Syllabus
Lectures
Pharmacoepidemiology as an important source of information on the safety of pharmacotherapy. The role of pharmacoepidemiology in different sectors. Classification of pharmacoepidemiological studies.
Association and causality, association indicators in clinical research. Types of bias and confounders in observational studies.
Data resources - databases. Randomized controlled trial in pharmacoepidemiology (randomization, blindness, population, placebo).
Terminology. Systemic elements of safety culture in providing health care.
Medication review and its impact on safety of pharmacotherapy in healthcare facility. Methods of reporting adverse effects and risk behavior of health professionals and patients. Classification of drug-related problems.
Use of drugs in health care facility, including high-risk medicines.
Monitoring, evaluating, and improving quality of health care in healthcare facility from pharmacist´s, nurse’s, and the auditor´s point of view.
The role of pharmacovigilance in process of identifying the risks of pharmacotherapy.
Seminars
Information resources used by clinical pharmacists.
Systematic overview, meta-analysis (critical appraisal, interpretation of results).
Cohort study, case-control studies, cross-sectional study.
A critical appraisal of the published evidence.
Ensuring patient safety in health care facilities (accreditation, internal and external health assessment, quality indicators, standards, reporting of adverse effects).
Ensuring patient safety in the outpatient area including pharmacovigilance.
Independent student´s work and presentation (focused on pharmacoepidemiology and safety of pharmacotherapy).
Annotation
Within the course students are more deeply acquainted with the issues of observing and quality assessment of provided health care, the management of patient safety in the healthcare facility, the role of pharmacovigilance centers in the process of revealing the risks of pharmacotherapy as well as pharmacoepidemiological research and critical appraisal of its results as the evidence for risk assessment of pharmacotherapy.
Special interest is focused on culture of safety when using drugs. Students are familiar with system elements in safety culture at different levels. The importance of particular tools for the development of safety culture, including accreditation processes in healthcare facilities, the role of clinical pharmacy department, or the need for close co-operation with pharmacovigilance activities, are discussed. In addition, the importance of pharmacoepidemiology is pointed out as well as different methods used in clinical research, and assessment of association and causality. Students obtain basic knowledge of critical appraisal of pharmacoepidemiological research and tools used for this kind of evaluation.