FDA Calls for Physician Action in Reporting Adverse Drug Events

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Agency Taps Epocrates to Educate Clinicians on Importance and Ease of Reporting

Adverse drug events (ADEs) occur commonly in the healthcare system with more than 100,000 hospitalized patients experiencing fatal drug reactions, according to estimates. The U.S. Food and Drug Administration (FDA) is working with Epocrates, Inc. to raise awareness among clinicians of the importance and ease of reporting serious adverse events, errors and product quality problems. This is one of many current initiatives FDA and its MedWatch program is implementing to help more physicians and other healthcare professionals manage the risks of medical product use and reduce the potential for patient harm.

To help increase reporting, Epocrates targeted a DocAlert® message to the more than 500,000 clinicians who use the company's products with guidelines on how they can quickly and accurately report adverse drug events to the FDA. This mobile message highlights the simple, secure and confidential process to report an adverse event, such as side effects or quality concerns associated with FDA-regulated drugs, biologics, medical devices and dietary supplements or cosmetics.

"Physicians are on the frontline when it comes to patient care, and working with Epocrates helps us remind them of safety and error reporting directly at the point of patient contact," said Norman Marks, M.D., medical director of the FDA's MedWatch program. "We want physicians to understand that by taking a few minutes to submit a report, that action may be the necessary first step that triggers an evaluation and action by the FDA and ultimately reduces the risk of patient harm."

The government agency emphasizes that timely reporting helps to more effectively identify adverse events and potentially prevent errors from occurring in the future. Physicians are reminded that reporting is not an admission of fault, and the FDA has created a secure, confidential and HIPAA-compliant environment for sharing patient data and reports of serious events.

This instructional message on ADE reporting is a natural extension of the FDA MedWatch safety alerts that Epocrates' subscribers currently receive about drug recalls, new indications and safety protocols. Other agencies, including the CDC (Centers for Disease Control) and AHRQ (Agency for Healthcare Research and Quality), also share important medication safety updates and medical and practice management news that are delivered to the company's large clinician network. These brief and timely DocAlert messages are conveniently delivered directly to clinicians' mobile devices, such as Palm®, Windows Mobile® and BlackBerry® devices.

"This is a great opportunity for us to use our messaging capabilities to help raise awareness for the FDA's voluntary adverse event reporting process and provide valuable clinical news and updates to our subscribers," said Kirk Loevner, chief executive officer and chairman for Epocrates. "This initiative further supports Epocrates' long-standing mission to help increase patient safety and reduce medical errors."

For more information on reporting ADEs to the FDA, please visit http://www.fda.gov/medwatch.

Epocrates is a leading provider of clinical information and decision support tools to healthcare professionals. Epocrates currently has more than 500,000 active subscribers worldwide, including more than one in four U.S. physicians and more than one in three U.S. medical students. The company's subscription-based services enable healthcare professionals to make more informed medical decisions, reduce medical errors and practice more efficiently. For more information about Epocrates, please visit http://www.epocrates.com/company.

Erica Sniad Morgenstern
Epocrates Public Relations
(650) 227-6907
pr @ epocrates.com

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