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A03719 Summary:

BILL NOA03719
 
SAME ASNo Same As
 
SPONSORAubry
 
COSPNSRRosenthal L, Benedetto, Jaffee
 
MLTSPNSRCahill, Colton, Kolb, McLaughlin, Perry, Rivera, Thiele
 
Add 3346, Pub Health L; amd 6816-a, Ed L
 
Prohibits a pharmacist from substituting any anti-epileptic drug for the prescribed anti-epileptic drug without notification of and the informed consent of the prescriber and patient or such patient's parent, guardian or spouse.
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A03719 Actions:

BILL NOA03719
 
01/30/2017referred to higher education
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A03719 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A3719
 
SPONSOR: Aubry (MS)
  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 treat- ment 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 epilep- tic 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 diag- nosed with epilepsy. People with epilepsy are concerned about the avail- ability 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 estab- lished formulations of both brand and generic products. Not all people with epilepsy are the same. The unique nature of epilepsy, more precise- ly 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 break- through (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 break- through 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-convul- sant 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 consider- ation A.3528 was referred to higher education in 2009 and 2010. A.6574 was referred to higher education in 2011 and was held for consid- eration in higher education in 2012. A.3062 was referred to higher education in 2013 and 2014. A.2991 was referred to higher education in 2015 and 2016.   FISCAL IMPLICATIONS: None.   EFFECTIVE DATE: This act shall take effect immediately.
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