Sunday, April 27, 2008

RADAR Detects Adverse Events

According to Charles Bennett MD, PhD, Buehler Professor of Geriatrics and Economics at the Feinberg School of Medicine at Northwestern University, the RADAR project has helped healthcare professionals and patients find knowledge to avoid potentially adverse drug and device events. He explained how effectively and thoroughly the “Research on Adverse Drug Events and Reports (RADAR) project is able to detect adverse reactions. His comments were made at the “Consumer Connectivity—Social Networking and Health Searches” session held at April’s 5th Annual World Health Care Congress in Washington D.C.

RADAR a monitoring program and project was developed at Northwestern University. RADAR has proven to be very valuable in identifying serious and often-fatal drug reactions. Adverse drug and device reactions account for as many as 100,000 deaths annually, In general, more than half of the most serious adverse drug reactions have been discovered seven or more years after a drug has been marketed.

Dr. Bennett said “In one case, a patient at Northwestern Memorial Hospital had a potentially fatal toxicity termed TTP. The patient’s life was saved with plasmapheresis (dialysis of the blood). Additional investigation indicated that the patient had received 14 days of the anti-platelet agent ticlopidine. Questions were posed as to whether it was possible that this commonly used drug could occasionally result in potentially fatal drug toxicity.

This is where querying the social network proved to be invaluable. The first step was to contact Directors of Centers providing therapeutic plasma exchange services. Next, a list of all therapeutic plasma exchange centers was obtained from the supplier of the equipment used in this procedure.

From there, medical directors were queried on whether they had seen patients with an almost fatal drug reaction. Surprisingly, almost every medical director had seen such a case. In total, 60 cases of TTP following ticlopidine administration were identified but unfortunately, 20 of these patients had died. The end result was that a safety report was prepared and the drug was basically removed from the market.

RADAR is performing a number of valuable social networking services in the internet age. In another situation, RADAR raised concern that some patients were allergic to polymers that coat drug eluting stents placed in coronary arteries. An allergic reaction to the polymers can be potentially fatal.

The background on this situation was placed on www.angioplasty.org. Interested patients responded and expressed interest in the need to evaluate this concern. In doing further investigation, patients had to undergo a formal evaluation for the possibility of an allergic reaction. Patients that had adverse drug reactions reported this information to the RADAR project. This was followed up with more investigation and the information was fed back not only to the patient but also to relevant safety officials.

Dr. Bennett stressed that all in all, RADAR has proved to be a powerful new instrument that supplements existing FDA surveillance systems and has helped save hundreds to thousands of patient lives

For information on the World Health Care Congress, go to www.worldcongress.com.