Date of Award

2016

Embargo Period

8-1-2024

Document Type

Dissertation

Degree Name

Doctor of Health Administration

College

College of Health Professions

First Advisor

Kit N. Simpson

Second Advisor

Jillian B. Harvey

Third Advisor

Vincent Omachonu

Fourth Advisor

Lisa K. Saladin

Abstract

Generic drugs have been approved for use by the Food and Drug Administration (FDA) since 1984 on the basis of demonstrated bioequivalence as compared to the brand name version. Generic drugs constitute approximately two- thirds of all prescriptions dispensed in the US and account for <20% of total pharmaceutical expenditure (Patel et al., 2011). However, concerns about the safety and bioequivalence of the generic versions of specific drugs are raised regularly (Kesselheim et al., 2010). Despite evidence supporting bioequivalence, many observational studies have shown an increase in seizure occurrence with the use of generic drug formulations (Papsdorf et al., 2009; Berg et al., 2008; for review see Yamada & Welty, 2010). These issues have not slowed the trend by medical insurance companies to mandate use of generic drugs over brand name drugs, and commercial and government insurance programs continue to prioritize the use of generics in most circumstances (Keenum et al., 2012). Although the use of generic medications can result in substantial savings for the American patient, anecdotal evidence indicates that beliefs concerning the safety and effectiveness of generic drugs compared to brand name medication may persist among patient subgroups as well as among medical practitioners (Figueiras et al., 2010; Ngo et al., 2013). While generic drug substitution may lead to immediate cost savings, these substitutions may be associated with additional expenses incurred due to increased adverse events, lack of adherence to therapy, and to the resulting failure of those therapies (Shin et al. 2014). The purpose of this study is to examine: 1) the extent to which generic switch is practiced for privately insured US patients; 2) variations in adherence to AED medications for patients by brand name and generic AED and switching between the two, and 3) medical outcomes based on compliance to treatment. We examine factors associated with the use the antiepileptic brand drug Dilantin® manufactured by Pfizer, generic Phenytoin, and generic switch in 19-64 year old patients who have private insurance.

Rights

All rights reserved. Copyright is held by the author.

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