PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, VOL 3: zyxw 15 1-1 55 (1994) SPECIAL REPORT zyxw Communication in Pharmacovigilance* N. MOORE', D. MONTER02, R. COULSON', F. DE ABAJO*, C. KREFT-JAIS', A. BIRON' AND R. PALOP' zyxwvut 'French Pharmacovigilance System, Agence du Midicament, France; 'Instituto de Salud Carlos III, Madrid, Spain; 'Medicines Control Agency, London, UK SUMMARY Pharmacovigilance is a field where communication is paramount. Information, such as single case reports, is transferred from health professionals to National Regulatory Administrations and between administrations and industry. The cumulation of reports may be used for information purposes, and to assist in the identification of possible signals. These are then assessed by the analysis of individual and aggregate cases, the latter being exchanged between administrations for multinational analysis at the European level. Once a decision has been made on a possible alert, the decisions and the reasons thereof must be transmitted to administrations and to other correspondents, such as health professionals, the pharmaceutical industry and WHO. Within the CARE project of the DGXIII European Nervous System telematics research programme, the Pharmacovigilance Pilot, consisting of representatives of the French, Spanish, and UK pharmaco- vigilance systems, set out to identify and describe the messages corresponding to these communication needs, and the methods best suited to effective telematic transmission. The messages identified concern: the transmission of individual case reports, the transmission of cumulative and aggregate case reports, and of regulatory decisions. Each of these information messages have been structured for future inclusion into a network for electronic data interchange between administrations in pharmacovigilance. In time they should provide a common electronic vocabulary enabling all parties involved in pharmacovigilance to communicate telematically. Transmission options have been considered also. In view of the large number of existing and potential partners involved in the communication processes in pharmacovigilance, ED1 (electronic data interchange) seems the most appropriate method to exchange these messages. Two of these, concern- ing the single case and the aggregate cases (rapid alerts) have been submitted to the Western European EDIFACT Board MD9 for integration into EDIFACT (as MEDADR and MEDPHV). zyx KEY WORDS zyxwvutsrqpo - Pharmacovigilance, drug information, drug safety, telematics, electronic data interchange, regulations, Europe. INTRODUCTION results in decisions improving the safety of use of medicines. The evaluation of the risk covers several distinct Pharmacovigilance can be defined as that field of pharmacology that strives to ensure the safe use domains. bf medicinaiproducts. It is based on all the tech- niques that can give information on drug-related risks, on the evaluation of that risk, and ultimately Addressee for communications and reprints: Nicholas Moore, CHU de Rouen, 76031 Rouen Cedex, France. *This work was done under a research contract with CEC DGXIII (ENS E 2005). The seriousness of the risk i.e. how often does the reaction when it occurs cause significant morbidity, or death, endanger the patient's life, entail significant changes in the drug regimen, etc. The frequency of the reaction: during normal use of the drug in the target population, how often does the reaction occur. CCC 1053-8569/94/030151~5 zyxwvutsr 0 1994 by John Wiley & Sons, Ltd. Received 31 March 1994 Accepted 19 May 1994