PHARMACO - VIGILANCE

Teachers: 
BALLABENI Vigilio
Credits: 
5
Year of erogation: 
2021/2022
Unit Coordinator: 
Disciplinary Sector: 
Pharmacology
Semester: 
Second semester
Year of study: 
4
Language of instruction: 

Italian

Language of instruction: 

Italian

Learning outcomes of the course unit

At the end of the training the student should have acquired knowledge and skills related to drug safety, tools, figures and organisms involved in the PV being able to:
1. Understanding the underlying mechanisms of Adrs (knowledge and understanding).
2. Critically analysing the generation and flow of suspicious ADR reports within the PV network (ability to apply knowledge and understanding).
3. Communicating PV data and information also to an inexperienced public through formal lexically appropriate documentation (communication skills).
4. Evaluating the therapeutic advantages and risk profiles in the overall evaluation of a new drug (autonomy of judgment)
5. Linking the topics covered in PV teaching with the contents of the course of Pharmacology and Pharmacotherapy and to be continuously updated through the consultation of scientific literature and institutional sources (learning skills).

At the end of the training the student should have acquired knowledge and skills related to drug safety, tools, figures and organisms involved in the PV being able to:
1. Understanding the underlying mechanisms of Adrs (knowledge and understanding).
2. Critically analysing the generation and flow of suspicious ADR reports within the PV network (ability to apply knowledge and understanding).
3. Communicating PV data and information also to an inexperienced public through formal lexically appropriate documentation (communication skills).
4. Evaluating the therapeutic advantages and risk profiles in the overall evaluation of a new drug (autonomy of judgment)
5. Linking the topics covered in PV teaching with the contents of the course of Pharmacology and Pharmacotherapy and to be continuously updated through the consultation of scientific literature and institutional sources (learning skills)

Prerequisites

No one

Course contents summary

Bases of Pharmacovilance (PV), adverse drug reactions (ADRs). New drug safety in preclinical and clinical (pre-marketing) studies. Spontaneous reporting, causality assessment, regulatory agencies. Post-marketing PV, observational and interventional clinical studies.
Appropriate use of medications in elderly. Elements of organ/apparatus PV

Historical and regulatory bases of Pharmacovilance (PV), adverse drug reactions (ADRs).
New Drug safety in preclinical and clinical (pre-marketing) development
Spontaneous reporting, signals, causality assessment, national/international PV regulatory agencies
Post-marketing PV, descriptive and analytical methods, observational and interventional clinical studies
Therapeutic inappropriateness, use of medications in elderly and deprescription approach
Safety of over-the-counter drugs and in off-label use, Elements of organ/apparatus PV

Course contents

• Introduction and historical background on Pharmacovigilance (PV)
• Evolution of regulatory interventions in PV
• Adverse reactions to drugs (ADRs); type, classification, relevance
• Safety studies of new drugs: pre-clinical data and pre-registration trials
• Spontaneous reports of suspected ADRs, vaccinovigilance
• Causality assessment, decision-making algorithms, signal generation
• Data flow in the national PV network,
• National and international bodies and agencies (AIFA, EMA, .) involved in the PV
• Data mining in PV databases (EUDRAVIGILANCE)
• Epidemiological aspects of PV, Descriptive and analytical methods
• Observational studies, interventional studies. meta-analysis/systematic reviews
• Therapeutic inappropriateness, PV in elderly and deprescription approach
• PV of over-the-counter drugs and off-label use of medications
• Notes on organ/apparatus PV

• Introduction and historical background on Pharmacovigilance (PV)
• Evolution of regulatory interventions in PV
• Adverse reactions to drugs (ADRs); type, classification, relevance
• Safety studies of new drugs: pre-clinical data and pre-registration trials
• Spontaneous reports of suspected ADRs, vaccinovigilance
• Causality assessment, decision-making algorithms, signal generation
• Data flow in the national PV network,
• National and international bodies and agencies (AIFA, EMA, .) involved in the PV
• Data mining in PV databases (EUDRAVIGILANCE)
• Epidemiological aspects of PV, Descriptive and analytical methods
• Observational studies, interventional studies. meta-analysis/systematic reviews
• Therapeutic inappropriateness, PV in elderly and deprescription approach
• PV of over-the-counter drugs and off-label use of medications
• Notes on organ/apparatus PV

Recommended readings

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

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 with the help of slides that will be uploaded regularly on the Elly platform (after each lesson) and that will be available upon registration online to the course. Continuing the COVID-19 pandemic emergency, 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 making available on Elly the links to find the recordings of the lessons

Frontal oral lessons with the help of slides that will be uploaded regularly on the Elly platform (after each lesson) and that will be available upon registration online to the course. Continuing the COVID-19 pandemic emergency, 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 making available on Elly the links to find the recordings of the lessons

Assessment methods and criteria

At the end of the course, the assessment of learning involves the performance of a written structured test through the administration of a questionnaire consisting of:
- six multiple choice questions (3/30 for each correct answer);
- three open-ended questions (4/30 for each correct answer);
The duration of the written test (including the answers to the questionnaire ECONOMIC ANALYSIS OF HEALTH INTERVENTIONS) is 1 hour and is evaluated on a scale of 0-30. The assignment of a 30/30 with honors occur in the case of the achievement of the maximum score coupled with lexically appropriate performance in open-ended questions.
The results of the exam are published on the Esse3 portal within 3 days from the date of the exam. Students can view the details of their exam, by appointment with the teacher.
Continuing the COVID-19 pandemic emergency, the examinations will be carried out at a distance individually by sharing the questionnaire from the computer of the examiner who will ask the candidate to identify/formulate the correct answers.

At the end of the course, the assessment of learning involves the performance of a written structured test through the administration of a questionnaire consisting of:
- six multiple choice questions (3/30 for each correct answer);
- three open-ended questions (4/30 for each correct answer);
Eligibility will be achieved by reaching an assessment of 18/30 or more
Continuing the COVID-19 pandemic emergency, the tests will be carried out at a distance individually by sharing the questionnaire from the computer of the examiner who will ask the candidate to identify/formulate the correct answers

Other informations

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