Study 5 Federal Requirements for Pharmacy Practice with 12 free online flashcards. Review key terms, definitions, and concepts with this interactive flashcard deck.
What are the general federal bases for dispensing a prescription-only drug?
A prescription-only drug generally requires a written prescription from an authorized practitioner, an oral prescription promptly reduced to writing and filed, or a prescriber-authorized refill.
What should a pharmacist do when prescription directions raise a material concern?
Check that the prescription is authorized and complete, resolve material ambiguities with the prescriber, and evaluate whether the drug and directions can be dispensed safely.
What core information does federal law specify for a prescription-container label?
Core information includes the dispenser’s name and address, prescription serial number and prescription or filling date, prescriber’s name, patient’s name if stated, and the prescription’s directions and cautions.
What designation must a prescription drug bear before dispensing?
The prescription drug must bear “Rx only” before it is dispensed.
When must a Medication Guide generally be provided?
When dispensing a drug subject to the requirement, the authorized dispenser generally must give the FDA-approved Guide to the patient or the patient’s agent, unless a regulatory exemption applies.
When must Medicaid prospective drug review occur?
For Medicaid-covered outpatient prescriptions, state plans must provide for review of drug therapy before the prescription is filled or delivered.
What potential problems are screened for in Medicaid prospective drug review?
Screening includes potential therapeutic duplication, drug–disease contraindications, drug interactions, incorrect dosage or duration, allergies, and clinical abuse or misuse.
What counseling offer is required for Medicaid prescriptions?
The pharmacist must offer counseling to each beneficiary or caregiver presenting a prescription. The offer is generally made in person when practicable or through a toll-free telephone service where required; counseling may be refused.
What topics should Medicaid counseling standards address?
Standards address professionally significant matters such as the medication’s name, dose and route, directions and precautions, important adverse effects and interactions, self-monitoring, storage, refills, and missed doses.
What information should Medicaid patient profiles include?
Pharmacies must make reasonable efforts to obtain and maintain profiles with relevant history, allergies, medications, and pharmacist comments.
Do Medicaid counseling requirements apply federally to every prescription?
No. These explicit federal counseling and prospective-review requirements apply to Medicaid-covered outpatient prescriptions; they are not a universal federal counseling mandate for every prescription and patient.
How must HIPAA-covered pharmacies protect health information?
HIPAA-covered pharmacies must protect protected health information with appropriate administrative, technical, and physical safeguards.