PHARMACOVIGILANCE
Academic year and teacher
If you can't find the course description that you're looking for in the above list,
please see the following instructions >>
- Versione italiana
- Academic year
- 2016/2017
- Teacher
- SERGIO TANGANELLI
- Credits
- 1
- Didactic period
- Secondo Semestre
- SSD
- BIO/14
Training objectives
- 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 Pharmacovigilance – principles, methodologies, risk management & pharmacoepidemiology and pharmacoeconomy.
-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, considering children, elderly, pregnant and lacting women.
-Identify, quantify, document and communicate adverse drug reactions.
-Adverse drug reactions – mechanisms, analysis, reporting, vulnerable populations
-Increase knowledge and understanding of factors and mechanisms which are responsible for drug-related injuries
-Drugs interactions – epidemiology, mechanisms, detection and prevention
-Gain an understanding of important pharmacoepidemiological concepts and methods can be applied to specific pharmaceutical risk management
-Principles of optimal pharmacotherapy
-Clinical trials – bioethics of drug safety, pharmacovigilance in trial design, applications for marketing authorisation
-Regulatory framework and legislation Prerequisites
- The students must have an educational background within biochemestry, physiology, basic pathology, pharmacology and pharmacotherapy
Course programme
- General and specific aims of Pharmacovigilance.
Pharmacovigilance – principles, terminology, methodologies and risk management.
Benefit-Risk Assessment
Pre-Clinical and Clinical Aspects of Pharmacovigilance. Translational research in clinical trials
Post-Marketing Safety Surveillance
Clinical Drug Safety. Data analysis and epidemiology.
Good Pharmacovigilance Practices.
Adverse drug reactions in terms of – definitions, classification, diagnosis, monitoring, management, prevention and epidemiology.
Drugs in Pregnancy and Lactation.
Metodology: spontaneous reports of suspected adverse drug reactions. Case report. Blind, not blind and randomized controlled clinical trails.
How, what, when and who should report and compilate the suspected adverse reaction sheet
Regulatory and Legal Basis of Pharmacovigilance Didactic methods
- Teaching include traditional lectures.
Exercises for the correct compilation of the sheet reporting suspected adverse drug reaction. Learning assessment procedures
- The examination is written, lasting one hour and is aimed at verifying the proper preparation of the student. In particular, it is formulated of 10 questions; 6 of which are in the true / false formula and other 4 that require a short comment relating to risk management in adverse reactions induced by drugs and the utility that their knowledge plays in the medical and pharmacological practice. Each correct answer is worth 1 point, the wrong answer or not formulated, 0 points.To pass the exam is need to acquire a minimum of 18 points out of 30.
Reference texts
- Mann’s. Pharmacovigilance, 3rd Edition. Edited by: Elizabeth B. Andrews, Nicholas Moore Editors Wiley-Blackwell
Drug Safety Evaluation, Shayne Cox Gad, Wiley
Drug Benefits and Risks: International Textbook of Clinical Pharmacology Chris van Boxtel, Budiono Santoso, Ralph Edwards ley
