VOLUME 37, ISSUE 17
ISSUE DATE: SEPTEMBER 6, 2005
RULE ADOPTIONS
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
NEW JERSEY STATE BOARD OF DENTISTRY

37 N.J.R. 3432(a)

Adopted Amendment: N.J.A.C. 13:30-5.1
Adopted New Rules: N.J.A.C. 13:30-8.1A and 8.4

Continuing Dental Education Requirements for Dentists; Deep Sedation; Sleep Dentistry; Enteral Sedation with Single or Multiple Pharmacological Agents

Proposed: August 16, 2004 at 36 N.J.R. 3629(a).

Adopted: May 4, 2005, by the New Jersey State Board of Dentistry, Sally-Jo Placa, D.M.D., President.

Filed: August 11, 2005 as R. 2005 d.304, with substantive changes not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).

Authority: N.J.S.A. 45:6-1 and 45:1-15.1.

Effective Date: September 6, 2005.

Expiration Date: August 16, 2010.

Federal Standards Statement

A Federal standards analysis is not required because the adopted amendment and new rules are governed by N.J.S.A. 45:6-1 et seq., and are not subject to any Federal standards or requirements

Full text of the adoption follows (additions to proposal indicated in boldface with asterisks *thus*; deletions from proposal indicated in brackets with asterisks *[thus]*):

13:30-5.1 Continuing dental education requirements for dentists

(a)-(h) (No change.)

(i) Licensees who complete the required 20 hours of continuing education credit pursuant to the requirements for parenteral conscious sedation and/or general anesthesia permit holders as set forth in N.J.A.C. 13:30-8.2 and 8.3 shall be given credit for all 20 hours so completed. Licensees who complete the required 20 hours of continuing education credit pursuant to the requirements for enteral sedation permit holders as set forth in N.J.A.C. 13:30-8.4 shall be given credit for all 20 hours so completed.

(j)-(l) (No change.)

13:30-8.1A Deep sedation; sleep dentistry

(a) No dentist shall administer, dispense or prescribe any pharmacological agent which shall cause a patient to lapse into deep sedation unless the dentist possesses a general anesthesia (GA) permit issued by the State Board of Dentistry pursuant to N.J.A.C. 13:30-8.3 and the dentist complies with all requirements set forth in N.J.A.C. 13:30-8.3. For purposes of this section, "deep sedation" means an induced state of depressed consciousness accompanied by partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or to respond purposefully to physical stimulation or verbal command, which is produced by pharmacological or non-pharmacological agents or a combination thereof.

(b) A dentist who uses or advertises the terms "sleep," "sleep dentistry," "sleeplike-state," or any similar words or combinations thereof in connection with the provision of dental services shall be considered to be inducing deep sedation as defined in (a) above.

13:30-8.4 Enteral sedation with single or multiple pharmacological agents

(a) For purposes of this section, the following words and terms shall have the following meanings, unless the context clearly indicates otherwise.

"Anxiolysis" means the diminution or elimination of anxiety.

"Enteral" means any method for the introduction of pharmacological agents, including oral, sublingual, rectal *[, nasal]* or any other method which relies upon absorption through the *[skin]* *gastrointestinal tract or oral mucosa and introduction through the nasal passages* or any other mucous membrane.

"Enteral sedation with single or multiple pharmacological agents" means the administering, dispensing or prescribing of one or more pharmacological agents to be used concurrently *or sequentially* for the purposes of causing *anxiolysis and* a depressed level of consciousness *[and/or anxiolysis]*, but not a loss of consciousness. For purposes of this section, pharmacological agents shall include any non-parenteral agent, and shall exclude any agent introduced by intravenous, intramuscular, subcutaneous, submucosal, or inhalation routes, including nitrous oxide inhalation analgesia.

(b) *[No]* *As of July 1, 2006, no* dentist shall administer, dispense or prescribe enteral sedation with single or multiple pharmacological agents (hereinafter "enteral sedation") unless the minimum standards of training and procedure set forth in this section are satisfied.

(c) *[No]* *As of July 1, 2006, no* dentist shall administer, dispense or prescribe enteral sedation unless such dentist possesses an enteral sedation permit issued by the State Board of Dentistry, except as provided in (d) below, for a specified practice location which shall be renewed biennially. A dentist shall obtain a separate enteral sedation permit for each practice location at which enteral sedation is administered, dispensed or prescribed.

(d) A dentist who holds a current general anesthesia (GA) permit issued by the Board pursuant to N.J.A.C. 13:30-8.3, or a current parenteral conscious sedation (PCS) permit issued by the Board pursuant to N.J.A.C. 13:30-8.2, shall be authorized to use enteral sedation and shall not be required to apply for an enteral sedation permit pursuant to this section, provided the dentist complies with all requirements set forth in N.J.A.C. 13:30-8.3 or 8.2.

(e) *[No]* *As of July 1, 2006, no* dentist may administer, dispense or prescribe any pharmacological agent in a dosage which has the potential to inhibit patient response beyond anxiolysis without the possession of an enteral sedation permit issued pursuant to this section

(f) A dentist applying for a Board permit to administer, dispense or prescribe enteral sedation shall complete an application as provided by the Board. The dentist shall submit as part of a completed application, a certification verifying that the dentist has completed Board approved post-doctoral course work at an accredited dental school *, in a hospital-based program* or in a college or university clinical setting sufficient to prepare a dentist to satisfactorily use enteral sedation safely and effectively. Such course work shall consist of a minimum of 40 hours of didactic training in basic enteral sedation, physical evaluation, recognition and management of complications and emergencies, and patient monitoring.

(g) A dentist applying for an enteral sedation permit shall be exempt from the course work requirements set forth in (f) above provided the applicant submits proof of having satisfied one of the following conditions:

1. The dentist holds a current general anesthesia (GA) permit issued by the Board pursuant to N.J.A.C. 13:30-8.3;

2. The dentist holds a current parenteral conscious sedation (PCS) permit issued by the Board pursuant to N.J.A.C. 13:30-8.2;

3. The dentist has completed an accredited general practice residency, or has graduated from a post-doctoral training program within the three years immediately preceding application. The general practice residency or the post-doctoral training program shall include a minimum of 60 hours of training in general anesthesia or conscious sedation; or

4. The dentist has completed an accredited general practice residency, or has graduated from a post-doctoral training program more than three years preceding application, and has completed a minimum of 20 hours of didactic training in basic enteral sedation, physical evaluation, recognition and management of complications and emergencies, and patient monitoring within the three years immediately preceding application. The general practice residency or the post-doctoral training program shall include a minimum of 60 hours of training in general anesthesia or conscious sedation.

(h) An applicant for an enteral sedation permit shall obtain emergency training by completing "Basic Life Support: Course C" of the American Heart Association or its equivalent or a course in Advanced Cardiac Life Support or its equivalent and shall maintain current certification in such course. The applicant shall furnish proof of this training and certification to the Board upon application for an enteral sedation permit and proof of recertification upon biennial renewal of the permit.

(i) A dentist may administer, dispense or prescribe enteral sedation only in a dental treatment setting and shall:

1. Provide for appropriate monitoring of the patient during the administration of the enteral sedation;

2. Be prepared to manage any reasonably foreseeable complications *, including, but not limited to, the capability of rescuing the patient from a deeper level of sedation than intended*; and

3. Be in attendance immediately in the operatory *[until]* *to ensure* the patient's protective reflexes *[have returned]* *are sufficient to protect the patient's airway and the patient can breathe spontaneously and without assistance* and *until* the patient is determined by the dentist to be *appropriately* stable *[and ambulatory]* *for discharge*.

(j) An applicant for an enteral sedation permit shall certify to the Board upon application for a permit and upon biennial renewal of the permit that the dentist employs a licensed health care professional who will be present in the office, trained to assist in the monitoring of the patient whenever enteral sedation is employed. The applicant shall further certify such health care professional is trained in, and capable of, monitoring vital signs and assisting in emergency procedures and that the health care professional maintains current certification in "Basic Life Support: Course C" or its equivalent or in Advanced Cardiac Life Support or its equivalent.

(k) An applicant for an enteral sedation permit shall certify as part of the application for a permit and upon biennial renewal of the permit that he or she possesses basic equipment and supplies to deal with emergency situations. The permit holder's facility shall contain the following readily accessible and properly operating equipment:

1. Suction equipment capable of aspirating gastric contents from the mouth and pharynx;

2. A portable oxygen delivery system including full face masks and a bag valve-mask combination with appropriate connectors capable of delivering positive pressure and oxygen-enriched patient ventilation;

3. A blood pressure cuff (sphygmomanometer) of appropriate size and a stethoscope or equivalent monitoring devices;

4. A pulse oximeter or equivalent device;

5. An emergency drug kit; and

6. *[Back-up]* *Emergency backup* lighting, suction and a pulse oximeter or equivalent device *[operated by battery and/or generator]*.

(l) Prior to the administration, dispensing or prescribing of enteral sedation, a physical evaluation of the patient shall be conducted by the permit holder and a complete medical history shall be obtained which shall include the patient's previous medications, allergies and sensitivities. The patient history shall be maintained in the patient's record for a period of not less than seven years. Specific notations on the use of enteral sedation shall be kept as part of every patient record and shall include the type of agent, the dosage, the duration of sedation, the patient's vital signs during administration *and recovery*, and any untoward reaction.

(m) A dentist who holds an enteral sedation permit shall certify to the Board upon biennial license renewal that the holder has completed at least 20 hours during the previous two-year period in continuing education courses, consistent with the requirements set forth in N.J.A.C. 13:30-5.1, in at least one of the following areas:

1. Physiology;

2. Pharmacology;

3. Patient evaluation;

4. Patient monitoring; and/or

5. Medical emergencies.

(n) Any designee of the Board shall be authorized during ordinary business hours to enter and inspect any dental office for the purpose of enforcing the provisions of this section.

(o) A dentist who utilizes the services of an enteral sedation permit holder or an M.D. or D.O. who is a member of the anesthesiology staff of an accredited hospital or who is authorized to perform anesthesia services by the Board of Medical Examiners pursuant to N.J.A.C. 13:35-4A shall not be deemed to be administering enteral sedation, provided that the enteral sedation permit holder, M.D. or D.O. remains present during the administration of the enteral sedation and bears full responsibility during the entire procedure until the patient has recovered fully and has been discharged.

(p) An enteral sedation permit holder invited by a dentist to provide enteral sedation services at a specific location shall bear full responsibility for compliance with all provisions of this section including the minimum requirements for assisting staff and equipment set forth in (j) and (k) above. When an enteral sedation permit holder utilizes mobile equipment and supplies to administer enteral sedation pursuant to this section, the mobile equipment and supplies of the permit holder shall be inspected by the Board or its designee not less than once every three years. "Mobile equipment and supplies," for purposes of this subsection, means any equipment and/or supplies which are transported and used by a permit holder to administer enteral sedation in one or more locations. When more than one permit holder utilizes the mobile equipment and supplies, it shall be the responsibility of the permit holder using the equipment and supplies to ensure that the mobile equipment and supplies satisfy the requirements of this section as set forth in (k) above prior to the administration of enteral sedation.



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