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Non-FDA approved use of medication



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  #1  
Old Nov 27, 2007, 08:12 PM
Registered User
Join Date: Aug 2001
Unhappy Non-FDA approved use of medication

Would I be operating outside of the NJ Nurse Practice Act by giving a
prescribed medication for a use not approved by the FDA?
A doctor has prescribed Wellbutrin for a 13 year old student of mine.
This student is non-compliant with taking his meds at home for his mother.
He has been suspended X3 already this year, and as a condition for his
return, he must come to my office every am to take his medication (per our
Superintendent of Schools).
"Wellbutrin XL is not FDA approved for use in treating any indications in
the pediatric population." The prescribing information goes on to quote the
BOX WARNING for Clinical Worsening and Suicide Risk.
I have the necessary signatures (PMD and Parent) for medication
administration. I personally have no problem helping out in this situation,
but am unsure where I stand professionally. I realize that there
are many times that medications are used for off-label reasons, but I have
never done so at school. Wellbutrin is a drug that requires
a consistent blood-level, and if he's not taking it for his mom, then he
will only be taking it 5 days/week. I also don't want to be the one
responsible if this student suffers from one of the adverse reactions or
events.

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  #2  
Old Nov 27, 2007, 08:14 PM
Suesquatch's Avatar
Urbanite
Join Date: Jan 2006
Re: Non-FDA approved use of medication

I can't speak to the NJ Nurse Practice Act, but I certainly don't have a problem with doctors using meds for off-label things.

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  #3  
Old Nov 27, 2007, 09:45 PM
Premium Member
Join Date: Oct 2001
Re: Non-FDA approved use of medication

Check with your state BON, but I know of no restrictions on nurses administering medications used for off-label purposes. As long as you have a valid prescription written by an licensed healthcare provider, and the plan of care has been agreed to by the child's parents, I don't see any problems.

Having worked in NICU, where MOSt of the meds used are for off-label purposes, I would have been in trouble long ago!

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