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Posted on 04.30.01
Dofetilide: A New Medicine with a Unique Risk Management Program
By Nancy Allen LaPointe
Dofetilide is a new prescription drug that was introduced to the market in 2000 for treating 2 abnormal heart rhythms, atrial fibrillation and atrial flutter. When it granted approval to market dofetilide in the U.S., the U.S. Food and Drug Administration (FDA) required a unique risk-management program to minimize the risk of a potentially life-threatening abnormal heart rhythm called torsades de pointes.
Torsades de pointes is very rare, but it is a possible side effect of many different drugs, including dofetilide. The risk of torsades de pointes can be reduced by careful dosing and by not combining dofetilide with certain other medicines.
The FDA has required that all caregivers complete an educational program before the patient begins taking dofetilide. The requirement applies not only to the physician who prescribes it but also to the pharmacist who dispenses it, the nurse who gives it, and even the ECG technician who monitors the patient's heart rhythm.
Another part of the requirements is that patients must be hospitalized when starting dofetilide. In addition, once the person is discharged from the hospital, he or she can obtain more dofetilide only from 1 national mail-order pharmacy. This is the first time that the FDA has required such a strict set of guidelines for a new medicine to treat a heart disorder.
What do healthcare providers think of this program? That is exactly what researchers at the Duke CERTs want to know.
All caregivers who have completed the dofetilide educational program at Duke University Medical Center have been surveyed to find out their thoughts about the educational program and dosing guidelines. They also have been tested on their memory of 3 specific guidelines.
The preliminary results indicate that most providers believe that the program is necessary for the safe prescribing of dofetilide and that the potential risks from dofetilide justify the time and resources for the program. However, most providers do not feel that dofetilide is potentially more dangerous than other medicines used to treat abnormal heart rhythms.
Interestingly, despite completing the educational program, only about 1 in 4 of the respondents answered all the memory questions correctly.
The full analysis will be completed shortly. A related study, also being done by the Duke CERTs, will evaluate how well providers actually follow the guidelines in their practice.