Italian Phytovigilance adverse reactions database’s evaluation

by Leonardo Giraudo, Pharmacovigilance Compliance Expert

Cannabis as therapeutic option for multiple clinical condition, is generally well tolerated?

Medical Cannabis consumption is significantly increasing worldwide, but most people still wonder if its use can be considered actually safe. To answer this question, we have analyzed the data related to safety issues reported in Italy, in the Phytovigilance database, due to the use of Medical Cannabis. As with all medicinal products, for those containing substances of chemical synthesis or of vegetal origin, in order to obtain the benefit expected at the therapeutic doses, some risks are accepted. These risks are the adverse drug reactions that are constantly monitored, even after the post-authorization for the marketing. The Italian phytovigilance system receives and manages the reports of suspected adverse events due to the use of Medical Cannabis; since 2016, a periodic reporting covering six months is published by the “Istituto Superiore di Sanità” with a summary of the cases received.

Adverse Reaction Database_Site_PQE

In Italy, Medical Cannabis can be prescribed as magistral preparations, such as oil extracts, decoction filter bags, and bags for inhalation through an authorized device. Medical use of Cannabis is authorized in Italy and reimbursed within the National Health System for selected medical conditions

Read the full article on GQC website

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