Re: 21 polo horses that died post-injection

The SkepVet — Thu, 30 Apr 2009 15:26:47 GMT

there are two click on's when you post here, one click on for question the other click on discussion. I clicked on discussion because I am skeptical that the majority of vets in the USA really want the FDA to leave us alone while we juice/jug our patients?

Got the information below from the americal association of equine practitioners website which confuses the issue for me how the law in the USA applys to these 21 polo pony deaths

quote "Compounding is not permitted by the FDA but as
long as everyone plays by the rules, the government will
exercise what it calls discretionary
enforcement. (They will leave us
alone.)"

"Enforcement Discretion
COMPOUNDING IS NOT permitted by the FDA..
however,
FDA recognizes that veterinarians often compound drugs and therefore exercises its
ENFORCEDMENT discretion to permit compounding
FDAs Compounding Policy
(www.fda.gov/ora/compliance_ref/cpg/) (rev 7/14/03)"

"So here is what we have: under strict interpretation of the
law, compounding is illegal, however the government recognizes
the need for compounded products in specific situations.
As such, they have provided these guidelines and as
long as everyone plays by the rules, the government will
exercise what it calls discretionary
enforcement. (They will leave us
alone.)

"EQUINE VETERINARY EDUCATION / AE / March 2007 iii
our direction and the liability
falls solely on the
prescribing veterinarian.
Should an adverse reaction
occur and you are
found negligent, then
standard of practice
claims for your defense
may not be admissible.
The fact that the use of
compounded drug substitutes
and the off-label
use of medical devices is common practice will not constitute
a viable defense in a malpractice suit. The
AVMA-PLIT has stated their feelings on the use of compounded
medications which can be reviewed at
www.avmaplit.com.
The amount of product compounded must be commensurate
with the need of the animal identified in the
VCPR-based prescription. You should only order the
specific amount of product you need, for that particular
animal, at the time you need it. You should not order
excess.
All relevant state laws relating to compounding must be
followed. If you do not know your applicable state laws
then call your State Pharmacy Board and get informed.
The expiration date of a compounded drug should be for
the duration of therapy. In other words, if you have a
compounded product that is to be used on a horse for 30
days, at the conclusion of those 30 days, the product has
expired.
Veterinarians cannot use compounded drugs to merely
save money over other FDA-approved available products
that a compounding pharmacy may claim are similar.
There are medical devices for the veterinary field that
are being sold and promoted illegally for off-label use as
drugs for intra-articular or intravenous use for the treatment
of DJD. Claims of this nature should put you on
guard and should steer you away from such compounding
pharmacies for ethical and liability reasons (The
AAEP is currently addressing this issue amongst the
compounding pharmacies relative to their exhibition
status in the annual trade show held during the convention
each year).
The use of compounded medications is a necessary part
of equine practice. The use of compounded medications
should be on an as-needed basis only, keeping on hand
The AAEP Board of Directors is committed to informing
the members on the legal use of compounded medications.
This article follows part 1 (Compounding 101) from last
month with examples to further clarify the principles.
Federal regulations require that in order to compound a
drug legally:
A valid Veterinarian-Client-Patient relationship (VCPR)
must exist. You cannot order compounded drugs for
owners living elsewhere unless their horses are under your
care in your practice.
The health of the animal must be threatened or suffering
or death may result from failure to treat. This is why the
FDA does not allow the compounding of injectable
deslorelin. You cannot make a case that the mare will die
if she doesnt ovulate on time. Additionally, the FDA has
mechanisms in place to allow for importation of
Ovuplant. This also applies for any other drug that you
may desire to have compounded. If the health of the animal
is not threatened, then you cannot get it compounded
legally.
There must be no FDA-approved, commercially available,
animal or human drug that, when used as labeled
or in an extra-label fashion in its available dosage form
and concentration, will appropriately treat the patient.
Oral altrenogest is commercially available and is an
FDA-approved product to be given daily. One may
consider daily dosing inconvenient but inconvenience
does not count as a reason to compound a long-acting
injectable product.
The compounded product must be made from an FDAapproved,
commercially available animal or human drug.
You should not compound phenylbutazone paste
whether its apple-flavored or at twice the concentration
because its already available as an FDA-approved product.
If you do decide to compound your own phenylbutazone
paste, then you are required to make it from the
FDA-approved powder or tabs on the market. The FDA
allows compounding when the approved product is not
in the required concentration, but it is difficult to convince
the FDA that your apple-flavored, compounded
phenylbutazone paste at two times the normal concentration
is needed for the health of the animal.
The product must be compounded by a licensed veterinarian
or a licensed pharmacist on the order of a veterinarian
within the practice of veterinary medicine."

art malernee dvm

Re: 21 polo horses that died post-injection

Arlo Guthrie — Wed, 29 Apr 2009 16:56:52 GMT

Art, this looks like the answer to a question noone has asked. Did you accidentally post it in the wrong forum/website?!

To give some context, I guess you are talking about this incident: http://www.huffingtonpost.com/2009/04/20/21-polo-horses-die-at-flo_n_189086.html