Personalized Patient-driven Drug Safety Monitoring Program

Reading time: 3 – 5 minutes

iGuard is one of the first web-based services that allows you to get free personalized safety alerts and updates about your medications. The company claims that [1]:

… patients can feel safer because they will be sent the drug safety information they need, when they need it.

After enrollment, patients who regularly take medications can choose to receive patient-specific updates regarding the safety of their medications. Participants in iGuard will receive these updates whenever new information is learned about their medicines, allowing them to make the most informed decisions about their healthcare.

In 2006, the Institute of Medicine released a report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public”, which advised expansion of the Food and Drug Association’s (FDA) authority to require postmarketing surveillance of approved drugs [2]. The report found that the drug safety system in the U.S. is impaired by a number of factors, including:

• Serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety.
• An organizational culture in the Center for Drug Evaluation and Research (CDER) that is not optimally functional.
• Unclear and insufficient regulatory authorities particularly with respect to enforcement.
• FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.

Most drug approvals are based on clinical trials involving a few hundred or a few thousand patients, but many uncommon side effects don’t emerge until a drug is being used by millions of people. iGuard automatically distributes information information received from the FDA and from drug manufacturers as alerts to patients. In addition, they have a clinical review team that evaluates other sources, including journals, academics and private researchers, which may also warrant an alert to patients. With iGuard, patients and physicians will have access to the most current information available associated with individual medications.

Drug safety is an important issue. Indeed, a study recently published in the Archives of Internal Medicine analyzing all serious adverse drug events and medication errors in the U.S. reported to the FDA from 1998-2005 found that there was a marked increase in reported deaths and serious injuries associated with drug therapy over the study period [3].

An online webcast is scheduled for this Thursday, October 4th at 2:00 PM EST. The webcast will be presented by Hugo Stephenson, M.D., B.Sc. and Judith Jones, M.D., Ph.D. and will provide information on what iGuard is and how it works. They will explain how simple it can now be for anyone and everyone to better assess the level of risks associated with the drugs they are taking or prescribing. Listeners will be able to ask any questions live via email and have them answered by Dr. Stephenson and Dr. Jones during the webcast.

I believe iGuard is a valuable initiative with great potential. It’s an important resource for e-Patients and one that can help you manage your own healthcare in partnership with your doctor. I encourage you to listen in this Thursday, October 4th and see if iGuard can help you.

References

1. The iGuard Vision. http://www.iguard.org/help/about/.
2. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Institute of Medicine of the National Academies. 2006 Sep 22.
3. Moore et al. Serious adverse drug events reported to the food and drug administration, 1998-2005. Arch Intern Med. 2007 Sep 10;167(16):1752-9.
   View abstract