Informed consent from parents or guardians of minors for certain medications with “black box" warnings

To:  New Jersey Legislators

ASSEMBLY, No. 378

STATE OF NEW JERSEY

213th LEGISLATURE

PRE-FILED FOR INTRODUCTION IN THE 2008 SESSION

Sponsored by:

Assemblyman PATRICK J. DIEGNAN, JR. District 18 (Middlesex)

Assemblywoman NILSA CRUZ-PEREZ District 5 (Camden and Gloucester)

Assemblyman MICHAEL J. DOHERTY District 23 (Warren and Hunterdon)

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 of February 20, 2008]

Introduced Pending Technical Review by Legislative Counsel

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 consent from the individual's parent or legal guardian for the notification.

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 consent from the individual's parent or legal guardian for the notification.

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 and Senior Services, 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 would require physicians, advanced practice nurses, and other authorized prescribers to obtain informed consent from parents or legal guardians of minors prior to prescribing them psychotropic medications that are accompanied by a "black box warning."

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.

Sincerely,

The Undersigned

The Informed consent from parents or guardians of minors for certain medications with “black box" warnings Petition to New Jersey Legislators was created by and written by Lisa Van Syckel (lvansyckel61@yahoo.com).  This petition is hosted here at www.PetitionOnline.com as a public service. There is no endorsement of this petition, express or implied, by Artifice, Inc. or our sponsors. For technical support please use our simple Petition Help form.