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June 15, 2012

 

 Federal law could affect mobile practice

​Veterinarians express concern over drug access

This photo shows a lockbox used to transport controlled substances inside a California veterinarian’s truck.

Posted on May 30, 2012

Dr. Lisa S. Couper isn’t allowed to carry some drugs she sees as essential for her mobile mixed animal practice.

She is among Northern California veterinarians with ambulatory or mobile practices who said Drug Enforcement Administration officials told them that they are violating federal law if they routinely carry controlled substances in their vehicles.

“I wasn’t aware that it was against the code until now,” she said. “Now that I am, what do I do? What are the DEA’s intentions?

“If they really are intent on enforcing, I’m going to have to call it quits.”

Barbara L. Carreno, a spokeswoman for the DEA, said the federal Controlled Substances Act, which Congress passed in 1970, requires that practitioners—including veterinarians, physicians, and dentists—have separate registrations for every location where they store, distribute, or dispense controlled substances. The agency has let practitioners in human and veterinary medicine register in one location and prescribe controlled substances in others, and some practitioners have been confused by that allowance.

Dr. Grant R. Miller, director of regulatory affairs for the California VMA and a veterinarian whose patients include horses, cattle, sheep, and goats, said a DEA official indicated to him that veterinarians would be allowed to bring the amount of a drug they intend to use during the day, although that allowance is not written in regulations.

“They’re saying you can’t take these things out in the field and use them without having some kind of preset amount that you’re going to dispense,” he said.

Dr. Miller said that would, for example, allow a veterinarian carry the drugs needed for a previously scheduled appointment, such as to spay or neuter an animal. But he interprets the allowance to mean that a veterinarian would not be able to carry controlled substances for use in an emergency or a bulk amount of ketamine needed to conduct a one-day spay and neuter clinic at a rural pet store, where the numbers and sizes of animals arriving would be unknown.

On the basis of reports from California VMA members, Dr. Miller said it appeared that officials in a DEA office in Sacramento were contacting veterinarians who registered their home address as their place of business. The VMA posted on its website a copy of a letter that states a DEA official was reviewing registrations and asking veterinarians to provide their business addresses. By early May, the VMA was receiving eight or 10 calls daily from veterinarians concerned about the issue. The number of calls dropped to a few weekly by mid-May.

Dr. Couper said her mobile practice has been registered at her home address for the past 25 years. In responding to one of the DEA inquiries, she found out that she was allowed to treat patients or dispense controlled substances there, but she was told that her mobile clinic had been transporting controlled substances illegally.

Notice issued over confusion

Back on Dec. 1, 2006, the DEA published a Federal Register notice intended to alleviate confusion over the agency’s rules regarding the handling of controlled substances by practitioners, including veterinarians. In addition to stating that practitioners can store, administer, or dispense controlled substances only at registered locations, the notice states that practitioners need a separate registration for each state where they prescribe a controlled substance. The notice clarified but didn’t change what was allowed under federal regulations.
 
“The Controlled Substances Act would have to be amended by Congress to do that because our regulations implement the law as passed by Congress, and we don’t have the authority to change it,” Carreno said.
 
Violating the Controlled Substances Act can result in various penalties, depending on the circumstances of each violation, Carreno said. Administrative actions could include sending a letter to admonish a registrant that he or she was violating the law, initiating proceedings to withdraw DEA registration, and, if public health or safety were threatened, suspending the individual’s registration, according to an August 2011 Government Accountability Office report.
 
Practitioners can face civil penalties such as fines for violating record-keeping requirements for controlled substances. More serious violations, such as illegal distribution, fraud, tax evasion, and money laundering, can result in criminal charges, according to the GAO report.
 
In a letter sent to the DEA April 30, 2012, Dr. Ron DeHaven, AVMA CEO, asked the DEA to exercise enforcement discretion when investigating ambulatory veterinary practitioners who hold valid state licenses and DEA registrations.
 
His letter indicates many AVMA members, particularly those in rural and large animal practices, provide mobile or ambulatory services because animal owners could not easily bring their animals to a clinic or hospital. Many companion animal veterinarians also provide house call services and operate mobile clinics.
 
Dr. DeHaven’s letter expresses support for the intent of the DEA Diversion Control Program but concern that enforcing existing regulations “will make it impossible for veterinarians to comply with the regulations while providing their patients with appropriate and complete veterinary care and fulfilling their ethical responsibilities.”
 
The letter notes that the AVMA has been meeting with DEA officials since 2009 to address the regulations and has been told that Congress would need to amend the Controlled Substances Act to change the current regulations to address the AVMA’s concerns.
 
Dr. M. Gatz Riddell, executive vice president of the American Association of Bovine Practitioners, noted that not all veterinarians have facilities to accept patients, and not all clients can deliver their animals to a clinic or hospital. He indicated that enforcement of the existing regulations could hinder veterinarians’ abilities to anesthetize, sedate, or provide analgesia for their patients in the field.
 
“It would really impede a veterinarian’s ability to provide for the prevention of pain and suffering of their patients in certain conditions,” he said.

Rising concern, changing practice

 Dr. Thomas W. Graham of Davis, Calif., stopped carrying pentobarbital, diazepam, xylazine, and butorphanol in his vehicle after he was told this spring that the practice was illegal. He intends to comply with all directions from the DEA, and he fears penalties could result if he were to fail to follow those directions and his truck were searched during a DEA inspection or a state police traffic stop. He thinks agency officials are trying to do what is best to implement a law structured by Congress.

Dr. Graham, who is a bovine practitioner, said, however, some alternatives to controlled substances are less reliable for providing humane care.
 
“I have a surgery today that I’m supposed to do to remove an eye in a cow, and I guess I’ll just use lidocaine,” Dr. Graham said. “And I’m not happy with it.”
 
Dr. Miller noted that, even if he is allowed to carry amounts of controlled substances intended for use, he often would need to see the patient to determine its weight, the amount of pain it was in, and the severity of its condition before he could know how much of any particular drug was needed. The calculated amount of a barbiturate needed for euthanasia could be insufficient if an animal were agitated, he said.
 
“We couldn’t have an extra supply on hand in the field when we’re euthanizing an animal,” he said.
 
Dr. Couper said she has an ethical obligation to carry proper drugs to care for her patients, but following the rules as they were explained to her would leave her unable to carry sufficient amounts of controlled substances to re-sedate an animal, if needed, or adapt in situations involving spilled drugs, missed injections, or faulty catheters.
 
Dr. Graham hopes congressional involvement isn’t needed. For now, he uses a .22 Magnum handgun for euthanasia, and he won’t carry controlled substances until he has assurances that the practice is legal.