PHARMACOVIGILANCE AND HOSPITAL MEDICINES
Academic year and teacher
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- Versione italiana
- Academic year
- 2019/2020
- Teacher
- LUCA FERRARO
- Credits
- 9
- Didactic period
- Primo Semestre
- SSD
- BIO/14
Training objectives
- The course of Pharmacovigilance and hospital medicines provides solid practical foundations for future pharmacist and hospital pharmacists. The pharmacist today has shifted more toward providing information and instruction about appropriate drug use. Pharmacists have become a consultant on drug therapy and can contribute to the safe use of drugs. Efficacy, safety and quality of the drugs are three most important characteristics in any registration criteria. However, pre registration research/studies on theses aspects cannot be extrapolated to effectiveness of drugs under real user conditions. Drug related morbidity including adverse drug reaction is a universal costly problem. In this context, Pharmacovigilance is recognised as the pharmacological discipline essential for understanding the safety of medicines. Pharmacovigilance monitors the safety of a drug once it has been launched onto the market. It detects medicines that cause serious adverse drug reactions and ensures they are re-evaluated or removed from the market to protect public health. It is related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance identify adverse events and their rates with the possible risk factors. An understanding of the clinical aspects of adverse reactions is a fundamental requirement which helps to understand the benefit, harm, effectiveness and risk of medicines. As a discipline, pharmacovigilance is intimately linked to pharmacology, drug development, clinical research, and impacts on many specialist areas such as, medical practice and public health. Pharmacovigilance is a demanding science
Key features of the course include to:
¿ Asses all aspects of hospital pharmacy including pharmacy, dispensary and drug distribution, administration and management, aseptic compounding, pharmacoeconomics and medicines information.
¿ Demonstrate an understanding of, and critically evaluate, issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects.
¿ Contribute to reduce the risk of drug-related problems in healthcare systems, including children, elderly, pregnant and lacting women.
¿ Identify, quantify, document and communicate adverse drug reactions. Safety Reporting, Safety Systems and Processes, Signal Detection and Risk assessment.
¿ Increase knowledge and understanding of factors and mechanisms which are responsible for drug-related injuries, drug-drug and food-drug interactions.
¿ Gain an understanding of important pharmacoepidemiological concepts and methods can be applied to specific pharmaceutical risk management Prerequisites
- The students must have an educational background within “Biochemestry”, “Physiology”, “Basic Pathology”, “Pharmacology and Pharmacotherapy”.
To take the final examination (learning assessment procedures), students must have passed the exam of Pharmacology and pharmacoterapy. Course programme
- Course contents:
HOSPITAL PHARMACY
• History of the hospital pharmacy
• Organization of a Pharmaceutical Department
• Role of the hospital pharmacist
• EAHP standards of the hospital pharmacy
• The department pharmacist
Preclinical experimentation
• Clinical experimentation: the phases of clinical development
• Drawings of experimental studies
• Efficacy of clinical trials (Nuremberg Code, Helsinki Declaration, GCP)
• The ethics committee
• Profit / non-profit experimentation
• Evidence based medicine
• Observational studies
• Role of the hospital pharmacist in clinical trials
reading and understanding of a RCT protocol
Development and marketing of drugs
• Registration and marketing
• Registration procedures
• Compassionate use and named patient program "
• Off-label drugs "
• Rare diseases and orphan drugs
• The reimbursement classes
• Prescribing appropriateness: AIFA notes, therapeutic plan, AIFA monitoring registers
• The classification method according to the ATC / DDD system "
reading and understanding of a study observation protocol
• Equivalent and biosimilar medicines
• Information flows of the pharmaceutical prescription
contrast agents, vaccines
FARMACOVIGILANZA
• History of pharmacovigilance
• Definition and classification of adverse drug reaction
• Definition and classification of adverse drug reaction
• Pathogenic mechanisms of adverse reactions and predisposing factors
• Attribution of the causal relationship
• Active and passive pharmacovigilance
• Active and passive pharmacovigilance
• Spontaneous reporting and the report card
• Active and passive pharmacovigilance
• The Head of Pharmacovigilance
• Additional monitoring
• Risk managment plan
• The national network and supranational pharmacovigilance organizations. National, European and international regulations on pharmacovigilance. Main databases.
Pharmacovigilance in clinical trials
Vaccine vigilance
Meddra terminology
AEFI
compilation of the ADR report form
phytovigilance
Cardiovascular adverse reactions, haematological dermatological
endocrine-metabolic, gastroenterological, neurological Didactic methods
- Course structure
¿ Teaching include traditional lectures.
¿ Exercises for the correct compilation of the sheet reporting suspected adverse drug reaction. Presentation and discussion of case report of adverse reactions. Learning assessment procedures
- Assessment methods
The assessment of learning will be carried out with an oral test that will be oriented both to the verification of learning of the general concepts of hospital pharmacy and pharmacovigilance and to the implementation of these concepts through the compilation of adverse reaction form or equivalence assessments of principles active according to the ATC classification Reference texts
- Mann’s. Pharmacovigilance, 3rd Edition. Edited by: Elizabeth B. Andrews, Nicholas Moore Editors Wiley-Blackwell
Goodman e Gilman, "Le basi farmacologiche della terapia", McGraw-Hill
Caputi, De Ponti, Pagliaro, “Reazioni avverse a farmaci – Sospetto e diagnosi” – Raffaello Cortina Editore.
Sito AIFA. www.agenziafarmaco.gov.it
Sito Farmacovigilanza. www.farmacovigilanza.org
Self-directed learning is facilitated by the provision of detailed course material.
