MPJE Prescription Dispensing Requirements 5 — Questions and Answers
Question 1: Under the Poison Prevention Packaging Act (PPPA), which of the following is exempt from child-resistant container requirements?
- Sublingual nitroglycerin tablets
- Oral contraceptives in manufacturer's original dispensing package
- Liquid preparations of acetaminophen for adults
- Both A and B (Correct answer)
Correct answer: Both A and B
Both sublingual nitroglycerin and oral contraceptives in unit-dose packaging are exempt from PPPA child-resistant container requirements.
Question 2: A patient who is hard of hearing requests large-print labels on all prescriptions. Under HIPAA and pharmacy law, how should the pharmacist respond?
- Pharmacies are not required to provide large-print labels under federal law
- The pharmacist should accommodate the request as part of effective communication requirements under the ADA (Correct answer)
- Large-print labels may only be provided if the pharmacy has the technical capability
- The prescriber must authorize a large-print label accommodation in writing
Correct answer: The pharmacist should accommodate the request as part of effective communication requirements under the ADA
The Americans with Disabilities Act (ADA) requires pharmacies to provide effective communication, which includes accommodations such as large-print labels for patients with visual or hearing impairments.
Question 3: A pharmacy technician presents a completed prescription bag to a pharmacist for final verification. The pharmacist notices the NDC on the vial does not match the prescription. This is an example of which type of error prevention step?
- Point-of-sale barcode scan verification
- Final pharmacist verification (drug utilization review) (Correct answer)
- Prospective DUR screening
- Tech-check-tech program oversight
Correct answer: Final pharmacist verification (drug utilization review)
The pharmacist's final check before dispensing, including verifying NDC against the prescription, is the final pharmacist verification step that catches preparation errors.
Question 4: A prescriber writes a prescription for 'Zolpidem CR 12.5 mg – dispense #30, 3 refills.' Zolpidem is a Schedule IV controlled substance. Under federal law, what is the maximum number of refills permitted?
- 3 refills as written by the prescriber
- 5 refills within 6 months of the original prescription date (Correct answer)
- No refills are permitted for Schedule IV substances
- Refills are unlimited within 12 months for Schedule IV
Correct answer: 5 refills within 6 months of the original prescription date
Federal law limits Schedule III–V prescriptions to a maximum of 5 refills within 6 months of the date issued, so the prescriber's 3 refills are within the allowable maximum.
Question 5: Which of the following best describes a pharmacist's 'corresponding responsibility' for controlled substance prescriptions?
- The pharmacist is responsible for billing the correct insurance for controlled substance dispensing
- The pharmacist shares legal responsibility with the prescriber for ensuring a controlled substance prescription is issued for a legitimate medical purpose (Correct answer)
- The pharmacist must confirm the diagnosis before dispensing any Schedule II medication
- The pharmacist must co-sign all Schedule II prescriptions to accept responsibility for dispensing
Correct answer: The pharmacist shares legal responsibility with the prescriber for ensuring a controlled substance prescription is issued for a legitimate medical purpose
Under 21 CFR 1306.04, both the prescriber and the pharmacist share corresponding responsibility for ensuring a controlled substance prescription serves a legitimate medical purpose.
Question 6: A pharmacy receives a bulk prescription for methadone 40 mg tablets for a patient with severe chronic pain. Which statement is correct?
- Methadone for pain can be prescribed by any DEA-registered practitioner on a standard Schedule II prescription (Correct answer)
- Methadone for pain requires a special DEA waiver in addition to a standard controlled substance prescription
- Methadone for pain can only be dispensed by opioid treatment programs (OTPs)
- Methadone 40 mg tablets are not a valid FDA-approved dosage form for pain management
Correct answer: Methadone for pain can be prescribed by any DEA-registered practitioner on a standard Schedule II prescription
Methadone prescribed for pain (not maintenance therapy) may be written by any DEA-registered practitioner on a standard Schedule II prescription; OTP registration is only required for maintenance treatment of addiction.
Question 7: A patient drops off a prescription for a controlled substance that appears to have been altered. The quantity was changed from 30 to 90 in a different ink color. The pharmacist should:
- Fill the prescription for the original quantity of 30 and counsel the patient about the alteration
- Refuse to fill the prescription, retain it if possible, and contact the prescriber and/or law enforcement (Correct answer)
- Fill the prescription as written for 90 since the prescriber can authorize any quantity
- Ask the patient to return with a new, unaltered prescription without notifying authorities
Correct answer: Refuse to fill the prescription, retain it if possible, and contact the prescriber and/or law enforcement
A visibly altered controlled substance prescription must not be filled; the pharmacist should refuse dispensing, retain the prescription if it is safe to do so, and report to the prescriber and/or law enforcement.
MPJE Prescription Dispensing Requirements 5
Under the Poison Prevention Packaging Act (PPPA), which of the following is exempt from child-resistant container requirements?