Learning objectives
PHARMACOVIGILANCE
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).
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
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
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 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
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 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
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
Lectures with the help of slides, used to support the study of the recommended text. On the Elly platform will also be made available links to enjoy 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.
Assessment methods and criteria
PHARMACOVIGILANCE
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
ECONOMIC ANALYSIS OF HEALTH CARE INTERVENTIONS
The assessment of the achievement of the objectives of the course through evaluation of learning provides a written test structured in 5 closed multiple choice questions evaluated with a scale of 0-30. Each question involves the acquisition of 6/30 in the case of an exact reply, in the case of a partial reply 3/30 and in the case of a wrong answer or not given 0/30. As the COVID-19 pandemic continues, if it is not possible to carry out profit tests in the presence, The tests will be carried out remotely through the sharing of examination questionnaires on the MS Teams platform by the examiner in compliance with the procedures described in the specific guide (http://selma.unipr.it). The results of the exam are published
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
