SFKK18008U  Pharmacoepidemiology and Pharmacovigilance

Volume 2018/2019
Education

MSc Programme in Pharmacy or Pharmaceutical Science (danish programmes Cand.Pharm and Cand.Scient.Pharm) - elective

MSc Programme in Pharmaceutical Sciences (english programme) - elective

 

Content

The principles of pharmacoepidemiology and pharmacovigilance are presented, including the related processes in the pharmaceutical industry and regulatory authorities. Lectures are supplemented with group discussions and exercises with calculations in a spreadsheet or statistical software. During the last weeks of the course, the students will in groups prepare a project report based on a case scenario where they develop and write up either an epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written report is evaluated, presented orally and critically assessed by the other groups. Topics are:

 

  • Introduction to pharmacovigilance
    • Definitions, background and history
    • Institutions and individuals involved in pharmacovigilance
    • Sources of information on drug-related risks
  • Pharmacoepidemiological methods
    • Measures of occurrence and effect
    • Cohort and case-control study designs
    • Sources of error, bias and confounding
    • Data sources, validity and limitations
    • Analysis of epidemiological studies
    • Drug utilisation studies and quality indicators of drug use
    • Post-approval safety studies – protocols and practice
  • Spontaneous reporting systems
    • Individual case safety reports, clinical diagnosis coding and causality assessment
    • Quantitative signal detection and signal evaluation
  • Regulatory aspects of pharmacovigilance
    • Pharmaceutical industry safety reporting and risk management plans
    • Good pharmacovigilance practices
    • Regulatory processes and decisions
    • Benefit/risk assessment
Learning Outcome

The aim of the course is to give students knowledge about the principles of pharmacoepidemiology and pharmacovigilance. Additionally, to provide students with an understanding of the different types of evidence produced by experimental and observational studies of drug effects, and of the strengths and weaknesses of different study designs and methods. The students should be able to choose design and data sources that best fit the purpose of a study, and to critically evaluate published literature on drug safety, efficacy and effectiveness. They should be able integrate results from safety surveillance and post-approval studies with other preclinical and clinical safety information.

 

After completing the course the student is expected to be able to:


Knowledge

  • understand pharmacoepidemiological and pharmacovigilance methods used to generate the evidence for benefit/risk assessments
  • understand and explain central pharmacoepidemiological and pharmacovigilance concepts.
  • explain principles of safety surveillance and risk management, including the obligations of the pharmaceutical industry and the basis for regulatory decisions.
  • identify and summarise the limitations of pharmacoepidemiological studies and safety surveillance systems.

 

Skills

  • describe, analyse and interpret the results of pharmacoepidemiological studies and safety surveillance.
  • assess and discuss the limitations of data and methods in published literature and safety reports.
  • summarise and prioritise safety information obtained with different methods in a structured way.
  • communicate information on safety issues and drug-related risks.


Competences

  • independently develop a protocol and plan for a post-authorisation safety study.
  • perform a general benefit/risk assessment of a drug, integrating results from studies on efficacy and safety, data from safety surveillance systems and other information.
  • outline a risk management plan for a marketed drug based on information on safety issues and patterns of use.

Selected textbook chapters, lecture notes, laws, documents, recommendations, circulars, guidelines and scientific papers.

Course teaching is based on the assumption that students have knowledge corresponding to the content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy and Toxicology. For MSc students Principles of Pharmacology and Pharmacology: From Physiology to Therapy.
Lectures: 40 (45 min.)
Group and classroom discussions: 15 (45 min.)
Case project and report: 70
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Credit
7,5 ECTS
Type of assessment
Course participation
Written assignment
Course certificate: During the last weeks of the course, the students will in groups prepare a project report based on a case scenario where they develop and write up either an epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written report is evaluated, presented orally and critically assessed by the other groups.
The assessment will be based on the project report and satisfactory participation in the course in general.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

To obtain a course certificate the student must be able to:


Knowledge

  • understand pharmacoepidemiological and pharmacovigilance methods used to generate the evidence for benefit/risk assessments
  • understand and explain central pharmacoepidemiological and pharmacovigilance concepts.
  • explain principles of safety surveillance and risk management, including the obligations of the pharmaceutical industry and the basis for regulatory decisions.
  • identify and summarise the limitations of pharmacoepidemiological studies and safety surveillance systems.

 

Skills

  • describe, analyse and interpret the results of pharmacoepidemiological studies and safety surveillance.
  • assess and discuss the limitations of data and methods in published literature and safety reports.
  • summarise and prioritise safety information obtained with different methods in a structured way.
  • communicate information on safety issues and drug-related risks.


Competences

  • independently develop a protocol and plan for a post-authorisation safety study.
  • perform a general benefit/risk assessment of a drug, integrating results from studies on efficacy and safety, data from safety surveillance systems and other information.
  • outline a risk management plan for a marketed drug based on information on safety issues and patterns of use.
  • Category
  • Hours
  • Lectures
  • 40
  • Preparation
  • 81
  • Theory exercises
  • 10
  • Project work
  • 70
  • Class Exercises
  • 5
  • Total
  • 206