Members of the epilepsy community have for years reported experiencing seizures and other harmful side effects after switching from one version of an antiepileptic drug (AED) to another, whether the switch was brand-to-generic, generic-to-brand, or generic-to-generic. By law, the amount of medication delivered by one AED may differ from the amount delivered by another AED that the Food and Drug Administration (FDA) deems "equivalent," and it may deliver the medication at a different rate. There is growing evidence that these variations, however slight, can mean the difference between controlled epilepsy and breakthrough seizures or other negative consequences.
Patients today are most typically switched from brand-name drugs to generics, or from one generic drug to another, for a single, non-clinical reason: pressure to reduce costs. In most states, unless a physician explicitly writes "dispense as written" or "no substitution," pharmacists can switch a patient to a lower-cost generic drug without the consent or knowledge of either the patient or the physician.
The Epilepsy Foundation appreciates that cost-control is a worthy goal and, in general, it enthusiastically supports providing patients with greater access to generic medications. The Foundation is committed to the welfare of people with epilepsy and their families, and the high cost of many name-brand medications is a particularly significant issue for people with epilepsy, many of whom will take medication on a daily basis for the remainder of their lives. The Foundation welcomes the opportunity that generic medications present to lower the overall costs of delivering effective healthcare to individuals and society.
But the Foundation believes equally that short-sighted cost considerations should never be allowed to trump efficacy or take precedence over patient welfare. Indeed, if a patient is switched off of a well-functioning drug to avoid costs, the direct economic consequences borne by society if the cheaper drug fails—whether incurred in the form of increased ambulance rides and emergency-room admissions, greater numbers of in-patient doctor visits, or lost worker-productivity—will quickly eliminate any short-term savings occasioned by the switch. Meanwhile, the concurrent human costs borne by patients and their families can be immeasurable.
Based on evidence in the clinical literature as well as reports from physicians and patients, the Epilepsy Foundation has developed serious concerns about policies that permit or require AED substitutions without the consent of the doctor and patient. In fact, the results of the Epilepsy Foundation's recent survey, 'In Their Own Words: Epilepsy Patients' Experiences Changing the Formulation of the Drugs They Use to Prevent Seizures,' demonstrate that for many patients with epilepsy, AED substitutions have been neither effective nor safe. In addition, the scientific literature now contains:
- clinical confirmation that switching between "equivalent formulations of the same anti-epileptic drug, whose differing effects in the body are not considered "significant" by the FDA, caused serious adverse consequences in patients
- case studies affirmatively establishing that switching between "equivalent" AEDs can lead to breakthrough seizures
- statistical analysis showing that persons with epilepsy who recently switched between "equivalent" AEDs sought more in-patient and emergency care than those who did not,
- case studies documenting that epilepsy patients on the brand name and generic versions of "equivalent" AED medications had different levels of therapeutic medication in their blood, and
- population data revealing that epilepsy patients have "switch[ed] back" to brand-name medication at significantly higher rates than patients who have switched to generic drugs to treat other long-term conditions.
Two distinguishing features of epilepsy further suggest that AED-switching should be approached with special caution. First, seizure control can be an all-or-nothing proposition. Slight changes in the amount of medication received by a person with epilepsy can mean the difference between a fully controlled condition and breakthrough seizures. Critically, the patient with epilepsy exists in either of only two states: the patient is either seizure-free, or is not. In some patients, there may be correspondingly little room for error when changing the patient's dosage or prescription. Second, the consequences of a breakdown in a well-functioning seizure-control regimen can be catastrophic. The consequences of a breakthrough seizure can be extreme: seizures increase the likelihood of serious bodily injury and death, and, even when no physical injury occurs, seizures often result in significant social, legal and developmental consequences, including loss of the patient's driver's license, loss of employment, and loss of self-esteem.