First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
PHARMACY
Course unit
PHARMACOEPIDEMIOLOGY
MEP3051896, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2015/16

Information on the course unit
Degree course 5 years single cycle degree in
PHARMACY (Ord. 2009)
FA1732, Degree course structure A.Y. 2009/10, A.Y. 2019/20
N0
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Number of ECTS credits allocated 6.0
Type of assessment Mark
Course unit English denomination PHARMACOEPIDEMIOLOGY
Department of reference Department of Pharmaceutical and Pharmacological Sciences
Mandatory attendance No
Language of instruction Italian
Branch PADOVA
Single Course unit The Course unit can be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Lecturers
Teacher in charge MARIA CECILIA GIRON BIO/14

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses BIO/14 Pharmacology 6.0

Course unit organization
Period First semester
Year 5th Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Lecture 6.0 48 102.0 No turn

Calendar
Start of activities 30/09/2019
End of activities 18/01/2020
Show course schedule 2019/20 Reg.2018 course timetable

Syllabus
Prerequisites: Basic knowledge of Pharmacology and Pharmacotherapy, as well as Pharmacovigilance and Toxicology, is necessary.
Target skills and knowledge: By the end of the course, the student will be able to:
- understand observational and analytical clinical studies regarding drug's and medical device's safety profile
- broaden his understanding of study design issues and methods in pharmacoepidemiology and drug utilization by means of electronic health record database research
- explain confounding and other biases (e.g. the indication-related methods of adjusting for confounding)
- know the principles of evidence-based medicine in the evaluation of drugs and medical devices
- know how to measures the association or risk quantification in pharmacoepidemiological studies and related issues
- have an overview of the role of pharmacoepidemiological databases and know to use them
- analyze and appraise pharmacoepidemiological studies and their results.
Examination methods: The student will have about 60-min time for reading and understanding a pharmacoepidemiological article, published in an international journal, proposed by the lecturer. The final examination will consist in an oral interview with each student on the pharmacoepidemiological clinical study, descibed in the article. The judgment will be based on the student's appreciation of the issues and on his ability to make a critical evaluation of the evidence.
Assessment criteria: The evaluation of the student will take into account:
- the understanding the main thematic areas addressed during the course
- the capacity to evaluate and critical evaluate drug issues in terms of patient benefit, side effects, and cost-effectiveness
- his appreciation of the critical issues in performing pharmacopidemiological studies
- his ability to perform a critical appraisal on post-marketing issues related to drug or medical device utilization taking into account effectiveness and appropriate utilization for cost savings purposes

These different aspects for evaluating student knowledge and capacity will be discussed comprehensively and practically during the critical appraisal a pharmacoepidemiological article, published in an international peer review journal, proposed by the lecturer.
Course unit contents: - Pharmacoepidemiology: history, aims, and the role of postmarketing drug evaluation
- Essential Statistics for Epidemiology Part I - Descriptive Statistics
- Essential Statistics for Epidemiology Part 2 - Inference
- Introduction to critical appraisal of premarketing trials
- Design and Usefulness of analytical, clinical, control-case, observational prospective or retrospective studies, case series, case report etc.
- Selection and information bias, confounding and interaction
- Electronic Healthcare Records and databases in Pharmacoepidemiology
- Causal relationship between a drug exposure and an adverse event
- Measures of occurrence and measures of effect, data representation and significance of the data
- Survival analysis
- Power and Sample Size
- The defined daily dose: history, role, practical use and limitations
- Pharmacoepidemiological studies for the drug assessment of long-term safety and efficacy/effectiveness, prscribing appropriateness, patient compliance and persistence etc.
- Ethical issues in pharmacoepidemiology
- Structure of Italian healthcare system; Local, regional and national committees on the Assessment of the Drug Safety System (PTO, CTRF etc.), national (AIFA, MINSAL, ISS, Agenas, etc.)and international regulatory agecies (EMA, FDA,NICE etc.)
- Role of pharmacoepidemiology in specific populations
- HTA and pharmacoepidemiology
- Critical Appraisal of Cohort Studies and Case-Control Studies, Systematic Reviews & Meta-Analysis related to drugs, medical devices and alimentary supplements
- Pharmacoepidemiology and Pharmacoeconomics: integrated use for the systematic assessment of how well different treatment alternatives compare with one another in terms of patient benefit, side effects, and cost-effectiveness.
Planned learning activities and teaching methods: The course comprises 48 hours of front lectures with slides presentation, discussion sessions and seminars. Discussion sessions will be based on published articles on international peer reviewed journals, guidelines, and other references associated to the lectures.
Additional notes about suggested reading: Related Links:
- Italian Center of Epidemiology, Surveillance and Health promotion http://www.epicentro.iss.it/default.asp
- International Society for Pharmacoepidemiology:(ISPE) http://www.pharmacoepi.org/
- Inter-university Center of Epidemiology and Preventive Pharmacology (SEFAP): http://www.sefap.it
Textbooks (and optional supplementary readings)
  • Brian L. Strom, Stephen E Kimmel, Sean Hennessy, Pharmacoepidemiology. --: Wiley-Blackwell, 2012. Cerca nel catalogo
  • Yi Yang, Donna West-Strum, Understanding Pharmacoepidemiology. --: McGraw-Hill Medical (LANGE Clinical Science), 2010. Cerca nel catalogo
  • Michael J. Klepper , Barton Cobert, Drug Safety Data: How to Analyze, Summarize, and Interpret to Determine Risk. --: Jones & Bartlett Learning, 2010. Cerca nel catalogo
  • Barton Cobert , Pierre Biron, Practical Drug Safety From A to Z. --: Jones & Bartlett Publishers, 2008. Cerca nel catalogo
  • M Elseviers, B Wettermark, AB Almarsdóttir, et al. Editors., Drug Utilization Research: Methods and Applications. Methods and Applications.. --: Wiley Blackwell, 2016. Cerca nel catalogo
  • Post-Authorization Safety Studies of Medicinal Products. The PASS Book, Ayad Ali & Abraham Hartzema. --: Academic Press, 2018. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Lecturing
  • Problem based learning
  • Case study
  • Interactive lecturing
  • Problem solving
  • Loading of files and pages (web pages, Moodle, ...)

Innovative teaching methods: Software or applications used
  • Moodle (files, quizzes, workshops, ...)
  • One Note (digital ink)
  • Top Hat (active quiz, quiz)

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