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Comprehensiveness of adverse drug reaction reporting / Exhaustividad de la declaración de reacciones adversas medicamentosas

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Author(s): Navarro-Calderón E | Navarro MJ | Muelas J | Salazar A

Journal: Seguimiento Farmacoterapéutico
ISSN 1696-1137

Volume: 2;
Issue: 4;
Start page: 244;
Date: 2004;
Original page

Keywords: FEDRA | Pharmacovigilance | Adverse Drug Reaction Reporting Systems | Product Surveillance | Postmarketing

ABSTRACT
Expontaneous reporting is the most efficient method to identify risks of drugs used. Nevertheless, databases gathering individualized information on health resources use in great population groups provide an important information that reduce disadvantages of pasive reporting. Our aim was to assess the comprehensiveness of FEDRA in its hospital sources, and to determine systematic reporting patterns. Methods: A cross-sectional retrospective study was done to assess hospital discharges with adverse drug reactions in Valencia State from 1-Jan-1999 to 31-Dec-2001. Information sources were Conjunto Mínimo Básico de Datos (CMBD) and FEDRA. Results: 462 ADR were retrieved in FEDRA and 942 in CMBD. Differences of average age both between sources are shown: CMBD 55.66, and FEDRA 50.21 years old. Its is noticable the difference in women older than 65 years: 328 records separate CMBD from FEDRA in older than 65 years, where 251 correspond to women. So, there exists an underreporting in older than 65 years.

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