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A2020
ASSEMBLY, No. 2020
STATE OF NEW JERSEY
222nd LEGISLATURE
�
PRE-FILED FOR INTRODUCTION IN THE 2026 SESSION
Sponsored by:
Assemblywoman SHAMA A. HAIDER
District 37 (Bergen)
SYNOPSIS
���� Prohibits substitution of prescribed epilepsy drugs
by pharmacists without prior notification to and written consent of physician
and patient.
CURRENT VERSION OF TEXT
���� Introduced Pending Technical Review by Legislative
Counsel.
��
An Act
concerning substitution of epilepsy drugs and
supplementing P.L.1977, c.240 (C.24:6E-1 et seq.).
����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:
���� 1.��� a.� Notwithstanding any
law to the contrary, a pharmacist shall not interchange an anti-epileptic drug
or formulation of an anti-epileptic drug, brand or generic, for the treatment
of seizures associated with epilepsy without providing prior notification to,
and obtaining the signed informed consent of, the prescribing physician and the
patient, or the patient�s parent, legal guardian or spouse, as applicable.
���� b.��� As used in this act:
���� �Anti-epileptic drug� means
any drug prescribed for the treatment of epilepsy or a drug used to treat or
prevent seizures.
���� �Epilepsy� means a
neurological condition characterized by recurrent seizures.
���� �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.
���� �Seizure� means an acute
clinical change secondary to a brief disturbance in the electrical activity of
the brain.
���� 2.��� This act shall take
effect on the first day of the second month following the date of enactment.
STATEMENT
���� This bill prohibits
pharmacists from substituting brand or generic anti-epileptic drugs prescribed
to treat seizures without prior notification to, and the signed informed
consent of, the prescribing physician and patient, or the patient�s parent,
legal guardian or spouse, as applicable.
���� Different patients respond
differently to seizure control medications.� For anticonvulsant drugs, small
variations in concentrations between FDA equivalent rated drugs can cause toxic
effects or seizures when taken by patients with epilepsy.
���� Anticonvulsant drugs for the
treatment of epilepsy differ from other classes of drugs in several ways that
make therapeutic or generic interchange of agents problematic.� In most
patients, controlling seizures with medication requires a slow and precise dosage
regulation of one or several medications.� Changing from one formulation of a
drug to another can usually be accomplished, and risks minimized, if physicians
and patients monitor blood levels, seizures, and toxicity.
���� Pharmacists do not have access
to the patient�s complete medical history and may not know why a particular
drug product was prescribed.� While pharmacists are a vital part of the health
care team, documented consent should be obtained from both the treating
physician and the patient prior to any substitution in anticonvulsant
medication in the case where the prescribing physician does not check �do not
substitute� on the prescription.