Pharmacy Law and Regulations Flashcards
7 cards from real PTCE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Pharmacy Law and Regulations flashcards as text
Which of the following describes a 'narrow therapeutic index' (NTI) drug from a legal/regulatory standpoint?
Answer: A drug where small changes in dose or blood level can cause serious adverse effects or therapeutic failure
NTI drugs have a narrow margin between effective and toxic doses, requiring careful monitoring; many states require pharmacist notification before generic substitution.
Under federal law, a DEA Form 222 must be completed to order which class of controlled substances?
Answer: Schedule I and II only
DEA Form 222 (or its electronic equivalent, CSOS) is required specifically for ordering Schedule I and II controlled substances.
A patient opts out of child-resistant packaging for their prescription. What documentation is required?
Answer: A signed waiver from the patient or their caregiver on file
PPPA allows patients or caregivers to request non-child-resistant packaging, but a signed request must be kept on file to document the waiver.
Which federal agency oversees the National Provider Identifier (NPI) system?
Answer: Centers for Medicare & Medicaid Services (CMS)
CMS administers the NPI system under HIPAA, assigning unique 10-digit identifiers to healthcare providers including prescribers.
Under the Omnibus Budget Reconciliation Act (OBRA '90), pharmacists are required to offer counseling to:
Answer: Medicaid patients only
OBRA '90 mandates pharmacist counseling offers for Medicaid outpatients; however, most states have expanded this requirement to all patients.
A prescription label for a controlled substance dispensed to a patient must include which of the following by federal law?
Answer: The transfer warning 'Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed'
Federal law requires controlled substance labels to include a caution statement warning that transfer to anyone other than the intended patient is prohibited.
The FDA's 'black box warning' (boxed warning) is BEST described as:
Answer: The strongest warning the FDA requires, indicating serious or life-threatening risks
A black box warning is the FDA's most serious labeling requirement, reserved for drugs with significant risks of severe or life-threatening adverse effects.