General Flashcards

Under the Controlled Substances Act, which schedule includes drugs with accepted medical use but the highest potential for abuse?

Answer: Schedule II

Schedule II drugs have a currently accepted medical use but carry the highest abuse potential among scheduled drugs used in medicine.

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:

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.

Which federal agency is responsible for regulating the manufacturing and labeling of prescription drugs?

Answer: FDA

The FDA regulates drug manufacturing, labeling, safety, and efficacy under the Federal Food, Drug, and Cosmetic Act.

Under HIPAA, a pharmacist may disclose a patient's protected health information without authorization to:

Answer: Another treating provider involved in the patient's care

HIPAA's Treatment exception permits disclosure to other treating providers without patient authorization.

A drug product recalled due to a reasonable probability that use will cause serious adverse health consequences or death is classified as a:

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.

The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is used to determine:

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.

Which of the following is NOT required on the label of a dispensed outpatient prescription under federal law?

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.