If warfarin does not remain at the proper level in the bloodstream, patients might develop blood clots or internal bleeding, either of which can lead to death. For some patients, especially those who have atrial fibrillation or mechanical heart valves, long-term maintenance on warfarin is essential.
Traditionally, these patients have gone to their physicians' offices or to anti-coagulation clinics to be tested. But because it might be difficult for them to get to these clinics, many aren't tested as often as they should be. In recent years, patient self-testing (PST) has become accepted as a better way to ensure that those on warfarin receive the care they need in a timely manner.
A disease management company called Alere operates a service that trains and supports warfarin users who test themselves. Alere alerts physicians when the data from these patients indicates that the blood thinner has moved out of the target range for a positive therapeutic effect. Depending on a physician's preference, the company will provide either just these alerts or all of the data that a patient gathers from a monitoring device and testing strips.
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Although studies have shown that patient self-testing can produce better outcomes than testing in an anticoagulation clinic, errors can still occur because of a relative lack of automation in the process. So Alere is developing a new application that will fully automate the monitoring of warfarin patients, said Gary Liska, global director, clinical development and education, for the Waltham, Mass.-based firm, in an interview with InformationWeek Healthcare. The company is finalizing studies of this application and hopes to submit an application for approval by the U.S. Food and Drug Administration (FDA) in the near future.
Today, patients either call an 800 number or use a Web portal to send their self-testing data to Alere, explained Mark Wurster, MD, chief medical officer of Standing Stone, the Alere subsidiary that is building the automation tool. There is a possibility that patients could read or enter their data incorrectly, or that an Alere staffer could take it down wrong.
The new system that Alere is developing will use an infrared or Bluetooth device to upload the self-testing data automatically and will wirelessly transmit it to the Alere database. From there, data that signals the need for an immediate intervention could be faxed to a physician's office or sent directly to the patient's electronic health record (EHR), Wurster said. Alere has written interfaces to least 30 EHRs, he said, adding that this is much safer and more direct than sending faxes that could be misplaced or lost.
To date, 450,000 patients have used Alere's anticoagulation monitoring service, according to the company. An independent study of Alere data on patient self-testing was presented at a recent conference of the American College of Cardiology (ACC). The trial followed 29,500 patient self-testers in the U.S. for more than two years. The researchers concluded that patient self-testing, as part of a comprehensive support service, "delivered and sustained high quality control of warfarin," according to an Alere press release.
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