Drug safety experts call for increased patient involvement

Nov 27 2007

National drug safety experts, including representatives from the Center for Medicine in the Public Interest (CMPI) and the Critical Path Institute (CPI), will gather at the National Press Club and call for an improved approach to providing consumers with real time and individualized information about the risks and benefits of drugs on the market.

Raising issues and looking at solutions available to people today, the panel will investigate the role of patient-centric drug safety; the role of patients in managing their medicines; new efforts to reduce the risk associated with prescription drugs; and new tools available to patients and physicians that empower them to have current, personalized information.

With nearly half of all Americans taking a prescription drug and one in six taking three or more, the opportunity for improved health and safer, more effective prescribing is significant.

In addressing this growing problem, drug safety experts will urge people to take a more active role in understanding the risks and benefits of their medicines through real time updates -- something that headline news or research cannot provide today. Journalists and representatives from patient advocacy groups will have the opportunity to have dialogue with the experts on critical and timely issues.

First direct-to-patient medication recall a major milestone in patient safety

In a world-first for patient safety, iGuard.org -- a new, free medication safety information service--recently sent the first personalized electronic nationwide recall alert to patients who take gabapentin. The recall, voluntarily initiated by Ranbaxy Laboratories, affects more than 73 million tablets worldwide. More than 400 iGuard registrants take gabapentin and received the alerts.

"We are really proud to be part of this first patient-centric medication recall," said Dr. Hugo Stephenson, founder and president of iGuard. "Based on the overwhelmingly positive reaction we've had from patients and doctors, it's about time we started thinking about who needs this information the most.... patients!"

Mrs. J. Rogers, a recent registrant with iGuard, said, "I never would have heard about the [gabapentin] recall had it not come to me directly. I'm surprised and shocked that such a system wasn't in existence already."

Stephenson said, "For years we have taken for granted that we'll get personal recall notices for the cars we buy. Now the same opportunity is finally available for people that take medications."

iGuard provides patients with a simple way to check interactions between their medications and receive personalized alerts and recall notices as they occur. In its first month of operation, and still in its "beta" stage, iGuard has registered almost 7,000 users and is averaging between 250 and 500 new registrations per day.

Despite recent attempts to communicate drug safety questions earlier, agencies such as the FDA and manufacturers have been hampered in their ability to reach patients with safety communications. iGuard represents a simple way for patients to voluntarily register for alerts without compromising their privacy. iGuard receives information for its alerts from regulators such as the FDA, from manufacturers, and from major journals that it monitors for breaking research.

About CMPI

CMPI is a non-profit institution founded to promote advances in genomics and health information technology that make medicine more predictive, preventive and personalized. We do that through research, outreach and solutions focusing on how to use 21st century science to personalize medicine, improve wellbeing and extend life.

About iGuard

iGuard 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 The Critical Path Institute

Based in Tucson, Ariz., with offices in Rockville, Md., The Critical Path Institute (C-Path) was established in 2005 as an independent nonprofit research and education institute to serve as a "trusted third party" for collaborations among scientists from government, industry and academia. C-Path's vision is to help implement the FDA's Critical Path Initiative by developing faster, safer and smarter pathways to new medical products. For more information, visit http://www.c-path.org/.