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April 18, 2000 - Midwest Heart Specialists Electronically Slashes Drug-recall Response Time

DuPage County
Elmhurst
Naperville
Winfield
Downers Grove

Midwest Heart Specialists Electronically Slashes Drug-recall Response Time
Timely warning puts at-risk patient in the right place at the right time


April 18, 2000
Robert Fraser, 70, still shakes his head at the unusual sequence of events he credits for saving his life.

It's ironic, he says, that a Food and Drug Administration announcement withdrawing the diabetes drug, Rezulin*, from the market because of a risk of liver damage, prompted a phone call from his cardiologist's office. The caller from Midwest Heart Specialists explained that a computer search of the group's electronic medical records had red-flagged his chart because Rezulin was listed as one of his prescription medications. After reassuring him that the recall had nothing to do with the drugs he takes to manage his chronic heart failure, Fraser was asked to contact his primary care physician as soon as possible to discuss his diabetes treatment.

Fraser made an appointment for 1:30 that afternoon with his internist, David Kraman, M.D., Elmhurst. During the office visit, Fraser said that although he had experienced periods of mild-to-moderate chest pain for about two weeks, he shrugged them off, because rest brought relief. Dr. Kraman immediately sent him to Elmhurst Memorial Hospital for an emergency stent-angioplasty performed by Midwest Heart Specialists cardiologist Lawrence Barr, M.D.

"Now the angina is gone, and I feel like a new man," enthuses Fraser. "Luckily Midwest Heart Specialists called me, because otherwise I wouldn't have been in Dr. Kraman's office that day."

Phone calls were also made to nearly 300 other Midwest Heart Specialists patients on Rezulin, and follow-up letters were sent to their primary care physicians. Although the domino effect of the call to Fraser is unlikely to ever again be repeated, his story underscores a technological capability unmatched by any other physician group in the area.

Midwest Heart Specialists pioneered the use of wireless computing in a clinical setting, an initiative that brought national recognition by the Smithsonian Institution last year. Physicians carry wireless hand-held computers to record their patients' health history, which is stored in a confidentiality-protected database that can readily retrieve patient-sensitive information. So, just as in the case of the Rezulin recall, if another drug or treatment is found to have adverse side effects, the group's electronic medical record system can electronically sift through thousands of medical records at digital speed, and within minutes, identify the names of patient potentially at risk. A similar search through traditional paper charts could easily take days and even weeks.

"It's not even feasible; most primary care physicians do not have the time or personnel to do a manual search," says Dr. Kraman. "We tend to rely on TV, radio and newspaper reports to alert patients to drug recalls and warnings. Having Midwest Heart Specialists offer this service to their patients is tremendously valuable."

Rezulin was one of two drug recalls in as many months. In February, the U.S. Food and Drug Administration warned physicians that the nighttime heartburn drug, Propulsid**, may cause fatal heart rhythms. Midwest Heart Specialists identified 283 patients with prescriptions for the drug, and notified them and their physicians of the danger in a single day.

Midwest Heart Specialists is a physician practice of 33 board-certified cardiovascular specialists with four clinical offices in Naperville, Winfield, Downers Grove and Elmhurst, and four satellite offices in Yorkville, Bolingbrook, Sycamore and Sandwich.

*Rezulin (troglitazone) went on the market in 1997, and was widely used to treat type 2, or adult onset, diabetes. It works by restoring the body's sensitively to the insulin, a hormone needed to process sugar in the blood. The drug was taken off the market in March, after the FDA reported there were at least 61 patient deaths due to liver failure associated with its use.

**Propulsid (cisapride) is used to treat heartburn for acid reflux disease, a condition caused by a backflow of stomach acid into the esophagus. The drug hastens the movement of liquid and solid food through the digestive tract, reducing the likelihood of heartburn. The FDA warns that people with certain disorders-such as congestive heart failure, chronic obstructive pulmonary disease, advanced cancer and electrolyte problems-should not take the drug. Propulsid may cause serious interactions with other medications, including certain antibiotics, antidepressants, antifungals and protease inhibitors.