SENATE HEALTH, HUMAN SERVICES AND SENIOR CITIZENS COMMITTEE

STATEMENT TO

SENATE, No. 1642

with committee amendments

STATE OF NEW JERSEY

DATED:  MAY 13, 2019

      The Senate Health, Human Services and Senior Citizens Committee reports favorably and with committee amendments Senate Bill No. 1642.

      As amended by the committee, this bill requires physicians, physician assistants, 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,” which consent is to include a written acknowledgement that the parent or guardian received notification about the black box warning.  As amended, the bill specifies that in cases where written consent cannot be obtained but oral consent is provided, 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, physician assistant, advanced practice nurse, or other authorized prescriber who violates its provisions is subject to disciplinary action by the applicable State professional licensing board.

COMMITTEE AMENDMENTS:

      The committee amendments add a provision making the bill applicable to physician assistants, as well as to physicians, advanced practice nurses, and other authorized prescribers.

      The committee amendments clarify that informed consent provided under the bill is consent to issuance of the prescription, and that the written consent is to include an acknowledgement that the parent or guardian received the information concerning the side effects of the drug from the prescriber.

      The committee amendments add language clarifying that prescribers may document consent in the absence of written informed consent only when oral consent has been provided.