Learning objectives
At the end of the course the student is expected to be able to:
- Understand the nature and mechanisms underlying the side effects of ADRs and drug safety.
- to know the basic elements of the Pharmacovigilance-
- know the rules of Pharmacovigilance.
- know how to use the acquired knowledge for the control and monitoring of the drugs on the market
Prerequisites
No one
Course unit content
- 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
Full programme
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
Bibliography
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
Teaching methods
Frontal oral lesson with slides, used to support the study on the recommended textbook, which will be loaded daily on the Elly platform.
Continuing the COVID-19 pandemic, the frontal lessons in the presence will be made available also remotely in synchronous-streaming (in compliance with the class schedule) through the MS Teams application. In this case, always on the Elly platform will be made available links concerning the recordings of the lessons conducted in streaming.
Assessment methods and criteria
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.
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 (joined with the test of “ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS”) 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.
With the persistence of the pandemic COVID-19, if it is not possible to carry out the examinations of profit in presence, the tests will be carried out at a distance through the sharing of examination questionnaires on the MS Teams platform by the examiner in accordance with the procedures described in the specific guide (http://selma.unipr.it).
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.
Other information
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
