Definitions

PURPOSE: This rule defines terms used throughout the rules of Chapter 4. (1) The following words and terms, when used in this chapter, shall have the following meanings. (A) American Society of Anesthesiologists (ASA) Classifications—A five- (5-) category classification system used to assess a patient prior to sedation/anesthesia. Patients are categorized into one (1) of the five (5) following classes: 1. Class I—There is no organic, physiologic, biochemical, or psychiatric disturbance. The pathological process for which the operation is to be performed is localized and is not a systemic disturbance. The patient has no limits on his/her activity level and in general is to be considered in good or excellent health; 2. Class II—Mild-to-moderate systemic disturbance caused either by the condition to be treated surgically or by other pathophysiological processes. The disease processes are stable or medically controlled and they are not functionally limiting. Examples: tightlycontrolled insulin or non-insulin dependent diabetes; stable asthma; symptomatic hypertension; controlled thyroid disease; smoker; obesity; or severe anxiety; 3. Class III—Severe systemic disturbance or disease from whatever cause, even though it may not be possible to define the degree of disability with finality. Activity is significantly limited by the disease, but is not totally incapacitating. The patient may easily decompensate under stress. Examples: severe asthma; poorly controlled diabetes mellitus; angina, especially if unstable or frequent; or status post (S/P) myocardial infarction of cerebral vascular accident (CVA) less than six (6) months ago; 4. Class IV—Indicative of the patient with severe systemic disorder that is a constant threat to life and not always correctable by the operative procedure. Functionally incapacitating; a totally unstable patient who is in and out of lethal states. Examples: unstable angina; congestive heart failure/chronic obstructive pulmonary disease (CHF/COPD) requiring supplemental oxygen (O2) or wheel-chair confinement, uncontrolled systemic disease (diabetes mellitus); or symptomatic dysrhythmias; or 5. Class V—The moribund patient who has little chance of survival but is submitted to operation in desperation. A hospitalized patient of the expectant category. (B) Analgesia—The diminution or elimination of pain. (C) Anesthesiologist—A physician licensed by the Missouri State Board of Registration for the Healing Arts in accordance with Chapter 334, RSMo, with privileges in general anesthesia at an institution accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or the American Osteopathic Association (AOA). (D) Certified registered nurse anesthetist— A licensed registered professional nurse recognized as an advanced practice nurse by the Missouri State Board of Nursing, who is certified to administer anesthesia by a nationally recognized certifying body approved by the Missouri State Board of Nursing in accordance with Chapter 335, RSMo. (E) 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. (F) Deep sedation/general anesthesia permit—A document issued by the Missouri Dental Board to a dentist that allows the dentist to administer deep sedation/general anesthesia. (G) Deep sedation/general anesthesia site certificate—A document issued by the Missouri Dental Board to a specific dental office where deep sedation/general anesthesia is administered. (H) Dental office—A facility where dentistry is practiced in accordance with the provisions of section 332.071, RSMo. (I) Dentist—One who is currently licensed to practice as a dentist in Missouri and is ultimately responsible for the sedation procedure of a dental patient under his/her care. (J) Dentist-in-charge—A dentist duly licensed by the board to practice at a facility in which sedation anesthesia services are to be offered and who assumes the responsibility to assure that the facility is properly equipped and the sedation team is properly trained. (K) Enteral minimal sedation—A minimal level of sedation by a technique of administration in which the drug is absorbed through the gastrointestinal tract or oral mucosa. Enteral minimal sedation is not enteral moderate sedation, parenteral moderate sedation, deep sedation, or general anesthesia. (L) Enteral moderate sedation—A minimal-to-moderate level of sedation by a technique of administration in which the drug is absorbed through the gastrointestinal tract or oral mucosa (i.e., oral, rectal, or sublingual). Enteral moderate sedation is not parenteral moderate sedation, deep sedation, or general anesthesia. Drugs used for enteral moderate sedation shall not exceed one and one-half (1.5) times the maximum recommended dose (MRD) for a period of twelve (12) hours before and after the patient appointment (i.e., MRD for Triazolam is one-half milligram (0.5 mg). One and one-half (1.5) times the MRD for Triazolam is three-fourths milligram (0.75 mg) total dose for one (1) appointment). (M) Enteral moderate sedation permit—A document issued by the Missouri Dental Board to a dentist that allows the dentist to administer enteral moderate sedation. (N) Facility inspection—An inspection confirming the adequacy of the dental office to provide enteral, parenteral, or pediatric moderate sedation and/or deep sedation/general anesthesia by consultants or other personnel appointed by the board to ensure public safety. (O) 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. (P) Incremental dosing—Administration of multiple doses of a drug until a desired effect is reached, but not to exceed the maximum recommended dose (MRD). (Q) Inhalation—A technique of administration in which a gaseous or volatile agent is introduced into the lungs and whose primary effect is due to absorption through the gas/blood interface. (R) Local anesthesia—The elimination of sensation, especially pain, in one (1) part of the body by the topical application or regional injection of a drug. Note: Although the use of local anesthetics is the foundation of pain control in dentistry and has a long record of safety, dentists must be aware of the maximum, safe dosage limits for each patient. (S) Maximum recommended dose (MRD)—Maximum United States Food and Drug Administration (FDA) recommended dose of a drug, as printed in FDA-approved labeling for unmonitored home use. Drugs used for enteral moderate sedation shall not exceed one and one-half (1.5) times the maximum recommended dose (MRD) for a period of twelve (12) hours before and after the patient appointment (i.e., MRD for Triazolam is one-half milligram (0.5 mg). One and one-half (1.5) times the MRD for Triazolam is three-fourths milligram (0.75 mg) total dose for one (1) appointment). (T) Minimal sedation (Anxiolysis)—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. Note: In accord with this particular definition, the drug(s) and/or techniques used should carry a margin of safety wide enough never to render unintended loss of consciousness. Further, patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of minimal sedation. When the intent is minimal sedation for adults, the appropriate initial dosing of a single enteral drug is no more than the maximum recommended dose (MRD) of a drug that can be prescribed for unmonitored home use. The use of preoperative sedatives for children (aged twelve (12) and under) except in extraordinary situations must be avoided due to the risk of unobserved respiratory obstruction during transport by untrained individuals. Children (aged twelve (12) and under) can become moderately sedated despite the intended level of minimal sedation; should this occur, the guidelines for moderate sedation apply. Nitrous oxide/oxygen may be used in combination with a single enteral drug in minimal sedation. Nitrous oxide/oxygen when used in combination with sedative agent(s) may produce minimal, moderate, or deep sedation or general anesthesia. (U) Moderate sedation—A drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Generally, no interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Note: In accord with this particular definition, the drugs and/or techniques used should 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. Further, a patient whose only response is reflex withdrawal from a painful stimulus is not considered to be in a state of moderate sedation. The following definitions apply to the administration of moderate or greater sedation: 1. Titration—Administration of incremental doses of a drug until a desired effect is reached. Knowledge of each drug’s time of onset, peak response, and duration of action is essential to avoid over sedation. Although the concept of titration of a drug to effect is critical for patient safety, when the intent is moderate sedation, the dentist must know whether the previous dose has taken full effect before administering an additional drug increment; and 2. Supplemental dosing—During moderate 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 (0.5) 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 total aggregate dose must not exceed one and one-half (1.5) times the MRD on the day of treatment. (V) Moderate sedation site certificate—a document issued by the Missouri Dental Board to a specific dental office where enteral or parenteral moderate sedation is administered. (W) On-site evaluation—A performance evaluation of the competency of the sedation team by consultants appointed by the board to ensure public safety. (X) Operating dentist—The Missouri licensed dentist who is performing the dental procedure on a sedated patient. The operating dentist is ultimately responsible for all patient care, including sedation, regardless of whether the care is rendered personally by the dentist, or by another qualified sedation provider. (Y) Parenteral moderate sedation—A level of minimal to moderate sedation by a technique of administration in which the drug bypasses the gastrointestinal tract, i.e., routes of administration: intravenous (I.V.), intramuscular (I.M.), intranasal (I.N.), subcutaneous (S.C.), submucosal (S.M.), or intraosseous (I.O.). Parenteral moderate sedation is not deep sedation or general anesthesia. (Z) Parenteral moderate sedation permit— A document issued by the Missouri Dental Board to a dentist that allows the dentist to administer parenteral moderate sedation. (AA) Pediatric moderate sedation permit— A document issued by the Missouri Dental Board to a dentist to administer moderate sedation to pediatric patients as defined in subsection (1)(BB) of this rule. (BB) Pediatric patient—A patient aged twelve (12) or under. The use of preoperative sedatives for children (aged twelve (12) and under) except in extraordinary situations must be avoided due to the risk of unobserved respiratory obstruction during transport by untrained individuals. Children (aged twelve (12) and under) can become moderately sedated despite the intended level of minimal sedation; should this occur, the guidelines for moderate sedation apply. (CC) Qualified sedation provider—Any of the following who have satisfied the provisions of this rule: 1. A currently licensed dentist in Missouri with a valid permit to administer enteral, parenteral, or pediatric moderate sedation; 2. A currently licensed anesthesiologist; or 3. A currently licensed certified registered nurse anesthetist. (DD) Sedation team—Those individuals, including the qualified sedation provider and operating dentist, qualified pursuant to 20 CSR 2110-4.030(7)(B) involved with the treatment and/or monitoring of a sedation patient. (EE) Time-oriented anesthesia record— Documentation at appropriate time intervals of drugs, doses, and physiologic data obtained during patient monitoring. (FF) Transdermal—A technique of administration in which the drug is administered by patch or iontophoresis through skin. (GG) Transmucosal—A technique of administration in which the drug is administered across mucosa such as intranasal, sublingual, or rectal. (2) The following words and terms, when used in this chapter, shall have the following meanings. (A) Continual—Repeated regularly and frequently in a steady succession. (B) Continuous—Prolonged without any interruption at any time. (C) Immediately available—On site in the facility and available for immediate use. AUTHORITY: sections 332.031 and 332.361, RSMo 2000, and section 332.071, RSMo Supp. 2012.* This rule originally filed as 4 CSR 110-4.010. Original rule filed Sept. 15, 2004, effective April 30, 2005. Moved to 20 CSR 2110-4.010, effective Aug. 28, 2006. Rescinded and readopted: Filed July 26, 2012, effective Feb. 28, 2013. *Original authority: 332.031, RSMo 1969, amended 1981, 1993, 1995; 332.071, RSMo 1969, amended 1976, 1995, 2003, 2004, 2006; and 332.361, RSMo 1969, amended 1981.