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Texas Register Preamble


The State Board of Dental Examiners (Board) adopts this amendment to 22 TAC §108.7, concerning the minimum standard of care. This amendment requires dentists to hold a Level 1 Minimal Sedation permit to administer Halcion (triazolam), and provides that dentists should administer Halcion (triazolam) in an in-office setting. This amendment is adopted with no changes to the proposed text as published in the January 8, 2021, issue of the Texas Register (46 TexReg 268). The rule will not be republished.

Three comments were received after publication of the proposed rule amendment during the official comment period.

Dr. David W. Canfield provided a written comment in support of adoption of the rule as proposed. Dr. Canfield stated triazolam, although classified as a benzodiazepine, is unique in that it is classified entirely as a sedative-hypnotic by the manufacturer (package insert) and the Food and Drug Administration. The drug is not labeled as anti-anxiety, nor is it purported to have any anti-anxiety properties. Dr. Canfield is aware of practitioners having incidents that occurred after patients consumed triazolam, including patients who were involved in motor vehicle accidents, a patient who was injured from falling, difficulty getting patients who were medicated into the office safely, and patients who were dropped off without a designated driver or without appropriate post-sedation supervision. Dr. Canfield stated it is a dentist's obligation to assess that the patient is in appropriate condition for sedation on that particular day, which means current vitals and auscultation are imperative prior to medicine intake. The Board agrees with this comment and no changes to the proposed rule were made as a result of the comment.

The Texas Dental Association (TDA) provided a written comment in opposition of adoption of the rule as proposed. TDA stated the Board should not become overly prescriptive via rulemaking in a manner that interferes with dentists' autonomy, such as identifying and regulating specific drugs in rule, unless there is a data-driven patient safety need to do so. In the context of patient safety for anxiolysis, dosages and patient selection, not drugs, determine safe outcomes. TDA stated identifying and regulating a specific drug in rule will not improve patient safety; dentists can simply choose a different drug in the same drug class as there are several from which to choose. If the Board has data documenting patient safety concerns with the administration of certain drugs for anxiolysis, TDA stated a more concrete and direct approach would be to review the definition of anxiolysis in the Texas Dental Practice Act. TDA stated dentists do not need a sedation permit to administer anxiolytics and analgesics in the context provided by the statute. The Board disagrees with this comment as the Board does have data documenting patient safety concerns regarding the use of Halcion, and the drug is labeled as a sedative-hypnotic and not for anxiolysis. No changes to the proposed rule were made as a result of the comment.

The Texas Academy of General Dentistry (Texas AGD) provided a written comment in opposition of adoption of the rule as proposed. Texas AGD is not aware of data or evidence of patient morbidity or fatalities attributable to the prescribing or administering of Halcion for anxiolysis. Texas AGD stated there are existing regulations dentists are required to follow for standards of care for all drugs, whether prescribed out of the office or administered in the office. Should the Board move forward in adopting the rule, Texas AGD suggests changing it to either clearly allow Halcion to be prescribed for use at home or give clear guidance under which conditions a dentist may prescribe it for such use. Texas AGD is concerned that a rule requiring a dentist to have a Level 1 permit to prescribe or administer Halcion may have an adverse impact on patient care, since dentists will have one less option for special needs and other patients who have anxiety about treatment. The Board disagrees with this comment as the Board does have data documenting patient safety concerns regarding the use of Halcion. The amendment does not require dentists to administer Halcion in an in-office setting; however, it is best practice to do so, which is why the amended language includes the word "should." No changes to the proposed rule were made as a result of the comment.

This rule is adopted under Texas Occupations Code §254.001(a), which gives the Board authority to adopt rules necessary to perform its duties and ensure compliance with state laws relating to the practice of dentistry to protect the public health and safety.



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