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Pharmacological Deontology and Law

Code 13667
Year 5
Semester S1
ECTS Credits 6
Workload TP(60H)
Scientific area Ciências Farmacêuticas
Entry requirements Non-applicable.
Mode of delivery Face to face learning partly based on problem solving and associated with training in the context of biomedical simulation.
Work placements Not applicable
Learning outcomes Objectives:
1 - To promote reflection on the merits of Ethics, the Ethics and Law, with a special focus on pharmaceutical practice.
2 - To transmit knowledge of the regulatory and legal frameworks of the pharmaceutical profession.
3 - To develop skills in applying the rules in a practical context.
At the end of this course unit the student should be able to:
1 - Reflect on the foundations of ethics and science, to understand their roles and social connections and understand their historical insertion.
2 - Know the legal framework of the pharmaceutical profession and the normative content of the documents that apply on a mandatory nature, for example, the Code of Ethics.
3 - Apply ethical standards and laws to solve ethical problems of pharmaceutical practice in a real context.
Syllabus Deontology
1.Historical and conceptual introduction to Ethics
2.Origins and core concepts of Bioethics applied to Health Sciences
3.Deontology and Ethics applied to Pharmaceutical Sciences
3.1.Endogenous and exogenous regulation of pharmaceutical activity
3.2.Real-life cases of Deontology
4.Bioethical issues
4.1.Autonomy and self-determination
4.2.The end of life
4.3.Assisted reproductive technology
4.4.Eugenics and enhancement
4.5.Artificial Intelligence
Legislation
1.Basic notions
2.Community Pharmacy
2.1.Legal Regime of Community Pharmacies
2.2.Stores were to Sale Medicines and Health Products
2.3.Technical Responsibility
2.4.Licensing of entities
3.Medicines and health products
3.1.Medicine Statute
3.2.Prescription and drug dispensing rules
3.3.Medical devices
3.4.Food supplements
4.Labor Law
4.1.“Código do trabalho”
4.2.General labor law in public functions
4.3.ANF/SNF Collective Work Agreement
4.4.Pharmaceutical residency
Main Bibliography James Rachels, Elementos de Filosofia Moral, trad. port. Azevedo Gonçalves, Lisboa, Gradiva, 2004
Peter Singer, Ética Prática, trad. port. Álvaro Fernandes, Lisboa, Gradiva, 2002 (2.ª ed.)
Michael Sandel, O que o dinheiro não pode comprar. Os limites morais dos mercados, trad. port.
Alberto Gomes, Lisboa, Editorial Presença, 2015
José Manuel Santos, Introdução à Ética, Lisboa, Documenta, 2012
Dicionário de Filosofia Moral e Política IFILNOVA:
António A. Fernandes e Mara P. Guerreiro, Deontologia e Legislação Farmacêutica, Lisboa, Lidel,
2013
Legislação e declarações:
Declaração de Helsínquia (World Medical Association)
Convenção de Oviedo
Código Deontológico da Ordem dos Farmacêuticos
Estatuto da Ordem dos Farmacêuticos
Regulamento Disciplinar da Ordem dos Farmacêuticos (2017)
Regulamento (UE) n.º 536/2014
Lei da investigação clínica (Lei n.º 21/2014 de 16 de abril)
Legislação Farmacêutica Compilada
Teaching Methodologies and Assessment Criteria Teaching will be partly expository and partly based on problem-solving, associated with individual self-learning.
The assessment consists of 4 tests for a total of 18 values (4 x 4.5 values) and continuous qualitative assessment (AQ) (2 values).
The frequencies and the final exam consist of open-ended questions.
Final grade = F1 + F2 + F3 + F4 + AQ
Language Portuguese. Tutorial support is available in English.
Last updated on: 2021-02-04

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