Sponsored by:
Senator PATRICK J. DIEGNAN, JR.
District 18 (Middlesex)
Senator MICHAEL J. DOHERTY
District 23 (Hunterdon, Somerset and Warren)
Co-Sponsored by:
Senator Greenstein
SYNOPSIS
Requires physicians and other prescribers to obtain informed consent from parents or guardians of minors for certain medications with “black box warnings.”
CURRENT VERSION OF TEXT
As introduced.
An Act concerning the prescribing of certain medications to minors and supplementing Title 45 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. Prior to prescribing for an individual under 18 years of age any psychotropic medication, including but not limited to medication for the treatment of Attention Deficit Disorder or Attention Deficit and Hyperactivity Disorder, required by the federal Food and Drug Administration to have a “black box warning” on its labeling, a physician or other authorized prescriber shall inform the individual’s parent or legal guardian about the possible side effects of the medication and shall obtain informed written consent from the individual’s parent or legal guardian for the notification. In the event written consent cannot be obtained, the physician or other authorized prescriber shall make a notation in the patient’s file setting forth the date and circumstances of the informed consent.
A physician or other authorized prescriber who prescribes a medication in violation of this act shall be subject to disciplinary action by the State Board of Medical Examiners.
2. Prior to prescribing for an individual under 18 years of age any psychotropic medication, including but not limited to medication for the treatment of Attention Deficit Disorder or Attention Deficit and Hyperactivity Disorder, required by the federal Food and Drug Administration to have a “black box warning” on its labeling, an advanced practice nurse shall inform the individual’s parent or legal guardian about the possible side effects of the medication and shall obtain informed written consent from the individual’s parent or legal guardian for the notification. In the event written consent cannot be obtained, the advanced practice nurse shall make a notation in the patient’s file setting forth the date and circumstances of the informed consent.
An advanced practice nurse who prescribes a medication in violation of this act shall be subject to disciplinary action by the New Jersey Board of Nursing.
3. The Division of Consumer Affairs in the Department of Law and Public Safety, in consultation with the Department of Health, shall adopt, pursuant to the "Administrative Procedure Act," P.L.1968 c.410 (C.52:14B-1 et seq.), rules and regulations necessary to implement the provisions of this act.
4. This act shall take
effect 180 days after enactment.
STATEMENT
This bill requires physicians, advanced practice nurses, and other authorized prescribers to obtain informed written consent from parents or legal guardians of minors prior to prescribing them psychotropic medications that are accompanied by a “black box warning.” The bill specifies that in cases where written consent cannot be obtained, the prescriber must make a notation in the patient’s file indicating the date and circumstances of the informed consent.
The United States Food and Drug Administration (FDA) requires pharmaceutical companies to place a “black box warning” on a drug label if medical studies indicate that the drug carries a significant risk of serious or life-threatening adverse effects. A “black box warning” is the strongest warning that the FDA requires.
Under the bill, a physician, advanced practice nurse, or other authorized prescriber who violates its provisions is subject to disciplinary action by the applicable State professional licensing board.