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SafeRx database enables large-scale study of prescription medication safety

  • Science Highlights

When you walk away from your doctor’s office with a prescription in hand, you may think your problem has been solved – but a new set of health issues may be just beginning.

“Prescription medicines actually have a propensity to harm the very people they’re supposed to help,” says Kyle Hultgren, the director of the Purdue College of Pharmacy’s Center for Medication Safety Advancement (CMSA), whose mission is “making safe medication use common practice.”

One of the best ways to make medications safer is to learn as much as possible about how many people are harmed each year, which drugs are causing harm, and what kinds of harm are being caused. The problem with this approach is that for a long time, there wasn’t a central repository for such information, and collecting it individually from every medical practice in the United States is, as Hultgren puts it, “a tedious task that borders on the impossible.”

That changed a few years ago, when the Food and Drug Administration publicly released all the myriad data it collects about adverse drug events, a term that includes harm due to errors by medical professionals as well as adverse reactions to a drug.

Hultgren and his colleague Dan Degnan, the senior project manager at the Purdue center, knew that analyzing this data could lead to huge improvements in medication safety, but first they needed a way to manage and make sense of it. The FDA’s raw data consists of tens of millions of individual data points and is not organized in a way that’s useful to researchers.

Enter ITaP Senior Research Scientist Ann Christine Catlin and her team. Catlin, who specializes in bringing data to research groups and helping them make science out of it, worked with the CMSA team to design a data repository, known as the SafeRx database, which could be used to effectively tackle their questions about medication safety.

The SafeRx database has enabled Hultgren, Degnan and their colleagues to study adverse drug events across an entire population, look for trends in the ways in which people are harmed by prescription drugs and, ultimately, figure out steps that can be taken to improve prescription medication safety. The CMSA team is using the database to investigate questions such as whether adverse effects reported by patients match up with the known side effects identified by the FDA.

Examining this volume of data is unprecedented in the health care industry. “People have become numb to the idea of big data, but many people don’t realize how relatively far behind health care is in terms of the sharing of information,” says Hultgren. “Being able to work together on this is something that is unique on a level not seen in health care yet.”

One thing that makes the SafeRx database useful is that it includes data from several different sources. In addition to the FDA data, SafeRx includes data from the National Drug Code Registry and the National Library of Medicine, as well as self-reported patient complaints from social media sites, which Hultgren, Degnan and their team are using to investigate whether medical professionals report medication errors at the same rate people experience them.

“We’re building an environment that brings in data from many different sources and merges it together, so you can ask questions that cover data from completely disparate sources,” says Catlin. “I see that as a really important step forward.”

SafeRx was built using HUBzero, Purdue’s web-based platform for scientific collaboration, as well as data technologies Catlin has built and made a standard part of the HUBzero hubs she works on. “The HUBzero platform is really great, because you automatically get collaboration and you automatically have a structure where you can put your databases and repositories and advance your system,” says Catlin.

In addition to research, the SafeRx database has already proven useful for education and outreach. A Purdue School of Nursing class recently used the database as a primary source for learning about adverse drug events.

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