- Docente: Alberto Vaccheri
- Credits: 2
- Language: Italian
- Teaching Mode: Traditional lectures
- Campus: Bologna
- Corso: Single cycle degree programme (LMCU) in Medicine and Surgery (cod. 8415)
Learning outcomes
At the end of this course students know: - the regulatory framework of medicinal products and other products with health claims (nutraceuticals and food supplements) - the basic rules for appropriate prescribing - drug prescription regulatory framework in the National Health System - key elements in the evaluation of risk/benefit and cost/benefit assessment - clinical trials of medicinal products - sources of information on medicinal products - key variables in drug prescription
Course contents
- The clinical development of a new medicinal product (from phase I to phase IV)
- Requirements and criteria for regulatory approval of a new
medicinal product
- Access to drug therapy by citizens: prescribing rules, OTC
medicinal products
- Reimbursement of medicinal products by the National Health
System
- Pharmacovigilance
- Sources of information on medicinal products
- Value and limitations of evidence-based medicine in
pharmacotherapy
- Evaluation of the risk/benefit balance of a medicinal
product
- Drug interactions
- Drugs in pregnancy, in childhood and in the elderly
- Therapeutic drug monitoring
Readings/Bibliography
1) Evan J. Begg - L'ESSENZIALE IN FARMACOLOGIA CLINICA (Ed. italiana a cura di F. De Ponti & P. Strahinja). EMSI, Roma, 2006
2) Guida all'uso dei farmaci 5 - ediz 2008: disponibile al sito http://www.guidausofarmaci.it/
3) Farmaci e gravidanza: http://www.farmaciegravidanza.org/
4) REAZIONI AVVERSE A FARMACI. SOSPETTO E DIAGNOSI, a cura di A.P. Caputi, F. De Ponti e L. Pagliaro, Raffaello Cortina, Milano, 2009
Teaching methods
Lectures
Assessment methods
Oral examination
Teaching tools
Teaching material is essential for examination and can be downloaded (access restricted to UNIBO student) at: campus.unibo.it
Office hours
See the website of Alberto Vaccheri