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