Course program
Introduction
Natural product. Basic concepts and definitions (products of plant, animal and mineral origin, medicinal plant, pharmacognosy, phytotherapy, herbal drug, etc.).
Safety and efficacy of natural products.
Product categories: herbal medicinal product, food supplements, cosmetics, functional foods, nutraceuticals, novel foods, etc.
Sources of information on medicinal plants: the internet or not the internet?
Special part
Causes of natural product toxicity.
- Toxic compounds (sesquiterpene lactones, furanocoumarins, pyrrolizidine alkaloids, etc.).
- Quality of the product (variability, multi-component products, etc.)
- Subject dependent factors (improper use, physiological state, pathological state, genetic differences, microbiota, association with ethical drugs)
Adverse reactions and causality assessment.
- Definition of adverse reaction, adverse effect, adverse event and classification by type and severity
- Causality criteria (expert opinions, algorithms and probabilistic criteria)
Adverse Reaction Monitoring:
- Poison centers
- Phytovigilance (definitions, phyto-nutrivigilance, Italian System, VigiErbe)
- Differences between phytovigilance and pharmacovigilance
- Cosmetovigilance
- How to report an adverse reaction to natural products
Examples of adverse reactions of selected herbal preparations.
- Plants used for recreational purposes
- Plants used for ornamental purposes
- Medicinal plants used in neurological disorders
- Medicinal plants used in the body weight control
- Medicinal plants used as performance enhancers
Prerequisites
To effectively follow and study the topics covered in the course and to achieve the learning objectives provided by the course, it is essential that the student possess knowledge of basic subjects, in particular with regard to physiology, biochemistry, and botany.
Books
Testi adottati
- Mazzanti, Dell’Agli, Izzo. Farmacognosia e Fitoterapia. Piccin, 2020 (Capitoli 1, 3 e 6)
- Balduini, Costa. Tossicologia generale e applicata ai farmaci. Edra, 2015 (Capitoli 14 - 17)
Testi di consultazione per parti specifiche
- Casarett & Doull’s - Tossicologia - I fondamenti dell’azione delle sostanze tossiche (traduzione italiana della VII edizione), EMSI, Roma, 2010.
Siti di riferimento:
- https://www.epicentro.iss.it/fitosorveglianza/piante-officinali
- https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Herbal
- https://www.salute.gov.it/portale/home.html
- https://www.farmacovigilanzasif.org/
- https://www.sifweb.org/sif-magazine/categoria/farmacognosia-fitoterapia-e-nutraceutica
- https://www.vigiaccess.org/
- https://www.ospedaleniguarda.it/in-evidenza/leggi/centro-antiveleni
- https://www.issalute.it/
Materiale fornito dal docente
Frequency
Class attendance is mandatory. The lectures will allow the student not only to acquire specific knowledge but also to develop communication skills and technical language through the interaction in the classroom with the lecturer on topics related to the course.
Exam mode
Students will be examined for their acquired knowledge, to verify that they are congruent with the achievement of the educational objectives set by the course. Generally, three questions will be asked. However, this situation may vary according to specific cases, at the discretion of the professor. The exam will in any case be one and oral and will be considered passed on the basis of the achievement of 18/30. To obtain the minimum, the student must demonstrate that he has acquired sufficient knowledge of the safe use of herbal drugs and the preparations obtained from them. To achieve a score of 30/30 cum laude, the student must demonstrate that she/he has acquired an excellent knowledge of all the topics covered during the course, illustrating them in a reasoned and not mnemonic way.
Lesson mode
During the first part of the course, lectures will serve to provide students with the basic concepts of the subject. Subsequently, exercises will be carried out to allow students to put the acquired notions into practice, ensuring their consolidation.