Managed Care - March 2008 - (Page 27) and physical consequences for the epilepsy patient in areas of life such as employment AAN recommends guidelines and driving, and could lead to injury.” for AED substitution Too serious to take any chances, he says. “I n late 2006, the American Academy of Neurology issued have no problem with generics. I believe a number of recommendations regarding generic substithey’re valuable to our society and to patution for antiepilepsy drugs. “Epilepsy is unlike other disortients,” says Schachter. “If I could guarantee ders. Unlike a condition such as hypertension, where, if you that each generic my patient was receiving make a change in dose you can monitor blood pressure to was identical, I would feel more assured. But determine whether it’s working or not, with epilepsy you the generics themselves vary by manufachave an all-or-nothing phenomenon. You’re either seizure turer, and there can be dozens of manufacfree or you’re not,” says Gregory Barkley, MD, of Wayne State turers after the exclusivity period.” University in Detroit. He is one of the authors of the AAN poSchachter is far from alone in his concern. sition statement. The AAN recommends that: In a study from the Strong Epilepsy Center at • Such substitutions be approved only if the safety and the University of Rochester (N.Y.) Medical efficacy of treatment is not compromised Center, published last year in Applied Neu• Specific pharmacokinetic information about each AED rology¸ two thirds of reporting physicians generic be made available to physicians, and they said that a patient in their care experienced avoid switching between formulations of AEDs a breakthrough seizure when switched from • Labels identify specific manufacturers, and pharmacists a brand-name to a generic AED. be required to inform patients and physicians when “Our online study shows that there is a switching a patient between manufacturers • Organizations that encourage or mandate substitution significant problem, and there are conseof AEDs evaluate their responsibility for problems arisquences to this,” said Mark Berg, MD, who led ing from their policies. the study. Of the physicians who participated in the survey, 90 percent said they believed that generic It’s medical, not political substitution for a patient’s regular, effective AED The issue is medical, not political, says Harvard’s might result in breakthrough seizures. One in three Schachter, a member of the board of directors of the patients (34 percent) also believed this to be true. Epilepsy Foundation. Of concern is that bioequivThe overall effectiveness of generic AEDs also was alence studies are generally performed on a limited a concern to 75 percent of the physicians and 65 number of healthy volunteers, not on patients. percent of patients. Specifically, Schachter says, the bioequivalence of Notwithstanding the concerns of physicians, to generic AEDs is not tested on patients with epilepsy. date there has been no in-depth study of whether Doses used in studies may not yield relevant ranges drug-switching actually can cause epileptic seizures. of serum concentrations, and bioequivalence does “There is a good deal of anecdotal evidence,” says not guarantee that a generic will produce the same Schachter, “and the issue is discussed by neurolotherapeutic effect or result in the same adverse efgists at every professional seminar or meeting.” fects as the branded drug. In May 2006, the Epilepsy Foundation convened What’s more, “The characteristics of epilepsy a committee of medical experts to examine the and the potential serious ramifications of therapy question. The committee found a lack of authorifailure must be considered,” says Schachter. tative studies showing that such drug switches cause “Epilepsy is not like other medical conditions, such problems, says Schachter, who chaired the comas elevated cholesterol, because of the seriousness mittee. “We do believe that doctors should give exof seizure events. Epilepsy patients are particularly plicit approval for drug switches. An attack can vulnerable to the disadvantages of generic products, cause serious injury or death. The effects can be since slight deviations in the serum concentrations devastating.” of AEDs can be the difference between keeping a He said that the foundation is now studying the patient seizure-free and the occurrence of a breakdesign of a study that can determine the effect of through seizure. A breakthrough seizure after a drug switching. MC long remission can have significant psychosocial I MARCH 2008 / MANAGED CARE 27
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