BIFAP (Pharmacoepidemiologic Research in Public Health Systems) is a database of medical records belonging to the National Health System (SNS) aimed at investigating the patterns of use, safety and effectiveness of drugs. BIFAP is funded and administered by the Spanish Agency of Medicines and Medical Devices (AEMPS) and draws on the data recorded by family doctors and primary care paediatricians in Electronic Clinical Records (HCE-AP) provided by the Autonomous Communities (CCAA) that voluntarily participate through collaboration agreements.
AEMPS’ mission is to ensure compliance with the guarantees of quality, safety and efficacy of the medicinal products that are authorised, and that the relationship between the benefits and risks of the medicinal products is favourable in all cases. After authorisation of the medicinal product, pharmacovigilance’s task is to identify, quantify and assess the new risks and their impact on the medicinal products’ benefit-risk ratio.
In this scenario, electronic healthcare databases are of special importance and, along with other European regulatory agencies, AEMPS initiated a number of actions, including the BIFAP initiative, a database that makes it possible to carry out studies necessary for regulatory decision-making on medicinal products motivated by safety issues.
BIFAP is based on data recorded by family physicians and primary care paediatricians in the Electronic Clinical Record (HCE-AP). In order to ensure that BIFAP includes longitudinal information on the care activity related to the patients treated, the database is periodically updated, at least once a year, with data provided from each of the participating Autonomous Communities.
The BIFAP Program is managed by AEMPS, in the Pharmacoepidemiology and Pharmacovigilance Division of its Medicines for Human Use Department, which is the data controller.
Programme Management is the responsibility of the Pharmacoepidemiology and Pharmacovigilance Division, and its coordination within the Division is the responsibility of the Pharmacoepidemiology Unit.
Each member of thre BIFAP team signs a specific confidentiality document regarding access to BIFAP data.
BIFAP draws on the data recorded in the Electronic Clinical Record provided by participating Autonomous Communities. This participation is based on collaboration agreements detailing the commitments of each Autonomous Community and the AEMPS, as well as other operational aspects.
The commitments under the CCAA-AEMPS Agreements include establishing and maintaining an Advisory Committee composed of two representatives of the AEMPS and at least one representative from each of the autonomous communities participating in BIFAP. Other institutions contributing to the purposes of BIFAP and signing future collaboration agreements are also expected to participate in the Advisory Committee. Said Committee has an advisory role and ensures that BIFAP is consolidated and developed within the framework of the agreements.
The updated information on the composition of the Advisory Committee as well as the list of Collaboration Agreements is posted on the BIFAP website here.
In addition, BIFAP has a Scientific Committee which aims to advise AEMPS on the relevance, feasibility, interest, scientific suitability and technical quality of projects carried out with the BIFAP database. The updated composition of the Scientific Committee as well as all approved projects are published on the BIFAP website here.
The organisation of access, management and provision of the services provided by BIFAP is carried out by defining the different types of users. The BIFAP user profiles are as follows:
Access to the different services is made through the “BIFAP Services Web” (https://herramientas2bifap.aemps.es/ServiciosBifap/) in an area of the BIFAP Web exclusive to registered users. Depending on each profile and certain conditions, the user has access to the services or resources.
The resources that ultimately provide access to and access to BIFAP data are described in the BIFAP Data Access Governance document.
Access to these services is controlled based on the profile of each user, which is established in the system registration process, so that the profile determines the possible functions that each user performs.
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