Labeling, Patient Counseling, Documentation, and Privacy
What the label must show
The dispensed prescription label must include the pharmacy name, address, and telephone number; the prescription number; the date filled; the patient name; the prescriber's name; directions for use; quantity; number of refills (or none); and required cautionary statements, including the federal "Caution: Federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed." for controlled substances. An expiration or beyond-use date should reflect the manufacturer's expiration or the assigned BUD from compounding standards.
Counseling
An offer to counsel must be made for each new prescription, and counseling should occur when the pharmacist judges it necessary (e.g., changed dose, new device, high-risk drug). Counseling is a pharmacist function - technicians may support but not substitute. If the patient declines, document the refusal; unanswered offers should also be documented. Utah standards expect counseling in a private area where practicable.
Documentation and privacy
Maintain records of interventions, refusals, prescriber clarifications, and transfers. HIPAA requires limiting disclosures to the minimum necessary for treatment, payment, or operations, honoring patient rights (access, amendment, accounting, restriction requests), and safeguarding protected health information; business associate agreements are needed for vendors handling PHI. Utah confidentiality statutes add extra protection for certain categories such as mental health and HIV-related information.
Traps
Assuming HIPAA permits any disclosure to a prescriber's whole office staff, or that a signed authorization is never needed. Assuming verbal counseling can always be replaced by a printed leaflet.
Rule of thumb
"Offer, document, verify": offer counseling, document the outcome, verify identity before releasing PHI or dispensing to a third party.