Introduction to Drug Surveillance. Adverse drug reactions (ADRs): classification, mechanisms, risk factors. Causality relationship. Regional systems of drug surveillance. ADRs in the elderly, in pregnancy and lactation, in paediatric patients. ADRs from drug interactions. Main ADRs in relation to organs and organ systems. ADR signaling and its epidemiological evaluation. Clinical trials. Observational studies. Epidemiological studies. Meta-analyses.
Caputi AP, De Ponti F, Pagliaro L. Reazioni avverse a Farmaci - Sospetto e diagnosi. R. Cortina Ed.
Learning Objectives
The course provides the basic terminology used in drug surveillance; the knowledge of informatic tools for the study of drug risk/benefit ratio; the basis for understanding the significance of the systems for the spontaneous signalling of adverse drug reactions (ADRs); the basis for understanding the role of the pharmacist in drug surveillance; the acquisition of the ability to critically read a pharmacoepidemiological study.
Prerequisites
Courses required: General Pharmacology, Pharmacology and Pharmacotherapy I and II, Chemotherapy
Courses recommended: Pathology
Teaching Methods
Lectures with slides
Further information
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Type of Assessment
Oral exam
Course program
Introduction to Drug Surveillance. Adverse drug reactions (ADRs): classification, mechanisms, risk factors. Causality relationship. Regional systems of drug surveillance. ADRs in the elderly, in pregnancy and lactation, in paediatric patients. ADRs from drug interactions. Main ADRs in relation to organs and organ systems. ADR signaling and its epidemiological evaluation. Clinical trials. Observational studies. Epidemiological studies. Meta-analyses.