ACTION ALERT: Public comments needed to ensure informed consent for "off label" use of medications
Agency: Department of Health Professions
Board: Board of Medicine
Chapter: Regulations Governing the Practice of Medicine, Osteopathy, Podiatry, and Chiropractic (18 VAC 85-20)
Action Title: Ethical standards for practice
NEW REGULATIONS pertaining to medical ethics and informed consent are currently under consideration in Virginia, and public comments are being solicited. The proposed regulations address a long standing deficiency. While the proposals represent a big step in the right direction, there are still deficiencies that only you can help to address. This is a late appeal, and the regulations will be finalized in their current form unless 24 more people request the ask for consideration of the suggestions that I have recently submitted.
Current statutes and regs require professionals who are regulated by the Board of Medicine to practice in accordance with "the standards of ethics of his branch of the healing arts." However, the standards that have been adopted by various professional organizations (AMA, ACOG, etc.) are generally not intended to be used as substitutes for regulations, they are often vague and complicated, they change without notice to the states, not all professionals belong to the same organizations, etc.
The uniform regulations would require practitioners to obtain informed consent before performing surgical or invasive procedures, however, they would not apply to prescribing or administering medications, even for "off label" purposes such as the use of Cytotec to induce labor.
Therefore, I've submitted the following comment to the Board:
I am generally very pleased with the proposed regulations that would establish uniform standards of ethics for professions regulated by the Board of Medicine. However, I note the omission of one subject that I know to be of concern to many Virginians, which is the "off-label" prescription and administration of various medications. I realize that there are many legitimate reasons why it may desirable for practitioners to be allowed to use FDA approved drugs for purposes other than those for which they were initially tested, approved and intended. However, I firmly believe that the public has a right to be informed that such use is technically experimental, and what the associated risks may be.
Therefore, I urge 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 ยง 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."
My concern arises from my familiarity with the common use of the drug Cytotec (misoprostol) to induce or augment the labor of childbearing women, although I'm sure that this provision is also warranted with regard to the off-label use of other drugs.
I appreciate the simplified enabling of public participation that this forum provides.
Sincerely,
Steve Cochran
Floyd, VA
View and submit comments:
http://www.townhall.state.va.us/Forum/ListComments.cfm?Stage=2830
The process of promulgating these regulations began in June. The second and "final" Public Comment Period began on 11/28 and will end on 1/28/05. The Board will need to receive requests from at least twenty-five citizens in order to revise the proposed regulations at this stage in the process. If you agree in substance with the request that I've submitted, your request can simply state that you want the regulations to "require mandatory informed consent for the off-label use of medications." This will cause the draft to be amended and subjected to a new "final" round of consideration. Otherwise, a whole new process would need to be initiated to address the concern.
The Virginia Regulatory Town Hall web site makes it very easy for citizens to submit comments (after completing a simple registration process). I've collected and posted some of the information and links from the state web site at http://birthpolicy.org/medregs.html --or, if you're fairly web-savvy and familiar with the regulatory process, you can go straight to the applicable section of the Regulatory Town Hall web site --and you'll probably manage to make sense of it all on your own (also see, "How do I make on-line comments on regulatory changes?" at the bottom of this page).
This is a golden opportunity for citizens to participate in the regulatory process to hopefully ensure the ability of more women to make informed choices related to childbirth, and for all patients to make better informed health care decisions. It will familiarize midwifery advocates with the process by which direct entry midwives will be regulated, if and when the CPM bill is finally enacted.
Although the public comment period doesn't end until 1/28, the final public meeting (unless we succeed in adding this amendment to the draft) will be held in Richmond on Friday, January 21, 2005.
These regulations can go a long way toward ensuring the rights of childbearing women and many other patients of physicians in VA. Your help could be critical. 25 requests are needed to extend the process to allow for consideration of further amendments.
The process might seem somewhat complex at first, however, it's not really all THAT hard and we may learn that we the people can influence public policies, if we try.
For more info, see the links below, or feel free to contact me personally.
Steve Cochran
blog@vbfree.org
RELATED LINKS:
Institute for Childbirth Policy Reform - features selected info from the Town Hall's PDF files and other details
Virginia Birthing Freedom - same info as above, plus other Va. policy resources
Virginia Regulatory Town Hall - Proposed Regulation of Standards of Professional Conduct
- Proposed Regulation Agency Background Document (includes the summaries, basis and full text of all of the proposed regulations contained in this action)
18VAC85-20-21. Treating and prescribing for self or family.
18VAC85-20-22. Patient records.
18VAC85-20-23. Confidentiality.
18VAC85-20-24. Practitioner-patient communication; termination of relationship.
18VAC85-20-25. Practitioner responsibility.
18VAC85-20-30. Advertising ethics.
18VAC85-20-40. Vitamins, minerals and food supplements.
18VAC85-20-90. Pharmacotherapy for weight loss.
18VAC85-20-100. Sexual contact.
(you may want to review and comment on other sections as well)
Guide to the Regulatory Process
http://www.townhall.state.va.us/dpbpages/apaintro.cfm
How to Use the Regulatory Town Hall
http://www.townhall.state.va.us/dpbpages/howtouse.cfm
"How do I make on-line comments on regulatory changes?
The Town Hall contains an innovative feature for facilitating public participation in the regulatory process. The public comment forums on the Town Hall allow users to view comments made by others as well as submit comments of their own. At the present time, agencies are not required to host comment forums, so not every regulatory stage will have a public comment forum. Comment forums are only open for comment during the official comment period for a stage. After the comment period has closed, it is possible to view all of the comments that have been made, but it is not possible to enter a new comment. Whenever a comment forum is available, there will be a link on the Stage Information page to the comment forum. Another way to quickly access all currently-open comment forums is to use the View public comment forums link available on the menu bar.
View all comments:
http://www.townhall.state.va.us/Forum/ListComments.cfm?Stage=2830
Once you are in the comment forum section of the website, links are provided for viewing others comments and for entering your own. Currently, comments are limited to 750 words and users are limited to a two comments per forum.. You may enter your comment directly into the word-processing window provided on the web page, or you may cut-and-paste a comment you have prepared on your own word processor. After making your comment, be sure to save it. You must be a registered user in order to make comments on a forum. If you are not logged on to the site, you will be prompted to do so before making a comment.
Once you have made and submitted a comment, it becomes part of the official record of a regulatory action and cannot be changed. Of course, you are always free to submit a second comment to clarify or expand on your previous remarks."
