Teaching program for obligatory subject on Faculty of Medicine (English Division) in academic year 2012/2013 1. Subject: Clinical Pharmacology 2. Person responsible: Prof. dr hab. Anna Wiela-Hojeńska 3. Names of the lectors: 1. Paweł Petryszyn PhD, MD 2. Zofia Zaleska MD Classes: 4. Name of the Department/ Departments: Department of Clinical Pharmacology summer semester – XII 5. Year VI 6. Number of hours: Departments who participate in subject Department of Clinical Pharmacology Total: Summer semester Lecture Classes Seminar 15 15 7. Number of students in the group: 12-18 person 8. The aim of the teaching subject and the effect of education - skills and competence Knowledge of clinical pharmacokinetics, adverse drug reactions, drugs interactions, individualization of pharmacotherapy. 9. The essential issues of the subject: Clinical pharmacokinetics, adverse drug reactions, undesirable drug interactions, individualization of pharmacotherapy (in disease states, genetically determined changes in drug kinetics and pharmacodynamics reactions, in pregnancy, in children and elderly people, therapeutic drug monitoring). Basic of pain pharmacotherapy and rational antibiotic therapy. Summary of Product Characteristics and drug advertisement in optimization of pharmacotherapy. Pharmacoeconomics aspects of therapy. Clinical trials. 10. Criteria of the promotion: Attendance at classes, positive mark from oral/written test. 11. Literature: List of required and recommended handbooks: Primary literature: 1. Katzung B.G., Masters S.B., Trevor A.J.: Basic&clinical pharmacology. Mc Graw Hill Companies, 2012. 2. Sayberth H.W., Rane A., Schwab M.: Pediatric Clinical Pharmacology, Springer, 2011. 3. Langman L.J., Dagupta A.: Pharmacogenomics in Clinical Therapeutics. John Wiley&Sons, 2012. 4. Rascati K.L.: Essentials of Pharmacoeconomics. Lippincott Williams&Wilkins, 2009. 5. Friedman L.M., Furberg C.D., DeMets D.L.: Fundamentals of Clinical Trials. Springer, 2010. Secondary literature: 1. Altman R.B., Flockhart D., Goldstein D.B.: Principles of pharmacogenetics and pharmacogenomics. Cambridge University Press, 2012. 2. Bennett P.N., Brown M.J., Sharma P.: Clinical pharmacology. Churchill Livingstone Elsavier, 2012. 3. Friedman L.M., Furberg C.D., DeMets D.L.: Fundamentals of Clinical Trials. Springer, 2010. 4. Arnold R.J.G.: Pharmacoeconomics. From Theory to Practice. CRC Press Taylor &Francis Group, 2010. 1 12. The course detailed program (lectures, classes, seminars): 12.05. – 16.05.2014 Week XII: 10:15-12:30 Paweł Petryszyn PhD, MD 12:45-15:00 Zofia Zaleska MD Classes – summer semester Class topic 1. Adverse drug reaction (ADR), implications in clinical practice. 2. Recognition and analysis of ADR’s including drug interactions. Teacher Paweł Petryszyn PhD, MD Day 1 3. Monitoring and reporting of ADR. Pharmacovigillance. 1. Interpretation of Summary of Product Characteristics. Advertisement in medicine. What they should be? 2. Chronopharmacotherapy. 3. Basic of pharmacoeconomics. 4. Influence of phatological stages on drug kinetics and action. Day 2 Day 3 Day 4 5. Conduction of clinical trials. Good Clinical Practice. Ethics in clinical trials, placebo treatment. 6. Interpretation of clinical trial protocols, phase I, II, III and IV. Planning of clinical trials. 1. Individualization of pharmacotherapy in children and in old people. 2. Drug treatment in pregnacy. 3. Basic of rational antibiotic therapy. 1. Therapeutic drug monitoring. Drug dose adjustment base on serum drug concentration. 2. Adjustment of drug dose in patient with renal and liver failure. 3. Influence of liver and kidney function on drug elimination and drug action. Zofia Zaleska MD Paweł Petryszyn PhD, MD Zofia Zaleska MD Paweł Petryszyn PhD, MD Zofia Zaleska MD Paweł Petryszyn PhD, MD Zofia Zaleska MD 2 Day 5 1. EBM in pharmacotherapy. 2. Pain pharmacotherapy (efficacy and safety). Paweł Petryszyn PhD, MD 3. Genetical determination of drug action. Phenotyping and genotyping in optimizing patient therapy. Zofia Zaleska MD 3