| Abstract: | Though electronic communication and transfer of data is becoming commonplace, it is still rare between administrations. This is why CEC DGXIII started the European Nervous System (ENS) programme, to promote the use of telematics to facilitate the work of administrations. Pharmacovigilance is one of the pilots of CARE, an ENS project in health care. This pilot involves Instituto de Salud Carlos III (Spain), Medicines Control Agency (UK), and the French Pharmacovigilance System (France) along with Norsistemas Consultores (Spain). Its objective is to explore the possibilities of telematic transmission of Pharmacovigilance data between national administrations. The technical approach has tested the transmission of urgent drug alerts, information equivalent to that of the existing Rapid Alert scheme, up to now transmitted by fax. The network using international standards (Unix, X400, and EDI, based on X25 networks) has been set up between the three participating countries. The data structure for the drug alerts has been described and submitted to future European users. The message structure itself has been entered into the registration and validation process for EDIFACT certification. The application for message transmission has been written and is being tested and re-evaluated. The information contained in these messages will be initially entered manually, but could be generated from national databases. Though this network at the present only concerns three countries, it is expected that most EC countries will be linked in the near future. |
