Pharmacoepidemiology

Not applicable.

M1. Students should organize their learning process by valuing the skills of learning to learn and to work
collaboratively. From the bibliographic support recommended, students will integrate their knowledge, producing
group work and holistically analyzing practical cases that they report in the classroom. It is up to the teacher to act as a
facilitator of individual and group learning processes.
M2. The learning of students in this discipline will be done fundamentally through the study of theoretical material and
the analysis and discussion of practical cases.
M3. Students will be encouraged to work in groups, through collaborative knowledge dissemination tools, their
commitment and relation with these means being one of the relevant factors in learning the content.
The acquisition of knowledge is proven through a written evaluation test (60%) and carrying out a bibliographic
research work with presentation and/or through problem-based learning cases discussion (40%).

O1 – Develop skills and competencies within the epidemiological reasoning process in the context of drug utilization.
O2 – Acquire knowledge on methodologies for planning, execution and evaluation of drug utilization studies (DUS) ,
aiming to characterize the pattern of drug consumption and to promote the rational use of medicines.
O3 – Acquire knowledge about the data collection, data treatment and data analysis of drug utilization in nonexperimental
study models, specifically drug utilization studies, cohort studies, case-control and cross-sectional
studies to determine risk and exposure to drugs, and in experimental study models, specifically in clinical trials.
O4 – Apply concepts and methodologies of general epidemiology, clinical epidemiology and pharmacology to the study
of the use and effects of medicines.

1. General principles of Pharmacoepidemiology
1.1. Pharmacoepidemiology – Definition and concepts associated with the development of pharmacoepidemiological
studies.
1.2. Epidemiological indicators: Association measures and Impact measures in Epidemiology;
1.3. Pharmacoepidemiology studies design
2. Epidemiological studies
2.1. Observational Studies (cross-sectional, case-control, cohort)
2.2. Experimental Studies
2.3. Clinical Trials
2.4. Pharmacoeconomic studies
2.5. Confusion factors and bias in epidemiological studies
3. Drug utilization studies
3.1. Analysis of problem-cases in self-medication, medication errors, adherence to therapy, polypharmacy
3.2. Risk-Benefit assessment
3.3. Real-World Evidence
4. Application of epidemiology in pharmacy

NAO

Main

• Strom, Brian L., ed. Pharmacoepidemiology. John Wiley & Sons, 2006
• COBERT, Barton – Cobert’s manual of drug safety and pharmacovigilance. 2nd ed. Sudbury, MA : Jones & Bartlett Learning, 2012.

Secondary

• Hartzema AG, Porta M, Tilson HH. Pharmacoepidemiology. An introduction. 3rd edition. Harvey Whithney Books Company, 1998.
• World Health Organization. Adherence to long-term therapies: evidence for action. 2003.
• World Health Organization. Introduction to drug utilization research. World Health Organization, 2003.
• Wettermark, Björn, et al. “Introduction to drug utilization research.” Drug Utilization Research: Methods and Applications (2016): 1-12.
• Andrews, Elizabeth B., and Nicholas Moore, eds. Mann’s Pharmacovigilance. John Wiley & Sons, 2014.
• Ferner, Robin E., and Jeffrey K. Aronson. “EIDOS.” Drug safety33.1 (2010): 15-23.
• Aronson, J. K. (Ed.). (2015). Meyler’s side effects of drugs: the international encyclopedia of adverse drug reactions and interactions. Elsevier.
• Kaeding, M., Schmälter, J., & Klika, C. (2017). Pharmacovigilance in the European Union.
• Aronson, J. K. (2009). Medication errors: definitions and classification. British journal of clinical pharmacology, 67(6), 599-604.