FPGEE FPGEE Pharmacy Law and Ethics 1 — Questions and Answers
Question 1: Under the US Drug Enforcement Administration (DEA) schedules, which schedule includes drugs with the highest accepted medical use and the lowest potential for abuse?
- Schedule I
- Schedule II
- Schedule IV
- Schedule V (Correct answer)
Correct 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.
Question 2: The Poison Prevention Packaging Act (PPPA) requires child-resistant packaging for most OTC and prescription drugs primarily to:
- Protect pharmacists from contamination
- Prevent accidental ingestion by children under 5 years (Correct answer)
- Ensure tamper evidence for controlled substances
- Comply with FDA labeling regulations
Correct 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.
Question 3: A pharmacist receives a faxed prescription for a Schedule III controlled substance. Under federal law, this is:
- Prohibited under any circumstance
- Permissible; the fax serves as the original (Correct answer)
- Permissible only in emergencies with a follow-up written prescription within 7 days
- Permissible only with DEA Form 222
Correct 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.
Question 4: Under HIPAA, which of the following is a permitted use of protected health information (PHI) without patient authorization?
- Sharing PHI with the patient's employer for attendance records
- Disclosing PHI to a pharmaceutical company for marketing
- Using PHI for treatment, payment, and healthcare operations (TPO) (Correct answer)
- Posting PHI on social media for public health education
Correct 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).
Question 5: The Orange Book published by the FDA lists drug products rated as therapeutically equivalent using codes beginning with 'A'. The code 'AB' specifically means:
- The product meets bioequivalence standards resolved by adequate in vivo studies (Correct answer)
- The product has no known or potential bioequivalence issues
- The product is not bioequivalent to the reference listed drug
- The product requires prior authorization for substitution
Correct 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.
Question 6: Which DEA form is required for a DEA-registered pharmacy to order Schedule II controlled substances?
- DEA Form 106
- DEA Form 222 (or CSOS electronic equivalent) (Correct answer)
- DEA Form 41
- DEA Form 224
Correct 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.
FPGEE FPGEE Pharmacy Law and Ethics 1
Under the US Drug Enforcement Administration (DEA) schedules, which schedule includes drugs with the highest accepted medical use and the lowest potential for abuse?