Pharmacovigilance and Drug Safety

General knowledge on Pharmacology and Toxicology

The unit framework allows for the acquisition of knowledge and skills for understanding Pharmacovigilance systemsand adverse reactions related to medicines and their identification with a view to improving pharmacological care forpatients. It allows the acquisition of skills to identify drug-related problems in the general population (aspolymedication, self-medication misuse, drug interactions, misuse, abuse of medication, medication errors) and therelationship with the safety aspects of the drug. Allows the acquisition of skills related to risk management andpractical aspects of Pharmacovigilance.

The presentation of the theoretical framework allows an adequate explanation of the contents on concepts ofPharmacovigilance and Drug Safety. The theoretical-practical component of the teaching methodology allows, inaddition to the structured exposure of the contents, the exemplification of research and applicability to real situations,practical cases resolution and exploration of pharmacovigilance databases. The development and presentation of theworks enhances the development of capacities to carry out autonomous work to acquire individual knowledge andskills, provides moments of reflection and interaction that promote a critical spirit, and promotes the study andresearch on the exposed contents.

• Acquire knowledge and the development of attitudes and behaviours that allow the screening of adverse effectsassociated with the use of medicines and their notification to the National Pharmacovigilance System;
• Identify and characterize adverse drug reactions;
• Train for spontaneous notification of adverse drug reactions;
• Acquire knowledge in toxicology associated with the use of medicines;
• Understand the risks associated with the use of medicines, in self-medication and polymedication regimes;
• Characterize the types of medication errors and define prevention strategies;
• Characterize and anticipate possible interactions between drugs and other substances;

• General Principles of Pharmacovigilance – History and Principles
• National Pharmacovigilance System – Pharmacovigilance in Portugal, Europe and the world. The role of EMA andWHO in Pharmacovigilance
• Adverse Drug Reactions (ADRs) – concepts, definition and examples
• Classification of ADRs: Rawlins and EIDOS / DoTS
• Pre-clinical evaluation; requirements for authorization and registration of medicines. Pharmacovigilance in clinicaltrials
• Drugs that act on the nervous system, musculoskeletal system, digestive system and metabolism, cardiovascularsystem, respiratory system and skin.
• Spontaneous reporting of ADRs
• Pharmacovigilance databases
• Causality assessment – Naranjo, WHO classification
• Concepts of medication errors, polymedication and self-medication
• Drug Interactions
• Pharmacokinetics and Toxicokinetics – Factors that modify the toxicity of drugs.
• Treatment of acute drug poisoning – Antagonists and Antidotes

Theoretical exposition, resolution of practical cases, analysis of studies, individual research and work on a topic to be defined within the scope of the Curricular Unit.
The assessment comprises a moment of written and/or oral assessment (50%) and the development and presentation of an individual work (50%).

• Continuous assessment with discussion of case studies, written assignments and oral presentations.
• Final exam.

NAO