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iGuard Transforms Drug Safety Alert and Update Process
Date:10/4/2007

First service to provide patients & physicians with immediate, personalized

safety information

RESEARCH TRIANGLE PARK, N.C., Oct. 4 /PRNewswire/ -- Today hundreds of millions of Americans who regularly take prescription medicines have a new tool giving them access to the most current information about the risk profile of their medications through iGuard, a wholly-owned subsidiary of Quintiles Transnational Corp.

(Photo: http://www.newscom.com/cgi-bin/prnh/20071004/CLTH002 )

Reinventing the way that drug safety information is communicated, iGuard is the nation's only patient-driven program that provides timely, accurate and personalized drug safety information for patients and their physicians.

iGuard enables consumers to take an active role in managing their health through this free online service. To receive personalized alerts, patients enroll online at http://www.iguard.org and follow a simple series of steps to become part of a membership network. Patients create a secure personalized iGuard profile that includes questions about their demographics, medications, medical history, and conditions that could impact their drug safety risks.

Following completion of their profile, they are immediately sent personalized risk ratings about the medications they take, including interactions between drugs. In addition, when an issue with a drug arises, such as side-effect warnings, warnings from the manufacturer or a medical journal, or changes in the prescription label, iGuard will send a drug safety alert to patients and the physician or physicians they designated in their profile.

iGuard members will be asked to update their profile on a quarterly basis. Should a serious adverse event be suspected, iGuard will send a MedWatch form to the patient. Patients are instructed to give the form to their physician for completion. MedWatch is the U.S. Food and Drug Administration's safety information and adverse event reporting program. Physicians who suspect a serious adverse event associated with a drug has occurred submit the forms to the FDA. Because the data are ultimately reported to MedWatch by the patient's physician, iGuard is a patient-driven, physician-reported system.

Reports of adverse reactions to drugs increasing

The number of serious side effects and deaths reported to the FDA has more than doubled over an eight-year period, according to report recently published in the Archives of Internal Medicine (Vol. 167 No. 16, September 10, 2007). This, and the resulting media coverage, has heightened physician and patient awareness about the need for more immediate, accurate drug safety information.

People need immediate information

"iGuard puts the power of drug safety in the hands of each American, right where it should be," says Dr. Hugo Stephenson, iGuard's founder and president. "Consumers don't want to be drug experts -- they want a signal, an alarm, if something goes wrong. iGuard is the smoke detector for patients. It's always working in the background collecting data that can be used to identify safety signals, providing researchers access to the de-identified iGuard database, and communicating research findings back to patients based on the medications they are taking."

Stephenson, a medical doctor with a particular interest in epidemiology and risk management, works closely with patients, academics/government, pharmacists, physicians and the industry to advance drug safety in the US. An early pioneer in medical decision support, he is an internationally renowned expert on drug safety research, having previously led Quintiles' post- marketing and safety services division prior to starting iGuard.

Alerting millions of Americans at heightened risk

People taking multiple medications daily are at greater risk for dangerous drug interactions that may cause serious and even life threatening side effects. Millions of people are in this category and senior citizens are especially vulnerable to this phenomenon. iGuard provides a risk rating system to help people learn about drug interactions and other dangerous effects.

Dr. Judith Jones, MD., Ph.D., President and CEO of the Degge Group, Ltd., a drug safety research company, says, "Drug safety is front and center on the public health radar screen, and iGuard provides a unique, patient-centered solution in real-time."

About iGuard

iGuard is a wholly owned subsidiary of Quintiles Transnational Corp. and is the fastest and easiest way for patients to get information and safety updates on the drugs they are taking. This drug safety monitoring program facilitates bi-directional exchange of timely and relevant information, enabling patients to take an active role in managing their health. iGuard maintains an efficient communication channel where patients and health professionals can monitor, evaluate and share information about drug risks and benefits. Registration is free online at http://www.iguard.org.

About Quintiles

Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialization for the biotechnology and healthcare industries. With 19,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit the company's Web site at http://www.qtrn.com. Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Hugo Stephenson http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=67978


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