January 7, 2008
Legislation has been introduced in the Pennsylvania General Assembly that would require pharmacists to notify patients when there is a change in the anti-epilepsy medicine being dispensed to them when filling prescriptions. Pennsylvania State Senator Jay Costa is the prime sponsor of Senate Bill 119 and Representative Bill Adolph is the prime sponsor of House Bill 98.
To take a brief anonymous survey about how this issue may have affected you or your child, please click on the link below.
While we have not seen any action on the senate side, the House Health & Human Services Committee is expected to schedule a public hearing on H.B. 98 in April.
Here is what epilepsy/seizure disorder patients need to know about this issue:
- Pharmacies in Pennsylvania are currently permitted to interchange anti-epileptic medications without notifying patients or their physicians. The proposed legislation would protect the patients? right to receive notification when a pharmacy is interchanging anti-epileptic medication.
- Epilepsy medicines come in different forms. These medications work because the active ingredient is absorbed into a patient?s blood. However, the formulations that determine absorption rates can be very different. Formulation variances exist between brand name and generic and even between different generic manufacturers. The FDA allows a variance of as much as 45% - between a negative 20% to a positive 25%.
- Achieving seizure control without negative side effects and maintaining a therapeutic level of a specific anti-epileptic drug in a patient?s blood stream is a delicate process that can be easily disrupted when changed, causing loss of seizure control. When pharmacies purchase generic formulations from different wholesale manufacturers, they are not required to notify patients of this change before dispensing the drug. This means that while the patient believes he/she is receiving the same drug, the actual formulation of the medication is in fact different.
- Even occasional seizures prevent a person from obtaining and/or maintaining a driver?s license which limits independence, mobility and employment options. The variations in the formulation of medicines place patients at an increased risk of having seizures; pose a number of patient safety concerns and result in negative quality of life consequences for seizure patients of all ages. Once seizure control has been interrupted, regaining control is not necessarily automatic or assured.
- By even the most conservative estimates, more than 120,000 Pennsylvanians have a diagnosis of epilepsy or seizure disorder so this issue affects a significant number of people in the commonwealth.
- Physicians are required by law to report to PENNDOT that a patient is experiencing seizures; triggering a medical suspension of the patient?s driving privileges for a minimum of six months. Suspensions often result in lost wages, loss of employment, increased health care costs, emotional distress and a plethora of social burdens placed upon both the patient and the patient?s family.
- PENNDOT reports that in 2004 there were 3,794 medical suspensions of driver?s licenses due to seizure related conditions and that in 2005 the department suspended 4,324 licenses for the same reason ? a 14% increase. In 2006, this figure is on track to exceed 5,000 pointing to a trend of ever increasing numbers of seizure patients losing seizure control and experiencing a medical suspension of driving privileges.
- Children also suffer the consequences of unknown changes in their medicine resulting in absences from school and increased learning problems. Kids suffer from the negative social stigma associated with having seizures at school and when control is lost, sports and extracurricular activities are limited.
- Older seizure patients are likely taking more than one medication, increasing the risk of drug interactions. This often leads to compromised overall health and hospital admissions that are required to correct these problems, again driving up the overall cost of health care for this patient.
- Patients have a right to receive adequate, complete, honest and consistent notification when a change in their treatment is being made by third parties. Changes in drug formulations are not insignificant for epilepsy patients. Notification permits patients and physicians to weigh the risks associated with interchangeable medicines and provide patients with the ability to manage their seizures and their lives more effectively.
- This issue most simply stated is that the variability in the bioequivalence exceeds what is safe for most people who have epilepsy.
- Patients and society have come to rely upon a false sense of confidence in the bioequivalence of medications. Not all medications are equal in their formulation or efficacy and this is particularly true for anti-epileptic medications.
To learn more about how you can support House Bill 98 and Senate Bill 119, contact the EFWCP at 1-800-361-5885 or staff@efwp.org.
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