PHARMACO - VIGILANCE
OBJECTIVES OF THE COURSE
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)
5. Link the different topics covered in the course with the contents of other pharmacological and toxicological characterizing courses. Continuously updating through the consultation of scientific publications specific to the sector. (Learning skills).
Basic knowledge of Pharmacology and Pharmacotherapy is absolutely required
COURSE CONTENTS SUMMARY
- The Basics of Pharmacovigilance - The concept of risk - Mechanisms of
clinically relevant adverse reactions - Spontaneous reports of ADRs -
Pharmacoepidemiology, general concepts - The risk menagement -
Legislation in Pharmacovigilance - The
Historical examples of drug damage • Evolution of regulatory interventions in pharmacovigilance • Relevance of adverse drug reactions (ADRs) • Therapeutic appropriateness and iatrogenic pathologies • Classification, pathogenetic mechanisms, risk factors, epidemiology of ADRs • Drug safety in post-marketing phase • Attribution of causal relationship • Drug safety assessment: descriptive methods • Drug safety assessment: analytical methods • Italian Pharmacovigilance Network and suspected ADR alert card • ADRs of major organs and systems
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
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 that consists 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 30 minutes 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.
Frontal oral lesson in which the problems of Pharmacovilance are dialogically treated through the use of slides, used to support the study on the recommended textbook. The slides are loaded daily on the Elly platform elly.saf.unipr.it simultaneously to 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 teacher of Pharmacovigilance can be found by the students every day for a meeting after contact by e-mail.