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Learn About Medication
Statement on Subsitution of
Generic
Anti-epileptic Drugs
The Epilepsy Foundation of America (EFA) is seriously concerned about
mandatory substitution of generic anti-epileptic drugs without prior approval
of the patient and treating physician. Generic formulations of a number
of widely used anti-epileptic drugs (i.e. carbamazepine, phenytoin, primidone,
and valproic acid) have recently become available and present the opportunity
to reduce costs. Some states and some institutions (including prepaid
health plans) have mandated that the pharmacist fill a prescription with
the least expensive available drug. There may be significant differences
between the characteristics of brand name and generic anti-epileptic medications,
as well as among generic anti-epileptic drugs. A generic product may be
approved as equivalent to a brand name product even if it produces varying
bioavailability in some individuals.
The FDA guidelines allow for a therapeutic range that is too broad to
ensure that each individual will receive the same amount of anti-epileptic
drug when switching from a brand name to a generic anti-epileptic drug
or from one generic to another. The fact that these differences may exist
could result in adverse effects, including loss of seizure control and
the
development of toxic side effects. Changing from one formulation of the
drug to another can usually be accomplished, and risk minimized, if physicians
and patients monitor blood levels, seizures and toxicity.
EFA therefore strongly advised that all rule-making bodies -- including
those at the Federal and state level, as well as prepaid medical plans,
institutions, such as hospitals, correctional facilities, residential
facilities and others who make decisions about the availability of certain
medications -- (be made aware of) address the potential adverse effects
of
changing from one formulation of an anti-epileptic drug to another, by
requiring (without) the prior expressed permission of the treating physician
and (the agreement of) the patient.
Approved by the Board of Directors June, 1996. |
