FDA Expands EHR Data Analytics with Active Surveillance System | EHR and Health IT Consulting | Scoop.it

The Food and Drug Administration’s Sentinel Initiative, one of the first active surveillance infrastructures focused on identifying patient safety issues related to pharmaceuticals and other medical products, will expand past its pilot phase this year, announced Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research in a blog post.  As a planned continuation of the Mini-Sentinel project, the full-scale system will allow the FDA to leverage advanced EHR data analytics by scanning millions of files for adverse events linked to drugs that fall under the Administration’s purview.

“Over the past five years, the Mini-Sentinel pilot program has established secure access to the electronic healthcare data of more than 178 million patients across the country, enabling researchers to evaluate a great deal of valuable safety information,” Woodcock writes. “While protecting the identity of individual patients we can get valuable information from Mini-Sentinel that helps us better understand potential safety issues, and share with you information on how to use medicines safely. We have used Mini-Sentinel to explore many safety issues, helping FDA enhance our safety surveillance capabilities, and giving us valuable input in decision-making on drugs and vaccines.”

The Sentinel Initiative differs from previous drug safety monitoring efforts in that it allows FDA researchers to actively dive into EHR data and insurance claims to analyze potential adverse events and establish links to specific pharmaceutical products.  This allows the FDA to work more quickly to identify problems than if they continued to rely on voluntary reporting alone.  Mini-Sentinel has previously confirmed the safety of two vaccines intended to protect infants against rotavirus after the voluntary recall of a third product that raised the risk of intussusception in patients who received the immunization.

The expansion of the project will build upon successful use cases from Mini-Sentinel, Woodcock says.  The FDA will refine its EHR data analytics methodologies as it continues to grow into what the Administration hopes will be a national resource at the center of an industry-wide collaboration between researchers, pharmaceutical developers, and other healthcare stakeholders.

The success of this vision relies on cooperation from academic and research partners, all of whom will need to further develop industry data standards for the system to function effectively.  “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,” Woodcock wrote in a previous blog post touting the success of the pilot system.  “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.”

“From the outset, the goals of the Sentinel Initiative have been large and of ground-breaking scale,” she concludes. “We knew it would be years in the making, but Mini-Sentinel’s successful completion marks important progress. We look forward to continuing and expanding our active surveillance capabilities as we now transition to the full-scale Sentinel program.”