Pharmacovigilance

The starting point of this study was that Italy lacks epidemiological data on adverse drug reactions due to the lack of a system to monitor this. Even at an international level out-of-hospital monitoring of adverse reactions is infrequent. There is a real need to define the relevance of adverse drug reactions in paediatric practice and the interest of family paediatricians to the problem of flagging up such adverse reactions. 

The. l'Istituto Superiore di Sanità provided the operative protocol and the means to set up the network which were used to connect 29 family paediatricians who collected and sent more than 200 reports on adverse reactions to drugs in the study period. 

Using specific software, specially created for paediatric pharmacovigilance, the paediatricians with computer and modem were able to send accurate data on side effects to specific drugs seen during their work activities in real time to the central server via an automated system. 

The study lasted 12 months (April 1996 to April 1997). 24,000 children in the catchment areas of the 29 paediatricians were studied and 244 reports were made on 338 events correlated to 266 prescriptions of 73 drugs. 

It can be observed from these results that there is, in general, a large problem with under-reporting of ADE and that there is interest amongst paediatricians in the online reporting of pharmacoepidemiological data. The forms were of easy use and the online network an efficient way of collecting data for pharmacovigilance, definitely more so than the current system based on filling out of a form (Modello A). 
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The results of this study will be of great importance in the organisation of epidemiological networks for clinical research and the study of adverse effects of drugs.