Pharmaceutical Legislation and Ethics Flashcards

What is the DHA regulation on pharmacy advertising and promotion?

Answer: Pharmaceutical advertising must be DHA-approved, truthful, balanced, and must not promote prescription-only medications to the public

DHA regulates pharmaceutical advertising requiring prior approval, truthful and balanced information, no direct-to-consumer promotion of prescription medications, and compliance with advertising standards.

What is the DHA pharmacovigilance requirement for pharmacists?

Answer: Pharmacists must actively monitor, identify, and report adverse drug reactions and contribute to post-marketing surveillance

DHA requires all pharmacists to participate in pharmacovigilance by monitoring for adverse drug reactions, reporting through the established system, and contributing to the safety surveillance of marketed medications.

What are the DHA requirements for maintaining pharmacy records?

Answer: Maintain dispensing records, controlled substance registers, prescription files, and inventory logs for a minimum period as specified by DHA

DHA requires comprehensive pharmacy record-keeping including dispensing logs, controlled substance registers with dual signatures, prescription files, inventory records, and temperature monitoring logs for specified retention periods.

What is the DHA stance on telepharmacy services?

Answer: Telepharmacy is permitted under specific DHA guidelines covering consultation, prescription verification, and medication counseling

DHA has established guidelines for telepharmacy services, allowing pharmacists to provide consultations, verify prescriptions, and offer medication counseling remotely within defined regulatory parameters.

What continuing professional development does DHA require for pharmacist license renewal?

Answer: Pharmacists must complete a specified number of CPD hours covering clinical updates, patient safety, and regulatory changes during each license cycle

DHA mandates continuing professional development hours for pharmacist license renewal, covering clinical knowledge updates, patient safety practices, new regulations, and emerging therapeutic areas.

What is the DHA regulation on emergency dispensing without a prescription?

Answer: Limited emergency supply may be provided for essential chronic medications to prevent treatment interruption, with documentation and prescriber follow-up

DHA permits limited emergency supply of essential chronic medications when a prescription is not immediately available, provided the pharmacist documents the supply and follows up with the prescriber for authorization.