MPJE Dispensing and Labeling 4 ā Questions and Answers
Question 1: A prescription label reads 'Take 1 tablet twice daily.' The patient asks the pharmacist what 'b.i.d.' means. Which abbreviation matches this direction?
- q.d.
- b.i.d. (Correct answer)
- t.i.d.
- q.i.d.
Correct answer: b.i.d.
B.i.d. (bis in die) means twice daily, corresponding to the directions on this label.
Question 2: Under the Durham-Humphrey Amendment, which category of drugs requires a prescription from a licensed practitioner before dispensing?
- Any drug with a narrow therapeutic index
- Drugs that are habit-forming, not safe for self-medication, or require professional supervision (Correct answer)
- All Schedule IāV controlled substances only
- Drugs with FDA Black Box Warnings only
Correct answer: Drugs that are habit-forming, not safe for self-medication, or require professional supervision
The Durham-Humphrey Amendment defines legend drugs as those habit-forming, unsafe for self-diagnosis/treatment, or requiring practitioner supervision.
Question 3: A pharmacist is about to dispense a 30-day supply of warfarin. The patient's profile shows a new prescription for fluconazole from a different prescriber. What is the pharmacist's legal and professional obligation?
- Dispense both; prescribers have already reviewed the combination.
- Dispense warfarin only and refuse to fill the fluconazole.
- Conduct a drug utilization review (DUR) and counsel the patient on the significant interaction. (Correct answer)
- Dispense both without intervention because prescribers are responsible for drug interactions.
Correct answer: Conduct a drug utilization review (DUR) and counsel the patient on the significant interaction.
OBRA '90 requires pharmacists to perform prospective DUR and offer counseling, especially for significant drug interactions like warfarin-fluconazole.
Question 4: Which federal law requires pharmacies that dispense Medicaid prescriptions to offer patient counseling?
- The Prescription Drug Marketing Act
- OBRA '90 (Omnibus Budget Reconciliation Act of 1990) (Correct answer)
- The Drug Quality and Security Act
- The Hatch-Waxman Act
Correct answer: OBRA '90 (Omnibus Budget Reconciliation Act of 1990)
OBRA '90 mandated that pharmacies participating in Medicaid offer patient counseling and conduct prospective drug utilization review.
Question 5: A patient presents a prescription for amoxicillin 500 mg #30. The pharmacist has only 250 mg capsules in stock. Which action is most appropriate?
- Dispense 60 capsules of 250 mg with directions to take 2 capsules per dose and notify the prescriber. (Correct answer)
- Refuse to fill and refer the patient to another pharmacy.
- Dispense the 250 mg strength without altering the directions.
- Dispense the 30 capsules of 250 mg and tell the patient to return for the rest.
Correct answer: Dispense 60 capsules of 250 mg with directions to take 2 capsules per dose and notify the prescriber.
A pharmacist may make a therapeutic equivalent substitution in strength by adjusting quantity and directions after notifying the prescriber, as it constitutes the same drug.
Question 6: Under the Drug Supply Chain Security Act (DSCSA), which document must accompany a drug product through each transaction in the pharmaceutical supply chain?
- DEA Form 222
- Transaction Information, Transaction History, and Transaction Statement (T3) (Correct answer)
- FDA Form 483
- State Board of Pharmacy license
Correct answer: Transaction Information, Transaction History, and Transaction Statement (T3)
DSCSA requires the three-T documents (Transaction Information, History, and Statement) to travel with each drug product transfer to ensure traceability.
Question 7: A pharmacist discovers a dispensing error after the patient has left the pharmacy. What is the most appropriate first action?
- Document the error internally and wait to see if the patient reports a problem.
- Contact the patient immediately to prevent or minimize potential harm. (Correct answer)
- Report the error to the FDA MedWatch program before contacting the patient.
- Discard the documentation to avoid liability exposure.
Correct answer: Contact the patient immediately to prevent or minimize potential harm.
Patient safety requires the pharmacist to contact the patient immediately upon discovering a dispensing error to prevent harm and arrange correction.
MPJE Dispensing and Labeling 4
A prescription label reads 'Take 1 tablet twice daily.' The patient asks the pharmacist what 'b.i.d.' means.
Which abbreviation matches this direction?