Using electronic health records to help advance drug development and safety monitoring

By: Janet Woodcock, M.D.

Not long ago, electronic health records (EHRs) were an idea solely for the future. Today, they’re a reality. Paper records are becoming part of the past. These days, when patients go to their physician’s offices, they are much more likely to have their care documented electronically. EHRs give health care professionals more data to provide patients higher levels of quality care and safety.

Janet WoodcockNow that EHRs are more widely used, they collectively represent huge amounts of important data about the medical products and prescription drugs patients are using. Significant amounts of information in patient EHRs may be used in clinical research, with appropriate protection of patient privacy, to aid the development of new and more effective medical therapies or to provide information on using existing treatments more effectively and safely. These data, combined with other sources of electronic healthcare data such as information from healthcare claims, are being used to better understand the performance of medical products.

A key challenge for the research community is to effectively harness the data contained in EHRs. There are many kinds of EHRs and many ways to collect and store electronic data. To readily understand and combine information from different sources, we need to further standardize the data and the way it is exchanged. This work will allow computer systems to better “talk” to each other and, ultimately will lead to better treatment decisions as clinicians will have a more complete picture of their patients’ medical histories, including visits with other providers. 21st Century data sharing also will expand opportunities for researchers to ask questions that may improve our understanding of how and when drugs should be used. EHRs are only part of the puzzle, though. Defining standards for capturing data from clinical trials, and using standard terms for items such as “adverse events” or “treatments” will allow researchers to combine data from different clinical studies to learn more.

At FDA, we’re working to help realize the potential of electronic healthcare data to better protect and promote public health. FDA’s pilot program for the agency’s Sentinel System, dubbed Mini-Sentinel, uses electronic healthcare data, principally claims data but also including data from EHRs, to monitor the safety of FDA-regulated medical products.

Here’s a quick snapshot of how Mini-Sentinel works: 18 large health care organizations across the country serve as data partners for Mini-Sentinel. When FDA safety scientists have a safety question they can submit “queries” to the Mini-Sentinel data partners about the drugs being used by the patients cared for by their organization. Each partner organization maintains its own secure and privacy-protected data, in some but not all cases including EHR as well as claims data, but with the use of a common data model, the necessary information from all of the different systems can be analyzed in the same way. This capability enables Mini-Sentinel to provide answers to FDA questions about drug safety. The Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters. Thanks to the ability to access data from various sources, the Mini-Sentinel system can use the information from potentially more than 150 million covered lives in our nation’s health care system to help answer important drug safety questions.

FDA is actively engaged with standards-setting organizations to develop solutions that aid researchers, medical product developers and healthcare professionals in their efforts to increase our collective knowledge and tools in medicine. We collaborate with, and support others in our health care system and in the research community who are working on efforts to harness the power of electronic healthcare data. We applaud those endeavors and encourage others to join these efforts.

Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research

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