Pharmaceutical Ethics and Legislation
Ética e Legislação Farmacêutica
Curse code:9494333
Mara Sofia Inácio Pereira Guerreiro
Learning outcomes of the curricular unit:
The goal of this course is to develop knowledge and attitudes to promote a conduct in line with pharmacy ethics and with the legislation governing pharmacy and medicinal products. By the end of this course students should be able to:
- Explain the legal framework governing market access of medicines for human use
- List labelling and information leaflet requirements for these medicines
- Describe the legal framework governing medicines advertisement
- Discuss ethics in the health care provision by pharmacists and the code of ethics of the profession
- Give examples of professional behaviours that may result in civil liability, criminal liability, contravention or disciplinary actions
- Explain the legal framework of community pharmacy establishment and functioning
- Explain the legal procedures for dispensing prescribed medicines and for controlled substances
- List legal requirements for the establishment and functioning of retail stores selling non-prescription medicines
Syllabus:
- Introduction
- Legal framework governing medicinal products for human use
- Ethics in health care provision by the pharmacist
- Legal framework governing community pharmacies in Portugal
- Legal requirements pertaining to dispensing prescribed medicines and controlled substances
- Legal framework governing the sales of non-prescription medicines outside pharmacies
- Legal framework governing medical devices
Suggested Bibliography:
- Guerreiro MP, Fernandes AA (coord.) (2013) Deontologia e Legislação Farmacêutica. Lidel. ISBN-13: 978-9727578900
- Royal Pharmaceutical Society of Great Britain (2013). Medicines, Ethics and Practice: The Professional Guide for Pharmacists. (37ª ed). Pharmaceutical Press. ISBN-13: 978-0857111265