Medicinal plants and their derivatives are often used as constituents of so-called "natural" products and are sold under various product forms.
Medicines based on medicinal plants (called phytotherapeutic drugs) registered with the Italian Medicines Agency (AIFA), which have verified their quality, efficacy and safety, are on the market. These products therefore have approved indications and can be purchased in pharmacies. Some can be purchased upon presentation of a medical prescription (for example: hypericum for mild and moderate depression, serenoa repens for benign prostatic hypertrophy, etc.), while others are over-the-counter (OTC) drugs (such as for example hydroalcoholic extract of pelargonium sidoides, for treatment of the common cold). The latter is a traditional medicinal product of plant origin with a long history of consumption (consolidated use) and is present in the European Pharmacopoeia.
Medicinal plants approved in Italy can be included in galenic preparations prescribed by the doctor and prepared in pharmacies for various indications.
However, the best-selling products that contain medicinal plants are food supplements, free sale products without therapeutic indications, used as self-medication according to the instructions on the label. Improper use, which does not take into account age (such as infants and children), particular physiological conditions (such as pregnancy and breastfeeding), or diseases in progress, could prove to be counterproductive or even harmful. It is therefore important to inform your doctor when using supplements, especially when prescribing drugs, also to avoid the risk of drug interactions.
In particular, for these products, consumers must increase the awareness that a product is not safe just because it is "natural" and that indeed, precisely from the "physiological" activity responsible for the claimed effects, unexpected or undesirable effects could occur under certain conditions.
To contribute to the knowledge of the potential risks associated with the use of natural products, a surveillance system for suspected adverse reactions to these products is in place, coordinated by the Istituto Superiore di Sanità (ISS) in collaboration with AIFA and the Ministry of Health. .
Reports of suspected adverse reactions can be made by anyone who observes an undesirable reaction (adverse reaction) arising after the use of a supplement or a galenic preparation based on medicinal plants.
Reports can be made online via the Vigierbe platform. It is not necessary to be absolutely sure that the adverse event is attributable to the plant-based product because a group of experts will evaluate it after the report.
Adverse events of particular interest or seriousness are promptly communicated to the Ministry of Health for any measures (chemical analysis of the supplements, evaluation of the content, dosages, etc.).
For further information: a handbook for the correct use of food supplements is available on the website of the Ministry of Health.
Further information and updates can be found on the ISS (Epicentro) website in the phytovigilance section.