Pharmacology and Drug Administration Flashcards

What antimicrobial resistance (AMR) strategy does MOH implement?

Answer: National action plan including surveillance, antimicrobial stewardship, infection prevention, public awareness, and research collaboration

MOH's AMR strategy includes national resistance surveillance, antimicrobial stewardship programs in healthcare facilities, infection prevention measures, public awareness about antibiotic misuse, and research into new treatments.

What medication pricing regulation does MOH enforce?

Answer: Reference pricing system, price controls for essential medications, pharmacy margin regulations, and insurance reimbursement guidelines

MOH regulates medication pricing through reference pricing systems, price ceiling controls for essential medications, pharmacy dispensing margin regulations, and coordination with insurance reimbursement requirements.

What clinical trial regulation does MOH enforce?

Answer: Ethics committee approval, informed consent, ICH-GCP compliance, adverse event reporting, and investigational product management requirements

MOH regulates clinical trials through ethics committee review and approval, mandatory informed consent, compliance with ICH Good Clinical Practice guidelines, adverse event reporting, and investigational drug management.

What pharmacy inspection and compliance program does MOH operate?

Answer: Regular unannounced inspections covering licensing compliance, medication storage, controlled substances, dispensing practices, and documentation

MOH conducts regular unannounced pharmacy inspections evaluating licensing compliance, proper medication storage conditions, controlled substance management, dispensing accuracy, documentation, and professional standards.

What vaccine supply chain management does MOH oversee?

Answer: National cold chain management, stock monitoring, wastage tracking, distribution logistics, and quality assurance from manufacturer to administration point

MOH manages the national vaccine supply chain including cold chain integrity, stock level monitoring, wastage minimization, efficient distribution logistics, and quality assurance at every stage from receipt to administration.

What medical device regulation does MOH enforce?

Answer: Registration requirements, quality and safety standards, post-market surveillance, adverse event reporting, and recall procedures for medical devices

MOH regulates medical devices through registration/classification requirements, quality and safety standards compliance, post-market surveillance programs, adverse event reporting, and structured recall procedures.