Sponsored by:
Senator JOSEPH F. VITALE
District 19 (Middlesex)
SYNOPSIS
Prohibits substitution of prescribed epilepsy drugs by pharmacists without prior notification to and written consent of physician and patient.
CURRENT VERSION OF TEXT
As introduced.
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.