PHARMACO - VIGILANCE
Learning outcomes of the course unit
The course aims to enable the student to know and understand the basic elements related to the Pharmacovigilance system also in order to allow the student the ability to use the knowledge and understanding for the control and surveillance of marketed drugs. The course also aims to provide the knowledge and ability to understand concerning the nature and the mechanisms underlying the adverse effects of drugs.
Course contents summary
- The Basics of Pharmacovigilance
- The concept of risk
- Mechanisms of clinically relevant adverse reactions
- Spontaneous reports of ADRs
- Pharmacoepidemiology, general concepts
- The risk menagement
- Legislation in Pharmacovigilance
- The protagonists of Pharmacovigilance and the situation in Italy and Europe
• Historical examples of damage from drugs
• Evolution of regulatory interventions in Pharmacovigilance
• Relevance of adverse drug reactions ( ADRs)
• Therapeutic appropriateness and " iatrogenic diseases "
• Classification , pathogenesis , risk factors , epidemiology of ADRs
• Safety of the marketed drugs
• Attribution of causality assessment
• Drug safety assessment: descriptive methods
• Drug safety assessment: analytical methods
• Italian Network of Pharmacovigilance and report form for suspected ADR
• ADRs of the major organ systems
1) Reazioni avverse a farmaci
A.P.Caputi, F De Ponti, L. Pagliaro
(Ed. 2009) Raffaello Cortina Editore
2) Cobert's Manual of Drug Safety & Pharmacovigilance
(2nd edition, 2011) Jones and Bartlett Learning
Oral lecture integrated with power point slides. The student at the end of the course, using the knowledge gained will need to demonstrate knowledge and understanding about the rules of Pharmacovigilance, as these are motivated, edited and shown to users.
Assessment methods and criteria
The assessment of the achievement of the objectives of the course consists of a written exam. Through questions about the contents of the course will be determined whether the student has achieved the goal of knowledge and understanding of the content.