Unless the context clearly indicates otherwise, the following
words and terms shall have the following meaning when used in this
chapter.
(1)Analgesia--the diminution or elimination of pain.
(2)Anxiolytic--a dangerous drug or
controlled substance used to provide sedation and/or treat episodes
of anxiety.
(3)[(2)] Behavioral management--the
use of pharmacological or psychological techniques, singly or in combination,
to modify behavior to a level that dental treatment can be performed
effectively and efficiently.
(4)[(3)] Board/Agency--the Texas
State Board of Dental Examiners, also known as the State Board of
Dental Examiners, and, for brevity, the Dental Board, the Agency,
or the Board.
(5)[(4)] Child/children--a patient
under the age of thirteen (13) at the time of a dental treatment or
procedure. [twelve (12) years of age or younger.]
(6)[(5)] Competent--displaying
special skill or knowledge derived from training and experience.
(7)[(6)] Deep sedation--a drug-induced
depression of consciousness during which patients cannot be easily
aroused but respond purposefully following repeated or painful stimulation.
The ability to independently maintain ventilatory function may be
impaired. Patients may require assistance in maintaining a patent
airway, and spontaneous ventilation may be inadequate. Cardiovascular
function is usually maintained.
(8)[(7)] Direct supervision--the
dentist responsible for the sedation/general anesthesia
procedure shall be physically present in the facility and shall be
continuously aware of the patient's physical status and well-being.
(9)[(8)] Enteral--any technique
of administration of sedation in which the agent is absorbed through
the gastrointestinal (GI) tract or oral mucosa (i.e., oral, rectal,
sublingual).
(10)[(9)] Facility--a [
the] location where a permit holder practices dentistry and/or
provides sedation/general anesthesia [anesthesia/sedation
] services.
(11)[(10)] Facility inspection--an
on-site inspection to determine if a facility where the applicant
proposes to provide anesthesia/sedation is supplied, equipped, staffed
and maintained in a condition to support provision of anesthesia/sedation
services that meet the minimum standard of care.
(12)[(11)] General anesthesia--a
drug-induced loss of consciousness during which patients are not arousable,
even by painful stimulation. The ability to independently maintain
ventilatory function is often impaired. Patients often require assistance
in maintaining a patent airway, and positive pressure ventilation
may be required because of depressed spontaneous ventilation or drug-induced
depression of neuromuscular function. Cardiovascular function may
be impaired.
(13)[(12)] Immediately available--on-site
in the facility and available for immediate use.
(14)[(13)] Incremental dosing--administration
of multiple doses of a drug until a desired effect is reached, but
not to exceed the maximum recommended dose (MRD).
(15)[(14)] Local anesthesia--the
elimination of sensation, especially pain, in one part of the body
by the topical application or regional injection of a drug.
(16)[(15)] Maximum recommended
dose (applies to minimal sedation)--FDA maximum recommended dose (MRD)
of a drug, as printed in FDA-approved labeling for unmonitored home
use.
(17)[(16)] Minimal sedation--a
minimally depressed level of consciousness, produced by a pharmacological
method, which retains the patient's ability to independently and continuously
maintain an airway and respond normally to tactile stimulation and
verbal command. Although cognitive function and coordination may be
modestly impaired, ventilatory and cardiovascular functions are unaffected.
Medication administered for the purpose of minimal sedation shall
not exceed the maximum doses recommended by the drug manufacturer.
Nitrous oxide/oxygen may be used in combination with a single enteral
drug in minimal sedation. During longer periods of minimal sedation
in which the total amount of time of the procedures exceeds the effective
duration of the sedative effect of the drug used, the supplemental
dose of the sedative shall not exceed total safe dosage levels based
on the effective half-life of the drug used. The total aggregate dose
must not exceed one [and one-half times the] MRD on the
day of treatment. The use of prescribed, previsit sedatives for children
under the age of thirteen (13) [aged twelve (12) or younger]
should be avoided due to the risk of unobserved respiratory obstruction
during the transport by untrained individuals.
(18)[(17)] Moderate sedation--drug-induced
depression of consciousness during which patients respond purposefully
to verbal commands, either alone or accompanied by light tactile stimulation.
No interventions are required to maintain a patent airway, and spontaneous
ventilation is adequate. Cardiovascular function is usually maintained.
A Level 2 permit is required for moderate sedation limited to enteral
routes of administration. A Level 3 permit is required for moderate
sedation including parenteral routes of administration. In accordance
with this particular definition, the drugs or techniques used shall
carry a margin of safety wide enough to render unintended loss of
consciousness unlikely. Repeated dosing of an agent before the effects
of previous dosing can be fully appreciated may result in a greater
alteration of the state of consciousness than is the intent of the
dentist. A patient whose only response is reflex withdrawal from a
painful stimulus is not considered to be in a state of moderate sedation.
(19)[(18)] Parenteral--the administration
of pharmacological agents intravenously, intraosseously, intramuscularly,
subcutaneously, submucosally, intranasally, or transdermally.
(20)[(19)] Patient Physical
Status Classification:
(A)ASA--American Society of Anesthesiologists
(B)ASA I--a normal health patient
(C)ASA II--a patient with mild systemic disease
(D)ASA III--a patient with severe systemic disease
(E)ASA IV--a patient with severe systemic disease
that is a constant threat to life
(F)ASA V--a moribund patient who is not expected to
survive without the operation
(G)ASA VI--a declared brain-dead patient whose organs
are being removed for donor purposes
(H)E--emergency operation of any variety (used to
modify ASA I - ASA VI).
(21)Pediatric patient--a patient
who is under the age of 13 at the time of a dental treatment or procedure.
(22)[(20)] Portability--the
ability of a permit holder to provide permitted anesthesia services
in a location other than a facility or satellite facility.
(23)[(21)] Protective reflexes--includes
the ability to swallow and cough effectively.
(24)[(22)] Satellite facility--an
additional office or offices owned or operated by the permit holder,
or owned or operated by a professional organization through which
the permit holder practices dentistry, or a licensed hospital facility.
[(23) Supplemental dosing (applies
to minimal sedation)--during minimal sedation, supplemental dosing
is a single additional dose of the initial dose of the initial drug
that may be necessary for prolonged procedures. The supplemental dose
should not exceed one-half of the initial dose and should not be administered
until the dentist has determined the clinical half-life of the initial
dosing has passed. The aggregate dose must not exceed one and one-half
times the MRD on the day of treatment.]
(25)[(24)] Time-oriented anesthesia
record--documentation at appropriate time intervals of drugs, doses,
and physiologic data obtained during patient monitoring. Physiologic
data for moderate sedation, deep sedation and general anesthesia must
be taken and recorded at required intervals unless patient cooperation
interferes or prohibits compliance.
(26)[(25)] Titration (applies
to moderate sedation)--administration of incremental doses of a drug
until the desired effect is reached. Knowledge of each drug's time
of onset, peak response and duration of action is essential to avoid
over-sedation. When the intent is moderate sedation, one must know
whether the previous dose has taken full effect before administering
an additional drug increment.
The agency certifies that legal counsel has
reviewed the proposal and found it to be within the state agency's
legal authority to adopt.
Filed with the Office
of the Secretary of State on December 5, 2016
TRD-201606155 Kelly Parker
Executive
Director
State Board of Dental Examiners
Earliest possible date of adoption: January 15, 2017
For further information, please call: (512) 475-0977
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