The teaching is organized as follows:

Learning outcomes

------------------------ MM: FARMACOLOGIA GENERALE E SPECIALE ------------------------ General aims Aim of the course is education in pharmacology, i.e. reach a firm understanding that a drug is a tool intended to modify the wellbeing of the patients by interacting with molecular components of the cells and tissues. This interaction leads to modulation of physiological and pathological processes responsible of health and disease. The student will learn to use his/her knowledge in basic biomedical sciences with the goal of understanding the mechanism of action of a compound and the generation of therapeutic and toxic effects and adverse reactions. The student will appreciate the links connecting the effects (beneficial and adverse) with the plasmatic levels of a drug. Accordingly, he will learn the basic principles guiding the generation of plasma levels and their temporal changes and the effects of individual properties (genetic, metabolic, presence of diseases) on these dinamic changes. During the course teachers and students will explore the proprties (mechanisms of action, therapeutic, adverse rections, pharmacokinetic) of classes of drugs active on the Nervous System (Central, Periferal and Autonomic), on the Cardiovascular, the gastrointestinal and the endocrine systems; the pharmacological modulation of inflammatory, immune, infective and oncological processes will also be addressed. Specific aims At the end of the course the student will: know the rationale of therapies in order to select and use drugs on the basis of the pathology, the health of the patient, the scientific evidences of effectivness. He/she will also be able to monitor the efficacy of the therapy, the generation of positive symptoms and of adverse reactions. know the classification of drugs also in the context of the National Health System, how to prescribe a drug and the use of appropriate data bases also in the context of the Italian National Health System. kown the preclinical and clinical development of drugs, the organization of clinical studies and will be able to critically read the results of clinical studies and the use of their results in the daily practice understand the basic pharmacodynamic principles governing drug-receptor interaction and the generation of the effects with focus on signal transduction generated by activation/inhibition of drug receptors such as enzymes, ion channels, receptors for endogenous mediators with special interest to ligand activated ion-channel, G protein coupled receptors and intracellular receptors. understand the basic principles of pharmacokinetics know how to use pharmacokinetic criteria and data to establish individualized therapeutic regimens know for each class of drug the mechanism(s) of action and the symptoms generated in order to monitor efficacy and possible toxicity of the therapy; know the major differences between drugs belonging to a same class of drugs and the criteria for the selection for individualized therapy know the pharmacological properties, as described above, of the following classes of drugs: • active on the autonomic, peripheral and central nervous system • used in pulmunary diseases • active on the cardivascular system • active on the metabolic/endocrine systems • used for the control of infectious diseases • use to control inflammatory conditions • active on the immunesystem • used in oncology ------------------------ MM: FARMACOVIGILANZA ------------------------ At the end of the Pharmacovigilance module, the student must have achieved the following objectives: > Understand the etiopathogenetic mechanisms of adverse drug reactions > Understand the international classification of adverse drug reactions > Know the main epidemiological data on adverse drug reactions > Know the most important methods for the study of drug safety > Know to fill out a report of adverse drug reaction

Program

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MM: FARMACOLOGIA GENERALE E SPECIALE
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Detailed programme of the course Drug and placebo definition; historic and modern views of drugs Bioequivalent and biosimilar drugs Drug classification in Pharmacology and by the National Health System Drug development, clinical trials and postmarketing monitoring Pharmacodynamics: drug-receptor interaction, signal transduction and effect generation Pharmacokinetics: general principles, absorption, distribution, elimination and drug metabolism Pharmacogenetics and drug therapy individualization Pgharnmacogenetics and biotransformation of drugs Drugs acting on the autonomic system Drugs acting on the respiratory system Drugs active on the gastrointestinal system Drugs affecting platelet aggregation, the coagulation system including fibrinolytic agents Drugs for the control of dislipidemic states Drugs acting on the Periferal and the central Nervous System Drugs interacting with autacoids Pharmacology of the inflammation Drugs for the cardiovascular system and the therapies of cardiovascular disorders Ipoglicemic drugs including insulin Drugs active on the immune system Drugs used for the control of infections Antineoplastic therapies
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MM: FARMACOVIGILANZA
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WHO and EMA definitions of Adverse Drug Reaction (ADR) International Classification of ADRs: Types A, B, C, D, E, F Serious and non-serious adverse reactions: distinctive criteria; specific and non-specific ADRs Epidemiology of ADRs; data on morbidity and mortality Pathogenetic mechanisms of ADRs: dose-dependent and -independent; allergic reactions; pharmacogenetic reactions; teratogenicity; carcinogenesis Drugs in pregnancy and breastfeeding Pediatric adverse drug reactions Adverse drug reactions in the elderly patients Drug-drug interactions as cause of ADR Economic impact of ADRs Pharmacovigilance definition and history The reasons and objectives of Pharmacovigilance Main methodologies for the study of drug tolerability The Italian ADRs reporting system Italian and European pharmacovigilance legislation The Italian reporting card: criteria for compilation The Vigifarmaco Platform (on-line reporting) ADR reporting by citizens Web Searching and Big-Data

Bibliography

Examination Methods

Oral exam with question of general principles as well as on specific drugs and/or classes of drugs in a therapeutic context