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FDB Adds Boxed Warning Content to Help Ensure Patient Safety and Regulatory Compliance with High Risk Medications

First Databank (FDB), the leading provider of clinical drug knowledge that improves medication-related decisions and patient outcomes, today announced that Boxed Warning content has now been added to the FDB High Risk Medication Module™. The new drug knowledge enables FDB customers and other industry stakeholders to easily identify medications designated as high risk by the Food and Drug Administration (FDA) and have a Boxed Warning and/or a Risk Evaluation and Mitigation Strategy (REMS) requirement. The module’s initial release, in July 2013, covered medications with REMS requirements. Now, with the inclusion of medications with boxed warnings, the module covers a broader spectrum of high risk medications.

Boxed warnings—the FDA’s strongest warning for medicines that carry risks of special problems —serve as notices to prescribers, pharmacists and consumers about possible adverse effects of high risk medications. The FDA has put requirements in place to help ensure the safe use of high risk drugs with the use of boxed warnings and/or REMS, which are critical guidelines for clinicians and institutions that treat patients with these medications. Although high risk medications with boxed warnings are regularly prescribed, studies have shown that these requirements are not routinely followed by clinicians because the information does not appear within their normal EHR workflow.

To address this potential patient safety issue, the FDB High Risk Medication Module is designed to seamlessly integrate with healthcare information systems to provide current boxed warning and REMS information of high risk prescription drugs directly with the clinician’s workflow. The module helps clinicians meet FDA regulatory compliance by presenting actionable messages to the right user at the right time, while eliminating the manual and often tedious efforts required in monitoring drug manufacturers’ changes to boxed warnings and REMS. Additionally, FDB keeps track of when changes are made to the requirements and maintains historical information to support retrospective analysis or auditing.

Faced with increasing numbers of high risk medications with a boxed warning, the complexity of REMS requirements and penalties for non-compliance, health care providers need easy-to-use workflow solutions. Omnicare, a comprehensive provider of pharmacy and related services to elder care and other specialized health care settings across the United States, is one of many FDB customers whose users and their patients are directly impacted by the regulatory burden and complexity clinician’s face with prescribing, dispensing and administering high risk drugs.

According to Barbara J. Zarowitz, PharmD, vice president of clinical services, Omnicare, their clinicians are concerned with identifying, monitoring and prescribing the increasing numbers of high risk medications in use today that have important medical practice implications for patient safety. In addition, satisfying the constantly changing regulatory requirements is even more challenging outside the EHR workflow. Speaking at a recent FDB Customer Conference, Zarowitz commented that, “The provision of actionable information in the EHR workflow for drugs with boxed warnings is absolutely necessary for clinicians to maximize safe use of medications in our patients.”

“Our vision is to ensure that all medication warnings and required actions—from Boxed Warnings, to REMS requirements and associated Medication Guides—are easily accessible from one convenient source, to ease the burden the healthcare industry currently faces when working to comply with high risk medication guidelines,” said Lisa Geller, senior product manager, FDB.

About First Databank (FDB)

FDB (First Databank), part of the Hearst Health network, is the leading provider of drug knowledge that helps healthcare professionals make precise medication-related decisions. With thousands of customers worldwide, FDB enables our information system developer partners to deliver a wide range of valuable, useful, and differentiated solutions. As the company that virtually launched the medication decision support category, we offer more than three decades of experience in transforming drug knowledge into actionable, targeted, and effective solutions that improve patient safety and healthcare outcomes. For a complete look at our solutions and services please visit or follow us on Twitter and LinkedIn.

About Hearst Health

FDB is part of the Hearst Health network, which also includes Zynx Health, MCG (formerly Milliman Care Guidelines) and Homecare Homebase. The mission of the Hearst Health network is to help guide the most important care moments by delivering vital information into the hands of everyone who touches a person’s health journey. Each year in the U.S., care guidance from the Hearst Health network reaches 76% of discharged patients, 133 million insured individuals, 20 million home health visits, 1.88 billion retail pharmacy prescriptions and 3.26 billion prescription claims. Extensions of the Hearst Health network include Hearst Health Ventures and the Hearst Health Innovation Lab.

© 2014 First Databank, Inc. Part of the Hearst Health network. All trademarks mentioned herein are the properties of their respective owners.

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