History

To understand the way it functions, and some of the differences with other countries' pharmaco-vigilance systems, a little history is necessary. After the problem with thalidomide, and the other early drug safety scandals or scares, a number of clinical toxicologists and pharmacologists, usually associated with Poison Control Centres (Paris, Lyon, Marseilles) decided to set up units to inform their physicians of the risks of drugs, and provide for a local place to report ADRs. In 1973, a national centre was set up by the national order of physicians in collaboration with the French pharmaceutical manufacturers association. The same year, six experimental pharmacovigilance centres were created in France. Over the years, more pharmacologists joined the first ones, and the network of centres appeared. The heads of these centres, at the time without any official remit, met regularly during meetings of the French Association of Pharmacologists. As this network evolved, they had to work out common methodologies. From the mid-1970s the centres were officially recognised, the regular meetings started taking place at the Ministry of Health, and a unit was set up there to co-ordinate activities. In 1979 a decentralised system was put in place with a network of 15 centres, which was thereafter extended to 29 in 1984 and 31 in 1994. Since

1984 prescribers and marketing authorisation holders (MAHs) have been required to report ADRs. The national database was rejuvenated in

1985 so that online input became possible, and it could be accessed from all centres. In 1994 the Pharmacovigilance Unit was transferred to the French Medicines Agency (now Agence Française de Securite Sanitaire des Produits de Santé;, AFSSAPS). Good Pharmacovigilance Practices were evolved and sent to every prescriber in the country. To implement the new European legislation, two decrees came into force which defined the general organisation of the French pharmaco-vigilance system: the decree of March 1995 on general principles and the decree of May 1995 that especially related to human blood products.

The important point in this short history is that the system actually grew from the ground up, rather from the top down as in most other countries. At the present time, the 31 Regional Centres have a duty to collect and record ADR reports, and input them into the common database, after rapid causality assessment. The Heads of the Regional Pharmacovigilance Centres meet monthly at the AFSSAPS in the Technical Committee, a working group set up to prepare the work of the National Pharmacovigilance Commission (Advisory Board). The Technical Committee is responsible for co-ordinating the collection and evaluation of information on ADRs, conducting surveys and providing recommendations that are forwarded to the National Pharmacovigilance Commission, which recommends action to the Director of the Agency, to prevent or eliminate drug-related accidents (Table 16.1). This structure is in fact pretty close to that of the European system.

The Pharmacovigilance Unit of AFSSAPS is in charge of the co-ordination of the Regional Centres' activities, the organisation of meetings held by the Technical Committee and the National Pharmacovigilance Commission, the receipt and the evaluation of pharmacovigilance data sent by MAH and the exchange of information with other competent authorities (the European Agency for the Evaluation of Medicinal Products (EMEA), other Member States, the World Health Organisation (WHO), the Food

Table 16.1. A comparison of French and European systems.

France

vs. Europe

Prescribers, MAH

Prescribers, MAH

Signal

Rapid Alert System

31 Regional Centres

15 National Centres

Technical Committee

CPMP Pharmacovigilance

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