MCQ Quiz-Policy

MCQ Quiz: Policy

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Healthcare policy creates the framework in which all pharmacists practice. From federal laws governing drug approval to institutional policies on formulary management and state-level scope of practice rules, policy dictates how we provide patient care. For PharmD students, understanding these complex rules is essential for ensuring compliance and advocating for the future of the profession. This quiz will test your knowledge of the key policies that shape the world of pharmacy.

1. A health plan’s policy requiring a patient to try a less expensive, preferred medication before they will cover a more expensive alternative is known as:

  • Prior Authorization
  • A formulary exclusion
  • Step Therapy
  • A therapeutic interchange

Answer: Step Therapy

2. The Durham-Humphrey Amendment of 1951 is a key federal policy that:

  • Required drug manufacturers to prove the efficacy of their products.
  • Established the two classes of drugs: prescription (legend) and over-the-counter (OTC).
  • Created the Drug Enforcement Administration (DEA).
  • Mandated that all pharmacies offer patient counseling.

Answer: Established the two classes of drugs: prescription (legend) and over-the-counter (OTC).

3. A hospital’s Pharmacy & Therapeutics (P&T) Committee is responsible for developing which type of institutional policy?

  • The employee dress code.
  • The drug formulary and medication use policies.
  • The hospital’s billing and collection procedures.
  • The surgical operating room schedule.

Answer: The drug formulary and medication use policies.

4. The policy that requires pharmacists to offer counseling to Medicaid patients is a major provision of which federal law?

  • The Health Insurance Portability and Accountability Act (HIPAA)
  • The Controlled Substances Act (CSA)
  • The Omnibus Budget Reconciliation Act of 1990 (OBRA ’90)
  • The Kefauver-Harris Amendment of 1962

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

5. The CMS Medicare 5-Star Quality Rating program is a policy designed to:

  • Set the price for all prescription drugs.
  • Measure the performance of Medicare plans to help beneficiaries compare quality.
  • Regulate the practice of community pharmacy.
  • Provide a directory of all physicians who accept Medicare.

Answer: Measure the performance of Medicare plans to help beneficiaries compare quality.

6. Which government agency is primarily responsible for the policy and enforcement of the Controlled Substances Act?

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

Answer: The Drug Enforcement Administration (DEA)

7. In the state of Florida, which body is responsible for creating rules and policies that regulate the practice of pharmacy?

  • The Florida Medical Association
  • The Governor’s office
  • The Florida Board of Pharmacy
  • The Florida Pharmacy Association

Answer: The Florida Board of Pharmacy

8. A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety policy required by the FDA for certain medications with:

  • A high potential for abuse or serious adverse effects.
  • A low cost.
  • A generic alternative available.
  • An over-the-counter formulation.

Answer: A high potential for abuse or serious adverse effects.

9. The policy of “provider status” for pharmacists is a major advocacy goal aimed at allowing pharmacists to:

  • Bill for clinical services under programs like Medicare Part B.
  • Own and operate medical clinics.
  • Prescribe all medications without physician oversight.
  • Supervise physicians and nurses.

Answer: Bill for clinical services under programs like Medicare Part B.

10. A hospital policy based on The Joint Commission’s National Patient Safety Goals would likely include a process for:

  • Improving the taste of hospital food.
  • Managing employee schedules.
  • Improving the accuracy of patient identification and managing critical lab results.
  • Designing the layout of the hospital gift shop.

Answer: Improving the accuracy of patient identification and managing critical lab results.

11. The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that established policies for:

  • Drug manufacturing standards.
  • The protection of patient privacy and the security of health information.
  • The pricing of prescription drugs.
  • The advertising of healthcare services.

Answer: The protection of patient privacy and the security of health information.

12. USP Chapter <797> provides policies and standards for:

  • Non-sterile compounding.
  • The handling of hazardous drugs.
  • Sterile compounding to prevent patient harm from contamination.
  • The ethical conduct of pharmacists.

Answer: Sterile compounding to prevent patient harm from contamination.

13. A drug formulary is a policy tool used by payers to:

  • List every drug approved by the FDA.
  • Manage which medications are covered by a health plan to promote safe, effective, and affordable therapy.
  • Provide prescribing information to physicians.
  • Rank pharmacies based on their performance.

Answer: Manage which medications are covered by a health plan to promote safe, effective, and affordable therapy.

14. The policy that established the framework for ethical human subjects research, including the principles of respect for persons, beneficence, and justice, is found in the:

  • Kefauver-Harris Amendment
  • The Belmont Report
  • The Controlled Substances Act
  • The OBRA ’90 legislation

Answer: The Belmont Report

15. A hospital’s policy on “therapeutic interchange” allows a pharmacist to:

  • Dispense a generic drug for a brand drug as prescribed.
  • Automatically substitute a chemically different but therapeutically similar drug for a non-formulary drug, according to a pre-approved protocol.
  • Refuse to fill any prescription for a non-formulary medication.
  • Change a patient’s diagnosis in the medical record.

Answer: Automatically substitute a chemically different but therapeutically similar drug for a non-formulary drug, according to a pre-approved protocol.

16. A Continuous Quality Improvement (CQI) program, which may be required by state policy, is a process where a pharmacy:

  • Documents and reviews medication errors and incidents to identify and correct systemic problems.
  • Reports its daily profits to the state board.
  • Advertises its services to the community.
  • Compiles a list of its most frequently dispensed drugs.

Answer: Documents and reviews medication errors and incidents to identify and correct systemic problems.

17. The policy of requiring a medication to have a “black box warning” in its labeling is enforced by which agency?

  • The DEA
  • CMS
  • The FDA
  • The Joint Commission

Answer: The FDA

18. An Institutional Review Board (IRB) is a committee that operates under institutional policy to:

  • Manage the hospital’s budget.
  • Review and approve research involving human subjects to ensure it is ethical.
  • Negotiate contracts with drug wholesalers.
  • Oversee the pharmacy’s inventory.

Answer: Review and approve research involving human subjects to ensure it is ethical.

19. A health plan’s policy of using a preferred pharmacy network is a strategy to:

  • Make it more difficult for patients to get their medications.
  • Increase competition among all pharmacies.
  • Control costs by negotiating favorable reimbursement rates with a select group of pharmacies.
  • Ensure all pharmacies in the network are open 24 hours a day.

Answer: Control costs by negotiating favorable reimbursement rates with a select group of pharmacies.

20. The Prescription Drug Marketing Act (PDMA) is a federal law that established policies to prevent:

  • The sale of counterfeit, adulterated, or misbranded drugs.
  • Pharmacists from counseling patients.
  • The development of generic drugs.
  • The use of computers in pharmacies.

Answer: The sale of counterfeit, adulterated, or misbranded drugs.

21. A policy that allows pharmacists to administer immunizations has led to:

  • A decrease in vaccination rates.
  • An increase in the cost of all vaccines.
  • Increased patient access to preventive care and improved public health.
  • A reduction in the number of vaccines available.

Answer: Increased patient access to preventive care and improved public health.

22. Clinical practice guidelines are a form of “soft policy” that helps standardize care by:

  • Providing rigid rules that must be followed without exception.
  • Offering evidence-based recommendations for clinicians to use in their decision-making.
  • Replacing the need for clinical trials.
  • Being developed by insurance companies to limit care.

Answer: Offering evidence-based recommendations for clinicians to use in their decision-making.

23. A pharmacy’s policy for handling hazardous drugs should be based on the standards outlined in:

  • USP <797>
  • USP <800>
  • The Controlled Substances Act
  • The HIPAA Privacy Rule

Answer: USP <800>

24. A prospective drug utilization review (DUR) is a policy that requires a real-time check at the point of dispensing for issues like:

  • The patient’s ability to pay.
  • The pharmacy’s current inventory.
  • Therapeutic duplication or drug-drug interactions.
  • The patient’s preferred brand of medication.

Answer: Therapeutic duplication or drug-drug interactions.

25. A policy of requiring electronic prescribing for controlled substances is intended to:

  • Make prescribing more difficult for physicians.
  • Increase the number of forged prescriptions.
  • Reduce diversion and improve patient safety.
  • Eliminate the need for pharmacists to verify prescriptions.

Answer: Reduce diversion and improve patient safety.

26. The Kefauver-Harris Amendment of 1962 was a landmark policy that required drug manufacturers to prove not only safety, but also:

  • Affordability
  • Efficacy.
  • Good taste
  • Popularity

Answer: Efficacy.

27. A hospital’s antimicrobial stewardship policy is designed to:

  • Promote the use of the most expensive antibiotics.
  • Ensure all infections are treated with the same antibiotic.
  • Optimize antimicrobial use to improve patient outcomes and reduce resistance.
  • Restrict the use of all antibiotics within the hospital.

Answer: Optimize antimicrobial use to improve patient outcomes and reduce resistance.

28. Policy decisions made by a P&T committee are primarily based on:

  • The color of the medication.
  • The marketing budget of the drug manufacturer.
  • Evidence of a drug’s safety, efficacy, and cost-effectiveness.
  • The personal preferences of the committee members.

Answer: Evidence of a drug’s safety, efficacy, and cost-effectiveness.

29. The “Orange Book,” published by the FDA, contains policies and information regarding:

  • Herbal supplements.
  • The therapeutic equivalence of generic drugs.
  • Controlled substance schedules.
  • Vaccine recommendations.

Answer: The therapeutic equivalence of generic drugs.

30. The policy of requiring a pharmacist to be the “responsible person” for a pharmacy permit ensures:

  • That a specific individual is accountable for the legal and operational standards of the pharmacy.
  • That the pharmacy owner must be a pharmacist.
  • That the pharmacy can only be open when that specific person is on duty.
  • That the pharmacy has a designated manager.

Answer: That a specific individual is accountable for the legal and operational standards of the pharmacy.

31. Policies regarding the ratio of pharmacy technicians to pharmacists are set at what level?

  • Federal
  • State
  • Institutional
  • Manufacturer

Answer: State

32. The Poison Prevention Packaging Act (PPPA) is a policy that mandates the use of:

  • Child-resistant packaging for most prescription and certain OTC drugs.
  • Amber vials for all dispensed medications.
  • Auxiliary labels on all prescription bottles.
  • Easy-open caps for all patients.

Answer: Child-resistant packaging for most prescription and certain OTC drugs.

33. What is the primary purpose of a “Medication Guide” required by FDA policy for certain drugs?

  • To act as a marketing brochure.
  • To provide patients with important safety information and warnings in an easy-to-read format.
  • To replace the need for verbal counseling.
  • To list the price of the medication.

Answer: To provide patients with important safety information and warnings in an easy-to-read format.

34. A policy that allows for “emergency contraception” to be available without a prescription is an example of a policy that:

  • Limits patient access to care.
  • Increases public health by providing timely access to preventive medication.
  • Is opposed by all pharmacy organizations.
  • Only applies to married women.

Answer: Increases public health by providing timely access to preventive medication.

35. A “collaborative practice agreement” is a policy tool that:

  • Prevents pharmacists from talking to physicians.
  • Creates a formal agreement allowing a pharmacist to initiate or adjust drug therapy under a defined protocol.
  • Is required to dispense any controlled substance.
  • Outlines the pharmacy’s return policy.

Answer: Creates a formal agreement allowing a pharmacist to initiate or adjust drug therapy under a defined protocol.

36. Policies related to the disposal of controlled substances are primarily enforced by the:

  • FDA
  • CMS
  • EPA
  • DEA

Answer: DEA

37. The FDA’s policy on “adulterated” drugs refers to problems with the drug’s:

  • Labeling or claims.
  • Purity, strength, or quality.
  • Packaging.
  • Price.

Answer: Purity, strength, or quality.

38. The FDA’s policy on “misbranded” drugs refers to problems with the drug’s:

  • False or misleading labeling.
  • Chemical composition.
  • Clinical efficacy.
  • Manufacturing process.

Answer: False or misleading labeling.

39. HEDIS measures are policies used by health plans to:

  • Measure and report on the quality of care and service they provide.
  • Determine employee salaries.
  • Set patient copayments.
  • Select which pharmacies are in their network.

Answer: Measure and report on the quality of care and service they provide.

40. A pharmacist can advocate for a change in public policy by:

  • Contacting their legislator.
  • Joining and participating in a professional pharmacy organization.
  • Providing data and testimony to a government committee.
  • All of the above.

Answer: All of the above.

41. The policy creating Medicare Part D had what major impact on pharmacy?

  • It decreased the number of prescriptions filled for seniors.
  • It provided a prescription drug benefit to millions of Medicare beneficiaries.
  • It eliminated the need for pharmacists.
  • It made all prescription drugs free for seniors.

Answer: It provided a prescription drug benefit to millions of Medicare beneficiaries.

42. Which of the following is an example of an institutional policy, rather than a federal law?

  • The requirement that a new drug be proven effective.
  • A hospital’s specific list of drugs approved for its formulary.
  • The scheduling of oxycodone as a C-II controlled substance.
  • The requirement for a prescription to dispense amoxicillin.

Answer: A hospital’s specific list of drugs approved for its formulary.

43. A pharmacist’s “scope of practice” is determined by:

  • Federal law.
  • The pharmacist’s employer.
  • State-level policy and law.
  • The pharmacist’s personal preference.

Answer: State-level policy and law.

44. A policy of value-based contracting for a new drug means the payer’s reimbursement is tied to:

  • The number of units sold.
  • The manufacturer’s stock price.
  • The drug’s demonstrated performance and patient outcomes.
  • A flat per-member-per-month fee.

Answer: The drug’s demonstrated performance and patient outcomes.

45. The Orphan Drug Act of 1983 is a policy that:

  • Mandates that all pharmacies stock drugs for rare diseases.
  • Provides financial incentives to manufacturers for developing drugs for rare diseases.
  • Regulates the price of all orphan drugs.
  • Was designed to help orphaned children get access to medication.

Answer: Provides financial incentives to manufacturers for developing drugs for rare diseases.

46. A “retrospective” DUR is a policy where a health plan reviews claims data to:

  • Stop a prescription before it is dispensed.
  • Identify patterns of prescribing that may need educational intervention after the fact.
  • Set the formulary for the upcoming year.
  • Calculate patient copayments.

Answer: Identify patterns of prescribing that may need educational intervention after the fact.

47. Pharmacy policies and procedures are crucial for:

  • Ensuring consistent and safe operations within the pharmacy.
  • Creating more work for the staff.
  • Making the pharmacy less efficient.
  • They are not important for daily practice.

Answer: Ensuring consistent and safe operations within the pharmacy.

48. The FDA’s policy on off-label prescribing states that:

  • It is illegal for a physician to prescribe a drug for an unapproved use.
  • A manufacturer can actively promote a drug for an unapproved use.
  • A physician may prescribe a drug for an unapproved use based on their professional judgment, but a manufacturer cannot promote it for that use.
  • All off-label uses are automatically covered by insurance.

Answer: A physician may prescribe a drug for an unapproved use based on their professional judgment, but a manufacturer cannot promote it for that use.

49. Policies that expand the scope of pharmacy practice, such as pharmacist-led MTM, are driven by a need to:

  • Increase healthcare costs.
  • Utilize the clinical skills of pharmacists to improve patient care and fill gaps in the healthcare system.
  • Reduce the number of physicians.
  • Sell more over-the-counter products.

Answer: Utilize the clinical skills of pharmacists to improve patient care and fill gaps in the healthcare system.

50. The ultimate purpose of most health and pharmacy policies is to:

  • Increase the administrative burden on providers.
  • Protect and improve public health.
  • Maximize the profits of all stakeholders.
  • Make the healthcare system more complex.

Answer: Protect and improve public health.

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