Learning objectives

The aim of this course is to provide elements on the use, effectiveness and safety of drugs through pharmacovigilance and pharmacoepidemiology.

At the end of the course the students will know: the National and European legislation on pharmacovigilance; 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; the main mechanisms of side effects, adverse drug reactions (ADRs) and risk factors; ADR spontaneous reporting system and prescribing appropriateness; healthcare utilization databases; strengths and limitations of the spontaneous reporting systems; drug-drug interactions; pharmacovigilance in special populations (e.g., children, elderly, pregnant women); vaccines pharmacovigilance; risk management plan; PSUR; PASS and PAES studies;
reliable sources for drug information; the concepts and methodologies used to carry out pharmacoepidemiology studies; confounders, biases, including exposure and outcome misclassification; to write a study protocol and to interpret study results in pharmacoepidemiology and pharmacovigilance.

Prerequisites and basic notions

Knowledge of basic and clinical pharmacology

Program

Pharmacoepidemiology Module: Introduction to pharmacoepidemiology, different types of real-world data and general principles of real-world evidence, totality of evidence, observational study designs (case-control studies, cohort and cross-sectional studies, case-only studies), definition and management of confounding factors and bias, critical reading of observational studies. Pharmacovigilance Module: Introduction to Pharmacovigilance, Adverse Drug Reactions (ADRs): classification and terminology, Spontaneous reporting of ADRs, Causality assessment, International databases, disproportionality analysis, Generation and management of safety signals, PASS and PAES studies in pharmacovigilance and risk minimization measures, Active pharmacovigilance and sentinel systems, Pharmacovigilance in special populations – Pregnancy and breastfeeding, Pediatrics and Geriatrics, Pharmacovigilance in clinical drug trials, Lessons from the history of pharmacovigilance: thalidomide, diethylstilbestrol, rofecoxib, cerivastatin. cisapride, Vaccine Pharmacovigilance (vaccinovigilance), Risk Communication in PV

Bibliography

Didactic methods

Frontal lessons

Learning assessment procedures

Oral exam with a question on Pharmacoepidemiology and one on Pharmacovigilance

Evaluation criteria

Grade expressed out of thirtieths. The assessment takes into account both the concepts illustrated during the lessons and the technical language skills and the ability to make connections on topics that cut across the various lessons.

Exam language

italiano

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