91064 - Pharmacovigilance and Pharmacoepidemiology

Learning outcomes

At the end of the course the student: - knows the national and European regulations on pharmacovigilance; - knows and knows how to apply the epidemiological methodologies for drug surveillance in an appropriate manner; - knows and knows how to apply the procedures for the management of drugs after marketing; knows the main mechanisms of drug damage, the main adverse reactions and risk factors for their onset; - can handle reports of adverse drug reactions; - knows how to use databases of adverse drug reactions; - can identify reliable sources of information on medicines; - acquires the concepts and methods used to carry out studies of pharmacoepidemiology.

Course contents

PHARMACOVIGILANCE MODULE (3 CFU - Dr. Giulia Sita)

• Introduction to Pharmacovigilance: definition, aims and objectives
• Drug Iter: preclinical development, clinical drug evaluation
• Ethics committees: regulatory and ethical aspects
• Adverse Drug Reactions (ADRs): definition, classification, incidence, risk factor analysis, spillovers and costs; drug interactions; pharmacokinetic variability; pharmacogenetics; rational prescribing.
• Pathogenetic mechanisms of adverse reactions and predisposing factors.
• Active and passive pharmacovigilance.
• Spontaneous reporting and the report card
• Methods in Pharmacovigilance. National Network and New European Regulation
• Phytovigilance
• Cosmetovigilance
• Pharmacovigilance in veterinary medicine
• Vaccinovigilance
• Medical devices (MDs), classification and the vigilance system of MDs and in vitro diagnostic medical devices;
• Correct completion of the suspected ADRs report form and entry in the NN. Presentation and discussion of cases of adverse reactions
• Elements of Pharmacoeconomics

PHARMACOEPIDEMIOLOGY MODULE (2 CFU - Dr. Giulia Sita)

• Pharmacoepidemiology: definitions, methods, statistical quantities and practical applications
• Advantages and limitations of experimental and observational studies
• Pre-registration experimental studies of drugs and vaccines and AIC procedures. Concepts of superiority, equivalence and non-inferiority. Efficacy and effectiveness
• Clinical trials in pediatrics in Europe.
• Regulatory, scientific and ethical aspects of equivalent medicines and biosimilars
• Innovation in pharmacotherapy: orphan drugs and advanced therapies
• Off-label use of medicines: regulatory, scientific, and ethical aspects
• The ATC and DDD classification of medicinal products

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

Teaching methods

The course is organized in lectures.

Attendance to lessons is compulsory for 60% of lesson hours, as per the study program regulations, and is fundamental in the learning process of teaching.

Assessment methods

The end-of-course exam aims to evaluate the achievement of the educational objectives:

• To know the theoretical and methodological principles underlying pharmacoepidemiology and pharmacovigilance
• To know the fundamentals of pharmacoepidemiology and evidence-based medicine in drug evaluation
• To know the pharmacovigilance system and the pharmacist's responsibilities in terms of pharmacovigilance
• To acquire the ability to critically analyze pharmacoepidemiological research and pharmacovigilance studies

Verification of learning for both modules is through an oral examination, consisting of questions that will cover the topics covered in the course. The student's ability to deal cross-culturally and critically with the required topics will be assessed. Students who master the subject and possesses the specific language will be evaluated with marks of excellence.

Teaching tools

Didactic material: the didactic material presented in class will be available to the students in electronic format at the following link: https://virtuale.unibo.it

Office hours

See the website of Giulia Sita