Action | Ethical standards for practice |
Stage | Proposed |
Comment Period | Ended on 1/28/2005 |
16 comments
I have spoken to doulas, childbirth educators and mothers across the USA. And time and time again, we are reminded of the devestating effects of Cytotec. And time and time again physicians still use this drug on women. Yes, the possible side effects are serious in nature and I am disgusted that such a drug can be used on women, especially when two lives are at risk. Even more disgusting then the risks involed with this drug is the fact that doctor's do not inform women of the dangers of this drug. I think it is sad that doctor's are already ethically required to inform women of the risks of procedure, interventions, drugs, etc, but that it will take a panel such as this to enforce it. Please send a message tp physicians that women are not lab rats and should not be treated as such!
Thank You,
Sincerely,
Cindy Simpson, CD(DONA), CE
Informed consent is a basic expectation of careproviders. Sadly, this expectation is not being met and women are not being given evidenced-based care, especially in their childbearing options. A strong example of this statement is the off label usage of drugs like Cytotec in laboring women. Cytotec is a drug that is not approved by the FDA for this purpose and the manufacturer clearing states on the label that it is not to be used for obstetrical purposes ever. Many moms and babies have been harmed or even killed by this drug. The saddest part in this is that they were never informed that this drug is experimental or of the risks or alternatives.
Obviously, there are times when off-label usage has been beneficial. But, across the specialties from obstetrics to geriatrics, patients should be informed when a drug has not been approved for use in their situation. This seems like common sense, but so far common sense and ethical responsibilities have not made this a reality. Please modify this regulation to include informed consent for off-label usage of medication.
Thank you,
Crystal Musselman
Roanoke, VA
Please consider a provision that requires informed consent for the use of off-label , particularly in Obstetrics.
Thank you,
Brynne Potter
I am offended by the way that humans are treated as though they don’t have the common sense to make a judgment call for themselves without a "higher up" making the "right" decision for them. People have the right to have a trusting relationship with their physicians. This includes being very well informed about warnings of medications being prescribed to them. There is no trust left if they have to have this discussion with their physician AFTER they have already experienced the side effects that COULD HAVE been avoided. There is no such thing as "too much information". There would be far fewer law suits if physicians believed that people had the right to take their healthcare into their own hands.
I 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! Thank you for your work!
Alicia King
I am in favor of including provision for mandatory informed consent for the "off-label" prescription and use of medications. Patients can be trusted to be the decision-makers concerning their health and well-being and should be informed of all the details concerning the medication their doctors recommend, including benefits & risks and whether or not the FDA has tested and approved the drug for the use in which it is being prescribed, so that they can make a truly informed decision.
Thank you for your consideration.
Respectfully,
Kristin Schuchmann
I think it's bad legislation to restrict use of pharmaceutical agents only as labeled or to require 'informed consent' for off-label use in every instance. As the Board is likely aware, The AMA estimates that as many as 40% of prescriptions written are for off-label uses. To require 'informed consent' for pharmaceutical agents hogties prescribers, increases not only the cost of manufacture and sale of agents but the administration of agents by prescribers, pharmacists, and others. Further, it does not benefit the patient as in most uses, the ADE profile will be the same regardless of condition it's prescribed for. For instance, your chance of blood clots from Ortho-Evra doesn't change if you're taking it to prevent pregnancy or to treat irregular menses.
Prescribers are not stupid people. I've never seen one say "Hey, let's try Dilacor for that peptic ulcer you've got." They spend thousands of dollars and hours educating themselves on treatment protocols involvind the use of both labeled and off-label pharmaceutical therapy. Full prescribing information for both clinicians and patients is provided with every medication dispensed, with supplementary prescribing information provided online, in readily available publications such as the PDR and elsewhere. One need only to ask their prescriber 'Is this a labeled use for this drug?' to get not only the answer as well as their reasoning, if off-label, for prescribing.
Regina Brown
The need is for mandatory informed consent when considering the use of off-label drugs in the health care field. Too many womyn and babies have already died or had grave consequences from the application of Cytotec during labor and birth. It is imperative that mandatory regulations are put into place and upheld for the safety of all involved.
Sabine L Kennon CD CLD Student Midwife
I have read with attention all the public concerns about the “off label” use of medications in the current medical practice. It is important for all the public to be aware that the use of misoprostol (Cytotec) is not longer investigational. Research, with all the requirements established for medical investigation in human beings, have been undertaken and completed since 1996. Many dedicated, ethical organizations had participated and the consensus is that misoprostol is a useful medication to use for the induction of labor (See
It is important for everybody involved in this discussion to be aware that the guidelines for research are very carefully followed, and that these guidelines are stringent and all of them require a written informed consent with extensive explanation and education of the subjects, in this case patients, involved.
Finally, oxytocin –a medication FDA approved for labor, has a similar safety profile that misoprostol. One more time, the issue is the judicious and appropriate use of both medications and not the medications per se (See Mozurkewich E: The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term. American Journal of Obstetrics & Gynecology 2003, pp: 1026–1030)
It is important to notice, as I mentioned before, the safety profile of misoprostol is not different at all from the safety profile of oxytocin. What I am trying to convey is that both drugs can cause amniotic fluid embolism, labor hyperstimulation and fetal problems when are not used appropriately. Amniotic fluid embolism, although devastating, is very rare (1:20,000 to 1:30,000 livebirths in the
Since November 1999, ACOG has followed this issue very closely, and has issued at least three Committee Opinions regarding misoprostol (See Committee Opinions Numbers 228, 248, and 283). In the latter one, it refers to FDA labeling changes regarding the use of this medication for labor induction (See http://www.fda.gov/medwatch/safety/2002/cytotec_changes.PDF) and the ACOG position remains stable, within the standard use as proposed in the ACOG Committee Opinion #228, and re-emphasized on #283, the use of misoprostol for labor induction is an adequate, proven and efficacious approach where indicated.
One last comment about this issue. The idea that the use of medications, any medication with any degree of FDA approval, is devoid of risks is misleading. Best efforts are made, by all the organizations involved, in provide patients with the safest medications possible. Unfortunately, nothing is free of risks: Acetyl salicylic acid (aspirin), possibly the oldest drug in the market, has a list of uncommon side-effects that can affect different organs and systems such as severe hemorrhagic and coagulation disorders, Reye’s Syndrome, hepatitis, rhabdomyolysis and a large number of other rare entities
Thank you