Health IT plays key role in enhancing drug safety measures

The adoption of electronic health records and other telehealth systems has significantly enhanced drug prescription processes. They have taken the health care industry a long way since its paper documentation days when medical errors were more common, causing miscommunications between pharmacies and physicians. This is why drug safety surveillance is so important in ensuring quality patient outcomes and the reduction of medical errors. The Federal Food and Drug Administration has committed itself to enhancing drug safety surveillance for patients throughout the country. 

FDA starts new funding program for safety surveillance
A drug safety surveillance funding program was announced by the FDA in April in which the Center for Drug Evaluation and Research will participate. The grant funding will go toward initiatives that focus on improving drug safety surveillance within EHR systems and additional health care technologies. The project will take place over the course of the year with $1 million available to ensure that it is conducted properly. Physicians are able to volunteer to participate in the program and receive funding. To apply, providers must submit their applications by June 15, 2015.

The goal of the program is to allow the FDA to more accurately monitor how previously FDA-approved medications are impacting health outcomes after they are marketed. To do this, the funding program will measure and identify whether these drugs have been effective for patients. The project is set to begin on July 15, 2015. 

Sentinel Initiative set to enhance drug safety
Another major goal for the FDA is to create a health IT system that monitors the safety of drugs and important medical products following marketing. The Sentinel Initiative is a national system that will work effectively with existing technological platforms while tracking medical devices and medication.

The new system will enable FDA officials to establish new safety measures and medical products that have been approved by the FDA before the marketing process. The Sentinel system can be implemented through EHR databases, public health registries and insurance claims platforms, complementing the previously established system. To make sure that patient health information is not at risk, security and privacy safeguards are implemented in the system.

The FDA has begun a pilot, the Mini-Sentinel Pilot, to allow officials to check on the prescribed medications and safety and medical devices through a database containing over 150 million patient EHR charts. A total of 17 partners worked together to create the pilot. Throughout the initiative, the FDA will work to develop new analytic methods for sorting through EHR data.

FDA chooses Harvard Pilgrim to monitor new system
The pilot for the new Sentinel system enables researchers to get feedback from the FDA in weeks, while previous drug safety surveillance initiatives generally took months. To manage the Sentinel Initiative, the Harvard Pilgrim Health Care Institute received $150 million from the FDA on Oct. 1, 2014. The company's press release noted that the institute will work with over 50 academic and medical associations across the globe to successfully monitor the system.

"The FDA is pleased to see the pilot for the agency's Sentinel system, dubbed Mini-Sentinel, begin its transition to a full-fledged program," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in the release. "The Sentinel System will play an integral role in expanding the resources we have to track and understand important information about the drugs used by patients throughout the United States."

Richard Platt, M.D., M.S., professor and chair of the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute, spoke on behalf of Harvard Pilgrim to express the organization's pride in being chosen to manage the next stage of the Sentinel Initiative.