Nov
29
2006

California veterinarians are getting a legal education that changes the way they practice medicine or at least the way they supervise the administration of controlled substances. A review of the practice act and delegation of tasks to registered veterinary technicians (RVT) and assistants revealed a misinterpretation of state and federal laws that require doctors to be in the room when employees administer the drugs.

Some professionals describe this as one state’s interpretation of federal law while others worry that it could impact veterinarians on a national scale.

“Until recently, it was assumed by the [Veterinary Medical] Board and the profession that the delegation of controlled substances to either an RVT or unregistered assistant fell within this regulatory authority. In a legal opinion dated April 19, 2006, the Board’s legal counsel determined that this is not the case,” according to a legal brief.

Susan Geranen, executive officer of the California Veterinary Medical Board (VMB), explained that Californias Health and Safety Code section 11026 and 21 USC 802 (21), which cover controlled drugs, "are silent on RVTs and unregistered assistants. Absent specific authorization to administer a controlled substance RVTs and unregistered assistants are not permitted to do so."

Adrian Hochstadt, JD, AVMA assistant director of state legislative and regulatory affairs, noted that some California attorneys do not agree with this interpretation.

In July, the California VMB announced: “…both the California and Federal Uniform Controlled Substances Acts severely restrict the veterinarian’s authority to delegate administration of controlled substances. Absent specific regulation to the contrary, the delegation authority is limited to immediate (in the physical presence of the licensee) supervision… The conclusion, based on the legal opinion, is that under current law within the Acts, the administration of controlled substances cannot be delegated to either an RVT or an unregistered assistant (UA) unless they are in the physical presence of the licensed veterinarian, until such time that the board implements regulations to permit otherwise.”

Immediate supervision is onerous for veterinarians who operate kennels and overnight hospitals, said Ron Faoro, DVM, president of the California VMA. Prior to this situation, doctors believed that they could delegate administration of drugs with indirect supervision, which does not require doctors to be in the building.

“Obviously this is a huge problem for practitioners. I’m trying to abide by the law but if someone needs to give a narcotic to a patient in the hospital and it’s 11:30 p.m. and I’m at home I will have to drive down to the clinic,” Faoro said. “That is what the VMB is saying I will have to do.”

As California professionals grapple with interpretations of the federal law, which has not been enforced by the Drug Enforcement Agency (DEA) to date, industry professionals say the issue could easily stretch across state lines.

Federal law – as long as it is not found unconstitutional – generally supersedes state law if the two are in conflict, though states can impose stricter versions of a law if Congress does not address that particular area, said Adrian Hochstadt, JD, AVMA assistant director of state legislative and regulatory affairs.

In this case, Section 802 of the federal law allows states to define who can administer controlled substances by their own definition of practitioner as well as the type of supervision provided, Hochstadt explained. “There hasn’t been a ruling by the federal government, so it would appear that California could define whatever levels of supervision they [deem appropriate,]” he said. This is an opportunity for state VMAs to inform veterinarians about the controlled substance rules in their states, Hochstadt added.

A story about the California issue ran on page one of the November DVM Newsmagazine and California VMB officials have warned doctors that DEA officials can cite them for failure to abide by the law.

“It’s one of those things that you think, ‘holy moley! How did anyone miss this?’” Faoro said. “It’s not been enforced forever. It’s astonishing!”

Background
The issue first surfaced last year when credentialed technicians requested a review of the practice act in an effort to establish administration of controlled substances as an exclusive RVT task. The initial story, which ran in NEWStat, outlines the technicians’ requests, many of which were shelved until a later date for consideration.

Upon review of the laws, VMB lawyers recognized the reference to direct supervision and questioned whether it should be immediate, according to her interpretation of federal law.

In the future, both the VMB and the CVMA want to change the state pharmacy law to read “indirect supervision” instead of “direct” supervision of controlled substances administration, as outlined in Section 4826, but disagree on who should administer the drugs and how the practice act can be changed, Faoro said.

A proposed regulation supported by RVTs would amend Section 2036.5 to allow credentialed technicians to administer controlled substances with indirect supervision from the doctor. Veterinarians agree with a change to indirect, and argue that technicians and assistants should be able to administer the drugs.

The VMB issued the following statement in response to a request that veterinary assistants be allowed to administer drugs: “…These regulations are further constrained by the Acts in that unknown persons cannot be authorized to administer controlled substances under indirect supervision.”

Hochstadt explained that because the federal law seems to defer to states, California could adopt a law or regulation to allow assistants to administer the drugs if they choose to do so. In terms of legal interpretation of this federal law, Hochstadt added, “reasonable people can disagree on what it means until there is a conclusive determination.”

Nationwide, Faoro believes that many practitioners are unaware of the federal law that regulates the delivery of controlled substances. “It’s like a Pandora’s box, a can of worms that has been opened. I bet that 95 percent of the veterinarians in the country would be shocked to hear that this is a problem.”

Until a change is made to California law, veterinarians will be required to provide immediate supervision of controlled substances, the California VMB lawyer’s interpretation of the federal law. The VMB’s legal opinion, which provides background on this decision/interpretation, can be found online.

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