Learning objectives
1. Knowledge and understanding. The teaching of Pharmacovigilance aims to provide students with the knowledge of pathogenic mechanisms and predisposing factors that underlie the noxiousside effects of drugs.
2. Applied knowledge and understanding. At the end of the course student must be able to apply the regulations and procedures of Pharmacovigilance for the management of the safety of marketed drugs having understood concepts and methodologies related to pharmacoepidemiology studies.
3. Autonomy of judgment. At the end of the course students must be able to use the databases of ADR and identify reliable sources of information by independently reworking the knowledge related to the appropriate/ inappropriate use of drugs
4. Communication skills. Student must acquire a clear and simple technical-scientific language, so that they can communicate the knowledge learned in all public and private health areas in which the graduate in Pharmacy is called to operate.
5. Ability to learn. Students must have acquired the ability to refine and deepen their knowledge of Pharmacovigilance, and to update their own professional skills, through the consultation of regulatory documents, guidelines, specialized texts and critical reading of scientific articles related to pharmacoepidemiological studies.
Prerequisites
No one
Course unit content
- The Basics of Pharmacovigilance - The Concept of Adverse Drug Reaction (ADR) and ADR Classification - The system of spontaneous reporting of suspected ADR - Safety study in preclinical development and clinical evaluation of drugs - Regulatory bases of the Pharmacovigilance - Organs, organisms and figures of the drug surveillance in Italy and Europe
Full programme
Introduction to Pharmacovigilance: definition, aims and objective • Milestone of Pharmacovigilance history • Regulatory tools for drug surveillance in Italy and EU • Definitions and classification of adverse drug reactions (ADR) • Pathogenetic mechanisms of ADR and predisposing factors • National network for the reporting of suspected ADR • Safety evaluation in Preregistrative experimental studies of new drugs and post-markerting drug surveillance • Advantages and limitations of experimental and observational clinical studies • Active and passive pharmacovigilance • Main ADR Databases of supranational pharmacovigilance organizations • Main organ target of drug toxicity
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 lessons will be held using slides , which will be uploaded daily on the Elly platform immediately after the respective lesson. Slides are considered an integral part of the teaching material. As part of the teaching activity, in addition to the lectures, a weekly synchronous in-itinere test will be held within classroom to encourage direct interaction between teacher and learners, allowing students to informally verify the learning acquired on recent topics treated in the last lessons.
Assessment methods and criteria
The assessment of the learning outcomes occurr through a written test structured as follows: - six multiple-choice questions closed (evaluation equal to 3/30 for each exact answer); - three open-ended questions (evaluation equal to 4/30 for each correct answer); The time available for the test is 1 hour. The achievement of the maximum score (all correct answers) accompanied by adequate use of the technical-scientific language and mastery of the lexicon in answering to open-answers questions, will be evaluated with a grade of excellence (30/30 cum laude).. The results of the exam are published on the ESSE3 portal within 3 days from the date of the exam. Students can view their exam by appointment with the teacher.
Other information
The teacher is available to receive students, in presence or electronically, every day by prior contact by e-mail
