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Brand or Generic? Evaluation of an Epoprostenol Formulary Change

Laura Duvall

Namita Sood


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Conference: 2010 International PHA Conference and Scientific Sessions

Release Date: 06.24.2010

Presentation Type: Abstracts

Duvall L, Sood N. 
The Ohio State University Medical Center, Columbus, OH, USA

PURPOSEFlolan® (epoprostenol sodium), a prostacyclin analogue delivered by continuous intravenous infusion, is a highly effective therapy for the treatment of pulmonary arterial hypertension. Generic epoprostenol sodium (Teva pharmaceuticals) was FDA approved in April 2008 as a therapeutic equivalent (AB rated) to Flolan® (epoprostenol sodium). We assessed safety with interchanging between brand and generic epoprostenol sodium.

BACKGROUNDTrue bioequivalence between generic and brand epoprostenol sodium is not known. Due to the small dosing measurements with epoprostenol sodium, there is concern regarding whether or not any difference between the products would adversely affect patient outcomes. There is data to support switching stable patients from brand to generic epoprostenol sodium without adverse events (Channick, RN, et al.). Safety interchanging these products in the inpatient setting is not known. At The Ohio State University Medical Center (OSUMC), both generic and brand epoprostenol sodium products were kept on formulary for a 6-month trial period. During this time, all patients newly initiated on epoprostenol sodium would be started on generic epoprostenol sodium, while all patients previously prescribed epoprostenol sodium would be maintained on their home regimens, whether brand or generic. Following the 6-month trial period, OSUMC started exclusively using generic epoprostenol sodium for inpatient use, therefore patients who were on Flolan® (epoprostenol sodium) would receive generic epoprostenol sodium during their hospital admission. Generic epoprostenol sodium has been the sole product on formulary at OSUMC since June 9, 2009.

METHODSA retrospective analysis of all patient admissions between June 9, 2009 and December 9, 2009 was conducted to evaluate home epoprostenol sodium medication (brand or generic) versus OSUMC inpatient epoprostenol sodium medication (generic only).

RESULTSEleven patients met inclusion criteria, and accounted for 23 admissions. Each admission was evaluated to compare home epoprostenol sodium medication, dose, rate, dosing weight, and medication concentration with the generic epoprostenol sodium that was initiated at admission to OSUMC. Adverse events at the time the patient was transitioned to inpatient supply were also evaluated. On ten admissions, the patient was interchanged from Flolan® (epoprostenol sodium) to the OSUMC supply of generic epoprostenol sodium. In each case, the dose, rate, dosing weight and medication concentration remained the same as what the patient had been receiving at home. None of the patients needed acute dose adjustments and there were no documented adverse events in any of these patients when transitioned to inpatient supply. Supplying generic product only at OSUMC has led to a 35% cost savings.

CONCLUSIONSThis preliminary data suggests that brand and generic epoprostenol sodium can be used interchangeably without adverse effects and results in significant cost savings.