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
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
See storage differently! Storage performance problems have only gotten worse and harder to solve as applications have become largely virtualized and moved to a cloud-based infrastructure. Storage performance in a virtualized environment is not just about IOPS, it is about how well that potential performance is guaranteed to individual VMs for these apps as the number of VMs keep going up real time. In his session at 18th Cloud Expo, Dhiraj Sehgal, in product and marketing at Tintri, will discu...
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...