MPJE Federal 4 — Questions and Answers
Question 1: Under HIPAA, which of the following is considered a permissible disclosure of protected health information (PHI) without patient authorization?
- Sharing PHI with a marketing company for advertising purposes
- Providing PHI to a public health authority for disease surveillance (Correct answer)
- Disclosing PHI to an employer for pre-employment screening
- Releasing PHI to a law firm for civil litigation without a court order
Correct answer: Providing PHI to a public health authority for disease surveillance
HIPAA permits disclosure of PHI to public health authorities for activities such as disease surveillance without patient authorization.
Question 2: Under the federal DEA regulations, an automated dispensing cabinet (ADC) in a hospital must have which of the following for Schedule II controlled substances?
- Biometric access and perpetual inventory records (Correct answer)
- A separate DEA registration from the hospital pharmacy
- Dual-pharmacist sign-off for each withdrawal
- A separate DEA Form 222 for each ADC fill
Correct answer: Biometric access and perpetual inventory records
ADCs storing Schedule II substances must have access controls and maintain perpetual inventory records to account for all controlled substances.
Question 3: A pharmacist receives a faxed prescription for a Schedule II controlled substance from a physician. Under federal law, when may this fax serve as the original prescription?
- Never; Schedule II prescriptions must always be written originals
- When the patient is in a long-term care facility, hospice, or the substance is a compounded product for home infusion (Correct answer)
- When the prescriber provides a verbal authorization within 7 days
- When the pharmacy is located in a rural health shortage area
Correct answer: When the patient is in a long-term care facility, hospice, or the substance is a compounded product for home infusion
Federal DEA regulations permit a faxed Schedule II prescription to serve as the original when the patient is in a LTCF, enrolled in hospice, or for a compounded Schedule II product for home infusion therapy.
Question 4: Under the Controlled Substances Act, an emergency oral Schedule II prescription must be dispensed in what quantity?
- A full 30-day supply
- Only the quantity adequate to treat the patient during the emergency period (Correct answer)
- A maximum of a 72-hour supply
- Any quantity at the pharmacist's professional judgment
Correct answer: Only the quantity adequate to treat the patient during the emergency period
An emergency oral Schedule II prescription may only be dispensed in the quantity necessary to treat the patient during the emergency period.
Question 5: The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed qualifying physicians to prescribe which controlled substance for the office-based treatment of opioid use disorder?
- Methadone
- Buprenorphine (Correct answer)
- Naltrexone
- Naloxone
Correct answer: Buprenorphine
DATA 2000 allowed qualifying physicians to obtain a waiver to prescribe buprenorphine (Schedule III) in office-based settings for opioid use disorder treatment.
Question 6: Which federal regulation governs the requirements for pharmacy compounding under Section 503A of the FDCA?
- Compounding is only permissible for licensed outsourcing facilities registered with the FDA
- Compounding under 503A is permitted for individual patient prescriptions and must be based on a valid patient-specific prescription (Correct answer)
- Pharmacies may compound any FDA-approved drug in unlimited quantities for office use
- Compounded preparations under 503A are exempt from all USP standards
Correct answer: Compounding under 503A is permitted for individual patient prescriptions and must be based on a valid patient-specific prescription
Section 503A of the FDCA permits traditional pharmacy compounding for individual patients based on valid prescriptions, subject to specific requirements.
Question 7: Under the Controlled Substances Act, which of the following describes an 'electronic prescription for controlled substances' (EPCS)?
- A prescription sent via secure email attachment
- A prescription created, signed, transmitted, and received using DEA-compliant software with two-factor authentication (Correct answer)
- A prescription scanned and uploaded to a pharmacy portal
- A faxed prescription with a digital signature overlay
Correct answer: A prescription created, signed, transmitted, and received using DEA-compliant software with two-factor authentication
EPCS requires DEA-compliant software with two-factor identity proofing and logical access controls for the practitioner's digital signature.
MPJE Federal 4
Under HIPAA, which of the following is considered a permissible disclosure of protected health information (PHI) without patient authorization?