2024
Drug Risk Management and Patient Safety
Name: Drug Risk Management and Patient Safety
Code: CMS13762I
3 ECTS
Duration: 15 weeks/78 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
This UC presents the importance, methodologies and national and European systems of pharmacovigilance, and the processes of identification, assessment of suspicions and the characteristics of adverse reactions to drugs, in order to improve patient safety.
Sustainable Development Goals
Learning Goals
1. To understand the importance of pharmacovigilance as a fundamental element of drug risk management and patient safety;
2. To know the European and National Pharmacovigilance system;
3. To know and understand the methodologies in pharmacovigilance;
4. To know and evaluate the risk minimization measures;
5. To identify, process and evaluate suspected adverse drug reactions;
6. To know the clinical characteristics of the most common adverse drug reactions in each of the anatomophysiological/therapeutic groups (ATC);
7. Identify and evaluate the main key points related to medication, within the scope of patient safety.
2. To know the European and National Pharmacovigilance system;
3. To know and understand the methodologies in pharmacovigilance;
4. To know and evaluate the risk minimization measures;
5. To identify, process and evaluate suspected adverse drug reactions;
6. To know the clinical characteristics of the most common adverse drug reactions in each of the anatomophysiological/therapeutic groups (ATC);
7. Identify and evaluate the main key points related to medication, within the scope of patient safety.
Contents
1. Introduction to pharmacovigilance;
2. European and National Pharmacovigilance System;
3. Pharmacovigilance methodologies;
4. Risk minimization measures and patient safety communication;
5. Adverse drug reactions;
6. Patient safety: medication in transition of care; in polypharmacy; and in high-risk situations.
2. European and National Pharmacovigilance System;
3. Pharmacovigilance methodologies;
4. Risk minimization measures and patient safety communication;
5. Adverse drug reactions;
6. Patient safety: medication in transition of care; in polypharmacy; and in high-risk situations.
Teaching Methods
Theoretical-practical teaching will be integrated, expository and constructivist. In TP sessions, students should learn the main theoretical concepts, putting them into practice, with the critical analysis of scientific articles and resolution of practical cases. The fieldwork will be carried out under the protocol of the University of Évora - INFARMED, at the Regional Pharmacovigilance Unit of Center and North Alentejo.
The evaluation will be divided into two stages:
1. Continuous assessment:
- TP (60%), 30% theoretical test at the end of the semester and 30% group work;
- TC (40%), individual work.
For approval, the student must obtain a weighted average of 9.5 or more.
2. Evaluation by final exam (100%).
For approval, the student must obtain a rating equal to or greater than 9.5 values.
The evaluation will be divided into two stages:
1. Continuous assessment:
- TP (60%), 30% theoretical test at the end of the semester and 30% group work;
- TC (40%), individual work.
For approval, the student must obtain a weighted average of 9.5 or more.
2. Evaluation by final exam (100%).
For approval, the student must obtain a rating equal to or greater than 9.5 values.
Teaching Staff (2023/2024 )
- Ana Margarida Molhinho Advinha [responsible]
- Ana Margarida Molhinho Advinha [responsible]