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 of the toxicovigilance scheme
Since 1 January 2016, ANSES has been responsible for coordinating the national toxicovigilance scheme and the vigilance activities of the French poison control centres (CAPs)[1].
The work is overseen and coordinated by the Toxicovigilance Coordination Committee (CCTV) and by the Strategic Committee for CAP Vigilance Activities, which both report to ANSES.
The CCTV is made up of representatives from each CAP, the agencies (National Agency for Medicines and Health Products Safety – ANSM (in French), ANSES, French Public Health Agency – SPF) and the Directorate General for Health (DGS) (in French), Its main missions are to:
- investigate health signals and alerts forwarded by the CAPs or coming from other sources (French health authority, health authorities of other countries, automated detection, spontaneous reports, monitoring of indicators, etc.);
- respond to specific formal requests from the Ministry of Health and other public health authorities;
- provide expertise and contribute to monitoring of the toxic effects for humans of products, natural substances and pollution.
To carry out its missions, the CCTV is supported by an operational unit (made up of representatives from ANSES, the ANSM and the CAPs) that can be mobilised rapidly in the event of a health signal or alert.
The Strategic Committee for CAP Vigilance Activities, which was set up in 2017[2], is responsible for issuing opinions on the general organisation of CAP vigilance activities, on the developments required in terms of monitoring, expert appraisal and management of toxic risks, and on the strategic orientations of the CAPs' information system (SICAP). It is made up of representatives from the DGS, the DGOS, ANSES, the ANSM, the ANSP, the ASIP Santé, the INRS and four CAP members, including two that represent the SICAP.
ANSES coordinates and provides the scientific secretariat for the CCTV, the operational toxicovigilance unit and the Strategic Committee for CAP Vigilance Activities.
The work on toxicovigilance is supported by four working groups (WGs) coordinated by ANSES: "Vigilance for chemical products", "Toxicovigilance for regulated products", "Vigilance for natural toxins" and "Methods of using CAP data".
The network of poison control centres (CAPs) and the data collected by the CAPs that are relevant to toxicovigilance and other vigilance schemes
The toxicovigilance network is based on all eight CAPs in metropolitan France and two toxicovigilance schemes (DTVs) in the overseas territories.
The CAPs offer toxicological expertise around the clock via an emergency telephone hotline (RTU), open to anyone (general public, health professionals, etc.), and carry out the toxicovigilance tasks in conjunction with the regional health agencies[3]. The DTVs in the Americas and the Indian Ocean do not have an RTU on site, with this service being provided respectively by the Paris CAP for the French Caribbean and French Guiana, and the Marseille CAP for the islands of Reunion and Mayotte.
The calls received by the RTU concern people exposed to all types of natural or synthetic products, found on the market or in the environment, without restriction: human or veterinary medicines, maintenance and cleaning products, plant protection products, biocides, food supplements, drugs, cosmetics, fungi, animals, plants, etc.
Each teleconsultation is recorded in the SICAP in the form of a medical file. As part of their follow-up, these files are supplemented by the data needed for vigilance, in particular an assessment of the clinical severity of the cases, a causality assessment (i.e. on the strength of the causal link between exposure and the observed health problems), and precise documentation on the agents involved and the exposure context..
How are the data used for health protection and public health?
Toxicovigilance stakeholders have access to anonymised data from the poison control centres' information system. When one or more cases of poisoning attract the attention of the CAP network and of ANSES – constituting a health signal because of their unusual, serious or avoidable nature – a search in the information system and identification of similar cases enables this signal to be confirmed or refuted.
If necessary, additional work is carried out by the ANSES working groups (see above). The results are published on the ANSES website.
Exploitation of SICAP data therefore enables ANSES to contribute to toxicovigilance and the other national vigilance schemes it manages (pharmacovigilance for veterinary medicinal products, phytopharmacovigilance, nutrivigilance, monitoring and prevention of occupational diseases), in conjunction with the CAP network and the Agency's scientific expert groups.
[1] Healthcare modernisation act of 26 January 2016; decree on the transfer of toxicovigilance to ANSES dated 15 December 2016.
[2] Order on the composition of the Strategic Committee for CAP Vigilance Activities dated 14 June 2017.
[3] The toxicovigilance tasks of the CAP are set downin Art. R. 1340-5 of the decree dated 15 December 2016.