62170 - Pharmacovigilance and Pharmacoepidemiology

Learning outcomes

At the end of the course the student knows:

• the National and European Legislation on Pharmacovigilance;
• the epidemiological methods for drug surveillance;
• the procedures for the management of drugs after marketing;
• the main mechanisms of drug toxicity, the main adverse reactions (ADRs) and the risk factors for their onset;
• the managment of ADRs reports;
• the databases of ADRs;
• the identification of reliable sources of information on drugs;
• the concepts and methodologies used to carry out pharmacoepidemiological studies.

Course contents

MODULE PHARMACOVIGILANCE (4 CFU - Prof. Fabiana Morroni)

• Introduction to Pharmacovigilance: definition, aims and objectives
• The process of drug development and regulatory aspects: preclinical development, clinical evaluation of drugs
• Ethics committees: regulatory and ethical aspects
• Definitions and classification of adverse drug reactions (ADR): definition, classification, incidence, analysis of risk factors, and costs; drug interactions; pharmacokinetic variability; pharmacogenetics; rational prescriptions.
• Pathogenetic mechanisms of ADR and predisposing factors
• Active and passive pharmacovigilance
• Spontaneous reporting and the reporting form
• Methods in Pharmacovigilance. The national network and supranational pharmacovigilance organizations. National, European and international regulations on pharmacovigilance. Main databases.
• Causality Assessment in Pharmacovigilance.
• Phytovigilance
• Cosmetovigilance
• Pharmacovigilance in veterinary medicine
• Vaccinovigilance
• Pharmacovigilance in medical devices
• Exercises for the correct compilation of the sheet reporting suspected adverse drug reaction. Presentation and discussion of case report of adverse reactions
• Introduction to Pharmacoeconomics

MODULE PHARMACOEPIDEMIOLOGY (2 CFU - Prof. Domenico Motola)

• Pharmacoepidemiology: definitions, methods, statistical quantities and practical applications

• Advantages and limitations of experimental and observational studies

• Preregistrative experimental studies of drugs and vaccines and AIC procedures. Concepts of superiority, equivalence and non-inferiority. Efficacy and effectiveness

• Clinical trials in paediatrics in Europe

• Regulatory, scientific and ethical aspects of equivalent drugs and biosimilars

• Innovation in pharmacotherapy: orphan drugs and advanced therapies

• Off-label use of drugs: regulatory, scientific and ethical aspects

• The ATC and DDD classifications of drugs

Readings/Bibliography

Lecture files and the notes taken in class are essential for the preparation of the exam.

Lecture files are available at: https://virtuale.unibo.it

Students can refer to:

- Mann’s. Pharmacovigilance, 3rd Edition. Edited by: Elizabeth B. Andrews, Nicholas Moore Editors Wiley-Blackwell
- Caputi, De Ponti, Pagliaro, “Reazioni avverse a farmaci – Sospetto e diagnosi” – Raffaello Cortina Editore.

Teaching methods

ectures and seminars.

Attendance at the course is mandatory for 60% of class hours.

Assessment methods

The exam of both modules will consist in an oral test aimed at assessing the student's understanding and knowledge of the topics set out during the course. The achievement by the student of an organic vision of the issues addressed during the course and the use of an appropriate specific terminology will be assessed with a mark of excellence.

The marks obtained for each module, in proportion to the number of credits, contribute to the final grade of thirty.

Teaching tools

PC, websites.

The lecture files are available at: https://virtuale.unibo.it

Office hours

See the website of Fabiana Morroni

See the website of Domenico Motola