TORONTO, May 5 /PRNewswire/ -- Nearly half of all Americans take a prescription drug and one in six take three or more. The number of serious side effects and deaths reported to the U.S. Food and Drug Administration (FDA) has more than doubled over an eight-year period, according to recent reports.* This, coupled with the continuous stream of news about adverse drug events, has heightened physician and patient awareness about the need for better methods for communicating risks and alerts to patients and in a format that is easily understood.
The iGuard Risk Rating system presented today at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 13th Annual International Meeting held from May 3-17, 2008 in Toronto, Canada is helping to address this problem. The iGuard Risk Rating system is a (patent pending) process for summarizing the likelihood and severity of adverse events contained in each medication's prescribing information into a single rating. The iGuard Risk Ratings, from lowest to highest, are as follows: 1) Green: Low Risk - Suitable for widespread use; 2) Blue: General Risk - Use under normal care of a doctor; 3) Yellow: Guarded - Be on the lookout for safety events; 4) Orange: Elevated Risk - Create a personal risk reduction plan with your doctor; and 5) Red: High Risk - Requires careful consideration of risk versus benefit.
"Like the color code system developed for homeland security, the iGuard Risk Ratings summarize a patient's risk for developing serious side effects in a way that is easy to understand," said Elisa Cascade, co-author of the iGuard Risk Rating system. "Recognizing that many patients are taking multiple medications, the iGuard Risk Ratings are personalized to a patient's medication and health history so patients can be warned of potentially serious drug interactions and know which medications they need to be most diligent in monitoring."
Consumer feedback on the iGuard Risk Ratings has been very positive, especially for patients like Susan Wehrle of Merced California. "In my particular case, iGuard has proven extremely necessary because of the sheer volume of information I must track, and need to coordinate my multiple medications and numerous health conditions," said Susan. "At the present time, I'm diagnosed with 14 different medical conditions, and take a minimum of 17 different prescription medications daily, which doesn't even include my Chemotherapy drugs or any 'immediate need' [i.e., antibiotics, etc.] medications I might require. Without iGuard, it would be an insurmountable task, trying to track all the potential drug-drug interactions and safety precaution information on my own."
iGuard.org, headquartered in Princeton, NJ, is a free and secure source of information for registered users who want to get informed, stay informed and share feedback about their medications. It offers balance and timely content to help patients manage their healthcare for themselves or loved ones. Registration is free online at www.iguard.org .
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently. For more information: www.ispor.org , www.iguard.org
* US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. November 2006 DHHS Publication 2006-1232, p 28
Institute of Medicine (IOM). 2007. Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals, Workshop Summary. Washington DC: National Academies Press.