Faculteit Science and Engineering
Jaar 2019/20
Vakcode WMMP13001
Vaknaam Pharmacoepidemiology
Niveau(s) master
Voertaal Engels
Periode semester I b

Uitgebreide vaknaam Pharmacoepidemiology
Leerdoelen At the end of the course, the student is able to:
1) The student is able to reproduce and describe: the basic concepts of epidemiology (e.g. measures of frequency and
associations, research focus as etiology, diagnostics, prognostics and intervention, main study designs, causality
theory, validity and generalizability, basic data-analysis techniques, systematic and random errors, effect modification,
and basic pharmaco-economic concepts).
2) The student can examine the main research question, study design, study population, sources of information, exposure
and outcome, misclassification and types of biases (information bias, selection bias and confounding) in a pharmacoepidemiological
study paper.
3) The student is able to calculate frequency measures, life-tables, association measures, standardized effect measures
(direct and indirect) and Mantel-Haenszel stratification measures.
4) The student can debate the pros and cons of different study designs (e.g. RCT, case-control, cohort, prevalence
study) and quality of measure instruments.
5) The student is able to calculate confidence intervals for different frequency measures and association measures and to
understand their value in relation to p-values.
6) The student is able to understand and judge elementary statistics such as statistical distributions and statistical
testing and knows the basics of multivariate regression analysis such as linear, logistic and Cox-regression analysis and
can apply multivariate logistic regression.
7) The student has basic knowledge about data collection methods and can examine study data using a statistical
program and can interprete the statistical output.
8) The student is able to critically review a pharmaco-epidemiological study (article) and to evaluate its quality.
Omschrijving Introduction in the pharmacoepidemiology which forms the basis for the conceptual basic understanding and judgement of
pharmacoepidemiological research as presented in the scientific literature.
The following questions will be central:
1. What is the research question? Why is this question of interest to pharmacists? What is already known in the literature?
2. What study design has been chosen and why? What is the definition of the study population? Which in- and exclusion criteria are
used? Why?
3. What are according to the student and the authors the potential strengths and shortcomings of the study? How can the
conclusion be interpreted?
4. What do the results of the study mean for clinical practice?
The following topics will be touched upon during the lectures and practicals: position of pharmacoepidemiology within pharmacy,
frequency measures, spontaneous reporting systems, sources of information, record linkage, databases, study designs and risk
measures, bias and confounding, causality, literature review, pharmaco-economics and how do I appraise a pharmacoepidemiological
study article.
Uren per week
Onderwijsvorm Bijeenkomst (S), Hoorcollege (LC), Opdracht (ASM), Practisch werk (PRC)
Toetsvorm Schriftelijk tentamen (WE), Tussentoets (IT)
Vaksoort master
Coördinator prof. dr. E. Hak
Docent(en) and others ,dr. T.L. Feenstra ,prof. dr. E. Hak ,dr. C.C.M. Schuiling-Veninga
Verplichte literatuur
Titel Auteur ISBN Prijs
Epidemiology: an introduction. 2008
K. Rothman.
Entreevoorwaarden The course unit assumes prior knowledge acquired from (BSC Life Sciences, year 3), and Medical Statistics/Biostatistics elementary course at BSc level.
Opmerkingen Students who accomplished the equivalent course far-epi (= farmacoepidemiologie) in their bachelor programme cannot take this course in the master programme and need to follow 5 ECTS other relevant MSc course.

Minimum number of students 3
Opgenomen in
Opleiding Jaar Periode Type
MSc Medical Pharmaceutical Sciences: Pharmaceutical Design and Engineering  (Other possible Electives) - semester I b keuze
MSc Medical Pharmaceutical Sciences: Pharmaco-epidemiology  ( Master Courses) - semester I b verplicht
MSc Medical Pharmaceutical Sciences: Research  (Electives) - semester I b keuze
MSc Medical Pharmaceutical Sciences: Science, Business and Policy  (Electives (10 ECTS)) - semester I b keuze
MSc Medical Pharmaceutical Sciences: Toxicology and Drug Disposition  (Electives ) - semester I b keuze