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FDA Unveils Drug Database To The Public

Jun 9, 2014

The U.S. Food and Drug Administration (FDA) is releasing searchable data concerning prescription drugs. The publicly available searchable sets of data are part of the federal regulator’s so-called “OpenFDA” initiative.

OpenFDA, which is Cloud-based, is in its pilot stage, according to The Washington Post, and provides information on millions of adverse events involving drugs, including serious side effects, errors in product use, and quality problems that were reported to the agency between 2004 and 2013.

“Using this data, a mobile developer could create a search app for a smart phone, for example, [that] a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug,” Taha A. Kass-Hout, the FDA’s chief health informatics officer, wrote in a blog, The Washington Post reported. The agency intends on also including product recall data and pointed out that the information will not be able to be used to identify individuals.

According to HealthCare IT News, the thinking behind the app version of OpenFDA Search is to enable easy access to adverse event reports for health care providers and patients. In fact, this is one of the first apps to pull together FDA data and reports.

The app, created by Social Health Insights, enables users to enter search criteria, such as a date range for when an adverse drug event was reported, “patient age, country, manufacturer, medication brand name, reaction, pharmacologic class, drug indication, and product NDC,” according to Social Health Insights, wrote HealthCare IT News. Users may also choose from that list and click on a “Show Me the Data” button. The app then looks at 3.6 million adverse event reports to search for the requested information.

Social Health Insights noted that, if a user is searching for a particular brand, such as Tylenol, the app will return 468 reports. Adding the word “renal” to the search narrows the list to 18. When a patient or physician user knows the specific drug name, indication, and reaction, the OpenFDA search is simplified and easily enables the user to see if anyone else had a similar experience, which is the goal that FDA’s Kass-Hout, MD, is hoping for, according to HealthCare IT News.

Social Health Insights CTO and Co-Founder Mark Silverberg said OpenFDA is "the first search interface for the newly released API." OpenFDA Search Co-founder, Brian Norris, said the current iteration is a beta version and there may be bugs. He urges testers to contact them if they run into problems. Norris said that, for now, the project is a donation for “the betterment of humanity” and that a commercialization strategy has not yet been developed. "Our business model is building custom software and offering open data services to organizations wanting to get their data out there successfully," he said. "We see a lot of value in open data like the OpenFDA Adverse Events API, and I am sure we might find ways to commercialize in the future, but for now, we are happy to provide the community a simple way to search and graphically see the data,” he added, according to HealthCare IT News. "We also hope through small innovations like this we find great partners who share our innovation mission and can find new ways to leverage data sets like this one."

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