Welcome!

News Feed Item

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 http://www.fdbhealth.com 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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, discussed how they built...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Mobile device usage has increased exponentially during the past several years, as consumers rely on handhelds for everything from news and weather to banking and purchases. What can we expect in the next few years? The way in which we interact with our devices will fundamentally change, as businesses leverage Artificial Intelligence. We already see this taking shape as businesses leverage AI for cost savings and customer responsiveness. This trend will continue, as AI is used for more sophistica...
The “Digital Era” is forcing us to engage with new methods to build, operate and maintain applications. This transformation also implies an evolution to more and more intelligent applications to better engage with the customers, while creating significant market differentiators. In both cases, the cloud has become a key enabler to embrace this digital revolution. So, moving to the cloud is no longer the question; the new questions are HOW and WHEN. To make this equation even more complex, most ...
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, provided a fun and simple way to introduce Machine Leaning to anyone and everyone. He solved a machine learning problem and demonstrated an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intelligence and B...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
The past few years have brought a sea change in the way applications are architected, developed, and consumed—increasing both the complexity of testing and the business impact of software failures. How can software testing professionals keep pace with modern application delivery, given the trends that impact both architectures (cloud, microservices, and APIs) and processes (DevOps, agile, and continuous delivery)? This is where continuous testing comes in. D
SYS-CON Events announced today that Synametrics Technologies will exhibit at SYS-CON's 22nd International Cloud Expo®, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Synametrics Technologies is a privately held company based in Plainsboro, New Jersey that has been providing solutions for the developer community since 1997. Based on the success of its initial product offerings such as WinSQL, Xeams, SynaMan and Syncrify, Synametrics continues to create and hone in...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, examined the regulations and provided insight on how it affects technology, challenges the established rules and will usher in new levels of diligence arou...
Nordstrom is transforming the way that they do business and the cloud is the key to enabling speed and hyper personalized customer experiences. In his session at 21st Cloud Expo, Ken Schow, VP of Engineering at Nordstrom, discussed some of the key learnings and common pitfalls of large enterprises moving to the cloud. This includes strategies around choosing a cloud provider(s), architecture, and lessons learned. In addition, he covered some of the best practices for structured team migration an...
As you move to the cloud, your network should be efficient, secure, and easy to manage. An enterprise adopting a hybrid or public cloud needs systems and tools that provide: Agility: ability to deliver applications and services faster, even in complex hybrid environments Easier manageability: enable reliable connectivity with complete oversight as the data center network evolves Greater efficiency: eliminate wasted effort while reducing errors and optimize asset utilization Security: imple...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
The 22nd International Cloud Expo | 1st DXWorld Expo has announced that its Call for Papers is open. Cloud Expo | DXWorld Expo, to be held June 5-7, 2018, at the Javits Center in New York, NY, brings together Cloud Computing, Digital Transformation, Big Data, Internet of Things, DevOps, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...