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Chapter: Pharmacovigilance: Spontaneous Reporting - France

The optimisation of risk management activities and safe use of the medicinal products is a common concern of both the EMEA and the competent authorities of Member States.


The optimisation of risk management activities and safe use of the medicinal products is a common concern of both the EMEA and the competent authorities of Member States. In order to improve phar-macovigilance activities and to detect signals earlier, additional tools will be introduced by the new European legislation: reinforcement of the evaluation of safety data before granting of a marketing autho-risation, submission by pharmaceutical companies of risk management plans, development of an effec-tive communication on pharmacovigilance issues to healthcare professionals and the public and so on.

Pharmacovigilance must maintain a continuous monitoring system in order to evaluate adverse reac-tions which the clinical studies conducted before the marketing authorisation would not have identified. The submission of a risk management plan not only with the marketing authorisation application but also after the granting of a marketing authorisation is an important tool contributing to a pro-active approach.

The knowledge of the real conditions of prescrip-tion and use of the drugs is necessary to ensure their good use. Thus, it appears essential to conduct phar-macoepidemiological studies to investigate and quan-tify emerging risk. These studies are integrated in the risk management plans and should complete safety data received from the spontaneous reporting system. To that end, a scientific association (GIS) has been set up between the ministry of Health Directorate General of Health, the INSERM (National Institute for Medical Research), and the National Health Insurance System, to promote the use of the Health Insurance System databases to study post-marketing drug util-isation and risks. A Pharmacoepidemiology network has also been set up by INSERM to help with these studies, and with field studies, as needed.

To improve the efficacy of the pharmacovigilance system, complementary initiatives have been taken by AFSSAPS. The Agency is actively involved in a part-nership with patients and consumers associations to ensure a more active participation of these associa-tions in the pharmacovigilance activities. The aim of this initiative is to produce transparent information and to better define the role of associations in the evaluation and the risk management related to the use of medicinal products.

Beyond the management of adverse reactions occur-ring under the normal conditions of use of the drugs, it is important to take into account all adverse events associated with inappropriate drug use, including medication errors. The Regional Centres are deeply involved in the management of medication errors which can in many cases modify the benefit–risk ratio of the drug and result in the re-assessment of the conditions of use. Afssaps co-ordinates working groups including representatives of Regional Centres, prescribers and pharmacists in order to organise the collection of data, the production and dissemination of information among them with the aim of preventing medication errors.

In conclusion, the French System is based on a number of specificities which have proven successful.

·     The existence of a real network, where alert inves-tigation is done in the Regional Centres.

·     The use of common procedures, to ensure quality of data, including the use of the causality method.

·     The integration of the Centres in clinical pharma-cology department within university hospitals.

·     The emphasis of the drug information function, as a continuing source of education.


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