Script for non-FDA-approved uses?

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Julie P. - 24 Nov 2005 17:28 GMT

Is it legal and ethical for a provider to write an off-label script, where
the intended use of the medication is not an FDA-approved one?

Thanks!

Julie

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Pumbaa - 24 Nov 2005 19:58 GMT

> Is it legal and ethical for a provider to write an off-label script, where
> the intended use of the medication is not an FDA-approved one?
>
> Thanks!
>
> Julie

If the doctor has good literature references and knows what he is doing, I
would say sure. We used lidocaine IV a long time ago before it was ever
approved for cardiac use.

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Julie P. - 25 Nov 2005 03:14 GMT

>> Is it legal and ethical for a provider to write an off-label script,
>> where
[quoted text clipped - 7 lines]
> would say sure. We used lidocaine IV a long time ago before it was ever
> approved for cardiac use.

Thanks. I agree. But I know a lot of insurance plans though prevent
prescription coverage for any off-label uses. If and how they would find out
though is another matter, since diagnoses are often not written on the
scripts, as someone here posted.

Julie

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Gregory Poon - 24 Nov 2005 21:14 GMT

Legal? Yes. It's more commonplace than you think. Domperidone for
inducing lactation in new moms. Amitriptyline for migraine
prophylaxis. Propranolol for performance anxiety. Etc. Etc.

Ethical? That's very much a subject of even academic debate. Consider
this story though. A woman came to our pharmacy in tears because she
wanted to, but could not breastfeed her newborn, another pharmacy
refused to fill her script for domperidone from her obe/gyn for a non-GI
condition.

Gregory

> Is it legal and ethical for a provider to write an off-label script, where
> the intended use of the medication is not an FDA-approved one?
>
> Thanks!
>
> Julie

Reply to this Message

Julie P. - 25 Nov 2005 03:16 GMT

> Legal? Yes. It's more commonplace than you think. Domperidone for
> inducing lactation in new moms. Amitriptyline for migraine
> prophylaxis. Propranolol for performance anxiety. Etc. Etc.

Or Casodex for use in women to treat hirsutism (official FDA use would be
for prostate cancer for men).

> Ethical? That's very much a subject of even academic debate. Consider
> this story though. A woman came to our pharmacy in tears because she
> wanted to, but could not breastfeed her newborn, another pharmacy
> refused to fill her script for domperidone from her obe/gyn for a non-GI
> condition.

Wow, that is absolutely outrageous! She should have reported the pharmacist
to the state's governing board/college of pharmacy.

Julie

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Debjoy - 26 Nov 2005 01:48 GMT

> > Legal? Yes. It's more commonplace than you think. Domperidone for
> > inducing lactation in new moms.
[quoted text clipped - 9 lines]
>
> Julie

The prescription was probably not refused because of why it was prescribed.
The FDA doesn't allow the dispensing of domperidone except by a compounding
pharmacy. It can be ordered from Canada or New Zealand, or check with a
lactation specialist or LaLeche League for pharmacies that will make it.
The pharmacy I work at can't order the raw ingredients for it, but another
one nearby usually has it made in advance. You can't blame the pharmacist
for it.

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Bob G. - 25 Nov 2005 15:35 GMT

>Is it legal and ethical for a provider to write an off-label script, where
>the intended use of the medication is not an FDA-approved one?
>
>Thanks!
>
>Julie

Gosh Julie...you sure do have a lot of questions....BUT that is OK...

A physician can write anything he or she wishes for any use he or she
wishes to use it for... its legal... period..! The ethical part of
your question is harder to answer..but in general a Physician has the
right to PRACTICE medicine... and if you ever ask a Physician why he
practices instead of preforming you may be in for a shock...

Always bothered me that a Dentist can legally write for birth control
pills... ...ethical? ... I think not.... well who knows how that
Dentist practices his profession?

Bob G.

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Gregory Poon - 25 Nov 2005 17:02 GMT

I think most places have plugged that "loophole" by now. Dentists, like
nurse practitioners, chiropodists, midwives etc. have a restricted list
of drugs pertaining to their specialty/practice that they can legally
prescribe.

Gregory

> >Is it legal and ethical for a provider to write an off-label script, where
> >the intended use of the medication is not an FDA-approved one?
[quoted text clipped - 16 lines]
>
> Bob G.

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hawki63 - 25 Nov 2005 23:09 GMT

> I think most places have plugged that "loophole" by now. Dentists, like
> nurse practitioners, chiropodists, midwives etc. have a restricted list
> of drugs pertaining to their specialty/practice that they can legally
> prescribe.

sorry greg...don't know where you got the NP info...but you are wrong

am an np...have a dea number..and write for ANY drug out there...

not sure about chiropodists..not even sure they can write at all..

> Gregory
>
[quoted text clipped - 18 lines]
> >
> > Bob G.

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Patrick - 26 Nov 2005 05:39 GMT

I know a DDS that prescribed birth control pills as
an adjunct to some pre cancerous lesions that he
was treating his patient for (I guess some hormonal
therapy although I have never heard of it), so it
can be done. Also my primary care doc has a
practice with a certified family NP in it who I went
to Elementary School with, he is a great guy and
he prescribed a schedule II narcotic for me
before I had the chance to be referred to a pain
specialist. I work with some PAs in a local
community ER who prescribe whatever any doc
does, the only difference is at the end of the shift,
the ER doc reviews the charts. This is not a case
where the Doc is cosigning the script, this is after
the patient has been discharged and has left and the
doc is just reviewing the entire shifts charts. That case
may be just hospital policy and not even a legal
requirement, I am not sure.

Frankly I am tickled to death that NPs and PAs can
do as much as they can do. It expands healthcare to
more people and keeps healthcare costs down. If I were
not 41 years old I would go back to school and get my
PA with focus on internal medicine or my NP with focus
on primary care.

Signature

Patrick

Patrick H. Mason MS, OHST, EMT-I

A delusion shared by many is a culture; shared by some is a cult;
shared by 2 is love; but a delusion held by one is psychosis.

> > I think most places have plugged that "loophole" by now. Dentists, like
> > nurse practitioners, chiropodists, midwives etc. have a restricted list
[quoted text clipped - 30 lines]
> > >
> > > Bob G.

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HankG - 26 Nov 2005 12:20 GMT

> >Is it legal and ethical for a provider to write an off-label script, where
> >the intended use of the medication is not an FDA-approved one?
[quoted text clipped - 14 lines]
> pills... ...ethical? ... I think not.... well who knows how that
> Dentist practices his profession?

Wasn't (isn't) there a doctrine of 'scope of practice'? I once refused to
fill rx's for the son of a podiatrist. He was going overseas and the doc
wanted to prescribe all manner of anti-malarials and other meds.

HankG

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