Catalonia “pass” for Ameems Pharmacovigilance

the A database of biological pharmaceutical research In the public domain (AEMPS), it is advanced towards increasing integration Technological innovation. Currently, there are 12 independent societys that form part of this network and provide pseudonyms for medical records for all patients treated in their primary care centers. The last thing he joined La Rioja and Extreadura Last year, but it is open to the rest. These two joined Aragon, Astorias, Canary Islands, Kanabria, Castilla Y León, Castilla-La Mancha, Madrid, MURCIA, Navarra and Valencian Society.

Therefore, there are five regions that are not part of: Andalusia, Balearic Islands, Catalonia, Balad Basque and Galicia. “The process of joining the BIPAF technically complex and requires a series of procedures and several months of work to integrate systems. There are some Independent societies that are not recognized by prioritySay from AEMPS to Medical writing “BIFAP is open to merge the rest of CCAA and we hope that Next years we can apply With those who have not yet been combined, “they add.

From this newspaper, we contacted the unacceptable provinces and we received two answers. on the one hand, Wise He claims to be interested in participating in this database. For this reason, they have already created contacts for Obtaining the information necessary to start cooperation With those responsible for the database and to provide health professionals in the Balearic Islands, information and advice in Biological pharmaceutical studies design With the quality and unification of the BIFAP data.

“We believe that the information merged into The database should be stable and quality. Therefore, the different projects that we have now (changing the medical prescription databases, and new applications for medical records …) Then combine information with the required qualityThey point out from this Salut section.

In the opposite position it was found CataloniaWho confirms this They did not promote any specific work For the BIFAP integration, they have not received any application models in this regard. “We have one Solid infrastructure In order to access and analyze clinical data, through Catsalut, and D’AnCanció Deels System System System System System (SISAP). These systems allow us to develop biological pharmaceutical studies with high -quality information and adapt them to the needs of our health system, however, they claim that they are.Always open to evaluating cooperation The value can contribute to our system and contribute to research in favor of public health. “

For their part, primary care doctors, who are part of the beneficiaries of this data, regretted BIFAP access is not the same in all societies. Lorenzo Arminus del Olmo, spokesman for Spanish Association for General Doctors and Family (SEMG), is considered It is “very relevant” healthy data, But doctors cannot enter the network if they are not attached to the independent society they practice.

“This motivation and effort must be presented All societies may be. In this way, all doctors interested in cooperation and participation can get this access and It will be more fair For all health services, “he says to this newspaper.

Medicine network challenges

However, the challenges in this database do not stop. Now she has 22 million medical records were collected During the past twenty years, update is made annually. What is all this data? This folder makes it a “Related Information Source” To describe how to treat health problems; Study rare negative reactions; And the analysis of medications for limited or used use in the treatment of rare diseases. All apply to Clinical practice in Spain.

“This process increases the complexity in Extraction, monotheism and uniformity of data. BIFAP is necessary for technological innovation in line with, Merging advanced strategies The language processing in their procedures explains, “Sources from the agency led by Maria Jesus Lamas.

It should be borne in mind that BIFAP was created in 2001 by AEMPS to serve as The source of the information in the drug regulation service General health is from a network of cooperative doctors. After that, they left Merging CCAA with their data. The numbers support their operation: a total of 950 million records for health problems, 3100 million drug records, 133 million vaccination records And 10.5 billion public and analytical data records feed BIFAP.

Connect medical records

One of AEMPS is linking information Medical records of mothers with their children’s records To study the effects of drug exposure during pregnancy. As they point out, BIFAP participates in the ADEPT project, funded by European Pharmaceutical Agency (EMA, for its abbreviation in English), which will exactly evaluate the feasibility Use medical record databases As a data source for this purpose.

“The way this data can be linked This depends on the information systems for both CCAA. Currently, the BIFAP team collects information from CCAA participation to develop a strategy Allow bifap connection“Blind.

Another major challenge is integration in European health data area. In this regard, BIFAP is a resource that already provides data for investigators from the public field, whose “success” can be measured in more than 100 published scientific articles and must be performed The central paper in the transition in Spain To the generalized participation environment for health data provided by the newly approved European regulations.

After this line of participating in European projects, AEMPS sources emphasize this BIFAP integration in Darwin, the European Unionthe The huge data network at the European Medicine Agency (EMA)It was “success.” It was implemented last year and a very positive balance: “We have participated in four studies and there are currently three other plans. In addition, data quality requirements allowed improvement of improvement. Record and inter -operation operationsEssential to generate confidence in the scientific evidence produced by research projects with BIFAP “, summary.