Clinical Pharmacoepidemiology

Faculteit Science and Engineering
Jaar 2022/23
Vakcode WMMP015-05
Vaknaam Clinical Pharmacoepidemiology
Niveau(s) master
Voertaal Engels
Periode semester I a

Uitgebreide vaknaam Clinical Pharmacoepidemiology
Leerdoelen 1. The student is able to reproduce and describe: the basic concepts of epidemiology (e.g. measures offrequency and associations, research focus as etiology, diagnostics, prognostics and intervention, mainstudy designs, causality theory, validity and generalizability, basic data-analysis techniques, systematic andrandom errors, effect modification, and basic pharmaco-economic concepts).
2. The student can evaluate the main research question, study design, study population, sources ofinformation, exposure and outcome, misclassification and types of biases (information bias, selection biasand confounding) in a pharmaco-epidemiological study paper.
3. The student is able to calculate frequency measures, life-tables, association measures, standardized effectmeasures (direct and indirect) and Mantel-Haenszel stratification measures.
4. The student can evaluate 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 associationmeasures 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 andstatistical testing, and knows the basics of multivariate regression analysis such as linear, logistic and Cox-regression analysis and can perform multivariate logistic regression.
7. The student has basic knowledge about data collection methods and can examine study data using astatistical progThe student is able to critically review a pharmaco-epidemiological study (article) and to evaluate its quality.ram and can interprete the statistical output.
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)
(Final mark is based on score divided by 40 (22 and higher is sufficient for obtaining a 6). If on the basis ofthe examination of the 25 MC questions by the tentamenvoorziening, a question is deemed too difficult,lecturers can decide that either the question is flawed or that the question remains. In case the lecturersdecide that the question is flawed, the censuur for 6 will be lowered by one)
Vaksoort master
Coördinator prof. dr. E. Hak
Docent(en) H.J. Bos, BSc. ,dr. S. de Vos ,prof. dr. T.L. Feenstra , Guest Lecturer(s) ,prof. dr. E. Hak
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: Drug Toxicology & Translational Technology  (Electives) - semester I a keuze
MSc Medical Pharmaceutical Sciences: Pharmaceutical Design and Engineering  (Other possible Electives) - semester I a keuze
MSc Medical Pharmaceutical Sciences: Pharmacoepidemiology & Pharmacoeconomics  ( General Outline) - semester I a verplicht
MSc Medical Pharmaceutical Sciences: Research  (Electives) - semester I a keuze
MSc Medical Pharmaceutical Sciences: Science, Business and Policy  (Electives ) - semester I a keuze