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Announcement
Posted on 08.21.02
What do Healthcare Providers Think of the Risk Management Program for Dofetilide?
Nancy M. Allen LaPointe, PharmD
Last year we reported on a new, required program for dofetilide, a drug used to treat abnormal heart rhythms. The program is required because dofetilide itself can cause a potentially life-threatening abnormal heartbeat, torsades de pointes, as a side effect.
The risk of torsades de pointes can be reduced if correct doses of dofetilide are given and patients' electrocardiograms are monitored correctly. Other drugs used to treat abnormal heart rhythms also can cause torsades de pointes, but dofetilide is the only one for which an educational program is required and whose distribution is limited to hospitals with educated caregivers. We wanted to know what healthcare providers thought of this program.
A total of 146 healthcare providers completed the educational program for dofetilide at Duke University Medical Center in 2000. Investigators at the Duke CERTs then surveyed these providers to see what they thought about the dofetilide risk management program.
Of the 146 caregivers, 91 (35 doctors, 34 pharmacists, and 22 nurses) responded to the survey. It took them a little less than an hour to complete the educational program, but it took a total of 145 hours for them to get the hospital ready for treatment of the first patient with the drug.
The different healthcare providers agreed that the educational program was necessary and that the recommendations about dosing and monitoring of dofetilide were good. They did not think that dofetilide was more dangerous than other drugs used to treat abnormal heart rhythms. Finally, survey results indicated that although putting the risk management program into practice took much time, participating caregivers accepted the program.
This study is the first in a series of Duke CERTs studies evaluating the risk
management program for dofetilide, and is the first to be published.
The results of these studies will help determine whether this method for reducing
risk and improving the appropriate use of drugs is effective.