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anses

French Agency for Food, Environmental and Occupational Health & Safety

The national Toxicovigilance system

The aim of toxicovigilance is to monitor the acute or chronic toxic effects for humans of exposure to a natural or synthetic mixture or substance available on the market or found in the environment, for the purpose of undertaking alert and prevention actions (Article L. 1340-2 of the French Public Health Code). Toxicovigilance covers products that do not fall within the scope of other regulated national vigilance systems (pharmacovigilance, addictovigilance, cosmetovigilance, phytopharmacovigilance, nutrivigilance, etc.).

 

Implementation

Initially entrusted to the French Institute for Public Health Surveillance by the Directorate General for Health (DGS) in 2004, the coordination of toxicovigilance was strengthened by the French Act on Regional Health Governance in 2009 and then by the Toxicovigilance Decree in 2014.

French Act no. 2016-41 of 26 January 2016 on the modernisation of our healthcare system then entrusted ANSES (Health Alert & Vigilance Unit) with the coordination of toxicovigilance and, more broadly, the vigilance activities of the poison control centres (CAPs).

The Toxicovigilance Coordination Committee (CCTV), created in 2005, is made up of managers from each CAP, the relevant health agencies (ANSES, ANSM, French Public Health Agency), the Agricultural Mutual Insurance Scheme (MSA), the veterinary poison control centre of Lyon (CNITV) and the DGS. Its roles are as follows:

  • Respond to requests from the Ministry of Health and other public health authorities;
  • Investigate signals and alerts generated by CAPs or other channels;
  • Provide expertise and contribute to monitoring of the toxic effects for humans of products, natural substances and pollution.

 

The CCTV is supported by an operational unit and three working groups coordinated by ANSES: Vigilance for chemical products, Toxicovigilance of biocides and plant inputs, and Quality and methods. A fourth working group on medicinal products, Interface with toxicovigilance, is coordinated by the ANSM.

A strategic committee of organisations in charge of toxicovigilance will soon strengthen the strategic and decision-making role of the CCTV (Decree of 15 December 2016, Article R. 1340-2).

 

The network of poison control centres

Toxicovigilance relies on a network of nine CAPs (Angers, Bordeaux, Lille, Lyon, Nancy, Marseille, Paris, Strasbourg and Toulouse) and two toxicovigilance systems (DTVs) (French West Indies and Reunion Island). The CAPs are medical entities located in university hospital centres. Their missions include toxicological expertise, advice for medical care and prevention, by means of emergency telephone hotlines (RTU). The DTVs do not offer a hotline service.

Regarding toxicovigilance, the missions of the CAPs are defined by Article R. 1340-5 of the Decree of 15 December 2016. They are responsible for:

  • Monitoring, in their area of competence and in liaison with the regional health agencies (ARSs), cases of human poisoning falling within the sphere of toxicovigilance as defined in Article L. 1340-2. To that effect, they collect all useful information, in particular regarding the circumstances, causes and severity of the poisoning;
  • Recording data useful for toxicovigilance in the information system mentioned in Article R. 1340-6;
  • Alerting ANSES and the locally competent ARSs in the event of a threat to public health;
  • Providing toxicological expertise at the request of the competent government health services, the ARSs, ANSES, the French Public Health Agency and the ANSM.

 

Data used for toxicovigilance and data collected by CAPs useful to other vigilance systems

As part of their emergency hotline mission (tele-medicine), available 24/7, CAPs receive calls from both individuals and healthcare professionals asking them to assess a (usually individual) toxicological risk following exposure to a non-restrictive, wide variety of “agents”: these can include any product or substance, whether found naturally in the environment or produced by humans, as well as plants, fungi, animals or insects.

All calls to CAPs are recorded in the common information system of the CAPs: SICAP. CAPs can also record cases of poisoning collected from healthcare professionals in their local network, outside of hotline calls.

Since SICAP was established around 15 years ago, a total of 2.5 million cases of exposure, with and without symptoms, and 160,000 requests for information have been recorded. Approximately 190,000 cases of exposure are recorded every year, 45% or 50% of which are symptomatic.

ANSES's Health Alert and Vigilance Unit processes SICAP data to contribute to the other national vigilance systems coordinated by ANSES (pharmacovigilance of veterinary medicinal products, phytopharmacovigilance, nutrivigilance, RNV3P).