62170 - Pharmacovigilance and Pharmacoepidemiology

Learning outcomes

The aim of this course is to provide elements on the rational use of drugs through pharmacovigilance and pharmacoepidemiology. At the end of the course the students know:

 the procedures for commercializing drugs;

 the Italian National Health Service: pharmaceutical assistance;

 the methodologies for the quantitative and qualitative monitoring of drugs;

 the application of epidemiological methodologies on the use of drugs;

 National and European legislation on pharmacovigilance;

 the main mechanisms of side effects, adverse reactions and risk factors;

 the national pharmacovigilance network and the management of the single reporting form for suspected adverse reactions (ADR);

 reliable sources for drug information;

 the concepts and methodologies used to carry out pharmacoepidemiology studies.

Course contents

PHARMACOVIGILANCE MODULE (3 CFU - Dr. Luigi Patregnani)

• Process of a drug: preclinical development, clinical trials and commercialization;

• Ethics committees and reference legislation;

• Monitoring of quantitative and qualitative consumption of drugs and application of epidemiological methods on the use of drugs;

• Introduction to Pharmacovigilance: definition, aims and objectives;

• Definitions and classification of adverse reactions (ADR): definition, classification, incidence, analysis of risk factors, relapses and costs; drug interactions; pharmacokinetic variability; pharmacogenetics; rational prescriptions;

• Pathogenetic mechanisms of adverse reactions and predisposing factors;

• Active and passive pharmacovigilance;

• Spontaneous reporting and the single reporting form for suspected adverse reaction (ADR);

• Methods in Pharmacovigilance. National Network and New European Regulations;

• Vaccine surveillance;

• Pharmacovigilance in veterinary medicine;

• Medical devices (MD), classification and surveillance system of MD and in vitro diagnostic medical devices;

• Phytovigilance;

• Cosmetovigilance;

• Correct compilation of the rsingle eporting form for suspected adverse drug reaction and inclusion in the FNR. Presentation and discussion of cases of adverse reactions;

• Elements of Pharmacoeconomics.

PHARMACOEPIDEMIOLOGY MODULE (2 CFU - Dr. Luigi Patregnani)

• 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;

• Classification of drugs based on the supply and delivery by the National Health Service;

• ATC and DDD classification of medicines;

• Regulatory, scientific and ethical aspects of generic and biosimilar medicines;

• Innovative drugs, orphan drugs and advanced therapies;

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

Readings/Bibliography

The teaching material and the slides provided by the teacher are published on the specific website.

Reference texts:

- 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

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 achievements 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 the Pharmacoepidemiology module takes place through a written exam, consisting of 31 questions with 4 multiple answers, of which only one is correct. The questions concern the whole program of the course.

Verification of learning for the Pharmacovigilance module takes place through an oral exam, based on questions that will focus on the topics covered during the course. The student's ability to be able to deal with the required topics in a transversal and critical manner will be assessed. Students who master the subject and possesses the specific language will be evaluated with marks of excellence.

The final grade derives from the weighted average of the marks of the two modules.

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 [https://virtuale.unibo.it/]

Office hours

See the website of Luigi Patregnani