Pharmaceutical Practice and Management 1

Data

Official data in SubjectManager for the following academic year: 2022-2023

Course director

  • Dr. Lajos BOTZ

    professor,
    Department of Pharmaceutics and University Pharmacy

Number of hours/semester

lectures: 28 hours

practices: 0 hours

seminars: 14 hours

total of: 42 hours

Subject data

  • Code of subject: OPG-GI2-T
  • 3 kredit
  • Pharmacy
  • Pharm. theoretical module and practical skills modul
  • autumn
Prerequisites:

OPG-GI1-T completed , OPG-R1E-T > 0 completed , OPG-C1E-T completed

Exam course:

no

Course headcount limitations

min. 5 – max. 50

Topic

The topics of the semester introduce the basic functioning of the pharmaceutical and health-care market, further the basic fundamentals of economics relevant for pharmacy students. Methods of comprehensive analysis, evaluation and development of drug therapy, healthcare systems, the framework and regulation of pharmaceutical supply will be covered throughout the semester. Interactive discussions will cover essential topics regarding self-medication and over the counter products used in minor diseases. Students will improve their communicational skills in order to counsel patients more efficiently and improve adherence to medications. The undergraduates will acquire knowledge of the innovation of a new drug from a drug candidate, the formation of indications, marketing authorization, the life cycle of medicines and generics, as well as professional aspects of medication errors and adverse event.
Students can access the slides of the lectures and further reading material on a designated web based interface (e.g. MS Teams and/or Neptun Meet Street).

Lectures

  • 1. Drug authorization process, Patent of drugs 1 - Dr. Vida Róbert György
  • 2. Drug authorization process, Patent of drugs 2 - Dr. Vida Róbert György
  • 3. Variations of authorization processes (orphan drugs, generic, etc.) - Dr. Vida Róbert György
  • 4. Drug Research and Development - Dr. Vida Róbert György
  • 5. Nonclinical studies, preclinical development, Design and methodology in clinical trials - Dr. Vida Róbert György
  • 6. Clinical trials 1 - Dr. Vida Róbert György
  • 7. Clinical trials 2 - Dr. Vida Róbert György
  • 8. The drug supply chain, participants of the drug market 1. - Dr. Fittler András Tamás
  • 9. The drug supply chain, participants of the drug market 2. - Dr. Fittler András Tamás
  • 10. Prescribing and reimbursement of medicines in Hungary 1. - Dr. Fittler András Tamás
  • 11. Prescribing and reimbursement of medicines in Hungary 2. - Dr. Fittler András Tamás
  • 12. Equivalencies of drugs 1 - Dr. Vida Róbert György
  • 13. Equivalencies of drugs 2 - Dr. Vida Róbert György
  • 14. Midterm test - Dr. Vida Róbert György
  • 15. Pharmacovigilance 1 - Dr. Fittler András Tamás
  • 16. Pharmacovigilance 2 - Dr. Fittler András Tamás
  • 17. Organisation of Hungarian health system - Dr. Vida Róbert György
  • 18. Principles and basic terms of economics - Dr. Fittler András Tamás
  • 19. Requirements of opening and operation of pharmacies. Regulation of public drug supply. - Dr. Vida Róbert György
  • 20. Market mechanisms. Economic actors, sectors of economy. - Dr. Fittler András Tamás
  • 21. Perfect market and health market 1. - Dr. Fittler András Tamás
  • 22. Perfect market and health market 2. - Dr. Fittler András Tamás
  • 23. Social insurance, healthcare systems. - Dr. Zemplényi Antal Tamás
  • 24. Regulation regarding prescribing and dispensing of medicines in Hungary. Limitation of distribution of medicines in the EU. - Dr. Fittler András Tamás
  • 25. Requirements of opening and operation of pharmacies. Regulation of public drug supply - Dr. Fittler András Tamás
  • 26. End-of-the term test - Dr. Fittler András Tamás
  • 27. End-of-the term test - Dr. Vida Róbert György
  • 28. End-of-the term test - Dr. Fittler András Tamás

Practices

Seminars

  • 1. Basics of communication. Importance of good communication in pharmacy.
  • 2. Steps of good communication 1.
  • 3. Steps of good communication 2.
  • 4. Written communication, oral presentation.
  • 5. Introduction - self-care, legal issues.
  • 6. Introduction - patient assessment and consultation.
  • 7. Midterm test
  • 8. Sample presentation, PowerPoint presentation scheme.
  • 9. Nutrition, mineral replacement and vitamins.
  • 10. Dry skin, atopic dermatitis, acne.
  • 11. Smoking cessation.
  • 12. Minor burns, wounds.
  • 13. Simulation of a small, pilot clinical study.
  • 14. End-of-the term test

Reading material

Obligatory literature

Literature developed by the Department

List of study aids to acquire curriculum (books, notes, other) and all presentations can be downloaded from MS Teams and/or Neptun MeetStreet.

Notes

Recommended literature

J.L. Bootman, R. J. Townsend, W. F. McGhan (eds.): Principles of Pharmacoeconomics, Harvey Whitney Book Company, 2002.
Robert S. Beardsley, Carole L. Kimberlin, William N. Tindall: Communication Skills in Pharmacy Practice, 6th edition, Wolters Kluwer, Lipincott Williams & Wilkins, 2012.
Rosemary R. Berardi, Stefanie P. Ferreri et al.: Handbook of Nonpresciption Drugs, 17th edition, American Pharmacists Association, 2012.
John P. Griffin, John Posner, Geoffrey R. Barker: The Textbook of Pharmaceutical Medicine, 7th Edition, 2013.
Paul Rutter: Community Pharmacy - Symptoms, Diagnosis and Treatment. 4th Edition Elsevier 2017.

Conditions for acceptance of the semester

- Regular attendance of classes (maximum 25 % of absence is accepted),
- Assignments given in class should be carried out during term-time and,
- Written mid-term and end-of-the term test. Passing the tests is not obligatory; however advisable as you will likely have better results and a good recommended grade for PPM1. There is a retake opportunity only for the end-of-the term test.

Mid-term exams

End-of-the-term test is at the regular time of lectures.
The test will be on the whole semester’s curriculum. Additional questions can be included in the end-of-the-term test, if the student has not carried out an assignment during the semester or in case of unsuccessful midterm test.
In case of unsuccessful or missed end-of-the term test, a retake opportunity is granted to make up during the last week of the semester.
The end-of-the term test grade may be accepted as an examination grade, if passed.

Making up for missed classes

Retake opportunity is possible following personal discussion for the end-of-the term test.

Exam topics/questions

Assessment of the student performance is carried out according to a five-grade scale: 100-86,1% -excellent (5); 86-77,1% -good (4); 77-68,1% -satisfactory (3); 68-60,1% -pass (2); and below 60,0% -fail (1) respectively.

Final recommended grade for PPM1 is based upon the completion of the given assignments, self-care and nonprescription pharmacotherapy module, the mid-term test and the end-of-the term test. There is no practical grade for PPM1.

Examiners

  • Dr. Botz Lajos
  • Dr. Fittler András Tamás
  • Dr. Vida Róbert György

Instructor / tutor of practices and seminars

  • Dr. Fittler András Tamás
  • Dr. Somogyi-Végh Anna
  • Dr. Vida Róbert György