Learning objectives
PHARMACOVIGILANCE
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
- acquire the knowledge of Pharmacovigilance specific terminology and the resulting communicative competence
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
At the end of the training activity, the student should have acquired knowledge and skills regarding the Economic Analysis of Health Care Activities in the following terms:
- Acquire the ability to apply the main methods for the economic evaluation of the health care programmes.
- Know and understand the health costs.
- Know how to evaluate the clinical development of the new drugs and new technologies.
- Identify and analyse critically the evidence in literature.
- Acquire knowledge of pharmacoeconomic terminology and the resulting communicative skill
Prerequisites
No one
Course unit content
PHARMACOVIGILANCE
- 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 protagonists of Pharmacovigilance and the situation in Italy and Europe
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
Acquisition of the basic elements of health economics and economic analysis methods in health care. Acquisition of the knowledge of health economic methods: cost-effectiveness, cost-utility analysis and cost minimization techniques. Principles and concepts of outcome research, epidemiology and cost in health care. Concepts about development and price of medicines and health technologies.
Full programme
PHARMACOVIGILANCE
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
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
• Evolution of health-care expenditure and future prospects.
• The health-care system.
• Pharmaceutical market and regulatory policy.
• Health economics principles.
• Health-care costs.
• Main analysis techniques: cost minimization analysis, cost-effectiveness analysis, cost-benefit analysis.
• The concept of DDD (Defined Daily Dose).
• Drug epidemiology.
• Interventional and observational clinical studies and the importance of the economic data.
• The research and the critical evaluation of the evidence in literature.
• The ICER.
• The concept of QALY (Quality-Adjusted Life Year).
• Clinical research and new drug/ new technologies development.
Bibliography
PHARMACOVIGILANCE
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
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
Drummond, O'Brien, Stoddart, Torrance. Methods for the Economic Evaluation of Health Care Programmes
Teaching methods
PHARMACOVIGILANCE
Frontal oral lesson with slides, used to support the study on the recommended textbook, which will be loaded daily on the Elly platform where, to support the teaching activity will be made available the links concerning the recordings of the lessons conducted in streaming.
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.
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
Teaching is based on frontal oral lessons and lessons conducted in streaming. The slides, used to support the study on the recommended textbook, will be loaded weekly 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.
Assessment methods and criteria
PHARMACOVIGILANCE
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.
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
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: - ten multiple response closed questions (3/30 score for each correct answer); Penalty of -1/30 is provided for each incorrect answer . The duration of the written test (joined with the test of “Pharmacovigilance”) will be 1 hour and the test will be evaluated on a scale of 0-30.
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
PHARMACOVIGILANCE
The teacher is available to receive the students all the days in his office or remotely via video call on MS Teams after contact by e-mai
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
The teacher is available to receive the students remotely via video call on MS Teams after contact by e-mail (Giovanni.cremonesi@outlook.it)
2030 agenda goals for sustainable development
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