quiz will test your knowledge on the key provisions of these laws and the pharmacist’s legal duty to counsel.

1. The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) established a federal mandate for pharmacists to offer to counsel which patient population?

• a. All patients
• b. Medicare patients
• c. Medicaid patients
• d. Pediatric patients only

Answer: c. Medicaid patients

2. Which of the following is NOT one of the three main components of the OBRA ’90 mandate for pharmacy?

• a. Prospective Drug Utilization Review (Pro-DUR)
• b. Maintenance of patient records
• c. Mandatory therapeutic interchange
• d. Patient counseling

Answer: c. Mandatory therapeutic interchange

3. The federal OBRA ’90 law specifically requires the pharmacist to:

• a. Counsel every single patient on every prescription.
• b. Make an “offer to counsel” the patient or caregiver.
• c. Only counsel patients who have a drug interaction.
• d. Document the counseling session on a federal form.

Answer: b. Make an “offer to counsel” the patient or caregiver.

4. Most state pharmacy practice acts have expanded the principles of OBRA ’90 to apply to:

• a. Only Medicaid patients.
• b. Only cash-paying patients.
• c. All patients receiving prescriptions.
• d. Only patients taking controlled substances.

Answer: c. All patients receiving prescriptions.

5. A prospective drug use review (Pro-DUR) is a review of a patient’s profile that is conducted:

• a. After the prescription has been dispensed.
• b. Before dispensing the prescription.
• c. Once a year during an audit.
• d. Only when the patient requests it.

Answer: b. Before dispensing the prescription.

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

• a. True
• b. False

Answer: a. True

7. According to most state laws, who is permitted to provide patient counseling on a new prescription?

• a. The pharmacy cashier
• b. The pharmacy technician
• c. The pharmacist or a pharmacy intern under direct supervision.
• d. Any employee of the pharmacy.

Answer: c. The pharmacist or a pharmacy intern under direct supervision.

8. Which of the following is an example of a potential issue that would be identified during a Pro-DUR?

• a. Therapeutic duplication
• b. A potential drug-drug interaction
• c. Incorrect dosing
• d. All of the above

Answer: d. All of the above.

9. The primary purpose of laws requiring patient counseling is to:

• a. Slow down the dispensing process.
• b. Increase pharmacy revenue.
• c. Improve patient outcomes and ensure safe and effective medication use.
• d. Fulfill a documentation requirement for insurance companies.

Answer: c. Improve patient outcomes and ensure safe and effective medication use.

10. A pharmacist asks a patient, “Do you have any questions for the pharmacist today?” while handing them their prescription bag. This may not be considered a valid offer to counsel because:

• a. It is not specific enough.
• b. The question can be easily dismissed with a “no” answer.
• c. It is not done in a private setting.
• d. Both b and c.

Answer: d. Both b and c.

11. Counseling patients on the appropriate use of prescription medications and devices is a key objective in the IPPE curriculum.

• a. True
• b. False

Answer: a. True

12. If a patient or their caregiver refuses the offer to counsel, the pharmacist should:

• a. Insist on counseling them anyway.
• b. Document the refusal according to state law and pharmacy policy.
• c. Refuse to dispense the prescription.
• d. Counsel them in a louder voice.

Answer: b. Document the refusal according to state law and pharmacy policy.

13. A key part of patient counseling is using the “teach-back” method to:

• a. Test the patient’s memory.
• b. Assess the patient’s understanding of the information provided.
• c. Make the counseling session longer.
• d. Shame the patient for not listening.

Answer: b. Assess the patient’s understanding of the information provided.

14. A pharmacist hands a patient a leaflet with their prescription. Under most state laws, does this leaflet fulfill the requirement to counsel?

• a. Yes, written information is always sufficient.
• b. No, the offer of verbal counseling is still typically required.
• c. Yes, but only if the leaflet is in color.
• d. No, because leaflets are not FDA-approved.

Answer: b. No, the offer of verbal counseling is still typically required.

15. Displaying appropriate techniques when counseling patients is a key objective for student pharmacists.

• a. True
• b. False

Answer: a. True

16. Which of the following is NOT a topic commonly required to be covered during a counseling session?

• a. The name and description of the medication.
• b. The route, dosage form, and duration of therapy.
• c. Common severe side effects or interactions.
• d. The wholesale acquisition cost of the medication.

Answer: d. The wholesale acquisition cost of the medication.

17. OBRA ’90 was passed as part of a larger effort by the federal government to:

• a. Increase the number of pharmacies.
• b. Control costs in the Medicaid program by reducing adverse drug events.
• c. Decrease the number of pharmacists.
• d. Regulate drug prices directly.

Answer: b. Control costs in the Medicaid program by reducing adverse drug events.

18. A pharmacist providing counseling on a refill prescription is most important when:

• a. The patient has been taking it for years with no issues.
• b. The patient requests it.
• c. The pharmacist has a new clinical concern or the patient has a new symptom.
• d. Both b and c.

Answer: d. Both b and c.

19. The pharmacist’s responsibility to counsel is both a legal and a(n) ____ duty.

• a. optional
• b. ethical
• c. financial
• d. administrative

Answer: b. ethical

20. A key part of the “maintaining patient records” component of OBRA ’90 is to allow the pharmacist to:

• a. Perform an effective prospective DUR.
• b. Bill the patient’s insurance.
• c. Market new services to the patient.
• d. Report the patient to the DEA.

Answer: a. Perform an effective prospective DUR.

21. A pharmacy technician can ask the patient, “Would you like to speak with the pharmacist about your medication today?”

• a. Yes, this is an acceptable way to have a non-pharmacist extend the offer to counsel.
• b. No, only the pharmacist can interact with the patient.
• c. Yes, and the technician can also answer any clinical questions the patient has.
• d. No, because this violates HIPAA.

Answer: a. Yes, this is an acceptable way to have a non-pharmacist extend the offer to counsel.

22. A patient receives their prescription through the mail. How can a pharmacy typically fulfill the counseling requirement?

• a. The requirement is waived for mail-order pharmacies.
• b. By providing written information and a toll-free number for the patient to call and speak with a pharmacist.
• c. By sending a pre-recorded video.
• d. By assuming the patient will look up the information online.

Answer: b. By providing written information and a toll-free number for the patient to call and speak with a pharmacist.

23. The Professional Practice Skills Lab courses provide training in patient counseling.

• a. True
• b. False

Answer: a. True

24. A pharmacist who fails to counsel a patient on a serious, common side effect of a medication could be found:

• a. To be practicing efficiently.
• b. Negligent in their professional duty.
• c. In compliance with the law.
• d. To be a good businessperson.

Answer: b. Negligent in their professional duty.

25. A pharmacist’s counseling should be tailored to:

• a. The specific patient and their level of health literacy.
• b. A script that is read to every patient.
• c. The time of day.
• d. The patient’s insurance plan.

Answer: a. The specific patient and their level of health literacy.

26. The law course PHA5703 is foundational to understanding these requirements.

• a. True
• b. False

Answer: a. True

27. A Pro-DUR screen flags a potential interaction between a patient’s new prescription and an existing one. The pharmacist should:

• a. Override the alert and dispense the prescription.
• b. Use their clinical judgment to assess the significance of the interaction and contact the prescriber if necessary.
• c. Refuse to fill the prescription.
• d. Tell the patient to stop taking their old medication.

Answer: b. Use their clinical judgment to assess the significance of the interaction and contact the prescriber if necessary.

28. An active learning session on pharmacy law is a key part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

29. The purpose of maintaining a patient profile is to help the pharmacist identify:

• a. Therapeutic duplication.
• b. Potential allergies.
• c. Incorrect dosing.
• d. All of the above.

Answer: d. All of the above.

30. The “offer to counsel” applies to:

• a. Only new prescriptions in most states.
• b. Only refill prescriptions.
• c. Only controlled substances.
• d. All prescriptions, new and refill.

Answer: a. Only new prescriptions in most states.

31. The main intent of OBRA ’90 was to elevate the standard of pharmacy practice to a more:

• a. Product-focused model.
• b. Patient-centered, clinical model.
• c. Business-focused model.
• d. Technically-focused model.

Answer: b. Patient-centered, clinical model.

32. Which of the following is NOT a barrier to effective patient counseling?

• a. A lack of privacy at the pharmacy counter.
• b. The pharmacist using open-ended questions.
• c. The pharmacist using complex medical jargon.
• d. A busy and loud pharmacy environment.

Answer: b. The pharmacist using open-ended questions.

33. The final verification of a prescription by a pharmacist is part of the Pro-DUR process.

• a. True
• b. False

Answer: a. True

34. The specific requirements for what must be on a prescription label are determined by:

• a. Federal law only.
• b. The drug manufacturer.
• c. State Boards of Pharmacy.
• d. The patient.

Answer: c. State Boards of Pharmacy.

35. A pharmacist’s legal duty to counsel is separate from their ethical duty to ensure the patient understands their medication.

• a. True
• b. False

Answer: b. False

36. Patient counseling has been shown to improve:

• a. Medication adherence.
• b. Therapeutic outcomes.
• c. Patient safety.
• d. All of the above.

Answer: d. All of the above.

37. When counseling a patient on a medication with a REMS program, the pharmacist must:

• a. Ensure any required elements, like dispensing a Medication Guide, are fulfilled.
• b. Tell the patient the drug is too dangerous to take.
• c. Enroll the patient in a clinical trial.
• d. Ignore the REMS requirements.

Answer: a. Ensure any required elements, like dispensing a Medication Guide, are fulfilled.

38. The HIPPE curriculum requires students to display appropriate counseling techniques.

• a. True
• b. False

Answer: a. True

39. A pharmacist asks a patient, “What did your doctor tell you this medication is for?” This is a good open-ended question to assess:

• a. The patient’s understanding of the indication.
• b. The patient’s relationship with their doctor.
• c. The patient’s intelligence.
• d. The patient’s ability to pay.

Answer: a. The patient’s understanding of the indication.

40. An active learning session covering pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

41. Which of the following is NOT a key component of a counseling session?

• a. Verifying the patient’s identity.
• b. Discussing the purpose of the medication.
• c. Discussing common side effects.
• d. Discussing the pharmacy’s profit margin.

Answer: d. Discussing the pharmacy’s profit margin.

42. The three components of OBRA ’90 work together to:

• a. Increase the cost of medications.
• b. Create a system where pharmacists use patient information to perform a clinical review and then communicate essential information to the patient.
• c. Decrease the pharmacist’s workload.
• d. Eliminate the need for pharmacy technicians.

Answer: b. Create a system where pharmacists use patient information to perform a clinical review and then communicate essential information to the patient.

43. The laws regarding patient counseling apply to pharmacists in which setting?

• a. Community pharmacies only
• b. Hospital pharmacies only
• c. Long-term care facilities only
• d. All pharmacy practice settings where medications are dispensed for a specific patient.

Answer: d. All pharmacy practice settings where medications are dispensed for a specific patient.

44. A patient’s refusal to be counseled relieves the pharmacist of all liability associated with the prescription.

• a. True
• b. False

Answer: b. False

45. The ultimate goal of patient counseling is to:

• a. Fulfill a legal requirement.
• b. Empower the patient to take their medication safely and effectively.
• c. Prevent lawsuits.
• d. Make the prescription transaction take longer.

Answer: b. Empower the patient to take their medication safely and effectively.

46. A pharmacist’s professional judgment is key in determining the content and depth of a counseling session.

• a. True
• b. False

Answer: a. True

47. The CIPPE curriculum requires students to counsel patients on how to read and interpret a prescription label.

• a. True
• b. False

Answer: a. True

48. An active learning session on pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

49. A pharmacist providing counseling on a new inhaler should focus on:

• a. The cost of the device.
• b. The mechanism of action.
• c. The proper technique for using the device.
• d. The color of the device.

Answer: c. The proper technique for using the device.

50. The reason for learning the federal and state laws regarding counseling is to:

• a. Understand the minimum legal standard required for practice.
• b. Appreciate the pharmacist’s professional responsibility to the patient.
• c. Ensure patient safety and optimize medication outcomes.
• d. All of the above.

Answer: d. All of the above.