Friday, March 21, 2008

Generic medecine for Epilepsy patients? Not a good idea!

Epilepsy is a neurological condition that produces disturbances in the normal electrical functions of the brain. These can trigger seizures.Epilepsy and seizures affect more than 360,000 Floridians. About 84,600 of these are children.Ten percent of all Americans will experience a seizure in their lifetime. Three percent will develop epilepsy by age 75.

-Epilepsy Foundation of Florida

A physician writes a prescription for a brand-name drug, and the pharmacy substitutes a cheaper, generic medication. Both are approved by the Food and Drug Administration, which maintains that a generic substitute is equivalent to the original medicine. But are they always interchangeable?
Not if you are a patient with epilepsy, according to the Florida Epilepsy Foundation, which warns that when drugs are substituted, it is a serious medical issue.

The advocacy group is urging state legislators to support a bill called the Patient Safety Act (SB 2414 and HB 811) that would require a pharmacist to notify and secure informed consent of both patient and physician before altering any epilepsy patient's anticonvulsant prescription.

It's legislation that could affect more than 360,000 Floridians with epilepsy. More than 84,600 of them are children.

Dr. Basim Uthman, associate professor of neurology and neuroscience in the UF College of Medicine, explains that living with epilepsy is like walking a tightrope, where one slip can have dire consequences.

"You finally find the right medication at the right dose for a patient, and a small change can result in seizures," he warns. "The consequences can be major."

For comparison, Uthman describes a patient with high blood pressure controlled by medication. The patient sees his physician, who finds his blood pressure slightly elevated and adjusts the dosage of his meds.

The patient didn't feel a change when his blood pressure went up, and he didn't feel a change when his body made the adjustment to the new drug dosage.

In this case, it's more like driving down Interstate 75 than walking a tightrope, according to Uthman, who is also director of clinical neurophysiology laboratories and assistant chief of neurology service at the Gainesville Veterans Affairs Medical Center.

Veer slightly out of your lane, and you've got plenty of room to make the adjustment.
Slip on a tightrope, and you're in trouble without warning.

Uthman describes a 58-year-old patient who had been seizure-free for many years, although he was epileptic.

"His medication was changed by a pharmacist without telling him," the neurologist said. "They gave him the same dose, milligram for milligram, but it was not the same. They can do that, if the doctor does not write on the prescription 'medically necessary.' "

Uthman's patient had a seizure while driving, lost consciousness, totalled his car and subsequently lost his job.

"It took him two years to get his life back on track," Uthman said.

The chief executive officer of the Florida Pharmacy Association, Michael Jackson, said Wednesday that the Tallahassee-based group is not in favor of the bill.

"It is going to create a huge administrative burden on pharmacies and barriers to patients," he said. "We pharmacists cannot do anything without getting authorization from the physician to make a change."

On the other hand, Jackson points out, all the physician has to do is write "medically necessary" on the prescription and there is no problem.

"I certainly would not like to see a patient who's condition is very brittle go without medication because there was a need to get a signature on a piece of paper," he said.

Dr. Chris Sackellares is a professor of neurology and neuroscience at the McKnight Brain Institute in UF's College of Medicine. His research focuses on epilepsy and seizure disorders.

He explains that the FDA requires that generic drug formulations must be bioequivalent to a name-brand, patented drug. That does not mean they must be identical. The active ingredient will be the same, but the compounds they are mixed with need not be.

Currently, 64 percent of all prescriptions filed in the United States are for generics. In many cases, a patient's health plan requires him or her to pay a higher proportion of the cost for name-brand drugs.

Officials with the FDA say these lower-cost generics offer the same dose of the same active ingredient, delivered in the same way and manufactured according to the same quality standards.
Dr. Leslie Hendeles, a professor in the College of Pharmacy and the department of pediatrics at the University of Florida, supports that position.

"The 'bioequivalent' rating means the FDA required an appropriate study demonstrating that the rate and extent of absorption of the generic was not significantly different from the brand product," Hendeles reported in an e-mail to The Sun.

Some physicians, including Uthman and Sackellares, beg to differ. In the anticonvulsant drugs used to treat epilepsy, the two specialists agree that small variations can result in changes in levels of the drug in the patient's blood stream - changes that can trigger a seizure or toxicity. One leaves the patient unconscious, the other leaves him or her drowsy, wobbly and confused.

Uthman emphasizes that he is not campaigning against generic equivalents.

"We all want to have a cheaper drug that works for the patient," he said. "If he is doing fine on a reputable generic, I don't want him switched to a brand name. We'd have the same problem!"
What he wants, he said, is to change the law so that the decision over which drug to take is left to the epilepsy patient and the physician.

"I am not pushing for brand names, I am pushing for consistency in the delivery of the drug," he said.

He advises epilepsy patients who see him as a specialist but also have their own physician to ask the doctor when he or she writes the prescription to put down "medically necessary, no substitutions."

Furthermore, if the patient has been on a generic and it is working, the doctor should look up the name of the generic and its manufacturer and list that on the prescription.

Meanwhile, Uthman supports the Epilepsy Foundation's push to pass the Patient Safety Act in the current legislative session.

"I think it is good medicine, and I hope it will become law," he said.


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