Organization of Spanish Pharmacovigilance in the Multinational Situation: An Overview
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ORGANIZATION OF SPANISH PHARMACOVIGILANCE IN THE MULTINATIONAL SITUATION: AN OVERVIEW DOLORESMONTERO,MD, PHD, MARIANOMADURGA, PHARMD, MD, PHD, GLORIAMART~N-SERRANO, PHARMD,PHD, AND FRANCISCO J. DE ABAJO,MD, PHD
R A M 6 N PALOP,
Pharmacovigilance Unit, Instituto de Salud Carlos 111, Madrid, Spain
The Spanish Pharmacovigilance System is a decentralized system that was developed in 1982. Today, there are I5 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 sendec are individually evaluated and registered into the Farmacovigilancia Espariola-Datos& 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. Key Words: Phannacovigilance; Spain; Multinational
INTRODUCTION THE CREATION OF THE Spanish Pharmacovigilance System has been a step-wise process, which has been consolidated in the last few years. The first legislation on pharmacovigilance in Spain dates from 1973, but it was not until 1982 that the Spanish Pharma-
Presented at the DIA 8th Annual Emmeeting “The Maturing European Pharmaceutical Market: How to Operate it?,” May 5-7, 1996, Copenhagen. Reprint address: Francisco J. de Abajo, Pharmacovigdance Unit, Instituto de Salud Carlos III, Ctra. Majadahonda-Pozuelo, Km 2, 28220 Madrid, Spain.
covigilance System initiated its activity with a pilot experiment of voluntary reporting in one region. Three years later, and due to the positive results obtained in the pilot, the Ministry of Health decided to support, together with the regional governments, a decentralized pharmacovigilance system. The system structure is similar to the French pharmacovigilance system, with some peculiarities (1). Soon after, a scientific commission for advising the Ministry of Health on drug safety issues, the National Commission on Pharmacovigilance, was created; this commission meets regularly three times per year and although its role is to recommend actions
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D. Montero, M . Madurga, R. Palop, G. Marth-Serrano, and F. J. & Abajo
to the Ministry of Health (General Directorate of Pharmaceuticals), to date all of its recommendations have been
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