2024
Pharmacoepidemiology
Name: Pharmacoepidemiology
Code: CMS13744I
3 ECTS
Duration: 15 weeks/78 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese, English
Regime de Frequência: Presencial
Presentation
In this UC, concepts and methodologies of general epidemiology, clinical epidemiology and clinical pharmacology are presented to the study of the use and effects of medicines, and their application to pharmacoepidemiological studies, and the regulation in Pharmacovigilance and Pharmacoepidemiology.
Sustainable Development Goals
Learning Goals
The concepts and methodologies of general epidemiology, clinical epidemiology and clinical pharmacology will be explained and applied to the study of the use and effects of medicines.
At the end of the disciplin, students should have the skills and competences to consult and interpret pharmacoepidemiological studies with different types of designs in order to determine which therapeutic option presents the best benefit / risk ratio. Students should also be familiar with the regulations on Pharmacovigilance and Pharmacoepidemiology, the responsibilities of those involved in monitoring the safety of medicines and the constitution of the National Pharmacovigilance system.
At the end of the disciplin, students should have the skills and competences to consult and interpret pharmacoepidemiological studies with different types of designs in order to determine which therapeutic option presents the best benefit / risk ratio. Students should also be familiar with the regulations on Pharmacovigilance and Pharmacoepidemiology, the responsibilities of those involved in monitoring the safety of medicines and the constitution of the National Pharmacovigilance system.
Contents
Epidemiology and Pharmacoepidemiology: definition, problems, methodologies.
The natural history of medicines.
Legal and ethical aspects of pharmacoepidemiological research.
Types of pharmacoepidemiological studies: Clinical trials and Non-interventional studies. Main methodologies and designs used.
Pharmacoepidemiology in assessing the safety and efficacy / effectiveness of drugs.
The role of pharmacists and community pharmacies in carrying out studies on the use of medicines.
Pharmacovigilance. The National Pharmacovigilance System, Causal imputation, safety signal generation, safety signal confirmation, spontaneous notification procedures, risk estimation from spontaneous notification. Active pharmacovigilance.
The natural history of medicines.
Legal and ethical aspects of pharmacoepidemiological research.
Types of pharmacoepidemiological studies: Clinical trials and Non-interventional studies. Main methodologies and designs used.
Pharmacoepidemiology in assessing the safety and efficacy / effectiveness of drugs.
The role of pharmacists and community pharmacies in carrying out studies on the use of medicines.
Pharmacovigilance. The National Pharmacovigilance System, Causal imputation, safety signal generation, safety signal confirmation, spontaneous notification procedures, risk estimation from spontaneous notification. Active pharmacovigilance.
Teaching Methods
Teaching / learning takes place by integrating: i) theoretical classes using expository methods and active pedagogy; ii) theoretical-practical classes for discussion of works involving: a) discussion and critical analysis of scientific articles using various methodologies and designs of pharmacoepidemiological studies b) design of a study protocol to answer a research question proposed by the teacher related to effectiveness and / or drug safety.
In this UC the final assessment of learning results from the process of:
1. Continuous assessment: consisting of works developed / presented throughout the semester (40%) + a final theoretical exam (60%), or;
2. Final evaluation: consisting of a final global exam (100%).
In this UC the final assessment of learning results from the process of:
1. Continuous assessment: consisting of works developed / presented throughout the semester (40%) + a final theoretical exam (60%), or;
2. Final evaluation: consisting of a final global exam (100%).
Teaching Staff
- Ana Margarida Molhinho Advinha [responsible]
Certificações
