Mo. Code Regs. Ann. tit. 20, § 2110-4.030
PURPOSE: This rule provides for the requirements and guidelines dentists are required to follow in the administration of sedative drugs.
(1) Introduction.
(C) The goals of moderate sedation are—
to enable the practitioner to provide quality treatment;
leaves the office in a state of consciousness as close to normal for that patient as possible; and
response to treatment.
(2) Patient Records.
(A) The patient’s record shall provide a legible database that aids in treatment planning and selection of the sedation technique and shall furnish the following:
1. Database—
work);
applicable;
person to notify in event of emergency; and 20 CSR 2110-4
telephone number;
2. Medical history—
ry of the present illness or a brief statement about the patient’s problem; and
review including, but not limited to:
five (5) years;
tion, nonprescription, homeopathic): dosages, intervals, and recent changes;
ders, or abnormalities;
tions;
culties; (VIII) Previous hospitalizations; and
interrogative clarification of positive responses:
virus (HIV);
ders; and
3. Core physical examination—
stature, posture, and relative ambulatory ability;
ness, responsiveness, and verbal ability;
and rhythm, and respiration rate; and
present problem.
(3) Pre-Operative Patient Evaluation and Selection. AND INSURANCE
(A) Patients who are administered moderate sedation must be suitably evaluated to include, but not be limited to the following:
database by the dentist to determine that data pertaining to all of the following are present:
informed consent; and
telephone number;
history with opportunity for interrogative clarification by the dentist. The record must indicate that the dentist reviewed the medical history;
physical examination. The record must indicate the dentist reviewed the findings;
tions used by the patient, both prescription and non-prescription. The record must indicate the dentist reviewed the medication inventory;
Anesthesiologists classification; and
cians of record when indicated.
(ASA) classifications must be documented and substantiated.
(ASA) classifications:
logic, 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.
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.
bance 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; status post (S/P) myocardial infarction of cerebral vascular accident (CVA) less than six (6) months ago.
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.
has little chance of survival but is submitted to operation in desperation. A hospitalized patient of the expectant category.
(5) Informed Consent.
(B) All of the following requirements for informed consent must be satisfied and documented prior to administration of moderate sedation:
advised of the specific procedure inducing enteral, parenteral, or pediatric moderate sedation;
advised of the risks associated with the delivery of enteral, parenteral, or pediatric moderate sedation;
advised of the options to the delivery of the enteral, parenteral, or pediatric moderate sedation;
advised that moderate sedatives given by the enteral route must not exceed one and onehalf (1.5) times the maximum recommended dose (MRD);
be advised that unforeseen circumstances can occur and the dentist and the sedation team need permission in advance to change the plan of treatment if it is deemed in their professional judgment to be in the best interest of the patient;
afforded the opportunity to have concerns and questions addressed by the dentist; and
must be documented.
(6) Sedation Documentation Requirements.
(B) At a minimum, the anesthetic record must contain the following:
provider and sedation team members (dentist, anesthetist, assistants);
pulse rate, and percent of O2 saturation):
tions (to include the local anesthesia); and
minutes throughout the procedure;
sia procedure and the operative procedure;
route of administration, and flow rates);
dispensed, a copy of the prescription or a notation describing the medication should be in the patient’s chart with the instructions for use;
(all pertinent data, vital signs, and/or medications, etc.); and
(7) Monitoring Procedures.
(B) For the purpose of supervising and monitoring a moderately sedated patient, members of the sedation team shall be—
sedated patient;
Association’s Basic Life Support for the Healthcare Provider (BLS) or an equivalent certification approved by the Missouri Dental Board. Board-approved courses shall meet the American Heart Association guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) and provide written and manikin testing on the course material by an instructor who is physically present with the students. Online only courses will not be accepted to satisfy the BLS requirement or Advanced Cardiopulmonary Life Support (ACLS);
sedation from a board-approved course provider (certification of non-dentists shall be approved by their respective licensing authorities); and
gency response incident to the use of enteral, parenteral, and pediatric moderate sedation, including the use of resuscitation equipment and emergency medications.
(D) Monitoring criteria include:
or blood shall be continually evaluated. Oxygen saturation must be evaluated continuously by pulse oximetry;
excursions and/or auscultation of breath sounds; and
pressure and pulse and thereafter, as appropriate.
(E) Monitoring methods can be divided into mechanical and non-mechanical means.
1. Non-mechanical means shall include:
rhythm;
versation is an excellent gauge to depth of sedation. Is it quick, appropriate, and clear, or is it difficult to obtain, inappropriate and markedly slurred;
2. Mechanical means shall include:
cardiogram (ECG) and temperature monitor, if appropriate.
(8) Discharge Assessment and Procedures.
(C) The patient must be continually monitored during the recovery period and discharged only when the following criteria are met:
ry and stable;
and satisfactory;
tive reflexes intact;
quate;
precautionary assistance;
patient, the pre-sedated level of responsiveness should be achieved;
only be discharged after a two- (2-) hour observation period from the last dose of reversal agent and must meet the usual discharge criteria;
sion is confirmed; and
reviewed with and signed by the individual responsible for post-discharge supervision.
(9) Personnel.
(10) Facilities and Equipment.
(E) Equipment shall include:
(enteral sedation) and catheter suction (parenteral sedation);
system accommodating both adult and pediatric patients (if pediatric patients are treated);
prevent accidental administration of the wrong gas and equipped with a fail-safe mechanism;
ate accessories;
lator is recommended).
(G) Backup systems shall include:
assistance;
intensity to complete any procedure; and
any procedure.
(11) Resuscitation Equipment.
(C) All moderate sedation permit holders should have immediate access to—
1. Airway and ventilation equipment— AND INSURANCE
sizes to accommodate all sedated patients;
itive pressure;
emergency cricothyroidotomy; and
(I.V.) drug administration; and
section (15).
(D) In addition, parenteral moderate sedation permit holders should have immediate access to—
establishment of an I.V. route, and appropriate fluids;
mixing or dilution of drugs;
administration.
(12) Site Certificate.
(B) The board may require a facility requesting a site certificate for moderate sedation undergo a facility inspection. Facility inspections will be conducted by boardappointed consultants. A facility inspection will be deemed satisfactory when all criteria in subsections (12)(C) and (D) of this rule have been satisfactorily met.
sedation permit applicants shall receive an on-site evaluation.
applicants may receive an on-site evaluation.
facility where moderate sedation is administered in order to verify compliance with the minimum requirements of the moderate sedation rule.
(C) The facility shall be properly maintained and equipped. The dentist-in-charge shall verify via notarized affidavit the following exists and is in good working order:
gency medical personnel to dental facility and operatories used for sedation;
enables appropriate monitoring and emergency response;
and contains drugs and equipment of appropriate sizes to resuscitate a non-breathing, unconscious patient;
priate face masks;
cient intensity to complete any procedure;
cedure; and
(D) Sedation team members shall be capable of safely executing procedures associated with enteral and/or parenteral and pediatric moderate sedation. The dentist-in-charge shall verify the following via notarized affidavit:
parenteral, or pediatric moderate sedation is a qualified sedation provider as defined in subsection (1)(CC) of 20 CSR 2110-4.010 who maintains current certification and licensure in their field of practice;
tained as set forth in section (2) of this rule;
are employed as set forth in sections (3) and (4) of this rule. The dentist-in-charge and permitted dentists should be prepared to demonstrate knowledge of physical evaluation of patients, American Society of Anesthesiologists (ASA) classifications, and their application to appropriate patient selection;
lized as set forth in section (5) of this rule;
appropriately maintained as set forth in section (6) of this rule;
sedated patients is accomplished by sedation team members through recovery until discharge as set forth in section (7) of this rule;
for the management and treatment of sedated patients; and
determine when a patient can be safely discharged and appropriate post-operative instructions are given to responsible individuals who will supervise the sedated patient after discharge as set forth in section (8) of this rule.
(E) The sedation team shall be capable of responding to emergencies incident to the administration of enteral, parenteral, or pediatric moderate sedation. The sedation team should be prepared for the following emergencies and be competent in simulated responses:
col;
(13) Board-Approved Courses.
(A) A course satisfying the educational requirements for an enteral moderate sedation permit shall include, but not be limited to:
ation;
facilities;
sedatives and reversal agents;
exceed one and one-half (1.5) times the recommended dose of a sedative by the manufacturer.
sedated patient during treatment and recovery;
management and treatment of sedated patients;
cies incident to administration of moderate sedation;
experiences with direct clinical experience on a minimum of three (3) patients in a group of dentists/students no greater than five (5);
sedated patient and how to rescue that patient until they recover;
(DEA) record keeping; and
such as the American Dental Society of Anesthesiology (ADSA) moderate sedation fellowship exam or other board-approved test measuring knowledge required of a dentist essential for safe and efficient moderate sedation of dental patients.
(B) The sedation monitoring course content shall include, but not be limited to:
not limited to drug interactions with sedatives;
pertains to the sedated patient;
tial data and screening medical histories;
patient selection;
facilities;
sedated patient during treatment and recovery;
management and treatment of sedated patients;
common emergencies incident to administration of moderate sedation; and
edge necessary for safe, effective monitoring of a sedated dental patient.
(14) References.
(15) Emergency Drugs.
(A) Minimum required emergency drugs for enteral sedation.
(50%), (cake icing, candy, orange juice);
and
(B) Minimum required emergency drugs for parenteral sedation.
(50%), (cake icing, candy, orange juice);
mum);
(C) Suggested but not required emergency drugs.
drugs);
injectables);
________1. I understand that the purpose of moderate sedation is to more comfortably receive necessary care. Moderate sedation is not required to provide the necessary dental care. (See #4 options.)
________2. I understand that moderate sedation is a drug-induced state of reduced awareness and decreased ability to respond. Moderate sedation is not sleep from which I can be easily awakened. My ability to respond normally returns when the effects of the sedative wear off.
________3. I understand that my moderate sedation will be achieved by the following route: ________Oral Administration: I will take a pill approximately _______ minutes before my appointment. The sedation will last approximately to hours. Patients like oral sedation because they do not need an “I.V.” line. However the level of sedation is less predictable than with “I.V.” sedation.
________Intravenous (I.V.) Administration: The anesthesia provider will inject the sedative. The length of sedation may be shorter and the level more predictable than with oral sedation. The I.V. sedation will last approximately ____ to ________ hours.
________4. I understand that the options to moderate sedation are:
cedure is performed under local anesthetic with the patient fully aware. 20 CSR 2110-4
monly called laughing gas, nitrous oxide provides relaxation but the patient is still generally aware of surrounding activities. Its effects can be reversed in five (5) minutes with oxygen.
called deep sedation, a patient under general anesthetic has no awareness and must have their breathing temporarily supported. General anesthesia is more appropriate for longer procedures lasting three (3) or more hours.
________5. I understand that there are risks or limitations to all procedures. For sedation these include: ________(Oral Sedation) Inadequate sedation with initial dosage may require the patient to undergo the procedure without full sedation or delay the procedure for another time. Due to unpredictable patient response, it is not recommended that oral sedatives be given in successive or additive doses. ________An atypical reaction to sedative drugs that may require emergency medical attention and/or hospitalization. ________Inability to discuss treatment options with the doctor should the circumstance require a change in treatment plan.
________6. If, during the procedure, a change in treatment is required, I authorize the dentist and the sedation team to make whatever change they deem in their professional judgment is necessary.
________7. I have had the opportunity to discuss moderate sedation and have my questions answered by sedation team members including the dentist, if I so desire.
________8. I hereby consent to moderate sedation in conjunction with my dental care.
________________ __________ _________ Patient/Guardian Date Witness
AUTHORITY: sections 332.031 and 332.361, RSMo 2000, and section 332.071, RSMo Supp. 2012.* This rule originally filed as 4 CSR 110-4.030. Original rule filed Sept. 15, 2004, effective April 30, 2005. Moved to 20 CSR 2110-4.030, effective Aug. 28, 2006. Amended: 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. AND INSURANCE