MCQ Quiz: Managing Professional and Regulatory Affairs

Managing professional and regulatory affairs is a critical function that ensures pharmacy practice is conducted legally, ethically, and to the highest standard of care.This involves navigating a complex landscape of federal and state regulations while upholding the core tenets of professionalism.This quiz covers general principles related to this important aspect of pharmacy leadership and practice.

1. Which federal agency is primarily responsible for the regulation of prescription drug advertising and approval?

• a. The Drug Enforcement Administration (DEA)
• b. The Centers for Disease Control and Prevention (CDC)
• c. The Food and Drug Administration (FDA)
• d. The Centers for Medicare & Medicaid Services (CMS)

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

2. Which federal agency is primarily responsible for enforcing the laws and regulations governing controlled substances?

• a. The Food and Drug Administration (FDA)
• b. The Drug Enforcement Administration (DEA)
• c. The National Institutes of Health (NIH)
• d. The Board of Pharmacy (BOP)

Answer: b. The Drug Enforcement Administration (DEA)

3. The primary role of a state’s Board of Pharmacy is to:

• a. Set prices for medications.
• b. Represent pharmacists in labor negotiations.
• c. Protect the health, safety, and welfare of the public by regulating the practice of pharmacy within that state.
• d. Lobby the federal government.

Answer: c. Protect the health, safety, and welfare of the public by regulating the practice of pharmacy within that state.

4. The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) established a federal mandate for pharmacists to:

• a. Administer all immunizations.
• b. Perform a prospective drug use review (DUR) and offer to counsel Medicaid patients.
• c. Compound all sterile preparations.
• d. Provide free medications to all patients.

Answer: b. Perform a prospective drug use review (DUR) and offer to counsel Medicaid patients.

5. The Health Insurance Portability and Accountability Act (HIPAA) is a federal law primarily concerned with:

• a. Drug pricing and transparency.
• b. The manufacturing of pharmaceuticals.
• c. Protecting the privacy and security of patient health information.
• d. The regulation of controlled substances.

Answer: c. Protecting the privacy and security of patient health information.

6. A pharmacist’s “scope of practice” is primarily defined by:

• a. Federal law
• b. Their employer’s policies
• c. State law and Board of Pharmacy regulations
• d. National pharmacy organizations

Answer: c. State law and Board of Pharmacy regulations

7. A “Policy and Procedure” manual in a pharmacy serves to:

• a. Provide standardized guidance for staff to ensure compliance with laws and promote best practices.
• b. Fulfill a bookshelf space requirement.
• c. Be used only for training new employees.
• d. List the prices of all medications.

Answer: a. Provide standardized guidance for staff to ensure compliance with laws and promote best practices.

8. The “Pharmacist in Charge” (PIC) is the individual who is:

• a. In charge of the pharmacy’s budget.
• b. The oldest pharmacist on staff.
• c. Legally responsible for ensuring the pharmacy operates in compliance with all laws and regulations.
• d. The lead pharmacy technician.

Answer: c. Legally responsible for ensuring the pharmacy operates in compliance with all laws and regulations.

9. A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the FDA can require for certain medications with:

• a. Low efficacy.
• b. A low cost.
• c. Serious safety concerns to help ensure the benefits of the drug outweigh its risks.
• d. A generic equivalent available.

Answer: c. Serious safety concerns to help ensure the benefits of the drug outweigh its risks.

10. Professional pharmacy organizations like APhA and ASHP play a key role in:

• a. Issuing pharmacy licenses.
• b. Conducting inspections of pharmacies.
• c. Advocating on behalf of the profession and setting practice standards.
• d. Disciplining pharmacists for misconduct.

Answer: c. Advocating on behalf of the profession and setting practice standards.

11. A pharmacist receives a prescription for a controlled substance that appears to be fraudulent. The most professional and legally sound action is to:

• a. Fill the prescription immediately to avoid conflict.
• b. Refuse to fill the prescription and discreetly report it to the authorities.
• c. Fill the prescription but only give the patient half the quantity.
• d. Tell the patient the medication is out of stock.

Answer: b. Refuse to fill the prescription and discreetly report it to the authorities.

12. Continuing Pharmacy Education (CPE) is a regulatory requirement for:

• a. All healthcare professionals.
• b. Maintaining an active pharmacist license.
• c. Pharmacy technicians only.
• d. It is a voluntary activity.

Answer: b. Maintaining an active pharmacist license.

13. The process of peer review in professional affairs refers to:

• a. The evaluation of a pharmacist’s work by other professionals of equal standing.
• b. A performance review conducted by a manager.
• c. Patients reviewing their pharmacists online.
• d. A review of a pharmacy’s finances.

Answer: a. The evaluation of a pharmacist’s work by other professionals of equal standing.

14. A pharmacist who stays current with changes in pharmacy law and practice guidelines is demonstrating:

• a. A commitment to professional competence and lifelong learning.
• b. An unnecessary dedication to their job.
• c. A fear of being audited.
• d. A hobby.

Answer: a. A commitment to professional competence and lifelong learning.

15. What is the purpose of a collaborative practice agreement (CPA)?

• a. To allow a pharmacist to own a pharmacy with a physician.
• b. To create a formal practice relationship between a pharmacist and another provider, allowing the pharmacist to perform expanded patient care functions.
• c. To set the schedule for interprofessional meetings.
• d. To allow pharmacists to prescribe all medications independently.

Answer: b. To create a formal practice relationship between a pharmacist and another provider, allowing the pharmacist to perform expanded patient care functions.

16. Which of the following must be included on a prescription for a controlled substance?

• a. The patient’s address.
• b. The prescriber’s DEA number.
• c. The date the prescription was written.
• d. All of the above.

Answer: d. All of the above.

17. Managing a pharmacy’s compliance with HIPAA involves:

• a. Training staff on patient privacy.
• b. Implementing physical and electronic safeguards for patient information.
• c. Having a designated privacy officer.
• d. All of the above.

Answer: d. All of the above.

18. The term “ethics” refers to:

• a. The laws and regulations governing a profession.
• b. The moral principles and values that guide professional conduct.
• c. The policies and procedures of a specific workplace.
• d. The cost of providing care.

Answer: b. The moral principles and values that guide professional conduct.

19. A key professional responsibility for a pharmacist is to:

• a. Maintain patient confidentiality.
• b. Provide competent care.
• c. Act with honesty and integrity.
• d. All of the above.

Answer: d. All of the above.

20. A pharmacist who reports a medication error through their institution’s safety reporting system is participating in:

• a. A process that promotes a culture of safety and quality improvement.
• b. An activity that will lead to their termination.
• c. A violation of patient privacy.
• d. An unnecessary administrative task.

Answer: a. A process that promotes a culture of safety and quality improvement.

21. A conflict of interest in professional practice occurs when:

• a. A pharmacist and a technician disagree about workflow.
• b. A pharmacist’s personal interests or relationships could potentially compromise their professional judgment.
• c. A patient refuses to take a medication.
• d. A drug is on backorder.

Answer: b. A pharmacist’s personal interests or relationships could potentially compromise their professional judgment.

22. Which of the following is a key component of managing regulatory affairs in a hospital pharmacy?

• a. Ensuring compliance with The Joint Commission (TJC) standards.
• b. Managing sterile compounding according to USP <797>.
• c. Overseeing the management of controlled substances.
• d. All of the above.

Answer: d. All of the above.

23. The FDA’s MedWatch program is for:

• a. Patients to order medications online.
• b. Healthcare professionals and the public to voluntarily report adverse drug events and medication errors.
• c. Physicians to look up drug information.
• d. Pharmacists to renew their licenses.

Answer: b. Healthcare professionals and the public to voluntarily report adverse drug events and medication errors.

24. The Drug Supply Chain Security Act (“Track and Trace”) is a law designed to:

• a. Set drug prices.
• b. Protect consumers from counterfeit, stolen, or contaminated drugs.
• c. Regulate the advertising of drugs.
• d. Determine which drugs are controlled substances.

Answer: b. Protect consumers from counterfeit, stolen, or contaminated drugs.

25. A pharmacist’s professional network (e.g., through professional organizations) is a valuable resource for:

• a. Staying current on professional and regulatory issues.
• b. Finding mentors.
• c. Seeking advice on complex practice issues.
• d. All of the above.

Answer: d. All of the above.

26. The term “standard of care” refers to:

• a. The level of care that is legally required.
• b. The level of care that a reasonably prudent pharmacist would provide under similar circumstances.
• c. The highest possible level of care available anywhere in the world.
• d. The minimum level of care to avoid a lawsuit.

Answer: b. The level of care that a reasonably prudent pharmacist would provide under similar circumstances.

27. To manage regulatory affairs effectively, a pharmacy must:

• a. Have access to current state and federal law books and regulations.
• b. Have a designated compliance officer or manager.
• c. Conduct regular self-audits.
• d. All of the above.

Answer: d. All of the above.

28. An audit from the Board of Pharmacy is primarily intended to:

• a. Punish the pharmacy.
• b. Ensure compliance with state laws and regulations to protect the public.
• c. Increase the pharmacy’s profits.
• d. Be a routine, friendly visit.

Answer: b. Ensure compliance with state laws and regulations to protect the public.

29. The term “professional liability” or “malpractice” refers to:

• a. A compliment on a pharmacist’s practice.
• b. Negligence by a professional that results in harm to a patient or client.
• c. A type of insurance.
• d. The act of dispensing a medication.

Answer: b. Negligence by a professional that results in harm to a patient or client.

30. Which of the following is an example of a “technical” function a pharmacist manages?

• a. Ensuring the accuracy of a final prescription check.
• b. Counseling a patient on a new medication.
• c. Resolving a drug therapy problem.
• d. Recommending a dose adjustment.

Answer: a. Ensuring the accuracy of a final prescription check.

31. Which of the following is an example of a “clinical” function a pharmacist manages?

• a. Inputting a prescription into the computer.
• b. Counting tablets.
• c. Performing a comprehensive medication review (CMR).
• d. Ringing up a sale at the register.

Answer: c. Performing a comprehensive medication review (CMR).

32. A key professional responsibility when a new law affecting pharmacy is passed is to:

• a. Ignore it until the Board of Pharmacy sends a letter.
• b. Proactively learn the new requirements and implement necessary changes in practice.
• c. Assume the pharmacy software will handle everything automatically.
• d. Complain about the new law to patients.

Answer: b. Proactively learn the new requirements and implement necessary changes in practice.

33. The “Code of Ethics for Pharmacists” serves as:

• a. A legally binding document.
• b. A framework for ethical decision-making and professional conduct.
• c. A list of all pharmacy laws.
• d. A historical document with no modern application.

Answer: b. A framework for ethical decision-making and professional conduct.

34. A pharmacist maintaining a professional and respectful relationship with other healthcare providers is part of managing:

• a. Inventory
• b. Interprofessional affairs
• c. Finances
• d. The pharmacy’s physical layout

Answer: b. Interprofessional affairs

35. A quality improvement program in a pharmacy is a tool for:

• a. Identifying and punishing underperforming employees.
• b. Systematically monitoring and improving the quality and safety of pharmacy services.
• c. Increasing the number of prescriptions filled.
• d. Marketing the pharmacy to new patients.

Answer: b. Systematically monitoring and improving the quality and safety of pharmacy services.

36. A biennial inventory of controlled substances is a requirement from which agency?

• a. FDA
• b. State Board of Pharmacy
• c. DEA
• d. Both b and c

Answer: d. Both b and c

37. Maintaining one’s own well-being and managing stress is a key part of being able to:

• a. Manage professional affairs effectively and provide safe patient care.
• b. Work 80 hours a week without a break.
• c. Ignore workplace challenges.
• d. Pass every exam.

Answer: a. Manage professional affairs effectively and provide safe patient care.

38. Which of the following is NOT part of a pharmacist’s professional responsibility?

• a. Advocating for their patients.
• b. Maintaining competence.
• c. Guaranteeing a specific clinical outcome for a patient.
• d. Promoting public health.

Answer: c. Guaranteeing a specific clinical outcome for a patient.

39. A pharmacist who mentors a student is participating in:

• a. A waste of their time.
• b. The advancement of the profession.
• c. A required legal activity.
• d. A financial transaction.

Answer: b. The advancement of the profession.

40. A key professional attribute is:

• a. Integrity
• b. Honesty
• c. Compassion
• d. All of the above

Answer: d. All of the above

41. When there is a conflict between an ethical principle and a law, the pharmacist must:

• a. Always follow the ethical principle.
• b. Always follow the law.
• c. Seek guidance, as this is a complex situation, but ultimately must not break the law.
• d. Do whatever is easiest.

Answer: c. Seek guidance, as this is a complex situation, but ultimately must not break the law.

42. Managing the pharmacy’s compliance with USP <795> and <797> falls under:

• a. Financial affairs
• b. Professional affairs
• c. Regulatory affairs
• d. Both b and c

Answer: d. Both b and c

43. A pharmacist’s professional judgment is a key component of:

• a. Only dispensing.
• b. Every aspect of pharmacy practice.
• c. Only compounding.
• d. Only MTM.

Answer: b. Every aspect of pharmacy practice.

44. If a pharmacist is unsure about a legal or ethical issue, they should:

• a. Proceed and hope for the best.
• b. Consult with a trusted colleague, a professional organization, or the Board of Pharmacy.
• c. Ask a technician for their opinion.
• d. Look for the answer on social media.

Answer: b. Consult with a trusted colleague, a professional organization, or the Board of Pharmacy.

45. What is the primary purpose of a “drug take-back” program?

• a. To allow the pharmacy to reuse old medications.
• b. To provide a safe and environmentally sound way for the public to dispose of unwanted medications.
• c. To increase pharmacy foot traffic.
• d. To help patients save money.

Answer: b. To provide a safe and environmentally sound way for the public to dispose of unwanted medications.

46. A “conscience clause” is a regulatory issue that intersects directly with a pharmacist’s:

• a. Financial planning
• b. Inventory management
• c. Personal ethics and beliefs
• d. Clinical knowledge

Answer: c. Personal ethics and beliefs

47. Keeping accurate and complete records for prescriptions, compounding, and controlled substances is a key part of managing:

• a. Professional affairs
• b. Regulatory affairs
• c. Patient relationships
• d. Marketing

Answer: b. Regulatory affairs

48. Why is it important for a pharmacist to understand the new drug approval process?

• a. To be able to critically evaluate information about new drugs when they come to market.
• b. It is not important for a practicing pharmacist.
• c. So they can compound the drug before it is approved.
• d. To help them invest in pharmaceutical stocks.

Answer: a. To be able to critically evaluate information about new drugs when they come to market.

49. The overall management of a pharmacy’s professional and regulatory affairs aims to:

• a. Create as much bureaucracy as possible.
• b. Ensure the provision of care is safe, legal, ethical, and effective.
• c. Maximize profit above all else.
• d. Minimize interaction with patients.

Answer: b. Ensure the provision of care is safe, legal,ethical, and effective.

50. The ultimate reason for a student to learn about managing professional and regulatory affairs is to:

• a. Be prepared to practice pharmacy competently and ethically within the bounds of the law.
• b. Memorize all state and federal laws.
• c. Pass the MPJE (Multistate Pharmacy Jurisprudence Examination).
• d. Both a and c are correct.

Answer: d. Both a and c are correct.