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Universitatea de Medicină şi Farmacie Grigore T. Popa Iaşi Comisia pentru asigurarea calităţii DISCIPLINE RECORD/ COURSE / SEMINAR DESCRIPTION 1. Information about the program UNIVERSITY: GRIGORE T. POPA UNIVERSITY OF MEDICINE AND PHARMACY OF 1.1. IAŞI 1.2. FACULTY: PHARMACY SCHOOL / DEPARTMENT: PHARMACEUTICAL SCIENCES II 1.3. SUBJECT: PHARMACODYNAMICS AND CLINICAL PHARMACY 1.4. STUDY FIELD: PHARMACY 1.5. STUDY CYCLE: UNDERGRADUATE 1.6. STUDY PROGRAMME: IN ENGLISH 2. Subject data 2.1. SUBJECT: CLINICAL PHARMACY 2.2. Module leader: Assoc. Prof. Veronica Bild, PhD 2.3. Seminar leader: Assoc. Prof. Veronica Bild, PhD, Assist. Monica Neamţu, PhD 2.4. Year of study V 2.5. Semester in which is taught I 2.6. Evaluation type E1 2.7. Subject status Compulsor y 3. Duration of the course (hours per semester) 3.1. Number of 3 3.2. Number of 1 3.3.Seminar / lab 2 hours / week hours / week 3.4.Total number of learning hours 42 3.5.Total number of learning hours 14 3.6. seminar / lab 28 3.7.Distribution of activities in the course hours Study based on the manual, printed course, bibliography and notes 28 Additional research in the library, on specialized e-platforms and field study 16 Preparation for seminars, practical courses, portfolios and essays 13 Tutoring 1 Assessment - Other activities - 3.8. Number of hours of individual study 58 3.9. Number of hours per semester 100 3.10. Number of ECTS 4 4. Previous Knowledge (if applicable) 4.1. course related Clinical Pathology, Clinical Toxicology, Clinical Laboratory, Semiology, Pharmacodynamics therapeutic, General pharmacokinetics. 4.2. skill related - Knowledge of the drugs mechanisms of action, adverse drug reactions, interactions with clinical significance in case of pathology, polipathology, polymedication. - Knowledge of physiological constants in healthy adults and special groups (children,

pregnant women, elderly geriatric patient). - Knowledge of normal biological constants and their significance in different conditions disturbance. - Familiarize of the students with some aspect regarding food, the nutrients to be able to advise the patient on food behavior. 5. Requirements (if applicable) 5.1. course conditions Audio-video equipment. 5.2. seminar / laboratory conditions Audio-video equipment, patient record, teaching materials of treatment guides types, medical books. 6. Specific Skills Acquired Professional skills displayed by knowledge and skills Transversal skills (role skills, professional and personal skills) Storage, preservation and distribution of medicines, food supplements, cosmetics and other health care products Dispense prescribed medicines, food supplements, cosmetics, other health care products and pharmaceutical care Consultancy and expertise in the field of medicines, food supplements, cosmetics and other health care products Scientific analysis of pharmacotherapeutic prescription Advise patient Therapeutic supervision Monitoring of pharmacotherapy Symptomatic primary care Practical of basic parameters of clinical pharmacokinetics Autonomy and responsibility - the execution of some complex educational tasks under conditions of autonomy. Social interaction and teamwork - assuming the roles / functions of leadership of working or research teams, learning group work, Initiative and entrepreneurship. Written and oral expression skills. Respect and development of professional values and ethics. Problem solving and decision making. Recognize and respect for diversity and multiculturalism. Learning autonomy. 7. Course Objectives (confirmed by the grid of specific skills acquired) 7.1. General Objective Learning the basic notions: pharmacodynamics and clinical pharmacotoxicology. 7.2. Specific Objectives Learning the basic notions regarding: clinical pharmacotherapy, scientific analysis of pharmacotherapeutic prescription, therapeutics supervision, patient counseling, symptomatic primary care. 8. Contents 8.1. Course Teaching methods Observations 1. Clinical general

pharmacodynamics: pharmacological variability among individuals, drug interactions and their importance in clinic; interactions between drugs and alcohol and drugs and nutrients 2. Clinical general pharmacotoxicology: pharmacoepidemiology, pharmacovigilance 3. Clinical general pharmacotherapy: principles of rational scientific pharmacotherapy (individualizing and supervising pharmacotherapy: essential drugs, benefit/risk, benefit/cost ratios); pharmacoeconomy 4. Scientific analysis of a prescription writing: errors, analysis of treatment coherence 5. Scientific analysis of a therapeutic prescription writing (posology, precautions, contraindications, drug-drug interactions) on the same and on parallel prescription writings 6. Common and special therapeutic surveillance (patient compliance to prescribed treatment; surveillance criteria; pharmacotherapy monitoring) 7. Patient information and counseling concerning the therapeutic prescription writing. Primary symptomatic assistance Bibliography 1. Atkinson AJ, Huang S-M, Lertora JJL, Markey SP. Principles of Clinical Pharmacology, Third Edition. London: Academic Press, 2012. 2. Bennett PN, Brown MJ, Sharma P. Clinical Pharmacology. Eleventh Edition. London: Churchill Livingstone, 2012. 3. Bild V. Managementul farmacoterapiei durerii în practica farmaceutică. Iaşi: Editura Gr. T Popa, 2010. 4. Braunwald E, Isselbacher KJ, Wilson JD, Martin JB and col. Harrison's Principles of Internal Medicine. Fourteenth Edition. New York: McGraw-Hill, Med Div, 1997. 5. British National Formulary, The authority on the selection and use of medicines. Volume 67. Glasgow: BMJ Group and the Royal Pharmaceutical Society of Great Britain, 2014. 6. Cristea AN. Farmacie clinică, Vol II. Bucureşti: Editura Medicală, 2012. 7. Cristea AN. Farmacie clinică, Vol I. Farmacia Clinică în farmacia de comunitate. Bucureşti: Editura Medicală, 2006. 8. Cristea AN (coautori: Pavelescu M, Hriscu A). Tratat de farmacologie. Bucureşti: Editura Medicală, 2005. 9. Cristea AN. Farmacologie generală. Editura Didactică şi Pedagogică, Bucureşti, 1998-2010.

10. Di Piro JT and col. Pharmacotherapy. New York: McGraw-Hill, Med Div, 2005. 11. Di Piro JT. Encyclopedia of Clinical Pharmacy. New York: Taylor & Francis, 2003. 12. Goodman & Gilman s. The Pharmacological Basis of Therapeutics. New York: McGraw-Hill, Med Div, 2001. 13. Hall GD, Reiss BS. Appleton and Lange s Review of Pharmacy. Sixth Edition. New York: McGraw- Hill, Med Div, 2003. 14. Mattison D. Clinical Pharmacology During Pregnancy. First Edition. London: Academic Press, 2013. 15. Rang HP, Dale MM, Ritter JM, Flower RJ. Rang and Dale s Pharmacology. Sixth Edition. London: Churchill Livingstone Elsevier, 2008. 16. Tatro D. Drug Interaction Facts. St Louis, Missouri: Walters Eluwer Health, Inc, 2006. 8.2. Seminar / Practical lessons Teaching Methods Observations 1. The concept of clinical pharmacy. Introduction. Objectives. Clinical issues regarding general pharmacotherapy. Patients profile, working models 2. Clinical pharmacokinetics. Basis parameters and their clinical. Types of pharmacokinetics case studies 3. Clinical pharmacokinetics. Compartmentalized models. The pharmacokinetics for single doses and multiple doses; case studies 4. Clinical pharmacodynamics. Drugs interactions. Clinical manifestations accompanying the base pathology 5. Clinical pharmacotoxicology. Side effects (adverse reactions) - clinical implications. Pharmacoeconomy elements 6. Clinical issues in pregnancy, childhood and elderly (elements of pharmacokinetics, pharmacodynamics and pharmacotoxicology) 7. Topics of clinical pharmacy for a pathology of the respiratory system. 8. Topics of clinical pharmacy for a pathology of the cardiovascular system. Presentation of clinical cases. 9. Topics of clinical pharmacy for a pathology of the digestive system. Lecture, free discussion, application: model of compiling patient file application: preparation and analysis of patient file for: pregnant woman, child, elderly 10. Topics of clinical pharmacy for a

pathology of blood disorders. 11. Topics of clinical pharmacy for a pathology of the renal system. 12. Topics of clinical pharmacy for a pathology of pain. Presentation of clinical cases. 13. Topics of clinical pharmacy for a use of chemotherapy. Presentation of clinical cases. 14. Topics of clinical pharmacy for a scientifically rational therapy in primary symptomatic assistance Lecture, open discussion, achieving a clinical reasoning Bibliografie / Bibliography 1. Atkinson AJ, Huang S-M, Lertora JJL, Markey SP. Principles of Clinical Pharmacology, Third Edition. London: Academic Press, 2012. 2. Bennett PN, Brown MJ, Sharma P. Clinical Pharmacology. Eleventh Edition. London: Churchill Livingstone, 2012. 3. Bild V. Managementul farmacoterapiei durerii în practica farmaceutică. Iaşi: Editura Gr. T Popa, 2010. 4. Braunwald E, Isselbacher KJ, Wilson JD, Martin JB and col. Harrison's Principles of Internal Medicine. Fourteenth Edition. New York: McGraw-Hill, Med Div, 1997. 5. British National Formulary, The authority on the selection and use of medicines. Volume 67. Glasgow: BMJ Group and the Royal Pharmaceutical Society of Great Britain, 2014. 6. Cristea AN. Farmacie clinică, Vol II. Bucureşti: Editura Medicală, 2012. 7. Cristea AN. Farmacie clinică, Vol I. Farmacia Clinică în farmacia de comunitate. Bucureşti: Editura Medicală, 2006. 8. Cristea AN (coautori: Pavelescu M, Hriscu A). Tratat de farmacologie. Bucureşti: Editura Medicală, 2005. 9. Cristea AN. Farmacologie generală. Editura Didactică şi Pedagogică, Bucureşti, 1998-2010. 10. Di Piro JT and col. Pharmacotherapy. New York: McGraw-Hill, Med Div, 2005. 11. Di Piro JT. Encyclopedia of Clinical Pharmacy. New York: Taylor & Francis, 2003. 12. Goodman & Gilman s. The Pharmacological Basis of Therapeutics. New York: McGraw-Hill, Med Div, 2001. 13. Hall GD, Reiss BS. Appleton and Lange s Review of Pharmacy. Sixth Edition. New York: McGraw- Hill, Med Div, 2003. 14. Mattison D. Clinical Pharmacology During Pregnancy. First Edition. London: Academic Press, 2013. 15. Rang HP, Dale MM, Ritter JM, Flower RJ. Rang and Dale s Pharmacology. Sixth Edition. London: Churchill Livingstone Elsevier, 2008. 16. Tatro D. Drug Interaction Facts. St Louis, Missouri: Walters Eluwer Health, Inc, 2006. 9. The agreement between the course contents and the expectations of the representatives of the epistemic communities, professional associations and employers in the field related to the program The study program of the discipline is developed and revised periodically to meet the market dynamics of

academic and professional qualifications, so as to ensure the formation of graduates who are capable of integrating into the labor market in health systems. Also, the study program contributes to the development of professional skills needed in the labor market. 10. Assessment Activity 10.1. Assessment criteria 10.4. Course Answers to exam / colloquium (final examination). 10.5. Seminar / Practical lessons Final answers to practical laboratory work. Continuous testing during the semester (periodic testing by control works, essays, seminar activity). 10.2. Assessment methods Descriptive written paper Descriptive written paper Oral and practical examination, descriptive written paper, MCQ testing Minimal standard of proficiency: Promotion with minimum grade 5. Scientific analysis of the treatment regimen. Symptomatic primary care in community pharmacy clinical oriented. 10.3. Percentage of the final grade 50% 35% 15% Date: 10.12.2014 Signature of Coordinator for Teaching Activities Assoc. Prof. Veronica Bild, PhD Date of indorsement in the Council of the Department Signature of The Department Director Prof. Anca Miron, PhD