Pharmacoepidemiology and Drug Safety

The aim of this course is to enhance awareness of the patient safety management, to acquire the basic elements of safety culture with an emphasis on the involvement of pharmacists, and to obtain knowledge and skills required for assessment of the validity of evidences concerning effectiveness and safety of pharmacotherapy. These aspects are an integral part of the profession of clinical pharmacists, who are engaged in the safety of drugs and pharmacoepidemiology research in the Czech Republic as well as abroad.

In this course, students will become familiar with:

  • Monitoring and evaluation of the quality of care management and patient safety in healthcare facilities.
  • The role of pharmacovigilance centres in the process of identifying the risks of pharmacotherapy.
  • Pharmacoepidemiology research and critical appraisal of evidences concerning the risk assessment of pharmacotherapy.


  1. Pharmacoepidemiology as an important source of information about drug safety.
  2. Association and causality, association indicators in clinical research, critical appraisal of evidences concerning safety (or effectiveness) of pharmacotherapy.
  3. System elements of safety culture. Role of pharmacovigilance in the process of identifying the risks of pharmacotherapy.
  4. Methods of reporting adverse effects and risk behaviour of health professionals and patients. Medication review and its impact on the safety of pharmacotherapy in health care facilities.
  5. Monitoring, evaluating and improving the health care quality in health care facilities from the view of clinical pharmacists.
  6. Ensuring safety of patients in health care facilities - the role of the United Accreditation Commission.
  7. Individual work.


COHEN, Michael R. Medication errors. 2nd ed. Washington : American Pharmacists Association, 2007. 680 p. ISBN 1-58212-092-7

Expert Group on Safe Medication Practices: Creation of a better medication safety culture in Europe: Building up safe medication practices [online]. [cit. 9. 4. 2015]. Available from:

Institute for Safe Medication Practices [online]. [cit. 9. 4. 2015]. Available from

MALONE, Patrick M., KIER, Karen L. and STANOVICH, John E., 2012, Drug information: a guide for pharmacists. 4th ed. New York : McGraw-Hill Medical. ISBN 978-0-07-162495-4.

Pharmaceutical Care Network Europe [online]. [cit. 9. 4. 2015]. Available from:

SACKETT, David L. Evidence-based medicine : how to practice and teach EBM. 2nd ed. Edinburgh : Churchill Livingstone, 2000. 261 p. ISBN 0-443-06240-4

STROM, Brian L. ; KIMMEL, Stephen a HENNESSY, Sean. Pharmacoepidemiology. 5th ed. Chichester : Wiley-Blackwell, 2012. 953 p. ISBN 978-0-4706-5475-0

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