Mandatory Drug Switching: The Perfect Storm.

With most brands of anti-epileptic drugs going generic, and states such as Pennsylvania mandating pharmacies to use generic drugs (some of which have multiple manufacturers), this issue has become the perfect storm for people living with seizures.

The EFWCP has been working to bring greater awareness to the problem of medication substitution for several years. Medication substitution is when an antiepileptic drug (AED) is switched from a brand name AED to a generic, from one generic to another generic, or from a generic to a brand. When an AED is switched at the pharmacy level and a patient is not notified of that change, there are very dangerous consequences, including increased side effects, and most devastatingly, breakthrough seizures.

In May 2008, after months of advocating, EFWCP staff traveled to Harrisburg to testify in front of the House Health and Human services committee in support of House Bill 98. House Bill 98 stipulated that a patient should be notified if a switch was made in their medication, whether that was brand to generic, generic to generic, or generic to brand. Unfortunately, House Bill 98 did not become law, though we are continuing our fight and are in the process of introducing a new medication substitution bill.

In addition to House Bill 98, we published Silent Too Long, a magazine distributed to more than 25,000 Pennsylvanians, as a call to action regarding medication substitution and other patient advocacy issues. Without the loud and insistent voices of people in Pennsylvania who are affected by epilepsy, we will not see the kind of progress in research, in patient protections, and in quality of life that we believe is long overdue. We urged people to become an advocate who would help us reach out to our elected officials about issues important to people living with seizures, and we are pleased to report that over 500 people to date have registered to get involved.

With a strong group of advocates, we are looking forward to a year of growth and change in 2009. First and foremost, we will continue to fight for the rights of people with epilepsy when it comes to the issue of medication substitution. If you or someone in your family has a story about medication switching, we urge you to call us and share your story. It is important that Pennsylvania legislators hear your story and your voice, so please call us today at 1-800-361-5885. We will not rest until people with epilepsy have the rights they deserve!

The Epilepsy Foundation National has also now joined us in this fight. On May 7th, the Epilepsy Foundation announced findings that show people with epilepsy whose seizures have been controlled with a consistent drug therapy have a greater chance of increased seizures, greater side effects or sudden death when their medications are switched from one version of an AED to another, whether the switch is brand-to-generic, generic-to-brand or generic-to-generic. "We strongly urge the Food and Drug Administration to inform patients and their doctors about the possible dangers of medication switching, and we are calling on the FDA to do more research into this matter and to develop a standard that ensures equivalency and safety for all patients" said Eric R. Hargis, president and CEO of the Epilepsy Foundation.

The study, which surveyed more than 1,000 people with epilepsy, reveals that seizures worsened for 59 percent of people who had switched from a brand-name to a generic AED, while side effects increased for 49 percent of that same group. Additionally, seizures worsened for 15 percent of those who had switched from a generic to brand AED, while side effects increased for 18 percent of that same group. Furthermore, more than 25 percent of respondents reported experiencing problems after switching between different generic formulations of an AED. "Brand names of medications have different formulations than their generics, and generics also vary from each other in the exact amount of active ingredients in the drug as well as with the amount and type of filler ingredients included. While these variations might not mean much with some medications, for others, like AEDs, they can mean the difference between being seizure free and suddenly having a seizure while driving on the freeway," said Dr. Brien Smith, senior staff neurologist and medical director of the Comprehensive Epilepsy Program at Henry Ford Hospital.

The Epilepsy Foundation is filing a Citizen's Petition seeking action from the agency, and has taken the initiative to inform members of the health care and epilepsy communities about concerns raised in the recent studies. The Epilepsy Foundation National has created a campaign aimed at sharing these survey results with the rest of the country so that the FDA will respond and do more research into this matter and develop a standard that ensures equivalency and safety for all patients. They are also urging the FDA to inform patients and their doctors about the possible danger of medication switching.