The Food and Drug Administration (FDA) is exploring the possibility of gaining direct access to de-identified EHR information on millions of patients in order to glean data that will be useful in identifying risky pharmaceuticals and other patient safety threats. The ability to review large-scale longitudinal record sets will help pinpoint adverse effects in a timelier manner than the current system of voluntary reporting and subsequent piecemeal review.
“FDA currently has several tools available to address post-marketing safety issues,” the notice explains. “These include a spontaneous reporting system for adverse events related to drug and biologics therapy; several complementary product utilization databases; and a scientific program to support epidemiologic investigations that provides indirect access to US claims-based health encounter data for pharmacoepidemiology studies. To strengthen and complement these resources, FDA seeks to acquire direct access to a de-identified EMR data.”
The EHR data of a minimum of ten million research qualified patients and five million active patients will be included in the project. Half of the cases must be continuous for at least three years, “to facilitate the likelihood that all exposures and safety outcomes of interest be captured, permitting long-term longitudinal follow up of most patients for delayed adverse effects from drugs or other medical products.” The data will be updated monthly through an online database portal that will include the ability to download datasets for further research.
The project is just one in a series of efforts to harness the power of big data for research and improved outcomes. Cancer databases are growing at a rapid rate, allowing novel clinical trials and a centralized pool of easily accessible information, while growing concern over drug abuse and pharmaceutical safety has prompted state agencies to collect and disseminate data on doctor shopping and prescription fraud.
The FDA itself will not own or maintain the data itself, but is instead seeking a contractor to develop and manage the information. Interested vendors must have the capability to provide “technical and clinical support in the area of drug safety research to assist in the utilization of the data resource for epidemiologic studies,” as well as the ability to contact patients and their families for further information if necessary. The notice is a preliminary request for information and gives no concrete timeline for the development or deployment of the system. Source
