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. 2013 Apr 5;30(10):655–661. [Article in Spanish] doi: 10.1016/S0212-6567(02)79129-4

El Proyecto BIFAP: Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria

The BIFAP project: Database for pharmaco-epidemiological research in primary care

A Salvador Rosa a,*, JC Moreno Pérez b, D Sonego b, LA García Rodríguez c, FJ de Abajo Iglesias d
PMCID: PMC7679749  PMID: 12525343

Abstract

Objectives

To create a data base (BIFAP) with information provided by primary care doctors from the National Health System who use a computer at work, to evaluate its validity as a source of pharmacoepidemiological information and to use it for the study of the efficacy and safety of medicines.

Justification

Some data bases, such as the British GPRD, have shown great efficiency in pharmaco-epidemiological research and in analysis of alarm signals in pharmacovigilance: primary care doctors are in a very good position to obtain clinical information from their patients. It is recommended that the impact of medicines on various populations is evaluated, including of course those medicines most used in Spain.

Pilot phase

January 2000-end of 2003. 300–500 doctors took part: a) monitoring of certain recommendations on recording; b) dispatch every 2 or 3 months to the Spanish Medicines Agency (AEM) of anonymous information with its origin encrypted (basic demographic details, morbidity, prescriptions, other data of epidemiological relevance), which are analysed by computer to check whether they meet adequate recording standards; c) despatch to the AEM of copies of anonymous clinical reports from small samples of patients (for BIFAP validation studies).

Feasibility and perspectives

If BIFAP were viable, a standardised procedure for its use and protocols to support it as a research tool would be put in place.

Key words: Information systems, Data bases, Pharmaco-epidemiology, Primary health care

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