ECTS credits ECTS credits: 3
ECTS Hours Rules/Memories Student's work ECTS: 51 Hours of tutorials: 3 Expository Class: 9 Interactive Classroom: 12 Total: 75
Use languages Spanish, Galician
Type: Ordinary subject Master’s Degree RD 1393/2007 - 822/2021
Departments: Psychiatry, Radiology, Public Health, Nursing and Medicine
Areas: Preventive Medicine and Public Health
Center Faculty of Medicine and Dentistry
Call: Second Semester
Teaching: With teaching
Enrolment: Enrollable | 1st year (Yes)
1. Justify the importance of pharmacovigilance, as a complement to clinical trials.
2. Describe the main methods in pharmacovigilance.
3. Critically read pharmacovigilance studies.
4. Define the concept of pharmaceutical drug use study and its role in health administration.
5. Describe the main indicators of quality and quantity of prescription.
6. Know the main types of drug use studies.
1. Origin of pharmacovigilance. Importance from the point of view of Public Health. Objectives and functions.
2. Individual methods in pharmacovigilance: Anecdotal notification of adverse drug reactions (ADR), voluntary notification of ADR, notification of events linked to the prescription.
3. Data sources for pharmacovigilance studies.
4. Epidemiological methods applied to pharmacovigilance: Statistics of morbidity and mortality. Cohort studies, and case-control studies.
5. Concept of Drug Use Studies. Objectives.
6. Classification of medications. Indicators of spending, consumption and quality.
7. Types of EUM studies.
8. Design of Drug Use Studies.
9. Data sources in Drug Use Studies
Laporte, Joan Ramon, " Principles of the epidemiology of medicine", Barcelona Masson-Salvat 1993.
Strom BL, ed. Pharmacoepidemiology 4th ed. West Sussex, England: John Wiley & Sons, Ltd. 2005.
Figueiras A, Caamaño F, Gestal Otero JJ. Methodology of the studies of medicine´s use in primary health care. Gac Sanit. 2000; 14 (3): 7-19.
Matos L. Farmacoepidemiology. Xunta de Galicia. Santiago de Compostela 1995.
Hartzema AG; Porta MS, Wilson HF. Pharmacopeidemiology. An introduction. Harvey Whitney Books. 2nd Ed. Cincinnati 1991
Acquire advanced knowledge on the methods of evaluation of medicines and their effects on patients: considered individually, on specific groups of the population and on the community in general, and highlighting the role played by the medicines in the framework of public health
Apply knowledge, methods and epidemiological reasoning to the study of the uses and adverse effects of medicines in human populations
Carry out a critical reading of a pharmacovigilance study and Drug Use Study.
Know the tools to design a protocol for a pharmacovigilance and Drug Use Study.
The course begins with a face-to-face initial class according to the academic calendar. In the rest of the classes, different distance teaching techniques will be used (materials on the web, articles, videos). For this objective, the Moodle platform will be used. Discussion forums will be formed, so that students can interact and discuss among themselves and/or with the professor.
The tutorials may be carried out in person, by email or by videoconference.
The exams, consisting in the critical reading of a scientific work, can be carried out in person or by videoconference, according to the student's preference
Participation in the discussion forums: 10%.
Critical reading of an essay : 90%
30 hours of course follow-up
15 hours of final work
1 hour exam
- Participar de forma activa en los foros de discusión de la asignatura.
- Participar en la tutoría on-line voluntaria que se realiza a un mes de la evaluación final.
Adolfo Figueiras Guzman
Coordinador/a- Department
- Psychiatry, Radiology, Public Health, Nursing and Medicine
- Area
- Preventive Medicine and Public Health
- Phone
- 881812276
- adolfo.figueiras [at] usc.es
- Category
- Professor: University Professor
Maruxa Zapata Cachafeiro
- Department
- Psychiatry, Radiology, Public Health, Nursing and Medicine
- Area
- Preventive Medicine and Public Health
- maruxa.zapata [at] usc.es
- Category
- Professor: LOU (Organic Law for Universities) PhD Assistant Professor