Prohibits a pharmacist from substituting any anti-epileptic drug for a prescribed anti-epileptic drug without the informed consent of the prescriber and patient

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

A9303 (2007 - 2008) referred to higher education and held for consideration.

Fiscal implications

None.

Effective date

This act shall take effect immediately.