require mandatory informed consent for the off-label use of medications

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

Please consider a provision that requiring mandatory informed consent for the off-label use of medications.

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

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

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

Doctors should be required to give their patients all of the information about a drug that is being used for a purpose other than the FDA has approved. What is happening with the drug Cytotec must stop. Families are entitled to all of the information about a drug or procedure so that they can make evidence based choices.

 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

I stand adamantly in agreement with Mr. Cochran's proposal. As an RN working in Psychiatry, I am aware that informed consent requirements are not foolproof, but they are at least a reasonable beginning in assuring patient safety and self-empowerment. At a minimum, any psychotropic medication given to a child must must be discussed thoroughly with their parents or guardians, reasonable risks and benefits explained, and informed consent obtained in writing. Even more urgent is the need for informed consent for off-label use of drugs such as Cytotec in Obstetrics. Here the risks are so severe and the horror stories so compelling that most reasonable patients would probably refuse the drug if they were objectively informed. Thank you, Bill Hoyer, RN

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 support the proposed informed consent requirements for prescribing drugs for off-label uses.  The comment period should be extended.  Ken Runes

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 Goldberg AB: Journal of Midwifery & Women’s Health. July 2004; Crane JM: Best Practice Research. Clinical Obstetrics & Gynaecology. October 2004). This research is also supported by the American College of Obstetrician and Gynecologists (See ACOG Committee Opinion. Number 283. May 2003). In this sense, please be aware that the use of medications “off FDA label” is not an individual idea, originated with the sense of “let’s see what happens” as it is implied in some of the comments posted. It will also be as important to realize that medical research is a continuum. As new evidence and technology surface so our approach to the different conditions changes

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)

The misuse of Cytotec and the risks associated with its use in labor induction are perfect examples of the many reasons why informed consent is so crucial. The previous poster is mistaken when he claims that research has established Cytotec's safety. As the editor of the British Journal of Obstetrics and Gynaecology commented in the January 2004 issue, the studies done to date have been "too small to provide evidence on rare but important outcomes." Attempts at meta-analysis of the data (such the Journal of Midwifery and Women's Health article the previous poster references) are all but meaningless because of the serious disparities among the treatment protocols used. Amniotic fluid embolism is perhaps the most disturbing "rare but important outcome" associated with the use of Cytotec, yet women are rarely, if ever, informed of this risk. In fact, Cytotec was introduced into obstetrical practice before any research on it had been done at all, and thousands of women and babies have experienced adverse outcomes without ever having been informed of the lack of data on the drug's safety, the "rare but important outcomes" associated with it, or the fact that it's not FDA approved for labor induction. No one is suggesting a ban on the off-label use of Cytotec or any other medication. We're simply asking the BoM to consider including informed consent for off-label use of drugs in its revised ethical standards. Thank you for the opportunity to comment. Katherine Prown

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 US), and it is not any more frequent with misoprostol than with oxytocin.

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