Learning objectives
PHARMACOVIGILANCE
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).
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
At the end of the training activity the student should have acquired knowledge and skills related to the economic analysis of health interventions in the following terms:
1. Understanding the mechanisms underlying the health economy, methods of economic analysis and clinical development of medicines and health technologies (Knowledge and understanding)
2. Acquire the ability to correctly apply the main techniques of economic analysis in the health sector and be able to detect the health and non-health costs (ability to apply knowledge and understanding)
3. Acquire knowledge of pharmacoeconomic terminology and the consequent communicative competence and be able to communicate the results of the studies even to an untrained public (Communication skills)
4. Knowing how to evaluate the research and development path of new drugs and health technologies and to identify and critically analyze the evidence in the literature (Autonomy of judgment)
5. Link the different topics dealt with each other and with the disciplines of pharmaceutical legislation / pharmacy management. Continuously updating through the consultation of scientific publications specific to the sector (Learning skills)
Prerequisites
No one
Course unit content
PHARMACOVIGILANCE
Historical and regulatory bases of the PharmacoVigilance (PhV) - Adverse reactions to drugs (ADRs): type, classification, Relevance – ADRs Reporting and signals: causality assessment - National and international agencies/institutions involved in the PhV information flow - Pharmacoepidemiology, RCT and observational studies - Descriptive and analytical methods in PhV - Therapeutic inappropriateness and drug safety - Special organ/apparatus PhV elements
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
• Introduction and historical background of PharmacoVigilance (PhV) • Evolution of regulatory interventions in PhV • Adverse Drug Reactions (Adrs); typology, classification, relevance • Reporting of suspected ADRs, attribution of causality assessment, algorithms and causality scales, signal detection • National and international agencies/institutions (AIFA, EMA, .) involved in PhV information flow, • data mining • Database EUDRAVIGILANCE • Epidemiological PhV, descriptive and analytical methods • RCTs, observational studies and meta-analysis • Therapeutic inappropriateness and drug safety in older patients • PhV of OTC/SOP drugs• Off-label use of medications and safety • Special organ/apparatus PhV elements
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 immediately after 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 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
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
Oral frontal Lessons, Exercises and case-history-focused tutorials of widely-used drugs or with particular problems encountered during the professor's professional activity in the pharmaceutical industry.
Assessment methods and criteria
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 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.
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 is provided if the answer is incorrect
Other information
PHARMACOVIGILANCE
The teacher is available every day after contact by e-mail
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
The teacher can be contacted by e-mail
