CCP Regulatory Compliance 2 — Questions and Answers
Question 1: Under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which activity is REQUIRED of pharmacists when dispensing Medicaid prescriptions?
- Prospective drug utilization review and patient counseling (Correct answer)
- Compounding the medication on-site
- Obtaining a signed consent form from the patient
- Verifying the prescriber's DEA number
Correct answer: Prospective drug utilization review and patient counseling
OBRA '90 mandates prospective DUR and an offer to counsel Medicaid patients at the point of dispensing.
Question 2: A long-term care facility asks the consultant pharmacist to review medication regimens. Which federal regulation specifically requires this review for nursing facility residents?
- HIPAA Privacy Rule
- OBRA '87 (NHRA) (Correct answer)
- Combat Methamphetamine Epidemic Act
- Kefauver-Harris Amendment
Correct answer: OBRA '87 (NHRA)
OBRA '87, also known as the Nursing Home Reform Act, requires monthly pharmacist medication regimen reviews for nursing facility residents.
Question 3: Which agency is responsible for enforcing the Controlled Substances Act at the federal level?
- FDA
- DEA (Correct answer)
- CMS
- CDC
Correct answer: DEA
The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the Controlled Substances Act.
Question 4: A pharmacist discovers a significant medication error that caused patient harm at a nursing facility. Under federal guidelines, which document should be completed to report this to the FDA?
- MedWatch Form 3500A (Correct answer)
- DEA Form 106
- CMS Form 671
- OSHA Form 300
Correct answer: MedWatch Form 3500A
MedWatch Form 3500A is the FDA's mandatory reporting form for serious adverse drug events and medication errors.
Question 5: Under 21 CFR Part 211, which type of facility must comply with Current Good Manufacturing Practice regulations?
- Retail pharmacies dispensing non-sterile products
- Outsourcing facilities registered under Section 503B (Correct answer)
- Hospital pharmacies preparing unit-dose products
- All pharmacies compounding for identified patients
Correct answer: Outsourcing facilities registered under Section 503B
Section 503B outsourcing facilities must comply with FDA's cGMP regulations under 21 CFR Part 211.
Question 6: Which Schedule of controlled substances has no currently accepted medical use in the United States and a high potential for abuse?
- Schedule II
- Schedule III
- Schedule IV
- Schedule I (Correct answer)
Correct answer: Schedule I
Schedule I controlled substances have no accepted medical use and the highest potential for abuse.
Question 7: A consultant pharmacist reviewing LTC records finds a resident was given a benzodiazepine without a documented clinical indication. This most directly violates which regulatory standard?
- USP <797> sterile compounding standards
- F-tag 758 unnecessary drug use in nursing facilities (Correct answer)
- DEA Schedule IV documentation requirements
- HIPAA minimum necessary standard
Correct answer: F-tag 758 unnecessary drug use in nursing facilities
F-tag 758 (formerly F329) requires that nursing facility residents receive only necessary medications with documented clinical indications.
CCP Regulatory Compliance 2
Under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), which activity is REQUIRED of pharmacists when dispensing Medicaid prescriptions?