High Risk Medication Module Helps Ensure Patient and Medication Safety

First Databank (FDB), a leading provider of clinical drug knowledge that improves medication-related decisions and patient outcomes, has released 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 Risk Evaluation and Mitigation Strategy (REMS) requirement.

High risk medications can have serious life-threatening adverse effects but are approved by the FDA because the benefits of the drugs outweigh the risks for a specific condition. 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.

Recognizing the complexity the industry faces in complying with REMS, the FDA is holding a two-day meeting on July 25-26 where stakeholders will describe issues and challenges associated with standardizing REMS requirements. One key opportunity being addressed at the meeting is how health information technologies such as electronic health records, pharmacy management systems and electronic prescribing systems could be used to integrate REMS into the health care delivery system. The FDB High Risk Medication Module is designed specifically to be used within these electronic healthcare systems.

REMS can be lengthy, often change and are typically outside of the clinicians’ workflow, making it difficult for institutions to ensure users comply with REMS requirements. The FDB solution provides actionable messages written specifically for the type of user directly at the point of time they need it (such as the physician at prescribing versus the pharmacist at dispensing). Seeing only the action items most relevant to them, these targeted instructions reduce message overload so that users know exactly what they need to do to comply with REMS requirements.

The FDB High Risk Medication Module also eliminates the manual and often tedious effort required to monitor REMS changes from drug manufacturers. Additionally, FDB keeps track of when changes are made to the requirements and maintains historical REMS information to support retrospective analysis or auditing.

“Faced with increasingly complex REMS requirements and penalties for non-compliance, health care providers need easy-to-use workflow solutions,” said Lisa Geller, MBA, senior product manager, FDB. “Our vision is to ensure that all medication warnings and required actions—from Boxed Warnings, to REMS requirements and associated Medications 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,” continued Geller.