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1. What are the series of events that led the Veterinary
Medical Board to first realize that "immediate" supervision
by licensed veterinarians was required when registered veterinary
technicians or unregistered assistants were administering controlled
substances?
December 2005. The Board requested a legal opinion on the
proposed regulations to limit the administration of controlled
substances to only registered veterinary technicians (RVT)
to determine whether the proposed regulations were in conflict
with the Board of Pharmacy.
January 2006. Legal counsel determined that there was no
conflict with California Pharmacy law. However, it was determined
that there could be a conflict with other state or federal
laws associated with the delegation of controlled substances.
April 2006. The Board, based on a confidential legal opinion
by its legal counsel and testimony submitted at the April
2006 public hearing on RVT job tasks, removed the proposed
language regarding anesthesia, chemotherapy drugs and the
delegation of controlled substances for further discussion.
June 2006. In the interest of working together on the issue
of controlled substances, the Board requested a public letter
from its legal counsel and provided that letter to the California
Veterinary Medical Association for review.
July 2006. Comments received at the Board's
April public hearing regarding the lack of RVTs in California
indicated
that, if it is possible, the Board should consider expanding
the restriction in the Federal law of "immediate" supervision
when delegating controlled substances. At its July public
meeting, the Board voted to go forward with regulations to
expand the authority for veterinarians to delegate the administration
of controlled substances.
2. Why do doctors need to provide "immediate" supervision
instead of the "direct" supervision required by
the Practice Act? And when was this announced?
The opinion of the Board's legal counsel is that both
the California and Federal Controlled Substances Acts (Acts)
severely restricts 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. Immediate supervision is more
restrictive than "direct." 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. However, these regulations are further
constrained by the Acts in that unknown persons (unregistered
assistants/lay staff) cannot be authorized to administer
controlled substances under indirect supervision.
3. What are the Board's options for pursuing
either a legislative or regulatory change? What is the
timeline for a change?
The change would be regulatory. The Board adopted proposed
regulations at its October meeting that will authorize RVTs
to administer controlled substances under either direct or
indirect supervision of a veterinarian. The regulations will
also allow unregistered assistants to administer controlled
substances, but only under direct supervision of either a
veterinarian or an RVT. Barring any unforeseen circumstances,
those regulations will go into effect around April 1, 2007.
4. What are the national implications of this issue?
It is unknown to the Board if any national implications
exist since the Board's purview is limited to the State
of California.
5. How many other practice acts require "direct supervision" of
technicians and veterinary assistants when controlled drugs
are involved?
The Board does not monitor the practice acts of other states.
6. When does federal law supersede state law? If federal
law requires immediate supervision with controlled drugs,
why would the practice act differ from that?
This is not a matter of federal law superseding state law
since California has its own Controlled Substances Act that
mirrors the Federal Controlled Substances Act in the area
of administration of controlled substances. Therefore, there
is no conflict. The California Veterinary Medicine Practice
Act is silent on the matter of controlled substances, a subset
of "drugs." Since the California practice act
is silent on controlled substances the current law in the
Uniform Controlled Substances Acts that speaks to controlled
substances dictates and there is no inconsistency in the
law.
7. If Federal law requires immediate supervision, how can
the California Board change the law to allow an RVT to administer
controlled substances under indirect supervision?
Pursuant to California Health and Safety Code section 11026(c)
and 21 USC 802(21) a "person licensed, registered, or
otherwise permitted" to administer a controlled substance
may do so. Included in these sections is a list of those
professions already recognized. The sections 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. A change in regulation
specifically allowing the administration of controlled substances
would make RVTs and unregistered assistants "licensed,
registered, or otherwise permitted." However, the Board
is limited from extending full administration powers to unregistered
assistants because they are unknown to the state and thorough
review of the Acts demonstrates an intent of the Congress
and Legislature to know who has possession of, and access
to, controlled substances.
Although the California Veterinary Medicine Practice Act
speaks to the administration of "drugs" in Section
4826, it does not specifically address the administration
of the special subset of drugs known as "controlled
substances." Because controlled substances are a special
subset of drugs that are specifically addressed in both the
federal and California Controlled Substances Acts, a regulation
change is required to give veterinarians specific authority
to delegate administration of "controlled substances" at
levels of supervision less than immediate.
Business and Professions Code, Article 2.5, Section 4836,
gives the California Board the authority to make a regulatory
change relative to appropriate degrees of supervision required
for those tasks that may be performed by a registered veterinary
technician or an unregistered assistant, but it does not
specifically address "controlled substances."
Currently, there is no specific statutory authority that
authorizes the Board to allow, via regulation, veterinarians
to delegate the administration of controlled substances to
unregistered assistants under less than direct supervision.
However, the Legislature has the authority to enact a statute
that would specifically authorize veterinarians to delegate
the administration of controlled substances to unregistered
assistants under indirect supervision if it so chooses.
8. Is the "immediate supervision" a legal
interpretation of the federal law or does the law specifically
state this?
And if so, where?
Immediate supervision is the only reasonable understanding
of the phrase "in his presence" found in California
Health and Safety Code section 11002(b) and 21 USC 802(2)(A).
Immediate supervision is in the presence of the veterinarian.
Direct supervision does not require the animal health care
task be carried out in the presence of the veterinarian;
it only requires that the veterinarian be on the premises.
Indirect supervision only requires that orders be left for
an animal health care task; the veterinarian is not required
to be on the premises.
9. Business and Professions Code, Section 4827 provides
an exemption for shelter personnel, who are properly trained
(as defined in CCR Section 2039) to administer sodium pentobarbital
without the presence of a veterinarian. In light of the recent
legal opinion on the requirement for "immediate" supervision
when delegating the administration of controlled substances.
Can properly trained shelter personnel continue to administer
sodium pentobarbital without the presence of a veterinarian?
In section 4827, the California State Legislature has provided
a statutory exemption for a specific type of employee (trained
animal control shelter and humane society employees) and
for the use of a single, named (sodium pentobarbital), controlled
substance. This is a situation where the State has provided
specific statutory
permission
to anyone who meets the limited
criteria of being an animal control shelter employee
and only using sodium pentobarbital for euthanasia. It is
the
opinion of the Board's legal counsel that shelters
may continue to use properly trained personnel in administration
of this particular controlled substance for the limited specified
purpose of euthanasia.
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