SUMMARY

The aim of the BIFAP project is to evaluate the feasibility of establishing a computerized database aggregating information provided by general practitioners and pediatricians working in the Spanish National Health Service.

The ownership of this database will be public, and its use will be solely for carrying out epidemiological studies, and in particular pharmacoepidemiological studies. The information related to patients will be kept completely confidential strictly adhering to the current Spanish and European legislation. Collaboration in this project of general practitioners is personal, individual and voluntary.

BIFAP is a non-profit research project operated by the Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS), a public agency belonging to the Spanish Department of Health, with the collaboration of the Spanish Centre for Pharmacoepidemiological Research (Centro Español de Investigación Farmacoepidemiológica - CEIFE), a non-profit foundation devoted to epidemiological research of drug effects using automated databases. The BIFAP team include 4 trained physicians - Two epidemiologist, one clinical pharmacology specialist and a general practitioner-, a trained nurse and 3 computer scientist. See BIFAP team.
The BIFAP project is sponsored by three leading Spanish medical societies in primary care: Sociedad Española de Medicina Familiar y Comunitaria (SEMFYC), Sociedad Española de Medicina Rural y Generalista (SEMERGÉN) and Asociación Española de Pediatría de Atención Primaria (AEPAP). These societies disseminate information about the BIFAP project to their members, and have made appointments to the Scientific Advisory Board (SAB). The function of SAB is to supervise the implementation of the project that formally started in 2003 and is originally planned to run, in a first step, until 2006. By that time, the goal is to achieve a pool of collaborators in the range of 1000 general practitioners and pediatricians. At de end of 2006, 1002 physicians from 10 different autonomous communities in Spain collaborate with BIFAP. BIFAP database includes clinical and prescription data from around 2,2 million patients. In August 2006, AEMPS renewed the fundings to the project for two additional years with a two-years optional extension. The specific objectives for the project for this period of time are: to consilidate the BIFAP project and increase its visibility, to validate the information included in the database and to perform, at least, three epidemiological studies.

The main use of BIFAP will be to evaluate the beneficial and adverse effects of drugs as used in the general population. The database will be restricted to research purposes only.

It became clear after reviewing the different sources of information used in pharmacoepidemiology that the most cost and time-efficient approach is the primary care-based automated database. This type of database usually includes all the data elements necessary to carry out most of pharmacoepidemiologic studies without the need to link to other sources of data (record-linkage). The major exponent of this model is the General Practice Research Database (GPRD) in the UK that has been the source of inspiration to start the BIFAP project. The tremendous research output using the GPRD in pharmacoepidemiology could by itself justify the creation of similar databases in other countries, which is nothing more and nothing less that the primary intention of BIFAP in Spain.

More informations: "The BIFAP Project: Database for Pharmacoepidemiological Research in Primary Care", article published in December 2002 issue of "Atención Primaria" (Primary Care).