FDA Wants Access To EHRs
By Katie Wike, contributing writer
Food and Drug Administration would collect data from EHR systems to identify safety issues and dangerous pharmaceuticals
The Food and Drug Administration (FDA) posted a notice recently announcing it was looking to access de-identified EHR information data to gain a better understanding of patient safety threats, including identifying risky pharmaceuticals.
The notice states, “A vital part of FDA’s mission is to protect the public health. The Office of Surveillance and Epidemiology (OSE) and other offices in the FDA contribute to this effort by evaluating drug and biologics risks and promoting their safe use by the American people. In furtherance of this effort, FDA seeks continued access to a longitudinal patient-level electronic medical record (EMR) data.”
EHR Intelligence reports, “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.”
The project would include the records for at least 10 million research qualified patients, at least half of which would be active patients. Half of these patients will need to have been in the system for at least three years in order to capture all the valuable data on safety outcomes. An online portal would be updated monthly and have the ability to download even more data for study.
“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 Regulatory Affairs Professionals Society reports on their news page, Regulatory Focus, “At present, side effects are reported to FDA voluntarily, usually by healthcare professionals or companies using a variation of Form FDA 3500. As of 2013, consumers can also report side effects using Form FDA 3500B.
“The problem for regulators, however, is twofold. The first problem is that submission of the form is voluntary, and it is thought that the vast majority of adverse events are never reported to FDA. The second problem is the overall complexity of the form, which can result in inaccurate or incomplete reports. The form is, in other words, not a tool FDA can completely rely on.”
The proposed system would allow the FDA to "estimate the contribution of various risk factors," according to the agency, including demographics, health history, diagnoses and procedures, laboratory test orders and results, use of drugs and biologics, and health encounters like hospitalizations or visits to a physician.
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