BILL NUMBER:S2590

TITLE OF BILL:
An act
to amend the public health law and the
education law, in relation to requiring notification of and
the informed consent of the prescriber and the patient prior to the
substitution of a prescribed anti-epileptic drug

PURPOSE:
The bill requires that an interchange of an anti-epileptic drug or the
formulation of an anti-epileptic drug, brand or generic, for the
treatment of seizures may not occur without prior notification of and
the signed informed consent of the prescribing physician and
patient, or patient's parent, legal guardian or spouse of such person.

SUMMARY OF PROVISIONS:
Section one of the this bill creates section 3346 of the Public
Health Law, regarding the prohibitions on anti-epileptic drug
selection. It states that no pharmacist shall interchange an
anti-epileptic drug or formulation of an anti-epileptic drug without
the prior notification or and the signed informed consent of such
interchange from the prescribing physician and the patient, or the
patient's parent, legal guardian or spouse.

Section two amends Section 6816-a of the Education Law to exempt
              

epileptic drugs from the provisions allowing pharmacists to
substitute a less expensive drug product.

Section three is the effective date.

JUSTIFICATION:
Seizures and epilepsy develop in approximately 181,000 Americans of
all ages each year.
Overall, more that 2 million Americans have been diagnosed with
epilepsy. People with epilepsy are concerned about the availability
of all anti-epileptic drug options. This is the result of the unique
nature of epilepsy and the numerous different responses to
anti-epileptic medications that can be experienced by those with
epilepsy. It is critically important that
individuals with epilepsy and seizure disorders have access to all the
available anti-epileptic medications through prescription drug
formulations, including new as well as established formulations of
both brand and generic products.

Not all people with epilepsy are the same. The unique nature of
epilepsy, more precisely termed "the epilepsies" refers to the
various reasons that a seizure may occur and affect different parts
of the brain in very different ways. Anti-epileptic drug therapy is
usually started when a patient has had more than one unprovoked
seizure. Although one anti-epileptic drug product may prove to be
highly effective with an individual, accurate prediction of an
individual's response to medication is not possible.

There are a number of widely used anti-epileptic drugs available to
persons with epilepsy, however there may be significant differences
between the characteristics of anti-epileptic medications, The fact


that these differences exist could result in adverse effects,
including loss of seizure control and development of toxic side
effects. Changing from one formulation of anti-epileptic drug to
another is best accomplished, and with minimized risk, if physicians
and patients properly maintain the right to determine their
pharmaceutical course of therapy.
As a result of new anti-epileptic drugs and other forms of treatment,
which have been developed in recent decades, the control of seizures
has become an attainable goal for many people with epilepsy, However,
a recent study has shown that over 1 million individuals continue to
have persistent seizures even with treatment Many people with
epilepsy report regularly to the Epilepsy Foundation that they have
experienced breakthrough (unexpected) seizures, after long periods of
seizure control, when a formulation of their customary medication was
changed.

Seizures have the potential to be life-threatening, and can endanger
the individual and others, particularly if they occur without
warning, while the individual is engaged in the various activities of
daily living. Hence, to risk the occurrence of seizures by switching
products without the guidance of the individual's physician, when it
is known that breakthrough seizures could occur, is a matter of both
public and individual safety.

Recognizing the seriousness and potential problems associated with
people with epilepsy unknowingly having their medications switched,
both the National Black Caucus of Legislators and the American
Academy of Neurology have issued resolutions opposing substitution of
anti-convulsant drugs for the treatment of epilepsy without the
informed consent of the patient and treating physician.

LEGISLATIVE HISTORY:
S.5855 (2009-2010)
A.9303 (2007-2008) Referred to Higher Education and Held for
Consideration.

FISCAL IMPLICATIONS:
None.

EFFECTIVE DATE:
This act shall take effect immediately.