Abstract
The Spanish Pharmacovigilance System is a decentralized system that was developed in 1982. Today, there are 15 operational regional centers and a coordinating center that safeguards harmonization in working procedures. Health professionals and pharmaceutical companies are obliged to report suspected adverse drug reactions. All domestic reports, irrespective of reporter and sender, are individually evaluated and registered into the Farmacovigilancia Española-Datos de Reacciones Adversas (FEDRA) database.
Over the last few years the number of reports received annually has reached a plateau between 5,000 and 6,000; the contribution of the pharmaceutical companies to spontaneous reporting, although increasing, represented only 7% of the reports in 1995. Approval of the European legislation has had a clear impact on the amount of information received and exchanged, which is obviously influencing the procedures of the Spanish Pharmacovigilance System. The enormous effort toward risk identification that Europe is performing should be followed, from the perspective of the Pharmacovigilance Unit, by the creation of networks for improving accuracy in risk estimation.
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