US Adverse Drug Event Network

Introduction

Main Item

PDR Network and its partners today announced the launch of a new online network to collect and distribute adverse drug events in the United States.

The new service, called RxEvent, is now available to all U.S. prescriber's via integration into electronic health record ("EHR") platforms and other online services, including directly at www.RxEvent.org.

Roughly half a million adverse drug events are reported annually to the U.S. Food and Drug Administration ("FDA") and the number is growing rapidly according to data from the FDA. More than 90 percent of these reports come from pharmaceutical manufacturers who receive them initially from physicians and other providers, typically via telephone. Manufacturers then triage and attempt to investigate these reports, notifying the FDA when appropriate. Published studies indicate that as few as one in ten adverse drug events are actually reported by healthcare professionals largely due to the time-consuming and inefficient processes involved in reporting adverse drug events.

"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," explained Edward Fotsch, MD, CEO of PDR Network, the company providing the RxEvent service along with major EHR vendors and other partners. "RxEvent is part of the new suite of eCare Services that we are rolling out with content integrated into EHRs to increase drug and device efficacy and efficiency."

"Our network of physicians is growing rapidly and with it grows our ability to contribute to drug safety," stated Todd Rothenhaus, Chief Medical Information Officer, athenahealth, Inc. "RxEvent integrated into athenaClinicals® supports our mission of physician convenience and patient safety."

EHR use among physicians in the U.S. has grown dramatically and is approaching 50 percent, in part due to federal and industry subsidies to help cover the cost of these systems. Studies show that adverse drug event reporting integrated into EHRs increases the convenience, content and volume of adverse event reports. (1)

"Through our PrimeRESEARCH clinical trials network integrated within Greenway's PrimeSUITE® EHR, we know that providers are vigilant to adverse events and are seeking a streamlined reporting process," said Greenway® President and CEO Tee Green. "We are pleased to be working with PDR Network to further improve the efficiencies that enable our provider customers on the front lines to improve drug quality and patient safety through an EHR reporting system that will also advance our ability to enable innovative clinical trials procedures."

"Adverse drug event reporting is the tip of the spear in ensuring ongoing monitoring of prescription drugs. Drug safety requires a robust mechanism to identify, route, investigate and report adverse drug events," noted Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA. "Integration of adverse event reporting into EHR systems places this service at the prescriber's fingertips, adding to convenience and ultimately improved drug safety. We applaud PDR Network and their partners for their efforts."

Jim Naughton, MD, an internist and EHR user who practices in the San Francisco Bay Area has had early access to the RxEvent service. He commented, "We see adverse drug events in our practice and I have reported them at times in the past. But the process has been cumbersome and certainly inhibits reporting at times. RxEvent improves both EHRs and adverse event reporting by making reporting much more physician-friendly."

RxEvent will also be used by pharmacists who report tens of thousands of adverse events annually.

"Pharmacists are actively involved in promoting and monitoring safe medication use by their patients. By supporting RxEvent, we hope to facilitate enhanced reporting by pharmacists, who see tens of thousands of adverse drug events annually," said Thomas Menighan, executive vice president and CEO of the American Pharmacists Association (APhA). "Pharmacists represent a key contributor to drug safety and we are working closely with PDR, as well as pharmacists in all practice settings across the country, to ensure that RxEvent is immediately available to all U.S. pharmacists."

The RxEvent service integrated into EHRs provides quick and convenient access for physicians and has been designed to include pre-population of information as well as an improved mechanism for pharmaceutical manufacturers or the FDA to contact the reporting provider when additional information is required.

RxEvent and PDR Network's New eCare Services

PDR® eCare Services provides PDR's trusted and authoritative drug information and clinical content to prescriber's via their Electronic Health Records (EHR) and other digital platforms. Recent studies from industry and the federal government show that nearly 50 percent of physicians are now using EHR systems, and that government and industry incentives will cause that number to continue to grow rapidly. With PDR eCare Services, prescriber's are provided a broad suite of drug regulatory and marketing services including RxEvent, as well as FDA-approved labeling, Drug Alerts, REMS programs and CME, product support and medication adherence programs, all within their EHR. eCare delivers an efficient resource that empowers physicians to prescribe with all the drug information and support that they and their patients need. eCare with RxEvent offers the most comprehensive set of regulatory, safety and product support services available.

For more information on PDR Network programs and products, please visit www.pdrnetwork.com.

About Greenway Medical Technologies, Inc. -Greenway Medical Technologies provides innovative EHR, ambulatory healthcare and clinical research business solutions and services to more than 27,000 healthcare providers nationwide, in 31 specialties and sub-specialties, by enhancing the delivery of patient care through advanced health IT software and on-demand services that allow physician practices to function at their highest level of efficiency in group practice, IDN, REC, HIE, IPA, Accountable Care Organization (ACO) and Patient Centered Medical Home (PCMH) settings. Established in 1998, Carrollton, Ga.-based Greenway is a privately held company with more than 450 employees.

About the American Pharmacists Association -The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, is a 501 C6 organization, representing more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States.

About athenahealth -athenahealth, Inc. is the leading provider of cloud-based business services for physician practices. athenahealth's service offerings are based on proprietary web-native practice management and electronic health record (EHR) software, a continuously updated payer knowledge-base, integrated back-office service operations, and automated and live patient communication services. For more information, please visit www.athenahealth.com/ or call (888) 652-8200.

About PDR Network -PDR Network, LLC is the leading distributor of FDA-approved drug labeling information, product safety Alerts and REMS programs, including the Physicians' Desk Reference® ("PDR") - the most highly trusted drug information reference available, distributed to nearly 500,000 U.S. physicians and pharmacists and used by prescriber's over 70 million times a year. PDR Network provides innovative products and services to deliver industry-leading content across channels, including PDR.net®, mobilePDR®, PDR®3D and directly through electronic health record platforms.

PDR Network is the industry's #1 source of trusted and reliable drug information for prescriber's by pharmaceutical and device manufacturers, physicians and other healthcare professionals, the government and electronic health record developers. For more information, visit www.pdrnetwork.com

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