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Am I within my rights in refusing to administer a drug that might not be safe or legal in the U.S.?

Monday August 20, 2012
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Question:

Dear Nancy,

I work in a Community Services Board, where a patient has obtained a physician's order for domperidone. It cannot be manufactured in the U.S. and requires an Investigational New Drug Application in order to bring it in from Canada. Am I within my rights to refuse to administer this drug?

Bettie



Nancy Brent replies:

Dear Bettie,

Your question is not easily responded to because of its brevity, but also because investigational drugs and the Food and Drug Administration policies and procedures are well beyond the scope of this column. So, some general comments are made for your consideration.

Initially, it is important to note that domperidone is a very controversial drug. As you know, it is not FDA approved in the U.S. So, your question of whether or not to administer the drug is made with these two issues in mind and that it is not known under what conditions the drug has been ordered e.g., as part of an investigational drug trial, for nausea and vomiting, to enhance lactation?

Generally it would be questionable for a nurse to administer any drug where there is a question about its safety, and there seem to be many questions about the safety of this drug. It is unclear why a nurse would want to administer any drug that is a risk to the patient, one big risk being that it is not approved in the U.S. Moreover, because you know about the status of this drug, your knowledge of the potential risks may hold you more accountable for administering it, in spite of the warnings and nonapproval by the FDA.

You can try to determine whether your state nurse practice act provides you with any guidance in this area. If the community center has a pharmacy that works with it, this would be another resource for you. Clearly, a consultation with a nurse attorney or an attorney who works with nurses would be an excellent choice.

In the meantime, you may want to check the FDA's website at www.fda.gov and click on the Enforcement Actions, Warning Letters and Inspections links to see what the FDA's actions and procedures have been thus far with domperidone. There is a great deal of information about the medication there.

Last, a general comment about the administration of any drug that poses a risk to a patient. In addition to a licensed nurse, licensed physicians also are able to administer medications. The physician could do so in this instance, if he or she believes it should be administered.

Sincerely,
Nancy




Nancy J. Brent, RN, MS, JD, is an attorney in private practice in Wilmette, Ill. This information is for educational purposes only and is not intended as legal or any other advice. The reader is encouraged to seek the advice of an attorney or other professional when an opinion is needed.