Law and Ethics for Pharmacists - GAF307

• Title: Law and Ethics for Pharmacists
• Guaranteed by: Department of Social and Clinical Pharmacy (16-16220)
• Faculty: Faculty of Pharmacy in Hradec Králové
• Actual: from 2024
• Semester: winter
• Points: 0
• E-Credits: 2
• Examination process: winter s.:written
• Hours per week, examination: winter s.:20/0, Ex [HS]
• Capacity: unlimited / unknown (unknown)
• Min. number of students: unlimited
• 4EU+: no
• Virtual mobility / capacity: no
• State of the course: taught
• Language: English
• Teaching methods: full-time
• Note: deregister from the exam date if a requisite was not fulfilled; course can be enrolled in outside the study plan; enabled for web enrollment
• Guarantor: PharmDr. Tereza Hendrychová, Ph.D.
• Comes under: 3.ročník 2025/26 Pharmacy (EN19)
• Is co-requisite for: GAF343

Annotation

English

The subject acquaints students with major ethical systems, principles of medical ethics and ethical issues in various fields of pharmacy, basic principles of the western legal system and with basic institutes of private and public law, emphasizing examples and ethical and legal norms affecting the profession of pharmacist. The aim of the subject is to increase and improve the level of ethical and legal consciousness of pharmacy students, and to provide students with ability to apply ethical principles and basic principles of law in their future professional activities. Topics: Medical ethics; Pharmacy ethics; Introduction to Western legal systems; Basics of constitutional law, civil law, and public law; Health law of the European Union; Pharmaceutical law in the EU and USA.

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Czech

Předmět seznamuje studenty s obecnými etickými kategoriemi, principy zdravotnické etiky a etickými problémy v různých oblastech farmacie, základními principy západního práva a základními instituty soukromého a veřejného práva, s důrazem na etické a právní normy dotýkající se profese farmaceuta. Cílem předmětu je zvýšit a zkvalitnit úroveň etického a právního vědomí studentů farmacie a vybavit je schopností aplikovat etické a základní právní instituty v jejich budoucí profesní činnosti. Témata: Zdravotnická etika; Etika ve farmacii; Úvod do západních právních systémů; Základy ústavního, občanského a veřejného práva; Zdravotnické právo Evropské unie; Farmaceutické právo v EU a USA.

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Course completion requirements

English

The course ends with an exam in the form of a written test.

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Czech

Předmět je zakončen zkouškou ve formě písemného testu.

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Literature

English

Obligatory:

• Buerki, Robert A. Vottero, Louis D.. Pharmacy ethics : a foundation for professional practice. Washington, D.C.: American Pharmacists Association, 2013, 210 s. ISBN 978-1-58212-179-6.
• Rodgers, Ruth, Dewsbury, Catherine Lea, Andrew. Law and ethics in pharmacy practice. London: (PhP) Pharmaceutical Press, 2010, 162 s. ISBN 978-0-85369-885-2.

Recommended:

• . . In Beauchamp, Tom L., Childress, James Franklin. Principles of Biomedical Ethics . New York ; Oxford: Oxford University Press, 2019, s. -. ISBN 978-0-19-064087-3..
• Verhey, Allen (ed.). Religion and Medical Ethics: Looking Back, Looking Forward. : Wm. B. Eerdmans Publishing Co., 1996, 160 s. ISBN 978-0802808622.

Last update: prepocet_literatura.php (14.08.2025)

Czech

Povinná:

• Rodgers, Ruth, Dewsbury, Catherine Lea, Andrew. Law and ethics in pharmacy practice. London: (PhP) Pharmaceutical Press, 2010, 162 s. ISBN 978-0-85369-885-2.
• Buerki, Robert A. Vottero, Louis D.. Pharmacy ethics : a foundation for professional practice. Washington, D.C.: American Pharmacists Association, 2013, 210 s. ISBN 978-1-58212-179-6.

Doporučená:

• Beauchamp, Tom L., Childress, James Franklin. Principles of Biomedical Ethics. New York ; Oxford: Oxford University Press, 2019, 496 s. ISBN 978-0-19-064087-3.
• Verhey, Allen (ed.). Religion and Medical Ethics: Looking Back, Looking Forward. : Wm. B. Eerdmans Publishing Co., 1996, 160 s. ISBN 978-0802808622.

Last update: prepocet_literatura.php (14.08.2025)

Teaching methods

English

Lectures.

Last update: Hendrychová Tereza, PharmDr., Ph.D. (02.09.2024)

Czech

Přednášky.

Last update: Hendrychová Tereza, PharmDr., Ph.D. (02.09.2024)

Requirements to the exam

The exam takes the form of a written test: The first part contains 8 closed (multiple choice) questions from the field of ethics. No written or electronic materials (devices) are permitted during this part.  

The second part contains 12 closed questions from the field of law. Written or electronic materials are permitted in this part. It is forbidden to communicate with other people in any way. This will be specified by Dr. Kučera during law lectures.

For closed questions, there are 4 answers to choose from, and there is always one correct answer. The minimum number of points required to pass the exam is 12 points. 

Knowledge of following topics is required:

General and medical ethics – basics

Ethics in pharmacy (research, companies)

Constitutional law – basics

Civil law – basics

Public law – basics

Health law of the European Union, basic structure and principles of EU law

Pharmaceutical law in the EU (EMA, national authorities, marketing authorisations, clinical testing, advertising, internet sale, food supplements) 

Pharmaceutical law in the USA (FDA, marketing authorisation procedures)

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Syllabus

English

Introduction to ethical systems and theories

Medical ethics – contemporary principles and basic issues

Pharmacy ethics

Introduction to Western legal systems

·         Continental law system

·         Angloamerican law system

Basics of constitutional law, civil law, and public law

Health law of the European Union

Pharmaceutical law in the EU and USA

·         FDA, EMA, national authorities

·         Marketing authorisations, clinical testing, advertising, internet sale

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Czech

Úvod do etických systémů a teorií

Zdravotnická etika – současné principy a základní problémy

Etika ve farmacii

Úvod do západních právních systémů

·         Kontinentální právo

·         Angloamerické právo

Základy ústavního, občanského a veřejného práva

Zdravotnické právo Evropské unie

Farmaceutické právo EU a USA

·         FDA, EMA, národní autority

·         Registrace, klinické hodnocení, reklama, internetový prodej

Last update: Hendrychová Tereza, PharmDr., Ph.D. (23.09.2025)

Learning outcomes

The course provides the basic ethical and legal framework for the courses Pharmaceutical Care I and II, Clinical Pharmacy I, Social Pharmacy and Pharmacy Practice. After completing the course, students independently apply the principles of medical ethics and the legal system of a modern democratic state in the context of the future profession of pharmacist. They identify and discuss ethical issues in various areas of pharmacy. They characterize the basic legal regulations in the field of health care and areas closely related to the future practice of the health care profession. They become familiar with the legal regulations and interpret it practically. 

Learning outcomes:

Students on the basis of acquired knowledge and skills:  

• Define the role of ethics and law in health care (pharmacy)  

• Name, interpret and apply codes of ethics in the field of pharmacy  

• Discuss the ethical issues in the field of pharmacy  

• Define the different types of legal regulations at the level of EU (regulation, directive, decision)  

• Explain the relationship between different legal regulations 

• Explain the validity and effectiveness of legislation  

• Name, interpret and apply basic legal regulations in the field of health care (pharmacy) in EU 

Last update: Hendrychová Tereza, PharmDr., Ph.D. (31.03.2025)