Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Medicine
 
chapter
Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic [18 VAC 85 ‑ 20]
Action Ethical standards for practice
Stage Proposed
Comment Period Ended on 1/28/2005
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1/12/05  12:00 am
Commenter: Jill Carrillo

Informed consent addendum
 
Medical Practitioners have a responsibility to keep patients informed with respect to all aspects of their care, but particularly when using drugs for off-label purposes, particularly in Obstetrics, when there are two lives to consider. Therefore, I also agree with Mr. Cochran’s suggestion in urging the Board to include a 5th provision under "18VAC85-20-24(A), Practitioner-patient communication," that would 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." Your time and consideration is greatly appreciated! Jill G. Carrillo Richmond, VA
CommentID: 118