N.J. Admin. Code § 13:30-8.4
Current through Register Vol. 56, No. 8, April 15, 2024
Section 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 or any other method which relies upon absorption through the 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, 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 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 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 13:30-8.3, or a current parenteral conscious sedation (PCS) permit issued by the Board pursuant to 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 13:30-8.3 or 8.2.(e) 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 13:30-8.3;2. The dentist holds a current parenteral conscious sedation (PCS) permit issued by the Board pursuant to 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; or4. 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 the American Heart Association Basic Life Support for Healthcare Professionals, or its equivalent, and 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 medications for purposes of dental treatment and its management 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, being capable of rescuing the patient from a deeper level of sedation than intended and from a level other than anxiolysis that has produced sedation; and3. Be in attendance immediately in the operatory to ensure the patient's protective reflexes 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 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 the American Heart Association course in Basic Life Support for Healthcare Professionals, 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, as required by the Board, which shall be readily accessible and maintained in good operating condition. In addition to the equipment and supplies set forth at N.J.A.C. 13:30-8.26, 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. Emergency suction device;3. Mouth props (assorted adult and pediatric sizes);4. Blood pressure monitoring device;5. A pulse oximeter or its equivalent;6. An emergency drug kit consisting of, at a minimum, the following: iv. Vasodilators (coronary);v. Anti-bradicardic agents;vii. A muscle relaxant for treatment of laryngospasm;ix. A narcotic antagonist;xv. Benzodiazepine antagonist;xvi. Anti-arrhythmic (for example, lidocaine, amiodarone);xviii. Nitroglycerine (tablets, paste, or spray); and7. Battery-powered clocks or watches; and8. Yankauer type suction tips and catheter suction.(l) Prior to the administration, dispensing, or prescribing of enteral sedation, the permit holder shall conduct a physical evaluation of the patient, review the patient's up-to-date medical history, which shall include any changes and any medications, including natural and homeopathic 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 contemporaneous notations on the use of enteral sedation shall be kept as part of every patient record and shall include the agents utilized, the dosage, the duration of sedation, the patient's vital signs during administration and recovery, and any untoward reaction. The patient record, including medical history, shall be maintained in accordance with N.J.A.C. 13:30-8.7.(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 13:30-5.1, in at least one of the following areas:4. Patient monitoring; and/or(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. 13:35-4Ashall 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 through patient discharge, 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 at (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, drugs, and supplies of the permit holder shall be inspected by the Board or its designee not less than once every three years. "Mobile equipment, drugs, and supplies," for purposes of this subsection, means any equipment, drugs, 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, drugs, and supplies, it shall be the responsibility of the permit holder using the equipment, drugs, and supplies to ensure that the mobile equipment and supplies satisfy the requirements of this section as set forth at (k) above prior to the administration of enteral sedation.N.J. Admin. Code § 13:30-8.4
Former 13:30-8.4 repealed by R.2000 d.147, effective 4/3/2000.
See: 32 N.J.R. 215(a), 32 N.J.R. 1221(a).
New Rule, R.2005 d.304, effective 9/6/2005.
See: 36 N.J.R. 3629(a), 37 N.J.R. 3432(a).
Amended by R.2011 d.041, effective 2/7/2011.
See: 42 N.J.R. 2217(a), 43 N.J.R. 310(a).
In (b), (c), and (e), substituted "No" for "As of July 1, 2006, no".Amended by 53 N.J.R. 619(c), effective 4/19/2021