§793. Nitrous oxide inhalation analgesia; enteral moderate sedation; parenteral sedation; deep sedation; general anesthesia; definitions; permits; credentials; reporting; fees; limitations; exceptions

A. As used in this Section, the following terms have the meanings ascribed to them unless the context clearly indicates otherwise:

(1) "Analgesia" is the diminution or elimination of pain in the patient.

(2) "Board" is the Louisiana State Board of Dentistry.

(3) "Deep sedation" is a drug-induced depression of consciousness during which a patient cannot be easily aroused but responds purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. A patient may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

(4) "General anesthesia" is a drug-induced loss of consciousness during which a patient is not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. A patient often requires 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.

(5) "Local anesthesia" is the elimination of sensations, especially pain, in one part of the body by the topical application or regional injection of a drug.

(6) "Minimal sedation", except as provided in Paragraph (C)(9) of this Section, is a minimally depressed level of consciousness, produced by a pharmacological method, which allows the patient to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal commands. The drugs or techniques used to produce minimal sedation should have a margin of safety which is sufficient never to cause unintended loss of consciousness. A patient whose only response is reflex withdrawal from repeated painful stimuli shall not be considered to be in a state of minimal sedation.

(7) "Moderate sedation", except as provided in Paragraph (C)(9) of this Section, is a drug-induced depression of consciousness during which a patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No intervention is required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. The drugs or techniques used to produce moderate sedation should have a margin of safety which is sufficient 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 shall not be considered to be in a state of moderate sedation.

B. The following terms describing routes of administration shall have the meanings ascribed to them unless the context clearly indicates otherwise:

(1) "Combined moderate sedation" is any means of obtaining moderate sedation utilizing both inhalation analgesia and either an enteral or parenteral moderate sedation technique.

(2) "Enteral" is any technique of drug administration in which the drug is absorbed through the gastrointestinal (GI) tract or oral mucosa. Examples are oral, rectal, and sublingual.

(3) "Inhalation" is a technique of drug administration in which a gaseous or volatile agent is introduced into the pulmonary tree and whose primary effect is due to absorption through the pulmonary bed. An example is nitrous oxide-oxygen inhalation sedation.

(4) "Parenteral" is any technique of drug administration in which the drug bypasses the gastrointestinal (GI) tract. Examples are intramuscular (IM), intravenous (IV), intranasal (IN), submucosal (SM), and subcutaneous (SC).

(5) A dental hygienist who administers nitrous oxide inhalation analgesia in a dental practice shall receive a personal permit from the board and shall be in compliance with board rules and regulations which shall include educational requirements.

C.(1) When nitrous oxide inhalation analgesia, enteral moderate sedation, parenteral moderate sedation, deep sedation, or general anesthesia are used in a dental practice, board authorization shall be obtained in compliance with board rules and regulations to ensure that these procedures are performed in a properly staffed, designed, and equipped facility capable of handling the procedures, problems, and emergency incidents thereto for the level of anesthesia administered. Adequacy of the facility and competence of the anesthesia team shall be determined by the board through the use of qualified anesthesia consultants.

(2) A dentist who administers nitrous oxide inhalation analgesia, enteral moderate sedation, parenteral moderate sedation, deep sedation, or general anesthesia in a dental practice shall receive a personal permit from the board for the deepest level of anesthesia or analgesia to be administered and shall be in compliance with board rules and regulations.

(3) When nitrous oxide inhalation analgesia, enteral moderate sedation, parenteral moderate sedation, deep sedation, or general anesthesia is administered in any dental office or facility, each office shall receive an office permit from the board for the deepest level of anesthesia or analgesia to be administered and must be in compliance with board rules and regulations.

(4), (5) Repealed by Acts 2012, No. 485, §2.

(6) Minimal sedation.

(a) The following definitions apply to administration of minimal sedation:

(i) "Incremental dosing" is the administration of multiple doses of a drug, not to exceed the MRD of that drug, until a desired effect is reached.

(ii) "Maximum recommended dose" or "MRD" is the maximum dose of a drug as recommended by the United States Food and Drug Administration (FDA), and as printed in FDA-approved labeling for unmonitored home use of that drug.

(iii) "Supplemental dosing" is a single additional dose of the initial dose of the initial drug administered to a patient under minimal sedation as may be necessary in a prolonged procedure. The supplemental dose should not exceed one-half of the initial dose and should not be administered until the dentist has determined that the clinical half-life of the initial dosing has passed. The total aggregate dose of the drug shall not exceed one and one-half times the MRD of the drug on the day of the treatment.

(b) When minimal sedation of an adult is intended, the appropriate initial dosing of a single enteral drug is no more than the MRD of a drug that can be prescribed for unmonitored home use.

(c) Permits shall not be required for the induction of minimal sedation on a patient in a dental practice. Such induction of minimal sedation shall include the administration of an enteral sedative, narcotic analgesic medication, or both, administered in doses not exceeding the MRD as printed in FDA-approved labeling for unmonitored home use of the respective drugs.

(d) Except in extremely unusual circumstances, the cumulative dose shall not exceed the MRD. It is understood that even at appropriate doses, a patient may occasionally drift into a state that is deeper than minimal sedation. If the intent was to achieve minimal sedation and such sedation was conducted in accordance with the provisions of this Paragraph, then such circumstance shall not in itself constitute a violation of this Chapter. A permit shall not be required for the perioperative use of medication for the purpose of effecting minimal sedation.

(7) Moderate or greater sedation.

(a) The following definition shall apply to the administration of moderate or greater sedation: "titration" means administration of incremental doses of a drug until a desired effect is reached.

(b) Knowledge of the time of onset, peak response, and duration of action of each drug is essential to avoid oversedation. Although the concept of titration of a drug to the desired level of sedation is critical for patient safety, when the intent is moderate sedation, one must know whether the previous dose has taken full effect before administering an additional drug increment.

(8) No dentist licensed in accordance with the provisions of this Chapter shall use any enteral medication to induce moderate sedation unless such dentist has obtained a permit for such use in accordance with the provisions of this Chapter.

(9) For a patient under thirteen years of age, the administration of more than one agent of any type, including nitrous oxide, shall be considered moderate sedation, not minimal sedation, and shall require a full moderate sedation permit.

D. The applicant shall comply with the board's rules and shall furnish the board with qualifying documents that substantiate his credentials relative to the permit requested.

E.(1) Each licensed dentist or dental hygienist in the practice of dentistry or dental hygiene in this state shall submit a written report within a period of ten days to the board of any mortality or other incident which results in temporary or permanent physical or mental injury to a patient requiring hospitalization of the patient during or as a result of administration by the dentist or dental hygienist of local anesthesia, enteral sedation, nitrous oxide inhalation analgesia, parenteral moderate sedation, deep sedation, or general anesthesia.

(2) The report shall include detailed information pertaining to the following:

(a) Description of dental procedure.

(b) Description of pre-operative physical condition of patient.

(c) A description of all drugs and dosages administered.

(d) Detailed description of techniques utilized in administering the drugs given.

(e) Description of adverse occurrence which shall include:

(i) Description in detail of the symptoms of any complications including but not limited to onset and type of symptoms in patient.

(ii) Treatment instituted on the patient.

(iii) Response of the patient to the treatment.

(f) Description of the patient's condition on termination of any procedures undertaken.

(3) Failure to comply with the required reporting procedures stipulated herein may result in disciplinary action by the board. The information from a dentist or dental hygienist required under this Subsection may be a prerequisite for the issuance or renewal of his license or permit to practice dentistry or dental hygiene.

F. An initial authorization permit fee shall be charged, and an annual renewal fee may be charged by the board for each dentist and dental hygienist and facility making an application under this Section as set forth in the board's rules. Such fees shall be due and payable to the board at the same time as license renewal as provided for in R.S. 37:770 and 795.

G. The authority for the administration of anesthetic and sedative agents as described in this Section shall be limited as follows:

(1) The administration of enteral moderate sedation, parenteral moderate sedation, deep sedation, and general anesthesia shall be limited to qualified dentists licensed by the board for use on dental patients.

(2) The administration of nitrous oxide inhalation analgesia shall be limited to qualified dentists and dental hygienists licensed by the board for use on dental patients. Dental hygienists shall administer nitrous oxide inhalation analgesia only under the direct supervision of a dentist licensed by the Louisiana State Board of Dentistry to whom the board has issued a permit to administer nitrous oxide inhalation analgesia.

H.(1) The office permit is not required when the facility is part of a hospital or an outpatient surgical center which meets or exceeds the requirements set forth in Louisiana Administrative Code (Title 46-Professional and Occupational Standards-Part XXXIII Dental Health Professions:), Chapter 15. The reporting requirements of Subsection E of this Section shall apply to those practicing in a facility exempt from the office permit requirement.

(2) A personal permit is not required when the dentist uses the services of a third-party medical doctor, third-party doctor of osteopathy who specializes in anesthesiology, third-party certified registered nurse anesthetist, or an oral and maxillofacial surgeon who is permitted by the board to administer moderate sedation, deep sedation, and general anesthesia. Provided that the third-party anesthetist must remain on the premises of the dental facility until any patient given parenteral drugs is sufficiently recovered. However, when the requirement for obtaining a personal permit is waived by the board under the provisions of this Chapter with regard to the utilization of any third party provided for in this Paragraph, the dentist may utilize only the services of a third party previously determined by the board to be in compliance with the board's requirements for the administration of anesthesia in the dental facility following the initial inspection in relation to the application and equipment of the provider of anesthesia. Except for oral and maxillofacial surgeons, third-party anesthesia providers authorized pursuant to this Paragraph shall not be required to obtain a permit from the board or pay any fees or other assessments to the board.

I. The board reserves the right to inspect the facilities and/or assess the personnel covered under this Section. This inspection/assessment shall be conducted by a qualified person or committee duly appointed by the board. Such inspection and/or assessment may occur when a permit is requested or has been issued in accordance with the board's rules.

Acts 1986, No. 994, §1; Acts 1995, No. 1000, §1; Acts 2001, No. 712, §1; Acts 2003, No. 496, §1; Acts 2005, No. 162, §§1, 2; Acts 2010, No. 66, §1; Acts 2012, No. 485, §§1, 2.