The work program of EPI-PHARE aims to produce new knowledge on the use, misuse, benefits and risks of medicines and health products in real life, to ensure a national epidemiological surveillance of products or situations identified as constituting a challenge for public health, and bringing knowledge in crisis situations. Structured in 3 parts, it will provide health authorities with proactive and reactive expertise in the field of epidemiology of health products.
This target work program, adapted according to the resources, is carried out by epidemiologists, biostatisticians and data-managers of EPI-PHARE, but also in partnership with academic teams independently of industry.
The objective of this part is to proactively identify situations of misuse and/or safety concerns with health products. It is developed around 3 complementary approaches :
- Product-based approach : Drugs with massive exposure by the size of the populations concerned, the duration of exposure or the number or variety of prescribers; new drugs or with new indications; implantable or invasive medical devices
- Population-based approach, targeted on specific populations for which little data is available when drugs are put on the market: pregnant women, children, the elderly people, etc.
- Development of tools for pharmacoepidemiology
- Creation of databases and algorithms on adverse events: cerebral or gastrointestinal haemorrhages, hepatic toxicity, valvular heart disease, suicidal risk, etc.
- Creation of a dynamic mother / child cohort from SNDS data
- Statistical methodology, study design
- Hospital data warehouses and matching with the SNDS
The objective of this part is to quantify and characterize the use and risks of health products in a situation of alert or crisis. Faced with important and unforeseen challenges, EPI-PHARE will mobilize all his expertise to quantify and characterize retroactively the use and risks of health products affected by a crisis situation in order to provide health authorities with elements for their decision-making.
The objective of this part is to measure the impact, on the use and safety of health products, of decisions, communications and recommendations from the authorities and/or possible actions or communications from industry, healthcare professionals, patients, or media.