MPJE General 4 — Questions and Answers
Question 1: Under federal law, which of the following practitioners is NOT authorized to prescribe Schedule II controlled substances?
- Medical doctors (MD)
- Doctors of osteopathy (DO)
- Dentists
- Registered nurses (RN) (Correct answer)
Correct answer: Registered nurses (RN)
Registered nurses are not authorized to prescribe controlled substances under federal law; prescribing authority is granted to licensed practitioners such as MDs, DOs, and dentists.
Question 2: A pharmacy receives a suspicious order for a controlled substance from a supplier. Under DEA regulations, the pharmacist must:
- Fill the order and report it to the DEA within 72 hours
- Report the order to the DEA before filling it (Correct answer)
- Refuse the order and immediately call the DEA hotline
- Report it to the state board of pharmacy only
Correct answer: Report the order to the DEA before filling it
DEA regulations require registrants to report suspicious orders to the DEA prior to shipping or filling them.
Question 3: Which of the following is an example of a 'misbranded' drug under the FD&C Act?
- A drug manufactured in an unsanitary facility
- A drug with a label that omits required adequate directions for use (Correct answer)
- A drug that contains less active ingredient than stated
- A drug that has not undergone clinical trials
Correct answer: A drug with a label that omits required adequate directions for use
Misbranding refers to labeling defects, including missing required information such as adequate directions for use.
Question 4: Under the Drug Supply Chain Security Act (DSCSA), pharmacies must be able to trace prescription drug products through how many years of transaction history?
- 1 year
- 2 years
- 3 years (Correct answer)
- 5 years
Correct answer: 3 years
DSCSA requires pharmacies to maintain transaction information, transaction history, and transaction statements for three years.
Question 5: A patient requests that all of their prescriptions be dispensed in non-child-resistant containers. Which of the following is the correct procedure?
- A physician must authorize the request in writing
- The pharmacist may comply with a signed patient request on file (Correct answer)
- The pharmacist must deny the request to protect public safety
- A pharmacist supervisor must approve each such request
Correct answer: The pharmacist may comply with a signed patient request on file
Under PPPA, adult patients may waive child-resistant packaging for their own prescriptions with a signed request maintained on file.
Question 6: The term 'legend drug' refers to a drug that:
- Is listed in a state formulary
- Requires a prescription because it is not safe for self-medication (Correct answer)
- Has been approved by the FDA for more than 10 years
- Is available without a prescription in limited quantities
Correct answer: Requires a prescription because it is not safe for self-medication
A legend drug bears the federal legend 'Rx only' because it is not safe for use without professional supervision and therefore requires a prescription.
Question 7: Under the Ryan Haight Online Pharmacy Consumer Protection Act, prescribing a controlled substance via telemedicine generally requires:
- Prior DEA special registration only
- At least one in-person medical evaluation of the patient before the prescription is issued (Correct answer)
- Written consent from the patient's state insurance plan
- A minimum of three prior prescriptions from a brick-and-mortar pharmacy
Correct answer: At least one in-person medical evaluation of the patient before the prescription is issued
The Ryan Haight Act requires that a valid patient-prescriber relationship, including at least one in-person evaluation, exist before controlled substances may be prescribed via the internet.
MPJE General 4
Under federal law, which of the following practitioners is NOT authorized to prescribe Schedule II controlled substances?