Pharmacology and Drug Administration Flashcards

What is the MOH drug registration process for medications sold in the UAE?

Answer: Comprehensive evaluation of safety, efficacy, and quality data, including clinical trial evidence, manufacturing quality, and bioequivalence studies for generics

MOH drug registration requires comprehensive dossier review covering preclinical and clinical safety/efficacy data, manufacturing quality (GMP compliance), stability studies, and bioequivalence data for generic medications.

What controlled substance scheduling system does MOH use?

Answer: A multi-schedule classification system aligned with international conventions categorizing drugs by abuse potential and medical use

MOH uses a controlled substance scheduling system aligned with UN conventions, classifying drugs based on abuse potential and medical utility into categories with progressively stricter prescribing, dispensing, and storage requirements.

What is the MOH regulation on generic medication substitution?

Answer: Pharmacists may substitute with bioequivalent generics unless the prescriber specifies no substitution, with patient informed consent

MOH permits pharmacist-led generic substitution with bioequivalent products unless the prescriber explicitly prohibits it, requiring patient information and consent for the substitution.

What pharmacovigilance system does MOH operate?

Answer: National ADR reporting system, signal detection, periodic safety update reviews, and post-marketing surveillance of registered medications

MOH operates a national pharmacovigilance system including mandatory ADR reporting by healthcare professionals, signal detection and analysis, periodic safety update reviews, and post-marketing surveillance programs.

What medication safety standards does MOH require in healthcare facilities?

Answer: High-alert medication policies, look-alike/sound-alike safeguards, medication reconciliation, barcode verification, and medication error reporting and analysis

MOH requires comprehensive medication safety including high-alert drug identification and safeguards, LASA management, medication reconciliation at care transitions, technology-assisted verification, and non-punitive error reporting.

What herbal and traditional medicine product regulations does MOH enforce?

Answer: Registration requirements, quality and safety standards, labeling and packaging rules, health claim restrictions, and post-market surveillance

MOH regulates herbal and traditional medicine products through registration requirements, quality control standards, proper labeling and packaging, restrictions on unsubstantiated health claims, and ongoing safety surveillance.