42578 - Prescription of Drugs (L-Z)

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