MPJE General 2 — Questions and Answers
Question 1: Under the Controlled Substances Act, which schedule includes drugs with accepted medical use but the highest potential for abuse?
- Schedule I
- Schedule II (Correct answer)
- Schedule III
- Schedule IV
Correct answer: Schedule II
Schedule II drugs have a currently accepted medical use but carry the highest abuse potential among scheduled drugs used in medicine.
Question 2: A pharmacist receives a prescription for a Schedule II controlled substance via fax for a patient in a long-term care facility. Under federal law, this is:
- Prohibited; Schedule II prescriptions may never be faxed
- Permitted; the fax serves as the original prescription (Correct answer)
- Permitted as an emergency only, with original to follow in 7 days
- Permitted; the original must follow within 72 hours
Correct answer: Permitted; the fax serves as the original prescription
Federal law permits faxed Schedule II prescriptions for LTCF patients, and the fax itself serves as the original.
Question 3: Which federal agency is responsible for regulating the manufacturing and labeling of prescription drugs?
- DEA
- CDC
- FDA (Correct answer)
- FTC
Correct answer: FDA
The FDA regulates drug manufacturing, labeling, safety, and efficacy under the Federal Food, Drug, and Cosmetic Act.
Question 4: Under HIPAA, a pharmacist may disclose a patient's protected health information without authorization to:
- The patient's employer upon request
- Another treating provider involved in the patient's care (Correct answer)
- A law firm representing the patient's insurer
- The patient's adult child without the patient's consent
Correct answer: Another treating provider involved in the patient's care
HIPAA's Treatment exception permits disclosure to other treating providers without patient authorization.
Question 5: A drug product recalled due to a reasonable probability that use will cause serious adverse health consequences or death is classified as a:
- Class I recall (Correct answer)
- Class II recall
- Class III recall
- Voluntary market withdrawal
Correct answer: Class I recall
A Class I recall is the most serious, indicating that use of the product is likely to cause serious harm or death.
Question 6: The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is used to determine:
- Drug pricing benchmarks for Medicare Part D
- Therapeutic equivalence ratings for generic drug substitution (Correct answer)
- Maximum allowable quantities for controlled substance dispensing
- Recommended storage conditions for temperature-sensitive drugs
Correct answer: Therapeutic equivalence ratings for generic drug substitution
The Orange Book provides FDA therapeutic equivalence ratings (e.g., AB-rated) used to guide generic substitution decisions.
Question 7: Which of the following is NOT required on the label of a dispensed outpatient prescription under federal law?
- Patient name
- Drug name and strength
- Prescriber's DEA number (Correct answer)
- Directions for use
Correct answer: Prescriber's DEA number
The prescriber's DEA number is not required on the dispensed prescription label; it is required on the prescription itself for controlled substances.
MPJE General 2
Under the Controlled Substances Act, which schedule includes drugs with accepted medical use but the highest potential for abuse?