PHARMACO - VIGILANCE/PHARMACOECONOMICS
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.
The teaching of Pharmacoeconomics (part of the integrated teaching Pharmacovigilance / Pharmacoeconomics) aims to provide knowledge about the basic principles of pharmacoeconomics and the core elements in pursuit of the correct decision-making processes in the field of pharmacoeconomic.
The course also provides the methodological tools and skills for the assessment of economic impacts related to pharmacological interventions and health.
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
- The health care spending. Health demand and supply.
- The pharmaceutical expenditure and consumption of drugs in Italy.
- The equivalent (generic) drugs.
- The pharmacoeconomics: definition, objectives and perspectives.
- The methods of analysis (cost-effectiveness analysis, cost-utility analysis).
- Costs: survey and prospects.
- The information sources.
• 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
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
Information on any textbooks and teaching materials will be provided directly by the teacher.
Through oral lecture integrated with power point slides, the course content will be presented and discussed.
Assessment methods and criteria
The assessment of the achievement of the objectives of the course consists of a written exam. Through the use of a printed questionnaire with closed/open questions it will be determined whether the student has achieved the goal of knowledge and understanding of the content.