Pharmacoepidemiology and Public Health

Not applicable

• Lectures using audiovisual and interactive resources.
• Group work on topics of the program, aimed at deepening the knowledge to be acquired.
• Presentation and discussion of professional practice cases
• The assessment will include participation, a written test and the presentation of group work.

The framework of contents allows the acquisition of knowledge and skills to understand the Health System, the relevance of Public Health and its relationship with the use of medicines. It allows the acquisition of skills to carry out Drug Use Studies and their pharmacoepidemiological basis and the relationship with the safety aspects of the drug. Allows the acquisition of skills related to risk management and practical aspects of Pharmacovigilance

The Curricular Unit aims to create skills for the acquisition of knowledge about the epidemiological methodology applied to the study of the benefit-risk associated with the use of medication.

• The acquisition of basic knowledge about the methodologies for planning, executing and evaluating drug consumption studies, aiming at characterizing the drug consumption pattern and, consequently, promoting the rational use of the drug.
• The acquisition of knowledge about the collection, treatment and analysis of data related to the use of medicines
• The acquisition of knowledge and the development of attitudes and behaviors that allow them a motivated and adequate participation in the screening of adverse effects associated with the use of medications and their notification to the National Pharmacovigilance System.
• To learn the ability to apply concepts and methodologies of epidemiology and pharmacology to the study of the use and effects of medication, as well as knowledge about the organization and role of Public Health in its relationship with medication.

Pharmacoepidemiology (16 h)

• Introduction and concepts of Public Health – History, evolution, health indicators – 2 h
• Areas of Public Health intervention. Health in Portugal, Europe and the World. Identification of the main health needs and problems. National Health System. Main health programs and projects at national and international level. – 2 h
• Pharmacoepidemiology – Definition and concepts associated with the development of pharmacoepidemiological studies. Basic concepts. Epidemiological indicators. – 6 h
• Types of epidemiological studies: Study Designs in Epidemiology; Types of Observational Studies; The dimensions of epidemiological/ Observational studies; Types of Experimental Studies; Morbidity and Mortality Indicators; Measures of Association in Epidemiology; Impact Measures in Epidemiology; clinical trials
• Bradford Hill causality criteria. – 2 h
• Benefit-risk continuous assessment. Detection and investigation of safety signals
• Confounding factors and biases.
• Drug use studies – Study analysis: self-medication, medication errors, adherence to therapy, polymedication – 4 h
• Pharmacoeconomic studies

Pharmacovigilance (14 h)

• General Principles of Pharmacovigilance – 1 h
• The National Pharmacovigilance System – Pharmacovigilance in Portugal, Europe and the world. The role of EMA and WHO in Pharmacovigilance – 1 h
• Adverse reactions – concepts, definition and examples – 2 h
• Classification of Adverse Drug Reactions: Rawlins and EIDOS/DoTS – 2 h
• Signal generation – qualitative/quantitative methods. Databases in Pharmacovigilance – 1 h
• Spontaneous notification of adverse reactions – 1 h
• Causality. Causality imputation – Naranjo Algorithm, WHO classification – 2 h
• Cardiovascular, gastrointestinal, CNS, respiratory, ocular ADRs – 2 h
• Drug safety assessment. Pre-clinical safety assessment; requirements for authorization and registration of medicines. Pharmacovigilance in clinical trials – 1 h
• Risk assessment and management; Identification and quantification of drug risks – 1 h

NAO

Main references:

• 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 references:

• 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.