Support Informed Consent Amendment for Off-Label Use of Approved Medications

CLICK HERE > http://www.townhall.state.va.us/Stage/ViewStage.cfm?Stage=2830
TO COMMENT IN SUPPORT OF AN AMENDMENT TO PROPOSED BOARD OF MEDICINE REGULATIONS GOVERNING ETHICAL STANDARDS OF PRACTICE in VIRGINIA


Currently proposed regulations would require practitioners to obtain informed consent before performing surgical or invasive procedures, however, they would not apply to prescribing or administering medications, not even for "off label" uses, such as administering the ulcer drug Cytotec to induce childbirth in disregard of severe FDA approved label warnings, prescribing powerful adult psychotropic medications to control the behavior of young children even in the absence of studies of the effects that they may have on less than fully developed brains, and other less than scientifically supported applications for drugs that have received general FDA approval, albeit for entirely different purposes.

I've asked the BoM to extend the regulatory process in order to consider an amendment to proposed 18VAC85-20-24
that would somehow effectively state the following:
"5. Medications prescribed or administered for purposes other than those specifically approved by the U.S. Food and Drug Administration (FDA) shall be considered experimental, and informed consent, as defined in § 32.1-162.16 of the Code of Virginia, shall be obtained from the patient. Pursuant to this provision, informed consent shall also include the disclosure of all notices of warnings, contraindications or adverse reactions that appear in the FDA approved package inserts related to the use of such medications, and such informed consent should be obtained prior to reasonably foreseeable circumstances during which the practitioner may intend to prescribe or administer such medications."

It only takes a few minutes to register and post your comments to the Virginia Legislative Town Hall's public comment forum. The Board of Medicine will host a Public hearing in Richmond on Friday, 1/21 to otherwise conclude the approval of the previously proposed regluations.

Click here for more details: http://www.townhall.state.va.us/Stage/ViewStage.cfm?Stage=2830

Please ACT NOW! . . . and FORWARD THIS APPEAL to any related lists and blogs.

Thank you,