study program 2016/2017 subjects of the 9-10. … · balÁzs ferenc nÉmeti, associate professor...

UP FP Pharmacy major – obligatory subjects of the 9-10. semester - Course descriptions – academic year of 2016/2017

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University of Pécs Faculty of Pharmacy

PHARMACY Major

STUDY PROGRAM 2016/2017

Subjects of the 9-10. semesters

(obligatory subjects and criterion requirements)


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9th semester

OPG-GS3 Pharmacodynamics 3 ____________________________________________________________________________ 3

OPG-GSI Pharmaceutical Informatics _______________________________________________________________________ 7

OPG-GU4 Pharmaceutical Practice and Management 3 __________________________________________________________ 9

OPG-KLF Clinical Pharmacology __________________________________________________________________________ 13

OPG-NOV Herbal Medicine and Herbs in Nutrition ____________________________________________________________ 15

OPG-PMG Problemsolving Pharmacy _______________________________________________________________________ 18

OPG-TOX Toxicology ___________________________________________________________________________________ 20

OPO-KL2 Clinical Studies 2 ______________________________________________________________________________ 23

OPO-KLV Clinical Laboratory Investigations _________________________________________________________________ 26

OPS-SG3 Professional Practice Before State Examination 1 _____________________________________________________ 28

10th semester

OPS-SG4 Professional Practice Before State Examination 2 _____________________________________________________ 31


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OPG-GS3 PHARMACODYNAMICS 3

Course director: DR. BALÁZS FERENC NÉMETI, associate professor

Department of Pharmacology and Pharmacotherapy

4 credit ▪ final exam ▪ Pharmaceutical science theoretical knowledge and practical skills module ▪ autumn semester ▪ recommended semester: 9

Number of hours/semester: 24 lectures + 0 practices + 24 seminars = total of 48 hours

Course headcount limitations (min.-max.): 1 – 100

Prerequisites: OPG-GH2 completed + OPG-GK4 completed + OPG-GT4 completed

Topic

The aim of the course is to provide the students with pharmacological knowledge that is required for their future work in the pharmacy.

Important topics are pharmacology of the endocrine system; chemotherapy of microbial diseases including antibacterial, antifungal drugs,

antiviral antiprotozoal, anthelminthic agents, antiseptics and disinfectants; drugs used in chemotherapy of neoplastic diseases;

immunosuppressants, immunomodulators, drug treatment of rheumatoid arthritis. Further topics are pharmacogenetics; effects of age,

diet and diseases on drug action; drug interactions.

Conditions for acceptance of the semester

Maximum of 25 % absence allowed

Mid-term exams

The students receive a practice mark based on their performance during the semester. The mark will be registered in the NEPTUN. The

mark must be at least satisfactory as a prerequisite for taking the final exam. Around the 10th week of the semester, a written test is the

base of the practice mark. The test covers the subjects of seminars of the first 9 weeks of the semester. Should someone fail or want to

improve, they can do it one time by the end of the semester. On a final failure (that is, after the improvement attempt), the student cannot

take the exam.

Making up for missed classes

There is no way to make up for missed lectures or seminars.

Reading material

- Obligatory literature

- Literature developed by the Department

- Notes

- Recommended literature

Rang, Dale, Ritter, Moore: Pharmacology, 8th edition, Elsevier Churchill Livingstone, 2015

B. G. Katzung (ed.): Basic and Clinical Pharmacology, 12th edition, Lange Medical Books/McGraw-Hill, 2012

Lectures

1 Corticosteroids I

Dr. Pethő Gábor

2 Corticosteroids II

Dr. Pethő Gábor

3 Corticosteroids III

Dr. Pethő Gábor

4 Oestrogens and anti-oestrogens

Dr. Pethő Gábor

5 Progestins and anti-progestins

Dr. Pethő Gábor

6 Postmenopausal hormone therapy. Hormonal contraceptives

Dr. Pethő Gábor

7 Androgens, anabolic steroids and anti-androgens I

Dr. Pethő Gábor

8 Androgens, anabolic steroids and anti-androgens II

Dr. Pethő Gábor

9 Thyroid hormones, antithyroid drugs I

Dr. Sághy Éva

10 Thyroid hormones, antithyroid drugs II

Dr. Sághy Éva


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11 Hypothalamic and pituitary hormones I

Dr. Poór Miklós

12 Hypothalamic and pituitary hormones II

Dr. Poór Miklós

13 Hypothalamic and pituitary hormones III

Dr. Poór Miklós

14 Insulin, oral hypoglycaemic agents I

Sánticsné Dr. Pintér Erika

15 Insulin, oral hypoglycaemic agents II


16 Insulin, oral hypoglycaemic agents III. Glucagon


17 Parathyroid hormone, calcitonin, vitamin D and drug treatment of osteoporosis I

Dr. Sághy Éva

18 Parathyroid hormone, calcitonin, vitamin D and drug treatment of osteoporosis I

Dr. Sághy Éva

19 Drugs used in neoplastic diseases I

Dr. Németi Balázs Ferenc

20 Drugs used in neoplastic diseases II


21 Drugs used in neoplastic diseases III


22 Drugs used in neoplastic diseases IV


23 Immunosuppressants and immunomodulators


24 Drugs used to treat rheumatoid arthritis


Practices

Seminars

1 Basic principles of antimicrobial chemotherapy

2 Sulphonamides and trimethoprim

3 Fluoroquinolones, nitroimidazoles

4 Antibiotics impairing the function of the bacterial cell envelope I

5 Antibiotics impairing the function of the bacterial cell envelope II

6 Antibiotics impairing the function of the bacterial cell envelope III

7 Aminoglycosides

8 Tetracyclines

9 Macrolide antibiotics, chloramphenicol

10 Linezolid, lincosamides, streptogramins

11 Antituberculotic drugs

12 Anti-leprosy drugs

13 Antifungal drugs

14 Antiseptics and disinfectants

15 Antiviral drugs I

16 Antiviral drugs II

17 Antiviral drugs III

18 Antiviral drugs IV

19 Antiprotozoal drugs I

20 Antiprotozoal drugs II

21 Anthelminthic drugs I

22 Anthelminthic drugs II

23 Pharmacogenetics, pharmacogenomics

24 Effects of age, diet and disease on drug action. Drug interactions


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Exam topics/questions

1. Basic mechanisms of drug actions (examples of drug effects on receptors, ion channels, enzymes, carrier systems and effects mediated by physicochemical interactions)

2. Characterization of agonist-receptor interaction: occupancy, affinity, dose-response curve, potency, efficacy

3. Significance of signal transduction mechanisms in the effects of drugs. Tachyphylaxis and tolerance to drugs

4. Mechanisms of drug antagonisms

5. Transport of drugs across membranes

6. Absorption of drugs, oral bioavailability and presystemic elimination

7. Plasma protein binding and tissue distribution of drugs

8. Biotransformation of drugs

9. Excretion of drugs

10. Pharmacokinetics: zero and first order elimination, volume of distribution, clearance, elimination half-life, oral bioavailability, calculation of loading and maintenance doses

11. Drug development

12. Harmful effects of drugs and their mechanisms

13. Factors influencing drug effects: genetic constitution, age, diet, disease

14. Drug interactions

15. Cholinergic agonists and cholinesterase inhibitors

16. Muscarinic receptor antagonists

17. Neuromuscular blocking agents. Drugs acting on autonomic ganglia

18. Agents acting on the biosynthesis, storage, release and elimination of catecholamines

19. Adrenergic receptor agonists

20. Adrenergic receptor antagonists

21. Local anaesthetics

22. Calcium channel blockers

23. Drugs acting on the renin-angiotensin-aldosterone system

24. Diuretic drugs

25. Positive inotropic and other drugs used for treating congestive heart failure

26. Antianginal drugs. Drugs that increase regional blood flow

27. Antihypertensive drugs

28. Antiarrhythmic drugs

29. Antianxiety and hypnotic drugs

30. Alcohols: pharmacology, toxicology

31. Antipsychotic drugs

32. Antidepressants

33. Central nervous system stimulants. Nootropic drugs

34. Drug treatment of neurodegenerative disorders

35. General anaesthetics

36. Antiepileptic drugs

37. Opioid analgesic drugs: morphine and codeine

38. Opioid analgesic drugs: semisynthetic, synthetic opioids, opioid antagonists

39. Non-steroidal antiinflammatory drugs: aspirin, paracetamol

40. Non-steroidal antiinflammatory drugs: drugs other than aspirin or paracetamol

41. Adjuvant analgesics. Drugs used for treating gout. Centrally-acting muscle relaxants

42. Basic terms of drug abuse. Psychedelics, nicotine, cannabis, inhalants

43. Drugs used for treating hyperlipoproteinaemias

44. Drugs affecting hemostasis

45. Drugs affecting hematopoiesis

46. Histamine, H1 and H2 receptor antagonists

47. Serotonin, serotonin receptor agonists and antagonists. Drug treatment of migraine

48. Pharmacology of eicosanoids. Drugs acting on the smooth muscle: smooth muscle relaxants, pharmacology of the uterine muscle

49. Drugs used in bronchial asthma

50. Drugs used in allergic rhinitis. Antitussive, expectorant and mucolytic agents

51. Drugs used in the treatment of peptic ulcer

52. Emetics, antiemetics and prokinetic drugs. Digestives, drugs used in cholelithiasis

53. Laxatives, antidiarrheal agents, drug treatment of inflammatory bowel diseases

54. Corticosteroids

55. Oestrogens, antioestrogens, progestins, antiprogestins

56. Postmenopausal hormone therapy and hormonal contraceptives


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57. Androgens, anabolic steroids, antiandrogens

58. Thyroid hormones, antithyroid drugs

59. Hypothalamic and pituitary hormones

60. Insulin and oral hypoglycemic agents. Glucagon

61. Parathyroid hormone, calcitonin and vitamin D, drugs used for treating osteoporosis

62. Sulphonamides and trimethoprim. Fluoroquinolones. Nitroimidazoles

63. Beta-lactam antibiotics

64. Glycopeptide antibiotics, lipopeptides, polymyxines, gramicidins

65. Aminoglycosides, tetracyclines

66. Macrolide antibiotics , chloramphenicol, lincosamides, streptogramins

67. Antituberculotic drugs. Anti-leprosy drugs

68. Antifungal drugs

69. Antiviral drugs

70. Antiprotozoal drugs

71. Anthelminthic drugs

72. Antiseptics and disinfectants

73. Drugs used in the chemotherapy of neoplastic diseases: alkylating agents, antimetabolites

74. Drugs used in the chemotherapy of neoplastic diseases: alkaloids, antibiotics, hormonal agents

75. Drugs used in the chemotherapy of neoplastic diseases: biological therapy

76. Immunosuppressants and immunomodulators. Drug used to treat rheumatoid arthritis

In addition to the exam topics, an important part of the exam is answering questions that aim at assessing the general knowledge of the student.

Participants

Dr. Barthó Loránd (BALIAAO.PTE), Dr. Németi Balázs Ferenc (NEBMAAO.PTE), Dr. Pethő Gábor (PEGGAAO.PTE), Dr. Poór Miklós (POMNAAO.PTE), Dr. Sághy Éva (SAEPABO.PTE)


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OPG-GSI PHARMACEUTICAL INFORMATICS

Course director: DR. LAJOS BOTZ, professor

Medical Faculty (Medical School)

2 credit ▪ midsemester grade ▪ Pharmaceutical science theoretical knowledge and practical skills module ▪ autumn semester ▪ recommended semester: 9


Course headcount limitations (min.-max.): 5 – 50 Prerequisites: OPG-GI3 completed

Topic

Students will become familiar with pharmaceutical databases, IT communication systems and drug management software applications.

Pharmaceutical IT methods such as telemedicine, or Internet pharmacies will be also covered in lectures. Lectures will give students

insight into ethical and legal aspects of information sources, and their critical evaluation. The aim of the lectures is to consolidate the

pharmaceutical IT skills of students. Students will be equipped with up-to-date pharmaceutical IT skills: use of databases and Internet

information sources.

During the semester the students will become familiar with the basics of personal computer and network systems is general and with the

specifications of pharmaceutical informatics, such as the development and stages of pharmacy informatics, principles of pharmacy

softwares. Also the different software types and drug dispensing rules used in pharmacies are introduced in this semester. The basic

knowledge of drug interactions and the available techniques and databases for screening interactions in everyday practice is also an

emphasized topic. After acquiring the principles of informatics and pharmaceutical informatics the students will be able to synthesize the

elements and understand the functions of pharmacy information management systems. Even the possibilities and threats of online drug marketing and the capability of finding relevant and authentic pharmaceutical information on the web is the objective of this course.


Acceptance of term/semester (requirements of registration for the exam):

- Regular attendance of classes/lectures (maximum 25 % of absence is accepted),

- Assignments given in class should be carried out during term-time and,

- The mid-term and end-of-the-term test(s) should be passed (60,1%, minimum grade 2).

End-of-semester grade is given by end-of-the-term test’s result, any tests written throughout the semester and student performance during

the semester.

Examination and granting of grades: for Pharmaceutical Informatics grade (midterm grade) is given based on mid-term and end-of-the-

term test results.

Mid-term exams


Compensation is possible following personal discussion.

Reading material



List of study aids to acquire curriculum (books, notes, other) and all presentations can be downloaded from Neptun Meet Street.

- Notes


Ed. R. Fisher: Information Technology for Pharmacists, Pharmaceutical Press

Brent I. Fox, Margaret R. Thrower, Bill G. Felkey: Building Core Competencies in Pharmacy Informatics, American Pharmacists Association, 2010

Lectures

1 Personal computer and network system fundamentals 1.

Dr. Vida Róbert György

2 Personal computer and network system fundamentals 2.


3 Database systems, IT and search engines 1.


4 Database systems, IT and search engines 2.



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5 Drug interactions, Drug interaction databases 1.

Dr. Végh Anna


Dr. Végh Anna


Dr. Végh Anna


Dr. Végh Anna

9 Pharmaceutical Information Management Systems 1.

Dr. Fittler András Tamás







Practices

1 Evidence Based Medicine - Critical Appraisal.

2 Evidence Based Medicine: Outcome Measures.

3 Evidence Based Medicine: Calculations.

4 Evidence Based Medicine: Interpretation of results. Practice

5 Kaposi Mór Oktató Kórház visit




9 Retail Pharmacy software: features and structure of professional pharmaceutical systems.

10 Pharmaceutical software for the follow-up of work procedures (compounding, drug manufacturing).

11 Application of professional pharmaceutical software interfaces for the improvement of medication of patients (filtering of endangered patient groups and drug interactions).

12 Pharmacy software for the follow-up of work procedures: (management, accounting of prescriptions).

Seminars


Based on the topics of the lectures and seminars.

Participants

Dr. Botz Lajos (BOLFAAP.PTE), Dr. Fittler András Tamás (FIAQAAK.PTE), Dr. Végh Anna (VEAOABO.PTE), Dr. Vida Róbert György (VIRNAAO.PTE)


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OPG-GU4 PHARMACEUTICAL PRACTICE AND MANAGEMENT 3

Course director: DR. LAJOS BOTZ, professor

Department of Pharmaceutics and University Pharmacy

3 credit ▪ final exam ▪ Pharmaceutical science theoretical knowledge and practical skills module ▪ autumn semester ▪ recommended semester: 9



Prerequisites: OPG-GI3 completed + OPG-GH2 completed + OPG-GT4 completed

Topic

The lectures of the semester will further outline the pharmaceutical supply system, specific pharmacy practice knowledge in community

and clinical professional pharmaceutical practice and care. Students will acquire skills in finding, evaluating and interpreting reliable

pharmaceutical information by getting familiar with the concepts of evidence based medicine and pharmacy informatics. In this semester

also interactive discussions will cover essential topics regarding self-medication, patient counselling and over the counter products used

in minor diseases. Detailed discussion of pharmacy practice will cover personal and objective criteria of pharmacies, prescribing and

dispensing regulations, controlled drugs, ordering and stockpiling drugs. Ensuring medication safety in community and hospital

pharmacy setting is a key element of modern pharmaceutical practice, thus the lectures focus on relevant issues. Students will discuss

elements of ethical behavior and pharmacy ethics in practice.

Aims of lectures in pharmaceutical studies: The aims of the lectures in pharmaceutical studies are to broaden the pharmaceutical practice

and management skills of students, and to generate interest in pharmacy as a profession. Main aim of these studies is to solidify pharmacy

practice and related economic, clinical, pharmaceutical care, information technology, ethics knowledge in order to understand

pharmacoeconomics, drug allocation, pharmaceutical management, health economics, evidence based medicine, clinical pharmacy

services and general pharmaceutics.. Further goal is to help students to gain insight into practical pharmaceutical work and into other

professional knowledge. The interactive group work during the seminars will develop analytical, problem solving and creative thinking

skills. Topics discussed during the lectures, but not included in the notes/books will also be included in the exams. Students can access the slides of the lectures and further reading material on a designated web based interface (Neptun Meet Street).


Acceptance of term/semester (requirements of registration for the exam):

- Regular attendance of classes/lectures (maximum 25 % of absence is accepted),

- Assignments given in class should be carried out during term-time and,

- The mid-term and end-of-the-term test(s) should be passed (60,1%, minimum grade 2).

End-of-semester grade is given by end-of-the-term test’s result, any tests written throughout the semester and student performance during

the semester.

Examination and granting of grades: for Pharmaceutical Practice and Management 3 students must take an oral final exam.

Mid-term exams


Compensation is possible following personal discussion.

Reading material



- Notes


C. Bond (ed.): Evidence-based Pharmacy, Pharmaceutical Press, London, 2002.

A. J. Winfield, R. M. E. Richards (eds.): Pharmaceutical Practice, Churchill Livinstone

C. H. Knowlton, R. P. Penna (eds.): Pharmaceutical Care, ASHSP

M. Stephens (ed.): Hospital Pharmacy, Pharmaceutical Press, London, 2006.

Rosemary R. Berardi, Stefanie P. Ferreri et al.: Handbook of Nonpresciption Drugs, 17th edition, American Pharmacists Association, 2012.

Walker, Roger: Clinical Pharmacy and Therapeutics, 2011.

Edzard Ernst, Simon Singh: Trick or Treatment, W. W. Norton & Company, 2008. Section IV: Nutrition and Nutritional Supplementation, Section XI: Complementary and Alternative Medicine.

Edzard Ernst, Simon Singh: Trick or Treatment? Alternative Medicine on Trial

John P. Griffin, John Posner, Geoffrey R. Barker: The Textbook of Pharmaceutical Medicine, 7th Edition, 2013.


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Lectures

1 Hospital pharmacy services


2 Clinical pharmacy services 1.


3 Clinical pharmacy services 2.


4 Drugs in pregnancy and lactation

Dr. Végh Anna

5 Pharmaceutical Care: Geriatrics


6 Pharmaceutical Care: Neonates and paediatrics

Dr. Végh Anna

7 Antidotes for toxicological emergencies


8 Oncology pharmacy


9 Patient safety in clinical practice


10 Volume therapy


11 Pharmaceutical care in infectology


12 Assuring medication safety in community pharmacy practice


13 Controlled drugs; prescribing and dispensing regulations, international treaties


14 Monitoring medication safety


15 Ordering, procurement, stockpiling and storing


16 Personal and objective criteria for pharmacies


17 Detailed introduction to the dispensing practice


18 Evaluating Clinical Trials from the aspect of EBM


19 Fundamentals of Evidence Based Medicine and Clinical Epidemiology


20 Evidence-based Practice. Most important internet databases


21 How to formulate a question, searching strategy, evaluate methods, evaluate results, conclusions


22 Principles of critical appraisal


23 Interpreting results


24 Test

Dr. Botz Lajos

Practices

1 Seborrheic dermatitis, psoriasis

2 Allergy and contact dermatitis

3 Vaginal and vulvovaginal disorders

4 Fungal skin infections, Athlete’s foot

5 Headache and migraine

6 Disorders related to colds

7 Cough and expectorants

8 Fever


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9 Dyspepsia, heartburn and intestinal gas, diarrhoea and constipation

10 Pharmaceutical Ethics

11 Practical use of Evidence-based Practice: Answering therapeutic questions

12 Practical use of Evidence-based Practice

Seminars


Final exam topics for

PHARMACEUTICAL PRACTICE AND MANAGEMENT

(Basic principles of pharmacy and Pharmaceutical practice and management 1, 2 & 3)

Three exam topics shall be elaborated and presented during the final exam. Supplementary definitions and questions (which will not be

highlighted during the exam) below the listed exam titles aim to specify the required knowledge for each topic. Certain contents of

the discussed topics may be overlapping, while other exam topics require the association of professional pharmaceutical knowledge

introduced during different lectures/semesters.

1. History of Pharmacy and Medicine. Pharmacy as a profession.

2. Development and role of Pharmacopoeias and formularies in pharmacy.

3. Product categories in community pharmacies.

4. Regulation and organization of Hungarian health system.

5. The drug supply chain, stakeholders of the drug supply system.

6. Personal and objective criteria for community, branch and single-handed pharmacies in Hungary.

7. Regulation of the prescribing and dispensing of medicines in Hungary.

8. Regulation regarding controlled drugs in Hungary. International drug control treaties.

9. International and Hungarian health and pharmaceutical organizations.

10. Fundamentals of economics for pharmacists. Characteristics of market of healthcare and pharmaceuticals.

11. Health Economics and Pharmacoeconomics I.: Aims, methodology and the main methods.

12. Health Economics and Pharmacoeconomics II.: The concept, importance and measurement of the quality of life.

13. Drug utilization. Drug classification systems.

14. Rational and transparent drug selection. SOJA method. Decision Analysis.

15. Pricing and life cycle of drugs.

16. Health expenditures, drug/healthcare costs, cost-control techniques.

17. Development and types of social and health insurance systems. Characteristics of the Hungarian social and health insurance system.

18. Basics and practice of Marketing.

19. Drug Research and Development I.: Pre-clinical phase.

20. Drug Research and Development II.: Clinical trials.

21. Drug Research and Development III.: Phases in clinical trials.

22. Drug authorization process I.: Patent protection.

23. Drug authorization processes II.: Abridged authorization. Off-label use of drugs. Orphan drugs.

24. Drug authorization processes III.: Equivalencies of drugs. Substitution.

25. Placebo effect: the role of placebo in clinical trials and therapy.

26. Patient Rights.

27. Medication errors.

28. Adverse drug reactions.

29. Drug interactions.

30. Philosophy and development of evidence based medicine and pharmacy.

31. Hierarchy of medical information and clinical evidence clinical study designs.

32. The practical steps of evidence based practice.

33. Interpreting the results of evidence based practice: Outcome measures.

34. Hospital and clinical pharmacy I.: Life stages (pediatrics, geriatrics, gravidity and breast feeding).

35. Hospital and clinical pharmacy II.: Infectology and antibiotic stewardship.

36. Hospital and clinical pharmacy III.: Nutrition therapy. Fluid therapy.

37. Hospital and clinical pharmacy IV.: The development and services of hospital and clinical pharmacy.

38. Hospital and clinical pharmacy V.: Oncology pharmacy.

39. The development, basics and techniques of pharmaceutical care.

40. Pharmaceutical care of respiratory diseases: allergic rhinitis, asthma bronchiale, COPD.

41. Pharmaceutical care of cardiometabolic syndrome


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42. Self-Care and Nonprescription Pharmacotherapy I.: Patient assessment and consultation.

43. Self-Care and Nonprescription Pharmacotherapy II.: Dry skin, atopic dermatitis, acne, contact dermatitis and allergy.

44. Self-Care and Nonprescription Pharmacotherapy III.: Dyspepsia, heartburn and intestinal gas, diarrhea and constipation.

45. Self-Care and Nonprescription Pharmacotherapy IV.: Fungal skin infections, vaginal and vulvovaginal disorders.

46. Self-Care and Nonprescription Pharmacotherapy V.: Headache, fever, cough and disorders related to colds.

47. Self-Care and Nonprescription Pharmacotherapy VI.: Oral disorders, nutritional supplementation.

48. Good Communication in Pharmacy Practice. Written, electronic communication in Health care and holding oral presentations.

49. Medication adherence - Helping patients manage therapeutic regimens.

50. Pharmaceutical informatics.

Participants

Dr. Fittler András Tamás (FIAQAAK.PTE), Dr. Végh Anna (VEAOABO.PTE), Dr. Vida Róbert György (VIRNAAO.PTE)


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OPG-KLF CLINICAL PHARMACOLOGY

Course director: DR. ERIKA PINTÉR, professor


1 credit ▪ semester exam ▪ Pharmaceutical science theoretical knowledge and practical skills module ▪ autumn semester ▪ recommended semester: 9


Course headcount limitations (min.-max.): 2 – 40 Prerequisites: OPO-KL2 parallel + OPG-HT3 parallel

Topic

In the frame of this one semester subject (15 lectures) students get acquainted with the next clinical pharmacological terms and sections:

history of the drug research, rational drug design, preclinical development, safety pharmacology, clinical studies (Phase I-II-III-IV),

Good Clinical Practice. Documentation of clinical trials. Practical aspects of clinical studies. Evidence-based medicine.



Mid-term exams

None


None

Reading material



Lectures made available on Neptun.

- Notes


Lectures

1 History of drugs


2 History of drugs


3 Drug discovery and development

Dr. Bölcskei Kata


Dr. Bölcskei Kata


Dr. Bölcskei Kata

6 Preclinical testing

Dr. Bölcskei Kata


Dr. Bölcskei Kata


Dr. Bölcskei Kata

9 Design and conduct of clinical trials

Dr. Bölcskei Kata


Dr. Bölcskei Kata


Dr. Bölcskei Kata

12 GMP, GLP, GCP

Dr. Bölcskei Kata

13 GMP, GLP, GCP

Dr. Bölcskei Kata

14 Documentation of the clinical studies

Dr. Bölcskei Kata

15 Documentation of the clinical studies

Dr. Bölcskei Kata


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Practices

Seminars


Written exam based on the lectures

Participants


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OPG-NOV HERBAL MEDICINE AND HERBS IN NUTRITION

Course director: DR. TAMÁS ANTAL KŐSZEGI, associate professor

Department of Pharmacognosy



Course headcount limitations (min.-max.): 1 – Prerequisites: OPG-FG2 completed + OPG-GH2 completed

Topic

Aims of the subject: To give an overview for the students on the biological effects of generally used herbs, drugs and herbal nutrients on

the human body (beneficial and hazardous as well). To demonstrate the mode of action, indications and applications of herbal drugs in

the most important disease groups by showing practical examples and case reports. To make emphasis on the interactions of herbal

constituents with allopathic drugs used in modern medicine. The curriculum helps proper orientation among today’s frequent misbelieves

and myths by the methods of evidence based medicine.



Mid-term exams

A midterm is due in November


An absence rate of less than 25% is acceptable, no medical or other certificate is necessary. Management of catch up for absences is

possible by personal consultation with the tutor.

Reading material



All lectures are accessible at Coospace

- Notes


Aronson J.K. (ed.): Meyler’s Side Effects of Herbal Medicines, Elsevier, Amsterdam-Oxford-Tokyo, 2009

Barnes J., Anderson L.A., Phillipson J.D.: Herbal Medicines, 2nd edition, Pharmaceutical Press, London-Chicago, 2002

ESCOP Monographs, The Scientific Foundation for Herbal Medicinal Products, 2nd edition, Thieme, Exeter; Stuttgart; New York, 2003

European Medicines Agency guidelines; www.ema.europa.eu

Lectures

1 Major biological effects of herbs used in the human diet

Dr. Kőszegi Tamás Antal

2 Characteristics of an optimal nutritional regime for maintenance of health in regard of herbal constituents of different diets


3 Biochemical testing methods for the assessment of biological effects of herbal extracts in cellular model systems


4 Effects of antioxidants and other cytoprotective molecules of plant origin on cell energetics and free radical levels


5 Application of plant extracts and monitoring procedures of their action at the body level


6 Herbal formulations with immuno-modulant activity; case discussion


7 Application of herbal medicine based on ethnopharmacobotany and evidence based medicine

Dr. Papp Nóra

8 Application of herbal medicine based on ethnopharmacobotany and evidence based medicine

Dr. Papp Nóra

9 Dermatological use of medicinal plants

Dr. Papp Nóra

10 Medicinal plants in management of weight loss

Dr. Papp Nóra

http://www.ema.europa.eu/


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11 Medicinal plants in management of common cold

Dr. Bencsik Tímea

12 Blood cholesterol lowering medicinal plants

Dr. Bencsik Tímea

13 Medicinal plants with antidiabetic potential

Dr. Bencsik Tímea

14 Antiviral medicinal plants

Dr. Bencsik Tímea

15 Complementary therapy of chronic bone and joint diseases


16 Rheumatoid arthritis; case discussion


17 Interactions between drugs, medicinal plants, and foods

Dr. Horváth Györgyi

18 Interactions between drugs, medicinal plants, and foods


19 Nutritional and herbal medicine approaches in malignant diseases


20 Complementary therapy of malignant diseases; case discussion


21 Restoration of the various balances in the gastrointestinal tract by phytotherapy and microbiological therapy


22 Useful complementary methods in the diseases of the gastrointestinal tract; case discussion


23 Herbal sedatives - indications and contraindications


24 Use of medicinal plants in the prevention and treatment of cardiovasular diseases


Practices

Seminars


1 Why plants used in human nutrition may be considered to function as medicinal herbs? Give examples.

2 What types of cytoprotective factors can be found in fruits and vegetables?

3 What are the most important constituents of plant origin in the human diet for maintenance of health?

4 Give a few examples for in vitro assessment of biological effects of plant extracts in cellular models.

5 How antioxidant capacity can be measured using in vitro cellular models? How cell energetics can be characterized by laboratory approaches?

6 What does immune modulation mean? List a few practical examples with the mention of active ingredients.

7 Use and misuse of common and vernacular names of plants and drugs.

8 Which medicinal plants have an antiviral effect and against which viruses?

9 Medicinal plants used in the treatment of cardiovascular diseases (indications and contraindications).

10 Give examples on mineral supplementation in bone and joint diseases (microbiological therapy as well).

11 Different complementary immune modulant therapies in rheumatoid arthritis disease.

12 Which medicinal plants can be used in the treatment of mild dermatological diseases?

13 Medicinal plants in management of weight loss.

14 Name those complementary therapies or processes that are contraindicated in malignant diseases (active agents, ingredients).

15 Explain why restoration of function, bacterial micro flora and permeability of the gastrointestinal tract is of vital importance?

16 Major indication of phytotherapeutical treatments in certain diseases of the gastrointestinal tract (name the active agents as well).

17 Types, possible mechanisms, and evaluation methods of interactions between drugs and medicinal plants.

18 Explain the following type of interactions (with plant samples): misunderstood, possible, probable, and proved.

19 Which are the most important steps of the ethnobotanical investigations?

20 List reliable sources (books and websites), where you can find information on traditional and evidence-based medicinal use of plants.

21 Which are the most important steps of pre-clinical and clinical studies that may support the traditional use of plants?

22 List examples for blood cholesterol lowering medicinal plants. Which synthetic drugs and medicinal plants have the same mechanism of actions?

23 Which active compounds are responsible for the blood cholesterol lowering effect of garlic? What are their mechanism of action and side effects? What is the mechanism of action of red rice and why is it dangerous to use?

24 What is the mechanism of actions of the medicinal plants used against cough? List some examples to each group.


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25 Which essential oils can be used in common cold? What are their contraindications and mechanisms of action?

26 Characterize the herbal sedatives and anxiolytics (mode of action, indications, and contraindications).

27 Which medicinal plants have antidiabetic potential? Which were used to develop synthetic drugs?

Participants


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OPG-PMG PROBLEMSOLVING PHARMACY



2 credit ▪ midsemester grade ▪ Pharmaceutical science theoretical knowledge and practical skills module ▪ autumn semester ▪ recommended semester: 9


Course headcount limitations (min.-max.): 1 – 40 Prerequisites: OPG-GH2 completed + OPG-HT3 parallel

Topic

Training for the practical aspects of the pharmacist praxis. Discussions of the case reports.



Mid-term exams


None

Reading material



Lecture notes made available on Intranet

- Notes


Lectures

1 Drug therapy problems of cardiovascular diseases, (palpitations, chest pain, edema, dizziness, weakness, headache)


2 Drug therapy problems of cardiovascular diseases, (palpitations, chest pain, edema, dizziness, weakness, headache)


3 Tasks of the pharmacist in the treatment of diabetes


4 Drug treatment of gastrointestinal disorders (anorexia, vomiting, diarrhea, constipation, abdominal pain, bloody stools)

Dr. Bölcskei Kata

5 Drug treatment of gastrointestinal disorders (anorexia, vomiting, diarrhea, constipation, abdominal pain, bloody stools)

Dr. Bölcskei Kata

6 Pharmacotherapeutic problems of respiratory diseases (cough, runny nose, shortness of breath, wheezing, chest pain)

Dr. Bölcskei Kata

7 Pharmaceutical problems of coagulation disorders (warfarin, heparin therapy, interactions, bleeding)

Dr. Bölcskei Kata

8 Neurological diseases pharmacotherapy problems: (dizziness, headache, tinnitus, loss of consciousness, pain, paralysis)

Dr. Bölcskei Kata

9 Neurological diseases pharmacotherapy problems: (dizziness, headache, tinnitus, loss of consciousness, pain, paralysis)

Dr. Bölcskei Kata

10 The specific pharmacological problems of pediatrics 1


11 The specific pharmacological problems of pediatrics 2


12 Inflammatory, allergic diseases


13 Anxiety, depression, drug abuse


14 Support of the antidepressant therapy by the pharmacist



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15 Pharmacological problems of pain management 1

Dr. Bölcskei Kata

16 Pharmacological problems of pain management 2

Dr. Bölcskei Kata

17 Problem solving in the current scope of antimicrobial therapy 1

Dr. Botz Lajos

18 Problem solving in the current scope of antimicrobial therapy 2

Dr. Botz Lajos

19 Medication problems during pregnancy and lactation


20 Contraception, therapeutic use of drugs for treatment of genitals


21 Drugs used for treatment of sensory organs


Practices

Seminars


Written exam based on the lectures.

Lecture notes made available on Intranet

Drug therapy problems of cardiovascular diseases, (palpitations, chest pain, edema, dizziness, weakness, headache)

Medical treatment of gastrointestinal disorders (anorexia, vomiting, diarrhea, constipation, abdominal pain, bloody stools)

Pharmacotherapeutic problems of respiratory disease (cough, runny nose, shortness of breath, wheezing, chest pain)

Pharmaceutical problems affecting coagulation disorders (warfarin, heparin therapy, interactions, bleeding)

Neurological diseases pharmacotherapy problems: (dizziness, headache, tinnitus, loss of consciousness, pain, paralysis)

The specific pharmacological problems of pediatrics

Inflammatory, allergic diseases

Anxiety, depression, drug abuse

Problems of pharmacological pain management

Problem solving in the current scope of antimicrobial therapy

Applications of dermatological preparations (rash, itching, peeling, dermatitis, wound care, dry skin)

Arising medication problems during pregnancy and lactation

Contraception, therapeutic use of drugs for treatment of genitals.

Drugs used for treatment of sensory organs.

Participants

Dr. Botz Lajos (BOLFAAP.PTE), Dr. Bölcskei Kata (BOKFABO.PTE), Dr. Fittler András Tamás (FIAQAAK.PTE), Sánticsné Dr. Pintér Erika (PIEMAAO.PTE)


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OPG-TOX TOXICOLOGY

Course director: DR. BALÁZS FERENC NÉMETI, associate professor




Course headcount limitations (min.-max.): 1 – 60 Prerequisites: OGGHT3 parallel + OPG-GK4 completed

Topic

Toxicology as a subject deals with the adverse health effects, including developmental adverse effects and carcinogenic effects, of drugs

and other xenobiotics (e.g., pesticides, solvents, metal compounds, toxic gases, chemical warfare agents, mushroom- and plant-derived

toxins) caused by overdose or excessive exposure. It describes the manifestations of the harmful effects, the molecular mechanisms

involved in the adverse outcome, the major factors influencing the development of toxic injury, the diagnostics of the adverse health

effects, as well as their prevention and treatment. The principles and practice of safety evaluation of drugs (toxicity testing) and risk assessment of chemicals are also discussed.



Mid-term exams

Students are requested to take two mid-term tests during the semester, around weeks 6 and 10. Reaching 60% of the achievable score is

the pre-requisite for taking the exam.


There is no way to make up for missed classes.

Reading material



Teaching materials available on the Neptun Meet Street.

- Notes


Casarett & Doull’s Toxicology, 8th edition, McGraw-Hill, 2013.

The toxicology chapters of Pharmacology textbooks,

e.g., Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 12th edition, 2011: Drug Toxicity and Poisoning; Environmental Toxicology;

Timbrell, J.A.: Principles of Biochemical Toxicology, 4th edition, Taylor & Francis, Inc., London, 2008.

Lectures

1 The scope of toxicology. Human intoxications - Occurrence and classification. Causes of poisoning-related death.

Dr. Gregus Zoltán

2 Management of the poisoned patients I (emergency care, diagnostic procedures)

Dr. Gregus Zoltán

3 Management of the poisoned patients II (decontamination, antidotes)

Dr. Gregus Zoltán

4 Management of the poisoned patients III (enhancement of the elimination of toxicants, supportive treatment)

Dr. Gregus Zoltán

5 Drug intoxications I

Dr. Poór Miklós

6 Drug intoxications II

Dr. Poór Miklós

7 Drug intoxications III

Dr. Poór Miklós

8 Intoxication with metals I. Mechanisms of metal toxicity. Protective mechanisms. Metal chelators.


9 Intoxication with metals II. Lead, mercury, cadmium.


10 Intoxication with metals III. Arsenic, chromium, cobalt, nickel, manganese.



21

11 Intoxication with pesticides I. General properties. Insecticides: halogenated hydrocarbons.

Dr. Poór Miklós

12 Intoxication with pesticides II. Insecticides: Organophosphates and carbamates. Herbicides.

Dr. Poór Miklós

13 Intoxication with pesticides III. Fungicides. Rodenticides. Fumigants.

Dr. Poór Miklós

14 Intoxication with solvents I. Benzol, aliphatic hydrocarbons, carbon disulfide.


15 Intoxication with solvents II. Alcohols, glycols, halogenated hydrocarbons.


16 Toxic gases (CO, HCN and cyanogenic compounds, H2S).

Dr. Gregus Zoltán

17 Hemolytic chemicals, methaemoglobin-forming chemicals.

Dr. Gregus Zoltán

18 Chemical warfare agents


19 Mushroom poisonings. Chemical teratogenesis I


20 Chemical teratogenesis II


21 Chemical carcinogenesis I

Dr. Gregus Zoltán

22 Chemical carcinogenesis II

Dr. Gregus Zoltán

23 Toxicity testing and risk assessment - Principles and practices I

Dr. Gregus Zoltán

24 Toxicity testing and risk assessment - Principles and practices II

Dr. Gregus Zoltán

Practices

Seminars


1. The scope of toxicology. Human intoxications: occurrence and classification. Causes of poisoning-related death

2. Management of the poisoned patient: emergency care, diagnostic procedures

3. Management of the poisoned patient: decontamination, antidotes, enhancement of the elimination of toxicants, supportive care

4. Drug intoxications: drugs causing diminished level of consciousness

5. Drug intoxications: drugs causing excitation or cardiac dysfunction

6. Drug intoxications: drugs causing metabolic disturbances or tissue necrosis

7. General mechanisms of metal toxicity, metal chelators, protective mechanisms

8. Intoxication with metals: lead, mercury

9. Intoxication with metals: cadmium, arsenic

10. Intoxication with metals: chromium, cobalt, nickel, manganese, barium, thallium

11. Intoxication with pesticides: general features, rodenticides, fumigants

12. Intoxication with pesticides: insecticides

13. Intoxication with pesticides: herbicides, fungicides

14. Intoxication with solvents: benzene, aliphatic hydrocarbons

15. Intoxication with solvents: alcohols, glycols

16. Intoxication with solvents: halogenated hydrocarbons, carbon-disulfide

17. Toxic gases: carbon-monoxide, hydrogen-cyanide and cyanogen compounds, hydrogen sulfide

18. Hemolyzing and methemoglobin-forming agents

19. Mushroom poisonings

20. Chemical and biological weapons

21. Chemical carcinogenesis: genotoxic carcinogens

22. Chemical carcinogenesis: non-genotoxic carcinogens, unclassified carcinogens, carcinogenicity testing

23. Xenobiotic-induced fetal malformations

24. Toxicity testing: principles and practice

25. Risk assessment


22

In addition to the exam topics, an important part of the exam is answering questions that aim at assessing the general knowledge of the student.

Participants


23

OPO-KL2 CLINICAL STUDIES 2


Department of Pharmacognosy

5 credit ▪ semester exam ▪ Pharmaceutical biology and medical theoretical knowledge module ▪ autumn semester ▪ recommended semester: 9


Course headcount limitations (min.-max.): 2 – Prerequisites: OPO-KL1 completed

Topic

The task of the subject is the transmission of the most fundamental knowledge of the clinical studies for the pharmacy students. The

curriculum covers the most important diseases focusing on their pharmacotherapy. The task of this subject to promote the accurate knowledge pharmacotherapy in the clinical practise.



Mid-term exams


None

Reading material



Lecture notes

- Notes


Lectures

1 Gestation time, pregnancy diagnosis, growth of the uterus during pregnancy. Uncomplicated spontaneous labor. Disorders of

pregnancy: hyperemesis gravidarum, abortion.

Dr. Kovács Kálmán András

2 Ultrasound examinations during pregnancy. Procedures for assessment of the status of the fetus in utero. Location of the fetus in

utero and its diagnosis.


3 Laying, holding, rotational and integration abnormalities. Natal complications: breech, vacuum forceps, sectio Caesara, preterm

birth, preeclampsia, diabetes and pregnancy, placenta praevia, abruptio placenta, preterm rupture.


4 Contraception. Gynecological inflammations. Sterility testing and management.


5 Cancer screening, gynecologic cancers (cervical and endometrial cancer, ovarian cancer). Benign tumors of the uterus (myoma).


6 Growth and development during childhood

Dr. Csábi Györgyi

7 Infant nutrition

Dr. Csábi Györgyi

8 The bacterial infections in pediatric care practice

Dr. Csábi Györgyi

9 Exsiccatio, fluid replacement, oral rehydration. Antifebrile therapy, treatment of convulsion

Dr. Csábi Györgyi

10 Neurological disease symptoms, peripheral and central nervous system disorders.

Dr. Pál Endre

11 Stroke.

Dr. Pál Endre

12 Encephalitis and meningitis, intracranial and spinal tumors.

Dr. Pál Endre

13 Multiple sclerosis, Parkinson’s disease, epilepsy.

Dr. Pál Endre

14 Peripheral nervous system diseases, myopathies.

Dr. Pál Endre


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15 Examination of psychiatric patient.

Dr. Tényi Tamás

16 Organic mental disorders.

Dr. Tényi Tamás

17 Endogenous psychoses.

Dr. Tényi Tamás

18 Non-psychotic psychiatric disorders. Psychiatric therapies.

Dr. Tényi Tamás

19 Ear, nose, laryngology. The outer and middle ear.

Dr. Bauer Miklós

20 The inner ear. Audiological and vestibular basics.

Dr. Bauer Miklós

21 The nose.

Dr. Bauer Miklós

22 The pharynx.

Dr. Bauer Miklós

23 The larynx, trachea, esophagus and neck.

Dr. Bauer Miklós

24 Basics of preventive dentistry, pediatric dentistry.

Dr. Balásné Dr. Szántó Ildikó

25 Oral surgery treatments, pain relief.


26 Restorative dental treatments.


27 Basics of prosthodontics.


28 Dental development, orthodontic anomalies, drug-induced dental lesions.


29 Orthopedic examination possibilities, orthopedic screenings, pediatric orthopedic disorders.

Dr. Tunyogi Csapó Miklós

30 Large joint diseases and their medical and surgical management


31 Spinal diseases and their conservative and surgical treatment.


32 Joint injuries and their pharmacological and surgical treatment.


33 Orthopedic surgery perioperative complications, prevention, and treatment.


34 Drugs for treatment of urine storage and emptying disorders.

Dr. Damásdi Miklós

35 Medical treatment of uro-oncological diseases.


36 Medical treatment of erectile dysfunction.


37 Medical aids in urological practice.


38 Urologic clinics of stone diseases and its drugs.


39 The structure of skin, essential phenomena.

Dr. Kinyó Ágnes

40 Infectious skin disease, pyoderma, bacterial, viral and fungal diseases.

Dr. Kinyó Ágnes

41 STD diseases and sexual health care.

Dr. Kinyó Ágnes

42 Dermatological tumors. Immunpathological disorders in dermatology.

Dr. Kinyó Ágnes

43 Eye examination of the patient. (The functional anatomy of the organ of vision, functional and morphological methods of analysis.)

Dr. Varsányi László Balázs


25

44 Chronic eye diseases (glaucoma, cataracts, age-related macular degeneration, symptomatology, basic examinations, interpretation of findings, therapy).


45 Acute ocular diseases. (Symptomatology, basic examinations, interpretation of findings, therapy).


46 Childhood eye diseases. Ocular symptoms of general disorders. Neuroophthalmology.


47 Traumatology in ophthalmology and intraocular tumors.


48 Treatment of spondylarthritis. Treatment of gout. Treatment of infection-triggered arthritis.

Dr. Sütő Gábor

49 Non-biological and biological base therapeutic drugs in rheumatoid arthritis.

Dr. Sütő Gábor

50 Rules of the utilization of non steroidal antiinflammatory drugs in rheumatology and clinical immunology. Management of acute

and chronical pain in rheumatology.

Dr. Sarlós Gézáné

51 Pharmacological treatment of osteoporosis.

Dr. Sarlós Gézáné

52 Treatment with corticosteroids and cytostatic agents in autoimmun diseases.

Dr. Czirják László István

53 The primary care of cancer patients, the TNM system, prognostic factors and onkoteam decision.

Dr. Mangel László

54 The principles and practice of radiochemotherapy.

Dr. Bellyei Szabolcs

55 The clinical implications of chemotherapy and

Dr. Karádi Oszkár

56 Modern targeted therapies and basics of hormone replacement therapy.

Dr. Karádi Oszkár

57 The practice of supportive therapy in oncology.

Dr. Boronkai Árpád

58 Specificity of General Practice, the holistic approach.

Dr. Bán Ildikó

59 Physician-pharmacist relationship. Team work. Role-playing. Dr. Ágnes Csikós

Dr. Bán Ildikó

60 GP office and staff. Pharmacist-patient relationship.

Dr. Bán Ildikó

Practices

Seminars


Written exam based on the lectures.

Participants


26

OPO-KLV CLINICAL LABORATORY INVESTIGATIONS

Course director: DR. TAMÁS ANTAL KŐSZEGI, associate professor

Institute of Laboratory Medicine

2 credit ▪ midsemester grade ▪ Pharmaceutical biology and medical theoretical knowledge module ▪ autumn semester ▪ recommended semester: 9


Course headcount limitations (min.-max.): 1 –

Prerequisites: OPO-KL2 parallel + OPO-IMM completed + OPO-KOT completed

Topic

Clinical Laboratory Investigations is a subject based on a solid knowledge in chemistry, biochemistry and physiology. It gives a practical

guide to understand and interpret a wide variety of modern laboratory tests by showing the molecular basis of them. The subject includes

classic chemical and biochemical methods, immunochemistry, hematology, blood coagulation, toxicology and molecular biology. The

major methodological aspects and applications are discussed during the lectures.



Mid-term exams

One midterm multiple choice is due in November


An absence rate of less than 25% is acceptable, no medical or other certificate is necessary.

Reading material



All lectures are accessible at Coospace

- Notes


W.J. Marshall, S.K. Bangert: Clinical Chemistry, 5th ed., Mosby Co, 2004, ISBN 0723433283

G.J. Beckett, S.W. Walker, P. Rae, P. Ashby: Lecture Notes on Clinical Biochemistry, 7th ed., Blackwell Co., 2005

W.J. Marshall, S.K. Bangert: Clinical Chemistry, 6th ed., Mosby Co, 2008 ISBN 9780723434559

Lectures

1 Clinical Biochemistry: analysis of samples obtained from the human body and interpretation of test results. Different factors influencing the results of lab tests. Informational value of test results (reference intervals, statistical approaches).


2 Clinical Biochemistry: analysis of samples obtained from the human body and interpretation of test results. Different factors influencing the results of lab tests. Informational value of test results (reference intervals, statistical approaches).


3 Different laboratory approaches in water and electrolyte disorders. Internal and external quality controls.


4 Different laboratory approaches in water and electrolyte disorders. Internal and external quality controls.


5 Analysis of plasma proteins. Separation techniques and basis of immunochemical methods.


6 Analysis of plasma proteins. Separation techniques and basis of immunochemical methods.


7 Analysis of plasma enzymes. Routes of release of enzymes into the extracellular space. Enzymes as tissue markers.


8 Analysis of plasma enzymes. Routes of release of enzymes into the extracellular space. Enzymes as tissue markers.


9 Carbohydrate metabolism and laboratory tests in endocrine diseases.


10 Carbohydrate metabolism and laboratory tests in endocrine diseases.



27

11 Laboratory diagnostics of cardiac and skeletal muscle diseases. Inherited and acquired disorders. Importance of the half-life of tested parameters.


12 Laboratory diagnostics of cardiac and skeletal muscle diseases. Inherited and acquired disorders. Importance of the half-life of tested parameters.


13 Iron, porphyrin and hemoglobin metabolism. Automated immunochemical measurements.


14 Iron, porphyrin and hemoglobin metabolism. Automated immunochemical measurements.


15 Disorders of lipid metabolism. Automated hematological analyses.


16 Disorders of lipid metabolism. Automated hematological analyses.


17 Acid-base balance. Methods and interpretation of test results.


18 Acid-base balance. Methods and interpretation of test results.


19 Calcium, magnesium and bone metabolism. Laboratory findings in bone diseases.


20 Calcium, magnesium and bone metabolism. Laboratory findings in bone diseases.


21 Laboratory tests in kidney diseases. Tumors and tumor markers.


22 Laboratory tests in kidney diseases. Tumors and tumor markers.


23 Different approaches in liver and gastrointestinal diseases. Basic methods in investigation of disorders in hemostasis.


24 Different approaches in liver and gastrointestinal diseases. Basic methods in toxicology and interpretation of results.


Practices

Seminars


In every new semester new multiple choice questions are to be worked out.

Participants


28

OPS-SG3 PROFESSIONAL PRACTICE BEFORE STATE EXAMINATION 1

Course director: DR. KLÁRA MAYER, assistant professor

Department of Pharmacotechnology

4 credit ▪ midsemester grade ▪ Final/Rotational (year) module ▪ autumn semester ▪ recommended semester: 9



Prerequisites: OPG-GH1 completed + OPG-GI2 completed + OPR-SG2 completed

Topic

Two month of course Pharmacy Practice 3 is the first part of the 6 month of practice in the rigorous year. Aim of the first part of rigorous

year is to expand the knowledge and approach of student with practice oriented pharmaceutics, knowing the aspects of pharmaceutical care, economy and preparing magistral medicines in the pharmacy.

The 6 months are the 6 thematic, from this 1-3 parts must in the 2 months 2 part in the Professional Practice Before state Examination I.

The practice 2 months can be homeland or Hungarian or foreign countries pharmacy.


Brief daily report must be done during the practice which has to be presented. Tutor pharmacist and chief pharmacist has to evaluate

students work and confirm the pharmacy practice with their signature. Student must work daily 8 hours during two month of practice.

Proposal in the Hungarian pharmacy practice with Hungarian Student together.

Mid-term exams




During the 6 months practice only 5 days are allowed to miss confirmed by a physician. More days of missing must be supplemented.

Reading material


Dévay: The Theory and Practice of Pharmaceutical Technology, e-book, http://gytsz.pte.hu/en/egyseg/oktatasianyagok/1620/


- Notes

Final exam - test-book


European Pharmacopoeia

Pharmacopoeia Hungarica

Hungarian National Formulary: Formulae Normales VII (FoNo VII)

Compendium

Lectures

Practices

1.a) Clinical Pharmacy 1. parts

Knowing the structure of hospital/clinic

Studying the relationship between the pharmacy and other wards

Controlling role of the pharmacy regarding drug utilization and storage of different wards

Federal laws affecting clinical pharmacy practice

Preparing drugs specified for clinical pharmacies under the supervision of the tutor pharmacist

Knowing and operating with special appliances on different divisions (galenic division, parenteral division) of the pharmacy under the supervision of the tutor pharmacist

Knowing basic galenic preparations of the pharmacy containing knowledge of preparation of infusions, peritoneal dialysis

solutions; knowing the conditions for preparations, analytical and microbiological control methods and storage

Recognizing and repairing incompatibilities

Participating in economical tasks of the pharmacy

Pharmaceutical economy, ordering medicines

Studying drugs, medical aids, nutritions, diagnostics, x-ray contrast materials stored in pharmacy

Studying relationship with pharmaceutical manufacturers and distributors

Studying drug order from foreign countries

http://gytsz.pte.hu/en/egyseg/oktatasianyagok/1620/


29

Treatment of drugs and ingredients of increased control

Studying participation of the pharmacy in the therapy

Knowing the intelligence service of the pharmacy

Studying role and function of Board of Pharmaceutical Therapy, knowing its protocols

Studying drug development clinical trials, knowing the documentation, federal laws regarding clinical trials

Studying the relationship between the pharmacy and the clinical laboratory

continuation „Clinical Pharmacy 2. parts”

..

2. Public pharmacy operation

Public pharmacies’ measures concerning drug supply

In the pharmacy’s farming tasks truth participation

The acquisition of management, technical knowledge

Medicine farming: the procession of the medicine order

The preparation of medicine orders

Contacts, information, the examination of orders, complaints lasted with the medicine wholesalers

With the implements to be checked increased related knowledge and tasks

In the course of the waste product, the returns, a damage truth tasks

It is related to changes in price tasks

The closings: daily, weekly, snow end ill. OEP meanings

The knowledge of measures, bulletins

A drawer pharmacy’s, „kézigyógyszertár” concepts, knowledge, tasks

The knowledge of the officinal literature

The acquisition of the officinal computer program with a skill level

..

3. Pharmaceutical practice, receipt, preparate

The accomplishment of the medicine making processes turning up in the pharmacy with the management of a teaching chemist

The pharmacy’s inner cheque activity in the process of the medicine making

Unique praescriptions his cognition, his completion, their comparison the official one with praescriptions

Pharmacopoeia, FoNo

Laboration concept, the differences of processes, completions the unique one prescriptions his making, documentation

His Manual cognition, his application and prescription his editing

The nomenclature of the stocks, regular pharmacopoeia full Latin ill. his abridged name

Medicine cheque: the incoming medicines, stocks, basis artefacts, vegetal drugs, bandages, etc. His regular receipt

The the examination of stocks and his documentation arrived

The laboured the cheque of artefacts (pl. 70% Ethanolum, Sirup. simplex)

The aseptic working in the pharmacy, a principle, practice

Sterile, documentation, sterile apparatus cheque

The recognition of incompatibilities, correct completions, physical, chemistry, kolloidikai the reasons of incompatibilities and technological solutions

1.b) „Clinical pharmacy 2. parts”

Directives of the pharmacy

Studying pharmaceutical literature

Knowing reagents applied in diagnostics including preparation

Treatment of biological samples, basic clinical examinations, normal levels

Knowing other special tasks of the pharmacy (e.g.: measurement of drug concentration in plasma)

Knowing basic databases used in clinical pharmacy

Knowing the quality assurance of the hospital emphasizing the regulations regarding the pharmacy




Participating in works on different divisions of the pharmacy (labelling, packaging, etc.)


Knowing basic galenic preparations of the pharmacy containing knowledge of preparation of infusions, peritoneal dialysis solutions; knowing the conditions for preparations, analytical and microbiological control methods and storage

Preparation of complex infusions (cytostatic infusions, parenteral nutrition infusions)

Knowing and preparation of special magistral formulas, comparing with official formulas of FoNo VII. or Manuale Pharmaceuticum


30




Participating in ordering of drugs on-line and off-line














Knowing the system of quality assurance


Seminars


Knowledge acquired is evaluated based on reports made during pharmacy practice and the evaluation of the tutor/chief pharmacist.

Participants

Dr. Mayer Klára (MAKMABO.PTE), Dr. Pál Szilárd (PASMAAO.PTE), Rezesné dr. Börzsei Rita Judit (BORPAAO.PTE)


31

OPS-SG4 PROFESSIONAL PRACTICE BEFORE STATE EXAMINATION 2

Course director: DR. KLÁRA MAYER, assistant professor

Department of Pharmacotechnology

14 credit ▪ midsemester grade ▪ Final/Rotational (year) module ▪ spring semester ▪ recommended semester: 10



Prerequisites: OGGHT3 completed + OPG-UI4 completed + OPG-GT4 completed

Topic

Aim of the first part of rigorous year is to expand the knowledge and approach of student with practice oriented pharmaceutics, knowing

the aspects of pharmaceutical care, economy and preparing medicines both in the public pharmacy (3 months)and in clinical/hospital (1

months) pharmacies. This course is expanded with practice in clinical/hospital pharmacies in order to learn the tasks and connections of the pharmacy with other wards of the hospital.

The 6 months have 6 thematics, one thematic 1-1 months time.

Proposal in the Hungarian pharmacy practice with Hungarian Student together.




The practice 4 months must in the Hungarian pharmacy.

Mid-term exams




During the 6 months practice only 5 days are allowed to miss confirmed by a physician. More days of missing must be supplemented.

Reading material


Dévay: The Theory and Practice of Pharmaceutical Technology, e-book, http://gytsz.pte.hu/en/egyseg/oktatasianyagok/1620/


- Notes

Final exam - test-book


European Pharmacopoeia

Pharmacopoeia Hungarica

Hungarian National Formulary: Formulae Normales VII (FoNo VII)

Compendium

Lectures

Practices

1. Clinical pharmacy

Knowing the structure of hospital/clinic

Studying the relationship between the pharmacy and other wards






Knowing basic galenic preparations of the pharmacy containing knowledge of preparation of infusions, peritoneal dialysis solutions; knowing the conditions for preparations, analytical and microbiological control methods and storage



Pharmaceutical economy, ordering medicines



http://gytsz.pte.hu/en/egyseg/oktatasianyagok/1620/


32









Directives of the pharmacy












Knowing basic galenic preparations of the pharmacy containing knowledge of preparation of infusions, peritoneal dialysis

solutions; knowing the conditions for preparations, analytical and microbiological control methods and storage

Preparation of complex infusions (cytostatic infusions, parenteral nutrition infusions)

Knowing and preparation of special magistral formulas, comparing with official formulas of FoNo VII. or Manuale

Pharmaceuticum


















Knowing the system of quality assurance


..

2. Public pharmacy operation

Public pharmacies’ measures concerning drug supply

In the pharmacy’s farming tasks truth participation

The acquisition of management, technical knowledge

Medicine farming: the procession of the medicine order

The preparation of medicine orders,

Contacts, information, the examination of orders, complaints lasted with the medicine wholesalers

With the implements to be checked increased related knowledge and tasks

In the course of the waste product, the returns, a damage truth tasks

It is related to changes in price tasks

The closings: daily, weekly, snow end ill. OEP meanings

The knowledge of measures, bulletins

A drawer pharmacy’s, „kézigyógyszertár” concepts, knowledge, tasks


33

The knowledge of the officinal literature


...

3. Pharmaceutical practice, receipt, preparate

The accomplishment of the medicine making processes turning up in the pharmacy with the management of a teaching chemist

The pharmacy’s inner cheque activity in the process of the medicine making

Unique praescriptions his cognition, his completion, their comparison the official one with praescriptions

(Pharmacopoeia, FoNo)

Laboration concept, the differences of processes, completions the unique one prescription his making, documentation

His Manual cognition, his application and előirat his editing

The nomenclature of the stocks, regular pharmacopoeia full Latin ill. his abridged name

Medicine cheque: the incoming medicines, stocks, basis artefacts, vegetal drugs, bandages, etc. his regular receipt

The examination of stocks and his documentation arrived

The laboured the cheque of artefacts (pl. 70% Ethanolum, Sirup. simplex)

The aseptic working in the pharmacy, a principle, practice

Sterile, documentation, sterile apparatus cheque

The recognition of incompatibilities, correct completions, physical, chemistry, kolloid reasons of incompatibilities and

technological solutions

..

4. Medicine wholesale (expedition), officinal quality assurance

The pharmacy’s inner cheque activity in the processes of the medicine wholesale


The categories of storage, storage, his documentations, the cold chain chekd his process

The cognition of the medicines, replaceabilities, strength / cross marks

The prescription in the case of his regularity, formal deficiencies the tasks

The treatment of veterinary science prescriptions

The artefacts which can be received without the prescription (OTC) his concept, knowledge, dispatching

The groups of products which can be distributed in a pharmacy, his knowledge

The recognition of incompatibilities, on emphasized one the pharmacology incompatibilities, tasks, solution opportunities

Solutions according to Polipragmazia cognition, hygienic viewpoints - contact with doctors, patients

The expense of artefacts to be checked increased, his documentations

The significance of the retaxa and his practice

Correct communication towards the patients in a principle and the practice

The knowledge of the officinal quality assurance system

...

5. Medicine - pharmaceutical review

Officinal literature, technical books the knowledge of journals, his availability

Correct communication towards the hygienic specialists

Hygienic counsel towards different age groups (school, caretaker at home)

Pedigreed medicines, nutritions, bandages, therapeutic equipment, his knowledge

The artefacts which can be received without the prescription (OTC) his concept, knowledge, dispatching

The groups of products which can be distributed in a pharmacy, his knowledge

For the officinal employees medicine review from an actual artefact (recording, in the framework of inner professional

development)

The correct assessment of homoeopathic prescriptions, products, his conceptual and practical knowledge

..

6. Pharmacist nurture

The cognition of the legal regulation being attached to the chemist nurture

The levels of the chemist nurture, the conditions of his order

Pharmaceutical Nurture Committee characters, his tasks

Good Pharmacy Practice (GPP) the knowledge of his governing principles

Elementary level chemist medicine safety cheque made in the framework of nurture vocational governing principle applying his knowledge and practical one

For the International Classification of the illnesses (in Hungarian BNO) his knowledge

BNO being found the most mostly the cognition of codes

The resuscitation of the pathologic and clinical knowledge of illnesses

Self-therapy the information of his concept, his practice, patients

Officinal literature, technical books the knowledge of journals, his availability

..


34

Seminars


Knowledge acquired is evaluated based on reports made during pharmacy practice and the evaluation of the tutor/chief pharmacist.

Participants

Dr. Mayer Klára (MAKMABO.PTE), Dr. Pál Szilárd (PASMAAO.PTE), Rezesné dr. Börzsei Rita Judit (BORPAAO.PTE)

study program 2016/2017 subjects of the 9-10. … · balÁzs ferenc nÉmeti, associate professor...

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