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.
STATE OF NEW YORK
________________________________________________________________________
635
2023-2024 Regular Sessions
IN ASSEMBLY
January 11, 2023
___________
Introduced by M. of A. AUBRY -- read once and referred to the Committee
on Higher Education
AN ACT to amend the public health law and the education law, in relation
to requiring notification of and the informed consent of the prescri-
ber and the patient prior to the substitution of a prescribed anti-ep-
ileptic drug
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. The public health law is amended by adding a new section
2 3346 to read as follows:
3 § 3346. Anti-epileptic drug product selection prohibited. 1. As used
4 in this section:
5 (a) "Anti-epileptic drug" means (i) any drug prescribed for the treat-
6 ment of epilepsy or (ii) a drug used to treat or prevent seizures.
7 (b) "Epilepsy" means a neurological condition characterized by recur-
8 rent seizures.
9 (c) "Seizure" means an acute clinical change secondary to a brief
10 disturbance in the electrical activity of the brain.
11 (d) "Interchange" means the substitution of one version of the same
12 anti-epileptic therapeutic product, including a generic version for the
13 prescribed brand, a brand version for the prescribed generic version, a
14 generic version by one manufacturer for a generic version by a different
15 manufacturer, a different formulation of the prescribed anti-epileptic
16 drug or a different anti-epileptic therapeutic drug product for the
17 anti-epileptic product originally prescribed.
18 2. No pharmacist shall interchange an anti-epileptic drug or formu-
19 lation of an anti-epileptic drug, brand or generic, for the treatment of
20 epileptic seizures without the prior notification of and the signed
21 informed consent of such interchange from the prescribing physician and
22 the patient, or the patient's parent, legal guardian or spouse.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD01565-01-3
A. 635 2
1 § 2. The opening paragraph of subdivision 1 of section 6816-a of the
2 education law, as added by chapter 776 of the laws of 1977, is amended
3 to read as follows:
4 [A] Except as provided in section thirty-three hundred forty-six of
5 the public health law, a pharmacist shall substitute a less expensive
6 drug product containing the same active ingredients, dosage form and
7 strength as the drug product prescribed, ordered or demanded, provided
8 that the following conditions are met:
9 § 3. This act shall take effect immediately.
