Organising vigilance
The vigilance system is organised around the collection and review of adverse event reports. The purpose of this system is to identify unexpected alert signals observed during wide use of the health products as early as possible, and thereby implement the public health required to guarantee patient safety.
ANSM is responsible for five vigilance categories
ANSM also carries out clinical trial vigilance.
www.signalement-sante.gouv.fr
An online reporting portal for adverse health events, www.signalement-sante.gouv.fr, has been available since 2017 thanks to a partnership between the French Ministry of Health and healthcare agencies, in particular ANSM. This portal is designed to increase health safety vigilance while also simplifying the reporting process. It is accessible to everyone, including both healthcare professionals and users.
Pharmacovigilance
Pharmacovigilance is carried out for all medicines used by patients in France: it examines adverse reactions that occur under normal conditions of use, as well as those that arise due to medication errors, abuse, misuse, overdose, and occupational exposure.It is active at the regional level through France’s 31 regional pharmacovigilance centres (CRPV), at the national level through ANSM, and at the European level through the European Medicines Agency (EMA) and Member States.
Addiction vigilance
Addiction vigilance consists of monitoring, assessing, preventing and managing the risk of abuse, misuse and drug dependence associate with the consumption, for medicinal purposes or not, of any psychoactive substance (plant or product), excluding alcohol and tobacco.At the national level, addiction vigilance relies on a network of 13 Drug Dependence-Addiction Evaluation and Information Centres (CEIP-A) managed by ANSM.
Haemovigilance
Haemovigilance consists of monitoring, assessing and preventing incidents and adverse reactions, occurring in donors and recipients of labile blood products. This monitoring applies to the entire transfusion chain, i.e. from labile blood product collection to recipient follow-up.Haemovigilance monitors and assess:
- adverse reactions occurring in blood donors,
- post-donation information, liable to compromise the quality or safety of the blood products obtained from these donations or from previous donations,
- incidents in the transfusion chain, from Labile Blood Products collection to recipient follow-up,
- adverse reactions occurring in Labile Blood Products recipients.
The objective of transfusion safety is to identify hazards that have caused, cause or are liable to cause incidents or adverse reactions that have endangered, endanger, or may endanger the health of donors or recipients with a view to eliminating or reducing the associated risks.
The haemovigilance system is based on local, regional and national tiers.
ANSM sets out the main priorities and the objectives of the haemovigilance system, and manages the missions of the various parties involved. In some cases, it may refer to competent authorities.
- ANSM receives reports from the various parties involved. It is also kept informed of the appearance of obstacles to the quality and safety of the stages of the transfusion chain. In addition, it receives data from epidemiological blood donor monitoring.
- ANSM can also carry out epidemiological surveys with the French National Blood Service, the Army Blood Transfusion Centre, and the National Reference Centre for HIV and hepatitis B and C viruses in blood transfusion of the French National Blood Transfusion Institute.
These epidemiological surveys enable the observation and analysis of health problems in the population, and the determination of their causes and risk factors. - ANSM can conduct studies, for example studies pertaining to the conditions of use of labile blood products, within the framework of the haemovigilance network tasked with forwarding data relating to the health safety of blood products.
Events and incidents reporting and assessment
All healthcare professionals (nurse practitioner, doctor, pharmacist, midwife, dental surgeon, etc.) who observe or are aware of an adverse event in recipient, serious adverse events in donors, serious incident, post-donation information, should report it without delay to the haemovigilance and transfusion safety correspondents (in french CHV-ST) of the healthcare institution or blood transfusion clinic where the incident occurred or the adverse reaction was observed.The CHV-ST reports in the e-FIT national electronic haemovigilance reporting system. The registered report can be accessed in real time by any of the parties involved in the haemovigilance network concerned by this report, particularly CRH-ST coordinators and ANSM.
The report is reviewed on-the-fly by the relevant CRH-ST reference center for haemovigilance and transfusion safety (in french CHR-ST) and ANSM. It is discussed throughout its lifecycle among the haemovigilance and transfusion safety correspondents, CRH-ST coordinator and ANSM until the end of the investigations, with a view to determining in particular the attributability of the LBP(s) in question in the onset of the reported adverse reaction, in the light of the data already known, the context of use and the profile of the patient in question.
Medical device vigilance
Medical device vigilance assesses incidents and risks of incidents involving a medical device. It is performed from the clinical trial phase, and throughout their life cycle.The medical device vigilance system is structured in three tiers. The national is managed by ANSM. The local tier involves local medical device vigilance correspondents who work in public or private healthcare institutions, healthcare professionals and manufacturers. They are all required to report any incidents or risks of incidents that come to their attention to ANSM. Additionally, there is a regional tier on a trial basis consisting of regional medical device vigilance correspondents.
This monitoring may result in preventive and corrective measures being adopted to prevent serious incidents or risks of serious incidents from occurring/recurring.
Reagent vigilance
Reagent vigilance assesses incidents and risks of incidents related to the use of in vitro diagnostic medical devices (IVDMDs).The reagent device vigilance system is also structured in three tiers. The national tier managed by ANSM. The local tier involves local local reagent device vigilance correspondents work in public or private healthcare institutions, healthcare professionals and manufacturers, who are required to report any incidents or risks of incidents that come to their attention to ANSM. Additionally, there is a regional tier on a trial basis, consisting of regional reagent device vigilance correspondents.
This monitoring may result in preventive and corrective measures being adopted to prevent serious incidents or risks of serious incidents from occurring/recurring.
