Pharmacoepidemiology and Pharmacovigilance Division, Medicines for Human Use Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.
Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1236-1245. doi: 10.1002/pds.5006. Epub 2020 Apr 26.
Base de Datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) is a population based database administered by the AEMPS (Spanish Agency for Medicines) of longitudinal electronic medical records (EMR) of patients attended in primary care. Its main purpose is to serve as source of information for independent studies on drug safety and support of medicines regulation activities. This article aim is to describe the characteristics of BIFAP, how to access the database and a summary of its potential for research.
Health problems are registered by primary care physicians as episodes of care and include socio-demographic data, results of diagnostic procedures, lifestyle data, general data, and interventions. A proportion of data on hospitalizations and specialist care are currently available through linkage with other data sources. EMRs of the Spanish healthcare system are provided by the regional administrations. Specific data extraction and standardization processes are performed.
BIFAP includes data from 12 million patients starting in 2001 and updated annually. Validation of drug and diagnosis definitions has been ascertained. Participation in international collaborative projects and a number of articles in peer reviewed journals reflect its contribution to the knowledge of the risks associated with medicines and drug utilization patterns.
BIFAP is a useful tool for generating scientific evidence on medicines related issues, helping regulatory decision making in Europe. The main strengths of BIFAP are related to large sample size, population-based, longitudinal nature and annual update of data. BIFAP shares common challenges with similar data sources including accurate and efficient identification of health outcomes and of treatment exposure.
基础药物流行病学在初级保健数据库（BIFAP）是一个基于人群的数据库，由 AEMPS（西班牙药品管理局）管理，包含初级保健患者的纵向电子病历（EMR）。其主要目的是作为药物安全性独立研究的信息来源，并支持药品监管活动。本文旨在描述 BIFAP 的特点、如何访问数据库以及其研究潜力的概述。
初级保健医生将健康问题作为医疗事件进行登记，包括社会人口统计学数据、诊断程序结果、生活方式数据、一般数据和干预措施。目前通过与其他数据源的链接，可获得部分住院和专科护理数据。西班牙医疗系统的 EMR 由地区管理部门提供。进行了特定的数据提取和标准化流程。
BIFAP 包含自 2001 年开始并每年更新的 1200 万患者的数据。已证实药物和诊断定义的验证。参与国际合作项目和一些同行评议期刊的文章反映了其对与药物相关的风险和药物利用模式的知识的贡献。
BIFAP 是生成与药物相关问题的科学证据的有用工具，有助于欧洲的监管决策。BIFAP 的主要优势在于其样本量大、基于人群、纵向和数据每年更新。BIFAP 与类似数据源面临共同的挑战，包括准确和有效地识别健康结果和治疗暴露。
