SANTA ROSA, Calif., April 1, 2014 (GLOBE NEWSWIRE) -- AdverseEvents, a healthcare informatics company, announced today at the Academy of Managed Care Pharmacy's (AMCP) Annual Conference in Tampa, Florida, the launch of AdverseEvents Explorer, a web based platform that includes the first and only real time scoring system that compares drugs' post-approval side effect risks (RxScore™), and an alerting tool that signals previously unidentified safety threats in advance of FDA regulatory action (RxSignal™).
AdverseEvents Explorer's launch furthers a paradigm shift in the healthcare industry, as the control of medical data moves away from the pharmaceutical companies and into the hands of the health insurers, health systems and hospitals that are best positioned to reduce health care costs and improve patient outcomes.
Side effects from FDA-approved drugs cause over $27B in avoidable costs to the healthcare system every year. To try to limit those side effects, the FDA collects and maintains a vast repository of adverse event data in its FDA Adverse Event Reporting System (FAERS). FAERS is a collection of over five million post-approval side effect case reports across all demographic groups. The FDA uses the database to monitor real world drug safety issues. Unfortunately, access to these data has been nonexistent for most managed care professionals. When data does become available, users are often stymied by FAERS' poorly formatted, incomplete, and oftentimes incorrect information.
The introduction and release of AdverseEvents Explorer as a decision support and formulary management tool provides payers and providers with easy to use, real time, and actionable drug safety information. AdverseEvents Explorer will lower costs and improve patient outcomes by making clean, reliable side effect data available and by pairing that information with proprietary analytic tools like RxScore and RxSignal to make the information actionable and predictable.
Starting today, the managed care industry will no longer need to rely solely on pharmaceutical companies, small and homogeneous pre-marketing clinical trials, or sporadic FDA regulatory actions for actionable drug safety information.
AdverseEvents Explorer Platform
As a web based software platform, AdverseEvents Explorer fits into the workflow of health insurers, health systems and hospitals by allowing for more efficient drug safety reviews and ensuring better prescribing decisions.
Similar to a FICO credit score, RxScore is the first drug safety scoring system that quickly summarizes comprehensive post-approval drug safety issues. An algorithmic scoring model based on over five million FAERS reports, RxScore provides a simple numerical indicator meant to reflect side effect risks linked to over 1,000 approved drugs. It enables intra- and inter-drug class comparisons to highlight broad and specific safety concerns, respectively.
RxScore is a simple numerical scale incorporating nine differentially weighted categories including key FAERS fields such as "Outcome," "Adverse Event Seriousness," and "Report Priority," as well as a disproportionality analysis (a statistical measure used by the FDA itself to help identify unexpected serious adverse events that were not previously recognized during a drug's pre-approval testing). The score is also negatively adjusted by factoring in both "Indication Seriousness" and a patient's existing comorbidities. The RxScore is presented as an easy to understand safety ranking.
RxSignal is a predictive algorithm that alerts users to emerging and/or previously unidentified side effect threats that may prompt a future FDA regulatory action (warnings, Black Box designations, product withdrawal or recalls, etc).
RxSignal's proven predictive power gives organizations the ability to make prescribing decisions that can dramatically lower overall costs and reduce adverse patient outcomes.
RxSignal applies a refined version of disproportionality analysis (DA) to FAERS case reports. DA is a statistical measure used by the FDA itself to help identify unexpected serious adverse events that were not previously recognized during a drug's pre-approval testing. RxSignal compensates for the known shortcoming of DA -- that it is typically calculated for a single drug and adverse event pair. There are more than 30 million drug-adverse event pairs in the FAERS database and most of these are not serious, previously known, or of little concern. RxSignal has overcome this shortcoming by analyzing hundreds of prominent FDA alerts from the past 12 years and demarcating key adverse events to be classified as being of significant interest to the FDA. RxSignal calculates DAs associated with these adverse events in order to predict if a given drug is likely to become the subject of an FDA action.
The AdverseEvents Explorer platform delivers accessible, actionable, and real-time FAERS data, providing the entire health care industry with a comprehensive view of post-marketing safety risks associated with FDA-approved drugs.
About Adverse Events, Inc.
AdverseEvents, Inc. (AEI) is a California-based healthcare informatics company that improves patient safety and reduces systemic healthcare costs through the comprehensive analysis of post-marketing drug side effect data. Utilizing data-mining and analysis technology, through its proprietary RxSuite™ of analytics, AEI makes post-marketing drug safety data accessible, actionable, and predictable.
In addition to managed care organizations, AEI also provides services to enterprise markets including the pharmaceutical industry and financial institutions.
Media Contact: Brian Overstreet AdverseEvents, Inc. 707-387-9230 x500