PHARMACO - VIGILANCE
Learning outcomes of the course unit
At the end of the training activity the student should have acquired knowledge and skills related to the safety of drugs, tools, figures and structures involved in pharmacovigilance.
In particular, the student should be able to
1. Understanding the mechanisms behind adverse drug-induced reactions (Knowledge and understanding).
2. Being able to critically analyze the generation and flow of suspicious ADR reports within the pharmacovigilance network (Ability to apply knowledge and understanding).
3. Be able to communicate the results of pharmacovigilance studies to an untrained public even in the form of lexically appropriate formal documents (Communication skills).
4. Knowing how to evaluate the therapeutic benefits and risk profiles of a given drug in the context of the assessment of innovation (Making judgments)
Course contents summary
Historical and regulatory bases of the PharmacoVigilance (PhV) - Adverse reactions to drugs (ADRs): type, classification, Relevance – ADRs Reporting and signals: causality assessment - National and international agencies/institutions involved in the PhV information flow - Pharmacoepidemiology, RCT and observational studies - Descriptive and analytical methods in PhV - Therapeutic inappropriateness and drug safety - Special organ/apparatus PhV elements
• Introduction and historical background of PharmacoVigilance (PhV) • Evolution of regulatory interventions in PhV • Adverse Drug Reactions (Adrs); typology, classification, relevance • Reporting of suspected ADRs, attribution of causality assessment, algorithms and causality scales, signal detection • National and international agencies/institutions (AIFA, EMA, .) involved in PhV information flow, • data mining • Database EUDRAVIGILANCE • Epidemiological PhV, descriptive and analytical methods • RCTs, observational studies and meta-analysis • Therapeutic inappropriateness and drug safety in older patients • PhV of OTC/SOP drugs• Off-label use of medications and safety • Special organ/apparatus PhV elements
1) Reazioni avverse a farmaci A.P.Caputi, F De Ponti, L. Pagliaro (Ed.
2009) Raffaello Cortina Editore 2) Cobert's Manual of Drug Safety &
Pharmacovigilance (2nd edition, 2011) Jones and Bartlett Learning
Frontal oral lesson with slides, used to support the study on the recommended textbook, which will be loaded daily on the Elly platform immediately after the lesson. To download the slides, it will be necessary to enroll in the online course. Slides are considered an integral part of teaching material.
The student at the end of the course, using the acquired knowledge, must demonstrate to have understood and to be able to apply the basic concepts of pharmacovigilance
Assessment methods and criteria
The assessment of the achievement of the objectives set by the course through evaluation of the learning will be performed with a written test structured in:
- six multiple response closed questions (3/30 score for each correct answer);
- three open questions (4/30 score for each correct answer);
The duration of the written test will be 1 hour and the test will be evaluated on a scale of 0-30. Laude is given in the case of achieving the highest score and using mastery of the disciplinary vocabulary in the texts of open questions.
Exam results are published on the Esse3 portal within 3 days of the exam date. Students can view the exam, after appointment with the teacher.
The teacher is available to receive students in presence (in the office) or at a distance via video call on MS Teams every day after contact by e-mai