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In the Case of Epilepsy, Generic Drugs and Random Product Substitution are Not Always "Good Medicine"
Date:5/27/2009

Nisola LLC launches campaign for stricter regulatory approval requirements and continuity of product supply.

New York, NY (PRWEB) May 27, 2009 -- A recent report released by Wolters Kluwer Health predicts that by the end of the year, nearly two-thirds of all drug prescriptions will be filled with generic drugs. This march to generics is fueled by several factors, which include the current economy, ever-increasing co-payment requirements for brand name drugs and pharmacies' desire to increase their profits by filling prescriptions with high margin generics versus lower margin brand name medicines.

This reliance on generics is generally considered a positive shift in healthcare as the vast majority of patients see significant cost savings without any noticeable change in their treatment. However, in the case of many neurological disorders, especially epilepsy, switching from a brand to a generic or between generics can be extremely dangerous.

The primary problem with random product substitution is that the Food and Drug Administration (FDA) does not require generic drugs to definitively demonstrate therapeutic equivalence to their brand name counterparts (i.e., the same clinical efficacy and safety profile). In fact, for approval, the FDA only requires that the generic be bioequivalent (i.e., within a certain range of a brand name drug's potency as measured by single-dose blood tests in healthy volunteers). Additionally, pharmacies, in their quest for profits, not only push patients to switch from brand name drugs to generics, but often switch from one generic manufacturer to another. Most alarmingly from an epilepsy patient's perspective, this means that one can receive a different generic brand every time they refill their prescriptions. This is understandably a nightmare for a patient trying to regulate their medications to avoid both seizures and/or side effects.

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