Clinical experience with generic levetiracetam in people with epilepsy

Until the present day, U.S. health care systems have adopted various measures to maximize cost savings. It has been well known to encourage or have mandatory requirements to use cheaper, generic drugs instead of their branded counterparts (Andermann et al., 2007). The U.S. Food and Drug Administration (FDA) has allowed generic medications that have shown short-term bioequivalence to be granted product license. However, bioavailability may be different from branded counterparts because of the use of other chemicals that are used to make generic medications (Borgheini, 2003). Generic medications must have the same dose and form as the brand name and must have been studied and determined to have equivalent bioavailability of the brand name (Andermann et al., 2007). Notwithstanding, variation of generic antiepileptic drugs (AEDs) versus name brand AEDs can be highly problematic among people with epilepsy (PWE). This has led to a debate on the appropriateness of generic substitution of AEDs to generic compounds. Because of the potential for poor clinical outcomes with generic AEDs, several agencies (UK National Institute for Health and Clinical Excellence (Andermann et al., 2007) and the American Academy of Neurology (AAN) (Borgheini, 2003) have instituted policies to discourage the substitution of generic AEDs from brand name due to the potentially negative consequences such as increased monitoring costs and loss of seizure control. Other countries have implemented stricter guidelines in dealing with generic AEDs. In Sweden the Medical Products Agency instituted a policy that certain AEDs (lamotrigine, carbamazepine, phenytoin, valproic acid, gabapentin) cannot be switched from brand name to generic (Borgheini, 2003; Andermann et al., 2007). The Italian Chapter of the International League Against Epilepsy instituted a policy that patients who are in seizure remission or with well-controlled seizure activity on a brand name AED, should not be switched from branded to generic medication (Perucca et al., 2006). Confirmatory observations lend support to the concerns involving generic AEDs. Recent studies have noted high switch back rates, loss of seizure control, increased toxicity, and increased health care utilization costs associated with generic AEDs (Andermann et al., 2007; LeLorier et al., 2008; Kesselheim 2010; Labiner et al., 2010; Sethi et al., 2010). Given these findings of poor outcomes, the AAN has instituted guidelines in 2006 opposing generic substitution of AEDs without attending/physician approval (Liow et al., 2007). Nevertheless, other organizations such as the FDA promote interchangeability with generic and branded AEDs. To our knowledge, none of the recent studies specifically investigated the potential consequences associated with Keppra or generic levetiracetam (LEV). The purpose of our study is to measure the proportion of PWE who switch back from generic to branded LEV required due to poor clinical outcomes directly associated with the generic compound.