Pharmaceutical Industry Launches Shared Digital Oversight Platform

By Mike Rozembajgier

A private pharmaceutical industry information company recently introduced a new database network for reporting and collecting information on adverse events resulting from prescription drug use. The database, RxEvent.org, was launched last week by PDR Network, a leading distributor of drug labeling information and the publisher of the Physicians’ Desk Reference. RxEvent is likely to have a significant impact on the Food and Drug Administration’s (FDA) oversight of the industry and the recall management process for pharmaceutical products. If it is adopted by key industry groups, the new network will enable regulators to raise a red flag on products that might be unsafe for consumers and even trigger a recall.

The FDA currently manages an Adverse Event Reporting System designed to support the agency’s post-marketing oversight of approved pharmaceutical product. But reporting on adverse events by health care providers is voluntary, and the process is time-consuming and inefficient, account ting for only about ten percent of adverse events. RxEvent aims to bridge that gap by giving prescribers the ability to quickly file reports on adverse events and getting information to manufacturers and integrating it into hundreds of other electronic databases that are easily accessible by healthcare professionals across the country.

This new online resource will give physicians and other health care providers better access to possible trends and critical information about the drugs they prescribe. In a press release detailing the websites launch, Edward Fotsch, MD, CEO of PDR Network, explained that “RxEvent was designed to improve the convenience of adverse event reporting for physicians, the cost-efficiency for manufacturers and the quality of information ultimately reported to the FDA.”

Even in its early stages, this new resource is already getting industry-wide support. A statement issued by Thomas Menighan, executive vice president of the American Pharmacists Association, notes that “by supporting RxEvent, we hope to facilitate enhanced reporting by pharmacists, who see tens of thousands of adverse drug events annually.”

All information collected on RxEvent will also be made available through various electronic health record (EHR) platforms and through other online services. A recent Healthcare IT News article about the launch of the database reports that, “EHR use among physicians in the U.S. has grown dramatically and is approaching 50 percent.” The article goes on to say that several studies have shown that EHR’s increase the convenience, content and volume of adverse event reports. With increasing buy-in from healthcare professionals, we can expect RxEvent to be successful in monitoring the effectiveness and safety of pharmaceutical products.

The increased use of digital platforms for collecting and relaying information about consumer products is especially useful in the pharmaceutical industry, where individual reactions to a drug could provide crucial information on its use and viability. RxEvent could lead to greater industry self-policing and oversight. Companies involved in pharmaceutical drug production and distribution should keep a close watch on these digital resources in order to stay a step ahead and be ready to efficiently manage a recall.

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