Abstracts

MEDICAID MANDATED CHANGE TO GENERIC PHENYTOIN: CONCENTRATION EVALUATIONS ON SAME DOSE FROM BRAND TO GENERIC

Abstract number : 2.349
Submission category :
Year : 2005
Submission ID : 5656
Source : www.aesnet.org
Presentation date : 12/3/2005 12:00:00 AM
Published date : Dec 2, 2005, 06:00 AM

Authors :
1Michael Collins, and 2Mary Kay M. Hermanson

In September 2004 the State of Wisconsin Medicaid program mandated a change to generic phenytoin for those patients on brand Dilantin unless there was Federal Medwatch form filed documenting an adverse event. This is in contrast to the previously accepted physician request for dispensing [ldquo]brand medically necessary[rdquo]. Other drugs newly included in that list included warfarin, cyslosporine and levothyroxine.
Pre and post phenytoin concentrations were measured for eight patients changed from brand Dilantin to Mylan[apos]s phenytoin and given the same dose. All patients had a fall in phenytoin concentrations and most required a dose adjustment to attain concentrations between 10-20mcg/ml. Some patients required a dose increase to the extent that the monthly cost for generic exceeded their previous cost for branded product. One patient reported breakthrough seizures during this transition.
Widespread complaints to the Medicaid program from patients and caregivers affected by this mandate resulted in a withdrawal of that requirement three months after its inception. Brand product may now be dispensed if the physician documents on a Medwatch form that they anticipate an adverse outcome. Retrospective chart review. Serum Concentration and Doses will be presented in table form. Change from brand Dilantin to generic formulation may result in a fall in serum concentrations.