Pharmacoepidemiology and Pharmacovigilance

Code:

MI255105

Acronym:

FARFAR

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2025/2026 - 1S

Active?	Yes
Responsible unit:	Pharmacology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	173	MICF - Transition Study Plan 2023/24 - 2024/25 - 2025/26	5	-	3	28	81

Teaching language

Portuguese
Obs.: Suitable for English-speaking students

Objectives

Pharmacoepidemiology and Pharmacovigilance examines the use, effectiveness, and safety of medications within populations by integrating principles of pharmacology and epidemiology. It focuses on studying patterns of drug utilization, identifying adverse drug reactions, and evaluating the long-term risks and benefits of pharmacological interventions in real-world settings. The course emphasizes methods for designing and analyzing data from observational studies, clinical trials, and post-marketing surveillance to ensure medications are used appropriately and safely on a population scale.

Learning outcomes and competences

• To compare typical pharmacoepidemiological study designs and identify strengths and weaknesses of each one.


• To be able to use drug utilization data as an exposition metric.


• To understand pharmacovigilance systems and causal analyses of adverse drug reactions.

Working method

Presencial

Program

• What is pharmacoepidemiology?


• Disease and drug classifications


• Databases with interest for pharmacoepidemiology


• PROMs (patient-reported outcome measures) & PREMs (patient-reported experience measures)


• Medication adherence to prescribed regimes


• Measures of frequency, association and impact


• Pharmacoepidemiologic study designs


• Validity (face, intern e extern)


• Bias, confounders and control


• Drug utilization studies


• Pharmacovigilance: concepts and definitions


• Coding systems in pharmacovigilance


• Adverse drug reactions causality imputing

Mandatory literature

Storm BL, Kimmel SE, ed; Textbook of pharmacoepidemiology. ISBN: 978-1-119-70107-1
Storm BL, Kimmel SE, Hennessy S, ed. ; Pharmacoepidemiology. ISBN: 978-1-119-41341-7
Cabrita, J.; A farmacoepidemiologia e a avaliação do beneficio/risco do medicamento, 2021. ISBN: 978-9-895-29966-9

Comments from the literature

Along with the theoretical classes, notes will be provided with text that may appear on the final exam.

Teaching methods and learning activities

Theoretical and practical teaching focuses on active learning through conceptual debates, execution, analysis, and discussion of practical experiences.

Theoretical classes are intended to provide a general introduction to each topic, serving as guidance and a complement to independent work.

Practical classes are designed to provide in-depth understanding and the acquisition of skills in the practical application of the concepts learned in theoretical classes.

keywords

Health sciences > Pharmacological sciences > Pharmacy

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	70,00
Trabalho prático ou de projeto	30,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Frequência das aulas	20,25
Trabalho laboratorial	20,25
Estudo autónomo	40,50
Total:	81,00

Eligibility for exams

According to assessment rules at FFUP.

Calculation formula of final grade

FINAL GRADE (0-20) = Practical assessment (0-6) + theoretical component assessment (0-14)

The theoretical component will be assessed by a final exam.
The practical component will be assessed by the arithmetic mean of the marks obtained in mini-tests carried out in each laboratory (or TP).

Special assessment (TE, DA, ...)

Students who exceed 25% absences from practical classes will have a practical assessment (6 points) during the midterm assessment week.