The Database for pharmacoepidemiological Research in Primary Care (BIFAP) is a project of the Spanish Agency of Medicines and Health Products (AEMPS). It has the support of the autonomous regions and major scientific societies involved.
It is a computerized database of medical records of Primary Health Care for pharmacoepidemiological studies. Today anonym zed information is available over 3 million patients from medical staff to 1,236 (1,029 GPs and 207 pediatricians) in Spain. BIFAP is the largest and most detailed public information source for pharmacoepidemiological studies in Spain and one of the most important in Europe. BIFAP is called to be a benchmark for epidemiological research in our country in the coming years.
The pilot phase BIFAP Project was developed over the period 2000-2003. BIFAP Project formally began in 2003 and its first phase ended in 2006, achieving the following objectives:
- Creation of the Data Processing Centre (DPC) of BIFAP, which has involved provided human resources and materials, including high-capacity computer to be used to host the database.
- Develop an application – export module – for primary care programs whose structure is compatible with BIFAP.
- To obtain prior authorization from the agencies that constitutes the National Health System, the collaboration of a sufficient number of physicians and primary care pediatricians.
- Validate the information using other sources of information and original medical records.
In 2008, a team of researchers at the Navarre Health Service (SNS-O) BIFAP requested the possibility of a research project with the base. It was the first experience BIFAP collaboration with an independent team. BIFAP accepted the challenge and began to develop the project.
The SNS-O team consisted of three primary care pharmacists and a medical epidemiologist. The aim of this study was to test the hypothesis that the use of long-term bisphosphonates might increase the incidence of hip fractures and atypical fractures in women over 65 years. The protocol design was made by the independent team and then discussed with the team BIFAP two-face meetings to qualify some aspects of it and reach a final protocol. Was considered, a case-control study nested in the cohort BIFAP.
BIFAP then extracted 100 cases of hip fracture to proceed with the validation of a small sample as a pilot. Four researchers from the team and two BIFAP Navarre evaluated the 100 cases independently. The results of this pilot the BIFAP evaluated and held a conference call to discuss the data.
Having resolved the doubts and little disagreement about the definition of “case”, BIFAP proceeded to extract all the cases in the base between 2005 and 2008. Independent team, about, evaluated 3,200 cases.
Later BIFAP cases reassessed as a criterion for quality control.
Validation was provided to investigators by enabling independent team of access to the Internet through the stories contained in BIFAP. It is important to note that the evaluation was blind in two respects. First, in the stories was omitted any reference to the medication used by patients. This avoided the potential bias that researchers consider as “probable case” to “doubtful cases” or “no case” by the fact that the patient was treated with any of the medications under study. In addition, names were omitted, so that one could not identify the physicians involved in the process of each patient, hospitals and cities of residence of the patients. This is impossible for researchers to identify or reach to track patients.
Once the validation has extracted BIFAP controls matched for different variables. Then generated the variables of the study and data sheet (data sheet). BIFAP provided the “data sheet” to separate computer for statistical processing of information and interpretation of results.
As a summary of this first experience of cooperation, we can say that BIFAP is a breakthrough in the investigation pharmacoepidemiological in Spain. Provides information on medical records of proven quality ensures the quality of the process of extracting information, monitors the work of independent investigative team and ensures the blind researchers, ensure that the project is of sufficient quality.
On the other hand, freedom of approach to the research questions that provided the independent team makes it possible, in practice, those researchers in the public system to respond to the existing therapeutic shortcomings.
It is desirable that the NHS there be any further research team that worked with BIFAP pharmacoepidemiology and that in the near future; establish partnerships with national groups and international research.
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