Teaching Methodologies
a) Expository classes using audiovisual and interactive media.
b) Work on the themes of the program, aimed at deepening the knowledge to be acquired.
c) Discussion of practical cases in class and analysis of articles in Journal Club format.
d) Analysis of databases of adverse drug reactions;
e) Written test / Written work
Types of evaluation:
i) Continuous assessment with discussion of case practical studies, written work and/or oral presentations.
ii) Final evaluation through final exam.
Learning Results
• Acquire knowledge and the development of attitudes and behaviours that allow the screening of adverse effectsassociated with the use of medicines and their notification to the National Pharmacovigilance System;
• Identify and characterize adverse drug reactions;
• Train for spontaneous notification of adverse drug reactions;
• Acquire knowledge in toxicology associated with the use of medicines;
• Understand the risks associated with the use of medicines, in self-medication and polymedication regimes;
• Characterize the types of medication errors and define prevention strategies;
• Characterize and anticipate possible interactions between drugs and other substances;
Program
• General Principles of Pharmacovigilance – History and Principles
• National Pharmacovigilance System – Pharmacovigilance in Portugal, Europe and the world. The role of EMA andWHO in Pharmacovigilance
• Adverse Drug Reactions (ADRs) – concepts, definition and examples
• Classification of ADRs: Rawlins and EIDOS / DoTS
• Pre-clinical evaluation; requirements for authorization and registration of medicines. Pharmacovigilance in clinicaltrials
• Drugs that act on the nervous system, musculoskeletal system, digestive system and metabolism, cardiovascularsystem, respiratory system and skin.
• Spontaneous reporting of ADRs
• Pharmacovigilance databases
• Causality assessment – Naranjo, WHO classification
• Concepts of medication errors, polymedication and self-medication
• Drug Interactions
• Pharmacokinetics and Toxicokinetics – Factors that modify the toxicity of drugs.
• Treatment of acute drug poisoning – Antagonists and Antidotes
Internship(s)
NAO
Bibliography
• INFARMED I.P. (2019) – Farmacovigilância em Portugal – 25 anos
• Mann, Ronald D., and Elizabeth B. Andrews, eds. Pharmacovigilance, 2007.
• World Health Organization. (2002). The importance of pharmacovigilance.
• Fornasier, G., Francescon, S., Leone, R., & Baldo, P. (2018). An historical overview over Pharmacovigilance.IJCP,40(4), 744-747.
• Ferner, Robin E., and Jeffrey K. Aronson. “EIDOS.” DrSaf 33.1 (2010): 15-23.
• Aronson, J. K. (Ed.). (2015). Meyler’s side effects of drugs: the international encyclopedia of adverse drug reactionsand interactions.
• Kaeding, M., Schmälter, J., & Klika, C. (2017). Pharmacovigilance in the European Union.
• Lodola, A., & Stadler, J. (Eds.). (2011). Pharmaceutical Toxicology in Practice: A Guide to Non-clinical Development.John Wiley & Sons.
• Aronson, J. K. (2009). Medication errors: definitions and classification. BJCP, 67(6), 599-604.
• Rolfes, L. (2018). Patient participation in pharmacovigilance: Rijksuniversiteit Groningen.