FDA's requirements for the use of dofetilide are described, and one hospital's strategy for meeting the requirements is discussed. Dofetilide is a specific class III antiarrhythmic agent approved for use in the conversion of atrial fibrillation and atrial flutter and the maintenance of normal sinus rhythm. It is available as an option for highly symptomatic patients who fail to respond to or do not tolerate other antiarrhythmic agents and patients with structural heart disease. Because of the risk of torsade de pointes associated with dofetilide, FDA has mandated in-hospital initiation of dofetilide therapy and has restricted its availability to hospitals and prescribers who have received appropriate education on dofetilide treatment initiation and dosing. Control of the drug's distribution is limited to a single wholesaler and a single mail-order pharmacy. These restrictions, along with the FDA labeling and the inherent risks associated with dofetilide use, have made this drug a complicated agent to use within an institution. When dofetilide was added to the formulary at Harper University Hospital, policies and procedures were developed to ensure appropriate use and monitoring. The use of dofetilide within health systems requires detailed procedures for prescribing, dispensing, and monitoring and thorough education of caregivers about those procedures. Pharmacists have a pivotal role in ensuring the appropriate use of dofetilide.

 

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				A. V Guanzon and M. A Crouch Phase IV Trial Evaluating the Effectiveness and Safety of Dofetilide Ann. Pharmacother., July 1, 2004; 38(7): 1142 - 1147. [Abstract] [Full Text] [PDF]