What's happening
This bill requires pharmacists to obtain notification and informed consent from both prescriber and patient before substituting any anti-epileptic drug.
Why it matters
Ensures patient safety by requiring explicit, documented consent. before pharmacists can switch any anti-epileptic medication, recognizing that even small changes in these drugs can trigger seizures or adverse effects in sensitive populations.
Empowers prescribers to oversee all changes. in anti-epileptic drug therapy, reducing the risk of unintended drug interactions or loss of seizure control that might occur when generics or alternative brands are substituted without their knowledge.
Protects vulnerable groups (such as children and those with legal guardians). by mandating that consent can come from a parent, legal guardian, or spouse, not just the patient, ensuring appropriate oversight and understanding of potential risks.
Modifies existing pharmacy law by creating an exception. to the general rule requiring pharmacists to substitute generic drugs when available, acknowledging that anti-epileptic drugs require stricter handling due to their complex and individualized effects.
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Who cares
Pharmacists and pharmacies
The bill would bar substitutions of anti-epileptic drugs used to treat epileptic seizures without prior notification and signed informed consent, creating an exception to the requirement to substitute less expensive equivalent drugs.
Physicians prescribing anti-epileptic drugs
Prescribing physicians would have to receive prior notification and give signed informed consent before a pharmacist could change the prescribed product or formulation.
Patients with epileptic seizures and their families
A substitution would require prior notification and signed informed consent from the patient or the patient's parent, legal guardian or spouse.
Brand-name and generic anti-epileptic drug manufacturers
The restrictions would cover brand-to-generic switches, generic-to-brand switches and changes between generic manufacturers, as well as different formulations or therapeutic products.
Headline styles
No Drug Swaps Without Consent
Plain English, a few words. Used as the page title.
Sponsors
History
- Referred to higher education
- Referred to higher education
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
3982
2019-2020 Regular Sessions
IN ASSEMBLY
January 31, 2019
Introduced by M. of A. AUBRY -- Multi-Sponsored by -- M. of A. BENEDET- TO, CAHILL, COLTON, JAFFEE, KOLB, PERRY, RIVERA, L. ROSENTHAL, THIELE -- 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 prescriber and the patient prior to the substitution of a prescribed anti-epileptic drug
The People of the State of New York, represented in Senate and Assembly, do enact as follows:
Section 1. The public health law is amended by adding a new section 3346 to read as follows:
§ 3346. Anti-epileptic drug product selection prohibited. 1. As used in this section:
(a) "Anti-epileptic drug" means (i) any drug prescribed for the treatment of epilepsy or (ii) a drug used to treat or prevent seizures.
(b) "Epilepsy" means a neurological condition characterized by recurrent seizures.
(c) "Seizure" means an acute clinical change secondary to a brief disturbance in the electrical activity of the brain.
(d) "Interchange" means the substitution of one version of the same anti-epileptic therapeutic product, including a generic version for the prescribed brand, a brand version for the prescribed generic version, a generic version by one manufacturer for a generic version by a different manufacturer, a different formulation of the prescribed anti-epileptic drug or a different anti-epileptic therapeutic drug product for the anti-epileptic product originally prescribed.
2. No pharmacist shall interchange an anti-epileptic drug or formulation of an anti-epileptic drug, brand or generic, for the treatment of epileptic seizures without the prior notification of and the signed informed consent of such interchange from the prescribing physician and 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.
LBD08096-01-9
A. 3982 2
§ 2. The opening paragraph of subdivision 1 of section 6816-a of the education law, as added by chapter 776 of the laws of 1977, is amended to read as follows:
[A] Except as provided in section thirty-three hundred forty-six of the public health law, a pharmacist shall substitute a less expensive drug product containing the same active ingredients, dosage form and strength as the drug product prescribed, ordered or demanded, provided that the following conditions are met:
§ 3. This act shall take effect immediately.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.