FPGEE Pharmacy Law and Ethics Flashcards

Under the US Drug Enforcement Administration (DEA) schedules, which schedule includes drugs with the highest accepted medical use and the lowest potential for abuse?

Answer: Schedule V

Schedule V drugs (e.g., cough preparations with <200mg codeine/100mL) have accepted medical use, low abuse potential, and limited physical dependence.

The Poison Prevention Packaging Act (PPPA) requires child-resistant packaging for most OTC and prescription drugs primarily to:

Answer: Prevent accidental ingestion by children under 5 years

The PPPA mandates child-resistant containers for most dispensed medications to reduce accidental poisoning in children under 5 years of age.

A pharmacist receives a faxed prescription for a Schedule III controlled substance. Under federal law, this is:

Answer: Permissible; the fax serves as the original

Federal law permits faxed prescriptions for Schedule III–V controlled substances, with the fax serving as the original prescription.

Under HIPAA, which of the following is a permitted use of protected health information (PHI) without patient authorization?

Answer: Using PHI for treatment, payment, and healthcare operations (TPO)

HIPAA's Privacy Rule permits use and disclosure of PHI without patient authorization for treatment, payment, and healthcare operations (TPO).

The Orange Book published by the FDA lists drug products rated as therapeutically equivalent using codes beginning with 'A'. The code 'AB' specifically means:

Answer: The product meets bioequivalence standards resolved by adequate in vivo studies

AB-rated products have demonstrated bioequivalence through adequate in vivo studies and can be substituted for the reference listed drug.

Which DEA form is required for a DEA-registered pharmacy to order Schedule II controlled substances?

Answer: DEA Form 222 (or CSOS electronic equivalent)

DEA Form 222 (or its electronic equivalent via CSOS) is the official ordering document for Schedule I and II controlled substances.