Can NPs prescribe meds for off label purposes?

Trauma Columnist · Feb 9, 2012

I do not do it. In fact, although my docs will go above the prescribed limits for some BP meds, I don't do that either unless I discuss it with them and then I document my discussion.

Easy way to get in really big trouble.

Cessna172 · Feb 9, 2012

Thank you traumaRUs, I appreciate your input. I haven't had a situation where this has occurred by my MD preceptor, but I agree it would be trouble waiting to happen for a NP.

nomadcrna, DNP, CRNA, NP · Feb 9, 2012

I practice according to EBM. If the current literature supports a use for a medication, I am willing to use it.

Off label use is using a medication for a process for which it is not currently approved for.

As in years ago, we used Toradol IV before it was approved for use in that manner. The medical literature backed up its use in that way.

The same with antibiotics, amoxicillin in particular. How long did it take the "approval" for the increased doses we routinely use now for OM? The literature supported our use of the increased dose long before it was officially approved.

core0 · Feb 9, 2012

Hi, I read my state's practice act, but can't tell if prescribing meds for off label use is permitted by NPs. Do any of you do it? This question has been bugging me for a while, so I'd like to hear from practicing NPs about this . I am in a FNP program, and graduate in December 2012. Thanks!

I'll come in with a different perspective. Off label use is any use where the indication, dosage, age group or form of administration was not approved.

On a routine basis we use drugs in ways that are not approved. The reason is that either for financial reasons or because of bureaucratic delays drugs may never get the specific indication for the use.

For example in the ICU we use Seroquel for delirium. The indications are Bipolar disorder, Schizophrenia and Acute depression. Given that it will shortly become generic its unlikely that there will ever be a delirium indication. However, there are multiple studies and and guidelines that recommend its use. The key is knowing what the background for the drug is and what the current practice patterns and research are.

The more specialized you are the more likely you will find yourself using a drug off label. In Peds GI for example when I was practicing none of the PPIs were approved for use in children. However with a wealth of research we prescribed them for all ages and worked with compounding pharmacies get acceptable forms.

In answer to your particular question I am not aware of any State that requires NPs to prescribe only for on label indications. For medications most states follow the medical practice act and allows prescription of approved drugs regardless of the indication. There are some special restrictions around potential abortifactants but otherwise indication is not addressed.

The key is to follow the old maxim of don't be the first and don't be the last. Don't be too cutting edge (Propofol in the bedroom comes to mind) don't cling to the indication after the standard of practice has move on.

Cessna172 · Feb 9, 2012

You all have given me some really good information on this subect. Things I would not have thought about yet (inexperienced, lol) seem so clear in your explanations. Thanks. I appreciate your input.

Bobby

zenman · Feb 9, 2012

Back to Seroquel. FDA approved for Acute schizophrenia, Schizophrenia maintenance, Acute Mania, Bipolar maintenance and Bipolar depression. Other off label uses are; major depressive disorders, other psychotic disorders, behavioral disturbances in dementias, behavioral disturbances in Parkinson's disease and Lewy body dementia, psychosis associated with levodopa treatment in Parkinson's disease, behavioral disturbances in children and adolescents, impulse control disorders, severe treatment-resistent anxiety, and sleep. We prescribe for off label uses all the time.

rnsrgr8t · Feb 9, 2012

I'll come in with a different perspective. Off label use is any use where the indication, dosage, age group or form of administration was not approved.
On a routine basis we use drugs in ways that are not approved. The reason is that either for financial reasons or because of bureaucratic delays drugs may never get the specific indication for the use.
For example in the ICU we use Seroquel for delirium. The indications are Bipolar disorder, Schizophrenia and Acute depression. Given that it will shortly become generic its unlikely that there will ever be a delirium indication. However, there are multiple studies and and guidelines that recommend its use. The key is knowing what the background for the drug is and what the current practice patterns and research are.
The more specialized you are the more likely you will find yourself using a drug off label. In Peds GI for example when I was practicing none of the PPIs were approved for use in children. However with a wealth of research we prescribed them for all ages and worked with compounding pharmacies get acceptable forms.
In answer to your particular question I am not aware of any State that requires NPs to prescribe only for on label indications. For medications most states follow the medical practice act and allows prescription of approved drugs regardless of the indication. There are some special restrictions around potential abortifactants but otherwise indication is not addressed.
The key is to follow the old maxim of don't be the first and don't be the last. Don't be too cutting edge (Propofol in the bedroom comes to mind) don't cling to the indication after the standard of practice has move on.

I agree with this. I work in peds and a LOT of the drugs we use are not "approved" for use in children (mostly because it costs drug companies a LOT of money to do the extra studies the FDA requires). The key is to use evidenced based practice and use meds that are already being used safely. Case in point, I treat kids with overactive bladder and use a lot of the anticholinergics on the market (Ditropan, Detrol, Vesicare, Enablex, Oxytrol). Ditropan is the only one approved for children but the other medications have been used safely in children for years and it is standard practice to use them. There have been some newer meds out (Sanctura for example) that I have not used yet b/c I will let my MD colleagues perscribe them first before I attempt on my own. I like the quote above, do not be the first or the last.

Cessna172 · Feb 10, 2012

Super info, it's great to hear from people who do this everday and I appreciate all of your wisdom on this. I will try to remember some of the little "nuggets" of knowledge given here. Thanks.

Bobby

Advanced Practice Columnist / Guide · Feb 12, 2012

You'll find that off label use of meds are common in hospitalized patients especially in academic medical centers and teaching hospitals aside from the fact that some drugs are used off label as part of an ongoing research study. As the other posters stated, as long as there is evidence in the literature that backs the benefit of the off label use, there typically isn't an issue with insurance reimbursement and it doesn't matter whether a physician or a non-physician provider is writing it.

At our institution, some examples I could think of are Haldol for ICU delirium if unable to take PO Seroquel (which core0 also mentioned), Propranolol for variceal hemorrhage prophylaxis for end-stage liver disease patients with known esophageal varices, Amiodarone for atrial fibrillation prophylaxis in open heart surgery, Dexmedetomidine for sedation of intubated patients longer than the maufacturer's recommendation of a 24-hour IV drip, and inhaled Nitric Oxide for lung inujry and RV dysfunction after cardiac surgery.

Cessna172 · Feb 12, 2012

Awesome info, thank you.

Bobby

psychonaut · Feb 12, 2012

Check your state practice act first.