[Literature review on pharmacovigilance of medicines derived from traditional pharmacopoeias. Part II: Risks assessment and prevention]. / Revue de la littérature sur la pharmacovigilance des médicaments issus des pharmacopées traditionnelles. Partie II : évaluation et prévention des risques.

After the initial stage of the pharmacovigilance process for medicines from traditional pharmacopoeias - which concerns the identification of the risks associated with their use - the risk assessment should now be approached. The latter makes it possible to detect potential signals early and to take preventive measures. We sought to understand, from a review of the literature, the steps and methods of risk assessment relating to traditional medicines, as well as the prevention strategies applied to them. All of the work carried out on the subject has shown that the steps and methods for assessing and preventing drug risks are the same for both conventional and traditional medicines. Risk assessment includes analysis of the quality of individual notifications, assessment of causality, detection and evaluation of signals. The World Health Organization method is the most widely used for causality assessment internationally, while disproportionality measures are the most applied for signal detection. Regarding prevention, risk communication is the main strategy for the risks associated with traditional medicines. This review suggests the involvement of traditional medicine practitioners both in the notification system and in the communication strategy on the risks associated with their products.

[Phytovigilance: A medical requirement and a legal obligation]. / La phytovigilance: impératif médical et obligation légale.

Phytovigilance consists in supervision of side effects and drug interactions consequential to use of herbal medicinal products, herbal food supplements, herbal cosmetics and/or medicinal plants. It includes thus pharmacovigilance applied to phytotherapy, nutrivigilance and cosmetovigilance but also addictovigilance in case of plants, which lead to drug addiction, and toxicovigilance in case of toxic plants. Becoming necessary owing to (acute or chronic) toxicity risks or to drug interactions risks (of pharmacocinetical or pharmacodynamical kind)--as far as it concerns interactions between several associated plants or between a plant and a chemical or biotechnological allopathic medicine--phytovigilance represents moreover a legal obligation. Pharmacovigilance--in case of herbal medicinal products--is indeed becoming mandatory according to title IX of the European directive 2001/83/EC, whereas nutrivigilance is imposed by the European Food Safety Agency (EFSA).