Is AMDUCA enough?

State board requires informed consent for certain extralabel uses
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NOTE: As of November 2007, the AVMA discontinued use of the term "informed consent" in matters relating to veterinary medicine replacing it with the term "owner consent".
(see JAVMA News, Dec. 15)

Two years ago, the Texas State Board of Veterinary Medical Examiners disciplined a veterinarian whose extralabel use of a flea medication to treat ear mites caused subsequent ear problems in the dog. The veterinarian had not obtained written consent from the owners. The board decided the veterinarian was negligent in not forewarning the clients that this product was not used routinely for this purpose.

As a result of this single disciplinary case, the Texas state board in November 2002 implemented a rule requiring veterinarians to inform clients of extralabel drug uses that are not commonly accepted or used in the veterinary community.

Was a state rule advisable, when extralabel drug use is regulated federally by the Animal Medicinal Drug Use Clarification Act?

While the rule was pending, the AVMA Council on Biologic and Therapeutic Agents decided to convey its opposition, asserting that AMDUCA adequately governs extralabel drug usage. Before COBTA could send its comments to the Texas board, however, the rule was finalized.

New rule 573.45 in the Texas administrative code, "Extra-Label or Off-Label Use of Drugs," defines extralabel or offlabel use, lists what a veterinarian should consider in exercising discretionary usage, and attempts to identify the circumstances that require informed consent.

The latter provision states: "If anticipated off-label use of a drug is not commonly accepted or used by average veterinarians in the community in which the veterinarian practices or if the off-label usage does not have an established safety record, the veterinarian shall orally or in writing inform the client that the off-label usage is not commonly accepted or used in the veterinary community and that such usage could pose a risk to the health of the animal. Any oral notification shall be recorded in the patient records."

COBTA chair Dr. Dawn M. Boothe noted, "Few drugs used in an extralabel fashion have undergone formal evaluation for safety in the target species. As such, the criterion of 'an established safety record' as set forth in the Texas provision will seldom be met. Yet, the inclusion of this criterion might be interpreted by animal owners to mean that such evidence generally does exist. I am concerned that the veterinarian is at greater risk to be civilly prosecuted. Further, the definition of 'commonly accepted' is not clear."

Two other considerations that concern Dr. Boothe, because of their vagueness, are the provisions that the veterinarian must consider "the established safety of the off-label usage" and "whether the off-label use of a drug meets the community standard of humane care and treatment set out in rule 573.22." That previously existing rule specifies: "Veterinarians shall exercise the same degree of humane care, skill, and diligence in treating patients as are ordinarily used in the same or similar circumstances by average members of the veterinary medical profession in good standing in the locality or community in which they practice, or in similar communities."

But it wasn't the new rule that caused a clamor from Texas veterinarians; it was the underlying disciplinary case.

Chris Copeland, general counsel for the Texas VMA, said that many Texas veterinarians responded negatively to the state board's disciplinary action. "They had a lot of concerns with the basic idea that 70 percent of drugs are being used offlabel ... and it's hit-or-miss if you use an offlabel drug and the client decides to (prosecute). They were looking for something concrete to use to decide if they're doing it right."

The TVMA publicized the proposed rule in its member publication and on its listserve. Copeland said their members' collective reaction was "it's not perfect, but they weren't sure there's anything better." The TVMA board had only minor language concerns. "They understood the (state) board was trying to help."

Lee Mathews, attorney for the Texas state board, confirms, "There wasn't any opposition to the rule, other than over use of the words 'average veterinarian.'" In the end, the state board retained the term for consistency throughout the administrative code.

In fact, Mathews said that the disciplinary case actually prompted many Texas veterinarians to ask the state board to provide specific guidance on extralabel drug use, so he believes they appreciate the new rule. "If they ever get in a situation where they're disciplined," Mathews said, "they can come in and say, 'Well, you know, under our rule, I looked at this and this and this, and I made a judgment,' and that probably helps their case."

While acknowledging that determining the "community standard of humane care and treatment" can be "difficult" and "vague," Mathews added, "If an offlabel use clearly is not known or is little known in the community where the guy practices, then it may not meet the community standard of care."

The attorney said the rule "didn't reference one way or another the adequacy or inadequacy of the federal act."

COBTA member Dr. Donald J. Klingborg, Davis, Calif., said, "Our profession fought for AMDUCA for generations, and it is working extremely well. The laws of the land already cover the necessary areas to protect our patients and the public from inappropriate extralabel use. The new Texas rule creates a circumstance where veterinarians are going to have a huge burden because of the large volume of drugs we use in veterinary medicine that are extralabel."

In contrast to human drug approvals, there are insufficient markets for manufacturers to get their products labeled for veterinary use. This makes extralabel use of human drugs, within a standard of practice, a common necessity for veterinarians. "We have 50 years of history with some of these products and know how to use them," Dr. Klingborg noted.

The AVMA and a coalition of animal interest groups continue to work for passage of the Minor Use and Minor Species Animal Health Act. This legislation would offer incentives to pharmaceutical companies encouraging them to develop drugs for less common animal species and indications.

The Texas board told Dr. Boothe, who is a professor at Texas A&M University, "they'd be happy to consider any points as far as interpreting or restating the rule," she reported. Given this assurance, COBTA will decide at its late-March meeting whether to draft comments for the Texas board's consideration. The council may also compile a fact sheet for veterinarians on extralabel drug use.