Abstracts

Issues surrounding the substitution of generic anti-epileptic drugs (AEDs) in the US are not fully understood. In addition, current experiences of US physicians have not been thoroughly examined. Here, views of patients and physicians toward generic substitution of AEDs and insights into physicians[apos] current experiences across the US are reported., Online-based surveys were carried out with 550 adult patients diagnosed with epilepsy and 606 physicians treating epilepsy from the US., The efficacy of generic AEDs was a concern to 75% of physicians and 65% of patients.
The vast majority (90%) of physicians agreed that generic substitution of a controlled patients[apos] regular, effective AED may cause the onset of breakthrough seizures. Fully 65% of physicians reported that they had had a patient experience a breakthrough seizure caused by a switch from a branded to a generic AED. Additionally, one-third (34%) of patients think that substitution with a generic AED is linked to breakthrough seizures.
Almost two-thirds (62%) of patients surveyed and 75% of physicians surveyed were aware that pharmacists may substitute a branded AED for a generic without physician consent. But less than half (43%) of physicians were aware of mandatory generic substitution laws for branded prescription medications. Eighty-one percent of patients and 87% of physicians agreed that the pharmacist should only be able to substitute an AED with a generic with physician consent. Half (53%) of physicians surveyed would be uncomfortable prescribing a generic medication to treat their patients[apos] epilepsy.
Over half of physicians (64%) and patients (57%), in general, prefer generic AEDs if there were a potential cost savings.
Among those surveyed, fewer physicians (52%) and patients (44%) were concerned about efficacy of generic medications for acute care. Concerns about safety of generic AEDs existed amongst 56% physicians, compared with 40% for generic acute care medications.
Ninety-four percent of patients would require at least a small amount of education or counseling from a healthcare professional if they were to switch their current AED for a generic., Both patients and physicians are concerned about the efficacy and safety of unrestricted generic AED substitution and nearly two-thirds of physicians reported that they had a patient experience a breakthrough seizure due to generic substitution. However, generic substitution practices are not well-understood by patients or by physicians. Physicians and patients recognize the cost savings of generic AEDs, but the perception that generic drugs are less effective may outweigh the cost benefit in many cases. The findings raise questions about the value of mandatory generic substitution requirements for medications with narrow therapeutic windows, such as AEDs., (Supported by GlaxoSmithKline.)