MPJE Pharmacist Practice Standards 4 — Questions and Answers
Question 1: A pharmacist receives a fax of a Schedule II prescription. Under federal law, which statement is CORRECT?
- Faxed Schedule II prescriptions are valid for all dispensing purposes
- Faxed Schedule II prescriptions may serve as the original only for specific exceptions such as compounded preparations for home infusion patients (Correct answer)
- Faxed Schedule II prescriptions are never valid under federal law
- Faxed Schedule II prescriptions are valid if the prescriber's signature is original on the fax
Correct answer: Faxed Schedule II prescriptions may serve as the original only for specific exceptions such as compounded preparations for home infusion patients
Federal law generally requires original written or electronic Schedule II prescriptions, but faxes may serve as the original for limited exceptions including home infusion, hospice patients, and compounded Schedule II substances.
Question 2: Under USP <797>, which of the following cleanroom classifications is required for the preparation of Category 2 sterile compounded preparations?
- ISO Class 5 only, with no additional ante-area requirements
- ISO Class 5 primary engineering control within an ISO Class 7 buffer room and ISO Class 8 ante-area (Correct answer)
- ISO Class 6 buffer room with ISO Class 5 ante-area
- Any classified cleanroom environment with documented cleaning logs
Correct answer: ISO Class 5 primary engineering control within an ISO Class 7 buffer room and ISO Class 8 ante-area
USP <797> requires Category 2 CSPs to be prepared in an ISO 5 PEC within an ISO 7 buffer room with an ISO 8 ante-room to ensure sterility.
Question 3: A pharmacist receives a prescription for a drug that has a REMS (Risk Evaluation and Mitigation Strategy) with required elements to assure safe use (ETASU). What must the pharmacist do before dispensing?
- Dispense the drug and provide the standard medication guide
- Verify that all REMS requirements are met, including any required certification or patient enrollment (Correct answer)
- Contact the FDA for dispensing authorization on each prescription
- Obtain written consent from the patient's primary care physician
Correct answer: Verify that all REMS requirements are met, including any required certification or patient enrollment
REMS programs with ETASU impose specific obligations on pharmacies and pharmacists, including certification, patient enrollment, and documentation, that must be met prior to dispensing.
Question 4: A pharmacist counsels a patient on a new antihypertensive medication but omits information about postural hypotension. The patient falls and is injured. Which element of negligence is MOST clearly demonstrated?
- Duty
- Breach of duty (Correct answer)
- Causation
- Damages
Correct answer: Breach of duty
By failing to warn about a foreseeable and significant side effect like postural hypotension, the pharmacist breached the standard of care owed to the patient.
Question 5: Under federal law, what is the maximum number of refills allowed for a Schedule IV controlled substance?
- 3 refills within 6 months
- 5 refills within 6 months (Correct answer)
- Unlimited refills within 12 months
- No refills are permitted for Schedule IV substances
Correct answer: 5 refills within 6 months
Schedule IV controlled substances may be refilled up to 5 times within 6 months of the original prescription date under federal law.
Question 6: A pharmacist discovers a discrepancy in the DEA controlled substance inventory during a biennial inventory. What is the required action?
- Document the discrepancy and continue operations unless theft is confirmed
- Immediately notify the DEA if theft or significant loss is suspected, filing DEA Form 106 (Correct answer)
- File a report with the state board only, as DEA reporting is optional for small discrepancies
- Wait until the end of the year to report discrepancies in the annual report
Correct answer: Immediately notify the DEA if theft or significant loss is suspected, filing DEA Form 106
Pharmacies must report significant losses or theft of controlled substances to the DEA using Form 106 and notify local law enforcement when theft or significant unexplained loss is discovered.
Question 7: Which of the following is a pharmacist's obligation when detecting a potential drug-drug interaction on a new prescription during prospective DUR?
- Refuse to fill the prescription and require the prescriber to rewrite it
- Dispense as written since the prescriber assumes full responsibility
- Evaluate the clinical significance, contact the prescriber if warranted, and counsel the patient appropriately (Correct answer)
- Automatically substitute a safer therapeutic alternative without prescriber consultation
Correct answer: Evaluate the clinical significance, contact the prescriber if warranted, and counsel the patient appropriately
Prospective DUR requires pharmacists to evaluate interaction severity, use professional judgment about prescriber contact, and ensure patients receive appropriate counseling.
MPJE Pharmacist Practice Standards 4
A pharmacist receives a fax of a Schedule II prescription.
Under federal law, which statement is CORRECT?