42578 - Prescription of Drugs (A-K)

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

Please, see the section in Italian

Teaching methods

Lectures

Assessment methods

Oral examination to assess achievement of the skills detailed in the learning outcomes (see the Italian version for details)

Teaching tools

Teaching material can be downloaded from the institutional repository (access restricted to UNIBO students).

Office hours

See the website of Fabrizio De Ponti