Generics are great, but ...
To The Editor,
In his recent article "Peoria Has a Different Drug Problem", DeWayne Bartels raises an important point: generic drugs are a necessary alternative to brand-name medications if we wish to reduce healthcare costs. For most patients, there is no appreciable difference in the action of a generic versus brand-name drug, and we should use generics whenever possible.
However, it is also important to note that in some cases, particularly where very specific dosing is necessary to achieve a therapeutic effect, some patients will be harmed by switching between different formulations of a drug. Epilepsy drugs are among those with which we need to exercise extra caution.
The Food and Drug Administration, in approving generic medications, requires that they be bioequivalent to their brand-name counterparts. However, few people realize that the FDA allows for an 80% to 125% variance in bioequivalence between two formulations of a drug, a range that the 20,000-member American Academy of Neurology says is too wide a margin to be safe for epilepsy patients.
For some patients, even a small decrease in bioavailability can be enough to cause breakthrough seizures, resulting in increased healthcare costs from additional doctor visits, emergency room trips, and the medical care necessary to re-establish reliable seizure control.
The patient may also lose driving privileges as a result of these seizures, impacting his or her employment and ability to function independently without additional services until seizure control is regained.
Generic medications can be a viable alternative for some epilepsy patients. Those who are seeing good results from a particular formulation of a drug should remain on that formulation, whether it be generic or brand-name.
However, the decision to switch a patient to a different formulation should be left to the physician rather than to a well-meaning pharmacist attempting to save a patient money, or to an insurance company understandably looking to reduce costs. In the case of epilepsy, the best balance between patient safety and cost savings is achieved by allowing the physician to make a determination on the use of generic medications on a case-by-case basis, and keeping the full range of generic and branded epilepsy drugs available to all epilepsy patients.
Victor W. Verni
Epilepsy Foundation of North/Central Illinois, Iowa, Nebraska