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

FDA’s Mini-Sentinel exceeds 100 million lives (and counting)… A major milestone in developing a nationwide rapid-response electronic medical product safety surveillance program

By: CDR Melissa Robb

Having secure access to the electronic healthcare data of patients is an essential 21st Century tool for detecting potential safety problems with medical products once they are in common use.

This is because studies conducted prior to approval may not be able to detect rare problems or problems that might emerge following long-term use of a product.

Congress recognized this need for additional information in the FDA Amendments Act (FDAAA) of 2007 when it authorized FDA to develop a nationwide rapid-response electronic surveillance system for monitoring the safety of FDA-regulated medical products such as drugs, vaccines, other biologics, and medical devices.  FDA calls this the Sentinel System.

Now FDA is proud to report that it has met and EXCEEDED the legislation’s goal of achieving secure access to data from 100 million patients by July 1, 2012. In fact, FDA met that goal in December, 2011, and currently has secure access to data concerning approximately 126 million patients nationwide derived from 17 different data partners.

To better understand how the Sentinel System will work, FDA has been conducting a pilot program, dubbed “Mini-Sentinel,” that incorporates access to these 100 million-plus records. So far FDA has used Mini-Sentinel to conduct more than 120 data requests to gather safety information on various medical products.

As an example of the promise of this system, consider FDA’s recent use of the Mini-Sentinel pilot to help inform our ongoing safety analysis of the blood pressure drug olmesartan. FDA had received reports through our Adverse Event Reporting System (AERS) suggesting that olmesartan was associated with more cases of celiac disease than other “sartan” drugs in its class (losartan, irbesartan, telmisartan, valsartan). Celiac disease is a potentially dangerous condition in which the small intestine is damaged and the patient cannot absorb nutrients. FDA, through Mini-Sentinel, submitted a query request to the data partners for specific information on the number of patients with celiac disease who had taken these drugs.  The resulting data report allowed FDA to determine that celiac disease did not occur significantly more often with patients who had taken olmesartan than with those who had taken other “sartan” drugs.

While the Sentinel System holds much promise, it is intended to supplement, not replace, FDA’s existing safety surveillance tools, including AERS, which relies on individual reports filed by manufacturers, health care providers and patients. When weighing risk against benefit of a medical product, FDA compiles information from a variety of sources before making a regulatory decision.

FDA is committed to maintaining the highest world-wide standards of safety surveillance capabilities. The Sentinel System  is our next step forward towards that goal.  Stay tuned. As always, we’ll keep you informed on progress.

CDR Melissa Robb is FDA’s Associate Director for Regulatory Affairs, Office of Medical Policy Initiatives