Legislation and pharmaceutical ethics

Duration

30h Th

Number of credits

Lecturer

Frédéric Lecomte

Language(s) of instruction

French language

Organisation and examination

Teaching in the second semester

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

I. Notions of general law, criminal law, criminal procedure as well as legal bodies and procedures in matters of breaches of health care and compensation legislation.
II. Research and analyze a regulatory text efficiently (laws, decrees, circulars, European regulations, European directives,...).
III. European and Belgian regulations in the following areas:

• Medicines, medical devices and food supplements: legal definitions and interpretations;
• Procedures for registering medicinal products and obtaining CE marking for medical devices - comparative analysis;
• Manufacturing and distribution of medicines and medical devices: the free distribution of medical devices and implantable medical devices active in Belgium will also be discussed with regard to its practical consequences;
• The essential elements of the manufacture and distribution of medicines will be discussed in detail; a brief comparison will be made with the manufacture and distribution of medical devices in Belgium;
• Information and advertising relating to drugs and medical devices - Belgian and European regulations on advertising will be considered from the point of view of patient protection as envisaged by the Federal Agency for Medicines and Health Products (FAMHP);
• Healing and pharmaceutical art practice - roles of medical boards;
• Regulatory specificities of pharmacies open to the public and hospital pharmacies;
• Specially regulated substances and medicines (narcotics, psychotropic drugs, toxics, other medicines subject to medical prescription): drug addiction and substitution treatments - drug dependence - laws and other implementing decrees which define and govern the licit or illicit use of these different substances - the specific provisions of the Regent's decree as well as the practical applications for delivery (doses and labeling).

Learning outcomes of the learning unit

At the end of this course, you should have developed the following learning outcomes, in the area of the skills targeted by the training, namely:

• Pharmaceutical expertise: Master and integrate knowledge to design a relevant response to current pharmaceutical legislation. Understand the legal framework in which the pharmacist evolves.
• Preparation and dispensing of drugs: Perform an adapted and responsible professional act in compliance with the legislation (e.g. doses, labeling, traceability, etc.).
• Health advice: Support a pharmaceutical act with oriented advice and ensure the follow-up of chronic patients as a reference pharmacist in compliance with the regulations in force.
• Communication: Communicate in a professional manner and adapte the message to the different interlocutors in order to be able to clearly explain to patients the rules of dispensing and the reimbursement criteria, etc.
• Scientific approach: Solve health-related problems by integrating and critically analyzing different scientific approaches that take into account the most recent regulatory changes.
• Sense of responsibility: Act in an ethical and responsible manner. Demonstrate discretion and respect the confidentiality of the exchanges with patients. Act in the best interest of the patient. Practice in accordance with pharmaceutical deontology.
• Quality: Evaluate, self-evaluate, update knowledge and improving practice. Be able to follow the evolution of the legal framework and understand the impact of regulatory changes on pharmacy practice.

Prerequisite knowledge and skills

Planned learning activities and teaching methods

Face-to-face learning activities: 
Some ex-cathedra lectures, alterning with discussions in connexion with distance learning activities.
In addition, exercices and demonstrations will illustrate the theoretical concepts and their understanding will be directly evaluated using the interactive Wooclap platform.    Distance learning activities:
Reading chapters in preparation for face-to-face discussions and performing exercises.

Mode of delivery (face to face, distance learning, hybrid learning)

Blended learning (face-to-face AND distance learning activities).

Organisational adjustments related to the current health context

If necessary, teaching in a synchronous virtual classroom (Collaborate)

Recommended or required readings

PowerPoint slides (and possibly textbook for some chapters) will available on the eCampus platform.
The main pharmaceutical laws will available on the eCampus platform.
Exercices and tests will be available on the eCampus platform.
The required and/or recommended readings will be available on e-Campus or online:

• The pharmaceutical code of ethics (Order of Pharmacists)
• Moniteur belge
• FAMHP
• NIHDI
• European Commission - Public Health
• EUR-Lex

Assessment methods and criteria

Below you will find information on the evaluation methods planned for in-person and remote exams as well as those planned for hybrid sessions. Depending on how the health crisis evolves, the chosen method will be communicated to you no later than one month before the start of the exam session.

Any session :

- In-person

written exam ( multiple-choice questionnaire, open-ended questions )

- Remote

written exam ( multiple-choice questionnaire )

- If evaluation in "hybrid"

preferred in-person


Additional information:

Written exam on the subject defined.

Work placement(s)

Possibility to do an internship during Q9.

Organizational remarks

Attendance at classes is not mandatory but is encouraged.

Contacts

Frédéric LECOMTE, Assistant professor
Department of Pharmacy Quartier Hôpital - Avenue Hippocrate 15 Bâtiment B 36 4000 LIEGE (Belgium)
Phone: +32 4 3664316 (Friday only) e-mail: f.lecomte@uliege.be
No secretariat