The State Board of Dental Examiners adopts new Chapter 110, Enteral Conscious Sedation and new §§110.1 Definitions, 110.2 Permit, 110.3 Permit Requirements and Clinical Provisions and 110.4 Effective Date with changes to the text published in the December 8, 2000 issue of the Texas Register (25 TexReg 12029). Changes were made to §110.1, Definitions at (3), (6), (7), (15) and added new definitions (18) and (19). Changes were also made to §110.2, Permit at subsection (b) and (e), and to §110.3 at subsection (c). No changes were made to §110.4. The new chapter will require that dentists who administer conscious sedation/anesthesia to patients, either orally or rectally, to obtain a permit to do so. The primary purpose of the new rules is to provide assurance to Texans that Texas dentists who administer conscious sedation through any route (those who administer conscious sedation parenterally, i.e., other than orally or rectally, are currently required to have a permit) have been adequately trained to do so. Depending on courses taken, a dental school graduate may not be fully trained to administer enteral conscious sedation. The new rules assure that such training will have been obtained by those who administer such sedation. Administration of medication for pain relief only will not require a permit under these rules. The rules also provide requirements for monitoring patients who are sedated, documentation of procedures followed and prescribe discharge criteria.

When the Board conducted public hearings in the summer of 1998 and again in 1999 on the parenteral conscious sedation rules, many speakers, especially those from the Texas dental schools, urged the Board to include enteral conscious sedation in those rules. The Board President appointed an ad hoc committee to study the issues and to prepare enteral conscious sedation rules. The rules adopted are the result of the Board's review of that committee's recommendations with changes based on input from the public.

Written comments were received and a public hearing was conducted by the entire Board on January 26, 2001. Most, if not all, commenters generally approved of the rules and proposed improvements to the rules rather than objecting to the concept of the rules. The Board has made minor changes to the rules in response to comments made. A discussion of all comments follows.

Written comments were made by four individuals. One commenter made written comments and suggested two changes. The first was a recommendation that §110.2(e)(2)(B) be changed by deleting the requirement that the permitted dentist and his/her staff must maintain current certification in basic cardiopulmonary resuscitation (CPR) and replacing it with a one time requirement that a PALS course be taken. Even though that section of the rule addresses both the dentist and staff, its effect is primarily directed toward staff. In order for dentists to renew their licenses they must submit proof of current completion of a cardiopulmonary resuscitation course. Staff should not be required to have training at the intense level provided by PALS. A basic CPR course is adequate to prepare them to assist the dentist in the event of an emergency. Further, CPR training for dentist and staff should periodically be reinforced and a one time program cannot accomplish this.

The commenter also proposed that §110.3 be amended to allow a dentist to make use of the service of a certified registered nurse anesthetist (CRNA) to administer anesthesia in a hospital or surgery center setting. The rule at subsection (d)(4) provides that a dentist may not allow a CRNA to administer anesthesia in the dentist's office unless the dentist has a permit for the procedure being performed. In a hospital setting where the hospital is responsible for the administration of anesthesia, non-dentists who administer anesthesia are not affected by the board's rules.

Another commenter also indicated that he heartily endorsed the rules. He suggested that various definitions of "supervision" be included and that the term "continuous direct supervision" be printed in bold type face. His issue is that by defining all types of supervision in the rules and by highlighting the one that applies in the context of these rules the reader will have no question about which definition applies. The board is of the opinion that only definitions that apply should be included within the rule and that highlighting is unnecessary since there is only the one definition of supervision.

Another commenter also wrote and commented that §110.3(c) and (d) should be amended to make it clear that a permit is required when nitrous oxide/oxygen inhalation sedation is used with any enteral agent by changing (c) as follows: "Administration of nitrous oxide inhalation conscious sedation in combination with enteral administration of any agent, including minor tranquilizers used for anxiolysis, used for any sedation procedure requiring a permit under board rules requires both an enteral conscious sedation permit and a nitrous oxide/oxygen inhalation conscious sedation permit.".

His point is well taken as the proposed language requires a permit only when an enteral agent is being used for sedation purposes. The better view is that when any enteral agent is being used in combination with nitrous oxide/oxygen inhalation conscious sedation an enteral conscious sedation permit is required. Accordingly the language proposed by the commenter is adopted.

The same commenter also noted that subsection (d) of §110.3 could be interpreted by some readers to allow administration of potent benzodiazepines in combination with nitrous oxide/oxygen inhalation conscious sedation without a permit. The Board is of the opinion that the language change to subsection (c) discussed above makes it clear that such an interpretation is unreasonable.

Another commenter made written comments and made three suggestions. First, that "anesthesia services" be amended to read "anesthesia/sedation services". The board agrees and the term is changed in each place it shows up in all the rules. The commenter also suggested that §110.1(7) be amended to make it clear that the Board could require a facility inspection of a location where a permitted dentist is employed. The Board agrees with the commenters' point but the Board is of the opinion that the language should be changed beyond the insertion of the word "in" to avoid reference to "primary or satellite facilities". The language is changed as follows: "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; may be required by the State Board of Dental Examiners prior to the issuance of a sedation/anesthesia permit or any time during the term of the permit."

The commenter also proposed inclusion of a definition of the term "anesthesia/sedation services". The Board is of the opinion that the term is defined by the context of the entire set of rules, and that an attempt to define the term would not serve to clarify the issue.

Two other commenters appeared at the public hearing and in general offered support for the rules as published. Both, however, offered suggested changes.

The first speaker appeared on behalf of the Texas Dental Association. He proposed that the board include a definition of the term "enteral". The board agrees that a definition is appropriate, and proposes to amend §110.1 by adding new definition (18) as follows: "(18) Enteral sedation - sedation that is achieved by a route of administration through the alimentary tract either orally or rectally."

The Texas Dental Association representative also suggested adding a list of minor tranquilizers be included in §110.3(d) to avoid questions concerning who must be permitted. The ad hoc committee appointed by the Board devoted a great deal of time to the issue and determined that listing those agents requiring a permit before use would be difficult to administer for a number of reasons including the fact that such a list would frequently change as new drugs are developed and as existing drugs are approved or accepted for oral use. More troubling than frequent changes to a list is the fact that many agents used for sedation are also used for analgesic and anxiolytic effect. To require that a dentist who, for example, wishes to orally administer Demerol for relief of pain to have an enteral conscious sedation permit simply because Demerol is also used for sedation is not reasonable. The Board recognizes that leaving it to the practitioner to define the purpose for which a medication is administered may result in a few individuals claiming that a permit is not needed when in fact medications are being administered for sedative effect. Nevertheless, the positive effect of these rules, the assurance that dentists who use enteral agents for sedation are trained to do so, far out weigh the possible negative mentioned. Should the Board attempt stricter rules, the legitimate outcry from the profession would likely be so great that the rules would not be adopted.

The Board will monitor the effectiveness of the rules and should they prove to be ineffective because of this "loophole" the Board can consider closing it.

Another individual appeared at hearing and proposed several changes addressed below. The commenter proposed adding a definition of "protective reflexes". The Board agrees and has added new definition (19) to §110.1 as follows: "(19) Protective reflexes - includes the ability to swallow water sprays and breath independently without coughing (i.e., laryngospasm) as well as maintain an unobstructed airway (i.e., lack of snoring and other signs of an obstructed airway). Severe and/or persistent coughing is probably indicative of a deep sedation level and partial loss of protective reflexes."

The commenter also suggested that §110.1(15) should be amended by changing the word "conscious" to "consciousness". The Board agrees and has made the change.

The commenter proposed amending Rule §110.1(3) to reflect that patient s who are sleeping and whose only response to painful stimuli is a reflex withdrawal are not in a state of conscious sedation. The Board agrees and the last sentence of paragraph (3) is amended as follows: "...Further, patients who are sleeping and whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of conscious sedation."

The commenter also proposed amending the definitions of deep sedation, §110.1(4) to show "sleep" as an example of depressed consciousness and to provide that a patient may lose the ability to independently maintain an airway on room air. The definition in the rule is the definition used by the American Dental Association in its anesthesia guidelines. The Board is of the opinion that it is an appropriate description for use in these rules.

The commenter also proposed that §110.2 be amended to provide for different permits for dentists who orally sedate children, and for those who orally sedate adults. The ad hoc committee also discussed this type of approach at great length and determined that requiring a permit only for administration of enteral conscious sedation for children or having multiple levels of permits was not the most effective way to fully address the concerns with enteral sedation. Further, two levels of permits would impose an additional administrative burden on the agency with very little, if any, benefit. The commenter proposed language changes to §110.2(e)(C) to address dentists who would be permitted to sedate children only. Since the rules do not provide for levels of permits there is no need for this change.

The commenter recommended amending §110.3(b) to provide that enteral sedation may only be used to achieve conscious sedation unless the practitioner has a deep sedation permit. These rules address only conscious sedation levels and are not intended to in any way affect administration of deep sedation by those dentists having a deep sedation permit. Further, an individual who is permitted under these rules only is not permitted to administer deep sedation, whatever the route.

The commenter also proposed amending §110.3(h)(4) to eliminate an exception for brief procedures on the basis that the period of sedation will outlast the time of the procedure. Once a procedure is completed and the patient is in recovery the section of the rule addressing recovery will control. That section (i) requires continual monitoring of vital signs until oxygenation and circulation are stable.

The commenter also proposed that §110.3(h)(2) be amended to emphasize a need to monitor patients on room air unless oxygen saturation of the blood falls below 93%. This change falls under the heading of the knowledge needed to safely administer enteral conscious sedation. A permit will not be issued to licensees until they have completed appropriate training. This addition is not needed.

The last two proposals made by the commenter are similar to the comment addressed above in that they would add verbage to the rules that is part of the information that is included in the training necessary to obtain an enteral conscious sedation permit. The first is a proposal to add a statement that use of nitrous oxide/oxygen inhalation conscious sedation may obscure respiratory depression because nitrous oxide/oxygen inhalation conscious sedation is administered with oxygen. The second is an admonition to the permittee to be mindful of the pharmacological half life of the drugs utilized.

Finally, the Board on its own has amended §110.2(e)(1)(A) to include a requirement that completion of training must include documentation that the applicant has administered enteral conscious sedation in a minimum of five cases.

The new rules are adopted under Texas Government Code §2001.021 et.seq; Texas Civil Statutes, the Occupations Code §254.001(a) which provides the State Board of Dental Examiners with the authority to adopt and enforce rules necessary for it to perform its duties, and to ensure compliance with laws relating to the practice of dentistry to protect the public health and safety.