Organization of Spanish Pharmacovigilance in the Multinational Situation: An Overview
| Autor: | Gloria Martín-Serrano, Francisco J. de Abajo, M. Madurga, Dolores Montero, R. Palop |
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| Rok vydání: | 1997 |
| Předmět: |
Estimation
medicine.medical_specialty Operations research business.industry Public health Public Health Environmental and Occupational Health Pharmacology (nursing) Legislation Harmonization Pharmacy Accounting Decentralization Multinational corporation Drug Guides Pharmacovigilance Medicine Pharmacology (medical) business |
| Zdroj: | Drug Information Journal. 31:889-893 |
| ISSN: | 2164-9200 0092-8615 |
| Popis: | 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 pharmaceuti-cal 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 EspaAola-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. |
| Databáze: | OpenAIRE |
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