The following article appearing in the November 3, 2011, edition of Veterinary Practice addresses the liability issues a veterinarian may be exposed to when violating the law regarding compounded medications.
Legal Exposure Might Not be Worth the
Savings
Using a compounded drug instead of an FDA-approved
animal medication could open a veterinarian to legal exposure if the animal has
a bad outcome.
By Marie Rosenthal, MS
For Veterinary Practice News
Posted: Nov. 3, 2011, 2:35 p.m. EDT
Some veterinarians believe they are helping clients
reduce costs by ordering compounded drugs instead of medications approved by
the U.S. Food and Drug Administration.
But there’s a reason compounded drugs are cheaper than
FDA-approved medications, pharmaceutical companies say. Compounding pharmacies’
quality-control procedures are rarely as stringent or comprehensive as the good
manufacturing practices required by the FDA for approved products. Therefore,
the safety and efficacy of compounded drugs are not guaranteed.
In a case of therapeutic failure of a compounded
product when an FDA-approved medication is available, the amount the
veterinarian saves the client might turn a competitive advantage into a serious
disadvantage. That prescription could leave the veterinarian exposed to legal
liabilities because the FDA does not test or approve compounded drugs.
Liability Dangers
“Many times veterinarians don’t understand that they
are the first in line in liability in the event that a compounded product goes
bad,” says Denise E. Farris, Esq., owner of Farris Law Firm LLC in Kansas City,
Mo.
“If there is an adverse reaction, he or she is liable
to the client for veterinary malpractice. The liability coverage may not cover
that activity because most policies do not cover ‘gross negligence’ or
‘intentional acts.’
“If a veterinarian is prescribing a compounded
product, the veterinarian could be charged with negligence because he or she
knew or should have known that the product was untested and its efficacy was
not proven,” she says.
She adds that there can be further liability if a
client is not fully informed about the risk of using the compounded substitute.
Several studies have reported quality problems with
compounded drugs, including subpotency, superpotency and contamination. In
2006, 33 percent of active pharmaceutical ingredients for human drugs used by
compounding pharmacists or finished compounded human drugs failed an FDA test,
primarily because of sub- or super-potency or a lack of uniformity. Potency
ranged from 67.5 percent to 268.4 percent of the amount of drug declared on the
product labeling, according to the FDA.
In its report, the FDA says, “The results of the
survey suggest that problems with the quality of compounded drugs occur
throughout the country.”
Finding a Place
This is not to say that compounded products do not
have a legitimate place in equine medicine. They do, the FDA acknowledges, but
it says that place is narrow.
In a 2006 warning letter to a veterinary compounding
pharmacy, the FDA wrote: “The drugs that pharmacists compound are rarely
FDA-approved and thus lack an FDA finding of safety and efficacy.”
The FDA regards traditional compounding as the
extemporaneous combining, mixing or altering of ingredients by a veterinarian
or a pharmacist as ordered by a veterinarian (or physician) to create
medication tailored to the specialized needs of an individual patient.
“Compounding is a very narrow, specific field,” says
Jeffrey T. Berk, VMD, who practices equine medicine at Equine Medical
Associates in Lexington, Ky. “A compounded product is supposed to be produced
for a particular patient, for a particular condition, at a particular time and
is obviously tailored for a unique need for which there is no approved
product.”
Many clients think that compounded drugs are generic
substitutions of a name-brand medication, but they are not. By law, compounding
pharmacies are not allowed to make large quantities of medications using
commercial-scale equipment—that could be construed as manufacturing drugs
without a license.
Although the compounding pharmacist is supposed to use
FDA-approved active ingredients when compounding a drug, the final compounded
drug formulation is not an FDA-approved medication because it has not been
tested for efficacy, safety, potency, sterility, dosage or even stability.
Approvals
Generic drugs are subject to FDA oversight just as
brand-name medications are, but compounded drugs are not. A pharmaceutical
company that wants to make a generic version of a brand-name medication must
prove to the FDA that the generic is equivalent in all characteristics to the
brand-name medication. The generic drug must also meet the same manufacturing
quality control requirements as the brand-name product.
“There are appropriate times and ways to compound, and
there are inappropriate ways to compound,” says Lynne White-Shim, MS, DVM, an
assistant director in the American Veterinary Medical Association’s Scientific
Activities Division. “When a veterinarian is deciding how to treat his or her
patient that has a medical condition, the veterinarian needs to follow federal
rules if he or she decides on an extralabel use of a product, and compounding
rules are a component of extralabel drug-use rules.”
The experts say there is a hierarchy to prescribing
medications, especially when it comes to food animals. The rules allow for
greater flexibility when treating non-food animals, says Dr. White-Shim:
* The
first choice should be an FDA-approved veterinary medication indicated for that
species and marketed for that condition;
* The
second choice should be an FDA-approved veterinary medication which might be
indicated for another species;
* The third choice would be an FDA-approved human medication indicated
for that condition; and
*
Fourth, if there are no FDA-approved medications, a compounded drug.
“If a veterinarian is prescribing a compounded product
knowing that there is an equivalent FDA-approved medication on the market, then
that is an FDA violation,” says Farris, the attorney. “If there is an
FDA-approved medication, FDA regulations prohibit veterinarians from
prescribing a compounded equivalent, and prohibit a compounding pharmacy from
producing it.”
Limitations
Generally speaking, compounding pharmacies are
restricted from promoting or advertising unapproved new animal drugs, creating
and marketing compounded preparations that mimic FDA-approved medications, and
manufacturing large quantities of drugs under the guise of compounding or
distributing these preparations wholesale.
They are permitted to advertise in certain instances,
such as when the compounded product serves many patients that do not have
access to an FDA-approved product.
Some compounding pharmacies skirt the law,
veterinarians and pharmaceutical companies contend, and the FDA lacks the
resources to prosecute every violation.
Berk notes that the American Association of Equine
Practitioners and the AVMA, which have issued guidance for veterinarians about
the appropriate use of compounded products in veterinary medicine, encourage
the FDA to become more involved in enforcing compounding regulations.
“Veterinarians are under additional legal exposure
when they use compounded drugs,” Berk says.
The experts provide these tips to limit that exposure:
* Make
sure you have a valid veterinarian-client-patient relationship and provide full
disclosure about the compounded drug, its risks and why it is being prescribed.
* Use
compounded drugs only if an FDA-approved medication (indicated for either
animals or human use) is not available or cannot adequately treat the medical
condition at hand, and the health of the animal is threatened, or if suffering
or death may result from failure to treat.
*
Check whether the pharmacy is certified by an independent body, such as the
Pharmacy Compounding Accreditation Board.
*
Contact the state board of pharmacy to find out the status of the pharmacy
within the state and assure that it is licensed to compound in that state.
“Veterinarians often believe they are providing a cost
savings to the client, but their clients may not understand that the cost of
the legitimate FDA-approved products include long-term testing for efficacy,
safety, consistency and purity. There might also be a lack of understanding of
the legal ramifications the veterinarian faces,” says Farris.
“In addition,” Farris continues, “the owner relies on
the veterinarian to provide the appropriate standard of care. Using untested,
unproven compounded products when there is an FDA-approved medication available
not only violates FDA regulations, but increases the veterinarian’s liability
exposure in circumstances not typically covered by insurance.”